Astrazeneca plc, of London, agreed to sell the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in the U.S. and Canada to Cheplapharm Arzneimittel GmbH, of Greifswald, Germany. Seroquel and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in those territories. Cheplapharm will make an up-front payment of $35 million to Astrazeneca and may make future sales-contingent payments of up to $6 million.
Aztherapies Inc., of Boston, disclosed the publication of preclinical data in Scientific Reports demonstrating the anti-inflammatory properties of cromolyn in a mouse model of amyotrophic lateral sclerosis (ALS). The study was conducted by investigators at Massachusetts General Hospital in collaboration with the company. Findings support the potential of targeting neuroinflammation with cromolyn to treat ALS, as evidenced by injected cromolyn’s ability to delay the onset of neurological symptoms, reduce neuroinflammation, decrease the expression of pro-inflammatory cytokines and chemokines, increase spinal cord motor neuron survival, and decrease denervation of muscle in a mouse model of ALS.
Biocorrx Inc., of Anaheim, Calif., provided an update on VDM-001, a new opioid antagonist being developed to reverse opioid overdose. Last year, Biocorrx Pharmaceuticals, the company’s controlled subsidiary, partnered with VDM Biochemicals Inc., of Lake Forest, Calif., in order to further develop and validate VDM-001 for potential future commercialization. VDM-001 may represent an effective alternative to naloxone in the overdose reversal market, the company said. Early preclinical data showed that the effects of fentanyl, which is responsible for thousands of deaths annually, may be completely prevented by VDM-001. At the same time, VDM-001 was found to be well-tolerated and without any signs of toxicity.
Boston Biomedical Inc., of Cambridge, Mass., entered an alliance in oncology research with three oncology centers: Columbia University, Harvard University and The Wistar Institute. Sumitomo Dainippon Pharma Group, of Osaka, Japan, which consists of Sumitomo Dainippon Pharma and its subsidiaries, Boston Biomedical, and Tolero Pharmaceuticals Inc., of Lehi, Utah, will have access to novel targets and platform technologies that may be discovered by the three U.S. institutions in the course of research projects supported by this alliance for the development of cancer drugs.
Dnanexus Inc., of Mountain View, Calif., said the FDA awarded a five-year, $20 million contract to power the precisionFDA Collaborative Omics Environment in the Cloud. PrecisionFDA has enabled significant advances in regulatory science for next-generation sequencing-based drugs and devices, bringing together government, academic and industry to crowdsource a reference standard approach to the validation of bioinformatics pipelines assessing genomic variation. Under this award, Dnanexus, with partner Deloitte LLC in New York, will use its FedRAMP-authorized platform-as-a-service to enhance precisionFDA capabilities for sponsor-reviewer interaction, add support for multi-omics, and provide a library of analytical, statistical and machine learning applications, accessible to reviewers and powerful enough for bioinformaticians, the company said.
Dnarx LLC, of San Francisco, disclosed the publication in Science Advances of data demonstrating the capabilities and efficacy of its pioneering HEDGES (High-level Extended Duration Gene Expression System) DNA-based, nonviral gene therapy delivery and expression platform. The data demonstrate significant advantages of HEDGES over viral vector-based approaches to gene therapy. Results show that a single HEDGES administration durably produced FDA-approved protein therapies, including cytokines and monoclonal antibodies at therapeutic levels in mice.
Evotec SE, of Hamburg, Germany, disclosed an expansion of the company’s strategic partnership with Celmatix Inc., of New York. Also, with investors including Life Sciences Innovation Fund and Topspin Fund, Evotec is participating in a funding round which will allow Celmatix to expand its broader, innovative, therapeutics initiatives. The companies are collaborating to develop preclinical programs for highly prevalent, yet underserved conditions affecting women’s reproductive health, including endometriosis, polycystic ovary syndrome and infertility.
Cmab Biopharma Inc., of Suzhou, China, and Shenzhen Fapon Biopharma Inc., of Shenzhen, China, disclosed an agreement for the development and manufacturing of an undisclosed biologic drug project. Fapon will avail itself of Cmab’s fully integrated chemistry, manufacturing and controls process development and manufacturing platform, the European audited product quality system, and the experienced regulatory team in IND filings in China and the U.S. Terms were not disclosed.
Gen1e Lifesciences Inc., of Palo Alto, Calif., acquired an exclusive, worldwide and all-fields license to the University of Maryland, Baltimore's specific and function-selective p38a kinase inhibitor program. Gen1e is developing cures for inflammatory diseases based on a next-generation p38a kinase inhibitor effort, and the first indication is acute respiratory distress syndrome (ARDS) followed by other disease areas. ARDS is a life-threatening inflammatory condition with no FDA-approved treatment and a 40% mortality rate, the company noted. ARDS will be followed by development of programs for other inflammatory and age-related diseases.
The public-private Innovative Medicines Initiative (IMI) AMR Accelerator said it launched the Collaboration for Prevention and Treatment of Multi-Drug Resistant Bacterial Infections (COMBINE) to accelerate efforts to combat antimicrobial resistance (AMR). COMBINE will be funded by IMI, a joint initiative between the European Commission, which will supply €8 million (US$8.9 million), and the European Federation of Pharmaceutical Industries and Associations, which will provide in-kind contributions totaling €17 million. COMBINE will support projects in the AMR Accelerator by seeking to establish data management guidelines, to improve and standardize animal infection models and to optimize trial design. Initial partners in COMBINE include the European academic institutions Uppsala University, Fraunhofer-Gesellschaft, Paul-Ehrlich-Institut and Statens Serum Institut; small and medium-sized enterprises Asclepia, Biocom, Grit42 and Beam Alliance; and pharma companies Glaxosmithkline plc, of London, Evotec SE, of Hamburg, Germany, and Janssen Pharmaceutica NV, a unit of New Brunswick, N.J.-based Johnson & Johnson.
Iontas Ltd., of Cambridge, U.K., and Adaptate Biotherapeutics Ltd., of London, agreed to generate and optimize antibodies for immuno-oncology targets. The deal provides Adaptate access to Iontas’ technology, allowing the selection of high-affinity antibodies based on their function, stability, expression and developability. No financial terms were released. Adaptate is a spinout of London-based Gammadelta Therapeutics Ltd. and is focused on gamma delta T-cell therapies.
Kane Biotech Inc., of Winnipeg, Manitoba, will receive up to $3.4 million from an unnamed government agency to continue development of DispersinB to treat biofilm-mediated antimicrobial resistance in nonhealing chronic wounds. The award is subject to terms and conditions to be agreed upon with the funding agency. Further information will be provided before the end of the first quarter of 2020. Boston’s Kyn Therapeutics Inc. rebranded itself as Ikena Oncology. It also unveiled a new discovery program for modulating the Hippo signaling pathway for cancer treatment. Ikena has five development and discovery programs with multiple clinical and regulatory milestones expected in 2020, including report of preliminary clinical data on its lead program, IK-007, an EP4 antagonist.
Merrimack Pharmaceuticals Inc., of Cambridge, Mass., received a $5 million milestone payment from Paris-based Ipsen SA from the ongoing clinical trial evaluating Onivyde (irinotecan liposome injection) in patients with small-cell lung cancer. As a result, Merrimack’s board authorized a cash dividend of $6.7 million on its common stock. Merrimack could receive up to $450 million in contingent milestone payments related to its sale of Onivyde to Ipsen in April 2017 and up to $54.5 million in contingent milestone payments related to its sale of anti-HER3 programs to 14ner Oncology Inc., of New York, in July. The company wants to sell its remaining preclinical and clinical assets.
Metrion Biosciences Ltd., of Cambridge, U.K., and Lifearc extended their year-long neuroscience-focused ion channel drug discovery collaboration. The two are studying selective small-molecular modulators of a specific two-pore domain potassium ion channel target, one likely involved in neurological pathogenesis. Lifearc is responsible for all new chemical syntheses, with Metrion providing ion channel screening. The extension takes the project into January 2021.
Mission Therapeutics Ltd., of Cambridge, U.K., and Abbvie Inc., of North Chicago, identified several deubiquitylating (DUB) enzymes as potential drug targets in their Alzheimer’s and Parkinson’s R&D collaboration. This is the first major milestone reached in the partnership. Abbvie has the option to gain exclusive rights to develop and commercialize DUB inhibitors against up to four selected targets. Mission could receive success-based milestone payments and royalty payments for each commercialized product.
Mylan NV, of Canonsburg, Pa., and Biocon Ltd., of Bengaluru, India, launched Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab, Roche Holding AG), for the U.S. market in a 420-mg multidose vial and a 150-mg single-dose vial. Ogivri was the first biosimilar trastuzumab approved by the FDA. Ogivri is approved for all indications of Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinomas.
The Court of Common Pleas for Franklin County, Ohio, ruled in favor of Navidea Biopharmaceuticals Inc., of Dublin, Ohio, in its case against Capital Royalty Partners II LP (CRG). Navidea has been in ongoing litigation with Capital in its capacity as a lender and as a control agent for other affiliated lenders party to the CRG loan agreement in the Ohio court. The claims were for breach of contract, conversion and unjust enrichment against the lenders for their collection of more than $66 million. On Nov. 27, the court found that when CRG collected more than $66 million, it took an excess recovery and breached the global settlement agreement. The court awarded Navidea $426 million, plus statutory interest. The court also found no unjust enrichment or conversion by CRG.
Piramal Enterprises Ltd., of Newcastle, U.K., said its Pharma Solutions (PPS) contract development and manufacturing organization will partner with Bergenbio ASA, of Bergen, Norway, to develop the Axl tyrosine kinase receptor inhibitor bemcentinib to treat older adults with relapsed acute myeloid leukemia. PPS will deploy its Xcelerate Integrated Solutions platform, which takes advantage of the company’s network of discovery and development capabilities across sites in North America, Europe and India. Financial terms were not disclosed.
Proteostasis Therapeutics Inc., of Boston, said it was notified in writing by Nasdaq that its shares regained compliance with the minimum bid requirement after its common stock surpassed $1 for at least 10 consecutive trading days. On Tuesday, the company’s shares (NASDAQ:PTI) gained 24 cents to close at $2.64.
Resonant Therapeutics Inc., of Houston, said it inked an agreement with Janssen Research and Development LLC, a unit of Johnson & Johnson, of New Brunswick, N.J., to discover and validate tumor and immunological targets and to validate certain therapeutic candidates. The collaboration will leverage the capabilities of Resonant’s Impact tumor microenvironment model and target validation platform and Janssen’s oncology organization to speed development in emerging targets and therapeutic opportunities. Additional details were not disclosed.
Tonix Pharmaceuticals Holding Corp., of New York, said it regained compliance with Nasdaq’s minimum bid requirement after completing a 1-for-10 reverse split of its outstanding common stock on Nov. 1. Subsequent to the split, Tonix said it was notified in writing by Nasdaq that its shares closed at or above $1 for at least 10 consecutive trading days. On Tuesday, the company’s shares (NASDAQ:TNXP) closed at $1.13 for a loss of 8 cents.
Wuxi Atu Co. Ltd., a subsidiary of Wuxi Apptec Co. Ltd., of Shanghai, and Genemedicine Co. Ltd., of Seoul, South Korea, said they formed a strategic partnership to develop and manufacture oncolytic virus products. Wuxi Atu is set to provide overall process development, manufacturing and IND regulatory filing services for Genemedicine's oncolytic virus candidates. Financial terms were not disclosed.