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French pharma giant Sanofi (SNY - Free Report) and partner Regeneron were hit by a court injunction blocking the sale of their PCSK9 inhibitor Praluent in the U.S. Meanwhile, Allergan provided a preliminary look at its expectations for 2017.
Recap of the Week’s Most Important Stories
Sanofi’s Praluent Hit by Court Injunction: Sanofi and Regeneron suffered a setback with the United States District Court in Delaware granting biotech major Amgen's request for a permanent injunction prohibiting the sale of Praluent, Sanofi and Regeneron’s PCSK9 inhibitor. The injunction relates to a patent infringement lawsuit filed by Amgen and follows a favorable jury verdict received by Amgen in Mar 2016.
The injunction is not effective immediately with the court giving 30 days for the defendants to seek expedited review. Needless to say, Sanofi and Regeneron intend to appeal the injunction as well as the jury verdict in favor of Amgen.
The injunction is a pretty big setback for Sanofi and Regeneron. Although sales of PCSK9 inhibitors have not picked up as expected, they are still expected to have blockbuster potential especially if positive data is generated from currently ongoing cardiovascular outcomes studies.
Allergan Guides to Mid-Single-Digit Top-Line Growth & Double-Digit EPS Growth in 2017: Allergan provided a preliminary outlook for 2017 with the company expecting revenues to grow in mid-single-digits while earnings are expected to grow in double-digits. Detailed information will be provided on the fourth quarter call in February. While revenues will be driven by new product launches, international growth and growth from key products, earnings growth will be driven by revenues, operating expense management, a lower share count and lower interest expense. Guidance does not include accretion from the recently announced Lifecell acquisition deal (Read more: Allergan to Buy LifeCell to Boost Regenerative Medicine Suite).
The company expects stable Restasis revenues while Namenda franchise sales will continue to erode especially with the expected entry of a generic version of Namenda XR in the fourth quarter of 2017. The preliminary outlook is in line with current expectations. Allergan is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
J&J - Bristol-Myers in Immuno-Oncology Clinical Trial Collaboration: Johnson & Johnson’s (JNJ - Free Report) Janssen Biotech entered a clinical trial collaboration with Bristol-Myers (BMY - Free Report) under which a combination of J&J’s Darzalex (a CD38-directed cytolytic antibody) will be evaluated in combination with Bristol-Myers’ checkpoint inhibitor Opdivo in phase Ib/phase II studies for multiple myeloma and solid tumor types.
J&J also announced that DePuy Synthes Products entered into an asset purchase and development agreement with Interventional Spine, Inc., a privately held manufacturer of expandable cage and minimally invasive surgery (MIS) technologies for spinal fusion. Financial details were not provided. We note that J&J is in talks with Actelion as well regarding a possible transaction (Read more: J&J Resumes Talks with Actelion: Did Sanofi Just Lose Out?).
Pfizer’s Biosimilar Humira Hits Primary Endpoint: Pfizer (PFE - Free Report) continues to deliver on its biosimilar pipeline with the company reporting positive data on its biosimilar version of AbbVie’s top-selling blockbuster drug, Humira. Pfizer said that PF-06410293 met the primary endpoint by showing similar efficacy to Humira in patients with moderate to severe rheumatoid arthritis. Humira is approved for a wide range of indications including rheumatoid arthritis. We note that last year in September, the FDA had approved Amgen’s Amjevita, a biosimilar version of Humira, though the product is yet to be launched.
The NYSE ARCA Pharmaceutical Index was up 3% over the last four trading days with all major pharma stocks recording a gain. AstraZeneca (AZN - Free Report) was up 4.9% during this period. However, over the last one year, AstraZeneca has underperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares declining 13.9% compared to the industry decline of 2.6%. Over the last six months, Merck (MRK - Free Report) gained 3.6% while Bristol-Myers declined 18.5% (See the last pharma stock roundup here: Cempra Plunges to 52-Week Low, Shire Drug Label Expanded).
What's Next in the Pharma World?
Watch out for the 35th annual J.P. Morgan Healthcare Conference where several companies will be present providing pipeline updates, preliminary results as well as 2017 guidance.
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Pharma Stock Roundup: PCSK9 Inhibitor Praluent in News, Allergan's Preliminary 2017 View
French pharma giant Sanofi (SNY - Free Report) and partner Regeneron were hit by a court injunction blocking the sale of their PCSK9 inhibitor Praluent in the U.S. Meanwhile, Allergan provided a preliminary look at its expectations for 2017.
Recap of the Week’s Most Important Stories
Sanofi’s Praluent Hit by Court Injunction: Sanofi and Regeneron suffered a setback with the United States District Court in Delaware granting biotech major Amgen's request for a permanent injunction prohibiting the sale of Praluent, Sanofi and Regeneron’s PCSK9 inhibitor. The injunction relates to a patent infringement lawsuit filed by Amgen and follows a favorable jury verdict received by Amgen in Mar 2016.
The injunction is not effective immediately with the court giving 30 days for the defendants to seek expedited review. Needless to say, Sanofi and Regeneron intend to appeal the injunction as well as the jury verdict in favor of Amgen.
The injunction is a pretty big setback for Sanofi and Regeneron. Although sales of PCSK9 inhibitors have not picked up as expected, they are still expected to have blockbuster potential especially if positive data is generated from currently ongoing cardiovascular outcomes studies.
Allergan Guides to Mid-Single-Digit Top-Line Growth & Double-Digit EPS Growth in 2017: Allergan provided a preliminary outlook for 2017 with the company expecting revenues to grow in mid-single-digits while earnings are expected to grow in double-digits. Detailed information will be provided on the fourth quarter call in February. While revenues will be driven by new product launches, international growth and growth from key products, earnings growth will be driven by revenues, operating expense management, a lower share count and lower interest expense. Guidance does not include accretion from the recently announced Lifecell acquisition deal (Read more: Allergan to Buy LifeCell to Boost Regenerative Medicine Suite).
The company expects stable Restasis revenues while Namenda franchise sales will continue to erode especially with the expected entry of a generic version of Namenda XR in the fourth quarter of 2017. The preliminary outlook is in line with current expectations. Allergan is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
J&J - Bristol-Myers in Immuno-Oncology Clinical Trial Collaboration: Johnson & Johnson’s (JNJ - Free Report) Janssen Biotech entered a clinical trial collaboration with Bristol-Myers (BMY - Free Report) under which a combination of J&J’s Darzalex (a CD38-directed cytolytic antibody) will be evaluated in combination with Bristol-Myers’ checkpoint inhibitor Opdivo in phase Ib/phase II studies for multiple myeloma and solid tumor types.
J&J also announced that DePuy Synthes Products entered into an asset purchase and development agreement with Interventional Spine, Inc., a privately held manufacturer of expandable cage and minimally invasive surgery (MIS) technologies for spinal fusion. Financial details were not provided. We note that J&J is in talks with Actelion as well regarding a possible transaction (Read more: J&J Resumes Talks with Actelion: Did Sanofi Just Lose Out?).
Pfizer’s Biosimilar Humira Hits Primary Endpoint: Pfizer (PFE - Free Report) continues to deliver on its biosimilar pipeline with the company reporting positive data on its biosimilar version of AbbVie’s top-selling blockbuster drug, Humira. Pfizer said that PF-06410293 met the primary endpoint by showing similar efficacy to Humira in patients with moderate to severe rheumatoid arthritis. Humira is approved for a wide range of indications including rheumatoid arthritis. We note that last year in September, the FDA had approved Amgen’s Amjevita, a biosimilar version of Humira, though the product is yet to be launched.
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up 3% over the last four trading days with all major pharma stocks recording a gain. AstraZeneca (AZN - Free Report) was up 4.9% during this period. However, over the last one year, AstraZeneca has underperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares declining 13.9% compared to the industry decline of 2.6%. Over the last six months, Merck (MRK - Free Report) gained 3.6% while Bristol-Myers declined 18.5% (See the last pharma stock roundup here: Cempra Plunges to 52-Week Low, Shire Drug Label Expanded).
What's Next in the Pharma World?
Watch out for the 35th annual J.P. Morgan Healthcare Conference where several companies will be present providing pipeline updates, preliminary results as well as 2017 guidance.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?
Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>