New nonclinical data from Aravive Inc., of Houston, noted that AVB-500, its lead candidate, reduced tumor size and blood vessel density in animal models of clear cell renal cell carcinoma. The company said the data suggest an anti-GAS6 therapy may be effective in preventing and treating tyrosine kinase inhibitor-resistant disease, "supporting the rationale for combining AVB-500 with anti-angiogenic agents in the treatment of advanced kidney cancer." The study results were published in Cancer Research.
Bristol-Myers Squibb Co. (BMS), of New York, extended the expiration date to Oct. 31 for offers to exchange notes issued by Celgene Corp., of Summit, N.J., for up to $1.98 billion of the aggregate principal amount of new notes to be issued by BMS. The exchange offer is conditional upon closing BMS' acquisition of Celgene, which is expected to occur before year-end. BMS and Celgene entered the deal, valued at about $74 billion, at the start of the year. (See BioWorld, Jan. 4, 2019.)
Great Bay Bio Ltd., of Hong Kong, and China's Guangzhou Boji Medical Biotechnological Co. plan to develop injectable biologics to treat anemia caused by chronic kidney disease. The companies created a joint venture to share R&D and both will funnel capital into the venture. Boji will run the phase I study, which will be conducted with patients in China.
Inscopix Inc., of Palo Alto, Calif., and Evanston, Ill.-based Astellas Research Institute of America LLC, part of Astellas Pharma Inc., plan to develop drug screening assays for treating psychiatric disorders in the next two years. Inscopix develops mapping of neural activity in brain circuits and the research institute investigates anti-infective, dermatology and urology-related products.
The Institute for Clinical and Economic Review (ICER) concluded that cardiovascular disease (CVD) drugs Xarelto (rivaroxaban, Johnson & Johnson) and Vascepa (icosapent ethyl, Amarin Corp.) "provide gains in quality-adjusted survival and overall survival over optimal medical management." The report concluded that, "assuming clinical signals within the trial hold for patients treated with these interventions and current net prices, the base-case results suggest that costs for treatment with either [therapy] would fall below commonly cited thresholds for cost effectiveness. The results were relatively robust to sensitivity and scenario analyses," ICER added.
Novan Inc., of Morrisville, N.C., submitted a request for a pre-IND meeting with the FDA for new product candidate SB-207. The company anticipates the meeting will be held in December. The product incorporates the company's existing drug substance, berdazimer sodium, with a new formulation specifically engineered and tailored to be effective within a number of viral indications.
The U.S. District Court for the District of Maryland entered a final judgment against Bobby Dwayne Montgomery, a former executive of Columbia, Md.-based Osiris Therapeutics Inc. for his role in Osiris' fraudulent conduct. The SEC's action, filed Nov. 2, 2017, charged Osiris with routinely overstating company performance and issuing fraudulent financial statements for a period of nearly two years, and charged several of its former officers for related misconduct. The SEC alleged that Montgomery, Osiris's former chief business officer, caused Osiris to book fictitious revenue and provided false information to Osiris' auditors. Montgomery consented to a judgment enjoining him from future violations of the provisions of the federal securities laws that prohibit falsifying books and records and lying to auditors, and ordering him to pay a civil penalty of $40,000.
Redhill Biopharma Ltd., of Tel Aviv, Israel, signed a collaboration with Cosmo Pharmaceuticals NV, of Dublin. The deal includes an exclusive license agreement for the U.S. rights to Aemcolo (rifamycin) for traveler's diarrhea and a simultaneous private investment by Cosmo of $36.3 million in Redhill at $7 per American depositary share representing about 13.5% over the closing price on Oct. 17, with a 180-day transfer restriction. Following the transaction, Redhill will maintain a debt-free balance sheet with approximately $59 million of cash and cash equivalents.