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Pharma Stock Roundup: Drug Pricing Remains in Focus, Merck Drops Odanacatib
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While drug pricing and Mylan remained in the news this week as well, companies like Merck (MRK - Free Report) , Bristol-Myers (BMY - Free Report) and Novo Nordisk (NVO - Free Report) came out with regulatory/pipeline updates.
Recap of the Week’s Most Important Stories
Mylan now Being Investigated by New York AG, Allergan CEO Issues Statement: The drug pricing issue remains in focus with Mylan now being investigated by the New York Attorney General (AG) for potentially anti-competitive business practices and violation of antitrust laws related to EpiPen. Meanwhile, on a positive note, Allergan’s CEO issued a blog post addressing the drug pricing controversy and said that the company will not engage in price gouging actions or predatory pricing and will limit price increases.
Novo Nordisk Diabetes Drug Pushed Out by 3 Months: Just like Sanofi (SNY - Free Report) , Novo Nordisk is also facing a delay in the regulatory process for its diabetes combination drug. Novo Nordisk announced that the FDA has pushed out the PDUFA date for its type II diabetes combination drug, IDegLira, by three months. IDegLira is a fixed-ratio combination of Tresiba and Victoza (Read more: Novo Nordisk's IDegLira Review Period Extended in the U.S.).
Last month, the FDA had pushed out the action date for Sanofi’s combination diabetes drug (Lantus; basal insulin glargine 100 Units/mL and GLP-1 receptor agonist Adlyxin (ex-U.S. trade name: Lyxumia; lixisenatide). While Sanofi will now get a response in Nov 2016 (Read more: Sanofi Diabetes Combination Drug FDA Action Date Extended), the FDA is expected to issue a decision regarding the Novo Nordisk drug in Dec 2016.
Merck Drops Odanacatib, Gets BTD for Keytruda: Merck has finally decided to discontinue the development of its experimental osteoporosis treatment, odanacatib. The company said that the increased risk of stroke does not support further development of the treatment and the company will not be seeking regulatory approval for the product (Read more: Merck Stops Development of Odanacatib for Osteoporosis).
Meanwhile, Merck is currently working on expanding the label of one of its most promising new drugs, Keytruda. The company is looking to get the cancer treatment approved for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. With the FDA granting priority review, a response should be out by Dec 24, 2016. Merck also got Breakthrough Therapy Designation (BTD) for this indication. Approval for this indication would boost Keytruda’s sales significantly. Merck is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allergan Buys RetroSense & Bayer Ups Monsanto Offer Price: In a bid to boost its eye care pipeline, Allergan acquired private, clinical-stage biotech company RetroSense which is focused on novel gene therapy approaches to restore vision in patients suffering from blindness. Allergan paid $60 million upfront and will make additional payments on the achievement of regulatory and commercialization milestones related to the lead development program, RST-001, which is being evaluated for the treatment of retinitis pigmentosa (Read more: Allergan Takes Over RetroSense; Boosts Eye Care Pipeline).
Meanwhile, Bayer raised its offer for Monsanto and said that it is prepared to shell out $127.50 per Monsanto share. This is not the first time that Bayer raised its offer (Read more: Bayer Raises Offer to Purchase Monsanto Yet Again).
EU Label Expansion for Bristol-Myers Drug: Bristol-Myers’ blockbuster drug, Orencia, gained EU approval the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. Approval was expected considering the EMA Committee for Medicinal Products for Human Use (CHMP) had issued a recommendation in favor of approval in July (Read more: Bristol-Myers' Orencia Gains EU Approval for Expanded Use).
Although drug pricing remains in focus, pharma stocks recovered some lost ground with the NYSE ARCA Pharmaceutical Index gaining 0.9% over the last four trading days. All major pharma stocks recorded a gain during this period with Eli Lilly (LLY - Free Report) rising 3.4%. Over the last six months, Bristol-Myers declined 14.3% while Merck was up 20.6% (See the last pharma stock roundup here: Mylan EpiPen Pricing in Focus, FDA Nod For Novartis Biosimilar).
What's Next in the Pharma World?
While Mylan will continue to remain in the news as investors, lawmakers and media remain focused on drug pricing, watch out for an update on Teva’s generics business following the close of the Actavis generics deal.
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Pharma Stock Roundup: Drug Pricing Remains in Focus, Merck Drops Odanacatib
While drug pricing and Mylan remained in the news this week as well, companies like Merck (MRK - Free Report) , Bristol-Myers (BMY - Free Report) and Novo Nordisk (NVO - Free Report) came out with regulatory/pipeline updates.
Recap of the Week’s Most Important Stories
Mylan now Being Investigated by New York AG, Allergan CEO Issues Statement: The drug pricing issue remains in focus with Mylan now being investigated by the New York Attorney General (AG) for potentially anti-competitive business practices and violation of antitrust laws related to EpiPen. Meanwhile, on a positive note, Allergan’s CEO issued a blog post addressing the drug pricing controversy and said that the company will not engage in price gouging actions or predatory pricing and will limit price increases.
Novo Nordisk Diabetes Drug Pushed Out by 3 Months: Just like Sanofi (SNY - Free Report) , Novo Nordisk is also facing a delay in the regulatory process for its diabetes combination drug. Novo Nordisk announced that the FDA has pushed out the PDUFA date for its type II diabetes combination drug, IDegLira, by three months. IDegLira is a fixed-ratio combination of Tresiba and Victoza (Read more: Novo Nordisk's IDegLira Review Period Extended in the U.S.).
Last month, the FDA had pushed out the action date for Sanofi’s combination diabetes drug (Lantus; basal insulin glargine 100 Units/mL and GLP-1 receptor agonist Adlyxin (ex-U.S. trade name: Lyxumia; lixisenatide). While Sanofi will now get a response in Nov 2016 (Read more: Sanofi Diabetes Combination Drug FDA Action Date Extended), the FDA is expected to issue a decision regarding the Novo Nordisk drug in Dec 2016.
Merck Drops Odanacatib, Gets BTD for Keytruda: Merck has finally decided to discontinue the development of its experimental osteoporosis treatment, odanacatib. The company said that the increased risk of stroke does not support further development of the treatment and the company will not be seeking regulatory approval for the product (Read more: Merck Stops Development of Odanacatib for Osteoporosis).
Meanwhile, Merck is currently working on expanding the label of one of its most promising new drugs, Keytruda. The company is looking to get the cancer treatment approved for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. With the FDA granting priority review, a response should be out by Dec 24, 2016. Merck also got Breakthrough Therapy Designation (BTD) for this indication. Approval for this indication would boost Keytruda’s sales significantly. Merck is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allergan Buys RetroSense & Bayer Ups Monsanto Offer Price: In a bid to boost its eye care pipeline, Allergan acquired private, clinical-stage biotech company RetroSense which is focused on novel gene therapy approaches to restore vision in patients suffering from blindness. Allergan paid $60 million upfront and will make additional payments on the achievement of regulatory and commercialization milestones related to the lead development program, RST-001, which is being evaluated for the treatment of retinitis pigmentosa (Read more: Allergan Takes Over RetroSense; Boosts Eye Care Pipeline).
Meanwhile, Bayer raised its offer for Monsanto and said that it is prepared to shell out $127.50 per Monsanto share. This is not the first time that Bayer raised its offer (Read more: Bayer Raises Offer to Purchase Monsanto Yet Again).
EU Label Expansion for Bristol-Myers Drug: Bristol-Myers’ blockbuster drug, Orencia, gained EU approval the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. Approval was expected considering the EMA Committee for Medicinal Products for Human Use (CHMP) had issued a recommendation in favor of approval in July (Read more: Bristol-Myers' Orencia Gains EU Approval for Expanded Use).
Performance
LARGE CAP PHARMA Industry Price Index
LARGE CAP PHARMA Industry Price Index
Although drug pricing remains in focus, pharma stocks recovered some lost ground with the NYSE ARCA Pharmaceutical Index gaining 0.9% over the last four trading days. All major pharma stocks recorded a gain during this period with Eli Lilly (LLY - Free Report) rising 3.4%. Over the last six months, Bristol-Myers declined 14.3% while Merck was up 20.6% (See the last pharma stock roundup here: Mylan EpiPen Pricing in Focus, FDA Nod For Novartis Biosimilar).
What's Next in the Pharma World?
While Mylan will continue to remain in the news as investors, lawmakers and media remain focused on drug pricing, watch out for an update on Teva’s generics business following the close of the Actavis generics deal.
Confidential: Zacks' Best Investment Ideas
Would you like to see a hand-picked "all-star" selection of investment ideas from the man who heads up Zacks' trading and investing services? Steve Reitmeister knows when key trades are about to be triggered and which of our experts has the hottest hand. Click for his selected trades right now >>