BioSpace BioPharm Exec
Wednesday, June 28, 2017
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Let's Get Rid Of Clinical Trials


Let's Get Rid of Clinical Trials

We're living in volatile times. If I were to put a positive spin on that, I'd say that we're living in times where a lot of accepted ways of doing things are being questioned...More...
There's been a wealth of clinical data over the past month, not least from the annual ASCO meeting that kicked off the month of June. We gave a preview of what to expect just before the meeting, and that was fairly true to most of the headline-grabbing releases, so we'll skip some of the ASCO news here.

But if one theme of ASCO was immune-oncology combinations, another recent theme has been the cracks in the foundations for checkpoint inhibitors. Opdivo failed in lung cancer last year, Tencentriq failed in bladder cancer in May, and now Keytuda—which has managed to see its star rise versus its rivals—is having a spot of trouble in multiple myeloma.

On the positive side, Bluebird Bio reported impressive results in the same disease for its CAR-T therapy, and Loxo Oncology is opening up a new way of looking at cancer treatment with larotrectinib. This TRK inhibitor has highly effective in patients with genetic TRK fusions—no matter where their actual cancer occurred. So while TRK fusions are very rare, it has results in over a dozen different cancers. And Clovis Oncology has seen a marked change in fortune over the past couple years. Its strong results for its PARP inhibitor in BRCA-positive ovarian cancer is a further boost. -KT
More Deaths Lead Seattle Genetics (SGEN) to Discontinue Phase III Leukemia Study
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Clovis Oncology (CLVS) Stock Soars as Ovarian Cancer Trial Dazzles
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Deaths Force Merck (MRK) to Halt Enrollment for Blood Cancer Studies
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Loxo Oncology (LOXO) Seeks FDA Approval After Breakthrough Drug Larotrectinib Helped Almost Everyone Who Took It
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Genentech's (RHHBY) Perjeta-Based Adjuvant Breast Cancer Care Shows Minor Improvement, Puma Biotech (PBYI) Shares Jump
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More Bench To Clinic News
Further management changes at Biogen continue to fuel speculation about what strategy the company may be pursuing, and whether it could be seeking a sale. The latest to leave is Biogen CFO Paul Clancy, who will take over the same position at Alexion. His departure follows that of former CEO George Scangos last year, followed more recently by senior management in R&D and human resources. Former HR head Kenneth DiPietro, at least, has just been replaced by Ginger Gregory, who comes over from Shire Pharmaceuticals. -KT
Biogen (BIIB) Brings Ex-Shire (SHPG) Exec Into C-Suite
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What Biogen (BIIB) CFO's Departure Means for Company's M&A Strategy
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Effective Immediately: Bristol-Myers (BMY) Exec to Take the Reins at Kleo
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Founding CEO of Editas Medicine (EDIT) Lands New Gig at Top Biotech VC Firm
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Novartis (NVS) Rejects Trump's Proposition to Create More U.S Jobs
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More Career Track News
This past month's deal news was arguable dominated by the breakup, rather than formation, of partnerships. Few disease markets have gotten more attention of late than non-alcoholic steatohepatitis, or NASH. With estimates that sales of drugs for this largely unaddressed disease could run to $40 billion, eyes are on every viable candidate. That's why it was a big deal that AstraZeneca terminated its partnership with Regulus. That company has also shelved its hepatitis C drug. Another company to get the cold shoulder despite working in a hot area is NewLink Genetics. It has regained rights to its IDO inhibitor navoximod from Genentech. The company is focusing its efforts on its more advanced IDO inhibitor, indoximod, but it is playing catch-up with Incyte. -KT
SoCal's Regulus (RGLS) Sinks After AstraZeneca (AZN) Bails on Lead NASH Drug
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Disney-Backed Dragonfly Nabs $33M From Biotech Bestie Celgene (CELG)
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NewLink Genetics (NLNK) Stock Plunges After Genentech (RHHBY) Bails on $1B+ IDO Deal
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Bay Area GRAIL's Billion Gamble on the Perfect Cancer Test
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New Immuno-Onco Deal With Merck KGaA (MKGAF.PK) Could Make This UK Biotech a $1B Company
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Repare's $68 million Series A round is an aggressive bet on its strategy to trigger "synthetic lethality" in cancer cells. It is building on the idea of PARP inhibitors, which stop cancerous cells from repairing themselves, but only in cases when another mechanism—BRCA 1 and BRCA 2—isn't working. Repare's platform is looking for drugs based around other two-gene lethality combinations, since many cancers feature a defect in at least one DNA repair mechanism. And yes, Celgene is an investor. -KT
Repare Bursts From Stealth Mode With $68M and a Team Packed With Industry Alums
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Google's (GOOG) Verily (GOOGL) and Novartis (NVS) Jump Into Medicxi's $300M Life Science Investment Fund
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Up and Coming Scientist Gets Funding for CAR-T Startup CARMA Therapeutics
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Sanofi (SNY) Commits $673M in Biologics
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2 Biotechs Insiders Just Bought $70M Worth of Stock In
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More Money Talk News

Launching a biosimilar just got about 6 months faster thanks to a Supreme Court ruling. In Sandoz v. Amgen, Amgen argued that Sandoz couldn't send it notice of its intent to market a biosimilar of Neupogen until that biosimilar was actually approved. The court disagreed, meaning that an extra 6-month process can now be run in parallel. That's not all there was to the case, which is complex and involved matters not settled by the Supreme Court. As it stands, it's a setback for Amgen in this specific case. But since the company has an active pipeline of its own biosimilars, it will presumably benefit from the ruling as well.

Meanwhile, Endo Pharmaceuticals is—depending on who you ask—either responsible to a significant degree for the present opioid crisis, or a victim of an attempt to make tamper-proof pills that went very, very wrong. Several years ago, Endo asked FDA to take the non-tamper proof Opana off the market, reasoning that this would reduce abuse (and, of course, protect their franchise). But instead, there was evidence that Opana ER gets injected more often—since the easiest way to defeat the protective coating is to cook it off—leading users more quickly to severe addiction and alternatives like heroin. Now FDA has taken the unusual step of asking Endo to remove the tamper-proof product from the market because of abuse potential. -KT
Landmark Ruling: Amgen (AMGN) Loses Bid to Delay Biosimilars
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Hundreds of Patient Deaths Linked to Roche's (RHHBY) RA Drug Actemra
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First Time Ever: FDA Asks Endo Pharma (ENDP) to Stop Selling Opana ER Amid Opioid Crisis
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Feds Accuse 'Greedy' Pharmakon Execs of Selling Drugs That Sickened Babies
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Association of University Technology Managers Release: New Report: Licensing Of Academic Patents Has Contributed Up To $1.3 Trillion To U.S. Economy
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More Legal Briefs News
There's been only one new chemical entity approval in the past month. Baxdela is in the undersung antibiotic space. But in addition to being a victory for Melinta Therapeutics, its approval is a success for Ligand's business model, which has the company with over 100 "shots on goal" through dozens of partnerships, each carrying royalties ranging from very small (2.5% in the case of Baxdela) to double-digits. -KT
Ligand's (LGND) Partner Melinta Announces U.S. FDA Approval Of Baxdela (Delafloxacin) For Acute Bacterial Skin And Skin Structure Infections (ABSSSI)
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FDA Calls Omeros (OMER)' Kidney Disorder Drug a Breakthrough
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Bay Area's Coherus Craters After the FDA Spurns Its Biosimilar for Amgen's (AMGN) Neulasta
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Amgen (AMGN) And Allergan (AGN) Announce FDA Advisory Committee Meeting To Review ABP 215, A Biosimilar Candidate To Bevacizumab
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Alkermes (ALKS) Release: FDA Approves Two-Month ARISTADA For Treatment Of Schizophrenia
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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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