Bio Roundup: EpiPen Shortage, Bluebird’s Bet, Biotech IPOs & More

Xconomy National — 

It’s back-to-school season and that means it’s time to load up on school supplies. For many students and schools, one crucial item is in high demand but hard to come by: the EpiPen.

Some schools stock the epinephrine autoinjectors so they can respond quickly to a student’s allergic reaction to food. Though the autoinjectors are sold by Mylan (NASDAQ: MYL), they’re made by a Pfizer (NYSE: PFE) subsidiary whose manufacturing problems have disrupted shipments. A generic version from Teva Pharmaceutical (NYSE: TEVA) won FDA approval last week, but it isn’t expected to become available until sometime in fall. To ease the current EpiPen shortage, the FDA this week extended the 20-month shelf life of the injectors by four months.

In other news this week, a stalled cancer drug found a new owner, three more biotechs filed for IPOs, and President Donald Trump makes a surprising healthcare appearance in our roundup. Should we get to those stories? That would be best.


—Bluebird Bio (NASDAQ: BLUE) paid Gritstone Oncology $20 million upfront, plus a $10 million equity investment, to cement a partnership that will use Gritstone’s artificial intelligence technology to find tumor targets for new cancer immunotherapies.

—Sierra Oncology (NASDAQ: SRRA) acquired myelofibrosis drug momelitinib from Gilead Sciences (NASDAQ: GILD) for just $3 million upfront. Gilead acquired the drug for $510 million in 2012 but shelved it when Phase 3 results didn’t show enough advantage over a similar myelofibrosis drug already on the market.

—Exact Sciences (NASDAQ: EXAS) struck a deal with Pfizer to co-promote Cologuard, the Madison, WI, company’s flagship diagnostic for colorectal cancer screening.

—Abbvie (NYSE: ABBV) continued to pour its windfall from last year’s federal tax-cut bill into charities.


—It’s been a strong year for IPOs, and healthcare leads all sectors in new public companies. Three more joined the IPO queue as Entasis Therapeutics, Principia Biopharma, and Gritstone Oncology all filed to go public to finance their respective clinical trial plans.

Renovia secured $42.3 million to support clinical tests of its smartphone app and medical device for treating pelvic floor disorders in women.

—RDMD, whose founder organized a hackathon last year to find answers for his own rare disease, raised a $3 million seed round to build registries for rare-disease patients. The company will make money by aggregating and selling patient data to drug industry researchers.

—TraceLink, which has commercialized software for tracking pharmaceuticals along the supply chain, raised $93 million, which the North Reading, MA, company says will support additional R&D.

—In other IPO news, San Diego-based Bionano Genomics (NASDAQ: BNGOU) raised $20.5 million in its stock market debut. The company, which sells a genomics analysis system, sold 3.36 million shares at $6.125 per share, near the low end of its targeted $6 to $7 range.

—Rakuten Aspyrian, a biotech with operations in San Diego, Japan, and Germany, raised $150 million in Series C financing to bring its head and neck cancer drug, ASP-1929, into Phase 3 testing.

—Seattle’s Apogen Biotechnologies topped off its Series A round with $4 million, led by the venture arm of drug maker Merck KGaA.


—Kala Pharmaceuticals (NASDAQ: KALA) won FDA approval for lotoprednol etabonate, an eye drop that uses the Waltham, MA, company’s nanoparticle technology to more efficiently deliver a pain and inflammation therapy to the eye.

—Lanadelumab (Takhyzro), an injectable drug that Shire (NASDAQ: SHPG) developed to prevent the swelling attacks from the rare disease hereditary angiodema, was approved following a priority review.

—Dompé Pharmaceutical got an FDA nod for cenegermin (Oxervate), the first approved treatment for neurotrophic keratitis, a rare degenerative eye disease.

—The FDA approved the cell-based manufacturing process Seqirus uses to make influenza vaccines at its Holly Springs, NC, plant. The subsidiary of CSL (ASX: CSL) says it can now more than double production of its Flucelvax vaccine for the upcoming flu season.

—The growing reach of immunotherapy to treat lung cancer was bolstered with two approvals. Late last week, the FDA gave a conditional nod to nivolumab (Opdivo) from Bristol-Myers Squibb (NYSE: BMY) as a standalone treatment for small-cell lung cancer previously treated with two other therapies. To gain full approval, BMS must confirm early-stage results in a larger study. The agency also granted full approval to a combination of chemotherapy and pembrolizumab (Keytruda) from Merck (NYSE: MRK) in a specific type of previously untreated non-small cell lung cancer.

—The FDA rejected the Allergan (NYSE: AGN) drug ulipristal acetate as a treatment for bleeding in women who have uterine fibroids. According to Allergan, the regulator cited post-marketing safety reports about the drug, which is commercially available in Europe and Canada.

–The FDA also rejected stannsoporfin, a Mallinckrodt (NYSE: MNK) drug to treat newborns who are at risk of severe jaundice. The U.K.-based drug maker said the decision was expected after an FDA advisory committee voted against recommending approval in May due to safety concerns.


—Veteran venture investor Lisa Suennen, aka “Venture Valkyrie,” is leaving a top post at GE Ventures after less than two years. Suennen spent part of that time building CSweetener, a mentor network for women in the health and life-science sectors, and will continue to develop it.

—Susan Hockfield, an MIT neuroscience professor and member of the Koch Institute, shared her thoughts about the life sciences in advance of a keynote talk scheduled for Sept. 6 during Xconomy’s Xcelerate conference, part of Biotech Week Boston.

—President Trump topped Modern Healthcare’s annual list of the most influential people in healthcare, but he didn’t get a purple “disrupter” label.

Alex Lash contributed to this report.

Photo by Flickr user City of Boston Archives via a Creative Commons license