Alcon SA, of Geneva, said it signed an agreement to acquire exclusive U.S. commercialization rights to Simbrinza (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% from Novartis AG, of Basel, Switzerland. Simbrinza, a fixed combination of a carbonic anhydrase inhibitor and an alpha-2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, was approved by the U.S. FDA in 2013. Under the terms, Alcon and Novartis will immediately begin a transition period where Novartis will continue to sell Simbrinza and transfer the net profit to Alcon. Following the transition period, Alcon expects to manufacture and commercialize Simbrinza for the U.S. market, while Novartis will retain all rights outside of the U.S. Alcon will pay $355 million at closing, which is expected to occur in the second quarter of 2021.
Annovis Bio Inc., of Berwyn, Pa., said it entered a research collaboration with the University of California, San Diego designed to study the ability of the company's lead compound, ANVS-401, to normalize brain development in Down syndrome (DS) mice. The study will dose healthy and DS female mice starting before fertilization with either placebo or ANVS-401 and follow the mother through pregnancy to lactation and the fertilized egg from embryo through old age. At different points, the study will measure levels of various neurotoxic proteins, axonal transport and inflammation in the brains of the mothers and the offspring to see the differences between a healthy brain, a DS brain and an ANVS-401-treated DS brain. The study will also measure learning and cognition throughout the life span of the mice and will obtain interim data at every step of development while following the mice into old age.
Brooklyn Immunotherapeutics LLC, of Brooklyn, N.Y, said it acquired an exclusive license for mRNA gene editing and cell therapies technology of Factor Bioscience Ltd., of Cambridge, Mass., and Novellus Therapeutics Ltd., also of Cambridge, pursuant to an exercise of a previously announced option. The license includes use of a process to develop gene editing compounds using mRNA, for which preclinical data demonstrate a high degree of efficiency, as well as being non-immunogenic and non-mutagenic.
Capricor Therapeutics Inc., of Los Angeles, said it signed an exclusive, worldwide licensing agreement with Johns Hopkins University (JHU) to include engineered exosomes for vaccines and therapeutics as part of the company’s exosome technology portfolio. Under the terms, Capricor was granted rights to JHU’s co-owned interest in intellectual property described in the licensed patent applications, enabling Capricor to exclusively develop, manufacture and commercialize, with the right to sublicense, IP related to exosome technology for applications across both vaccine and therapeutic areas. Capricor is the co-owner of the intellectual property associated with the patent applications covered by the agreement.
Delix Therapeutics Inc., of Boston, said a study published in Cell revealed DLX-1 as a new compound inspired by the chemical structures of common psychedelic substances that demonstrates sustained antidepressant effects but without hallucinogenic properties. DLX-1 – also known as AAZ – is the second published example of a non-hallucinatory Delix compound capable of achieving rapid and sustained therapeutic efficacy in preclinical animal models, the company said.
Hikma Pharmaceuticals plc, of London, said it signed an exclusive license and distribution agreement with Aft Pharmaceuticals Ltd., of Auckland, New Zealand, for the commercialization of Combogesic IV, the U.S. trade name of Maxigesic IV, an intravenous, opioid-free postoperative pain relief medicine. Under the terms, Hikma gains exclusive rights for the sales, marketing and distribution in the U.S. Terms were not disclosed.
Inozyme Pharma Inc., of Boston, said preclinical data published in the Journal of Bone and Mineral Research showed treatment with INZ-701 was associated with increased plasma levels of pyrophosphate, a potent regulator of mineralization, as well as improvements in several other disease markers and decreased mortality in a mouse model of ENPP1 deficiency.
Melinta Therapeutics Inc., of Morristown, N.J., and Hikma Pharmaceuticals plc, of London, said they entered an exclusive licensing agreement for Vabomere (meropenem and vaborbactam) and Orbactiv (oritavancin), two anti-infective injectable products, for the Middle East and North Africa (MENA) region. Under the terms, Hikma is responsible for the registration and commercialization of the two products across its 18 MENA markets. In the U.S., Orbactiv is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections due to designated susceptible gram-positive pathogens, and Vabomere is indicated for the treatment of patients 18 and older with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible gram-negative pathogens. The deal extends Hikma’s existing partnership with Melinta for their intravenous and oral formulations of antibiotic Baxdela (delafloxacin).
Mindset Pharma Inc., of Toronto, said two of its short-acting psychedelic drug candidates, DMT and 5-MeO-DMT, have exhibited positive in vitro screening characteristics. The DMT and 5-MeO-DMT analogues, optimized for reduced toxicity and improved pharmacokinetic and pharmacodynamic characteristics, could have potential as next-generation psychedelic medicines, the company said.
Mirum Pharmaceutics Inc., of Foster City, Calif., and Canbridge Pharmaceuticals Inc., of Beijing, said they entered a licensing agreement, in which Canbridge has agreed to develop and commercialize maralixibat in greater China (China, Hong Kong, Macau and Taiwan). Maralixibat, an investigational, orally administered medication, is being evaluated in Alagille syndrome, progressive familial intrahepatic cholestasis and biliary atresia (BA). Under the terms, Mirum is entitled to receive an $11 million up-front payment, R&D funding and up to $109 million for the achievement of future regulatory and commercial maralixibat milestones, with significant double-digit tiered royalties based on product net sales. In collaboration with Mirum, Canbridge has agreed to oversee Mirum’s clinical study sites in China, with the goal of accelerating enrollment of the global phase IIb EMBARK study, which was recently initiated for patients with BA. Canbridge would also have the right to manufacture maralixibat in greater China under certain conditions.
Moderna Inc., of Cambridge, Mass., said it is making new funding commitments to increase supply at its owned and partnered manufacturing facilities, which it expects will increase global 2022 capacity to up to 3 billion doses of its COVID-19 vaccine, depending upon the mix between the authorized Moderna COVID-19 vaccine at the 100 μg-dose level and potentially lower doses of the company’s variant booster candidates and pediatric vaccines, if authorized. The company said it will use its cash balance to fund those investments. Moderna also raised its 2021 manufacturing supply forecast to between 800 million to 1 billion doses.
Olatec Therapeutics LLC, of New York, said preclinical data published in the Proceedings of the National Academy of Sciences showed that blocking NLRP3 with oral dapansutrile resulted in a significant reduction in tumor growth and progression when compared to untreated mice with induced melanoma.
Repertoire Immune Medicines Inc., of Cambridge, Mass., said it entered a new collaboration with Yale University focused on understanding the basis of cellular immunity of multiple sclerosis by determining what types of antigens are activating T cells in patients. Repertoire and Yale will work together to identify the specificity of various subsets of T cells with a goal of understanding the immunologic causes of the disease.
Selecta Biosciences Inc., of Watertown, Mass., and Asklepios Biopharmaceutical Inc., of Research Triangle Park, N.C., updated their collaboration to evaluate gene therapy candidate MMA-101 and ImmTOR for the treatment of methylmalonic acidemia (MMA). Selecta will assume all rights to the MMA program and will continue to progress the MMA-101 and ImmTOR combination through clinical development. Askbio’s decision to give all rights to Selecta was attributed to an internal strategic review and prioritization of its portfolio. Due to a manufacturing issue the companies believe is related to a component sourced from a third-party, Selecta said it now expects that submission of the IND for MMA-101 and ImmTOR will be delayed until at least the fourth quarter of 2021. A detailed assessment of the manufacturing process is currently being conducted, and the company expects to provide an update on program timelines as they are clarified. ImmTOR manufacturing continues to proceed smoothly, and there is no impact to any of Selecta’s ImmTOR programs, the company said. Shares of Selecta (NASDAQ:SELB) fell 19% to close April 29 at $3.15.
Sirnaomics Biopharmaceutical Co. Ltd., of Suzhou Biobay, China, a subsidiary of Sirnaomics Inc., said it entered a partnership agreement with Walvax Biotechnology Co. Ltd., of Yunnan, China, for the co-development of its anti-influenza siRNA therapeutic candidate, STP-702. Sirnaomics will out-license to Walvax the exclusive development and commercialization rights for territories including mainland China, Taiwan, Hong Kong and Macao. Based on the agreement, the company will receive an initial payment of about $6.4 million, with additional milestone payments and royalty sharing based on product sales.
Tris Pharma Inc., of Monmouth Junction, N.J., said it acquired Park Therapeutics Inc., of Morristown, N.J., a company developing a phase III-ready new chemical entity for the treatment of pain. Studies have shown that the drug’s potential to provide efficacy in nociceptive and neuropathic pain, while maintaining a differentiated safety profile, results from its dual mechanism of action as an agonist of the nociceptin/orphanin FQ (NOP), DOP and MOP receptors and partial agonist of KOP receptors. Financial terms of the acquisition were not disclosed.