Dr Reddy’s launches first generic darbepoetin alfa

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Dr. Reddy's Laboratories Ltd. (NYSE:RDY) announced today the launch of Cresp® - the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India. Cresp® has been approved in India for the treatment of anemia due to chronic kidney disease and anemia due to chemotherapy.

“Cresp® will offer patients in India an improved treatment regimen at affordable pricing. The launch of Cresp® by Dr. Reddy's is a significant step in redefining the treatment of anemia in India and underscores our commitment to provide affordable and innovative medicines to patients in India.”

Darbepoetin alfa is a modified version of epoetin alfa (rHuEPO), which is engineered to have a longer half life, increasing (up to 3 times) the time it remains in the blood. This results in a reduced frequency of doses, providing a simpler and more convenient treatment option for patients and physicians as compared to treatment of anemia with epoetin which is the current standard of care in India.

Dr. Reddy's will be launching Cresp® in both vials and prefilled syringes (PFS).

Commenting on the launch, GV Prasad, Vice-Chairman and CEO, Dr. Reddy's said, "Cresp® will offer patients in India an improved treatment regimen at affordable pricing. The launch of Cresp® by Dr. Reddy's is a significant step in redefining the treatment of anemia in India and underscores our commitment to provide affordable and innovative medicines to patients in India."

"The launch of Cresp® is a significant achievement, demonstrating once again our development capabilities in the area of biosimilars. RedituxTM, launched three years ago, was the first, and still the only biosimilar monoclonal antibody in the world. Cresp® represents another important first as the only biosimilar Darbepoetin alfa in the world. Cresp® offers convenient dosing, predictable rise and excellent long term control of Hb," said Cartikeya Reddy, Senior Vice President and Head of Biologics, Dr. Reddy's.

Notes to the editor:

  • Eprex® is the originator brand of epoetin marketed by Johnson & Johnson. Eprex is a registered trademark of Johnson & Johnson.
  • Darbepoetin alfa was developed and launched by Amgen in 2001 under the brand name of Aranesp®. Aranesp® is a registered trademark of Amgen.
  • Annual global sales of darbepoetin alfa in 2009 were $2.65 billion (Source: Amgen 2009 Annual Report).
  • US sales of darbepoetin alfa $1.25 billion (Source: Amgen 2009 Annual Report).
  • In India, epoetin's are a multiproduct market (highly genericized); Eprex being the originator commands a premium price.
  • Cresp has been affordably priced to offer significant monthly savings to patients when compared to Eprex, the originator brand of epoetin marketed by Johnson & Johnson and many of the other biosimilar epoetin therapies available in India.
  • Dr. Reddy's currently markets Grafeel TM (biosimilar filgrastim) and Reditux TM (biosimilar rituximab) in India and several other countries.
  • Dr. Reddy's pipeline of biosimilars includes a pegylated molecule in late stage clinical trials, two products in late stage development which are scheduled to enter clinical trials and several others in early stage development.

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