Can Biogen Idec’s
(NASDAQ:BIIB) promising multiple sclerosis pill be derailed -- or at least delayed -- by a rival drug maker?
The big Israeli drug company Teva Pharmaceutical Industries
(NYSE:TEVA) petitioned the US Food and Drug Administration to hold off on approving Biogen’s experimental MS drug known as BG-12 until medical experts can convene to review the safety of the treatment. The FDA is scheduled to make an approval decision on BG-12 by the end of March.
Teva, which sells the MS drug Copaxone, says in its “citizen petition” to the FDA that “it is especially important for the agency to ensure that the risks and benefits of the drug are thoroughly evaluated and that appropriate safeguards are implemented to maintain an acceptable risk-benefit profile.”
Certainly, sales of Copaxone, an injected drug, stand to be hurt by the approval of Biogen’s pill. The medicine would be only the second oral treatment for MS approved in the US, behind Novartis’
(NYSE:NVS) Gilenya. Wall Street analysts predict BG-12 will be a blockbuster product because it’s effective, convenient, and generally regarded as safe.
In its petition, Teva says other drugs such as Gilenya and Biogen’s Tysabri have shown to have “serious safety issues” following US approval. “Given the complexity of both MS and the human immune system, it is difficult to predict the full range of the clinical effects of a new treatment even after in-depth clinical testing necessary for marketing approval,” Teva says.
In particular, Teva says it discovered “some troubling information” about Biogen’s drug that suggested potential kidney problems in animal testing. Teva says it found the information on a website.
“Teva filed the petition soon after the renal toxicity data seen in BG-12 animal studies came to our attention. Those data, combined with the well-documented safety issues seen with some of the newer agents led us to take a stand for MS patients and urge the Agency to convene an advisory committee meeting before approving any new MS agents,” Teva spokeswoman Denise Bradley says in an emailed statement.
Teva is asking for a hearing of outside experts -- a government advisory panel to review the drug and give its own recommendation for approval. Convening a panel would potentially delay an approval ruling, which already was postponed from late December.
When the FDA decided to delay, the agency told Biogen that it needed more time to make its decision but gave no indication that the drug required more testing, which would significantly slow a potential approval, Biogen spokeswoman Kate Niazi-Sai says.
To date, the FDA has not indicated there will be an advisory committee hearing to consider Biogen’s drug, she says.
BG-12’s safety issues, which include flushing, diarrhea, and nausea, are “well known and manageable” and human studies show there are no known risks of cancer, serious infections, or other major events, Niazi-Sai says. Kidney side effects seen in Biogen’s human studies were similar whether a patient was taking BG-12 or a placebo. “We have confidence in our data,” she says.
“The goal really here is to bring a safe and effective drug to market,” she adds. “We’re not concerned about protecting market share, which it appears Teva is trying to do.”
Shares of Biogen fell less than 1% to $143.85 in afternoon trading Thursday. The stock is up 25% in the past 12 months. Teva’s US shares rose 1% to $38.79. The company’s shares are down almost 14% in the past year.
“Current (Wall Street) consensus widely assumes general on-time approval of BG-12,” RBC Capital analyst Michael Yee says in a note. “We assume on-time approval and that a (petition) is something a competitor may try to do to delay any new competition.”
The FDA has about nine months to respond to a citizen petition, says agency spokeswoman Sandy Walsh. She declined to comment on a potential advisory panel hearing for the Biogen drug.
See Teva’s petition here
No positions in stocks mentioned.
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