Three Biotechs Face Near-Term FDA Decisions

Three Biotechs Face Near-Term FDA Decisions
March 21, 2016
By Mark Terry, Breaking News Staff

Three biotech companies are facing important decisions by the U.S. Food and Drug Administration (FDA) that have the potential to dramatically influence company stock. The Motley Fool put these three companies under the microscope: Insys Therapeutics (INSY), Amicus Therapeutics (FOLD) and Portola Pharmaceuticals (PTLA).

Insys Therapeutics

Chandler, Ariz.-based Insys Therapeutics is expecting a decision by the FDA on April 1 for oral marinol. The company focuses on a variety of marijuana-derived drugs. Marinol is being evaluated for use in treating anorexia in AIDS patients and as a treatment for nausea and vomiting related to chemotherapy. The company’s branded marinol product is Syndros, and is an oral formulation that can be administered as a liquid.

Syndros has a potential nine-figure annual sales potential. The market for marinol products is currently $150 million annually and growing. Insys’ primary product is Subsys, a fantanyl pain killer for oncology treatments.

Subsys sold about $331 million in 2015, up 49 percent from 2014, but the company’s stock price has wavered due to investigations into improper off-label marketing. Writing for The Motley Fool, Todd Campbell says, “Because of the Subsys overhang, an FDA rejection would probably result in a bigger move downward than an approval would cause shares to pop higher.”

Insys stock is currently trading for $18.68 per share.

Amicus Therapeutics

Cranbury, N.J.-based Amicus Therapeutics is awaiting an approval for its Galafold for Fabry disease by European Union drug regulators. The decision is scheduled for March 29 to 31. The company’s stock has bounced all over the place due to delays over approvals, but Campbell has noted before that if it gets approved in the EU, the stock could recover.

Galafold would compete with Shire ’s Replagel in the EU, but because it has a different mechanism of action than Replagel, Galafold has the potential to be used alongside it. Replagel generated $441 million in sales in Europe last year, and Campbell predicts Galafold could hit nine-figure sales in Europe. Sanofi also markets Fabrazyme for the disease as well. Both Replagel and Fabrazyme act by replacing the enzyme missing in Fabry patients. For patients who still produce some of the enzyme, Galafold aids in getting the enzymes to work better.

Amicus Therapeutics is currently trading for $8.22 per share.

Portola Pharmaceuticals

South San Francisco-based Portola Pharmaceuticals filed with the FDA for andexanet alfa, which would be the first approved drug for factor Xa anticoagulants. These are generally considered to be better than standard treatment warfarin. Although the FDA won’t decide on Portola’s product until later this year, it has new clinical trial data expected in April.

That trial will compare betrixaban, its factor Xa anticoagulant, to Sanofi’s Lovenox. Campbell writes, “If betrixaban outperforms Lovenox, then Portola could have a billion-dollar blockbuster drug on its hands. Prior to losing patent protection, Lovenox sales were eclipsing $3 billion annually.”

Portola Pharmaceuticals currently trades for $28.99 per share.

Back to news