Teva Pharmaceutical Industries Ltd. (TEVA)’s plan to switch patients to a longer-acting version of its Copaxone treatment suffered a setback as a U.S. court ruling gave the $4 billion drug less than a year of patent protection.
Teva wants to move as many as half of the multiple-sclerosis patients taking daily Copaxone injections to a three-times-weekly version of the medicine. The U.S. Court of Appeals decision to invalidate a 2015 patent may allow generic competitors such as Cambridge, Massachusetts-based Momenta Pharmaceuticals Inc. (MNTA) to lure away patients with cheaper copies as early as next year, said Marc Goodman, an analyst at UBS AG.
“This not only moves up the potential generic Copaxone launch into 2014 but it also doesn’t give Teva much time to convert patients,” said Goodman, who is based in New York. The analyst said he changed his earnings forecast to reflect a generic competitor by 2014 and a 15 percent patient conversion instead of a previously forecast 30 percent.
Teva, based in Petach Tikva, Israel, markets a 20-milligram Copaxone injection, which generates more than five times the revenue of its second-best-selling branded drug, Treanda. A longer-acting, 40-milligram dose of Copaxone was effective in lowering relapse rates in MS patients compared with a placebo in a late-stage trial last year.
Because Teva expects the U.S. Food and Drug Administration to approve the long-acting version by early 2014, the extra year without generic competition would be key to moving its patients to the higher dosage.
“Teva wanted to switch a significant portion of its prescriptions to the 40-milligram dose but that will be de facto impossible if the market goes generic in May 2014,” said Ori Hershkovitz, a partner at Sphera Funds Management Ltd., a Tel Aviv-based health-care hedge fund.
Teva’s American depositary receipts fell 2 percent to $39.90 at the close in New York. Momenta, which is developing a generic version with Novartis AG (NOVN), gained less than 1 percent after adding 12 percent to $17.34 on July 26. Mylan Inc., which is developing a copy with Natco Pharmaceuticals, fell 1 percent and Natco added 20 percent in Mumbai.
Teva expects 30 percent to 35 percent of its patients to switch, Jon Congleton, senior vice president at Teva’s Global Medicines Group, said in a first-quarter earnings conference call. Market research done by Teva showed as many as half of all Copaxone patients would transition to fewer weekly injections, Congleton said. The newer formulation would have patent protection through 2030.
Generic-drug makers still face hurdles in getting their products to the market next year. Teva can seek a review before the U.S. Supreme Court and the company said it will appeal the decision. The FDA would need to approve copies of the drug and Teva says that the regulator should require lengthy clinical trials not typical for generic medicines because Copaxone is a complex molecule.
“Since the generics did not receive FDA approval, nor is there any indication as to when, if at all, such approval would be received, it is too early to assess if there will be any impact on Copaxone, and specifically on our launch of Copaxone 40-milligram 3-times-a-week,” Teva said in an e-mailed statement.
Momenta’s application with the FDA for a generic has been under review for five years and the regulatory pathway “remains murky,” said David Steinberg, a San Francisco-based analyst at Deutsche Bank AG. There is a real possibility that a generic to Copaxone may not emerge for a number of years, said Steinberg, who has a buy recommendation on Teva.
A generic approval in 2014 is increasingly possible as the FDA demonstrates more willingness to approve complex drugs, said Ronny Gal, an analyst at Sanford C. Bernstein & Co. Gal estimated the chances of a generic entrant next year at 50 percent.
To contact the editor responsible for this story: Phil Serafino at firstname.lastname@example.org