Adaptate Biotherapeutics Ltd., of London, was spun out of London-based Gammadelta Therapeutics Ltd. to focus on regulating gamma delta T-cell activity using therapeutic antibodies. Gammadelta Therapeutics will continue to focus on gamma delta T-cell-based cell therapy products. Abingworth LLP and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, invested in the founding of Adaptate, and Takeda has a time-limited option to acquire Adaptate Biotherapeutics in the future.
Akebia Therapeutics Inc., of Cambridge, Mass., filed a complaint in federal district court against the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services challenging the rescinding of Medicare Part D coverage for Akebia's Auryxia (ferric citrate) for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD) not on dialysis. The complaint also seeks to reverse a decision to require prior authorization for Auryxia when used for the control of serum phosphorus levels in adult patients with CKD on dialysis.
Blueprint Medicines Corp., of Cambridge, Mass., licensed BLU-782, its ALK2 inhibitor being developed for the treatment of fibrodysplasia ossificans progressiva (FOP), to Ipsen SA, of Paris. Blueprint will receive $25 million up front and is eligible for up to $510 million in development, regulatory and sales-based milestone payments in up to two indications, including FOP. Blueprint will also receive royalties ranging from the low- to midteens on worldwide aggregate annual net sales.
Editas Medicine Inc., of Cambridge, Mass., and Asklepios Biopharmaceutical Inc. (Askbio), of Research Triangle Park, N.C., said they entered a research collaboration to explore in vivo delivery of genome editing medicines to treat neurological diseases. The collaboration will involve Askbio's capsid development, clinical-stage AAV vector delivery system and manufacturing expertise, along with Editas' genome editing technologies. Specific terms were not disclosed.
Eyevance Pharmaceuticals Inc., of Fort Worth, Texas, said it acquired Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05%, a fixed-dose topical antibiotic and corticosteroid combination indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists, and Natacyn (natamycin ophthalmic suspension) 5%, indicated for the treatment of fungal blepharitis, conjunctivitis and keratitis, from Basel, Switzerland-based Novartis AG. The company said Hayfin Capital Management LLP provided debt financing and an equity investment to support the transaction; no other terms were provided.
GC Pharma Ltd., of Seoul, South Korea, and Vaxess Technologies Inc., of Cambridge, Mass., said they partnered to commercialize a painless and refrigeration-free flu vaccine in a patch format. The deal will combine GC's influenza vaccine with Vaxess' Mimix smart-release patch technology. Financial terms were not disclosed.
Insilico Medicine Inc., of Rockville, Md., and Chemdiv Inc., of San Diego, said they launched a new collaboration to provide certain pharmaceutical and biotechnology companies with end-to-end drug discovery solutions. The collaboration combines artificial intelligence techniques with an integrated drug discovery shared risk platform. The commercial terms of the deal will include technology access, success-focused milestone and royalties.
Mycovia Pharmaceuticals Inc., of Durham, N.C., said it entered an exclusive license and development and technology transfer agreement with Gedeon Richter plc, of Budapest, Hungary, to commercialize and manufacture VT-1161, an oral antifungal product candidate, in Europe, Latin America, Australia, Russia and other CIS countries. The product is in phase III trials for the treatment of recurrent vulvovaginal candidiasis (RVVC), a chronic infectious condition that affects nearly 138 million women worldwide each year. Phase IIb studies have shown VT-1161 to have strong safety and efficacy profiles in RVVC patients, with as low as 0% recurrence rates through 48 weeks. Mycovia is eligible to receive milestone payments related to clinical, regulatory and commercial success of the product.
Orgenesis Inc., of Germantown, Md., which provides centralized CDMO manufacturing and development services through its subsidiary, Masthercell Global Inc., said it entered a co-development agreement with San Jose, Calif.-based Accellix Inc. The agreement will enable Orgenesis to integrate Accellix's optic system, cartridges, reagents and software into its point-of-care cellular therapy processing services and platform. Financial details were not disclosed.
Petagene Ltd., of Cambridge, U.K., said its Petasuite software has been selected to compress the genomics datasets for Cambridge, U.K.-based Astrazeneca plc's Centre for Genomics Research (CGR). To date, the center has processed more than 200,000 genomics datasets, generating over a petabyte of data. The compression software will enable the CGR to compress more than 200,000 BAM files in a 24-hour period and will add the compressed data to tiered cloud storage.
Sandoz AG, a division of Basel, Switzerland-based Novartis AG, and Pear Therapeutics Inc., of Boston, said Pear will assume responsibility to commercialize Pear's prescription digital therapeutics, Reset and Reset-O, new therapies for the treatment of substance use disorder and opioid use disorder. The companies previously signed a co-promotion agreement. Sandoz attributed the decision to the firm's transformation and subsequent leadership change, which has resulted in a reinforced focus on and capital allocation for Sandoz's core business. (See BioWorld, March 2, 2018.)
Sorrento Therapeutics Inc., of San Diego, said a Los Angeles Superior Court judge rejected biopharma entrepreneur Patrick Soon-Shiong's attempt to allow him and his company, Nantpharma LLC, of Culver City, Calif., avoid claims filed by Sorrento earlier this year, alleging a "catch and kill" scheme to keep Sorrento's cancer drug, Cynviloq, off the market. The judge's decision, among other things, denied Soon-Shiong's and Nantpharma's motion to stay or dismiss Sorrento's arbitration against them, thus allowing the case to proceed in full, Sorrento said. The lawsuit, filed in April, alleges the scheme was intended to preserve Soon-Shiong's personal financial interest in competing drug Abraxane (nab-paclitaxel, Celgene Corp.), which he had developed. In May 2015, Nantworks Inc., through Nantpharma, entered a deal to take over a subsidiary of Sorrento for rights to Cynviloq, a next-generation paclitaxel, paying $90 million up front and pledging up to $600 million in regulatory milestones and another $600 million if sales targets are hit. (See BioWorld, May 18, 2015.)