In a deal that could be worth up to $937.5 million, Biogen Inc. licensed rights to phase II-stage, brain-penetrant BTK inhibitor orelabrutinib from Innocare Pharma Ltd. for the treatment of multiple sclerosis (MS) and autoimmune diseases. It’s the first mega out-licensing deal for the Chinese firm, which will receive $125 million up front and is eligible to receive up to $812.5 million in potential development milestones and commercial payments, plus tiered royalties in the low to high teens on potential future net sales.

The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said.

Novo Nordisk A/S has acquired a clinical-stage humanized monoclonal antibody and transthyretin amyloidosis (ATTR) program in a deal that could bring Prothena Corp. plc potential development and sales milestone payments of up to $1.2 billion. Also in the agreement, Dublin-based Prothena brings in $100 million in up-front and near-term clinical milestones payments as Novo gets full worldwide rights to the intellectual property and related rights of Prothena’s ATTR amyloidosis business and pipeline.

In an exclusive licensing agreement, Astrazeneca plc will get the global rights to research, develop and commercialize protein stimulator of interferon genes, STING inhibitor compounds, from F-star Therapeutics Inc. Astrazeneca is responsible for currently preclinical STING inhibitor compounds from F-star, which retains rights to all its STING agonists in clinical development for treating cancer.

DUBLIN – Having spent more than 150 years devoted to marketing tobacco, Philip Morris International Inc. is now embracing human health and wellness as part of what it calls a “beyond nicotine” strategy, under which it has tabled a £1.50 (US$2.07) per share offer for Vectura Group plc. The offer implies an enterprise value of £852 million or about $1.2 billion for Chippenham, U.K.-based Vectura, which majors in formulation and device development for inhaled drugs.

Biopharma deal-making activity continues to keep the same pace as 2020, but the value of completed mergers and acquisitions is still painfully languishing in comparison with other recent years. While pandemic partnerships appear to be falling, oncology and regenerative medicine are driving the high-money deals, as are an increasing number of billion-dollar pacts. Meanwhile preclinical efforts account for about 23% of this year’s total value, and the amounts of up-front payments, particularly for clinical-stage products, are rising.

A collaboration between Oncosec Medical Inc. and Merck and Co. that yielded positive phase II study data has paved the way for a phase III study between the two companies. Oncosec’s DNA-plasmid interleukin-12 (IL-12) Tavo (tavokinogene telseplasmid) will be combined with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a randomized, global phase III study for treating late-stage metastatic melanoma.