The launch for Glatopa, the new generic of Teva's Copaxone from Novartis' Sandoz, is still in the very early going. But so far, things look good--very good.
It's still very early going for Momenta and Sandoz' Glatopa, the generic of Teva's multiple sclerosis star Copaxone. But if the current trend continues, the newcomer could be following in the footsteps of some pretty impressive launches.
On Thursday, Momenta and Novartis' Sandoz launched their copy of Teva blockbuster Copaxone after a U.S. court nixed the multiple sclerosis drug's patent for the second time. Industry watchers largely expected the move, Bernstein's Ronny Gal wrote in a note to clients. The real question? When Mylan will enter the market with its own copy.
It's been a long legal road for Copaxone, and one that took yet another turn Thursday as the U.S. Court of Appeals struck down the drug's patent for the second time.
Mapi Pharma has closed a $10 million (€9 million) Series A round to finance mid-phase trials of its once-a-month version of Teva's blockbuster multiple sclerosis drug, Copaxone. The round follows two aborted attempts to raise cash in a Nasdaq IPO.
Generics makers have been champing at the bit to get a copy out of Teva's Copaxone, the best-selling multiple sclerosis med that generated $4.2 billion in revenue last year. But according to Momenta CEO Craig Wheeler, his company's version--a joint effort with partner Sandoz, Novartis' generics unit--may be the only knockoff around for a while.
The cost of multiple sclerosis drugs has skyrocketed over the past 20 years, and it's not just new drugs driving that increase. Not one MS drug has a list price of less than $50,000 per year in the U.S., and some treatments cost 7 times more now than they did in 1995, a new study found.
It's been a long battle since a court upturned Teva's Copaxone patent in July 2013, but a Supreme Court fight, several petitions and a regulatory journey later, Copaxone generics are here.
It's not just that Teva doesn't want the FDA to approve generics of its MS star, Copaxone. It really, really, really does not want the FDA to approve them, and it's filed yet another citizen's petition to the agency with a crop of reasons why it shouldn't.
After scouring Teva Pharmaceutical for potential marketing and kickback violations for more than a year, the U.S. Justice Department decided not to join up with whistleblowers suing the company. But the two former sales reps are persisting with civil claims that the Israel-based drugmaker used kickbacks, disguised as speaking fees, to persuade doctors to boost prescriptions of its multiple sclerosis drug Copaxone and Parkinson's med Azilect.