Shareholders and warrant holders of Asahi Kasei Pharma Denmark A/S agreed to a conditional voluntary public offer for purchasing all issued and outstanding shares and warrants of Veloxis Pharmaceuticals A/S. The offer expires Jan. 14. Asahi Kasei is putting up $1.3 billion to buy Cary, N.C.-based Veloxis and its Envarsus XR, a form of tacrolimus for prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus and for use in de novo kidney transplant patients.
Bavarian Nordic A/S, of Copenhagen, Denmark, signed an agreement to sell its priority review voucher for a total cash consideration of $95 million. The buyer was undisclosed. Bavarian Nordic was awarded the voucher in September 2019 upon approval of Jynneos vaccine for the prevention of smallpox and monkeypox.
Bioarctic AB, of Stockholm, Sweden, started a research collaboration with Eisai Co. Ltd., of Tokyo, aimed at further studying the unique profile of the investigational drug candidate BAN-2401. The deal is in addition to the existing development and commercialization agreement for BAN-2401. Payments to Bioarctic under the research pact total as much as €3.25 million (US$3.6 million). The program is planned to continue through the end of June 2021 and results are expected to be presented at future scientific conferences.
Bioinvent International AB, of Lund, Sweden, signed a clinical trial collaboration and supply agreement with Merck & Co. Inc., of Kenilworth, N.J., to evaluate the combination of Bioinvent's BI-1206, one of its proprietary anti-FcγRllB antibodies and Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab) in a phase I/IIa trial for patients with solid tumors. Terms were not disclosed.
Bridgebio Pharma Inc., of Boston, said its subsidiary Origin Biosciences, focused on developing and commercializing a treatment for molybdenum cofactor deficiency type A, and Medison Pharma Ltd., of Petach Tikva, Israel, signed an exclusive license agreement under which Medison received rights from Origin to distribute, market, sell and otherwise commercialize Origin’s drug product known as fosdenopterin (BBP-870/ORGN-001) in Israel. Fosdenopterin is a cPMP replacement therapy. Origin recently initiated the rolling submission of an NDA for the drug. Origin will receive an up-front cash payment and will receive milestone payments upon the achievement of certain milestone events and ongoing royalties on net sales of fosdenopterin.
Should Chondrial Therapeutics Inc., of Bala Cynwyd, Pa., become a wholly owned subsidiary of Zafgen Inc., of Boston, as the two companies plan, Chondrial stockholders will become majority owners of Zafgen’s outstanding common stock. The proposed merger will result in a combined publicly traded, clinical-stage biopharmaceutical company with a new name, Larimar Therapeutics Inc. Chondrial’s lead asset, CTI-1601, is in clinical development for treating Friedreich’s ataxia, a mitochondrial disease caused by a genetic defect that typically appears in childhood or adolescence.
CNS Pharmaceuticals Inc., of Houston, said it completed GMP reprocessing of its lead drug candidate, berubicin, with partner Anthem Biosciences Pvt. Ltd., of Banglaore, India. The step was undertaken pursuant to previously disclosed positive feedback from the FDA regarding the pre-IND meeting proposal to use a lyophilized drug product (berubicin) in phase II trials.
Cytodyn Inc., of Vancouver, Wash., and Vyera Pharmaceuticals LLC, of New York, signed a commercialization and license agreement (CLA) and a related supply agreement to commercialize leronlimab (PRO-140) in the U.S. for the treatment of HIV. Under the terms, Cytodyn will maintain responsibility for the development and FDA approval of leronlimab for all HIV-related and other indications, while Vyera has been granted an exclusive license to market and distribute leronlimab in the U.S. for the treatment of HIV. Vyera has agreed to pay up-front and regulatory and sales-based milestone payments of up to $87.5 million, as well as a royalty of 50% on net sales. Vyera also agreed to make an investment in Cytodyn of $4 million in the form of registered Cytodyn common stock.
Hitgen Inc., of Chengdu, China, and Osaka’s Mitsubishi Tanabe Pharma Corp. agreed to develop small molecules for treating undisclosed targets. Mitsubishi will pay Hitgen an assignment fee for licensing and Hitgen granted Mitsubishi exclusive rights for development and commercialization. No financial terms were disclosed.
Oslo-based Nordic Nanovector ASA’s R&D project Nanoyield received $1.3 million from the Norwegian Research Council to help produce Nordic’s CD37-targeting antibody NNV-003. The molecule is the antibody component of the radioimmunoconjugate Alpha37, the targeted alpha therapy for B-cell cancers. The project is a partnership with Sintef Biotechnology, of Trondheim, Norway. Preclinical data shows that one injection of Alpha37 is well-tolerated, produces an anticancer effect and improves survival in preclinical models of CD37-positive chronic lymphocytic leukemia and non-Hodgkin lymphoma.
Pfenex Inc., of San Diego, earned a $15 million development milestone under its development and license agreement with Jazz Pharmaceuticals plc, of Dublin. The milestone is associated with process development activities for PF-745, a long-acting Erwinia asparaginase. The companies entered their deal in the summer of 2016.
Soligenix Inc., of Princeton, N.J., will receive $850,000 in nondilutive funding from the New Jersey Technology Business Tax Certificate Transfer Program. The program allows businesses to sell their unused net operating loss carryovers and unused R&D tax credits to New Jersey’s unaffiliated, profitable corporate taxpayers to fund additional R&D, purchase equipment and/or facilities. Soligenix is developing therapies to treat cutaneous T-cell lymphoma, oral mucositis in head and neck cancer, and severe inflammation from Crohn’s disease and acute radiation enteritis.
Preliminary results of the modified Dutch auction by Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., to repurchase up to $225 million in value of its ordinary shares show 297,891 ordinary shares were properly tendered and not properly withdrawn at or below the expected final purchase price of $91 per share, including shares that were tendered through notices of guaranteed delivery. Taro expects to purchase the shares for an aggregate price of about $27.1 million. The shares represent approximately 0.77% of Taro’s issued and outstanding ordinary shares as of Dec. 16.
Vaccitech Oncology Ltd., of Oxford, U.K., entered a collaboration with the Ludwig Institute for Cancer Research and Cancer Research UK to develop Vaccitech’s VTP-600 in a phase I/IIa clinical trial as first-line non-small-cell lung cancer (NSCLC) therapy. VTP-600 is administered intramuscularly and designed to stimulate the immune system to produce sustained cytotoxic CD8+ T cells specific for cancers expressing the antigens, including NSCLC. VTP-600 can be administered selectively to patients whose tumors express MAGE-A3 alone and those which also express NY-ESO-1. Cancer Research UK’s Centre for Drug Development will sponsor and manage the trial of VTP-600 in combination with current standard of care and first-line treatment (chemotherapy and anti-PD-1) in about 80 NSCLC patients. The trial is expected to begin in the first quarter of 2020. Vaccitech holds an option to license the trial results for further clinical development and commercialization of VTP-600.