Drug Approvals and licensing deals were the areas of focus in the biotech space last week. While Gilead’s HCV Drug, Eplcusa, was approved in China, BioMarin’s Palynziq got FDA approval. On the other hand, Alexion’s offer to acquire Sweden-based Wilson Therapeutcis was accepted by the latter’s shareholders.
Recap of Important Stories:
Gilead’s Epclusa Gets Approval in China: The China Drug Administration (“CDA”) approved Gilead’s GILD Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. The CDA also approved Epclusa in combination with ribavirin (RBV) for adults with HCV and decompensated cirrhosis. The approval was based on positive results from five phase III studies, ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4 and ASTRAL-5, wherein high overall rates of SVR12 (defined as undetectable HCV RNA 12 weeks after completing therapy) in the range of 92-100%, were achieved across difficult-to-cure patient populations including treatment-experienced patients and those with compensated or decompensated cirrhosis. The approval will further expand Gilead’s geographic reach and somewhat boost its dwindling HCV portfolio.
Gilead is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BioMarin Gets FDA Approval ForPalynziq: BioMarin Pharmaceutical Inc. BMRN obtained standard approval from the FDA for Palynziq (pegvaliase-pqpz) injection for the reduction of blood phenylalanine (Phe) concentrations in adult patients with phenylketonuria (PKU), who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management. In March 2018, the European Medicines Agency also accepted the company’s Marketing Authorization Application for Palynziq. In the United States, Palynziq is the first enzyme therapy approved for the treatment of PKU. The drug will complement sales of BioMarin’s other drug Kuvan.
Alexion’s offer For Wilson Acquisition Accepted: Alexion ALXN announced that its offer to acquire Sweden-based Wilson Therapeutics has been accepted by its shareholders, who represent 97.7% of the total number of shares and votes in the latter. The acquisition has also been approved by relevant regulatory authorities. The settlement of the tendered shares will occur on May 30. The acquisition will add a late-stage candidate, WTX101, to Alexion’s pipeline as the company looks to diversify its portfolio and reduce its dependence on its blockbuster drug Soliris. WTX101 enjoys Fast Track designation in the United States. and Orphan Drug Designation for the treatment of Wilson disease in the United States and Europe Union.
Cara Therapeutics Gains on Licensing Deal: Shares of Cara Therapeutics, Inc. CARA jumped significantly last week following the announcement of a licensing deal with Vifor Fresenius Medical Care Renal Pharma Ltd. The company licensed worldwide rights, to commercialize Korsuva (CR845/difelikefalin) injection for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in dialysis patients except in the United States, Japan and South Korea. We remind investors that the FDA granted Breakthrough Therapy Designation to Korsuva injection for this indication. Per the terms of the deal, Cara is entitled to receive an upfront payment of $50 million in cash and an equity investment of $20 million to acquire Cara common stock at a price of approximately $17/share. Cara is also entitled to receive additional payments of up to $470 million, which includes $30 million in regulatory and up to $440 million in tiered commercial milestones. The company will also receive tiered royalties based on net sales of Korsuvainjection in the licensed territories.
Celgene to Repurchase Shares: Celgene Corporation CELG announced that the company will repurchase $3 billion of its common stock. The company also plans to enter into an accelerated share repurchase (ASR) agreement to repurchase an aggregate of $2 billion of its common stock. The planned ASR will use the existing authorized share repurchase program as well as part of the new authorization.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index lost 0.26% over the last four trading sessions. Among the major biotech stocks, Alexion lost 2.03%. Over the past six months, Celgene lost 24.52%, while Vertex gained 7.99% (See the last biotech stock roundup here: Biotech Stock Roundup: FDA Gives Nod to Amgen's Drugs, EU Approves Exelixis' Cabometyx).
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
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