SAN FRANCISCO, CA / ACCESSWIRE / December 6, 2018 / Jaguar Health, Inc. (JAGX) (''Jaguar'' or the ''Company''), a commercial stage pharmaceutical company focused on developing novel, sustainably derived gastrointestinal products on a global basis, today announced that it has engaged T.R. Winston & Company, LLC (''T.R. Winston'') to provide strategic advice with respect to collaboration, licensing and development activities in support of Mytesi® and crofelemer. Mytesi is FDA-approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS who are on antiretroviral therapy.
The Company is pursuing a pipeline of follow-on indications for Mytesi (crofelemer), many of which are supported by Phase 2 or proof-of-concept data. Jaguar's lead development program is cancer therapy-related diarrhea (CTD), an important indication in support of patients who are undergoing cancer treatment with traditional and novel chemotherapeutic agents. The Company's near-term objective is to meet with FDA to discuss the anticipated protocol for a planned single pivotal trial for the evaluation of crofelemer in CTD. Jaguar anticipates that this indication will use the same formulation and dosing that is used for Mytesi's currently approved indication. Additionally, Jaguar recently approved a request for an investigator-initiated trial of crofelemer for idiopathic/functional diarrhea; and crofelemer is in development for rare disease indications for infants and children with congenital diarrheal disorders and short bowel syndrome; for irritable bowel syndrome (IBS); and for supportive care for inflammatory bowel disease (IBD).
In line with the Company's partnering strategy, on September 24, 2018, Jaguar and Knight Therapeutics (''Knight''), a Canadian specialty pharmaceutical company, entered into a distribution, license and supply agreement that grants Knight the exclusive right to commercialize Mytesi and related products in Canada and Israel, along with a right of first negotiation to commercialize Mytesi and related products in specified Latin American countries.
''We believe that we are extremely well positioned with a deep pipeline of GI and supportive care indications based on the active pharmaceutical ingredient, crofelemer, of our first-in-class product, Mytesi. Jaguar has GMP commercial manufacturing in place, and we have Phase 2 or proof-of-concept data for most of our proposed follow-on indications for crofelemer,'' Lisa Conte, Jaguar's President and Chief Executive Officer, stated. ''Through our engagement with T.R. Winston, we are seeking partners that share our commitment to making this important anti-secretory agent available to relieve suffering across patient populations, spanning geographies around the world. T.R. Winston possesses extensive industry knowledge, and the experience and expertise to assist us in identifying like-minded partners with the resources to assist us in reaching our pipeline goals.''
Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis. Our wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
About T.R. Winston & Company
T.R. Winston & Company, LLC (''T.R. Winston'') is a full-service merchant, corporate and investment banking firm. T.R. Winston represents Fortune 100 and emerging growth companies, institutional investors, and family offices, with a commitment to long-term relationship banking based on value creation, integrity and measurable performance. T.R. Winston's strategic advisory business encompasses mergers & acquisitions, licensing and public-private healthcare partnership advisory. In addition to merchant, corporate and investment banking activities, T.R. Winston maintains prime services and institutional trading.
Certain statements in this press release constitute ''forward-looking statements.'' These include statements regarding the development of possible follow-on indications for Mytesi, the Company's near-term objective to meet with FDA to discuss the anticipated protocol for a planned single pivotal trial for the evaluation of crofelemer in CTD, Jaguar's expectation that the CTD indication will use the same formulation and dosing that is used for Mytesi's currently approved indication, and the belief that the Company is extremely well positioned with a deep pipeline of GI and supportive care indications based on the active pharmaceutical ingredient, crofelemer, of Mytesi. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''aim,'' ''anticipate,'' ''could,'' ''intend,'' ''target,'' ''project,'' ''contemplate,'' ''believe,'' ''estimate,'' ''predict,'' ''potential'' or ''continue'' or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Jaguar Health, Inc.
SOURCE: Jaguar Health, Inc.