It was a busy week for the biotech sector after the second-quarter earnings with collaborations and pipeline updates taking center stage. While Amgen AMGN secured a key win against Novartis for Enbrel, Amarin AMRN plunged on a delay in the approval of Vascepa.  Meanwhile, Regeneron obtained FDA approval for a syringe formulation of its lead ophthalmology drug, Eylea.

Recap of the Week’s Most Important Stories:

Amgen Gets Favorable Ruling Against Novartis for Enbrel Patents: Amgen announced that a district court of New Jersey has upheld the validity of its two patents on blockbuster rheumatoid arthritis drug, Enbrel, against Novartis’ NVS generic arm, Sandoz. The two patents describe and claim Enbrel, and methods for making it. Novartis said it will appeal the ruling to the U.S. Court of Appeals for the Federal Circuit. Sandoz received FDA approval for the biosimilar version of Enbrel, Erelzi, in August 2016. However, Erelzi could not be launched in the United States due to the ongoing litigation with Amgen. The latest district court ruling prevents Sandoz from launching Erelzi, at least for now. Shares were up on the news as it wards off competition for now for one of Amgen’s largest drugs.

Amgen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Amarin Down as FDA Decides to Hold AdCom Meeting: Shares of Amarin Corporation plunged after it announced the receipt of a notice from the FDA stating that the agency plans to hold an advisory committee meeting (AdCom) regarding its review of the pending supplemental new drug application (sNDA) for the label expansion of Vascepa. The meeting is tentatively scheduled for Nov 14, 2019. Amarin is seeking approval for a label expansion of the drug based on the REDUCE-IT cardiovascular outcomes study. The FDA was previously set to take action on the sNDA on Sep 28. Hence, with the AdCom meeting being scheduled in November, the action date will now be postponed. This, in turn, will result in the delay of tentative approval. The company did not give any details on why the FDA decided to hold the meeting.

Gilead’s Biktarvy Gets Approval in China: Gilead Sciences, Inc. GILD announced that the China National Medical Products Administration (NMPA) has approved its once-daily, single-tablet regimen, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF) for the treatment of HIV-1 infection. The drug is already approved in the United States and Europe. The approval of the drug in Japan is supported by data from four ongoing phase III studies — Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults.

Regeneron Gets FDA Approval for Eylea Syringe:  Regeneron Pharmaceuticals REGN announced that the FDA has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the Eylea (aflibercept) Injection prefilled syringe. The approval provides physicians a new way to administer Eylea that requires fewer preparation steps as compared to vials. The Eylea prefilled syringe is expected to be available to physicians and patients this year. We note that Eylea is indicated to treat neovascular (wet) age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).

Separately, Regeneron announced that its study evaluating four investigational therapies for Ebola virus infection was stopped early as its candidate, REGN-EB3, demonstrated a highly statistically significant result compared to Mapp Biopharmaceutical Inc.’s ZMapp in preventing death. ZMapp served as the control arm of the study because it was considered the standard of care based on the previous PREVAIL II clinical study. The independent data safety monitoring board decided to stop the study after reviewing interim mortality data from 499 patients. The study was conducted in the Democratic Republic of Congo (DRC), the center of the current outbreak.

Alnylam Collaborates With Ironwood for Givosiran: Alnylam Pharmaceuticals, Inc. ALNY announced its collaboration with Ironwood Pharmaceuticals, Inc. (IRWD) for the former’s givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the potential treatment of Acute Hepatic Porphyria (AHP).  Per the agreement, Ironwood will provide AHP disease education to gastroenterologists and other healthcare practitioners whom it currently calls on for its own drug, Linzess. Givosiran has received Priority Review and Breakthrough Therapy designations from the FDA. The candidate also enjoys an Orphan Drug status in the United States. The Prescription Drug User Fee Act (PDUFA) date for givosiran is set for Feb 4, 2020.

Upon a potential approval, Ironwood sales specialists will begin promoting givosiran, thereby supporting Alnylam to commercialize the drug.


Medical – Biomedical and Genetics Industry 5YR % Return


Medical – Biomedical and Genetics Industry 5YR % Return

Medical – Biomedical and Genetics Industry 5YR % Return

The Nasdaq Biotechnology index gained 2.23% in the last five trading sessions. Among the biotech giants, Amgen gained 11.74% in the period. Over the past six months, shares of Amgen have gained 10.86%, whereas the Biogen stock has declined 27.46%. (See the last biotech stock roundup here: Biotech Stock Roundup: Celgene, Amgen, Gilead Impress in Q2, Other Pipeline Updates)


What’s Next in Biotech?

Stay tuned for more pipeline updates.

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Amgen Inc. (AMGN) : Free Stock Analysis Report
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