Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback Biotherapeutics LP, is being evaluated in a phase III study for the treatment of non-hospitalized patients with mild to moderate COVID-19. An earlier study found it unlikely to deliver clinical benefit for hospitalized patients.
For the second time, the biopharma industry’s largest event will be held virtually as BIO Digital 2021, with pandemic preparedness and infectious diseases a running theme throughout many of the scheduled sessions.
DUBLIN – Aelis Farma SAS is banking $30 million up front as part of a strategic collaboration and option license deal with Indivior plc involving AEF-0117, its candidate drug for treating cannabis-related disorders, including addiction and psychosis. It could receive another $100 million, should Invidior trigger the option on completion of a phase IIb trial in the U.S.
Scohia Pharma Inc. has secured an agreement with Huadong Medicine Co. Ltd., enabling the former to tap the greater China market for SCO-094, its GLP-1R and GIPR dual agonist.
DUBLIN – Auris Medical Holding Ltd., an early pioneer of targeted therapy for hearing disorders, is planning to exit the field and pivot into RNA-based therapeutics by acquiring a U.S. firm, Trasir Therapeutics Inc., which has developed an oligonucleotide delivery platform for delivery of short interfering RNA and other therapeutic RNA payloads to sites outside the liver.
Kyowa Kirin Co. Ltd. has partnered with Amgen Inc. to jointly develop and commercialize KHK-4083, Kyowa Kirin’s phase III-ready anti-OX40 fully human monoclonal antibody for the potential treatment of atopic dermatitis. Kyowa Kirin will receive a $400 million up front, while milestone payments could add an additional $850 million. Significant royalty payments on future global sales could sweeten the blockbuster deal.
Morphosys AG is to acquire Constellation Pharmaceuticals Inc., financed by gambling a huge chunk of its income on the U.S. firm’s BET inhibitor pipeline drug – an approach that has to date produced mixed results in cancer.
Locust Walk Acquisition Corp. CEO and biotech veteran Chris Ehrlich said his firm sifted through more than 90 prospects before setting on a merger with Effector Therapeutics Inc., focused on selective translation regulation inhibitors (STRIs) in cancer.
Pieris Pharmaceuticals Inc. is banking $20 million up front and could receive up to $1.4 billion more in preclinical, clinical and commercial milestones from a multi-program collaboration and license agreement in respiratory disease and ophthalmology with Genentech.
BEIJING, China and SANTANDER, Spain – Antengene Corp. and Calithera Biosciences Inc. entered a worldwide exclusive license agreement to develop and market the CD73 inhibitor CB-708 (ATG-037), as part of a push to use the small-molecule inhibitor to grab significant market share in Asia Pacific and global markets.
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