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East Coast Biotech Roundup: WaVe, Shkreli, Intarcia & More

Xconomy Boston — 

The top story in biotech this week was the FDA’s approval of the first drug meant to boost women’s sex drive. The controversial flibanserin (Addyi) had been rejected in the past by the agency, and even post-approval faces questions about potential safety issues, effectiveness, and potential market reach. Nonetheless, Valeant Pharmaceuticals quickly snapped up the owner of the drug, Sprout Pharmaceuticals of Raleigh, NC, in a $1 billion deal. But even amidst the summer doldrums, there was plenty more going on. So get your mind off your libido and scan the headlines below.

—Boston- and Japan-based WaVe Life Sciences became the latest biotech to amass the type of investor group that can support an initial public offering. The company, which is developing “stereopure” RNA drugs, raised a $66 million Series B from backers like Foresite Capital, Fidelity Management and Research, and New Leaf Venture Partners. Existing investors like RA Capital Management also participated. WaVe is targeting rare ailments such as Huntington’s disease and Duchenne muscular dystrophy, and expects to have its first drug in clinical trials by the end of 2016. (Check out this story on WaVe’s Series A for more on its approach to RNA drugmaking.)

—My colleague Alex Lash this week took an in-depth look at the efforts of gene therapy and gene editing companies—among them Bluebird Bio (NASDAQ:BLUE) and, potentially, Editas Medicine—to develop treatments for sickle cell disease.

—Boston- and Hayward, CA-based Intarcia Therapeutics said that its implantable drug-device for diabetes, ITCA650, bested Merck’s diabetes drug sitagliptin (Januvia) in a head-to-head Phase 3 trial, leading to greater declines in both weight loss and blood-glucose levels. Bloomberg has more on the study, which Intarcia has pointed to as a key validating point for its technology.

—Cambridge-based Aveo Oncology (NASDAQ: AVEO) was all but left for dead a few years ago after its prospective cancer drug, tivozanib, was voted down by an FDA advisory panel. But the company showed signs of life this week when it cut a licensing deal with Novartis for a prospective treatment for cachexia, a muscle-wasting condition associated with things like cancer and congestive heart failure. Here’s more on the deal, which could be worth a total of $326 million if things break right for Aveo.

—Just a week after leading a $90 million round for his new startup, Turing Pharmaceuticals, Martin Shkreli was sued by his old one, Retrophin (NASDAQ: RTRX). The $65 million suit includes a slew of allegations, among them: Shkreli created Retrophin to pay off claims to investors in his hedge fund, MSMB Capital, and that that hedge fund was left “virtually bankrupt” by a single trade in in 2011. (You can read the suit here.) Shkreli fired back in pieces published by Forbes and Bloomberg, calling the allegations “preposterous” and claiming that he plans to file his own legal action against Retrophin.

—Cambridge-based Biogen (NASDAQ: BIIB) is teaming with Columbia University to try to better understand the underlying biology that causes amyotrophic lateral sclerosis, or ALS. Biogen and Columbia will sequence the genomes of 1,500 ALS patients. The goal is to figure out how different genetic alterations lead to different forms of the disease, and hopefully develop therapies tailored to those conditions.

—Lexington, MA-based Inotek Pharmaceuticals (NASDAQ: ITEK) raised $79.2 million in a stock offering before discounts due to underwriters. The cash will support Inotek’s development of the prospective glaucoma drug trabodenoson, which is expected to begin Phase 3 testing in the fourth quarter.

—Roche bought another startup this week; this time it was Wilmington, MA-based Kapa Biosystems, a company with genomic tools that help with next-generation sequencing. Roche didn’t disclose the terms of the deal, but the buyout came just a week after the Swiss drugmaker paid $190 million for a Bay Area startup called GeneWEAVE Biosciences.

—Norwood, MA-based Corbus Pharmaceuticals’ (NASDAQ: CRBP) experimental drug resunab won a fast-track designation from the FDA as a potential treatment for systemic sclerosis, a deadly autoimmune disease. Corbus shares jumped about 34 percent after the announcement.

—Berkeley Heights, NJ-based Edge Therapeutics said that its experimental drug EG-1962 met its goals in a small, early-stage study of patients recovering from aneurysms. Edge produced interim results from that trial in February, and filed papers with the SEC last week to go public.

Photo of The High Line in Manhattan courtesy of flickr user David Shankbone via a Creative Commons license.