BioSpace BioPharm Exec
Wednesday, July 27, 2016
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Could It Get Any Worse?


Could It Get Any Worse? A Horrible 2016 Keeps Heading Downhill

It was easy to see that, for the biotech sector, 2015 would be a tough act to follow. Back in January, I opened the year with a discussion of biotech's looming "hangover"—seven factors weighing on the sector—along with what I hoped were mitigating points...More...


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It seems like bad news dominated the clinical space this month—I already mentioned Juno, which got a clinical hold put in place and then quickly taken away following some deaths in its JCAR015 program (and, we subsequently learned, one in a JCAR014 trial). Zafgen decided to scrap its program for beloranib in Prader-Willi Syndrome after some clinical trial deaths first reported last year.

But there is one piece of remarkably good news: Sage Therapeutics reported very strong results for SAGE-547 in treating postpartum depression. The drug showed better than a 12 point improvement versus placebo in a clinical depression score, was effective within 60 hours, and was persistent through a 30-day follow-up. This was a mid-stage study that needs confirmation, but it bodes well for patients and the company. -KT
Gilead (GILD)'s Odefsey Successful in Two Phase IIIb Studies
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SAGE (SAGE)' Stock Explodes as Drug Eliminates Postpartum Depression in Mid-Stage Study
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Juno (JUNO) Halts CAR-T Cancer Trial After Three Patient Deaths
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Tesaro (TSRO)'s Phase III NOVA Trial of Niraparib Hits Primary Endpoint; NDA and MAA Planned for Q4 2016
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Why Investors Should Pay Attention to Seattle Genetics (SGEN)' Drug Trial
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More Bench To Clinic News
George Scangos has announced he will depart Biogen as soon as a replacement is found. Judging by most metrics, whether it's stock price, revenues, or profits, it's hard to view his tenure as anything but a smashing success. Yet the company has seen its challenges lately as its dominance in multiple sclerosis is being challenged. Forays into areas like cancer have met mixed success, disappointing results for anti-LINGO give the company one less Hail Mary shot at a huge market, and it has put more emphasis on longshot programs in Alzheimer's disease. A new CEO—particularly one more focused on headline-inducing M&A—could energize investors. Time will only tell, however, if Scangos' current course is the right one. -KT
Biogen (BIIB) CEO Steps Down Amid Stellar Q2 Financials, Hunt for New Leader Begins
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Zafgen (ZFGN) Pinks Slips 34% of Workforce, Scraps Lead Obesity Drug After Deaths
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400+ Women are Suing Drug Giant Merck (MRK) Over Unequal Pay
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Celgene (CELG) Exec Takes Leave to Work on Trump Campaign
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Zafgen (ZFGN)'s Alicia Secor Steps Up as Juniper Pharma (JNP)'s President and CEO
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More Career Track News
With all the chatter about setbacks for deaths in the trials of Juno's lead program and setbacks for CAR-T, there's been another current running: How about other similar strategies, like bispecific antibodies? They could accomplish much of the same thing, recruiting T cells to activate the immune system against cancer. Well, Celgene is wasting no time hedging its bets. It has a major deal with Juno, but now it is also in bed with Jounce. The deal, with a no-kidding-around $225 million upfront payment, which gives it access to Jounces JTX-2011 and four early-stage programs. JTX-2011 is a monoclonal rather than bispecific antibody, but it targets and activates the Inducible T Cell CO-Stimulator (ICOS), which the companies believe can stimulate a robust immune response. -KT
Cambridge Startup Jounce Lands $2.5B Deal With Biotech's Best Friend Celgene (CELG)
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Bayer (BAY) Sweetens Deal to $54.7B for Monsanto (MON)
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Galenica (GALN.SW) to Acquire Bay Area's Relypsa (RLYP) for $1.53B
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Already Partners, Bayer (BAY) and X-Chem Whip Up a New R&D Pact Worth $528M
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Vertex (VRTX) and Moderna Hammer Out $315M+ Deal to Treat Cystic Fibrosis Using mRNA Technology
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More Golden Handshakes News

Top Jobs
• Genetown (Cambridge, Massachusetts)

Jounce Therapeutics
VP, Discovery
Reporting directly to the CSO, the successful candidate will lead the development and implementation of the scientific and business strategy for the Discovery Group at Jounce.

• BioCapital (Rockville, Maryland)

MacroGenics
VP, Regulatory Affairs
Will be responsible for developing the global regulatory strategy for development-stage programs including CMC, regulatory submissions, regulatory compliance, regulatory advice etc.

• BioAus (Adelaide, South Australia)

Bionomics
VP, Medicinal Chemistry
Seeking a qualified (more than 8 years post-doctoral and industry experience), highly motivated, experienced individual to contribute to the development of our overall medicinal chemistry approach as well as specifically impact a number of our small molecule drug discovery programs.

• Biotech Bay (San Francisco, California)

Alector
Director/Sr. Director, Nonclinical Dev. of Antibody Therapeutics
Seeking a highly qualified manager-scientist to join the preclinical development management team and assume a role in directing the external and internal antibody product development activities.

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Some interesting new startups are being formed. Oncorus is focusing on oncolytic viruses—viruses that grow exclusively in cancer cells and kill them—with an initial focus on glioblastoma. Fulcrum Therapeutics is seeking to develop small molecule "on and off switches" for genes, focusing initially on Fragile X Syndrome and a form of muscular dystrophy. And Morphic Therapeutic is based around the work of Timothy Springer, who discovered the first integrins and intracellular adhesion molecules (ICAMs) in the 1980s. Injectable drugs that targeted integrins were somewhat problematic, but Springer believes his team has gotten around many problems and are pursuing small molecule anti-inflammatories. -KT
Patheon (PTHN)'s Much-Anticipated IPO Prices at $21 a Share
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Amgen (AMGN) and Merck KGaA (MKGAF.PK) Invest in Boston's Akili, Increasing Funding Round to $42.4M
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Former bluebird bio (BLUE) CSO Takes the Reins at Oncorus; Startup Launches with $57M Series A
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GW Pharma (GWPH) to Raise $252M from U.S. Investors via Public Offering
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With Investments from Pfizer (PFE) and AbbVie (ABBV), Morphic Therapeutic Closes a $51.5M Series A Round
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More Money Talk News

There's tax inversion, but that's a difficult and expensive process that involves an acquisition, relocation of headquarters, and a potential legal battle. Gilead has reportedly pursued an easier path: Shifting key patents for its hep C drugs offshore, reassigning profits and defering taxes...$9.7 billion worth, according to Americans for Tax Fairness. Gilead hasn't responded to this, and ATF only says it "appears" that Gilead is using this scheme. But Gilead certainly isn't be the only company holding massive amounts of cash offshore, perhaps hoping for a return of the repatriation tax "holiday" that Congress offered up in 2004. -KT
Amgen (AMGN) Coughs Up $95M to Settle Class Action Suit
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Gilead (GILD) Used Legal Loopholes to Avoid Paying $10B in Taxes Last Year
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Theranos Says Elizabeth Holmes Will Remain CEO, But it May Stop All Lab Operations
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Eisai Company (ESALY.PK) to Consider Legal Action in UK Cancer Drug Row
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Pfizer (PFE) to Highlight Risks of Opioid Painkillers to Escape Chicago Lawsuit
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More Legal Briefs News
Valeant has had a busy and volatile month with FDA. An advisory committee unanimously recommended approval of brodalumab, albeit with a risk plan, despite an associated risk of suicide. The treatment for plaque psoriasis has a PDUFA date of November 16. Valeant and its partner Progenics Pharmaceuticals also won approval for Relistor, their treatment for opioid-induced constipation (which, given the nationwide opioid addiction epidemic, is certainly an issue). This is an oral version of an existing drug. However, FDA rejected the company's glaucoma drug Vesneo, citing manufacturing issues at a Florida plant.

Also, two new chemical entities were approved since our last issue: Epclusa, Gilead Sciences' combination of sofosbuvir and velpatasvir for hepatitis C; and Xiidra, lifitegrast ophthalmic solution for dry eye disease. Epclusa is Gilead's best chance to fight back against Merck's Zepatier—it is the only single tablet regimen for all genotypes of hepatitis C and is thus tremendously important to the company, although it may not stir up a lot of generalist interest in the sector for those looking for major new innovations. That may also go for Xiidra, even though Shire expects it to bring in north of $1 billion annually in a market that numbers some 16 million people in the U.S. alone. -KT
Shire (SHPG) Soars After the FDA Approves Long-Awaited Dry-Eye Disease Drug
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Gilead (GILD) Release: FDA Approves Epclusa For Treatment Of Chronic Hepatitis C Virus Infection
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Amid Trial Concerns, FDA Delays Approval Decision for Merck & Co. (MRK)'s C. Diff Drug, New PDUFA Date Set
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Valeant (VRX), Progenics (PGNX) Shares Climb on Constipation Drug Approval
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FDA Panel Says Valeant (VRX)'s Psoriasis Med Should be Approved with Risk Plan
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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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