Amag Pharmaceuticals Inc., of Waltham, Mass, said it completed sale of its rights to Intrarosa (prasterone) to Millicent Pharma Ltd., of Larne, Ireland, for up to $125 million, including up-front fixed consideration of $20 million and contingent, sales-based milestone payments of up to $105 million. Amag will be entitled to certain sales milestone payments, including $25 million the first time Intrarosa net sales exceed $65 million during any consecutive 12-month period, a second sales milestone payment of $35 million the first time Intrarosa net sales exceed $115 million during any consecutive 12-month period, and a third milestone payment of $45 million the first time Intrarosa net sales exceed $175 million during any consecutive 12-month period.
In a trial sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, Amarin Corp. plc, of Bridgewater, N.J., and Dublin, is studying icosapent ethyl (Vascepa) on inflammatory biomarkers and other patient outcomes in COVID-19 patients. The primary endpoint is the effect of Vascepa vs. usual care on high-sensitivity C-reactive protein levels from baseline to 14 days in adults with a COVID-19-positive diagnosis. The study design also includes endpoints to assess rates and COVID-19 infection severity.
Ampio Pharmaceuticals Inc., of Englewood, Colo., said it has filed INDs for Ampion with the FDA for treatments that include inhalation and intravenous applications for COVID-19 patients. In vitro studies on cell cultures confirmed Ampion’s mechanism of action may be suitable to inflammatory conditions such as acute respiratory distress syndrome and the cytokine storm associated with COVID-19, the company said.
Correvio Pharma Corp., of Vancouver, British Columbia, said it obtained a final order from the Supreme Court of British Columbia approving acquisition of all shares of Correvio for $76 million by London’s Advanz Pharma Corp. Ltd., including repayment of some Correvio debt. Correvio shareholders approved the arrangement May 15. The deal is expected to close May 27.
Miramar, Fla.-based Generex Biotechnology Corp. said its COVID-19 vaccine program reached a milestone by manufacturing 33 Ii-Key-SARS-CoV-2 peptides using antigenic epitopes predicted by computational vaccinology algorithms. Once the peptides pass quality assurance testing, they will be shipped to clinical laboratories for screening using blood and plasma samples from recovered COVID-19 patients. The studies will provide data to select Ii-Key-SARS-CoV-2 peptides for a vaccine to promote B-cell production of neutralizing antibodies and activate CD4+ T-cell responses promoting immune memory and potential long-term protection from coronavirus infection. Additionally, the vaccine screening program will address safety of the Ii-Key-SARS-CoV-2 peptides using an in vitro assay modeling the cytokine storm associated with COVID-19.
Innocan Pharma Ltd., of Tel Aviv, Israel, a wholly owned subsidiary of Innocan Pharma Corp., of Calgary, Alberta, signed a letter of intent with Adva Biotechnology Ltd. to enter an exosome production and development agreement. Adva develops therapy manufacturing solutions. Innocan intends to load the produced exosomes with cannabidiol to develop a COVID-19 treatment and additional CNS indications.
Miami University, of Oxford, Ohio, and Psybio Therapeutics Inc., of Boca Raton, Fla., are collaborating to develop molecules to treat mental health issues, including depression, anxiety, post-traumatic stress disorder and substance dependency. Psybio has a research sponsorship with Miami University for the next two years to further develop a platform technology enabling the biosynthesis of psilocybin and other psychoactive molecules that occur naturally in certain plants and fungi. Additionally, Miami granted Psybio a global exclusive license to technology generated from the research.
Roche Holding AG, of Basel, Switzerland, said it acquired Seattle-based Stratos Genomics Inc., an early stage sequencing technology company, to advance the development of its nanopore sequencer. Roche gains access to Stratos’ chemistry, sequencing by expansion (SBX). The Roche nanopore sequencer, once developed, will combine electronic and biological components to sequence DNA for clinical diagnostic testing. Financial terms of the deal were not disclosed.
The Russian Direct Investment Fund (RDIF), of Moscow, a sovereign wealth fund, and the Chemrar Group, also based in Moscow, said they started the final stage of a multicenter, randomized, open comparative clinical trial of the drug favipiravir on patients hospitalized with COVID-19. The study will involve 330 patients as well as additional research and medical centers. An application for the accelerated registration of favipiravir has been submitted to the Russian Ministry of Health.
In an agreement worth more than $231 million over the next eight years, Samsung Biologics Co. Ltd., of Yeonsu-gu, South Korea, will provide additional manufacturing and supply capacity to Glaxosmithkline plc, of London. The deal will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022.
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., said its board has determined that the latest acquisition proposal from Melinta Therapeutics Inc., of New York, is a “superior offer” under the terms of the agreement and plan of merger, to which the company is a party along with Acelrx Pharmaceuticals Inc., of Redwood City, Calif., and its merger subsidiary (the Acelrx merger agreement). As a result, Tetraphase has given notice to Acelrx of the determination and of its intention to consider changing its recommendation of the Acelrx merger agreement or its termination unless Acelrx proposes revisions to its terms or makes another proposal on or before May 29. Melinta has offered to acquire Tetraphase for $27 million in cash, plus an additional $12.5 million in cash potentially payable under contingent value rights. Shares of Tetraphase (NASDAQ:TTPH) closed May 22 at $2.64, up 14.8%.
Tiziana Life Sciences plc, of London, said it intends to demerge its Stemprinter, for the prediction of disease recurrence in breast cancer patients, and genomics-based personalized medicine businesses into a separate company and undergo a capital reduction to facilitate the spin-out and listing of Stemprinter as an independent entity. The action would allow shareholders to benefit from both Tiziana’s rapidly developing drug portfolio and the standalone value of Stemprinter as it progresses through its own development milestones, the company said.