Date: 2015-03-03
Type of information: Licensing agreement
Compound: remogliflozin etabonate
Company: Islet Sciences (USA - NC) Brighthaven Ventures (USA - NC)
Therapeutic area: Hepatic diseases - Liver diseases - Metabolic diseases
Type agreement: licensing development commercialisation
Action mechanism: SGLT2 inhibitor. Remogliflozin is a selective SGLT2 inhibitor in phase 2b clinical development for type 2 diabetes and NASH.
Disease: NASH (non-alcoholic steatohepatitis)
Details: * On March 3, 2015, Islet Sciences, a biopharmaceutical company developing new medicines and technologies for the treatment of metabolic disease, announced that it has entered into a license agreement with Brighthaven Ventures for exclusive rights to develop and commercialize SGLT2 inhibitor remogliflozin etabonate. Remogliflozin is in phase 2b development for type 2 diabetes and non-alcoholic steatohepatitis (\"NASH\"). Remogliflozin has been dosed in over 800 people in more than twenty clinical trials. In twelve-week phase 2b clinical studies, remogliflozin demonstrated HbA1c lowering greater than 1% with no significant adverse events and low incidence rates of genitourinary infections, a common side effect associated with SGLT2 inhibitors. Remogliflozin also demonstrated strong postprandial glucose disposal and improvements in both insulin sensitivity and beta cell function. In patients with impaired renal function, remogliflozin showed little plasma accumulation relative to patients with normal renal function and, therefore, no dose adjustment is expected for this large (>35%) segment of the diabetic population. The review by a central IRB and the FDA of the protocol for a phase 2b clinical study of remogliflozin was conducted in late 2014. Clinical site selection is underway with initial dosing expected to commence Q2 of 2015. The study is designed as a 12-week double blind, placebo controlled, and dose-ranging study of remogliflozin in type 2 diabetics. Upon effectiveness of the agreement, Islet Sciences will be granted exclusive rights to remogliflozin in the global territory outside of Japan, Korea, Taiwan, China, and Latin America. On September 30, 2014, Islet entered into a merger agreement with BHV with the parent company to be named Avogenx. Concurrent with entering into the exclusive license agreement, the previously executed merger agreement has been terminated. As a result of the termination of the merger agreement, Avogenx is submitting a request to the Securities and Exchange Commission to withdraw its previously filed Form S-4 registration statement related to the merger.
Financial terms: In addition to an upfront fee of $5 million, Islet is required to pay up to $35.1 million pre-regulatory approval and up to $76.75 million post-regulatory approval if certain development, regulatory and commercial milestones are successfully achieved. Royalties under the license agreement are due on net sales in the territory during the term of the agreement. The exclusive license will only become effective upon Islet raising a minimum of $10 million and paying BHV the upfront fee by May 31, 2015.
Latest news:
