Several pharma companies provided pipeline and regulatory updates this week. While Nivalis NVLS plunged on disappointing data from a phase II study, Merck MRK got priority review for a couple of regulatory applications for its promising cancer treatment, Keytruda.
Recap of the Week’s Most Important Stories
Nivalis Plunges on Mid-Stage Study Data: Clinical-stage pharma company Nivalis lost more than half of its market cap on the failure of its investigational cystic fibrosis treatment, cavosonstat, in a mid-stage study. Following the disappointing results, Nivalis said that it will continue to investigate the therapeutic potential of cavosonstat and its GSNOR inhibitor portfolio to determine the path forward (Read more: Nivalis Cystic Fibrosis Study Misses Primary Endpoint).
Priority Review for Keytruda Label Expansion: Merck’s anti-PD-1 therapy, Keytruda, got priority review from the FDA for a couple of indications this week. Merck is looking to expand Keytruda’s label for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or patients who have relapsed after three or more prior lines of therapy and for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. While a response for the cHL indication is expected on Mar 15, 2017, a response regarding the MSI-H indication should be out on Mar 8, 2017 (Read more: Merck: Keytruda's Priority Review for New Cancer Indication). Keytruda is one of the most important and promising new products in Merck’s portfolio and the company is working on expanding its label into additional indications.
J&J to Appeal Jury Verdict: Johnson & Johnson JNJ and DePuy announced that they intend to appeal a jury verdict returned against the companies in a federal multidistrict litigation (MDL) proceeding in the United States District Court for the Northern District of Texas in Dallas. The $1 billion plus verdict was given in the trial that consolidated six individual cases concerning DePuy’s ULTAMET Metal-on-Metal Articulation hip replacement.
J&J and Merck are some of the better-performing pharma stocks having outperformed the Zacks categorized Large Cap Pharmaceuticals industry -- while J&J and Merck gained 8.4% and 15%, respectively, year-to-date (YTD), the Zacks categorized Large Cap Pharmaceuticals industry declined 8.1% during this period. J&J and Merck are both Zacks Rank #3 (Hold) stocks. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AstraZeneca Inks Deal with Bicycle Therapeutics: AstraZeneca AZN is teaming up with biotech company, Bicycle Therapeutics, for the identification and development of bicyclic peptides (Bicycles - small molecule medicines designed to overcome many of the limitations of existing drug modalities) for the treatment of respiratory, cardiovascular and metabolic diseases. AstraZeneca could end up shelling out more than $1 billion under the deal including an upfront payment, future R&D funding, development, regulatory and commercialization milestone payments. The company will also pay royalties on products resulting from the collaboration.
Pfizer Signs Deal with IBM Watson, Provides Pipeline Updates: Pfizer PFE and IBM Watson Health will collaborate for the use of IBM Watson's cognitive computing capabilities to speed up Pfizer’s immune-oncology efforts. Watson for Drug Discovery is a cloud-based offering that aims to help discover new drug targets and alternative drug indications.
Pfizer also provided some pipeline updates -- the company announced positive data from a study conducted on its biosimilar version of Roche’s RHHBY blockbuster cancer drug, Herceptin (trastuzumab), for HER2-positive metastatic breast cancer (Read more: Pfizer's Herceptin Biosimilar Meets Primary Endpoint in Study). Pfizer also announced positive top-line data from a study evaluating Lyrica as adjunctive therapy in pediatric epilepsy patients (4 to 16 years of age) with partial onset seizures.
Meanwhile, Pfizer and Merck KGaA announced that they got priority review from the FDA for avelumab for metastatic Merkel cell carcinoma (MCC). Approval could make avelumab the first treatment to gain FDA approval for metastatic MCC, a rare and aggressive skin cancer estimated to affect about 2,500 Americans every year (Read more: Pfizer/Merck KGaA: Priority Review for Cancer Drug Avelumab).
Large Cap Pharmaceuticals Industry Price Index
Large Cap Pharmaceuticals Industry Price Index
The NYSE ARCA Pharmaceutical Index declined 1.3% over the last five trading days with Lilly declining almost 3%. Lilly’s shares continue to feel the impact of the solanezumab setback. We note that Lilly has underperformed the Zacks categorized Large Cap Pharmaceuticals industry with the company declining 21.7% YTD. Meanwhile, Pfizer’s shares were up slightly (0.1%) over the last five trading days.
Over the last six months, Merck gained 7.9% while Bristol-Myers BMY declined 22.4% (See the last pharma stock roundup here: Lilly Alzheimer's Drug Fails, J&J in Acquisition Talks with ALIOF).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates as well as deals and collaborations. Several companies including Merck and AstraZeneca will be present at the World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer with data on approved and pipeline cancer drugs.
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