Amgen Inc., of Thousand Oaks, Calif., said it completed purchasing 49% of Amgen Astellas Biopharma K.K. (AABP) shares from Tokyo’s Astellas Pharma Inc. AABP is a joint venture between Amgen and Astellas, established in 2013 and now a wholly owned Amgen affiliate in Japan named Amgen K.K. Its pipeline includes candidates for treating cancer and cardiovascular, bone and neurological diseases
Azurrx Biopharma Inc., of New York, said it received about €581,000 (US$635,062) for its 2017 CIR (French Research Tax Credit) following the successful conclusion of its audit. It marks the second CIR payment Azurrx has received in 2020. In March, the company said it received $1.13 million for its 2018 CIR, for an aggregate total of $1.77 million in nondilutive funding received in 2020. The company anticipates it will receive the 2019 CIR payment by the end of this year. The French R&D tax credit initiative gives eligible research-based French companies, which are subject to corporate tax in France, the ability to claim tax relief of up to 30% on costs incurred in R&D activities. The CIR has been used to fund Azurrx’s ongoing MS-1819 clinical trials, including its phase II combination therapy study in cystic fibrosis.
New data from Cardiol Therapeutics Inc., of Oakville, Ontario, show its cannabidiol formulation significantly reduced hypertrophy and produced a dose-dependent reduction of key inflammation markers, decreases in fibrosis and lower B-type natriuretic peptide expression, the company said. The findings confirm the anti-inflammatory and antifibrotic activity of the formulation in a heart failure model, the company added. The data show cannabidiol reduced the amount of BNP released, the company added. The results support Cardiol’s plans for phase II international trial in acute myocarditis, an inflammatory form of heart failure.
Citius Pharmaceuticals Inc., of Cranford, N.J., said it signed an exclusive six-month option agreement to in-license a stem cell therapy for acute respiratory distress syndrome from a subsidiary of Cambridge, Mass.’s Novellus Inc. Novellus uses non-immunogenic synthetic messenger ribonucleic acid molecules to create induced pluripotent stem cells that then generate mesenchymal stem cells. Citius focuses on anti-infectives and cancer care.
Daré Bioscience Inc., of San Diego, said it received $730,722 from a grant supporting the Ovaprene postcoital test clinical study research, given by the Eunice Kennedy Shriver National Institute of Child Health & Human Development, a division of the NIH. Having previously received two tranches under the grant, the total is now nearly $2 million. The NIH issued the final award for the project after reviewing data from the completed clinical study and commercialization plans for Ovaprene, an investigational hormone-free, monthly contraceptive.
Diffusion Pharmaceuticals Inc., of Charlottesville, Va., said it began a cooperative research effort with the University of Virginia Health and the Integrated Translational Research Institute of Virginia (iTHRIV), to evaluate Diffusion’s small molecule in patients with acute respiratory distress syndrome (ARDS) associated with COVID-19 infection. iTHRIV is an NIH-funded Clinical and Translational Awards program. COVID-19 patients are at risk for developing ARDS, which can lead to death from systemic hypoxemia. Diffusion and UVA and iTHRIV researchers said the oxygen-enhancing molecule’s mechanism of action could benefit COVID-19 patients by mitigating the multiple organ failure that often accompanies systemic hypoxemia.
Eisai Co. Ltd. and Seikagaku Corp., both of Tokyo, said they agreed to a co-development and marketing alliance in China for SI-613 (diclofenac conjugated sodium hyaluronate), a potential osteoarthritis knee treatment from Seikagaku. The companies will jointly develop SI-613 in China for knee osteoarthritis. Seikagaku is to supply products to Eisai, which will oversee distribution. They will equally share development costs while Eisai will pay Seikagaku an undisclosed up-front payment, and development as well as sales milestones.
Emergent Biosolutions Inc., of Gaithersburg, Md., said it signed an agreement with Novavax Inc., also of Gaithersburg, to provide molecule-to-market contract development and manufacturing services to produce Novavax’s Nanoflu, its recombinant quadrivalent seasonal influenza vaccine candidate with its Matrix-M adjuvant. The vaccine met all primary objectives in a phase III trial evaluating immunogenicity and safety in adults 65 and older. Emergent will provide drug substance manufacturing services, including technology transfer and process validation and performance qualification to pave the way for commercial manufacturing.
Eyepoint Pharmaceuticals Inc., of Watertown, Mass., said it is taking several measures, including a reorganization of its commercial operations and the cancellation or deferral of planned spending, to conserve cash in response to a significant decline in product demand associated with shut-downs of customer facilities and postponements of elective surgical procedures in response to COVID-19. Among the actions, Eyepoint will downsize its current workforce, with reductions coming primarily from the external Dexycu sales force and supporting commercial operations, as cataract surgery is considered a non-essential procedure due to the pandemic. It plans to allocate its remaining Dexycu commercial resources to high-volume ambulatory surgery centers in key U.S. regions. It also will continue to invest in its Yutiq commercial operations, as treatments for patients suffering from non-infectious uveitis affecting the posterior segment of the eye continue to be deemed essential during the COVID-19 pandemic, given that irreversible blindness is a potential consequence of delaying treatment. The reorganization is expected to result in annual savings of about $7 million from workforce reductions and one-time savings of approximately $10 million from other planned expenditure cancellations and deferrals. Based on those actions, coupled with cash conservation activities, Eyepoint said it is able to reconfirm its expected cash runway into 2021 under current assumptions for the duration of the COVID-19-related closures across the U.S. Shares of Eyepoint (NASDAQ:EYPT) closed April 1 at 86 cents, down 16 cents, or 15.7%.
Flexion Therapeutics Inc., of Burlington, Mass., said it entered an exclusive license agreement with HK Tainuo and Jiangsu Tainuo, a subsidiary of China Shijiazhuang Pharmaceutical Co, Ltd., of Hebei, China, for the development and commercialization of Zilretta (triamcinolone acetonide extended-release injectable suspension) in greater China, including mainland China, Hong Kong and Macau, and Taiwan. HK Tainuo will pay Flexion an up-front payment of $10 million and it will be eligible to receive up to $32.5 million in aggregate development, regulatory and commercial sales milestone payments. HK Tainuo will be responsible for the clinical development, product registration and commercialization of the compound in greater China. Separately, Flexion said it is temporarily suspending its active clinical trials, including the phase I study evaluating the safety and tolerability of FX-201, its investigational intra-articular gene therapy product candidate, in patients with osteoarthritis (OA) of the knee, and the phase II trial evaluating the efficacy of Zilretta in patients with shoulder OA or adhesive capsulitis. The decision was based on the recent guidance from the FDA to ensure the safety of trial participants and minimize risk to trial integrity from disruptions caused by COVID-19. The company continues to advance the preclinical program for FX-301, its product candidate being developed as a locally administered peripheral nerve block for control of postoperative pain.
GE, of Boston, said it completed the sale of its biopharma business to Danaher Corp., of Washington, for $21.4 billion, including approximately $21 billion in cash as well as Danaher’s assumption of certain pension liabilities. The net proceeds to GE totaled approximately $20 billion.
Immunitybio Inc., of El Segundo, Calif., said it is collaborating with Microsoft to leverage the company’s Azure platform to perform a highly detailed computational analysis of the spike protein structure of the SARS-CoV-2 virus. The protein is the key to the mechanism the virus uses to invade cells in the body and cause an infection. The spike protein binds to the ACE2 receptor on the surface of an epithelial cell in the human respiratory tract. With the availability of the model, researchers working on vaccines and treatments have a clear therapeutic target that will streamline their work in finding ways to treat the pandemic, the company said.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said it has received data from research conducted at one of the U.S. Regional Biocontainment Laboratories supporting brilacidin’s direct inhibition of SARS-CoV-2. Vero cells, a monkey kidney cell line commonly used to screen small-molecule inhibitors of viruses, were pretreated with brilacidin at increasing concentrations (at 2 µM and at 10 µM) for two hours prior to the infection. Cells treated with the vehicle alone (dimethyl sulfoxide) were maintained alongside, as controls. At 16 hours post-infection, researchers observed a dose-dependent reduction in the SARS-CoV-2 infectious viral titers from the brilacidin-treated cells as compared to the vehicle-alone control.
Macromoltek Inc., of Austin, Texas, said its computational de novo design capability is speeding up the development of human monoclonal antibodies for the potential treatment of COVID-19. The platform generates de novo antibody designs using an automated process of structural modeling and machine learning.
Modalis Therapeutics Co., of Tokyo, licensed intellectual property from Editas Medicine Inc., of Cambridge, Mass., allowing Modalis to develop its epigenetic gene modulation technology, CRISPR-GNDM (Guide Nucleotide Directed Modulation), to treat patients with serious genetic disorders. Financial terms of the deal were weren't disclosed.
Oramed Pharmaceuticals Inc., of New York, is delaying its exploratory clinical study of its oral leptin drug candidate in adults with type 1 diabetes due to the COVID-19 outbreak.
Ostrich Pharma USA, of Cambridge, Mass., has developed ostrich antibodies that bind to SARS-CoV-2, the virus that causes COVID-19. Antibodies from the first 10 ostriches that were vaccinated have been used in masks, nasal drops and candies for use in Japan. The company is making plans for producing and deploying the antibodies in the U.S.
Paratek Pharmaceuticals Inc., of Boston, started receiving funding from the Biomedical Advanced Research and Development Authority to set up manufacturing for its antibiotic Nuzyra (omadacycline) in the U.S. The company expects to receive $20 million for the project.
Regenxbio Inc., of Rockville, Md., granted Ultragenyx Pharmaceutical Inc., of Novato, Calif., an exclusive worldwide license, with rights to sublicense, to its NAV AAV8 and AAV9 vectors for use as gene therapy treatments for an undisclosed rare metabolic disorder. Regenxbio will receive $7 million up front and is eligible for ongoing fees, milestone payments and royalties on net sales of products that use the vectors.
Sanbio Co Ltd., of Tokyo, and Ocumension Ltd., of Hong Kong, are collaborating to develop Sanbio’s mesenchymal stem cell medicines with an initial focus on SB-623 cells in retinitis pigmentosa and dry age-related macular degeneration and MSC-2 cells in optic neuritis. Ocumension will pay for the first $6 million of preclinical and manufacturing development, and the companies will split the remaining preclinical and manufacturing costs equally. Ocumension will have rights to sell the drugs in greater China, including mainland China, Hong Kong, Macau and Taiwan. Sanbio is eligible for milestone payments of up to $71 million and tiered royalties from the single digits to the low teens.
Soleo Health Inc., of Frisco, Texas, was selected by Grifols SA, of Barcelona, Spain, as one of the specialty pharmacy limited drug distribution providers of Xembify (immune globulin subcutaneous human-klhw). This is Grifols’ first 20% immune globulin and is indicated for the treatment of primary immunodeficiencies in patients 2 and older. Xembify is for subcutaneous injection only and was approved by the FDA in July 2019.
Sorrento Therapeutics Inc., of San Diego, established an agreement with the University of Texas Medical Branch at Galveston for preclinical testing of Sorrento’s COVID-19 therapeutic product candidates.
Ultragenyx Pharmaceutical Inc., of Novato, Calif., granted a nonexclusive license to its HeLa producer cell line platform for large commercial-scale AAV-based gene therapy product manufacturing to Daiichi Sankyo Co. Ltd., of Tokyo. Daiichi also gains access to Ultragenyx's HEK293 transient transfection system for AAV manufacturing. Ultragenyx will receive $125 million up front and Daiichi Sankyo is making a $75 million equity investment in the company at a price of approximately $60 per share. Ultragenyx is eligible for another $25 million upon completion of the technology transfer and single-digit royalties on net sales of products manufactured using either system.
Vaccibody AS, of Oslo, Norway, is expanding into infectious diseases, led by Gunnstein Norheim, former director of vaccine science at Coalition for Epidemic Preparedness Innovations.