Back in February, the FDA green-lighted Kalydeco to treat cystic fibrosis in patients with one of 8 distinct gating mutations, dramatically swelling the orphan drug's patient pool.
Biotech Vertex has pulled the plug on work in the hepatitis C arena, an area it was expected to dominate with its Incivek until Gilead Sciences redefined the category with Sovaldi, a drug now expected to become the top seller of all time.
Any drugmaker knows that no matter what a drug's sticker price, its sales can only go as far as its patient pool will take it. So for Vertex, whose cystic fibrosis med Kalydeco had reached nearly all eligible patients in the U.S. and Europe, a new FDA approval to treat more CF sufferers is pretty significant.
Hepatitis C drugs like Vertex's Incivek are quickly becoming a thing of the past. A new generation of easier-to-tolerate, interferon-free treatments like Gilead's Sovaldi is moving in, and Vertex's fourth-quarter revenues showed it. But a hefty one-time royalty payment helped the company turn a profit, even despite plummeting sales of Incivek--one of just two drugs it currently has on the market.
A new report starkly illustrates how quickly things can change in the pharma industry, showing how a drug darling becomes a market dud.
What happened? A new wave of hepatitis C treatments, led by Gilead Sciences' sofosbuvir. Heartily backed by an FDA advisory panel Friday, sofosbuvir is first in a class of treatments aimed at shortening hep C treatment, boosting its effectiveness and easing its notorious side effects. The coming all-oral drug cocktails will shut out interferon--and shunt Incivek aside.
Vertex Pharmaceuticals asked the FDA to approve broader use of its cystic fibrosis drug Kalydeco. Already marketed for patients with a G551 "gateway" mutation, Kalydeco could be approved to treat patients with at least one non-G551 mutation.
EvaluatePharma has an antidote to any starry-eyed thinking about new drug launches. According to EP Vantage's new state-of-the-industry report, many of last year's rollouts are already disappointments, at least compared with previous sales projections.
Vertex Pharmaceuticals ($VRTX) watched its once-high-flying hepatitis C drug go into a nosedive for the fourth quarter. Incivek sales plummeted by 51% to $222.8 million, as fewer new patients elected to start therapy.
As Big Pharma looks to tap the burgeoning drug market in China, companies are realizing they can't bulldoze in with U.S.-approved drugs and expect a red carpet. Instead, firms such as Vertex and AstraZeneca's MedImmune are looking to partner up with local expertise to speed their way to capitalization.