HONG KONG – Seikagaku Corp. and Ono Pharmaceutical Co. Ltd. have cleared the final hurdle for Joyclu (diclofenac etalhyaluronate sodium), with Japan’s Ministry of Health, Labour and Welfare granting manufacturing and marketing approval for the osteoarthritis (OA) therapy, the first agent to be approved in Japan for improving hip joint function in OA. The intra-articular injection was also approved for the treatment of knee joint OA.
Marking its second acquisition this year after snapping up cancer-focused Five Prime Therapeutics Inc., Amgen Inc. is adding to its inflammatory disease portfolio through the purchase of Seattle-based Rodeo Therapeutics Corp. The deal includes $55 million up front for the private company's shareholders, plus contingent milestone payments worth up to an additional $666 million. Rodeo's lead preclinical program targets 15-prostaglandin dehydrogenase to increase tissue levels of prostaglandin PGE2.
If the March 25 vote from a joint FDA advisory committee meeting is anything to go by, the long and bumpy development road for Pfizer Inc.’s tanezumab, a nonopioid pain drug, may have just gotten longer and bumpier. In what was nearly a unanimous vote, the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee said the sponsor’s proposed risk evaluation and mitigation strategy (REMS) was not adequate to ensure the benefits of tanezumab in alleviating osteoarthritis pain outweigh its risks, which include further joint deterioration.
With the December PDUFA date already blown, Pfizer Inc. is headed into a day-and-a-half FDA advisory committee meeting this week to make the case for 2.5-mg tanezumab, a potential first-in-class treatment in the U.S., partnered with Eli Lilly and Co. Inc., for chronic pain due to moderate to severe osteoarthritis.
Anaptysbio Inc. is calling it quits for developing imsidolimab in treating moderate to severe palmoplantar pustulosis (PPP) after its phase II Poplar trial failed to hit its primary endpoint. However, the company said it would continue imsidolimab development for five other indications, including a phase III trial in treating generalized pustular psoriasis (GPP) that’s set to begin in mid-2021.
Rigel Pharmaceuticals Inc. cut the biggest deal of the company’s life with its new collaboration with Eli Lilly and Co. that could be worth $960 million. The two will co-develop and commercialize Rigel’s R-552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases.
Slate Bio Inc., a startup developing an interleukin 2 fusion cytokine for the potential treatment of autoimmune and inflammatory diseases, has closed a $1.75 million seed financing led by Epidarex Capital. Financing for the company, a spinout of the University of Virginia, also came from the UVA Licensing & Ventures Group Seed Fund, Center for Innovative Technology's GAP Biolife Fund, VTC Seed Fund, Pharmadirections Inc., company management and others.
The Human Skin Cell Atlas, comprising transcriptomes of 528,253 single cells, shows that cellular processes involved in skin development in embryos are reactivated in inflammatory skin diseases. In addition to suggesting potential new drug targets for atopic dermatitis and psoriasis, the transcriptomes provide a new route to understanding other inflammatory diseases.
Forge Therapeutics Inc. spinout Blacksmith Medicines Inc. said Eli Lilly and Co. has committed up to $300 million in milestone payments to back its creation of five new immuno-oncology and inflammation-focused medicines targeting human metalloenzymes.
HONG KONG – Kira Pharmaceuticals is riding high after completing a $46 million fundraiser and appointing Frederick Beddingfield as CEO. “The $46 million comprises a series A of $18 million and a series B of $26 million, with investors Quan Capital, 6 Dimensions Capital, Qiming Venture Partners, and Sinopharm Capital participating in both rounds,” Beddingfield told BioWorld.
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