Acura Pharmaceuticals Inc., of Palatine, Ill., announced a license, development and commercialization agreement with Abuse Deterrent Pharmaceuticals LLC, a special purpose company representing a consortium of investors that will finance Acura's operations and completion of development of LTX-03 (hydrocodone bitartrate with acetaminophen) immediate-release tablets utilizing Acura's Limitx technology. The agreement grants AD Pharma exclusive commercialization rights in the U.S. to LTX-03. In exchange, AD Pharma will make monthly license payments to Acura of $350,000 up to the earlier of 18 months or FDA's acceptance of an NDA for LTX-03, as well as royalties and potential sales-related milestones. Acura's shares (OTCPink:ACUR) climbed 23.3% to close at 27 cents on Wednesday.
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia, said NP-120, its repurposed lead candidate for treatment of idiopathic pulmonary fibrosis (IPF), showed superiority in reducing fibrosis over two globally approved therapies for IPF, Esbriet (pirfenidone, Roche Holding AG) and Ofev (nintedanib, Boehringer Ingelheim International GmbH), in a well-established in vivo animal model study of IPF. NP-120 (20 mg/kg) dosed three times daily showed a 56% reduction in fibrosis vs. untreated controls (p=0.015), while pirfenidone (100 mg/kg) dosed twice daily showed a 44% reduction in fibrosis vs. untreated controls (not statistically significant) and nintedanib (40 mg/kg) dosed once daily showed a 51% reduction in fibrosis vs. untreated controls.
Arbutus Biopharma Corp., of Warminster, Pa., sold part of its royalty interest on future global net sales of Onpattro (patisiran, Alnylam Pharmaceuticals Inc.) to OMERS, the defined benefit pension plan for municipal employees based in the Province of Ontario, Canada. The royalty interest was sold to OMERS, effective as of Jan. 1, 2019, for $20 million in gross proceeds before advisory fees. OMERS will retain the entitlement until it has received $30 million in royalties, at which point 100% of the entitlement will revert to Arbutus.
Biocorp, of Issoire, France, entered negotiation with Sanofi SA, of Paris, aimed at introducing the former's Mallya connected device into Sanofi's integrated diabetes care platform. Mallya is a smart sensor cap that clips onto an injection pen enabling automatic recording and transmission of dosage information via a dedicated mobile application. Mallya is the only connected device for injection pens that has been evaluated to meet the accuracy requirements needed for a CE Class IIb medical device designation by the European regulatory authorities, Biocorp said. Under the terms, Biocorp will get an initial payment of €4 million (US$4.5 million) from Sanofi to support related development activities.
Confo Therapeutics NV, of Ghent, Belgium, and Dynabind GmbH, of Dresden, Germany, disclosed a drug discovery collaboration on an undisclosed G protein-coupled receptor (GPCR). The collaboration will combine Confobody-enabled GPCRs with Dynabind's Dynamic DNA-Encoded Library for the discovery of small-molecule GPCR-modulating compounds. Under the terms, Confo will gain exclusive, worldwide rights to any drug candidates arising from the collaboration and will be responsible for their development, manufacturing and commercialization.
Evotec SE, of Hamburg, Germany, said the transaction to acquire Just Biotherapeutics Inc., of Seattle, has been completed. Evotec acquired Just in order to integrate machine-learning technologies and flexible methods for the design, development and manufacturing of biologics into Evotec's drug discovery offerings. Just's approximately 95 employees and its biologic development and manufacturing site will expand Evotec's U.S. footprint, the company said.
Lannett Co. Inc., of Philadelphia, commented on the FDA's denial of a citizen petition submitted by Genus Lifesciences Inc., of Allentown, Pa., requesting that the FDA refuse to accept any submissions related to Lannett's 505(b)(2) NDA for cocaine hydrochloride topical solution 4% and 10%. Lannett said it has addressed all issues in the FDA's complete response letter and expects to gain approval in early 2020.
Morphosys AG, of Planegg, Germany, said a €22 million (US$24.8 million) milestone payment from London-based Glaxosmithkline plc was triggered by the latter dosing the first patient in a phase III program of otilimab in rheumatoid arthritis.
Nosopharm SAS, of Lyon, France, and Evotec SE, of Hamburg, Germany, signed a partnership aimed at advancing Nosopharm's lead candidate, NOSO-502, to the clinical stage, as well as developing a second-generation odilorhabdin drug candidate. Financial terms of the agreement were not disclosed. Initial focus will be on chemistry, manufacturing and control as well as clinical trial application-enabling and filing activities related to NOSO-502, ahead of the planning of phase I trials for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. The drug inhibits the bacterial ribosome with a new mechanism of action and is intended for the treatment of nosocomial infections caused by Enterobacteriaceae, including polymyxin– and carbapenem-resistant Enterobacteriaceae.
Telix Pharmaceuticals Ltd., of Melbourne, Australia, disclosed the appointment of Grupo RPH, of Porto Alegre, Brazil, as contract manufacturer and product distribution partner for Brazil. The partnership will initially focus on TLX591-CDx (68Ga-PSMA-11) for the imaging of prostate cancer, but the agreement is structured to be able to include other Telix products in the future. Terms were not disclosed.