Momenta/Sandoz Copaxone generic may be the only one around for a while, exec says

Momenta CEO Craig Wheeler

Generics makers have been champing at the bit to get a copy out of Teva's ($TEVA) Copaxone, the best-selling multiple sclerosis med that generated $4.2 billion in revenue last year. But according to Momenta ($MNTA) CEO Craig Wheeler, his company's version--a joint effort with partner Sandoz, Novartis' ($NVS) generics unit--may be the only knockoff around for a while.

As Wheeler recently told investors on the company's Q1 conference call, the FDA tested the newly approved Momenta/Sandoz product--dubbed Glatopa--as well as some other meds currently on the Indian generics market. Of those, only Glatopa could be considered interchangeable with Copaxone, the agency concluded.

If other candidates tested nonequivalent, "it could result in a significant delay for competitors as they retrench to develop the needed analytic package to allow them to properly manufacture and approvable generic," Wheeler told investors, noting that "we could possibly have an extended period of sole generic status for this product."

And that could spell pricing power for the pair. Sandoz--which has the call on pricing--hasn't given any hints as to what it might charge for Glatopa. But if the therapy is up against just Copaxone itself, it may not need to sink too far below Teva's $60,000 sticker to grab market share, the Boston Business Journal notes--especially considering that not one MS drug on the U.S. market currently bears a list price less than $50,000 per year.

"This is a market that we believe will be very … into the high quality generic to help payers and patients get the treatments they need at more affordable prices," Wheeler said.

Meanwhile, though, the Israeli drugmaker is still pushing full steam ahead with its safeguard strategy, converting patients over to a new, longer-lasting version of the drug that it thinks will thwart generics makers. As Teva CFO Eyal Desheh said last week on his company's own Q1 call, Copaxone's successor now boasts more than 20% of total market share in the U.S., and the company expects "very little switch back" from that treatment to a generic product.

- read Momenta's call transcript
- read Teva's call transcript
- see the BBJ's take

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