Alvotech ehf, of Reykjavik, Iceland, said Abu Dhabi-based investment company Yas Holding acquired a 2.5% stake and signed an agreement for the exclusive partnership and supply of three Alvotech biosimilar candidates, which Yas plans to commercialize in the Middle East and North Africa. The partnership was valued at about $45 million, including the purchase of new shares, an up-front license payment and subsequent milestone payments. Alvotech's initial pipeline contains seven biosimilar monoclonal antibodies and fusion proteins aimed at treating severe immune and inflammatory conditions.
Boehringer Ingelheim GmbH (BI), of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said they will modernize their alliance, effective Jan. 1, 2020, to focus their combined expertise and investment on continued development and commercialization of Jardiance (empagliflozin) in type 2 diabetes, heart failure and chronic kidney disease. Although Trajenta (linagliptin) and Basaglar (insulin glargine) remain part of the alliance, primary responsibility for development and commercialization will rest with the innovator company BI for Trajenta and Lilly for Basaglar. Under the amended agreement, the companies also plan to revise their margin sharing structure for payments, beginning Jan 1. Lilly said it expects no changes to its 2019 financial guidance or 2020 financial goals. Additional terms were not disclosed.
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said it initiated a compassionate use program for namodenoson (previously CF-102) to treat hepatocellular cancer (HCC). The program is open to liver cancer patients who exhausted available treatment options and were not enrolled in the company's phase II study. Namodenoson is being administered by Salomon Stemmer, professor at the Institute of Oncology at Rabin Medical Center and the study's principal investigator. The completed study concluded that namodenoson increased overall survival in individuals with HCC with Child Pugh B7, the largest subpopulation, compared to placebo, but the trial did not meet its primary endpoint. Can-Fite said it completed an end-of-phase II meeting with the FDA in which the agency agreed with the company's proposed pivotal phase III trial design to support an NDA submission in HCC.
Cerecor Inc., of Rockville, Md., said it closed the sale of a portfolio of pediatric assets to Aytu Bioscience Inc., of Englewood, Colo. The deal was valued in excess of $43 million, including the assumption of liabilities and product-related obligations. The portfolio included the product lines Aciphex Sprinkle, Cefaclor for Oral Suspension, Karbinal ER, Flexichamber, Poly-Vi-Flor and Tri-Vi-Flor. Aytu paid Cerecor $4.5 million in cash and issued approximately 9.8 million convertible preferred Aytu shares, representing a consideration of approximately $12.5 million. Aytu also assumed Cerecor's outstanding payment obligations to Deerfield CSF LLC in the amount of $15 million and other liabilities in excess of $11 million. Cerecor said funds from the transaction, coupled with the removal of short-term obligations, extended its runway toward NDA submission of CERC-801, a genetically targeted substrate replacement therapy to treat phosphoglucomutase 1 deficiency. In conjunction with the transaction's close, Aytu said it will undertake an integration and cost saving plan to accelerate its time to profitability, including a reduction in force of overlapping sales representatives, sales managers and other redundancies. The company expects to realize more than $5 million in annual savings once employee separation and other transaction-related expenses are paid, resulting in a cash burn reduction of approximately 40%. On Monday, Aytu shares (NASDAQ:AYTU) gained 6 cents to close at $1.09 while Cerecor (NASDAQ:CERC) closed at $3.44, down 5 cents.
Galapagos NV, of Mechelen, Belgium, said Gilead Therapeutics A1 Unlimited Co., an affiliate of Gilead Sciences Inc., of Foster City, Calif., delivered a notice to exercise initial warrant A, with issuance of the resulting shares expected next week. The transaction, approved by Galapagos shareholders on Oct. 22, entitles Gilead to subscribe for a maximum number of shares sufficient to bring ownership by the company and its affiliates to 25.1% of Galapagos' issued and outstanding shares. Gilead said it intends to subscribe for approximately 2.6 million new shares at €140.59 (US$156.48) apiece, totaling approximately €368 million (US$409.6 million), bringing its ownership to approximately 16.2 million Galapagos shares, or 25.1% of the 64.6 million shares expected to be outstanding following exercise of the warrant deal. At the outset of the third quarter, the companies inked a 10-year R&D alliance giving Galapagos $3.95 billion in cash up front and $1.1 billion in equity in return for Gilead's option to ex-European rights on all assets emerging from the Belgium firm's clinical and preclinical pipeline. (See BioWorld, July 16, 2019.)
Hillstream Biopharma Inc., of Chester, N.J., said it is collaborating with contract development and manufacturing organization Ardena to secure manufacturing feasibility and capacity for Hillstream's Quatramer portfolio, which includes HSB-1216, a formulation of salinomycin encapsulated within the Quatramer technology that is initially targeting small-cell lung cancer. Financial terms were not disclosed.
Immuron Ltd., of Melbourne, Australia, said it received a cash refund of AU$530,000 (US$365,366) under the Australian governments' Research and Development Income Tax Concession incentive program, for eligible R&D expenditure incurred during the 2019 financial year. Immuron is advancing IMM-124E/Travelan for use in preventing traveler's diarrhea.
Mannkind Corp., of Westlake Village, Calif., said it achieved the second of four development milestones specified in its licensing and collaboration agreement with United Therapeutics Corp., of Silver Spring, Md., for the development and commercialization of a dry powder formulation of treprostinil. Treprostinil technosphere is being assessed in trials to treat pulmonary arterial hypertension.
Mateon Therapeutics Inc., of Santa Clara, Calif., said it completed its acquisition of Pointr Data Inc., a privately held developer of cluster computer and artificial intelligence (AI) technologies, to create a publicly traded AI and blockchain-driven immuno-oncology company developing a pipeline of TGF-beta immunotherapies for late-stage cancers such as gliomas, pancreatic cancer and melanoma. Saran Saund, former CEO of Pointr, will assume the role of chief business officer/general manager of the AI division at Mateon, and Burcak Beser, former chief technology officer at Pointr, will assume the role of senior vice president/chief technology officer of the AI division at Mateon.
Nanoviricides Inc., of Shelton, Conn., said it reached an agreement with Theracour Pharma Inc., of West Haven, Conn., on terms of the license to develop its VZV-binding nanomicelle candidate against the virus that causes chickenpox in children and shingles in adults. Theracour agreed to accept no cash at execution of a license agreement, and Nanoviricides' agreed to issue 500,000 shares of series A preferred stock to Theracour as a milestone payment when the VZV candidate's IND becomes effective. Theracour also is entitled to a milestone payment of $1.5 million when Nanoviricides completes a phase I study and an additional milestone payment of $2.5 million when Nanoviricides completes phase II trials. Other compensation will be consistent with existing license agreements between the companies, including a 15% royalty to Theracour on net sales and 15% of sublicensing revenues.
Phoremost Ltd. and Sentinel Oncology Ltd., both of Cambridge, U.K., said they expanded their collaboration to accelerate SOL-686, an allosteric Polo-like kinase 1 inhibitor, through preclinical and IND-enabling studies to treat glioma. Financial terms were not disclosed.
Tmunity Therapeutics Inc. and Oncora Medical LLC, both of Philadelphia, said they inked a strategic collaboration involving access to Oncora's real-world data platform to support the design of Tmunity's cell therapy programs. Financial terms were not disclosed.
Vifor Pharma AG, of St. Gallen, Switzerland, said it inked a commercial partnership with Janssen Pharmaceuticals Inc., a unit of the Janssen Pharmaceutical Cos. of Johnson & Johnson, of New Brunswick, N.J., to commercialize Invokana (canagliflozin) jointly in the U.S. to treat diabetic kidney disease (DKD) and reduce the risk of hospitalization for heart failure in individuals with type 2 diabetes who have DKD. Janssen will continue to lead marketing for Invokana. Vifor's U.S. nephrology sales force will promote the drug to nephrologists, complemented by Janssen's existing sales and institutional representatives. The field medical teams of both companies also will support the collaboration. Financial terms were not disclosed.