Adamas Pharmaceuticals Inc., of Emeryville, Calif., said it entered a settlement agreement with Sandoz Inc., of Princeton, N.J., that resolves ongoing litigation concerning Sandoz’s abbreviated new drug application (ANDA) requesting FDA approval to market a generic version of Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson's disease. It has granted Sandoz a nonexclusive license to make, use, sell, offer to sell and import the products that are the subject of Sandoz’s ANDA as of March 4, 2030, or earlier in certain circumstances, including a potential for an accelerated license date if the unit sales of the drug in the 12-month period ending July 31, 2025, or any subsequent 12-month period decline by a specified percentage below the unit sales in the year ended Dec. 31, 2019.
Antabio SAS, of Labège, France, said it was awarded up to $4.4 million in a second tranche of funding from CARB-X, the global nonprofit partnership dedicated to tackling the rising threat of drug-resistant bacteria. The funding will support the development of the company’s small-molecule candidate for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis (CF) patients. Its Pseudomonas elastase inhibitor program is being used to develop an inhaled product for an adjunct to existing therapy that will aim to reduce the severity of P. aeruginosa disease and enhance pathogen clearance by targeting the LasB elastase, a key virulence determinant that contributes to tissue damage and inflammation in infected CF lungs.
Beigene Ltd., of Beijing, said its global strategic oncology collaboration with Thousand Oaks, Calif.-based Amgen Inc., signed last year, has become effective. Beigene will assume responsibility for the commercialization and development in China of Amgen’s three oncology medicines, Xgeva (denosumab), Kyprolis (carfilzomib) and Blincyto (blinatumomab), that have been approved or filed in China. In addition, the companies will collaborate to advance 20 investigational oncology assets in Amgen’s pipeline, with Beigene leading development and commercialization in China. Amgen purchased 15.89 million of Beigene’s American depositary shares (representing 206.6 million ordinary shares) for approximately $2.8 billion in cash.
Arena Pharmaceuticals Inc. and Beacon Discovery Inc., both of San Diego, entered a strategic, multiyear partnership, Project Cabrillo, to create medicines across a range of G protein-coupled receptor targets in a variety of immune and inflammatory diseases. Beacon is responsible for drug discovery, and Arena shoulders development and commercialization duties. Financial terms were not disclosed.
The discovery and development agreement between Dicerna Pharmaceuticals Inc., of Lexington, Mass., and Novo Nordisk A/S, of Bagsvaerd, Denmark, has closed, as the two plan to explore more than 30 liver cell targets to treat chronic liver disease, nonalcoholic steatohepatitis, type 2 diabetes, obesity and rare diseases. Dicerna will conduct and fund discovery and preclinical development to clinical candidate selection for each liver cell target. Novo handles all further development. Dicerna retained the right to opt into two clinical-stage programs derived from the collaboration. Dicerna receives an up-front fee of $175 million, following delivery of a program startup package to Novo expected early in the first quarter. Dicerna receives $25 million annually for each of the first three years of the collaboration, subject to delivery of RNAi molecules for a defined number of targets to Novo, and up to $357.5 million per target in development, regulatory and commercialization milestone payments, plus tiered royalties on product sales ranging from the mid-single-digits to midteens. Also, Dicerna issued 2.27 million shares of Dicerna common stock to Novo in connection with its $50 million equity investment in Dicerna.
Diomics Corp., of San Diego, and the University of California, Irvine, created a sponsored research agreement to study islet transplantation for type 1 diabetes patients using biomaterials to protect the transplanted islets. Improved islet transplantation has been shown to restore natural insulin production for those patients. No financial details were released.
Emmaus Life Sciences Inc., of Torrance, Calif., received the initial purchase order relating to Oman-based retail pharma Taiba Healthcare’s early access program for Endari (L-glutamine oral powder) to reduce acute complications of sickle cell disease in adult and pediatric patients 5 and older. The collaboration expands Emmaus’ reach into the Middle East and North Africa.
Inmune Bio Inc., of La Jolla, Calif., disclosed the publication of new positive data in Alzheimer’s Research & Therapy. The data highlight lead compound XPro-1595, a therapy designed to lower the risk for Alzheimer’s disease in obese individuals. The new data suggest that XPro-1595 may have therapeutic potential to block various features of Alzheimer’s-like pathology in mice. The drug is described as a next-generation anti-inflammatory that can cross the blood-brain barrier to affect neurodegenerative diseases by selectively inhibiting soluble tumor necrosis factor and alleviate inflammation.
Intrexon Corp., of Germantown, Md., said it will refocus the company on health care, change its name to Precigen Inc. and has appointed Helen Sabzevari as president and CEO. The new Precigen will encompass Intrexon's wholly owned health care subsidiaries Precigen, Actobio Therapeutics, Exemplar Genetics and its majority ownership interest in Triple-Gene, as well as equity and royalty interests in therapeutics and therapeutic platforms from companies not controlled by the parent firm. Intrexon has executed binding agreements to sell its smaller non-health care businesses for $65.2 million plus certain contingent payment rights and entered an agreement to sell $35 million of its common stock.
Mediwound Ltd., of Yavne, Israel, signed a distribution agreement granting Balance Medical Pty Ltd., of Queensland, Australia, the exclusive rights to market and distribute Nexobrid in Australia, New Zealand and Singapore for the treatment of severe burns. Nexobrid is a topically administered biologic product that removes eschar in patients with deep partial and full-thickness thermal burns, and it is approved in the EU and other international markets. Terms were not disclosed.
Opiant Pharmaceuticals Inc., of Santa Monica, Calif., signed a letter of intent with the NIH to collaborate on the development of OPNT-004 (drinabant), a cannabinoid receptor antagonist, for the treatment of acute cannabinoid overdose. The agency will provide development resources around certain preclinical activities and studies in order to support Opiant’s planned filing of an IND. Opiant licensed exclusive global rights for the development and commercialization of drinabant from Sanofi SA, of Paris.
Psomagen Inc., of Rockville, Md., said its Psomagen-Macrogen Consortium acquired all key assets of Ubiome Inc., of San Francisco. Through the move, Psomagen said it becomes a player in the microbiome sector. The acquisition includes a microbiome patent portfolio comprising 246 patents (60 registered U.S. patents and 186 applications), anonymized microbiome data, nearly 300,000 samples, and laboratory equipment from Ubiome’s lab. The price was $7.05 million, corresponding to 1% of Ubiome’s estimated corporate value, Psomagen said.
Pulmatrix Inc., of Lexington, Mass., said it entered a licensing and development agreement with the Lung Cancer Initiative, part of New Brunswick, N.J.-based Johnson & Johnson, in which the latter gains an option to access a portfolio of narrow spectrum kinase inhibitors intended for development in lung cancer interception. Under the terms, the Lung Cancer Initiative will pay a $7.2 million up-front payment and an additional $2 million milestone payment upon completion of the ongoing phase Ib study of RV-1162/PUR-1800 in stable chronic obstructive pulmonary disease patients, on track for year-end 2020. If the Lung Cancer Initiative exercises the option on RV-1162/PUR-1800 and the portfolio of those kinase inhibitors, Pulmatrix is eligible for up to $91 million in additional development and commercial milestones, as well as royalty payments.
Redhill Biopharma Ltd., of Tel Aviv, Israel, said it provided Salix Pharmaceuticals Ltd., of Bridgewater, N.J., with a notice of termination of their 2014 license agreement and has regained the worldwide exclusive rights to RHB-106, an encapsulated formulation for bowel preparation, currently under development. Terms were not disclosed.