Dr. Reddy’s Laboratories and Alchemia Limited, Brisbane, Australia
announced today that Dr. Reddy’s has received final approval of Dr. Reddy’s
ANDA for Fondaparinux Sodium Injection, a bioequivalent generic version of
Arixtra(R), in the US market on July 11, 2011 by FDA. The approval covers 2.5
mg/ 0.5 mL, 5.0 mg/ 0.4 mL, 7.5 mg/ 0.6 mL and 10 mg/ 0.8 mL doses of the drug
in prefilled color-coded, single-dose syringes with automatic needle safety
device. Dr. Reddy’s will manufacture fondaparinux under license using a
patented process developed by Alchemia.
Commenting on the approval, G.V. Prasad, Vice-Chairman and
CEO of Dr. Reddy’s, said, “The fondaparinux approval demonstrates the
strong technical capabilities of the teams at Dr. Reddy’s and Alchemia. Given that
this is a complex generic molecule which is difficult to manufacture at scale,
competition is likely to be limited for the foreseeable future. Accordingly,
from a commercial perspective, Dr. Reddy’s will promptly execute a phased
launch that initially plays to our strengths in select wholesale and retail
outlets, and subsequently enhance share over time in the coming quarters to
augment the growing annuity of upsides in our North America Generics
business.”
Pete Smith, CEO of Alchemia, said, “This collaboration
has succeeded due to the expertise, dedication, and close communication between
the teams at both companies. This approval is a major milestone for Alchemia,
fondaparinux representing a significant source of potential future income for
the company.”
