Once again, deals and collaborations made news in the biotech sector with BioMarin (BMRN) announcing its intention to acquire Prosensa (RNA) and Five Prime Therapeutics (FPRX) signing a second immuno-oncology focused deal with Bristol-Myers Squibb.
Meanwhile, AbbVie (ABBV) continues to progress with its hepatitis C virus (HCV) treatment with regulatory timelines fast approaching.
Recap of the Week’s Most Important Stories
1. BioMarin is looking to acquire Dutch company, Prosensa, and could end up paying up to $840 million for the acquisition. This includes two $80 million payments which depend on the time-specific approval of Duchenne muscular dystrophy (DMD) candidate, drisapersen. While it’s a high risk deal considering drisapersen failed in a phase III study and GlaxoSmithKline backed out of a partnership agreement for drisapersen, rewards will be equally high if drisapersen gains regulatory approval. Although quite a few companies are working on bringing DMD treatments to market, Prosensa has already started the rolling NDA submission in the U.S. and could have a head start over competitors if approval comes on schedule. Prosensa shares shot up 62.6% on the acquisition news (Read more: Prosensa Soars on $680M Buyout Offer from BioMarin).
2. Clinical-stage biotech company, Five Prime Therapeutics, struck a deal with Bristol-Myers under which Five Prime’s antibody (FPA008) will be evaluated in combination with Bristol-Myers’ promising PD-1 inhibitor Opdivo (nivolumab). The combination will be evaluated for safety, tolerability and preliminary efficacy in six types of cancer – non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. This marks the second immuno-oncology collaboration between the companies. Immuno-oncology is an area that has been attracting a lot of attention and the possibility of combining antibodies targeting PD-1 and CSF1R to get an enhanced anti-tumor immune response looks interesting and may well represent the next generation of immunotherapies for cancer patients. Five Prime’s shares shot up 31.4% on the deal.
3. AbbVie could gain EU approval for its experimental HCV cocktail treatment sometime in the first quarter of 2015. The EU’s CHMP has provided positive opinions for the investigational, all-oral, interferon-free treatment of Viekirax plus Exviera for use with or without ribavirin (RBV) in patients with genotype 1 (GT1) and genotype 4 (GT4) chronic HCV infection. Meanwhile, a response from the FDA regarding the approval status of the candidate should be out shortly (Read more: AbbVie's HCV Cocktail Treatment Closer to EU Approval).
4. Amgen (AMGN) has decided that it will not be continuing with studies being conducted on its advanced gastric cancer treatment, rilotumumab. The company’s decision was based on a planned safety review of a late-stage study which showed a higher incidence in the number of deaths in the rilotumumab and chemotherapy arm compared to the chemotherapy only arm (Read more: Amgen Ends Gastric Cancer Drug Studies on Safety Review). Meanwhile, Amgen and partner AstraZeneca fared well in a phase III study with their experimental psoriasis drug, brodalumab, beating Johnson and Johnson’s Stelara. The companies are now planning to enter into discussions regarding regulatory filings.
5. Biogen’s (BIIB) oral multiple sclerosis (MS) treatment, Tecfidera, will now carry a warning in its label regarding the occurrence of progressive multifocal leukoencephalopathy (PML) and subsequent death of a MS patient who was being treated with Tecfidera. On its third quarter call in October, Biogen had confirmed the PML case. Tecfidera, approved in the U.S. in Mar 2013 and the EU in Feb 2014, is one of Biogen’s most successful product launches. Tecfidera, which is the number one oral MS treatment in the U.S., has already brought in sales of $1.99 billion in the first nine months of 2014. The updated label should not impact scrips significantly – with one PML case being reported out of more than 100,000 patients, patients may be willing to overlook safety concerns given Tecfidera’s impressive efficacy.
Performance
Over the last five trading days, Celgene was the highest gainer with shares increasing 4.02%. Meanwhile, Gilead lost the most during this period (down 2.51%).
Vertex (VRTX) recorded the highest gain (60.74%) among major biotechs over the last six months.
Overall, the NASDAQ Biotechnology Index was up 1.51% over the last five trading days (See the last biotech stock roundup here: Geron Soars on $935M J&J Deal, Gilead’s Harvoni Approved in the EU).
| Company | Last Week | Last 6 Months |
| AMGN | 0.00% | 43.13% |
| BIIB | -0.05% | 1.90% |
| GILD | -2.51% | 24.92% |
| CELG | 4.02% | 47.96% |
| REGN | -0.05% | 38.70% |
| ALXN | 0.21% | 18.77% |
| VRTX | 2.84% | 60.74% |
What's Next in the Biotech World?
While nothing specific is lined up later this week, stay tuned for the usual pipeline and regulatory updates.
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