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Wednesday, August 31, 2016
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A Look at Who's Next In the Life Sci M&A Boom


A Look at Who's Next in the Life Sci M&A Boom

The dog days of summer aren't the usual time for anticipating a wave of corporate activity, but that's exactly what has been happening in August...More...


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In an environment of declining revenues and uncertainty, biopharma, device and R&D companies need to evaluate their portfolios. Manufacturers must make tough decisions about which products and projects to pursue to optimize revenue and reduce risk. CHI's Strategic Resource Management and Portfolio Management Event, Oct 31-Nov 4, 2016, Philadelphia, PA. http://www.executivedecisionmaking.com
Opdivo's failure as a first-line therapy for NSCLC was a surprising disappointment, but Biogen and Ionis had a very different sort of surprise: Nusinersen was so successful in its treatment of Type 1 (infantile-onset) spinal muscular atrophy that the trial was halted and the companies will file for approval. If the drug proves as effective in other types of SMA, sales could easily top $2 billion. Biogen gets the bulk of that, with Ionis taking a modest royalty. -KT
Bristol-Myers (BMY)'s Failed Lung Cancer Data Sends Stock Plunging
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Biogen (BIIB) Pays Ionis Pharma (IONS) $75M for Successful Late-Stage Nusinersen Data
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Vertex (VRTX) Dumps Phase III Cystic Fibrosis Study
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Spark Therapeutics (ONCE) Touts Long-Term Positive Phase III Gene Therapy Data
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Pfizer (PFE) Depression Study Data Drums Up More Business for 23andMe
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More Bench To Clinic News
We've been talking about a potential uptick and M&A, and one of the side effects of that is more shuffling in the C-suite. We've been seeing some of that already with Medivation's CMO jumping ship, as well as Baxalta's (merged with Shire) sr. vp and Treasurer becoming CFO of Acadia. Stemcell's merger with Microbot is also shifting around some resumes. -KT
Medivation (MDVN) Exec Jumps Ship to Become CMO at BeiGene (BGNE)
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Acadia (ACAD) Scores Former Baxalta (BXLT) Exec as New CFO
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Eli Lilly (LLY)'s Incoming CEO May Carry First Alzheimer's Drug Across The Finish Line
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Editas Medicine (EDIT) Nabs Former Bristol-Myers (BMY) Exec as New CSO
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StemCells (STEM) CEO, CFO and Three Directors Stepped Down the Day of Microbot Merger That Boosted Stock Sevenfold
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More Career Track News
Pfizer's acquisition of Medivation gets it access to Xtanda—at least, the half of Xtandi that doesn't go to Astellas—as well as a couple of promising oncology products in the pipeline. Still, there are plenty of suggestions that Pfizer paid too much for the company--about 15 times its share of Xtandi sales from 2015 and about 5.8 times its share of peak-year sales projections. Those objections will be silenced if talazoparib (PARP inhibitor for breast cancer) and pidilizumab (B-cell lymphoma) are successful.

Meanwhile, immuno-oncology deals continue along hot and heavy, however. Both Regeneron and Amgen entered into separate I/O partnerships with Advaxis and Adicet Bio, respectively. Advaxis shares skyrocketed in the news, as investors saw it as a validation of the company's neo-epitope technology. Advaxis hopes to sequence patients' tumors, identify unique mutations, and use a bacterial vector to activate a specific immune response. However, human trials have yet to begin for either Advaxis' or Adicet's therapies. -KT
Pfizer (PFE) Scoops Sanofi (SNY) With $14B Buyout Deal for Medivation (MDVN)
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Rumors Again Swirl Over BioMarin (BMRN) Being a Possible Plan B for Sanofi (SNY)
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San Diego's Illumina (ILMN) Jumps on Report of Thermo Fisher Scientific (TMO) $30B Offer
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Amgen (AMGN) Forges Pre-clinical R&D Pact Worth $540M With Advaxis (ADXS)
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After Bagging $51M in Early 2016, Bay Area's Adicet Bio Inks a Five-Year R&D Deal with Regeneron (REGN)
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More Golden Handshakes News

Top Jobs
• LoneStar (Grand Prairie, Texas)

Neos Therapeutics
CCO
Will be tasked with running a leading edge compliance program and will have broad oversight over the compliance aspects of Neos' operation. The CCO will be expected to Chair the Compliance Committee.

• Biotech Beach (San Diego, California)

HUYA Bioscience
CFO
Will be responsible for driving our corporate development and M&A activities, and for the overall management of HUYA's financial and administrative matters. regulatory compliance, regulatory advice etc.

• Biotech Bay (San Ramon, California)

Galena Biopharma
Sr. Director, Clinical Operations Lead
Will manage overall operational implementation and close out of the clinical project to execute on the study and scientific plan and ensures overall quality over the life of a study to meet study endpoints and overall program goals and objectives.

• Biotech Bay (Emeryville, California)

BioClin Therapeutics
VP of Clinical Operations & Development
Candidate is responsible for the strategic planning, starting, executing, managing and completing one or multiple oncology clinical development programs.

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Here's another small indication that there isn't a powder keg of M&A waiting for a spark: Acadia just raised $200 million. As in, it needed the money because it didn't get a better offer from a suitor—the recent approval of Nuplazid for Parkinson's-related delusions notwithstanding. Of course, if it also gets approval for Alzheimer's-related psychosis, that will be a whole other story. -KT
Bay Area Life Sciences VC Firm Sofinnova Scores $595.5M
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Thar Pharma Files for $50M IPO
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Activist Investor Jeffrey Smith Wants to Overturn Depomed (DEPO) Board and Run it Like Olive Garden
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Tioma, Originally Founded as Vasculox, Scores $86M Series A Financing
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Acadia (ACAD) Prices Public Offering Of Common Stock
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More Money Talk News

It's probably not a great month when there seems to be more biopharma news concerning lawsuits than anything else. Juno is facing angry patients, Valeant is dealing with angry investors, and Pfizer just paid another big settlement. Celgene is accused of a scheme involving using charities to boost sales. But the most headlines were grabbed by Mylan—another company putting forward a huge price in an election year. Yikes! -KT
Facing Public Backlash and Pressure from Clinton, Mylan (MYL) Caves and Lowers Price of EpiPen
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Juno (JUNO) Facing Class Action Lawsuit Following Patient Deaths
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Valeant (VRX) Faces New Fraud Lawsuit Filed By Former Investor
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Pfizer (PFE) to Fork Over $486M to Settle Lawsuit Over Celebrex, Bextra
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Celgene (CELG) Accused of Donating Millions to Charities as Part of a Business 'Scheme to Gain Billions'
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More Legal Briefs News
It's been a slow summer month at FDA. Only one new chemical entitiy approved since our last issue, and that approval came in late July. Moreover, that one approval—for Sanofi's Adlyxin (lixisenatide)—is very late in coming. As in, years late. It enters an increasingly crowded GLP-1 market, and may have a hard time taking share from Victoza, which has some compelling data on reducing cardiovascular risks. -KT
Clovis Oncology (CLVS) Rockets as FDA Agrees to Priority Review of Rucaparib NDA
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Amgen (AMGN) Remains Hush-Hush Over FDA Rejection of Parsabiv
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Bay Area's Portola (PTLA) Plummets as FDA Rejects AndexXa NDA
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With Hopes of Bolstering Sanofi (SNY)'s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S.
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Endo (ENDP) Withdraws Its Supplemental NDA for Pain Drug OPANA
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More Rockville Files News

Karl Thiel is an analyst for The Motley Fool and a longtime follower of the biotech industry. He lives in Austin, Texas.

You may contact Karl Thiel at news@biospace.com.

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