Biotech Stock Roundup: Gilead In Patent Infringement Lawsuit, Enbrel Biosimilar Approved

The overall healthcare sector was under pressure over the last week with focus going back to the pricing policies of pharma and biotech companies. Meanwhile, biosimilars are picking up pace with the FDA approving Sandoz’s biosimilar version of Amgen’s (NASDAQ:AMGN) multi-billion dollar drug, Enbrel. Gilead (NASDAQ:GILD) is facing a patent infringement lawsuit related to its hepatitis C virus (HCV) drugs that contain sofosbuvir.

Recap of the Week’s Most Important Stories

Gilead in HCV Patent Infringement Lawsuit: Gilead is facing a patent infringement lawsuit from the University of Minnesota related to its HCV drugs that contain sofosbuvir. Gilead currently sells three drugs containing sofosbuvir - Sovaldi, Harvoni, and Epclusa.

According to the lawsuit, patent rights assigned to the University by Dr. Carston R. Wagner, Endowed Chair in Medicinal Chemistry in the University’s College of Pharmacy, cover Gilead’s drugs. The lawsuit mentions that Gilead has reaped tens of billions of dollars in sales of those drugs, without the University’s authorization and also without compensating the University.

All three drugs brought in total sales of more than $8 billion in the first half of 2016 while combined sales of Harvoni and Sovaldi crossed $19 billion last year. Epclusa is a recent addition to Gilead’s HCV portfolio. Although Gilead’s HCV product sales have slowed down in recent times, we expect investor focus to remain on such patent infringement lawsuits as an unfavorable outcome could result in the company paying out damages as well as royalties.

Biosimilar Version of Amgen’s Enbrel Approved: Amgen, which is already facing biosimilar competition for one its drugs (Neupogen), could face biosimilar competition for its top-selling drug, Enbrel, as well now that the FDA has approved Sandoz’s Erelzi. Erelzi, Sandoz’s biosimilar version of Enbrel, has been approved for the treatment of multiple inflammatory diseases. However, Amgen is not giving up without a fight. The company has already filed a patent infringement lawsuit against Sandoz to keep away cheaper versions of Enbrel from the market (Read more: Novartis Gets FDA Nod for Biosimilar Version of Enbrel).

Amgen had some other updates as well – the company reported positive top-line results from the primary analysis of a late-stage study on Prolia in patients receiving glucocorticoid treatment. Prolia is one of Amgen’s six growth products. Amgen also presented data at the European Society of Cardiology (ESC) Congress 2016 on its PCSK9 inhibitor – Repatha. The company said that Repatha consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups or with familial hypercholesterolemia (Read more: Amgen Reports Positive Data on Prolia and Repatha).

Regeneron Also Presents PCSK9 Data: Amgen was not the only company to present data on PCSK9s. Regeneron (NASDAQ:REGN) and partner Sanofi (PA:SASY) were also at the ESC Congress with detailed positive results from ODYSSEY ESCAPE, a late-stage study on their PCSK9 inhibitor, Praluent (Read more: Regeneron/Sanofi Present Positive Phase III Praluent Data).

ARIAD Seeks Speedy Review for Lung Cancer Drug: Oncology-focused ARIAD (NASDAQ:ARIA) has finished submitting its rolling NDA in the U.S. for brigatinib, an ALK inhibitor for the potential treatment of patients with metastatic ALK+ non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib. ARIAD is seeking speedy approval for its drug – if the FDA grants priority review, a response will be out 8 months after the NDA submission instead of 12 months. Approval would make ARIAD a two product commercial company in 2017 (Read more: ARIAD Finishes Rolling NDA for Lung Cancer Drug Brigatinib).

Rigel Could File for Fostamatinib in 1Q17: Clinical-stage biotech company Rigel’s (NASDAQ:RIGL) shares were up on news that fostamatinib met the primary endpoint in the first of two double-blind studies in a late-stage clinical program for the treatment of adult chronic/persistent immune thrombocytopenia (ITP). Results from the second study are expected in October/November. Rigel could be in a position to seek FDA approval in the first quarter of 2017 provided the second study is also successful and results from a planned interim analysis of a phase III extension study are favorable (Read more: Rigel Stock Up on Positive Phase III Fostamatinib Data).

Performance

The NASDAQ Biotechnology Index declined 1.9% over the last five trading days reflecting the overall weakness in the healthcare sector following the Mylan (NASDAQ:MYL) EpiPen pricing controversy. All major biotech stocks declined over the last five trading days with Alexion (NASDAQ:ALXN) sliding 4.7%. Over the last six months, Amgen was up 14.6% while Alexion lost 16.6% (See the last biotech stock roundup here: Medivation to Pfizer (NYSE:PFE), Clovis Priority Review).

What's Next in the Biotech World?

Watch out for the usual pipeline and regulatory updates from biotech companies.

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