Acerus Pharmaceuticals Corp., of Toronto, said the revised partnership agreement with Englewood, Colo.-based Aytu Bioscience Inc., to accelerate the U.S. growth of Natesto, a nasal gel formulation of testosterone, is now operational. The companies have mutually waived the closing conditions of the revised partnership agreement, including the requirement that Acerus complete a raise of a minimum of $10 million on or before the end of January 2020, enabling it to launch a U.S.-based specialty sales force, which will promote the product to urologists and endocrinologists. Going forward, Acerus will assume all regulatory and clinical responsibilities and costs for the product in the U.S. and will take on a more expansive role in matters such as U.S. marketing, reimbursement and medical strategy. To establish a high performing commercial footprint in the U.S., Acerus said it has also engaged contract commercial organization Syneos Health Inc. to be its commercialization partner.
Alteogen Inc., of Daejeon, South Korea, signed a nonexclusive global license agreement with a top 10 global pharmaceutical company to use ALT-B4, Alteogen’s hyaluronidase-derived technology called Hybrozyme. ALT-B4 is a recombinant human hyaluronidase enzyme that enables large-volume subcutaneous administration of biologics that would otherwise be administered as an I.V. injection. Under the terms of the agreement, Alteogen has granted worldwide rights for the undisclosed firm to develop and commercialize multiple products in combination with Hybrozyme technology while Alteogen will be responsible for the clinical and commercial supply of ALT-B4 materials. Alteogen will receive an initial payment of $13 million and is also eligible to receive additional milestones upon the pharma company’s achievement of specified development, regulatory and sales milestones, totaling up to $1.373 billion.
Biomed X GmbH, of Heidelberg, Germany, disclosed the successful completion of the first joint research project with Boehringer Ingelheim GmbH, of Ingelheim, Germany, in the fields of chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis. Biomed X received a milestone payment and the results of the project were transferred to Boehringer. During the four-year project term at Biomed X, the research team systematically explored epigenetic regulators in different cell types of the human lung as a potential new target class for the treatment of chronic and disabling lung diseases. By comparing epigenetic and transcriptomic profiles from patients in different disease stages with healthy ex-smokers on the level of individual cell types, the team successfully identified a set of new potentially disease-modifying drug targets in lung fibroblasts and alveolar type II cells.
Cyrus Biotechnology Inc., of Cambridge, Mass., and the Broad Institute of MIT and Harvard have embarked on a scientific collaboration to optimize CRISPR for use in developing novel human therapeutics. Feng Zhang will be the principal investigator for Broad for the collaboration. He is also an investigator of the Howard Hughes Medical Institute. Researchers from Cyrus and Broad will work together to mitigate the possibility of the body mounting an immune response against CRISPR. The teams are committed to making the results of their collaboration broadly available for research to help ensure that therapeutic development has the best chance of success, while also considering important ethical and safety concerns, Cyrus said.
Eli Lilly and Co., of Indianapolis, unveiled its first shared innovation lab, located in South San Francisco, designed to speed the discovery of innovative medicines through collaboration with local biotech companies. Lilly Gateway Labs will offer companies direct access to Lilly scientists, team members and executives, as well as exposure to Lilly's scientific and functional expertise. Companies who work in Lilly Gateway will have the opportunity to collaborate with Lilly on projects of mutual interest, participate in shared learning forums with Lilly experts and partners, and have the potential for financial investment from Lilly, venture funds or both, the company said.
Inceptua Group GmbH, of Berlin, and Bendalis GmbH, of Oberhaching Germany, signed an exclusive clinical trial supply agreement for oncology generics. Through the agreement Inceptua becomes the exclusive distributor of Bendalis’ products for their use in clinical trials worldwide, offering clinical trial sponsors quick access to “Brexit-safe” oncology standard-of-care medicines produced within the EU. As a part of the agreement, Bendalis will maintain stock of specific products on a consignment basis, offering Inceptua’s clients on-demand access.
Kamada Ltd., of Rehovot, Israel, signed an agreement with Alvotech Ehf, of Reykjavik, Iceland, to commercialize Alvotech’s portfolio of six biosimilar product candidates in Israel, upon receipt of regulatory approval from the Israeli Ministry of Health. Kamada will leverage its expertise and presence in the Israeli market to distribute, in Israel, more than 20 products that are manufactured by third parties. Alvotech’s pipeline includes biosimilar product candidates aimed at treating autoimmunity, oncology and inflammatory conditions.
Kodiak Sciences Inc., of Palo Alto, Calif., signed a funding agreement to sell a capped royalty right on global net sales of KSI-301 to Baker Bros. Advisors for $225 million. KSI-301 is Kodiak's investigational therapy being developed for the treatment of retinal vascular diseases including age-related macular degeneration and diabetic eye diseases. Baker purchased a capped 4.5% royalty on net sales of the anti-VEGF antibody biopolymer conjugate therapy to be paid upon marketing approval in exchange for $225 million in committed development funding payable to the company. Unless earlier terminated or repurchased by the company, the royalty caps or terminates upon the date that Baker has received an aggregate amount equal to 4.5 times the funding amount paid to the company. Shares of Kodiak (NASDAQ:KOD) closed Monday at $51.05, up $21.45, or 72%.
Ligand Pharmaceuticals Inc., of San Diego, said Paris-based Sanofi SA has licensed rights to Omniab, its three-species transgenic-animal platform for producing mono- and bispecific therapeutic antibodies. Sanofi will pay Ligand an up-front platform access fee, development and regulatory milestone payments and potential royalties on sales of marketed products, all of undisclosed value.
Lunac Therapeutics, of Leeds U.K., said, along with the Medicines Discovery Catapult and the University of Leeds, it has been awarded £3.14 million (US$4.1 million) in funding under Innovate U.K.’s Biomedical Catalyst program. The funding will be used to develop "a new class of highly specific anticoagulant compounds that block an activated clotting enzyme, factor XII, for which there is strong evidence that inhibition will not increase the risk of bleeding," the company said. Lunac spun out of the university with £2.65M funding in the first close of a series A financing announced in November.
Medincell SA, of Montpellier, France, said the Bill & Melinda Gates Foundation has agreed to provide it with $19 million in grants over four years to support preclinical activities and a phase I trial for the injectable six-month bioresorbable contraceptive mdc-WWM. Medincell retained global marketing rights for the product. Medincell said that up to $11.75 million could be raised over the next 12 months including a first tranche of $4.75 million to be paid immediately. The additional $7.25 million may be collected later.
Nanoviricides Inc., of Shelton, Conn., said it has initiated safety and toxicology studies required to support its IND application for NV-HHV-101, a skin cream it is developing for the potential treatment of shingles rash.
Oncotelic Inc., an Agoura Hills, Calif-based subsidiary of Mateon Therapeutics Inc., highlighted the publication of new research on OT-101 (trabedersen), a phosphorothioate TGF beta 2-specific antisense oligodeoxynucleotide the company secured through a merger with Oncotelic earlier this year. A post-hoc analysis of the single-agent activity of OT-101 in adults with recurrent and/or refractory high-grade gliomas (HGG) published in the Nov. 28, 2019, edition of Cancers found that intratumorally administered OT-101 as a second-line therapy "exhibited clinically meaningful single-agent activity and induced durable complete response, partial response and stable disease ≥6 months in recurrent and/or refractory HGG patients."
Pharmaron Beijing Co. Ltd., a Beijing-based R&D services company, announced that 117 million H-shares have been listed on the main board of the Hong Kong Stock Exchange (HKEX:3759), equivalent to HK$4.344 billion (US$555 million) raised based on the offer price of HK$39.5 per share. The funds will be used for the development of the company’s global service platform, R&D capability, capacity improvements, strategic investments, M&A and operation support, Pharmaron said. The new listing, building on an existing listing of the company's A-shares listing on the Shenzhen Stock Exchange "has broadened Pharmaron’s financing channels to support its global growth strategy," the company said.
Puma Biotechnology Inc., of Los Angeles, said it will receive $4 million up front and up to $3 million in regulatory and sales-based milestone payments under terms of a newly revised agreement with Pierre Fabre SA, extending the Castres, France-based company's rights to develop and commercialize Nerlynx (neratinib) within Europe and part of Africa to the Middle East, South Africa, Sudan and Turkey.
Samyang Biopharm USA Inc., of Cambridge, Mass., a subsidiary of Seongnam, South Korea-based Samyang Pharmaceuticals Corp., secured global rights to develop, manufacture and commercialize SYB-010 (formerly CuraB-10) from Shoreline, Wash.-based Cancure LLC. The asset is an immune stimulatory monoclonal antibody targeting a tumor-released immune suppressive molecule soluble MHC I chain-related molecule MIC, for the potential treatment of cancer. Cancure will receive an up-front payment and is eligible for future clinical, regulatory and sales milestone payments, as well as royalties on net sales worldwide, though detailed financial terms were not disclosed. Samyang said it plans to file an IND in 2021.
Seattle Genetics Inc., of Bothell, Wash. and Tokyo-based Astellas Pharma Inc. have agreed to work with Merck & Co. Inc., of Kenilworth, N.J., to evaluate a combination of the antibody-drug conjugate enfortumab vedotin and Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with previously untreated metastatic urothelial cancer. Under the terms of the agreement, the three companies will conduct and fund a global, registrational phase III trial to be initiated in the first half of 2020 under the leadership of Seattle Genetics. Enfortumab vedotin is under FDA review for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. The PDUFA date is March 15, 2020.
Synthetic Biologics Inc., of Rockville, Md., received notice from NYSE American LLC that the company is not in compliance with listing standards because it reported a stockholder equity of $4.9 million and net losses in the five most recent quarters. Synthetic Biologics intends to file a plan by Dec. 26 of how it will regain compliance by Nov. 25, 2020.
Tetra Bio-Pharma Inc., of Ottawa, Ontario, and Alternavida SA de CV, of Mexico City, signed an agreement to co-develop and commercialize Tetra’s cannabinoid, Caumz (PPP-011), in Mexico. Alternavida will fund two clinical trial sites in Mexico for the phase III Serenity study in patients with advanced cancer pain and a phase II study in patients with fibromyalgia, which will save Tetra CA$10 million (US$7.5 million). Alternavida will be responsible for registering and commercializing Caumz in Mexico and has a first right of refusal for Colombia, Ecuador, Chile, Panama, Costa Rica, Honduras, Peru and the Dominican Republic. Tetra will receive CA$125,000 up front and is eligible for royalties on sales in Mexico of 10% in year one, 12.5% in year two and 15% in years three through 15.
Therapix Biosciences Ltd., of Tel Aviv, Israel, plans to advance Respectrum (THX-210) in patients with autism spectrum disorder. The study will compare Respectrum, which contains a nonpsychoactive cannabidiol and Therapix’s palmitoylethanolamide formulation Cannamide, to a cannabidiol-rich oil.