InnoPharma Announces FDA Approval of Decitabine for Injection, a Generic
Version of DACOGEN®
PISCATAWAY, N.J., Aug. 29, 2014
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
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
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
For further information contact:
John C. Deighan
Chief Financial Officer
(732) 885-2939 x162
SOURCE InnoPharma, Inc.
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