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InnoPharma Announces FDA Approval of Decitabine for Injection, a Generic Version of DACOGEN®
|By PR Newswire
|August 29, 2014 10:13 AM EDT
PISCATAWAY, N.J., Aug. 29, 2014 /PRNewswire/ -- InnoPharma, Inc. today announced the approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for decitabine for injection, a generic version of Eisai Inc.'s DACOGEN®. InnoPharma developed the generic formulation of decitabine for injection and entered into an agreement with Sandoz, Inc., pursuant to which Sandoz will sell, market and distribute decitabine for injection in the United States. According to IMS data, aggregate U.S. sales of DACOGEN were approximately $251 million for the twelve months ending in April 2014.
Decitabine for injection is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
"We are excited to see this important product reach the market. This approval further emphasizes InnoPharma's ability and commitment to develop and bring to market complex generic and innovative specialty pharmaceutical products," stated Navneet Puri, Ph.D., President and Chief Executive Officer of InnoPharma.
Decitabine for injection will be marketed in 20 mL single dose glass vials containing 50 mg decitabine, the same size and strength as the brand. The dosing regimen is identical to the brand.
On July 16, 2014, Pfizer Inc. (NYSE: PFE) and InnoPharma announced that they have entered into an agreement under which Pfizer will acquire InnoPharma. The closing of the transaction is subject to U.S. regulatory approval and is expected to occur during the third quarter.
About InnoPharma, Inc.
InnoPharma is a privately held, sterile product development company, focused on developing complex generic and innovative products in injectable and ophthalmic dosage forms. The Company has a broad portfolio of products under development, with formulations including solutions, suspension, lyophilized, emulsions, liposomes, micelles and lipid complexes. InnoPharma's pipeline includes small molecules with solubility and stability challenges, as well as difficult to produce and characterize polypeptides and carbohydrates. The Company has a comprehensive infrastructure for the development of its products in its state of the art R&D facilities in New Jersey, with the capability to handle potent and cytotoxic molecules. More information can be found at www.innopharmainc.com.
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees across more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics. In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).
DACOGEN® is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc.
For further information contact:
John C. Deighan
Chief Financial Officer
(732) 885-2939 x162
SOURCE InnoPharma, Inc.
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