Global Pharma Briefs: News from Novo Nordisk, Biogen, and BayerBy
A roundup of news from Denmark (Novo Nordisk, Heartseed), Switzerland (Biogen), and the US (Bayer, The Discovery Labs, University of Pennsylvania).
Novo Nordisk, Heartseed in $598-M Pact for Stem-Cell Therapy
Novo Nordisk and Heartseed, a Tokyo, Japan-based bio/pharmaceutical company, have entered into a $598-million exclusive worldwide collaboration and license agreement for development, manufacturing and commercialization of Heartseed’s lead asset, HS-001, an investigational cell therapy for treating heart failure.
HS-001 uses purified cardiomyocytes derived from induced pluripotent stem cells. Heartseed is planning to initiate a Phase I/II clinical trial in Japan in the second half of 2021 evaluating the safety and efficacy of HS-001 for the treatment of heart failure caused by ischemic heart disease. Japan’s Pharmaceutical and Medical Devices Agency has approved Heartseed’s clinical trial application to carry out the clinical trial.
Under the agreement, Novo Nordisk gains exclusive rights to develop, manufacture and commercialize HS-001 globally, except in Japan. Heartseed will maintain the rights to solely develop HS-001 in Japan, and Novo Nordisk has the rights to co-commercialize the product in Japan with Heartseed with 50/50 profit and cost sharing.
Heartseed is eligible to receive payments totaling up to $598 million, including $55 million in upfront and near-term milestone payments. Heartseed is also eligible to receive tiered high single-digit to low double-digit royalties of annual net sales outside of Japan.
Biogen’s Biologics Mfg Facility Granted Multi-Product License
Biogen’s biomanufacturing facility in Solothurn, Switzerland has received a GMP multi-product license from Swissmedic, the Swiss pharmaceutical regulatory agency.
The facility consists of multiple bio-manufacturing cells (BMCs) with site infrastructure in place to support future BMCs if needed. The site is a potential production site for aducanumab, a potential blockbuster drug for treating Alzheimer’s disease, co-developed with Eisai and currently under review by the US Food and Drug Administration. The facility expands on Biogen’s existing capacity in Research Triangle Park, North Carolina, and can accommodate potential manufacturing of other biologic assets.
Bayer To Acquire Noria Therapeutics, PSMA Therapeutics
Bayer has agreed to acquire Noria Therapeutics, a company focused on the development of targeted alpha therapeutics and theranostic agents, and PSMA Therapeutics, a subsidiary of Noria, to advance the platform of prostate-specific membrane antigen-(PSMA) targeting radiotherapeutics.
Through the acquisition, Bayer will obtain exclusive rights to a differentiated alpha radionuclide investigational compound based on actinium-225 and a small molecule directed towards PSMA.
The acquisition would broaden Bayer’s existing oncology portfolio of targeted alpha therapies (TATs), which currently includes Xofigo (radium Ra 223 dichloride), which is approved for metastatic castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases, and the proprietary platform of investigational TATs based on thorium-227.
The companies have exclusive global rights to technology licensed from Weill Cornell Medicine in New York and Johns Hopkins University. Financial terms of the agreement were not disclosed.
The Discovery Labs Signs Lease with Penn for Gene Therapy Program
The Discovery Labs, a King of Prussia, Philadelphia-based provider of cGMP manufacturing, turnkey laboratories, materials, and office space for life-sciences and technology companies, has signed a lease with the University of Pennsylvania’s (Penn) Gene Therapy Program (GTP), which will use The Discovery Labs’ suburban campus for a portion of its expanding research operations.
The lease establishes an anchor tenancy for The Discovery Labs’ new seven-million-square-foot life-sciences cluster in Philadelphia’s Cellicon Valley. The facility expands GTP’s available space for vector operations, including two dedicated floors for the expanded Penn Vector Core, a core facility that produces viral-based vectors for gene transfer for researchers both within and outside of Penn.
Terms of the deal include a multi-year lease and over 150,000 square feet of lab space encompassing two buildings on The Discovery Labs’ one-million-square-foot campus in King of Prussia, Pennsylvania. Penn Medicine joins GlaxoSmithKline, WuXi Biologics, and The Center for Breakthrough Medicines on the biotech innovation campus. GTP will be adjacent to The Discovery Labs’ 700,000-square-foot Innovation Renaissance campus and near the recently acquired 660,000-square-foot Philadelphia Inquirer printing plant that will be converted into life-science research and manufacturing facilities.
The new space will support discovery research all the way through submission of investigational new drug applications for clinical trials. Additional capabilities will include more capacity for non-clinical proof-of-concept research, large-scale vector production activities, expanded research manufacturing for preclinical projects, platform development and process optimization, and assay development and qualification, quality control testing, and technical transfer.