BioSpace BioPharm Exec
Wednesday, November 30, 2016
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Ok, So It's Hillary


What The...?! It's Trump!

Well, I couldn't have been more wrong with the premise of last month's column. Like much of America, I listened to pundits and polls, and assumed that Donald Trump wouldn't be able to overcome the very long odds required to beat Hillary Clinton...More...
The failure of Lilly's solanezumab is sorely disappointing for those impacted by Alzheimer's disease, although it's hard to call the results truly surprising. Not only is there the dismal track record for Alzheimer's drugs in the clinic, but there's also the fact that solanezumab had failed before, albeit in a different study with a slightly different population. But Lilly's bad news is also affecting other companies—particularly Biogen, which is expected to soon announce new data on its own drug, aducanumab. This drug has a different mechanism of action, but still relies on the hypothesis that halting the aggregation of beta-amyloid plaques will help the course of the disease. We should hear a little more at the Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego on December 9, 2016.

Biogen did at least have some good news, in that Spinraza (nusinersen) continues to look very promising in other forms of spinal atrophy, not just infant-onset. -KT
Devastation Hits as Eli Lilly (LLY)'s Alzheimer's Drug Flunks Late-Stage Study, Shares Tank
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Juno (JUNO) Halts CAR-T Trial for Second Time Following Additional Patient Deaths
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Gilead (GILD) Suffers Another R&D Setback as Myelofibrosis Drug Flops in Phase III, Gives Credence to Acquisition Urgency
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Stocks Rocket as Biogen (BIIB), Ionis Pharma (IONS) Halt Study on Positive Phase III
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Merck (MRK)'s Alzheimer's Contender Wows in Human Clinical Trial
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More Bench To Clinic News
It looks like biotech probably won't have an insider at the top levels of the Trump Administration, at least if that somebody was going to be Celgene vp of Corporate Affairs Rich Bagger. Bagger is returning to his position at Celgene after taking a leave of absence to work on Trump's campaign. Now biotech's hopes for inside influence seem to be riding on...Newt Gingrich. Gingrich's name has been floated for a number of cabinet and "advisory" positions, including Secretary of State (gulp). But he is at least a consistent supporter of medical research. -KT
This Could be The Reason Elizabeth Holmes is Still Leading Theranos
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Booming Shire (SHPG) to Take Over Sanofi Genzyme (SNY)'s HQ in Kendall Square, Eyes Hiring Another 400 Employees
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Celgene (CELG) Exec Out as Trump Puts Vice President Elect Leader of Transition Effort
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5 Biopharma Influencers Likely to Be on Trump's Transition Team
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Biogen (BIIB) Taps Former Spark Therapeutics (ONCE) Exec and a Finance Vet for Hemophilia Spin-off Company Bioverativ
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More Career Track News
While we wait for all those repatriated dollars to set off an M&A boom (see Introduction), current reality looks somewhat different. Astellas is trading Yen for Euros in its acquisition of Ganymed, a company with a promising gastric cancer drug. Celldex (with no overseas cash I'm aware of) is bolstering its pipeline by acquiring Koltan, a company that is developing technology to overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors. And Novartis isn't letting a weaker Euro scare it away from an opportunity it sees in U.S. company Selexys, which is developing an antibody that addresses sickle cell pain. Johnson & Johnson, at least, may be taking advantage of a strong dollar in its pursuit of Swiss company Actellion. -KT
Johnson & Johnson (JNJ) Makes a Play for This $19.9B Swiss Biotech
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Novartis (NVS) Scoops Up U.S. Sickle Cell Drugmaker Selexys in $665M Deal
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Bristol-Myers (BMY) Slams Down $100M to Make a Play Into NASH
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Celldex (CLDX) Takes Out Kolltan Pharma in $235M Deal
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Little-Known Ganymed Grabs a $1.4B Buyout Deal From Astellas (ALPMY)
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More Golden Handshakes News

Top Jobs
• Biotech Bay (South San Francisco, California)

NGM Biopharma
VP, Clinical Development
Will report directly to the CMO and be responsible for conceiving and implementing the clinical strategy of the development programs, as well as the design and execution of international clinical studies, oversight and interpretation of clinical trials data and clinical interactions with multidisciplinary groups across the company.

• Biotech Bay (South San Francisco, California)

Global Blood Therapeutics
Director, Medical Communications & Publications
Will be responsible for leading and developing a medical communication and publications strategy for GBT's clinical product(s) and trials and pipeline drugs, which will enable the company to realize its mission of delivering best-in-class medicines to patients with grievous blood disorders.

• Biotech Beach (San Diego, California)

Regulus
VP, Regulatory Affairs
Seeking a highly strategic and motivated Vice President Regulatory Affairs responsible for developing and overseeing the company's regulatory strategy to support its ongoing R&D programs.

• Pharm Country (Princeton, New Jersey)

Ophthotech
Director, Marketing
Will play a vital leadership role in the U.S. launch of Ophtotech's lead compound (E10030/pegpleranib), for the treatment of wet Age Related Macular Degeneration (AMD).

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This has been a tough year for biotech investors—at least those working in the public market. But for venture capitalists, 2016 continues a good run. The IPO market continues to plug along, returns are above average, and new funds are being raised. Third Rock's Fund IV brought in a record haul in an oversubscribed round, while Arch's Fund IX is still pulling in cash. -KT
Cambridge Upstart Magenta Therapeutics Bags $48.5M and Will be Helmed by Former GSK (GSK) R&D Head
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UK Antibodies Powerhouse Kymab Bags $100M and Two New Backers From China
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Biotech Venture Capital Mythbusting Redux
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VC Firm Arch Venture Inches Closer to $550M+ Biotech Fund
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Serial Biotech Startup Creator Third Rock Ventures Nabs a Record $616M
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More Money Talk News

The election of Donald Trump is rippling through government right now, with far more questions than answers. Some are taking an optimistic view, believing that Trump could help cut through the red tape that many critics have complained about for years. Others have pointed out his apparent disdain for science, and his explicit antipathy towards the NIH, as causes for concern. With post-election Trump seemingly back-pedaling from some of the positions of pre-election Trump, and neither offering more than vague outlines, it's hard to know what to expect. -KT
How Donald Trump Could Disrupt the FDA
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Top 8 Pharma Companies That Paid the Least in Taxes and How They Will Fare Under Trump
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7 Reasons Scientists are Terrified About Donald Trump's Presidency
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Two Private Investigators Accuse GSK (GSK) of Hiring Them Under False Pretenses
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Former Valeant (VRX) CEO and CFO May Face Criminal Charges
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More Legal Briefs News
There have been no novel drug approvals since October 21, but then the agency may be a little distracted right now. First there is, of course, the election of Donald Trump and what that might mean for the agency and reform, for better or worse. On top of that, it's coming under fire for its handling of Juno Therapeutics and its recent clinical hold of JCAR015. Back in July, FDA placed and then lifted a clinical hold on the CAR-T therapy in record time, lending credence to Juno's assertions that deaths in the trial were due to the chemotherapy drug fludarabine, not JCAR015 itself. With two more deaths, that explanation no longer holds water, and a number of critics are saying the agency has become too lenient.

Interestingly, these two things are related. Trump, like many Republicans before him, wants FDA to be quicker to approve drugs. But in the past, such policies haven't been accompanied with proposals to increase the agency's budget. If the agency is simply supposed to do more, more quickly, with the same amount of money, that means more flexibility and more shortcuts—exactly what it's coming under fire for with Juno and other recent decisions like the approval of Sarepta's etiplersen. It will be interesting to see how this unfolds. -KT
Bay Area's Dynavax (DVAX) Plunges After the FDA Spurns HEPLISAV-B Again
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FDA Calls It! Seattle Genetics (SGEN)' Adcetris is a Breakthrough for Lymphoma
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Latest Deaths in Juno (JUNO) Trial Puts Unwanted Limelight on the FDA
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Trump Promises to "Reform the FDA" in Post-Election Mission Statement
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President Elect Donald Trump And FDA
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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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