Merck KGaA acquires Abbisko benign tumor drug rights for $85M

Merck KGaA, a prominent German pharmaceutical company, has announced its strategic decision to invest $85 million to acquire the global commercialization rights for pimicotinib. This drug, developed by Abbisko Therapeutics, a Chinese biopharmaceutical firm, is aimed at treating non-malignant tumors. This agreement follows a previous arrangement where Merck KGaA had already secured rights to market pimicotinib in China, Hong Kong, Macau, and Taiwan. As part of the initial deal, Merck KGaA had paid $70 million upfront and agreed to potential milestone payments amounting up to $605.5 million, along with double-digit royalties.

Pimicotinib is an oral inhibitor targeting the CSF-1R pathway and is being developed for the treatment of tenosynovial giant cell tumor (TGCT), a type of benign tumor. TGCT manifests as recurring tumors in the joints, which can lead to pain, swelling, and stiffness, severely impacting the daily activities of those affected. Despite its debilitating nature, TGCT is a rare condition, with an incidence of less than 50 cases per million people globally each year.

The decision by Merck KGaA to expand its rights to include worldwide sales of pimicotinib was influenced by positive results from a Phase 3 international study announced by Abbisko Therapeutics. The study demonstrated that patients who received pimicotinib experienced a 54% objective response rate at 25 weeks, compared to a mere 3.2% in the placebo group. These encouraging results have already prompted preparations for a regulatory filing in China.

In the current market, there are two treatments approved for TGCT: Turalio, developed by Daiichi Sankyo, and Romvimza from Ono Pharmaceuticals. The latter received approval from the FDA just last month. Romvimza offers a twice-weekly dosage regimen, presenting a convenience benefit over pimicotinib, which is administered once daily.

Interestingly, Abbisko Therapeutics is not limiting pimicotinib’s potential to TGCT alone. The company has announced plans to explore the drug's efficacy in treating more prevalent conditions, such as chronic graft-versus-host disease and pancreatic cancer. Currently, pimicotinib is undergoing a Phase 2 trial in China for advanced pancreatic cancer, indicating the potential broad applicability of this therapeutic agent.

Merck KGaA’s acquisition of global rights to pimicotinib reflects the company's commitment to bolstering its oncology portfolio and addressing unmet medical needs in tumor treatment. By securing these rights, Merck KGaA positions itself to not only tap into existing TGCT markets but also to potentially leverage pimicotinib's application in other significant medical conditions. This strategic move underscores the firm's dedication to innovation and expanding patient access to novel therapies worldwide.