To bolster its obesity treatment pipeline, Eli Lilly and Co. is buying Versanis Bio Inc. in a massive cash deal that could reach $1.92 billion. The total amount of the deal includes an up-front payment and development and sales milestones payments. Privately held Versanis brings to Lilly bimagrumab, its lead asset and a monoclonal antibody that’s enjoying a resurgence since a failure in treating sarcopenia. Lilly flexed its weight-loss muscle in late June with fresh data from retatrutide, which is in a phase II study for treating obesity. A little more than a year ago, Lilly planted another flag in the obesity space with the U.S. FDA’s approval of a priority NDA for Mounjaro (tirzepatide), an injectable treatment for adults with type 2 diabetes.
Neuren, Acadia expand Daybue partnership; deal worth $527M plus royalties
Neuren Pharmaceuticals Ltd. and Acadia Pharmaceuticals Inc. have expanded their development and commercialization partnership for Daybue (trofinetide) beyond the U.S. to take the Rett syndrome treatment to the world in a deal valued at $527 million plus royalties. Under terms of the new deal, Neuren receives a $100 million up-front payment, plus additional commercial milestones pegged to Europe, Japan and the rest of the world that amount to $427 million. Neuren will also receive tiered sales-based royalties. If Acadia sublicenses trofinetide for any region outside of North America within the first two years, Neuren is entitled to a share of any up-front and development milestones received by Acadia.
Theseus stock toppled by skin reactions, discontinuance of GIST candidate
Shares of Theseus Pharmaceuticals Inc. (NASDAQ:THRX) plunged almost 69%, or $6.56, to trade midday at $2.96 after the company said it’s discontinuing enrollment in the ongoing phase I/II study and stopping development of THE-630 in patients with gastrointestinal stromal tumors (GIST). The Cambridge, Mass.-based firm cited several cases of hand-foot skin reaction in cohort 7 (27 mg) that blocked escalation to the necessary therapeutic level. In the first half of next year, Theseus plans to nominate a new, highly selective pan-variant KIT inhibitor candidate for GIST.
IPO window swings open for firms focused on atopic dermatitis, COPD and NASH
Two biopharma companies entered the public markets on July 14, with Apogee Therapeutics Inc. pricing a $300 million IPO, the second largest U.S. debut this year, and Sagimet Biosciences Inc. raising $85 million. Apogee, of San Francisco, and Waltham, Mass., is advancing APG-777 and APG-808, which are in development for atopic dermatitis and chronic obstructive pulmonary disease, while San Mateo, Calif.-based Sagimet’s lead candidate is the FASN inhibitor denifanstat for nonalcoholic steatohepatitis. Apogee’s shares (NASDAQ:APGE) were up 26% to $21.48 in early trading, while Sagimet’s shares (NASDAQ:SGMT) were slightly down by 6 cents to $15.94.
Dealmaking slows in Q2 amid FTC and IRA headwinds
There are at least two ways to look at biopharma deals and M&As in 2023. Through one vantage point, the volume of both, and the value of M&As, are at their lowest levels in at least five years – and deal values have declined by 8% compared with 2022. From another perspective, however, M&As appear to be picking up, and those same declining deal values in the first half of 2023 represent the third highest amount since 2017. Upcoming pricing negotiations as part of the Inflation Reduction Act (IRA) of 2022, the U.S. FTC’s recent challenge to the Amgen Inc. and Horizon Therapeutics plc merger agreement, as well as returning investors in the financial markets, have impacted dealmaking and merger efforts in the second quarter.
Genequantum, Aimed Bio partner again to develop five more ADCs
Another collaboration between two biopharmaceutical companies in the Asia-Pacific region is adding fuel to an already heated fire for antibody-drug conjugate (ADC) drug development worldwide. Suzhou, China-headquartered Genequantum Healthcare Co. Ltd. and South Korea’s Aimed Bio Inc. recently announced extending an existing partnership to jointly develop five ADC investigative drugs. The handshake adds to an initial collaboration inked in April 2022 to jointly develop GQ-1011, a “first-in-class” ADC that targets the fibroblast growth factor receptor 3.
Viiv Healthcare’s HIV treatment cabotegravir approved in China
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir oral tablet and long-acting injectable cabotegravir, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option. Cabotegravir is an integrase strand transfer inhibitor (INSTI). INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells, which is critical in the HIV replication cycle and is also responsible for establishing chronic disease.