Teva Pharmaceutical Industries last month began an effort to block or at least delay the launch of a drug that would compete with its blockbuster drug Copaxone, an injectable treatment for multiple sclerosis. Teva filed a citizen's petition to prevent the U.S. Food and Drug Administration approving Biogen Idec's pill BG-12, also a therapy for multiple sclerosis, which is an incurable degenerative disease.
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A citizen petition is a legal procedure based on the First Amendment, enabling any person or company to request that a government body inquire into activity or proceeding that could cause them irreversible damage.
An FDA advisory panel has until March 28 to decide whether BG-12 meets safety standards that would permit the drug to hit the market. Teva fears BG-12 could pose fierce competition to Copaxone, which currently has a roughly 40% share of the multiple-sclerosis market. It is also believed to be responsible for roughly 50% of Teva's profits.
Teva is urging the FDA to conduct additional tests before authorizing BG-12, which has the advantage of being administered orally, in contrast to Copaxone, which is administered by daily subcutaneous injection.
Presently, Copaxone sales are forecast to reach between $3.7 billion and $3.9 billion in 2013, down $200 million from 2012. The projected drop is based on the launch – actual or predicted - of orally administered drugs for multiple sclerosis, such as BG-12 and Sanofi's Aubagio, which the FDA approved in September 2012.
Teva is exhorting the FDA to solicit an opinion from a central nervous system expert before it approves BG-12, pointing to Biogen's recent publication of potentially worrying information regarding side effects, including kidney damage, for those treated with three capsules of the drug per day.
However, no statistically significant problems regarding patient's kidney function has been discovered at the dosage level of two capsules per day, which is likely to be approved by the FDA.
"Teva has been a global leader in the multiple sclerosis community for more than 20 years and wholeheartedly supports the ongoing research and development of new treatments for RRMS," Teva said in a statement, referring to relapsing-remitting multiple sclerosis. "This petition is our effort to bring to light some important points to protect the safety of patients."
Teva filed the petition, on behalf of the more than 300,000 patients with RRMS in the U.S., to urge the FDA to convene a meeting of the PCNS Advisory Committee to assess the risks and benefits of any new MS drug to ensure that appropriate safeguards are implemented to maintain an acceptable risk-benefit profile.