What Happened in Biotech in 2015?

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With the Receptos acquisition, Celgene added Ozanimod to its stable of drugs. Ozanimod, which is in late-stage clinical trials, targets treatment of ulcerative colitis and relapsing multiple sclerosis, and could eventually bring in annual sales of as much as $6 billion if approved. If all goes well, Ozanimod could hit the market as a treatment for relapsing multiple sclerosis in 2018.


Buyouts and politics can generate plenty of headlines, but biotechs are in business to develop and sell drugs. That selling can't happen unless a biotech manages to get its drugs approved by regulators. 2015 saw its fair share of significant approvals. Which was the most important approval of the year? My vote is for the new class of cholesterol drugs known as PCSK9 inhibitors.

Image Source: Sanofi/Regeneron

In July, Sanofi and Regeneron won the first FDA approval for a PCSK9 inhibitor for Praluent. Between 8 million and 10 million patients in the U.S. have a genetic condition that leads to high cholesterol levels that often can't be lowered by statins. PCSK9 inhibitors can potentially help these patients.

Estimates for peak annual sales for Praluent vary widely -- from $2 billion to more than $5 billion. However, Praluent and other PCSK9 inhibitors, including Amgen 's Repatha, face resistance from payers concerned about high prices.

Looking ahead

2016 is an election year in the U.S. Look for the politics of drug prices to remain a hot-button issue. Biotechs with high-priced specialty drugs could experience considerable volatility in their stock prices as a result.

Will the New Year bring more merger and acquisition activity? You can pretty much count on it. Celgene and Gilead by themselves have more than $23 billion in cash stockpiled. I suspect they will spend some of that money in 2016 buying smaller biotechs.

As for regulatory approvals next year, I'm especially interested in the fate of Gilead's Sovaldi/velpatasvir combo. The FDA is scheduled to make its decision on the treatment by June 28, 2016. If that treatment is approved, Gilead will have the first all-oral, single-tablet regimen for treating every type of hepatitis C.

I'll even make a prediction for the New Year: It will be both good and bad for biotech. Just like 2015 -- but with its own twists and turns.

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The article What Happened in Biotech in 2015? originally appeared on

Keith Speights owns shares of Celgene and Gilead Sciences. The Motley Fool owns shares of and recommends Celgene, Gilead Sciences, and Valeant Pharmaceuticals. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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