Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has taken its first step in the US biogenerics market. The company today submitted a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for XM02, a biosimilar for the treatment of severe neutropenia, a blood disorder characterized by abnormally low number of neutrophils, the most important type of white blood cell in the blood.
XM02 is a biosimilar to Amgen Inc. (Nasdaq: AMGN) brand drug Neupogen, which has annual sales of $800-900 million in the US.
Biosimilars are generic drugs based on biological drugs. In the absence of legislation regulating biosimilars, Teva submitted the BLA with the FDA.
Teva VP global branded products Moshe Manor told "Globes", "This is an important milestone for Teva. In the past two years, we've been talking about biosimilars, and today we took the important and exciting step to realize this strategy."
XM02 is already sold in several European countries, under the name TevaGrastim. Manor said that, to the best of Teva's knowledge, XM02 is the first biosimilar submitted for approval in the US.
Teva’s BLA submission is based on results from a clinical program of five studies with more than 680 patients. The key study was conducted in breast cancer patients. Two additional clinical trials evaluating safety and efficacy were conducted in lung cancer and Non-Hodgkin’s Lymphoma patients.
"Globes": What is the expected timetable for approving XM02?
Manor: "New products usually take a year for approval. In this case, we'll have to work with the FDA."
Generic drugs usually cost a fraction of the cost of the equivalent brand drugs. In the case of XM02, the clinical trials raises the cost of development and production. How will this affect the drug's price?
"Our policy is to submit products with the same quality as the brand drug at cheaper prices. We'll have to market this product, too. I can't comment on price policy, but the price probably won't be dramatically lower as in the case of normal generic drugs."
The US Congress has not yet established regulations for biosimilars. The regulations are due to be part of the Obama administration's healthcare reform. The last proposal approved includes a relatively long 12-year exclusivity period for biological drugs of biotechnology companies.
"We'll be in the biosimilar business no matter what. We're committed to the industry, and it's critical for our future growth. We readying for the legislation, but we've demonstrated that we can make progress even without an existing track."
In an unrelated development, the FDA yesterday did not approve Merck KgaA's (XETRA: MRK) oral multiple sclerosis drug, clabribine. Merck KgaA was the first company to submit an application for an oral multiple sclerosis drug to the FDA. Teva is developing its own oral multiple sclerosis drug, laquinimod.
Manor said, "We're pursuing clinical trials, and we plan to launch laquinimod in first half of 2012." He added that while he does not know why the FDA rejected clabridine, he believe that it is a major setback for Merck KgaA.
Manor added that Teva was also energetically pursuing the development of its own brand drugs.
Teva rose 1% at the opening on Nasdaq today to $53.34, giving a market cap of $47 billion. The share fell 0.9% on the TASE today.
Published by Globes [online], Israel business news - www.globes-online.com - on December 1, 2009
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