Biotech Stock Roundup: Avanir to be Acquired by Japanese Firm …
Mergers and acquisitions show no signs of slowing down in the biotech sector with a $3.5 billion acquisition agreement being announced. Meanwhile, Biogen (BIIB – Analyst Report) is advancing towards developing a treatment for Alzheimer’s disease.
Recap of the Week’s Most Important Stories
1. Biogen is set to move its experimental Alzheimer’s disease treatment, BIIB037, into late-stage testing based on promising interim results from an early-stage study announced at the Deutsche Bank BioFest conference. Biogen said that a statistically significant improvement in cognition was observed after 54 weeks of treatment along with dose/time dependent reduction in beta amyloid. Investors were cheered by the news sending shares up more than 6%.
The Alzheimer’s disease market represents huge commercial potential and Biogen could rake in multi-billions in sales on the successful development and approval of BIIB037. However, the big question is whether Biogen will succeed where many other companies like Pfizer, Johnson & Johnson and Eli Lilly have faced setbacks. The development of Alzheimer’s treatments has proved to be challenging, with several high-profile failures in this field.
2. U.S.-based Avanir (AVNR – Analyst Report) is set to be acquired by Japanese company, Otsuka in a deal valued at about $3.5 billion. With this acquisition, Otsuka will be able to strengthen its position in the central nervous system (CNS) disorder market.
Moreover, Otsuka is facing a major patent cliff with blockbuster drug Abilify slated to lose patent exclusivity in the U.S. in 2015. The Avanir acquisition will bring together Otsuka’s experience and track record in the area of mental illnesses and Avanir’s experience in neurologic diseases (including Nuedexta, approved for the treatment of pseudobulbar affect, a neurologic condition estimated to affect almost 2 million Americans). Avanir’s shares were up 12.8% on the deal.
3. Puma Biotechnology (PBYI – Snapshot Report), which was previously looking to file for FDA approval for its experimental breast cancer treatment in the first half of 2015, is now anticipating a delay in its filing plans. Based on the FDA’s requirements for preclinical carcinogenicity data, the PB272 (neratinib) filing is now scheduled for the first quarter of 2016.
Puma had earlier been focused on seeking approval for HER2-positive metastatic breast cancer. However, the company has now decided to file for extended adjuvant HER2-positive early stage breast cancer, due to which the safety data is needed by the regulatory agency.
4. The FDA will be reviewing Regeneron Pharmaceuticals, Inc.’s (REGN – Analyst Report) regulatory application for blockbuster eye drug, Eylea, for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME) on a priority basis. This means that a response from the agency will out by Mar 30, 2015 (Read more: Regeneron/Bayer’s Eylea to be Reviewed on a Priority Basis).
5. Alexion (ALXN – Analyst Report) provided Soliris related updates last week. The company said that Soliris has been recommended by NICE for use within the National Health Service in England as the first and only treatment for patients with atypical hemolytic uremic syndrome (Read more: Alexion’s Soliris Gets Final Positive NICE Recommendation).
Meanwhile, Soliris has been granted orphan drug designation in Japan for the treatment of patients with neuromyelitis optica (Read more: Alexion’s Soliris Gets Orphan Drug Status in Japan).
Performance
Over the last five trading days, Biogen was the highest gainer with shares increasing 7.49%. A major part of this gain was due to the encouraging Alzheimer’s disease data.
Vertex (VRTX – Analyst Report) recorded the highest gain (63.78%) among major biotechs over the last six months.
Overall, the NASDAQ Biotechnology Index was up 2.43% over the last five trading days (See the last biotech stock roundup here: BioMarin to Acquire Prosensa, AbbVie HCV Therapy Closer to EU Approval)
Company
Last Week
Last 6 Months
AMGN
4.34%
46.63%
BIIB
7.49%
3.16%
GILD
1.07%
25.31%
CELG
3.72%
48.78%
REGN
2.00%
36.20%
ALXN
4.16%
20.20%
VRTX
4.17%
63.78%
What’s Next in the Biotech World?
Later this week, the FDA is expected to issue a response regarding Incyte’s (INCY – Analyst Report) regulatory filing seeking approval for the use of Jakafi in patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
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Biotech Stock Roundup: Avanir to be Acquired by Japanese Firm …
