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Wednesday, April 26, 2017
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Who Will Trump Go After Next?

Who Will Trump Go After Next?

With health care reform exploding on the launch pad, and explosions of a more literal nature dominating the current news cycle, it might seem that drug companies can finally breathe a small sigh of relief...More...
Massive, long-term population studies used to be the province of government—think of the Framingham Heart Study or the Multicenter AIDS Cohort Study (MACS). But with government budgets already stretched thin and threatened with further cuts, we may see little of this kind of publicly funded research in the future. That's why it's interesting to see how the private sector steps in. The Verily division of Alphabet is launching the massive Project Baseline study, and the initial focus is broad rather than deep. The goal is to track all sorts of health parameters using smartphones and other sensors, and correlate this with genetic information, health outcomes, and other collected data. It's fundamentally different than the large studies we've seen in the past in that it launches with a huge faith in Big Data. Collect mind-numbing quantities of information, the thinking goes, and we'll find something interesting. Certainly it's an interesting and ambitious program. -KT
Google (GOOG)'s Verily Launches 10,000-Person Study to 'Create a Map of Human Health'

Genentech (RHHBY) Shows Off Late-Stage Hemophilia A Data

Vertex (VRTX) Gains Nearly $4B In Market Cap As New Cystic Fibrosis Drug Wows In Two Phase III Studies

AbbVie (ABBV)'s PARP Inhibitor Fails to Deliver in Two Late-Stage Studies

Novartis (NVS) Remains Hush-Hush About CAR-T Trial But the FDA is Impressed and Thinks It's a Breakthrough

More Bench To Clinic News
It's return-of-the-prodigal-CEO month. Former Medivation head David Hung joined Axovant (see Money Talk below). Then there's Dendreon's colorful former chief executive Mitch Gold, who's back in the public eye as his Alpine Immune Systems becomes publicly traded. Not through an IPO, but a reverse merger into what is essentially the shell of Nivalis Therapeutics. (These kinds of biotech reverse mergers don't have a great long-term track record, but there are exceptions—like Cougar Biotechnology, which came public through a shell and was later acquired by J&J for $1 billion). Juno is also doing some reshuffling as it looks to pull a little closer to Kite and Novartis in the CAR-T race. -KT
Editas Medicine (EDIT), Veritas Genetics Co-Founder and Biotech Phenom George Church Makes Time's 100 'Most Influential' List

And He's Back! Medivation (MDVN)'s David Hung to Helm Vivek Ramaswamy's Axovant (AXON)

Juno (JUNO) Taps Ex-Genentech (RHHBY) Scientist to Head Up R&D at New Bay Area Office

Ex-Dendreon (DNDN) CEO Returns to Biotech, Throws a Lifeline to Struggling Nivalis (NVLS)

Wait For It! Trump Tapped Congressman to Become the Next 'Drug Czar'

More Career Track News
Bristol-Myers Squibb is boosting its bank account by outlicensing some drugs to Roche and Biogen. These two companies, of course, are now frenemies since the approval of Roche's multiple sclerosis drug Ocrevus (see Rockville Files), which is expected to undercut Biogen products but also bring Biogen a royalty. Their rivalry in the CNS space is now potentially deepening. Roche is getting into the Duchenne muscular dystrophy race by licensing an anti-myostatin adnectin drug for $170 million upfront and $205 million in potential milestones. Biogen is deepening its pipeline in Alzheimer's disease with a drug that targets extracellular tau. It may also have a role in treating progressive supranuclear palsy. Biogen is paying $300 million upfront, up to $550 million in milestones, plus royalties and a potential $60 million near-term payment. -KT
Bristol-Myers (BMY) Inks Two Separate Pacts With Biogen (BIIB) and Roche (RHHBY) For a Total of Up to $1.1B

Sucampo (SCMP) Pays $200M Upfront for Rare Disease Biotech Vtesse

J&J (JNJ) Forges Peptide Discovery Pact Worth $1.5B With Japanese Biopharma Peptidream

OncoMed (OMED) Tanks After Bayer (BAY) Opts Out of Two Drugs

4-Person Biotech Pens R&D Deal Worth $1B With Drug Giant Novartis (NVS)

More Golden Handshakes News

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VP, Government Affairs
Will be primary responsible for developing and executing comprehensive government affairs strategies before federal, state and local governments (including related governmental branches and agencies).

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Will be responsible for leading and managing the strategic and operational performance of the Quality department (QA/QC), ensuring the successful delivery of business strategy, corporate goals and objectives.

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Axovant certainly created a lot of buzz this month. The company was in many ways a symbol of the biotech bubble back in 2015. It managed a $315 million IPO on the back of a single compound being developed for Alzheimer's disease. That's a risky enough proposition by itself, but this compound was chemically similar to another compound that had already failed, had been scrapped by GlaxoSmithKline, and had produced fairly unimpressive data to date. And the company was helmed by a then-29-year-old hedge fund manager with no real biotech experience.

And then the company scores David Hung as its new CEO. Hung, a formidable dealmaker who sold his company Medivation to Pfizer for $14 billion, is perhaps changing some of thinking around Axovant. It has at least changed the valuation, and that has allowed the company to immediately go out and raise cash on more favorable terms. There has been speculation about why Hung would gamble on this company, but he may have some good reasons. So far, so good. -KT
Cancer Biotech G1 Therapeutics Files for $115M IPO

Boston's SV Life Sciences Unveils Name Change, Debuts $400M Fund for Biotech

It's Official: Ovid CEO Just Filed for $86M IPO

Bay Area Startup Atomwise Offers a Compelling Deal to Scientists Hunting for New Drugs

Axovant (AXON) Announces Pricing Of $125M Public Offering Of Common Shares

More Money Talk News

There's a fine line between promotion and deception and…no, scratch that. The line isn't all that fine, and some companies crossed it egregiously enough to bring down the wrath of the SEC. Galena Biopharma, CytRx, ImmunoCellular Therapeutics, and Lion Biotechnologies were accused to paying for promotional articles that really amounted to misleading advertisements in part of a stock promotion scheme. The SEC actions involve articles published between 2011 and 2014. Manish Singh, who was CEO of both ImmunoCellular and Lion over the period, was cited individually, as was former Galena CEO Mark Ahn. Singh resigned from both ImmunoCellular and Lion; Ahn was fired from Galena. Interestingly, Steven Kriegsman (who is also on the board of Galena) is still CEO of CytRx, as he has been since 2002. Makes ya wonder. -KT
Up to 4,100 Children Victims of Sanofi (SNY)'s Epilepsy Drug, Says French Regulator

SEC Cracks Down on "Fake Biotech News"

It's Not Over Yet: Martin Shkreli Stays Mum on Plans for New Biotech Software Company

Drug Giant Aspen Pharmacare Plotted to Destroy Cancer Medicine to Jack Up Prices

Unfavorable Ruling Forces Acorda to Pink Slip 20% of Jobs

More Legal Briefs News
There have been three new chemical entities approved since our last issue. Ocrevus got greenlighted in late March. It is an important drug for Roche and for patients, since it is the first drug approved to treat primary progressive multiple sclerosis. It's also a challenge to Biogen, which is looking to protect its own multiple sclerosis franchise. Still, it softens the blow that Biogen actually collects a significant royalty on Ocrevus sales (13.5%-24%). Neurocrine got its first-in-class treatment for tardive dyskenesia approved, but it may not have the market to itself for long. Teva's Austedo, also approved this month for Huntington's Disease, is awaiting a second approval for the same indication. Neurocrine's drug looks to have some advantages in dosing, but Teva is likely to be aggressive on price. -KT
FDA Just Rejected Eli Lilly (LLY), Incyte (INCY)'s Rheumatoid Arthritis Drug Baricitinib

Teva (TEVA) Finally Wins FDA Approval for Potential Huntington’s Blockbuster Austedo

What a Day! Genentech (RHHBY) Lands FDA Approval for First Drug to Treat Severe Multiple Sclerosis

FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases

Nothing's Gonna Stop Neurocrine Biosciences (NBIX) Now: Shares Jumped on FDA Approval of the First and Only Drug to Treat Tardive Dyskinesia for Adults

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

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