| i3 Pharmaceuticals, LLC |
72319002502 |
Maraviroc Tablets 300mg 60CT |
Generic |
FDA |
2023-11-22 |
1410.8200 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| i3 Pharmaceuticals, LLC |
72319002402 |
Maraviroc Tablets 150mg 60CT |
Generic |
FDA |
2023-12-04 |
1410.8200 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Incyte Corporation |
50881000603 |
Zynyz Intravenous Solution 500mg/ 20ml 1 Vial per Carton |
Brand |
FDA |
2023-04-06 |
14240.0000 |
To market Zynyz, Incyte designed activities to increase awareness and understanding with healthcare providers about the product. Marketing activities will include education and training provided by our sales force. Consumer-directed communications to educate patients on the disease state and Zynyz are planned. At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines.
We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. Zynyz is indicated for the treatment of metastatic or recurrent locally advanced merkel cell carcinoma (MCC). |
None |
1000 |
None |
1 |
None |
None |
None |
None |
Comment regarding Field 7: Literature was used to derive an estimate of the MCC patient population because MCC is a niche tumor and is not included in recent SEER, American Cancer Facts or Globocan Cancer Fact Sheets. Literature included 1) D. Jacobs Assessment of Age, Period, and Birth Control Effects and Trends in Merkel Cell Carcinoma Incidence in the United States; JAMA Dermatology Jan. 2021 Volume 157 Number 1 2) Becker J. Merkel cell carcinoma. Ann Oncol 2010;21(suppl 7):81–85 and 3) Information from 21,445 cases of MCC in the USA. Data for 2001–2014 from National Program of Cancer Registries and SEER*Stat Database.
Comment regarding Fields 8 and 9: Acquisition fields left blank as drug was developed by Incyte.
Comment regarding Field 7: MCC is a rare and aggressive type of skin cancer and impacts less than 1 per 100,000 people in the U.S., but incidence rates are rapidly rising, especially in adults over the age of 65. There are ~1,000 estimated patients per year with locally advanced or metastatic MCC disease.
General Comment: In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17. Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Ingenus Pharmaceuticals, LLC |
50742036630 |
Gefitinib Tablets 250mg |
Generic |
FDA |
2023-05-02 |
3995.0000 |
Gefitinib 250 mg, 30 count tablets (ANDA 211591) have been priced in accordance with Ingenus Pharmaceuticals Contracts and Management Team policies and procedures. Establishing the WAC price at $3,995.00 constitutes a substantial reduction in the WAC pricing of the referenced listed drug, Iressa, listed at $7,788.88. At the time our pricing analysis was completed, our price represented a 49% reduction in price. Several factors were taken into consideration while determining Ingenus’ WAC pricing including but limited to API, production, packaging, and shipping costs. Ingenus’ WAC pricing will enable it to: i) recoup the costs it incurred in evaluating the economic landscape surrounding prospective products; ii) cover distribution costs; iii) provide rebates and discounts as required by partners in the supply chain; and iv) earn a reasonable return on investment. |
None |
15000 |
None |
None |
None |
None |
None |
None |
As a generic pharmaceutical manufacturer, Ingenus does not estimate the number of patients. The number entered in that field is based on a simple google search. |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054001501 |
SOHONOS 1.5mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
7182.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054010001 |
SOHONOS 10mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
47880.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054001001 |
SOHONOS 1mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
4788.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054002501 |
SOHONOS 2.5mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
11970.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054005001 |
SOHONOS 5mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
23940.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Iveric Bio |
82829000201 |
IZERVAY, glass vial; intravitreal injection; 2 mg (0.1 mL of 20 mg/mL solution); single-dose vial. |
Brand |
FDA |
2023-08-29 |
2100.0000 |
None |
1 |
1000000 |
1 |
1 |
2023-07-11 |
590000000.0000 |
None |
Because the purchase of IZERVAY™ was part of the purchase of a company, Iveric Bio, an Astellas Company submits the following explanation as to what else was included in the acquisition:
On July 11, 2023, Berry Merger Sub, Inc. (a wholly owned subsidiary of Astellas US Holding, Inc. (“Astellas”)) was merged with and into IVERIC bio, Inc. (“IVERIC bio”) with IVERIC bio surviving the merger and becoming a wholly owned subsidiary of Astellas (“Iveric Bio, An Astellas Company”). The details of the company converted into a subsidiary (prior to the acquisition) are publicly available (News | Astellas Pharma Inc) and include:
• Stated Capital of US$137 thousand (as of December 31, 2022)
• Consolidated Stockholders’ equity of US$534,657 thousand (as of December 31, 2022)
• Number of Shares Outstanding 137,976,851 (as of May 30, 2023)
• Total Equity of US$534,657 (as of December 31, 2022)
• Total Assets US$666,823 (as of December 31, 2022)
• Equity per share (US $) 4.42 (as of December 31, 2022)
As a result of this acquisition Astellas also acquired Labeler Code (82829) and NDC (82829-002-01) associated with the IVERIC bio product IZERVAY™ (avacincaptad pegol intravitreal solution), which received U.S. Food and Drug Administration (FDA) approval following the acquisition on August 4, 2023 and has a Market Effective Date of August 29, 2023.
The acquisition amount (US$40 per share, approximately US$5.9 billion in the aggregate) includes the full amount required to purchase all outstanding options and restricted stock units. |
Regarding Estimated Number of Patients: The estimated number of patients living with GA is 1,000,000 patients, per Yates JR, Sepp T, Matharu BK, et al; Genetic Factors in AMD Study Group. Complement C3 variant and the risk of age-related macular degeneration. N Engl J Med. 2007;357(6):553-561.
Regarding Acquisition Price: The price is US$5.9 billion, but the CA portal will not allow me to enter the last zero. |
None |