Atai Life Sciences AG, of Berlin, partnered with Neuronasal Inc., of Wexford, Pa., to develop a short-term treatment for mild traumatic brain injury (mTBI) or concussion. Neuronasal's treatment includes the intranasal delivery of low doses of N-acetylcysteine (NAC) to patients with acute mTBI. NAC is a well-established compound that has been used safely for decades, mostly as a mucolytic and to treat acute paracetamol intoxication, the companies noted. Terms were not disclosed.
Clinigen Group plc, of Burton-on-Trent, U.K., partnered with Copenhagen’s Orphazyme A/S on an early access program for arimoclomol in patients with Niemann-Pick disease type C (NPC) in the U.S. Arimoclomol has the FDA’s orphan drug, fast track and breakthrough designation and has generated positive results from a phase II/III trial in NPC. Orphazyme expects to ask the FDA for marketing approval of arimoclomol in NPC in the first half of 2020. NPC is a rare, genetic disease caused by the build-up of lipids in organs, including the brain.
Collplant Biotechnologies Ltd., of Rehovot, Israel, has joined the Advanced Regenerative Manufacturing Institute (ARMI). Manchester, N.H.-based ARMI is a public-private consortium of more than 150 partners from industry, government, academia and the nonprofit sector that develop manufacturing processes and technologies for cells, tissues and organs. About $80 million from the U.S. federal government is combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities. Collplant, whose products are based on recombinant human collagen, is developing 3D bioprinting of tissues and organs, and medical aesthetics.
Cytovia Therapeutics Inc., of New York, and the University of California, San Francisco, entered a three-year partnership to improve the performance, safety and persistence of natural killer (NK) cells and CAR NK cells. Cytovia has an exclusive option to license certain patentable inventions developed in the research program. No financial details were released.
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., and Northshore University Healthsystem, of Evanston, Ill., have agreed to study Eagle’s Ryanodex (dantrolene sodium) for traumatic brain injury in animal models. Ryanodex for injectable suspension is approved for treating malignant hyperthermia and for preventing it in high-risk patients. Northshore focuses on cerebral concussions and other traumatic brain injuries.
Generex Biotechnology Corp., of Miramar, Fla., said the payday for two dividends in Generex and its subsidiary, Nugenerex Immuno-Oncology, is delayed by an ongoing FINRA review and approval. FINRA required a new approval process for the previously announced pay date, the company said, although the record date had not changed. In October, Generex announced its merger transaction to list Nugenerex common stock as an independent, publicly traded company. Generex had expected to be quoted on a public exchange by the end of November. The merger is designed to help advance the company's Ii-Key technology and AE-37 immunotherapeutic vaccine program, currently enrolling in a phase II trial to establish the recommended dose in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) to enhance tumor-specific immune response and show efficacy in individuals with advanced triple-negative breast cancer.
Glycomimetics Inc., of Rockville, Md., and Apollomics Inc., of Pleasanton, Calif., reached an exclusive collaboration and license agreement to develop and commercialize uproleselan and GMI-1687 in mainland China, Hong Kong, Macau and Taiwan. Apollomics is responsible for clinical development and commercialization. The companies also agreed to advance the preclinical and clinical development of GMI-1687, a subcutaneous E-selectin antagonist. Glycomimetics receives an up-front cash payment of $9 million and could receive potential milestone payments of about $180 million, as well as tiered royalties on net sales. Apollomics is responsible for all costs related to development, regulatory approvals, and commercialization activities for uproleselan and GMI-1687. Glycomimetics retains all rights for both compounds in the rest of the world.
Ironwood Pharmaceuticals Inc., of Boston, and Allergan plc, of Dublin, said they reached agreement with Sandoz Inc., part of Novartis AG, of Basel, Switzerland, resolving patent litigation brought in response to Sandoz’s ANDA seeking approval to market generic versions of Linzess (linaclotide) prior to the expiration of the companies’ applicable patents. The settlement with Sandoz is the fourth patent infringement settlement the companies have reached with respect to Linzess. Pursuant to the terms, Ironwood and Allergan will grant Sandoz a license to market its 145-mcg and 290-mcg generic version of Linzess in the U.S., beginning Feb. 5, 2030 (subject to U.S. FDA approval), unless certain limited circumstances, customary for settlement agreements of that nature, occur. As a result of the settlement, the ongoing Hatch-Waxman litigation between the companies and Sandoz regarding Linzess patents pending in the U.S. District Court for the District of Delaware will be dismissed. Additional details regarding the settlement were not disclosed. The companies will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Mannkind Corp., of Westlake Village, Calif., said its Brazilian partner, Biomm SA, has received written notice from the Chamber of Regulation of the Medicines Market approving the proposed price of Afrezza (inhaled insulin) in Brazil. Biomm intends to commence marketing and distribution of Afrezza throughout Brazil, beginning the week of Jan. 13.
Mediwound Ltd., of Yavne, Israel, and its U.S. commercial partner, Vericel Corp., of Cambridge, Mass., said the U.S. Biomedical Advanced Research and Development Authority (BARDA) began procuring the bromelain gel product Nexobrid for emergency stockpile as a medical countermeasure to treat mass casualty emergencies involving thermal burns. The procurement represents a milestone of the Project Bioshield contract signed in September 2015 between Mediwound and BARDA. Inventory purchased by the agency will be managed by Mediwound. The initial BARDA procurement is valued at $16.5 million, with the first delivery expected by the end of this quarter and additional deliveries planned over the ensuing five quarters. BARDA holds an option to procure additional quantities of Nexobrid through funding of up to $50 million. A BLA submission for Nexobrid to the FDA is planned for the second quarter.
Novartis AG, of Basel, Switzerland, said it completed its acquisition by wholly owned subsidiary Medusa Merger Corp. for all outstanding shares of The Medicines Co., of Parsippany, N.J., for $85 per share. The companies inked the $9.7 billion agreement in November.
Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said a peer-reviewed paper published in Research and Reports in Urology provides evidence from a rat model for how the company’s fexapotide triflutate inhibits prostate enlargement by selectively eliminating prostate glandular cells while preserving key elements including nerves, blood vessels and adjacent structures.
Provention Bio Inc., of Oldwick, N.J., disclosed in a recent SEC filing that it was informed by Janssen Pharmaceutica NV, a unit of New Brunswick, N.J.-based Johnson & Johnson, that Janssen no longer intends to take up an option to buy back rights to CSF-1R inhibitor PRV-6527, which has been under development for Crohn’s disease. Instead, Janssen said it intends to support and expand the field of the license, development and commercialization agreement entered in April 2017 to facilitate the program’s continuation either directly by Provention or by way of Provention’s sublicensing rights under the agreement. Janssen indicated it intends to assist in transferring the compound’s manufacturing rights to Provention or a third party manufacturer and will irrevocably waive its rights to assume distribution and pricing decision-making authority. Provention previously disclosed that it does not intend to continue PRV-6527’s development directly and may explore sublicensing.
Pulmatrix Inc., of Lexington, Mass., said it entered a research collaboration with Nocion Therapeutics Inc., of Waltham, Mass., to explore new technologies to enable and improve inhaled drug delivery. The collaboration will leverage Pulmatrix's Isperse platform and expertise in seeking to transform promising assets to improve drug delivery and safety profiles. Financial terms were not disclosed.
Radiomedix Inc., of Houston, said it was selected for the 2019-2020 Commercialization Accelerator Program by the NIH Small Business Innovation Research(SBIR)/Small Business Technology Transfer program office. The award follows a two-year $2 million Phase II SBIR funded in part by the National Cancer Institute, National Institutes of Health and Human Services, under a contract focusing on the clinical development of 212Pb-Alphamedix for the targeted alpha-emitter therapy of neuroendocrine tumors.
Yeda Research and Development Co. Ltd., of Rehovot, Israel, the commercial arm of the Weizmann Institute of Science, and health care investment management firm Deerfield Management Co. said they forged a translational research initiative – Deerfield’s first outside the U.S. – to advance therapies for difficult-to-treat and rare illnesses toward clinical validation. Deerfield committed to provide up to $130 million of initial funding to support the initiative over 10 years through newly launched Orchard Innovations LLC. Deerfield also will provide operational, managerial and developmental know-how to further drug research in a range of indications. Orchard Innovations, wholly owned by Deerfield affiliates, will support R&D projects from Weizmann through various stages of drug exploration and advancement. Starting early this year, Yeda will submit project proposals to a committee of scientific leaders from Weizmann, Yeda and Deerfield. Accepted projects are expected to include a development plan aimed at achieving IND readiness, with Deerfield providing initial funding and development support and the opportunity for additional financial backing. Orchard Innovations will receive a license to intellectual property developed under Deerfield-supported projects at Weizmann.
Yisheng Biopharma Co. Ltd., of Beijing, and Tavotek Biotherapeutics, of Ambler, Pa., said they formed a strategic research alliance to collaborate on development involving lead oncology assets YS-ON-001 (Yivyka) and YS-ON-002, Yisheng’s immunotherapeutics based on the TLR3/RIG-I/MDA-5 signaling pathways of PIKA, and Tavo-301/303, a series of multispecific antibody-based immuno-oncology assets developed with Tavotek's Tavoselect platform. Although the initial objective is to co-develop combination therapy for cancer treatment, the companies said they are discussing R&D collaborations beyond oncology. Financial terms were not disclosed.