Hoping to muscle-in on the crowded schizophrenia market, Teva and French biotech MedinCell have been stopped in their tracks by the FDA.
The U.S. regulator has sent a complete response letter to the companies, rejecting their bid for approval of a long-acting, subcutaneous version of the decades-old medicine risperidone. Teva said it remains committed to bringing the new version to the market and will work with the FDA to address the recommendations in the letter.
The companies didn’t disclose the issues identified by the FDA. In a statement posted on its website, MedinCell’s CEO Christophe Douat said that Teva would pursue resolution of the matter.
“We fully trust that our partner, Teva, will remedy this quickly given the positive results of the phase 3 studies,” Douat said. “Teva remains confident in MedinCell’s technology for the development of extended-release injectable products.”
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Analysts at ODDO BHF said it is difficult to measure the impact of the CRL without knowing more.
“A delay of 9-12 months could be anticipated, although it is impossible to accurately speculate on the calendar for market approval,” they wrote. “Simple questions or a review of production sites would lead to a delay of only six months in contrast to a request for additional trials which would have a greater impact.”
Teva has been selling a generic version of Johnson & Johnson’s Risperdal for more than 10 years. But since then, J&J has regained its foothold in the schizophrenia market by successfully developing long-acting drugs.
Last September, J&J scored an FDA nod for Invega Hafyera, the only twice-yearly medication for the disorder. Last year, J&J rang up (PDF) $4.6 billion in sales of its variety of Invega and Risperdal drugs.
The FDA accepted Teva and MedinCell's application last August after results of two phase 3 trials showed the effectiveness of the treatment.
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ODDO BHF identified it as a positive sign that MediCell’s BEPO technology had not been called into question. The analysts remain optimistic that, if approved, the treatment can find its niche.
“We see two advantages with this technology: the capacity to reduce the side effects with the originator drug and boosting its observance with reduced administrations,” the analysts wrote. “This approach therefore provides a perfect solution to the issues affecting schizophrenia treatments.”