Launching a broad new front in its long-running battle against dementia and other neurological diseases, Biogen Inc. has moved to license multiple Sangamo Therapeutics Inc. programs for $350 million up front plus up to $2.37 billion in development, regulatory and commercial milestone payments. The deal is initially focused on development of ST-501 for tauopathies including Alzheimer’s disease (AD), ST-502 for synucleinopathies including Parkinson’s disease and an undisclosed neuromuscular target. It also includes exclusive rights for nine additional undisclosed neurological targets that Biogen can elect over five years.

Newly approved, Biohaven’s Nurtec looks to distinguish itself

With FDA approval on Thursday, Biohaven Pharmaceutical Holding Co. Ltd.’s Nurtec ODT (rimegepant) enters a massive market for treating migraine in adults. In the U.S. alone, more than 25 million people have been diagnosed and seek treatment. As Biohaven’s sales force marshals itself for a March launch, Nurtec will compete with Ubrelvy (ubrogepant, Allergan plc), which received FDA approval in December for acute migraine treatment, and Reyvow (lasmiditan, Eli Lilly and Co.), approved by the FDA in October, also for acute migraine. Biohaven stock (NASDAQ:BHVN) was up 4.5% at midday on Friday.

CHMP nixes Eli Lilly bid to broaden Emgality label in migraine

DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Friday Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches.

Offloading hemophilia B treatment to Medexus worth $100M-plus for Aptevo

Aptevo Therapeutics Inc. shares (NASDAQ:APVO) rose 14%, or 5 cents, to 45 cents on word that the Seattle-based firm sold its marketed recombinant hemophilia B therapeutic, Ixinity, to Medexus Pharmaceuticals Inc., of Verdun, Quebec. Total proceeds are estimated at more than $100 million, including an up-front payment of $30 million and potential milestone rewards of as much as $11 million related to regulatory and commercial achievements. For up to 15 years, Aptevo will collect deferred payments on U.S. and Canadian net sales, which based on the latest Aptevo forecast, could exceed $60 million. Ixinity contains recombinant coagulation factor IX (trenonacog alfa) – a purified single-chain glycoprotein derived from Chinese hamster ovary cells – and bears an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX.

Biocom 2020: Backstory of the FDA lifting its clinical hold and eventual approval of Inrebic

SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.

Singapore’s Tessa gains U.S. RMAT designation for CD30 CAR T, expands manufacturing efforts

HONG KONG – Singapore-based Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy designation by the U.S. FDA based on data from two independent phase I/II trials in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma. Tessa also has plans to open a 90,000-square-foot commercial-scale cell therapy manufacturing facility in Singapore by the end 2020. The facility will be built to run both clinical and commercial manufacturing of cell therapy products.

Combo product group says FDA draft downplays combo product agreement meetings

The FDA is well known for encouraging industry to meet with the agency “early and often” for complex premarket filings, but the Combination Products Coalition says a recent draft guidance seems to offer the exception. The group said the December 2019 FDA guidance for feedback on combination product applications “seems to generally discourage” the use of the combination product agreement meeting, adding that the complexity of some combination products suggests that such a meeting may well be crucial to an efficient application process.

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