Boehringer dumps its $250M NASH drug; Bavarian Nordic sells PRV for $95M; GBT inks deal with Syros, gets $150M loan
→ Four years after Boehringer handed out a $250 million deal to get a NASH drug from Pharmaxis, they’re sweeping it out of the pipeline. The German pharma company noted today that the drug posed a threat of drug interactions, scuttling its aspirations for the program. BI 1467335 joins a long — and growing — list of failures in the NASH field, where drug developers have been trying to field a therapy that can bend the needle on a disease that afflicts millions of people worldwide.
→ It looks like $95 million is the going price for priority review vouchers these days. The latest seller is Bavarian Nordic, which was awarded the PRV in September following the approval of its smallpox and monkeypox vaccine, Jynneos. The Danish biotech said it will be using the new funds to expand the manufacturing and commercial operations. The buyer — who can now shave six months off the review process on any drug they like — remains undisclosed. While this expedition ticket once commanded $350 million, the price has been steadily decreasing and AstraZeneca bought one from Sobi in August for just $95 million.
→ At one point about 4 years ago, Zafgen shares $ZFGN traded north of $46 and admiring investors were stoked by its blitz of upbeat announcements on a radical new obesity drug that promised to revolutionize treatment in a variety of large and small market niches. Then the ceiling caved in after their lead drug killed a patient, forcing the company to eventually scrap the effort. Today, after lingering on life support for more than a year following their second crippling clinical hold by the FDA, the shell of what’s left is being used by another biotech to reverse merge itself onto the Nasdaq. Chondrial Therapeutics goes into the reverse and will come out as Larimar Therapeutics with a lead program for Friedreich’s ataxia.
→ Global Blood Therapeutics is not letting the launch of its first drug hold it back from developing more treatments for sickle cell disease and beta thalassemia. The biotech is teaming up with Syros Pharmaceuticals to discover drugs that induce fetal hemoglobin on Syros’ gene control platform, with the ultimate goal of hitting potential targets that can switch on the gamma globin gene with oral medicines. GBT is kickstarting the collaboration with $20 million upfront and up to $40 million in preclinical research for at least three years — with up to $315 payable in option fees and milestones.
To help fund all that, and more, the company $GBT is taking a $150 million loan from Pharmakon Advisors that would offer “financial flexibility” to discover and develop potential treatments without diverting resources from the launch of Oxbryta, their newly approved inhibitor of deoxygenated sickle hemoglobin polymerization, said CFO Jeff Farrow in a statement.
→ Days after showcasing promising data on tucatinib, Seattle Genetics said the drug has now been designated a “breakthrough” therapy by the FDA for locally advanced or metastatic HER2-positive breast cancer. Added to the standard regimen of trastuzumab and capecitabine, the drug has been shown to extend OS and PFS even in patients with brain metastases. Filings in the US and Europe are planned for early 2020.
→ Eli Lilly CEO David Ricks is hitting back at Senator Elizabeth Warren (D-MA) after the Democratic presidential hopeful accused the company of failing to deliver on a promise to deliver lower-priced insulin to patients. Based on a new survey of pharmacies, Warren and Senator Richard Blumenthal (D-CT) said the half-price insulin — an authorized generic of Humalog dubbed Insulin Lispro — was often not in stock or available to patients. Ricks, speaking to CNBC, said the claims are “nonsense” and shows “what’s broken in the rest of the pharmaceutical system,” namely the middlemen in the supply chain such as pharmacy benefit managers.