Biocure Technology Corp., of Vancouver, British Columbia, said Biocurepharm Korea (BPK), a wholly owned subsidiary of Biocure Technology Inc., has entered a memorandum of understanding (MOU) with the Agency of Development of the Pharmaceutical Industry under the Ministry of Health, The Republic of Uzbekistan (MHU) and Gold-Dream LLC (GDL) in Korea. The main purpose of the MOU is to advance the discussions regarding a joint venture in Uzbekistan to produce biopharmaceuticals, basic drugs and vaccines required for Uzbekistan people and to further develop the pharmaceutical business there.
Hummingbird Bioscience Pte Ltd., of Singapore, said it was awarded a $13.1 million product development grant from the Cancer Prevention and Research Institute of Texas to support phase Ia/b trials of HMBD-002, its therapeutic antibody to treat V-domain Ig-containing suppressor of T-cell activation, or VISTA, mediated suppression of antitumor immunity in solid tumors and lymphomas that don't respond to existing therapies. The grant also will enable GMP manufacturing and investigational new drug submission for the HMBD-002 program and support relocation of the company's U.S. headquarters from South San Francisco to Texas. Human trials are expected to begin next year.
Innovent Biologics Inc., of Suzhou, China, and Chipscreen Biosciences Ltd., of Shenzhen, China, said they agreed to collaborate to evaluate the safety and tolerability of Innovent's sintilimab and Chipscreen's chidamide in combination with anti-VEGF monoclonal antibody IBI-305 in patients with advanced colorectal carcinoma. Under the terms, the two firms will jointly explore potential applications of the combination to establish the safety and efficacy in China.
The FDA sent out an alert Monday about another voluntary recall of a sartan-containing angiotensin II receptor blocker (ARB). Macleods Pharmaceuticals Ltd., of Mumbai, is recalling one lot of losartan potassium/hydrochlorothiazide 100mg/25mg combination tablets due to unacceptable amounts of N-nitrosodiethylamine in the active pharmaceutical ingredient (API), which was manufactured by Hetero Labs Ltd., of Hyderabad, India. Macleods is the third company to recall U.S. drugs containing losartan. Sandoz Inc. recalled one lot of its version of the product, and Torrent Pharmaceuticals Ltd. recalled several lots of 11 products containing losartan. Drug companies producing ARBs with other sartans also have issued recalls because of similar impurities in the API. (See BioWorld, Feb. 15, 2019.)
Neuren Pharmaceuticals Ltd., of Melbourne, Australia, reported preclinical data on NNZ-2591, a drug being developed for Phelan-McDermid syndrome. In the SHANK3 knockout mouse, treatment with NNZ-2591 for three weeks resulted in improvement in anxiety, repetitive behavior, motor performance and social interaction to wild-type levels, as well as a 60 percent reduction in susceptibility to seizures. Abnormal length of dendrite spines between brain cells, excess activated ERK protein and depressed level of IGF-1 seen in the knockout mice were also normalized after treatment with NNZ-2591. The company is conducting IND-enabling studies for the drug.
Recce Pharmaceuticals Ltd., of Sydney, said it raised approximately AU$1.8 million (US$1.28 million) that will result in 12.85 million fully paid ordinary shares being issued at AU14 cents per share. The funds will be used to strengthen the company's balance sheet as it advances its new class of broad-spectrum antibiotics toward approval to start human clinical trials.
Respirerx Pharmaceuticals Inc., of Glen Rock, N.J., entered a nonbinding memorandum of understanding and exclusivity agreement with Impression Healthcare Ltd., of Melbourne, Australia, over the commercialization of Respirerx's dronabinol for the treatment of obstructive sleep apnea in Australia, New Zealand and Southeast Asia.
Sta Pharmaceutical Co. Ltd., of Shanghai, a subsidiary of Wuxi Apptec, and Biolingus AG, of Nidwalden, Switzerland, said they formed an exclusive technology and marketing collaboration for sublingual delivery. Under the terms, Wuxi Sta will have exclusive access to Biolingus technology for sublingual and buccal delivery in the contract development and manufacturing organization sector. Financial terms were not disclosed.
The University of Dundee's Drug Discovery Unit inked a partnership with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, to pursue therapies targeting tau pathology in neurodegenerative diseases, including Alzheimer's disease. Working in collaboration with researchers Will McEwan at the University of Cambridge and Leo James at the MRC Laboratory of Molecular Biology, the Drug Discovery Unit identified drug-like molecules that prevent seeded misfolding of tau. The partnership with Takeda is intended to accelerate the progression of those molecules toward development. Financial details were not disclosed.
Ultragenyx Pharmaceutical Inc., of Novato, Calif., reported $16.3 million in total revenue for the fourth quarter of 2018, recognizing $11.6 million in total revenue for Crysvita (burosumab-twza), the first and only FDA-approved treatment for X-linked hypophosphatemia. That includes $9.9 million in collaboration revenue in the U.S. profit-share territory and $1.3 million in royalty revenue in the European territory from the collaboration and license agreement with Kyowa Hakko Kirin Ltd., of Tokyo. Net product sales for Crysvita in other regions were $400,000. Revenue from Mepsevii (vestronidase alfa), for mucopolysaccharidosis VII, was $2.7 million. Ultragenyx recognized $1.6 million in revenue from its research agreement with Bayer AG, of Leverkusen, Germany. SVB Leerink analyst Joseph Schwartz hailed the strong Crysvita launch, saying in a report that Ultragenyx is "strengthening its commercial presence with the launch of two drugs – Crysvita and Mepsevii – and a third drug candidate inching towards the finish line with the NDA filing of UX-007 approaching in mid-2019." The company ended the year with $459.7 million on its balance sheet. Shares of Ultragenyx (NASDAQ:RARE) closed Wednesday at $60.53, up $3.72.