Baxalta tots up winning hemophilia data as new med beats Advate in late-stage trial

Baxalta's key hemophilia A treatment picked up a new long-acting rival from Biogen ($BIIB) last year that threatened revenues for both the product and the newly-spun-off company. But now, Baxalta has good news to report: Its own long-acting product is looking strong in the clinic.

The candidate hemophilia A treatment, to be known as Adynovate when it hits the market, topped predecessor Advate when it came to clotting and preventing serious bleeds, the company said late last week. In a Phase II/III study, Adynovate nailed its primary endpoint in cutting down patients' annualized bleed rate, and it also effectively controlled all bleeding episodes--doing so with just one or two infusions in 95.9% of cases.

Baxalta's Dr. Leonard Valentino

"Adynovate has the potential to offer an important new option for patients, providing the combination of bleed prevention with a simple, twice-weekly dosing schedule," Dr. Leonard Valentino, Baxalta's global head of hematology medical affairs, said in a statement. "The results of this pivotal trial demonstrate the ability of Adynovate to help further personalize treatment regimens to minimize the impact that hemophilia has on patients' lives."

It's good news for Baxalta, which is playing catch-up when it comes to the market for long-acting hemophilia treatments. Last summer, Biogen rolled out its long-lasting contender, Eloctate, pricing it on par with older and less-convenient Advate to encourage patients to switch.

Luckily for Baxalta, though, Advate has been standing its ground. And as one physician told Leerink Partners analyst Danielle Antalffy in November, brand loyalty is part of the equation. "If a drug is working for his patients, they tend to stay on it," she wrote. And the fact that Baxalta has its own long-acting factors on the way--including Adynovate--"resonates with many of his patients," she said.

Baxalta is hoping that brand loyalty will hold through until it can bring Adynovate to market. The new drugmaker--which went solo just this month after spinning off from parent company Baxter--relies heavily on hemophilia sales, with Advate bringing in the lion's share.

Unfortunately for Baxalta, it has even more competition on the way. Bayer, for one, has said it plans to submit its BAY 94-9027 to the FDA in the second half of this year, and Novo Nordisk ($NVO) has a long-acting hemophilia A treatment in late-stage trials, too.

- read Baxalta's release