DUBLIN – With more than six months to go before an initial interim readout from its phase III pivotal trial of ilofotase alfa (recombinant human alkaline phosphatase) in sepsis-associated acute kidney injury (SA-AKI), AM-Pharma BV has already found a buyer for Japanese rights to the product. Kyowa Kirin Co. Ltd. is paying €20 million up front and could pay up to €225 million more in milestones attached to the progress of the program.
DUBLIN – With more than six months to go before an initial interim readout from its phase III pivotal trial of ilofotase alfa (recombinant human alkaline phosphatase) in sepsis-associated acute kidney injury (SA-AKI), AM-Pharma BV has already found a buyer for Japanese rights to the product. Kyowa Kirin Co. Ltd. is paying €20 million up front and could pay up to €225 million more in milestones attached to the progress of the program.
Women with endometriosis may be closer to finding relief from chronic inflammation and acute pain during menstruation after a group of international researchers have uncovered a new nonhormonal treatment target, neuropeptide S receptor 1.
The FDA has approved Korsuva (difelikefalin) from Cara Therapeutics Inc. for pruritis in patients undergoing hemodialysis, following a fast review. Korsuva is the first therapy approved by the FDA in the indication and is the first ever approval for the Stamford, Conn.-based company.
Aurinia Pharmaceuticals Inc. has added two potential drugs to its pipeline targeting autoimmune and kidney-related diseases through an acquisition and a licensing deal. Victoria, British Columbia-based Aurinia is building on its first ever FDA approval at the beginning of the year, for Lupkynis (voclosporin) for treating active lupus nephritis in adults.
Travere Therapeutics Inc. plans to file for accelerated approval in the first half of next year, based on data from the pivotal phase III Protect study of sparsentan, a dual-acting antagonist of the endothelin type A (ETA) and angiotensin II type 1 receptors, for IgA nephropathy (IgAN).
Fibrogen Inc. was braced for receiving a complete response letter (CRL) and it got one. The FDA suggested it would not approve roxadustat’s NDA for treating anemia of chronic kidney disease until more clinical work is conducted. In July, the FDA’s Cardiovascular and Renal Drugs Advisory Committee said basically the same thing as it voted 13-1 against approval for the nondialysis population and 12-2 against approval for patients on dialysis unless more trial data are submitted.
Organon & Co. will license exclusive global development, manufacturing and commercial rights to ebopiprant (OBE-022) from Obseva SA. Ebopiprant is a prostaglandin F2α receptor antagonist being developed for treating preterm labor by reducing inflammation and uterine contractions. Obseva could receive tiered double-digit royalties on commercial sales and as much as $500 million in up-front and milestone payments, including $25 million to be paid at signing, up to $90 million in development and regulatory milestones and up to $385 million in sales-based milestones.
Sweden’s Calliditas Therapeutics AB has licensed its rare kidney disease therapy to Stada Arzneimittel AG in Europe to help it navigate the complexity of the region’s market, ahead of a potential European and U.S. approval in the coming months.
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