Pharma Stock Roundup: Mylan, Endo Report 4Q Results, FDA Nod for AZN Diabetes Drug
This week, companies like Mylan MYL, Endo and Valeant reported earnings results. Meanwhile, several companies including Roche RHHBY and AstraZeneca AZN provided pipeline/regulatory updates.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: This week companies like Mylan, Endo and Valeant (Read more: Valeant Tops Q4 Earnings, Shares Down on Tepid View) reported fourth quarter results. Although Endo surpassed earnings and revenue estimates, the company’s guidance disappointed (Read more: Endo Beats on Q4 Earnings, Revenues; Guides Low). Mylan’s results were also better-than-expected (Read more: Mylan Beats on Q4 Earnings, Stock Up on Strong View).
Positive Data on Merck’s Antiviral Drug: Merck’s MRK investigational antiviral treatment for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult CMV-seropositive recipients of a bone marrow transplant (BMT) fared well in a pivotal late-stage study. Not only a fewer number of patients developed significant CMV infection while on Merck’s treatment, lower all-cause mortality was also observed in the letermovir arm compared to placebo. Merck intends to seek regulatory approval in the U.S. and EU this year. Merck has outperformed the Zacks categorized Large Cap Pharmaceuticals industry year-to-date with shares gaining 12.6% compared to the industry gain of 7.7%. Merck is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Pipeline Updates from Roche: Swiss drugmaker Roche had a couple of updates on the pipeline front -- the company reported positive data from a phase III study that showed that its Perjeta regimen helped people with an aggressive type of early breast cancer live longer without their disease returning compared to Herceptin plus chemo. A statistically significant improvement in invasive disease-free survival in people with HER2-positive early breast cancer was observed in the Perjeta plus Herceptin and chemo arm compared to the Herceptin plus chemo arm. Detailed data will be presented at a medical meeting this year.
The Perjeta, Herceptin and chemo combination is already approved for use as a neoadjuvant (before surgery) treatment for people with HER2-positive early breast cancer. Herceptin brought in sales of CHF 6,782 million in 2016 while Perjeta sales were CHF 1,846 million. However, quite a few companies are working on bringing biosimilar versions of Herceptin to market. Mylan expects a response from the FDA for its biosimilar version of Herceptin on Sep 3, 2017.
Meanwhile, Roche has started a second phase III study on its investigational Alzheimer’s disease treatment, crenezumab. The study will evaluate patients with prodromal or mild Alzheimer's disease. Results from the earlier phase III study are expected in 2020.
AstraZeneca’s Diabetes Combination Drug Gets FDA Nod: AstraZeneca gained FDA approval for its type II diabetes treatment, Qtern, which is a combination of a DPP-4 inhibitor and a SGLT-2 inhibitor. The combination treatment had gained EU approval last year in July though FDA approval took a while to come with the agency issuing a complete response letter in Oct 2015. The FDA had asked the company to provide more data.
AstraZeneca also entered into a deal with French drugmaker Sanofi’s SNY vaccines global business unit Sanofi Pasteur for the development and commercialization of MEDI8897 for the prevention of respiratory syncytial virus (RSV) associated illness in newborns and infants. Under the deal, AstraZeneca will get €120 million upfront and up to €495 million on the achievement of development and sales-related milestones. All costs and profits will be shared equally.
Priority Review for Pfizer/Merck KGaA Cancer Drug: Pfizer PFE and partner Merck KGaA’s investigational cancer treatment, avelumab, gained priority review in the U.S. for a second indication. A response from the FDA for the regulatory application for the treatment of metastatic urothelial carcinoma should be out by Aug 27, 2017. Avelumab was granted priority review for the treatment of metastatic Merkel cell carcinoma in Nov 2016.
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up 0.3% over the last five trading sessions with all major pharma stocks recording gains. Bristol-Myers BMY was up 1.9% during this period. Over the last six months, Lilly gained 7.9% while AstraZeneca was down 11.1% (See the last pharma stock roundup here: Is BMY the Next Acquisition Target? Priority Review for PFE, Novartis Drugs).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates. Merck is awaiting a response from the FDA for its anti-PD-1 therapy, Keytruda, for the treatment of previously treated patients with advanced microsatellite instability-high cancer -- a decision should be out by Mar 8.
A Full-Blown Technological Breakthrough in the Making
Zacks’ Aggressive Growth Strategist Brian Bolan explores autonomous cars in our latest Special Report, Driverless Cars: Your Roadmap to Mega-Profits Today. In addition to who will be selling them and how the auto industry will be impacted, Brian reveals 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Roche Holding AG (RHHBY): Free Stock Analysis Report
Sanofi (SNY): Free Stock Analysis Report
Astrazeneca PLC (AZN): Free Stock Analysis Report
Bristol-Myers Squibb Company (BMY): Free Stock Analysis Report
Pfizer, Inc. (PFE): Free Stock Analysis Report
Merck & Company, Inc. (MRK): Free Stock Analysis Report
Mylan N.V. (MYL): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
