Lung injuries linked to electronic cigarettes have topped 800 cases, including 12 deaths, according to the Centers for Disease Control and Prevention. Public health officials aren’t sure whether the injuries are from legally sold products made by companies such as Juul, or from black-market items such as those that allow users to “vape” the active ingredient in marijuana. But concerns have prompted vaping product bans in several states.
Former FDA commissioner Scott Gottlieb—a fierce critic of teen vaping during his tenure at the agency—told CNBC that e-cigarettes have a place helping to ween adult smokers from tobacco. But he said e-cigarette companies haven’t managed their products well in the marketplace, leading to rising teen use. He added that vaping products could attain over-the-counter status like nicotine patches, but companies would first need to conduct studies to assess the risk of lung injury—an expense they likely want to avoid. Perhaps there’s a regulatory lesson for others.
“I don’t think Juul realized that they’re a tobacco company operating in a highly regulated space when they started life as a Silicon Valley startup,” Gottlieb said.
Juul’s CEO stepped down this week. His replacement: K.C. Crossthwaite, a veteran of tobacco company Altria (NYSE: [[ticker:MO]]) who has extensive experience dealing with regulators. That story and much more in this week’s roundup.
DRUG DEVELOPMENTS
—Epigenetic drugs, which mess with the complex circuitry that helps our bodies make proteins, have long tantalized drug makers. But they have a limited purview, and mixed results thus far: Xconomy detailed how a new startup, Omega Therapeutics, aims to take things a step further.
—Many University of Washington discoveries in genome sciences are sitting on laboratory shelves or finding homes elsewhere in the country. This week, we took a look into a nascent effort to turn more of those innovations into Seattle-based genomic startups.
—An Enanta Pharmaceuticals (NASDAQ: [[ticker:ENTA]]) drug for the fatty liver disease nonalcoholic steatohepatitis succeeded in a short Phase 2 study and will move into further testing. But it’s unclear whether the treatment, EDP-305, stands out from other rival drugs, and shares fell 15 percent.
—The Medicines Co. (NASDAQ: [[ticker:MDCO]]) reported positive results from the final two Phase 3 studies of its long-lasting cholesterol drug inclisiran, paving the way for an FDA application by the end of the year and in Europe in 2020. Xconomy has detailed the potential issues awaiting inclisiran once it gets to market.
—Akcea Therapeutics (NASDAQ: [[ticker:AKCA]]) CEO Paula Soteropoulos and two other executives resigned in a management shakeup engineered just as the company is in the early stages of launching its first two drugs.
—In a research note, biotech analyst Geoffrey Porges of SVB Leerink said a notable drop in share price for Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]])—35 percent since March 1—could be, in part, because the industry is catching up to the company’s antibody drug development capabilities. Regeneron is “arguably the leading developer of monoclonal antibody therapeutics, but that positioning may no longer be that distinctive or valuable,” Porges wrote.
—House speaker Nancy Pelosi’s decision to open impeachment proceedings against President Donald Trump will make drug-price reform even more difficult to pass. Kaiser Health News has a roundup of several related news stories.
LET’S MAKE A DEAL
—Clovis Oncology (NASDAQ: [[ticker:CLVS]]) paid 3B Pharmaceuticals $12 million to co-develop radiopharmaceutical drugs.
—Rare disease drug developer Amryt Pharma completed an all-stock deal to acquire Aegerion Pharmaceuticals, a Novelion Therapeutics (NASDAQ: [[ticker:NVLN]]) subsidiary that was reorganizing under bankruptcy protection.
—New York-based ArTara Therapeutics—developing a drug for rare non-malignant masses called lymphatic malformations—is joining the public markets via a reverse merger with Proteon Therapeutics (NASDAQ: [[ticker:PRTO]]).
REGULATORY REFLECTIONS
—The FDA approved use of an Exact Sciences (NASDAQ: [[ticker:EXAS]]) colorectal cancer screening test in patients 45 and older, expanding the addressable market. Madison, WI-based Exact had previously marketed its Cologuard test for those 50 and older.
—Zogenix (NASDAQ: [[ticker:ZGNX]]) resubmitted its drug application for fenfluramine hydrochloride (Fintepla), a drug developed to treat a rare form of epilepsy called Dravet syndrome. In April, the FDA refused to review the drug due to deficiencies spotted in Zogenix’s paperwork.
—The FDA told Abeona Therapeutics (NASDAQ: [[ticker:ABEO]]) to delay a Phase 3 study of its cell therapy for recessive dystrophic epidermolysis bullosa, EB-101. Shares fell 12 percent.
—Several companies continued to recall generic heartburn medicines that contain ranitidine, the generic name for Zantac.
—In documents released by the FDA this week, Novartis (NYSE: [[ticker:NVS]]) blamed fired AveXis scientific founder Brian Kaspar and brother Allan, another ex-AveXis executive, for the data manipulation scandal surrounding its gene therapy Zolgensma. Novartis also said its internal investigation dragged because of a “lack of cooperation” from the Kaspars. Through their lawyer, they denied the charges. Reuters has more.
CASH GRABS & NEW STARTS
—Miessa Vaccines of South San Francisco raised a $30 million Series A to move an experimental vaccine for respiratory syncytial virus into human testing.
—German cancer immunotherapy and messenger RNA drug developer BioNtech inched closer to a US IPO, setting terms for an offering that would value the company at a whopping $4.5 billion.
—Amphivena Therapeutics of South San Francisco closed $62 million in Series C financing to back early tests of a type of cancer immunotherapy called a T cell engager.
—Deerfield Management will invest $635 million to turn a Manhattan property on Park Avenue South into a life sciences campus. The campus, which would add to a growing list of biotech incubators and shared lab spaces in New York, should be open for tenants by the end of 2021. Here’s more from the Wall Street Journal.
—Cancer drug developer ZielBio raised $25.1 million in Series A financing.
PEOPLE ON THE MOVE
—Former Marcolide Pharmaceuticals executive Mahesh Karande was named CEO of Omega Therapeutics… Gary Romano left Janssen to become chief medical officer of Passage Bio… Five Prime Therapeutics (NASDAQ: [[ticker:FPRX]]) CEO Aron Knickerbocker resigned… Adicet Bio hired Amgen’s Francesco Galimi as its chief medical officer… Brian Johns left GlaxoSmithKline (NYSE: [[ticker:GSK]]) subsidiary ViiV Healthcare to become chief scientific officer of HemoShear Therapeutics… Forma Therapeutics promoted Patrick Kelly to chief medical officer and appointed Todd Shegog chief financial officer… Hookipa Pharma named Christine Baker chief business officer and Roman Necina chief technology officer… Andrew Komjathy left Alkermes (NASDAQ: [[ticker:ALKS]]) to become chief commercial officer of Catabasis Pharmaceuticals (NASDAQ: [[ticker:CATB]])… Rgenix appointed Robert Wasserman chief medical officer… and Ruth Lehmann, a New York University cell biology professor, was elected director of the Whitehead Institute.
Ben Fidler and Alex Lash contributed to this report.
Photo by Flickr user Electric Tobaconist via a Creative Commons license
