Momenta Pharmaceuticals’ CEO Craig Wheeler said comments made by Teva leadership about a “purported” generic of Copaxone are “kind of humorous.”
Teva’s Copaxone, a multiple sclerosis drug that earns nearly $4 billion a year, is approaching patent expiry – and possible generic competition – on May 24. Assuming FDA approves a generic version of Copaxone, a synthetic peptide, sales of the brand name drug are likely to plummet as payers and patients opt for a lower-priced generic therapy.
But FDA’s decision to approve a generic version isn’t yet certain. And Teva is attempting to “throw wrenches” into the FDA review process, according to Craig Wheeler, CEO of Momenta Pharmaceuticals, a company (along with Mylan) that hopes to get an FDA approval for generic Copaxone as soon after the May 24th expiry date as possible.
“The latest [wrench lobbed] is this gene expression profile, which [Teva] is trying to say is different,” Wheeler tells PharmExec. “It’s an interesting angle, but you can begin to pick holes in it.” For one thing, says Wheeler, “there’s no way they have any of the US generic comparators…we wouldn’t give them our product, and I doubt Mylan would give them their product, so they don’t have anything involved in the US application processing.”
As for gene array expression for comparing Copaxone brand versus generic, Wheeler says it’s an unusual approach, which ought to require intense validation. “If you look at gene expression and how it works, it can vary animal to animal, it can vary by time of day, it can vary temporally,” says Wheeler. “If you applied statistics to the data they’ve shown, you would have a hard time showing that there’s any statistical significance in what they’re saying.”
Wheeler says Momenta is “very aware scientifically” of the data Teva put forward, which was published in PLOS ONE – the article was sponsored by Teva and authored by Teva employees – just days before J.P. Morgan. “Our package already had a bio-characterization in it, in terms of looking at secondary and tertiary biologies to show there’s no difference between our moledules,” says Wheeler. “The way [Teva has] done it…it’s nice to put up a big color graph in front of investors, but it doesn’t really hold a lot of scientific water.”
During Teva’s J.P. Morgan presentation, acting president and CEO Eyal Desheh repeated the word “purported” from the PLOS ONE study to describe Copaxone’s potential generic competition. In the case of Copaxone, the generic form is “not the same,” he said. Teva is developing a rejiggered version of Copaxone to be dosed three times a week, as opposed to once daily. Desheh said that PDUFA date is approaching; FDA accepted Teva’s supplemental NDA for Copaxone’s new thrice-weekly dosage formulation last May. Teva is “completely confident” in its ability to switch patients onto the new version, said Desheh. “Our goal is a 45% switch…and that’s conservative,” he said, before suggesting that Teva knows all of its 90 thousand MS patients on a first name basis.
If generic Copaxone is approved, payers are expected to respond enthusiastically. After all, there are no disease-modifying generics on the market for MS patients, notes Wheeler. And brand drug prices have gone through the roof. “In the last 10 years, for an average patient, the price of drug therapy for MS has gone from about $9,000 or $10,000 [annually], to over $60,000 a year,” says Wheeler. “New drugs come out and as soon as they’re priced, all the other drugs get priced up to that level, because there’s no competition.” As a result, “payers are feeling very abused by MS drug prices,” he says. “There’s nothing they can do.”