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Wednesday, February 22, 2017
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Biotech, Is It Time To Secede?

Biotech, Is It Time To Secede?

No, I'm not talking about Texas or the recent mumblings from California following the presidential election. I'm talking the nation's largest drug manufacturers and a lobbying group seemingly too hamstrung to watch out for its own best interests...More...
Celgene's $7 billion+ bet on Receptos appears to be paying off. Top-line results of the SUNBEAM study showed oral ozanimod outperforming Avonex in patients with multiple sclerosis, and with the RADIANCE trial—a phase 3 extension of an early study—expected to conclude in the second quarter, Celgene could file for approval soon. Celgene could prove disruptive to Novartis, since ozanimod works by a similar mechanism to Gilenya but may be safer. And it could of course be disruptive to Biogen. Indeed, these results have renewed suggestions that Celgene just go all-in on multiple sclerosis and acquire Biogen. -KT
Celgene (CELG) Announces Positive Results From Phase III SUNBEAM Trial Of Oral Ozanimod In Patients With Relapsing Multiple Sclerosis

Another Drug Bites the Dust: Merck (MRK) Stops Late-Stage Alzheimer's Study

Bay Area Biotech Ardelyx (ARDX) Rejoices as Lead Drug Hits Phase III Goals

Why Intercept Pharma (ICPT) Stock Jumped Nearly 10% On Friday After Providing Phase III Update

Acorda (ACOR) Rockets After Parkinson's Drug Hits Late-Stage Goals

More Bench To Clinic News
The Trump Adminstration's intentions regarding the Affordable Care Act have been, at best, unclear. But with the confirmation of Tom Price as HHS Secretary, the repeal camp has a loud voice. Now industry insiders are wondering who will head FDA. A number of names are being floated, including Jim O'Neill, an associate of Silicon Valley billionaire Peter Thiel. O'Neill thinks we should return to the pre-Kefauver days when drug companies did have to prove efficacy, only safety. Is industry excited at the prospect of flooding the market with snake oil? No they are not. The strong preference of industry is for former FDA deputy commissioner and venture capitalist Scott Gottlieb. -KT
Biotech Execs are Hoping Trump Will Pick This Man to Head the FDA

Questions Remain Over Suicide Death of Genentech (RHHBY) Lobbyist

Tom Price Confirmed as Donald Trump's Health Chief, But Stock Deals Still Raise Questions

Teva (TEVA) CEO Abruptly Steps Down, Ex-Celgene (CELG) Boss Named Chairman of the Board

Bay Area's Galena Biopharma  (GALE) CEO Steps Down, Effective Immediately

More Career Track News
Seattle Genetics has been on quite a run over the past year, and it is now boosting its pipeline with an eye to the future. The antibody-drug conjugate company is branching out with a license to IMMU-132, Immunomedics' solid tumor candidate in phase 2 studies. For $300 million upfront, it is securing rights in triple-negative breast cancer and options on urotheilial cancer, small cell lung cancer, and non-small cell lung cancer. Shares of Immunomedics spiked, but not everyone is happy. Activist investor venBio called it "a blatant and shameful maneuver" in which Immunomedics has given away its "crown jewel." -KT
Seattle Genetics (SGEN), Immunomedics (IMMU) Ink $2B Tumor Drug Deal

Deal Spree Continues as Allergan (AGN) Inks $2.47B Deal for This Bay Area Biotech

Ipsen (IPN.PA) Agrees to Hire 100 Merrimack (MACK) Employees Under $575M Cancer Deal

Bristol-Myers (BMY) Could Finally Go on the Market; Rumored Suitors Include Gilead (GILD), Pfizer (PFE), Novartis (NVS) and Roche (RHHBY)

SAGE (SAGE) Boss Gets Overenthusiastic About Drug, Walks Back Discussion of M&A Activity

More Golden Handshakes News

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With a $20 million series A investment from Versant, Jecure Therapeutics is the latest company to go after non-alcoholic steatohepatitis, a market some have estimated could reach $40 billion by 2025. Not too much detail available on their approach at this point, but they will be playing catch-up with the likes of Intercept Pharma (which just accelerated its development plans—see Bench To Clinic) and Gilead Sciences. -KT
With Ex-Juno (JUNO) Employees on Its Roster, Seattle's Silverback Therapeutics Files $10M Out of $60M Goal

Bay Area Biotech Surrozen Launches With $33M and Could Double Its Headcount by Next Year

New SoCal Biotech Jecure Makes Debut and Will Take on NASH

31-Year-Old Biotech Guru Brings in Another $55M for Axovant (AXON)

Vividion Launches With $50M and a Celgene (CELG) Alum as Executive Chairman

More Money Talk News

Is the CRISPR war over? Probably not. Feng Zhang (of Editas Medicine) and MIT-Harvard Broad Institute got the first key patent in the field, but this was pretty widely expected to be invalidated in a challenge from UC Berkeley. But that didn't happen—the U.S. Patent Trial and Appeal Board found "no interference in fact." This has been viewed as a win for Editas and a loss for Intellia and CRISPR Therapeutics. It's certainly a win for Editas, but it's not clear that it will hamper the other two companies much. Indeed, cross-licensing may still be necessary. -KT
This is Why the Decision on Who Invented CRISPR Matters

Why Secretive $5B Biotech Moderna May Not be Able to Commercialize Products Into Clinical Trials

First Ariad (ARIA), Now Senator Bernie Sanders Puts This Drug Company on Notice

How Much Money Embattled Theranos Has Left in the Bank

Insurer UHC Will Cover Biogen (BIIB) Spine Drug, But With Limits And Proof

More Legal Briefs News
Four new chemical entities have been approved since our last issue. The one getting the most attention is Emflaza, and it's not for good reasons (see Introduction). Marathon Pharmaceuticals jumped through the right hoops with this off-patent corticosteroid and won itself seven years of exclusivity plus a hugely valuable priority review voucher. Parents of boys with Duchenne muscular dystrophy get an overnight 6,000% price increase. -KT
Sarepta (SRPT) Under Pressure As Marathon Pharma Emflaza's Wins FDA Approval for DMD

FDA Clears Valeant (VRX)'s New Psoriasis Drug, But With Strings Attached

FDA Approves Amgen (AMGN)'s Parsabiv (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis

Synergy Pharma (SGYP) Release: TRULANCE (Plecanatide) Receives U.S. FDA Approval For The Treatment Of Adults With Chronic Idiopathic Constipation

Genentech (RHHBY)'s $94,000-a-Year Drug Tarceva: Why Faster FDA Approvals Could Backfire

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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