Adamis Pharmaceuticals Corp., of San Diego, said it entered an exclusive distribution and commercialization agreement with Emerge Health Pty. Ltd., of Victoria, Australia, to register and commercialize its Symjepi (epinephrine) injection products in Australia and New Zealand. Adamis will provide technical support to Emerge during the registration process, which it is estimated could take more than a year to complete. If successful, Adamis will begin supplying product to Emerge, which will have the responsibility for the full registration, reimbursement, sales, marketing and distribution of Symjepi.
Applied Genetic Technologies Corp., of Gainesville, Fla., and San Diego-based Otonomy Inc. said they entered a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the gap junction protein beta 2 gene (GJB2). Mutations in GJB2 account for approximately 30% of all genetic hearing loss cases. The companies will share equally the program costs and proceeds, and their agreement includes the possibility of exploring additional genetic hearing loss targets in the future.
Astellas Pharma Inc., of Tokyo, plans to invest $12.5 million in two innovation incubators operated by Cambridge, Mass.-based Labcentral, which specializes in biotech startups. The investment brings Astellas' total infusion in Boston-area life sciences development to more than $1 billion.
Astrazeneca plc, of Cambridge, U.K., is selling the global commercial rights, excluding China, Japan, Mexico and the U.S., to Losec (omeprazole) and its associated brands to Cheplapharm Arzneimittel GmbH, of Mesekenhagen, Germany. Cheplapharm will pay Astrazeneca about $243 million, plus sales-contingent milestones of up to $33 million in 2021 and 2022. The divestment includes medicines containing omeprazole marketed by Astrazeneca or its collaborators under the names Acimax, Antra, Mepral, Mopral, Omepral and Zoltum. Losec, a proton pump inhibitor discovered and developed by Astrazeneca, is designed to treat gastrointestinal reflux conditions and ulcers.
Bausch Health Companies Inc., of Laval, Canada, and its wholly owned subsidiary, Salix Pharmaceuticals Inc., of Bridgewater Township, N.J., filed a lawsuit against Sandoz Inc., a unit of Basel, Switzerland-based Novartis AG, alleging infringement of 14 patents in Sandoz's abbreviated NDA for Xifaxan (rifaximin) 500-mg tablets, which are designed to reduce risk of overt hepatic encephalopathy recurrence in adults and to treat irritable bowel syndrome with diarrhea in adults.
Bluewillow Biologics Inc., of Ann Arbor, Mich., said it received a Fast-Track Small Business Research Innovation contract from the National Institute of Allergy and Infectious Diseases for development of an intranasal therapeutic peanut allergy vaccine using its Nanovax platform. Pending approval of all phases, the contract will provide funding of up to $3.2 million, which will enable Bluewillow to complete preclinical research and prepare to file an IND for its candidate vaccine.
Elevatebio LLC, of Cambridge, Mass., has launched Highpassbio, whose lead candidate is an engineered T-cell receptor (TCR) T-cell therapy for HA-1-expressing tumors. The product is designed to treat or potentially prevent relapse of leukemia in patients who have undergone hematopoietic stem cell transplant. The product and approach were developed at the Fred Hutchinson Cancer Research Center.
Munich-based Ethris GmbH and Munster University Hospital received a research grant from the Central Innovation Program for SMEs to continue their research into treatments for primary ciliary dyskinesia. Those patients have recurrent infections of the upper and lower respiratory tract, leading to progressive lung, sinus and ear disease. Other manifestations may include situs inversus and infertility. The grant's amount was not disclosed.
Fulcrum Therapeutics Inc., of Cambridge, Mass., reported preclinical data for FTX-6058, formerly FTX-HbF, which is being developed for sickle cell disease and beta-thalassemia. Treatment of human erythroid progenitor cells from multiple donors with FTX-6058 increased fetal hemoglobin (HbF) to approximately 30% of total hemoglobin as measured by HPLC and mass spectrometry. The drug also increased HbF in animal models at plasma concentrations reasonably expected to be achieved in humans. Fulcrum has started IND-enabling studies and plans to file an IND in mid-2020.
The Institute for Clinical and Economic Review (ICER) has posted a draft scoping document outlining a planned review of the comparative clinical effectiveness and value treatments for cystic fibrosis. ICER's report will focus on elexacaftor/tezacaftor/ivacaftor from Boston-based Vertex Pharmaceuticals Inc. ICER also will examine any new data that has become available since its May 2018 review of three other treatments already approved by the FDA: tezacaftor/ivacaftor (Symdeko, Vertex Pharmaceuticals Inc.), lumacaftor/ivacaftor (Orkambi, Vertex Pharmaceuticals Inc.) and ivacaftor (Kalydeco, Vertex Pharmaceuticals Inc.). Comments can be submitted by email to firstname.lastname@example.org and must be received by 5 p.m. Eastern on Oct. 21.
Immunomic Therapeutics Inc., of Rockville, Md., assumed sponsorship of the IND application for ITI-1000 from the University of Florida (UF). ITI-1000 is currently being investigated in the phase II ATTAC-II trial at UF and Duke. The protocol will remain active, the existing principal investigators from UF and Duke will remain in place. ITI-1000 is a dendritic cell vaccine therapy for the treatment of glioblastoma multiforme.
Lantern Pharma Inc., of Dallas, disclosed a collaboration with the National Cancer Institute (NCI) to identify gene signatures that help predict a potential response of a patient's tumor to a drug therapy. The company will work with the DTB Genomics and Pharmacology Facility at NCI to apply its Cellminer and CellminerCDB platforms, regression models and algorithms to independently categorize gene predictors of response or sensitivity to Lantern's pipeline drug candidates by tumor type. The pact will enable identification of correlates from NCI-generated omics datasets – including DNA mutation, mRNA/miRNA expression, DNA methylation, DNA copy number and protein arrays – with Lantern's pipeline drug candidate bioactivity profiles through the NCI's Cellminer approach.
Les Laboratoires Servier SAS, of Paris, acquired Pixuvri (pixantrone) from CTI Biopharma Corp., of Seattle. Before the acquisition, the French company marketed the non-Hodgkin B-cell lymphoma treatment under a license from CTI. Terms of the deal weren't disclosed.
Mallinckrodt plc, of Staines-Upon-Thames, U.K., disclosed positive top-line findings from its observational registry to assess treatment patterns and response to Acthar Gel (repository corticotropin injection) in reducing the clinical impact of disease exacerbations in patients with multiple sclerosis (MS) relapse. The results for the main subsets of patients are highly statistically significant for all the efficacy endpoints. Mallinckrodt plans to share the data at an upcoming medical meeting. Acthar Gel is FDA-approved for the treatment of acute exacerbations of MS in adults.
Mimetas BV, of Leiden, the Netherlands, and Hubrecht Organoid Technologies, of Utrecht, the Netherlands, signed a strategic collaboration to market organoid models on a chip. The agreement includes a license to Mimetas to market Hubrecht organoids in an assay-ready format, as well as a collaborative effort to develop disease-specific models. Terms were not disclosed.
Moberg Pharma AB, of Stockholm, signed an exclusive license agreement with Taisho Pharmaceutical Co. Ltd., of Tokyo, for the development, registration and commercialization of MOB-015 in Japan. Moberg is eligible to receive milestone payments of up to $50 million contingent on development and commercial success, as well as supply fees including royalties. The drug is a new topical treatment for onychomycosis based on Moberg's patented formulation of terbinafine.
Navrogen Inc., of Philadelphia, signed a cooperative research and development agreement (CRADA) with researchers at the National Cancer Institute (NCI). The CRADA is focused on advancing antibody-based experimental medicines to targets associated with tumor-mediated immunosuppression. Researchers at the NCI have developed compounds that can target molecules on inflammatory cells and unlock their immunosuppressed state within the tumor microenvironment. Under the CRADA, Navrogen is responsible for validating and advancing the preclinical development of the compounds toward clinical trials.
Neurocycle Therapeutics Inc., of Cambridge, Mass., was awarded a grant from the Helping to End Addiction Long-term (HEAL) Initiative to advance development of its non-addictive treatment of chronic musculoskeletal pain. The company specializes in targeting specific receptor subtypes within the central nervous system to fight central sensitization disorders including chronic pain. The HEAL award is one of 375 grant awards across 41 states made by the NIH in fiscal year 2019.
Novartis AG, of Basel, Switzerland, said it founded the Novartis AI innovation lab and entered a multiyear alliance with Microsoft as its artificial intelligence and data science partner. The collaboration will focus on two core objectives: bringing AI capabilities to every Novartis associate and exploring the use of AI in areas such as generative chemistry, image segmentation and analysis aimed at personalized delivery of therapies and optimization of cell and gene therapies at scale. Microsoft and Novartis will also collaborate to develop and apply next-generation AI platforms and processes that support future programs across those two focus areas. The overall investment will include project funding, subject-matter experts, technology and tools.
Numab Therapeutics AG, of Zurich, Switzerland, formed a partnership with Eisai Co. Ltd., of Tokyo, to discover and develop multispecific antibody immunotherapies for cancer, using Numab's Match platform. Under the terms, Eisai has the option to acquire an exclusive license to develop and commercialize molecules that emerge from the research collaboration with Numab, which will receive from Eisai an up-front payment and research funding and is eligible to receive success fees, milestone payments and tiered royalties on sales. Exact terms were not disclosed.
Or-Genix Therapeutics Inc., of Worcester, Mass., and Fission Labs LATAM, of Madrid, Spain, are partnering to develop a dermatology product for blemishes, oily skin and alopecia in Latin America. Fission plans to start marketing the product in Peru, Mexico, Paraguay, Bolivia and Ecuador and eventually move into Chile, Colombia, Panama, Costa Rica, Argentina and Brazil. The companies plan to establish a joint committee to guide development and marketing of the product. Financial terms of the deal weren't disclosed.
PDS Biotechnology Corp., of Berkeley Heights, N.J., plans to focus on developing PDS-0101 as a combination treatment for advanced cancers following recently announced phase I data showing the drug induces CD8+ T cells. PDS has therefore decided not to start a planned phase II monotherapy study.
Platelet Biogenesis Inc., of Cambridge, Mass., signed a $56 million contract with the Biomedical Advanced Research and Development Authority to develop donor-independent platelets as a medical countermeasure for treatment of thrombocytopenia in victims of a nuclear or radiological event.
Sabin Vaccine Institute, of Washington, will receive $20.5 million from the Biomedical Advanced Research and Development Authority for process development and nonclinical activities of monovalent vaccines against Ebola Sudan and Marburg viruses that Sabin recently licensed from Glaxosmithkline plc, of London. The contract includes options for an additional $107.5 million in funding to support additional nonclinical studies, manufacturing of clinical material and phase II trials in the U.S. and Africa.
Tokyo-based Symbio Pharmaceuticals Ltd. bought the exclusive global rights from Chimerix Inc., of Durham, N.C., to develop, manufacture and commercialize brincidofovir in all human indications, excluding the prevention and treatment of smallpox. Symbio will be responsible for all future development, commercialization and manufacturing. Chimerix receives $5 million up front plus potential clinical, regulatory and commercial milestones of up to $180 million. It also could receive double-digit royalties on worldwide net sales.
Thermo Fisher Scientific Inc., of Waltham, Mass., completed its acquisition of an active pharmaceutical ingredient manufacturing facility in Cork, Ireland, from Glaxosmithkline plc, of London, for €90 million (US$98.4 million). Thermo Fisher is hiring approximately 400 employees who work at the manufacturing site.
Tmunity Therapeutics Inc., of Philadelphia, licensed a CAR T therapy targeting glypican 2 (GPC2) for the treatment of neuroblastoma from Children's Hospital of Philadelphia (CHOP). The treatment may also be expanded into medulloblastoma, small-cell lung cancer and other cancers that express GPC2. Tmunity and CHOP will collaborate to start IND-enabling studies, with CHOP carrying out a majority of the preclinical work and Tmunity responsible for development, manufacturing, regulatory and commercialization of the treatment. Terms of the deal weren't disclosed.
University of California, of Berkeley, Calif., University of Vienna, and Emmanuelle Charpentier were issued a patent from the U.S. Patent and Trademark Office covering the methods of targeting and binding or methods of cleaving a target DNA in a prokaryotic cell using Cas9 protein and single molecule DNA targeting RNAs. UC has 16 U.S. patents covering CRISPR/Cas9 and expects two more to be issued in the coming weeks, it said.