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Bio Roundup: Gottlieb Talks Vax, Acorda’s Axe, Adams, 23andMe & More

Xconomy National — 

In the nation’s capital, healthcare and life sciences were on center stage. Or stages, actually. On Capitol Hill, FDA commissioner nominee Scott Gottlieb, the drug industry’s favorite pick, told senators his extensive industry ties wouldn’t cloud his judgment or create conflicts. At a downtown convention center, Joe Biden slammed the Trump administration’s budget-cutting plans. And despite the White House’s wooing of the far right, the revival of Trumpcare, a.k.a. The American Health Care Act, has not gained traction; Congress is likely to jet off for its two-week recess with no new bill, leaving the administration strutting and fretting yet another hour upon the stage… a tale told by… well, let’s just get to the roundup, shall we?

—In his Senate hearing, Trump’s pick for FDA commissioner Scott Gottlieb said vaccine skeptics—count the president among them—need to give it a rest. “We need to … accept no for an answer and come to the conclusion that there is no causal link between vaccination and autism.” Gottlieb also underscored the urgency of fighting the opioid crisis; promised to fight for resources in the face of looming budget cuts; and insisted that his extensive healthcare industry ties, which he promises to disentangle if confirmed, were not conflicts of interest but in fact would make him a better regulator.

—At the American Association for Cancer Research meeting a few metro stops away, Joe Biden spoke out against the Trump budget cuts, which would slice nearly 20 percent from the National Institutes of Health. We’ve rounded up the top AACR headlines in a separate post.

BIOTECH TROUBLES, PRESENT AND PAST

—Acorda Therapeutics (NASDAQ: ACOR) announced plans to axe 20 percent of its workforce after losing a patent fight. The court ruling strips Acorda of four key patents that cover its top drug dalfampridine (Ampyra). As The Street notes, however, it’s unclear if the cuts will affect the salaries of top Acorda executives.

—Julian Adams, a key figure in the development of the multiple myeloma drug bortezomib (Velcade), left Infinity Pharmaceuticals (NASDAQ: INFI) in January after 13 years and a few tough clinical setbacks. Adams spoke with Xconomy about Infinity and his future with Israeli venture firm Clal Biotechnology Industries.

CLINICAL AND REGULATORY NEWS

—Bay Area genetic test maker 23andMe received FDA clearance to sell tests direct to consumers that highlight the risk of developing Parkinson’s disease, late-onset Alzheimer’s disease, and eight other conditions. It’s not 23andMe’s first FDA thumbs-up, but it’s the first to help people assess their genetic health risk, and the FDA acknowledged that the decision could clear the way for many more similar tests to come to market.

—Omadacycline, an antibiotic from Boston-based Paratek Pharmaceuticals (NASDAQ: PRTK), succeeded in the second of two Phase 3 trials, this time in patients with bacterial pneumonia. Paratek expects to file for approval next year.

—San Diego-based Zavante Therapeutics is planning to file for FDA approval early next year for its intravenous drug fosfomycin (Zolyd) after the antibiotic hit its goals in a key clinical trial.

—Israel’s Teva Pharmaceutical won FDA approval for deutetrabenazine (Austedo), a treatment for chorea, which are spastic movements that people with Huntington’s disease cannot control. The approval came with a “black-box” warning about serious side effects of suicidal thoughts and depression. Teva got the drug through its 2015 buyout of San Diego-based Auspex Pharmaceuticals.

DEALS AND DOLLARS

–Sucampo Pharmaceuticals (NASDAQ: SCMP) agreed to acquire Vtesse and its therapy for Niemann-Pick disease for $200 million. The deal marks the first big win for Cambridge, MA-based Cydan Development, the orphan drug startup accelerator from New Enterprise Associates.

—Zymeworks filed paperwork for an IPO of up to $75 million in order to support its experimental cancer treatments. The Vancouver, BC-based company has applied for stock listings on the New York and Toronto stock exchanges under the symbol “ZYME.”

—Somerville, MA, startup Finch Therapeutics—formed by some of the folks from nonprofit stool bank OpenBiome—received $10 million from Takeda to co-develop a microbiome drug for inflammatory bowel disease.

—-Synchron of Campbell, CA, raised a $10 million Series A round of financing to support clinical studies of its technology that aims to let paralyzed patients control robotic limbs through a neural interface.

—David Meeker, a 23 year Genzyme veteran who has been CEO since the Sanofi acquisition in late 2011, will leave the company at the end of June. Bill Sibold, a Sanofi immunology and oncology executive, will replace him.

Ben Fidler and Frank Vinluan contributed to this report.

Photo of the U.S. Capitol by Kevin Dooley shared via Creative Commons 2.0 license.