ThromboGenics NV (THR) rose the most in more than five years after it won the backing of U.S. regulatory advisers for ocriplasmin, its lead drug candidate for a type of eye disease.
ThromboGenics jumped 13 percent to 26.37 euros in Brussels trading, its biggest single day gain since January 2007. The Heverlee, Belgium-based company has a market value of 944.4 million euros ($1.16 billion).
Food and Drug Administration advisers voted 10-0 yesterday that the benefits of ocriplasmin outweigh its risks as a treatment for vitreomacular adhesion, or VMA, where a gel inside the eye liquefies to cause vision loss. The FDA is scheduled to decide by Oct. 17 whether to approve the sale of ocriplasmin and isn’t required to follow panel recommendations.
Approval may give ThromboGenics, with 2.4 million euros ($3.4 million) in sales last year, the first drug against a disease that is currently treated only with surgery. Ocriplasmin, which the company has proposed selling under the brand name Jetrea, could help about 500,000 people in the U.S. and the major European markets, and reap as much as $700 million in annual sales, according to Jefferies International.
“The FDA referred to VMA as a ‘ticking time bomb,’ which we believe bodes well for an approval in October,” Philippa Gardner, a Jefferies analyst in London, wrote in a note today.
Better Than Surgery
While panel members raised concern the medicine may not benefit a high proportion of patients, they said it was better than the alternative of surgery.
“I suspect the sponsor and the ophthalmology community will identify which patients will have a higher potential for benefit,” said Susan MacDonald, a panel member and director of comprehensive ophthalmology at the Lahey Clinic Medical Center in Peabody, Massachusetts, during the meeting.
Novartis AG (NOVN) bought marketings rights for the drug outside the U.S. in March in a deal worth as much as 375 million euros. The European Medicines Agency accepted ocriplasmin for review in October, and ThromboGenics has said it expects that regulator’s approval by the end of this year.
FDA staff found side effects including eye pain, perceived flashes of light, blurred vision and impaired vision happened two to four times more often in patients receiving ocriplasmin than those getting a placebo in a trial, according to a report posted on the agency’s website July 24.
Advisers voted 6-3 that additional studies aren’t needed to evaluate the safety of the effect of ocriplasmin on the retina before the drug is approved.
Post-market studies on the adverse complications “would be nice,” said Michael Repka, chairman of the panel and professor of ophthalmology and pediatrics at the Wilmer Ophthalmological Institute at Johns Hopkins Hospital in Baltimore.
To contact the editor responsible for this story: Reg Gale at firstname.lastname@example.org