Bio Roundup: Meldonium Slip, Kratom Crackdown, Zinc Fingers & More

Xconomy National — 

The 2018 Winter Olympics will end soon, and we did not skate through these games without a performance-enhancing drug allegation rearing its ugly head.

This time, the drug in question was meldonium (Mildronate), a product widely available over the counter in Russia and some Eastern European countries. Though Latvian pharmaceutical company Grindeks markets meldonium for heart conditions, the drug also reportedly boosts stamina and endurance. Meldonium is not approved by the FDA for any use and the World Anti-Doping Agency bans it.

Russian athlete Alexander Krushelnitsky tested positive for meldonium last week, and he initially denied wrongdoing, suggesting instead that his drink might have been spiked. But in an apparent deal to allow his fellow athletes to march under the Russian flag during this weekend’s closing ceremony, Krushelnitsky this week admitted using the drug. The admission stripped him and his wife, Anastasia Bryzgalova, of their bronze medals in mixed doubles curling.

In other news, the FDA’s opioid crackdown expanded to include certain dietary supplements, a peanut allergy drug posted promising study results, and Gilead Sciences bet on a gene editing technology not named CRISPR-Cas9. Here’s our roundup of this week’s top biotech and pharma headlines.


—The Trump administration allowed the expansion of short-term health insurance policies, from three months to one year, that don’t comply with Affordable Care Act regulations such as the requirement to cover pre-existing conditions.

—The FDA is extending its opioid crackdown to some dietary supplements. The regulator said that compounds in the ingredient kratom are opioids, and therefore should be removed from the market until they can be properly evaluated.


—Wave Life Sciences (NASDAQ: WVE) got a commitment for at least $230 million, including $170 million up front, from Takeda to co-develop a group of RNA drugs for neurological diseases.

—AbbVie (NYSE: ABBV) paid Voyager Therapeutics (NASDAQ: VYGR) $69 million to develop gene therapies for Alzheimer’s and other neurodegenerative diseases.

—With a new $66 million round, New York biotech Kallyope continued its fast growth. It also faces a key issue for startups graduating from the city’s incubators: can they find affordable space within New York?

—Continuing its cell therapy deal-making spree, Gilead Sciences (NASDAQ: GILD) paid Sangamo Therapeutics (NASDAQ: SGMO) $150 million to use its zinc finger gene editing technology to broaden the reach of Gilead’s CAR-T cancer treatments. Rival CAR-T developers Novartis and Juno Therapeutics (now owned by Celgene) previously cut deals with CRISPR-Cas9 gene editing companies for a similar purpose.

—Merck (NYSE: MRK) paid $394 million to acquire Viralytics. The two companies have been testing Viralytics’ CVA21, an oncolytic virus, in tandem with Merck’s immunotherapy pembrolizumab (Keytruda) in a variety of cancers.

—Germany’s Merck KGaA joined with Arkin Holdings, Pontifax and WuXi AppTec to put 20 million euros into Explore Bio, an investment vehicle targeting early-stage biotechs in Israel.

—Evelo Biosciences has raised $47.5 million in financing, seven months after the Cambridge, MA, microbiome drug developer raised $50 million in a Series B round of funding. The latest financing was first confirmed and reported by the Boston Business Journal.


—Aimmune Therapeutics (NASDAQ: AIMT) reported encouraging early data from a Phase 3 study testing its peanut allergy drug. The Brisbane, CA, company is now gearing up to file for FDA approval later this year.

—After refusing to look over an earlier approval application, the FDA has started reviewing Acorda Therapeutics’ (NASDAQ: ACOR) experimental Parkinson’s drug Inbrija, with a decision expected by Oct. 5.

—Vertex Pharmaceuticals (NASDAQ: VRTX) has begun the first of several Phase 3 trials with a three-drug cocktail in cystic fibrosis patients. Vertex believes the therapies could eventually treat a majority of people with the disease.

—The FDA again denied an appeal by PTC Therapeutics (NASDAQ: PTCT) of the agency’s rejection of Duchenne muscular dystrophy drug ataluren (Translarna). However, the FDA said it would consider an accelerated approval if PTC proves ataluren produces dystrophin, the muscle-boosting protein Duchenne patients lack, in an ongoing clinical trial.

—According to Bloomberg, eye doctors are reporting more instances of a rare, serious side effect in people taking aflibercept (Eylea), the age-related macular degeneration treatment from Regeneron Pharmaceuticals (NASDAQ: REGN).

—AstraZeneca (NYSE: AZN) notched another approval for its immunotherapy durvalumab (Imfinzi). The FDA made it the first maintenance treatment for stage 3 non-small cell lung cancer patients whose tumors can’t be surgically removed but haven’t spread yet after chemotherapy and radiation.

—In a ruling released late last Friday, a federal judge overturned a jury verdict that ordered Gilead to pay Merck $2.54 billion for patent infringement related to hepatitis C drugs. It was the largest award ever in a U.S. patent case, according to STAT.


—Merck CEO Ken Frazier explained to The New York Times why he quit one of President Trump’s business advisory councils last year. Frazier was the first CEO to quit, leaving the council to unravel, after Trump said the deadly violence at a white supremacist rally in Charlottesville, VA, was due to bigotry “on many sides.”

—Bristol Myers Squibb (NYSE: BMY) is laying off another 107 workers from its Wallingford, CT, research facility, the Meriden Record-Journal reported. The cuts are part of the company’s previously announced plans to shutter the site by the end of 2018.

—In a move expected to save $10 million, Achillion Pharmaceuticals (NASDAQ: ACHN) announced a corporate restructuring that will reduce headcount by 20 percent. The New Haven, CT, company will focus on rare disease drugs.

Ben Fidler and Alex Lash contributed to this report. 

Photo by Flickr user Benson Kua via a Creative Commons license.