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Wednesday, May 31, 2017
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Here's What to Look For at ASCO


Here's What to Look For at ASCO

We are at the climax of the clinical calendar, at least if you're interested in oncology: ASCO kicks off this Friday, and the biotech industry is already abuzz about...More...

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With ASCO about to kick off, cancer is topping the clinical news of the month (see Introduction). But there's more going on than just that. Certainly one area capturing a lot of attention is familial amyloid polyneuropathy (FAP)—a congenital form of TTR amyloidosis that is progressive and fatal. Two companies, Ionis Pharmaceuticals and Alnylam Pharmaceuticals, are racing for a treatment. Ionis' clinical results for Inotersen would have been viewed as a victory in other circumstances, since it significantly improved symptoms and quality of life. But with Alnylam expected to report results on its competitive drug Patisiran in the next few weeks, investors focused on safety issues. -KT
Aerie (AERI) Rockets as Eye Drug Wows in Key Phase III Study
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Shire (SHPG)'s $6.5B Dyax (DYAX) Bet Pays Off as Lanadelumab Wows in Phase III Study
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GlycoMimetics (GLYC) Stock Takes Off on Positive Phase II Leukemia Data, Breakthrough Tag
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Safety Concerns Raised as Ionis Pharma (IONS)'s Inotersen Meets Both Primary Endpoints in Late-Stage Study
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Genentech (RHHBY)'s Top Cancer Prospect Flunks Phase III Test
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More Bench To Clinic News
Henri Termeer was a businessman, not a scientist. And he brought his acumen to bear on Genzyme in the early 1980s—a time when the biotech industry was desperately in need of more than just ground-breaking science. Termeer's most lasting legacy will be his insight that pursuing rare diseases can serve many people traditionally ignored by the pharmaceutical industry while being profitable at the same time. He'll be sorely missed. -KT
Teva (TEVA) Cuts Another 500 Jobs, May Hire CEO Who Isn't Israeli
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Spotted in the Bay Area: Former FDA Head in Talks to Join Google (GOOG)'s Verily
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Biotech Loses a Legend: Genzyme Founder and Longtime CEO Dies at 71
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Biogen (BIIB) Exec Leaves to Put Together and Helm New Biotech Startup
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It's Official: New FDA Head Confirmed
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More Career Track News
Score one for the activists. Seattle Genetics backed out of its partnership with Immunomedics, worth up to $2 billion, after the very vocal protest of venBio, an ImmunoMedics investor. The deal had been in limbo since March, when a judge ruled it couldn't close while a proxy battle was underway at Immunomedics. In the end, venBio got everything it wanted: IMMU-132, a late-stage drug for triple-negative breast cancer, is still with the company. Moreover, Immunomedics CEO Cythina Sullivan and her husband CSO David Goldenberg, have stepped down. -KT
Biogen (BIIB) Spinoff Bioverativ (BIVV) Takes Out Bay Area's True North in $825M Deal
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AstraZeneca (AZN) Offloads Heart Drugs to Recordati in $300M Deal to Pump Up R&D
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Thermo Fisher Scientific (TMO) Bags Patheon (PTHN) in $7.2B Deal, Pantheon Stock Soars
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Stock Soars as Immunomedics (IMMU) CEO, COO Exit and Seattle Genetics (SGEN) Dumps $2B Deal
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This Boston Biotech Gets $57.5M Upfront, $2.1B Commitment From Drug Giant AstraZeneca (AZN)
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Top Jobs
• Genetown (Cambridge, Massachusetts)

X4 Pharma
VP, Clinical Operations
Candidate is an experienced leader with a focus on strategic planning and execution of clinical trials to gain regulatory approval of current and future X4 programs.

• Biotech Bay (Novato, California)

Ultragenyx
VP, Regulatory Affairs, CMC
Will be responsible for leading the Regulatory Affairs CMC group and developing, implementing, and advising on global CMC regulatory strategies for new and late stage programs to secure and maintain market access for product(s) in line with business objectives

• Biotech Bay (Fremont, California)

Ardelyx
VP, Experimental Medicine
Will be responsible for establishing a framework for design, conduct and reporting of experimental medicine clinical studies.

• Biotech Beach (San Diego, California)

Cello Therapeutics
VP, Product Development
Will be responsible for developing company's oncology portfolio based on the nanotechnology platform through research and understanding of global oncology product market.

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T-cell based therapies continue to garner a lot of investment interest, but GammaDelta Therapeutics is exploring a specific subset called (appropriately enough) gamma delta T- cells. Distinct from the typical alpha-beta T-cells, this subset don't seem to require the same antigen activation and are thought to be involved in an earlier, innate-like immune response. That's attracted a $100 million investment from Abingworth and Takeda, with the latter gaining the option to acquire the company later. Takeda has become increasingly aggressive about partnering and early-stage development. -KT
Cancer Biotech G1 Therapeutics (GTHX) Grabs $105M in IPO
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Takeda (TKPYY), Abingworth Infuse $100M Into a Tiny Biotech, Sealing an Option for M&A
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Former Xontogeny CEO Emerges to Helm Newly-Launched $25M Biotech Startup Accelerator
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Seattle's Genoa Pharma Banks $62M and Names a New CEO and CSO
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On a Roll: Magenta Therapeutics Nabs Another $50M, a Drug From Novartis (NVS) and Deal With Be The Match BioTherapies
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The controversy over Exondys 51 and its approval for Duchenne muscular dystrophy, despite questionable-at-best evidence of efficacy, rages on. A journalist from New York University is hoping to see communications between FDA officials regarding the drug, and has sued the agency after having his Freedom of Information Act request rejected. Meanwhile, Ionis Pharmaceuticals has more than just safety and a competitive drug to worry about when it comes to its amyloidosis drug IONIS-TTRx. An investigator in a phase 2 study was called out by FDA for operating under "objectionable conditions," calling the data he has produced into question. It should be noted, however, that this relates to an investigator-initiated study in cardiomyopathy—not the phase 3 study in familial amyloid polyneuropathy that just produced positive results. -KT
Journalist Sues FDA for Documents Related to Sarepta (SRPT)'s DMD Drug
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Stock Falls as FDA Slaps Warning on Researcher Studying Ionis Pharma (IONS)'s IONIS-TTRrx
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Theranos Quietly Settles Lawsuits With One of Its Biggest Investors
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Is This Fake News? Neurotrope (NTRP) Alzheimer's Release Takes Weird Spin
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Agreement Reached After Novo Nordisk (NVO) is Accused of Disguising Salespeople and Dealing Kickbacks
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More Legal Briefs News
There have been a whopping seven (7!) new chemical entities approved since our last issue, not to mention a number of important label expansions (see Introduction). That's more than we have space to discuss, but it's worth noting that 2017 is currently tracking ahead of 2015 in new drug approvals—and 2015 was a near-record year.

Regeneron's Kevzara is entering a crowded rheumatoid arthritis market and is hoping to make in-roads by (gasp!) actually competing on price. (Regeneron CEO Len Schleifer has been a vocal critic of excessive price hikes). Mitsubishi Tanabe, on the other, is eager to take advantage of America's tolerance for high drug prices. Its new ALS drug, Radicava, will be priced 4X higher here than it is in Japan. That will inevitably raise cost-benefit questions, since it is not clear how long, or even if, the drug extends survival. Nevertheless, on the basis of evidence that it slowed deterioration of symptoms, FDA actually requested Mitsubishi file for approval on the basis of Japanese data alone. -KT
Market Just Got More Crowded as Regeneron (REGN), Sanofi (SNY)'s New RA Drug Wins FDA Approval
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Mitsubishi Tanabe Wins FDA Approval for Radicava, the First New ALS Drug in 22 Years
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IMFINZI (Durvalumab) Approved For Previously Treated Patients With Advanced Bladder Cancer, Available Immediately At BioLogics
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Wowsers! FDA Approves BioMarin (BMRN)'s Brineura, the First Drug for Batten Disease
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Takeda (TKPYY)'s $5B Bet on Ariad (ARIA) Pays Off With Accelerated Approval of Lung Cancer Med
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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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