Chiesi Farmaceutici SpA has agreed to pay Affibody AB up to $214 million in a collaboration and licensing agreement to develop an inhaled treatment for respiratory diseases, with a further $423 million also in the cards if the deal is extended to two more programs. The fees consist of up front and milestone payments, based on certain development, regulatory and commercial achievements, with additional mid-single to low double-digit royalties on sales.
Targeted oncology firm Revolution Medicines Inc. is seeking $300 million through a public offering as it prepares to say farewell to Sanofi SA, partner for its most advanced RAS program, and with it the prospect of earning more than $500 million in developmental and regulatory milestone payments and tiered royalties on annual net sales.
The U.S. FDA issued Cytokinetics Inc. a complete response letter (CRL) for omecamtiv mecarbil, branding the clinical evidence behind it as not “persuasive” enough to establish its effectiveness for reducing the risk of heart failure events and cardiovascular death. The company is developing the drug as an add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization.
After a long and bumpy road to approval, Reata Pharmaceuticals Inc. is to roll out the first treatment for Friedreich’s ataxia in the U.S. for patients ages 16 and older after the FDA gave its anti-inflammatory drug, Skyclarys (omaveloxolone), the green light.
Armed with $193 million in combined series A and B rounds, Aera Therapeutics aims to address current challenges with delivering gene-based therapies via a self-assembling human-derived protein platform it has in-licensed from a well-known Harvard scientist’s lab.
Plans by the U.K. government to claw back from pharma companies another 3.1% of the proportion of the drugs they sell to the National Health Service have been heavily criticized by the pharmaceutical industry as sending the “worst possible signal” to global investors. The Department of Health and Social Care announced in a consultation in December that it planned to increase the statutory scheme payment percentage from 24.4% to 27.5% starting April 1, 2023.
Aqilion AB has sold rights to its TAK1 inhibitors to Merck KGaA in an exclusive license and research collaboration agreement worth at least €960 million (US$1.03 billion) including potential milestones and royalties. The global giant will pay the Swedish biotech – which is headquartered in Helsingborg – €10 million in cash up front for the program and potential development and commercialization milestones and tiered royalties on worldwide net sales of more than €950 million.
Disappointing phase II antitumor results with a drug that is designed to preserve the bone marrow during chemotherapy have dashed G1 Therapeutics Inc.’s hopes of expanding Cosela’s label to include metastatic colorectal cancer patients, at least for now. Cosela (trilaciclib) is an intravenous-administered transient CDK4/6 inhibitor designed to mitigate the side effects patients experience with current cytotoxic drug regimens used to treat aggressive cancers by offering myeloprotection and by preserving immune system function, so enabling patients to receive chemotherapy for longer and at higher doses.
