| AstraZeneca |
00310183030 |
Name- Fasenra Pen (benralizumab) Dosage- 30mg/mL solution Form- Injection: In a single dose pre-filled autoinjector |
2019-10-28 |
4895.7400 |
AstraZeneca will engage 20 sales representative(s) to cover the state of California. Patient brochures, clinical data, dosing/administration guides, and samples may be left behind in offices for informational purposes. In addition to sales representative promotion, Fasenra® commercials are televised on the national broadcast networks. AstraZeneca provides online resources via FasenraHCP.com for US healthcare professionals and Fasenra.com for patients and consumers. Patients may register for the FASENRA 360 support program via the website which will enroll them in a digital relationship marketing program to receive materials such as disease state education, patient brochures, and dosing reminders. The FASENRA® patient savings program for eligible commercially insured patients will be available for patients in California and can be found on Fasenra.com. FASENRA® is currently marketed in 47 countries. |
None |
1000000 |
None |
None |
None |
None |
None |
None |
FASENRA® (Benralizumab) is indicated as an add-on maintenance treatment of patients 12 years and older with severe eosinophilic asthma. FASENRA® (Benralizumab) is not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus. The reason for the blank fields related to acquisition of the product (columns 10-13) is due to the fact that AstraZeneca did not acquire the drug. |
None |
| Acorda Therapeutics, Inc. |
10144034260 |
INBRIJA (levodopa inhalation powder) |
2019-02-25 |
950.0000 |
o |
INBRIJA™ is currently only approved in the United States and is under review of the CHMP in Europe. INBRIJA is a unique drug-device combination, consisting of a proprietary inhaled formulation of levodopa delivered by a breath-actuated inhaler. INBRIJA is the first and only inhaled levodopa formulation to treat symptoms of OFF periods as needed in patients taking a carbidopa/levodopa regimen. o |
Acorda markets INBRIJA in the U.S. through our own specialty sales force. The marketing plan includes multiple comprehensive education and training initiatives, provided by our specialty sales force and account directors, for all stakeholders including health care practitioner (HCP) offices, patients, caregivers and Specialty Pharmacies. This includes training materials such as demonstration kits for HCP offices and specialty pharmacies and start kits for patients. People with Parkinson’s can suffer from cognitive challenges which make it very difficult for them to navigate the complex health insurance environment. Acorda has an active patient hub in place (Prescription Support Services) to assist patients in that health insurance navigation process to support access to INBRIJA. Our internal team of Regional Reimbursement Directors work directly with HCP offices on specific patient cases to help gain access through their insurance. Acorda offers a free sampling program to help patients and physicians evaluate effectiveness and tolerability, and a free drug Patient Assistance Program for uninsured patients with demonstrated financial hardship who satisfy eligibility criteria. Acorda provides co-pay assistance for commercially insured patients. INBRIJA is a specialty drug distributed through a closed network of specialty pharmacies under contract with Acorda. o |
When considering the price of INBRIJA one must consider that INBRIJA required over 20 years to develop, from the time the inhaled ARCUS technology was invented at MIT at the lab of Bob Langer. The ARCUS technology transforms molecules in a light, dry powder allowing delivery of an effective therapeutic dose of INBRIJA through the lungs. INBRIJA is a major innovation; it is one of only three pulmonary-delivered treatments approved for a non-pulmonary indication. The innovation of ARCUS – the dry powder inhalation system – allows for pulmonary delivery that bypasses the challenges that can be associated with oral levodopa that can lead to variability in absorption, contributing to OFF periods. |
None |
350000 |
None |
None |
2014-10-22 |
525000000.0000 |
None |
| AMAG Pharmaceuticals, Inc. |
64011070104 |
Vyleesi (bremelanotide Injection) 1.75 mg/0.3mL |
2019-08-19 |
899.0000 |
Promotion of Vyleesi to physicians or other health professionals will be limited to AMAG's sales force, digital media, and relevant medical conferences. Direct to consumer media will be used to help create awareness of Vyleesi among the indicated patient population who could experience generalized and acquired Hypoactive Sexual Desire Disorder (HSDD). Media will be limited to non-TV digital display and video advertising on social media and web sites. A copay program will be offered to commercially insured eligible patients to help offset patient OOP costs not covered by their insurer.Consistent with government regulations, government insured patients (e.g. Medicaid) will not be eligible for the copay program. AMAG is also evaluating the potential opportunity of offering samples of this product by rolling out a small pilot samples program. |
None |
None |
None |
None |
None |
None |
None |
None |
Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): Approximately 5.8 million premenopausal women have hypoactive sexual desire disorder (HSDD). Vyleesi was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Asegua Therapeutics LLC |
72626260101 |
agLDV/SOF (ledipasvir 90 mg/sofosbuvir 400 mg) tablets |
2019-01-02 |
8000.0000 |
Consistent with Section 127681(c) of the California Health and Safety Code, Asegua is limiting its response to that which is otherwise in the public domain or publicly available. The authorized generics launched at a list price of $24,000 for the most common course of therapy. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to beneficiaries who were previously denied coverage. |
None |
None |
None |
None |
None |
None |
None |
Response to “Acquisition Date” and “Acquisition Price”: These questions are not relevant to the authorized generic scenario. |
Response to "Estimated Number of Patients": Consistent with Section 127681(c) of the California Health and Safety Code, Asegua is limiting its response to that which is otherwise in the public domain or publicly available. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to beneficiaries who were previously denied coverage. Response to “Breakthrough Therapy?” and “Priority Review?”: These questions are not relevant to the authorized generic scenario. |
None |
| Asegua Therapeutics LLC |
72626270101 |
agSOF/VEL (sofosbuvir 400 mg/velpatasvir 100 mg) tablets |
2019-01-02 |
12000.0000 |
Consistent with Section 127681(c) of the California Health and Safety Code, Asegua is limiting its response to that which is otherwise in the public domain or publicly available. The authorized generics launched at a list price of $24,000 for the most common course of therapy. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to beneficiaries who were previously denied coverage. |
None |
None |
None |
None |
None |
None |
None |
Response to “Acquisition Date” and “Acquisition Price”: These questions are not relevant to the authorized generic scenario. |
Response to "Estimated Number of Patients": Consistent with Section 127681(c) of the California Health and Safety Code, Asegua is limiting its response to that which is otherwise in the public domain or publicly available. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to beneficiaries who were previously denied coverage. Response to “Breakthrough Therapy?” and “Priority Review?”: These questions are not relevant to the authorized generic scenario. |
None |
| Astellas Pharma US, Inc. |
00469133050 |
Prograf Granules (tacrolimus for oral suspension) 1mg |
2019-03-12 |
388.0500 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Prograf Granules was not acquired; therefore, columns 10 – 13 are intentionally left blank. |
None |
| Astellas Pharma US, Inc. |
00469123050 |
Prograf Granules (tacrolimus for oral suspension) 0.2mg |
2019-03-12 |
260.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Prograf Granules was not acquired; therefore, columns 10 – 13 are intentionally left blank. |
None |
| Amgen |
55513088002 |
Evenity 210 mg/2.34 mL (105 mg/1.17 mL x 2) |
2019-04-15 |
1825.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The estimated number of patients is not available in the public domain. In the U.S., 10 million Americans suffer from osteoporosis, and the disease is responsible for an estimated two million fractures per year. However, only 20 percent of patients who have had one or more osteoporotic-related fractures are treated. Acquisition date and acquisition price not applicable; Amgen co-developed this product with UCB |
None |
| Amgen |
55513013201 |
KANJINTI (420 mg multi dose vial) |
2019-07-19 |
3697.2600 |
US Marketing Plan: There will be no direct-to-consumer marketing for KANJINTI such as TV ads, magazine or journal ads. The only platform directed to patients is a section of the KANJINTI.com website entitled “For Patients – Getting to Know KANJINTI”. This section of the website is designed to educate patients about HER2+ breast or gastric cancer and potential treatment with KANJINTI, including important safety information. Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about KANJINTI, including the requirements for establishing biosimilarity to the reference product, Herceptin, and important safety information. Professional detailing entails resources such as a core visual aid, clinical reprints, and promotional leave-behind literature. There is no free drug or sample program. Amgen also contracts with payors and providers such as hospitals and clinics to offer KANJINTI at a competitive price and ensure access to the product for appropriate patients. International Marketing Plan: marketing plan information is not in the public domain. Reg. § 96076(c). US Pricing Plan: The U.S. Wholesale Acquisition Cost (WAC or "list price") of KANJINTI will be 15% lower than their reference products. KANJINTI is being made available at a WAC of $3,697.26 per 420 mg multi-dose vial, 15% below the WAC of Herceptin. At launch, KANJINTI is priced 13% below the current Herceptin Average Selling Price (ASP). International Pricing Plan: pricing plan information is not in the public domain. Reg. § 96076(c). |
None |
None |
None |
None |
None |
None |
None |
None |
Our estimate of appropriate patients potentially treatable with the class of drug to which KANJINTI belongs is ~42K a year and we intend to compete with other drugs in this class for a share of that patient population. Acquisition date and acquisition price not applicable as Amgen developed this drug product |
None |
| Amgen |
55513020601 |
MVASI (100 mg/4mL single dose vial) |
2019-07-19 |
677.4000 |
US Marketing Plan: There will be no direct-to-consumer marketing for MVASI such as TV ads, magazine or journal ads. The only platform directed to patients is a section of the MVASI.com website entitled “For Patients – Getting to Know MAVSI”. This section of the website is designed to educate patients about potential cancer treatment with MVASI, specifically for metastatic colorectal cancer (mCRC), advanced non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma (rGBM), metastatic renal cell carcinoma (mRCC), and advanced cervical cancer (CC), including important safety information. Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about MVASI, including the requirements for establishing biosimilarity to the reference product, Avastin, and important safety information. Professional detailing entails resources such as a core visual aid, clinical reprints, and promotional leave-behind literature. There is no free drug or sample program. Amgen also contracts with payors and providers such a hospitals and clinics to offer MVASI at a competitive price and ensure access to the product for appropriate patients. International Marketing Plan: marketing plan information is not in the public domain. Reg. § 96076(c). US Pricing Plan: The U.S. Wholesale Acquisition Cost (WAC or "list price") of MVASI will be 15% lower than their reference products. MVASI is being made available at a WAC of $677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial, 15% less than the WAC for Avastin. At launch, MVASI is priced 12% below the current Avastin Average Selling Price (ASP). International Pricing Plan: pricing plan information is not in the public domain. Reg. § 96076(c). |
None |
None |
None |
None |
None |
None |
None |
None |
Our estimate of appropriate patients potentially treatable with the class of drug to which MVASI belongs is ~40K a year and we intend to compete with other drugs in this class for a share of that patient population Acquisition date and acquisition price not applicable as Amgen developed this drug product |
None |
| Amgen |
55513020701 |
MVASI (400 mg/16mL single dose vial) |
2019-07-19 |
2709.6000 |
US Marketing Plan: There will be no direct-to-consumer marketing for MVASI such as TV ads, magazine or journal ads. The only platform directed to patients is a section of the MVASI.com website entitled “For Patients – Getting to Know MAVSI”. This section of the website is designed to educate patients about potential cancer treatment with MVASI, specifically for metastatic colorectal cancer (mCRC), advanced non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma (rGBM), metastatic renal cell carcinoma (mRCC), and advanced cervical cancer (CC), including important safety information. Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about MVASI, including the requirements for establishing biosimilarity to the reference product, Avastin, and important safety information. Professional detailing entails resources such as a core visual aid, clinical reprints, and promotional leave-behind literature. There is no free drug or sample program. Amgen also contracts with payors and providers such a hospitals and clinics to offer MVASI at a competitive price and ensure access to the product for appropriate patients. International Marketing Plan: marketing plan information is not in the public domain. Reg. § 96076(c). US Pricing Plan: The U.S. Wholesale Acquisition Cost (WAC or "list price") of MVASI will be 15% lower than their reference products. MVASI is being made available at a WAC of $677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial, 15% less than the WAC for Avastin. At launch, MVASI is priced 12% below the current Avastin Average Selling Price (ASP). International Pricing Plan: pricing plan information is not in the public domain. Reg. § 96076(c). |
None |
None |
None |
None |
None |
None |
None |
None |
Our estimate of appropriate patients potentially treatable with the class of drug to which MVASI belongs is ~40K a year and we intend to compete with other drugs in this class for a share of that patient population Acquisition date and acquisition price not applicable as Amgen developed this drug product |
None |
| AbbVie |
00074204202 |
SKYRIZI (risankizuman-rzaa) 150mg (carton containing two 75mg/0.83mL single-dose, pre-filled syringes) |
2019-04-29 |
14750.0000 |
SKYRIZI will be marketed to adult patients with moderate-to-severe psoriasis who are candidates for systemic therapy or phototherapy. SKYRIZI is dosed four times per year. The price of SKYRIZI is $14,750 per dose. The maintenance price of SKYRIZI is lower than the most widely-prescribed biologic treatments for moderate to severe plaque psoriasis. AbbVie recently received approval of SKYRIZI from: --Japanese Ministry of Health, Labour and Welfare for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis; --Health Canada for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; and --The European Commission for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. |
None |
None |
None |
None |
None |
None |
None |
None |
Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Based upon an academic analysis of data from the CDC National Health and Nutrition Examination Survey, it is estimated that approximately 1 million adults in the United States have chronic plaque psoriasis that is deemed to be moderate or severe. See e.g., Helmick C., et al., Prevalence of Psoriasis Among Adults in the U.S., 2003-2006 and 2009-2010 National Health and Nutrition Examination Surveys, Am. J. of Prev. Med., 47(1):37–45 (2014). SKYRIZI may be prescribed for that fraction of adults with moderate-to-severe psoriasis who are candidates for systemic therapy or phototherapy. SKYRIZI was developed by AbbVie, with research and development costs funded in part by AbbVie. On April 1, 2016, AbbVie acquired all rights to risankizumab, which was in Phase 3 development for psoriasis, from Boehringer Ingelheim pursuant to a global collaboration agreement. Since that date, all development costs have been funded by AbbVie, and AbbVie is responsible for all development going forward. AbbVie is studying the potential of risankizumab in other chronic conditions, including Crohn’s disease, psoriatic arthritis, ulcerative colitis and atopic dermatitis. |
None |
| AbbVie |
00074230630 |
RINVOQ (upadacitinib); 15mg extended-release tablets, 30 count bottle |
2019-08-20 |
4916.6700 |
RINVOQ will be marketed to adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The recommended dose of RINVOQ is 15mg once daily. The WAC price of a thirty-tablet bottle of RINVOQ is $4,916.47. The annual wholesale acquisition cost of RINVOQ is $59,000, which is lower than the current leading treatments for moderate to severe rheumatoid arthritis. RINVOQ is under review by the European Medicines Agency, as well as regulatory authorities in Canada and Japan, for the treatment of adult patients with moderately to severely active rheumatoid arthritis. |
None |
None |
None |
None |
None |
None |
None |
None |
RINVOQ was developed by AbbVie. Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2): Based upon an observational, retrospective, cross-sectional study using data from the US administrative health insurance claims databases (Truven Health MarketScan and IMS PharMetrics Plus database), it is estimated that approximately 1.3 million adults in the United States have rheumatoid arthritis. See e.g., Hunter T., et al., Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004–2014, Rheumatol. Int., 37(9): 1551-1557 (2017). RINVOQ may be prescribed for that fraction of adults with moderately to severely active rheumatoid arthritis who have had inadequate response or intolerance to methotrexate. |
None |
| Akorn Inc |
17478044708 |
Aminocaproic Acid Oral Solution, USP |
2019-11-04 |
2549.0200 |
None |
1 |
1800 |
None |
None |
None |
None |
None |
None |
Akorn indicated the 11/4/2019 date as the introduced to market date as that is when we first had product available to ship, the date we informed customers of the price and availability. This date was loaded into First Data Bank with WAC pricing. |
None |
| Ajanta Pharma USA, Inc. |
27241017529 |
Sildenafil Citrate For Suspension 10 MG/ML, 112 ML, Bottle |
2019-12-11 |
3000.0000 |
None |
1 |
197 |
None |
None |
None |
None |
None |
None |
This drug was not acquired |
None |
| AveXis |
07189412002 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a patient weight of 2.6 – 3.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412103 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 3.1 – 3.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412203 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 3.6 – 4.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412303 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 4.1 – 4.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412404 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 4.6 – 5.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412504 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 5.1 – 5.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412604 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 5.6 – 6.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412705 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 6.1 – 6.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412805 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 6.6 – 7.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189412905 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 7.1 – 7.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413006 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 7.6 – 8.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413106 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 8.1 – 8.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413206 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 8.6 – 9.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413307 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 9.1 – 9.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413407 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 9.6 – 10.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413507 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 10.1 – 10.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413608 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 10.6 – 11.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413708 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 11.1 – 11.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413808 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 11.6 – 12.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189413909 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 12.1 – 12.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189414009 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 12.6 – 13.0kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| AveXis |
07189414109 |
Zolgensma® (onasemnogene abeparvovec-xioi) is a one-time gene-therapy intravenous (IV) infusion. This NDC is for patients with a weight of 13.1 – 13.5kg |
2019-05-24 |
2125000.0000 |
The marketing for ZOLGENSMA® includes promotion to physicians, direct to consumer promotion, and other types of marketing (e.g., educational programs) |
None |
150 |
1 |
1 |
None |
None |
None |
None |
From June to December of 2019, we estimate that the average number of US patients prescribed ZOLGENSMA® across all NDCs listed will be 150. Zolgensma® (onasemnogene abeparvovec-xioi) is a landmark one-time, adeno-associated virus (AAV) vector-based gene-therapy treatment for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. AveXis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, AveXis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to AveXis or any of its affiliates now or in the future. AveXis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all AveXis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all AveXis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Amneal Pharmaceuticals |
69238147101 |
Erythromycin Tab Delayed Release 250 MG Bottle 100 x1 |
2019-07-18 |
671.0800 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238147201 |
Erythromycin Tab Delayed Release 333 MG Bottle 100 x1 |
2019-07-18 |
844.9600 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238147301 |
Erythromycin Tab Delayed Release 500 MG Bottle 100 x1 |
2019-07-18 |
1040.3500 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238179701 |
Hydroxyprogesterone Caproate IM in Oil 250 MG/ML Vial 1 x1 |
2019-03-08 |
682.5500 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
70121158505 |
Verapamil HCl IV Soln 2.5 MG/ML Vial 2 x25 |
2019-03-06 |
759.0000 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
70121163705 |
Ephedrine Sulfate IV Soln 50MG/ML Vial 1 x25 |
2019-10-28 |
726.0000 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238159403 |
Sirolimus Oral Soln 1 MG/ML Kit Bottle 60 x1 |
2019-10-28 |
1052.6200 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238159406 |
Sirolimus Oral Soln 1 MG/ML Bottle 60 x1 |
2019-10-28 |
1052.6200 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
65162028303 |
Paliperidone Tab ER 24HR 9 MG Bottle 30 x1 |
2019-10-10 |
825.1700 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
70121146302 |
Fulvestrant Inj 250 MG/5ML Syringe 5 x2 |
2019-10-01 |
1745.1500 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
65162087406 |
Bosentan Tab 125 MG Bottle 60 x1 |
2019-06-03 |
10608.0200 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
65162087306 |
Bosentan Tab 62.5 MG Bottle 60 x1 |
2019-06-03 |
10608.0200 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238159608 |
Aminocaproic Acid Oral Soln 0.25 GM/ML Bottle 236.5 x1 |
2019-09-05 |
2549.0200 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238154501 |
Trientine HCl Cap 250 MG Bottle 100 x1 |
2019-08-21 |
5000.0000 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
70121164707 |
Tigecycline For IV Soln 50 MG Vial 1 x10 |
2019-08-09 |
1040.0000 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238105103 |
Phytonadione Tab 5 MG Bottle 30 x1 |
2019-02-26 |
1607.6800 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238116507 |
Abiraterone Acetate Tab 250 MG Bottle 120 x1 |
2019-01-08 |
3499.4000 |
This is a generic product this is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238157401 |
Sildenafil Oral Susp 10MG/ML |
2019-12-02 |
3500.5000 |
This is a generic product that is not marketed. |
None |
None |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| American Regent |
00517656025 |
SELENIOUS ACID INJECTION |
2019-07-09 |
8575.0000 |
The prices negotiated with customers are confidential and not in the public domain or publicly available. American Regent sells its products directly to wholesalers, distributors and closed door pharmacies. American Regent also sells it product indirectly to several entities, including independent pharmacies, managed care organizations, hospitals, etc. These customers, called, "indirect customers," purchase our products primarily through our wholesale customers. The Product has not yet launched in any international jurisdiction. |
None |
None |
None |
None |
None |
None |
None |
None |
Estimated Volume of patients: No information specific to the estimated number of patients that may be prescribed by American Regent's Product is in the public domain or publicly available. Breakthrough Therapy: The product did not receive a breakthrough therapy designation or priority review. Acquisition Price - Not Applicable. American Regent developed the product. |
None |
| Ascend Laboratories, LLC |
67877050330 |
Cinacalcet 30mg 30 Tabs |
2019-06-17 |
685.5000 |
None |
1 |
468000 |
None |
None |
2019-06-17 |
0.0000 |
1 |
None |
While Ascend's estimated volume of patients who may be prescribed Cinacalcet is not available in the public domain, Cinacalcet is approved specifically for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. In the U.S., it is estimated that approximately 468,000 patients with chronic kidney disease (CKD) on dialysis have secondary hyperparathyroidism (HPT). |
None |
| Ascend Laboratories, LLC |
67877050430 |
Cinacalcet 60mg 30 Tabs |
2019-06-17 |
1371.2500 |
None |
1 |
468000 |
None |
None |
2019-06-17 |
None |
1 |
None |
While Ascend's estimated volume of patients who may be prescribed Cinacalcet is not available in the public domain, Cinacalcet is approved specifically for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. In the U.S., it is estimated that approximately 468,000 patients with chronic kidney disease (CKD) on dialysis have secondary hyperparathyroidism (HPT). |
None |
| Ascend Laboratories, LLC |
67877050530 |
Cinacalcet 90mg 30 Tabs |
2019-06-17 |
2057.0000 |
None |
1 |
468000 |
None |
None |
2019-06-17 |
None |
1 |
None |
While Ascend's estimated volume of patients who may be prescribed Cinacalcet is not available in the public domain, Cinacalcet is approved specifically for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. In the U.S., it is estimated that approximately 468,000 patients with chronic kidney disease (CKD) on dialysis have secondary hyperparathyroidism (HPT). |
None |
| Alnylam Pharmaceuticals, Inc. |
71336100101 |
GIVLAARI (givosiran)(189 mg/ml single dose vial) |
2019-12-12 |
39000.0000 |
Marketing Plan in the U.S. GIVLAARI will be marketed to healthcare professionals for the treatment of adults with acute hepatic porphyria (AHP) by a team of field-based sales professionals and its expenditures will include spending on the following areas. Alnylam has announced a U.S. gastrointestinal (GI) disease education and promotional agreement for GIVLAARI with Ironwood Pharmaceuticals, Inc., a GI healthcare company. Under the agreement, Alnylam will leverage Ironwood’s leading capabilities in GI to promote GIVLAARI to certain healthcare practitioners, augmenting Alnylam’s commercialization activities. GIVLAARI is currently being reviewed under accelerated assessment by the European Medicines Agency (EMA) for the treatment of patients with AHP, after receiving Priority Medicines (PRIME) Designation and Orphan Drug Designation from the EMA. Alnylam has also filed for marketing authorization in Brazil and intends to file in Japan and other countries in 2020. Alnylam’s marketing initiatives will focus on raising awareness of the ultra-rare disease acute hepatic porphyria (AHP) and supporting the launch of GIVLAARI and may include multiple comprehensive education and training initiatives that will be provided by Alnylam’s and Ironwood’s employees. Examples include the development of websites, webcasts and other digital media on the disease state AHP as well as GIVLAARI. In addition, Alnylam anticipates that it will participate at scientific meetings attended by Healthcare Providers (HCPs) and may engage with HCPs through booth attendance at scientific meetings, printed materials, speaker programs and one on one meetings. Pricing Plan in the U.S. When determining the price for GIVLAARI, the following factors influenced our decision-making: Treatment Effect - GIVLAARI has the potential to substantially benefit patients’ quality of life by reducing the frequency of AHP attacks by >70% compared to placebo. Potential to Offset Other Healthcare Costs - In the absence of GIVLAARI, an AHP patient can cost $400,000 - $650,000 annually for treatment of attacks, including hospitalization, hemin administration, and other medical interventions. GIVLAARI has been shown to reduce the frequency of attacks thereby providing the potential to reduce or avoid the costs of hospitalization and other interventions. Alnylam is estimating that the annual average effective net price will be $442,000 based on the average weight-based monthly dose of 1.2 vials per patient in the ENVISION study and before mandatory rebates to government institutions. Price may vary per individual insurance coverage and dosing. Ultra-Rare Patient Population - GIVLAARI is an RNAi therapeutic for the adult portion of a population of approximately 3,000 AHP patients with diagnosed, active disease in the U.S. and Europe. Existing Treatments Are Limited (Unmet Need) - GIVLAARI is a first-of-its-kind FDA-approved therapy available in the U.S. for the treatment of adults with AHP. Innovative Pricing - Value Based Agreements - Alnylam has announced a framework for value-based agreements (VBAs) designed to help patients with AHP gain access to GIVLAARI. Under this innovative framework for VBAs, participating government and commercial payers will pay the full value for GIVLAARI only when it delivers patient outcomes in the real-world setting similar to results demonstrated in clinical trials. An additional and newly designed Prevalence-Based Adjustment (PBA) feature will trigger rebates to participating payers if the number of diagnosed patients they cover exceeds current epidemiologic estimates for AHP. There are often uncertainties in diagnosis rates and disease prevalence estimates in ultra-rare diseases, making it challenging for payers to predict the number of patients who will be covered within their plans. This innovative approach offers greater certainty to payers that their overall financial risk will be adjusted if a substantially larger number of patients than currently estimated are identified, diagnosed, and treated with GIVLAARI. Alnylam’s Patient Access Philosophy - Alnylam’s VBA framework for ultra-rare diseases such as AHP builds upon Alnylam’s Patient Access Philosophy. As part of Alnylam’s Access Philosophy, the Company commits to not increase the price of GIVLAARI by more than the consumer price index for urban consumers (CPI-U), a measure of inflation, in the absence of significant investment associated with a meaningful label expansion. Commercially insured patients are expected to have little-to-no out-of-pocket costs for GIVLAARI. |
None |
3000 |
1 |
1 |
None |
None |
None |
None |
Cal. Health & Safety Code §127681 does not currently define “release of the drug in the commercial market” and Alnylam is not aware of any guidance issued by California or any California regulation that defines “release of the drug in the commercial market” for the purpose of Cal. Health & Safety Code §127681. As a result, for the purposes of compliance with Cal. Health & Safety Code §127681, Alnylam considers a drug to be “release[d] . . . in the commercial market” when Alnylam makes product available for shipment to its Wholesalers, Specialty Pharmacies and other customers who purchase directly from Alnylam. As authorized by Cal. Health & Safety Code §127681, this disclosure contains only information that Alnylam has identified as being in the public domain or publicly available. Alnylam provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681 and its provisions. In providing this report, Alnylam does not waive any rights, claims, or legal challenges with respect to Cal. Health & Safety Code § 127681 and related legislation or any implementing regulations thereof. |
None |
| Accord Healthcare, Inc. |
16729035192 |
Busulfan 6 mg/ml injection 8 pk |
2019-07-22 |
4000.0000 |
Marketing: Accord markets generic Busulfan 6 mg/ml in an 8 pack of vials. This product is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. Pricing: In order to set the wholesale acquisition price (“WAC”) of Busulfan, Accord reviewed the WACs available at the time of its launch. Accord discovered that the generic WACs were clustered right around $8,000 with one high and one low outlier. The brand WAC was $4,000 at the time. Accord reviewed market share data and evaluated whether the outliers had a disproportionate share of the market. Finding none, because the brand WAC was lower, consistent with Accord’s commitment to bringing affordable, safe medicine to market, Accord chose to match the brand WAC for Busulfan. Accord uses subscription-based services, such as Medi-Span Price Rx and purchased data from IQVIA to obtain this information. |
None |
0 |
None |
None |
None |
None |
None |
None |
Until receipt of a notice from the State of California on January 6, Accord was not aware that the California drug pricing transparency laws applied to launches of drugs that were previously on the market and new solely as to Accord. Accord is timely reporting pricing after being informed that the laws apply to generic launches. Accord did not acquire the NDC for Busulfan, the generic product was developed in house. Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of the Busullfan injection, but is instead reporting the WAC of an 8 pack of vials as this is the unit in which the vials are sold by Accord. |
None |
| Accord Healthcare, Inc. |
16729042101 |
Tacrolimus Ointment 0.03%/100g tube |
2019-06-05 |
694.5300 |
Marketing: Accord markets generic Tacrolimus ointment in two strengths that are each therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. Pricing: In order to set the wholesale acquisition price (“WAC”) of Tacrolimus ointment, Accord matched the lowest generic WACs available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. |
None |
0 |
None |
None |
None |
None |
None |
None |
Until receipt of a notice from the State of California on January 6, Accord was not aware that the California drug pricing transparency laws applied to launches of drugs that were previously on the market and new solely as to Accord. Accord is timely reporting pricing after being informed that the laws apply to generic launches. Accord did not acquire the NDC for Tacrolimus Ointment, the generic product was developed in house. Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Tacrolimus ointment but is reporting the WAC of a single tube of ointment. |
None |
| Accord Healthcare, Inc. |
16729042201 |
Tacrolimus Ointment 0.10%/100g tube |
2019-06-05 |
694.5300 |
Marketing: Accord markets generic Tacrolimus ointment in two strengths that are each therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. Pricing: In order to set the wholesale acquisition price (“WAC”) of Tacrolimus ointment, Accord matched the lowest generic WACs available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. |
None |
0 |
None |
None |
None |
None |
None |
None |
Until receipt of a notice from the State of California on January 6, Accord was not aware that the California drug pricing transparency laws applied to launches of drugs that were previously on the market and new solely as to Accord. Accord is timely reporting pricing after being informed that the laws apply to generic launches. Accord did not acquire the NDC for Tigecycline, the generic product was developed in house. Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Tacrolimus ointment but is reporting the WAC of a single tube of ointment. |
None |
| Accord Healthcare, Inc. |
16729036468 |
Tigecycline SDV 50 mg 10 pack |
2019-03-28 |
1252.0000 |
Marketing: Accord markets generic Tigecycline in a ten pack of 50 mg vials. The drug is therapeutically equivalent to the innovator (brand) drug. As such, Accord relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Accord does not interact with physicians and markets solely to distributors, hospital groups, group purchasing organizations and like entities based solely on price and availability. Accord does not market based on any aspects of the drug itself. Further, Accord does not aim to treat a certain number of patients, it simply looks at the size of the total market and aims to achieve a certain market share. Pricing: In order to set the wholesale acquisition price (“WAC”) of Tigecycline, Accord matched the lowest generic WAC available at the time of its launch. Accord uses subscription-based services, such as Medi-Span Price Rx to obtain this information. |
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Until receipt of a notice from the State of California on January 6, Accord was not aware that the California drug pricing transparency laws applied to launches of drugs that were previously on the market and new solely as to Accord. Accord is timely reporting pricing after being informed that the laws apply to generic launches. Accord did not acquire the NDC for Tigecycline, the generic product was developed in house. Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information. Accord does not have information as to what constitutes a 30 day supply of Tigecycline but is reporting the WAC of 10 pack of vials, which is the unit by which Accord sells the drug. |
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