News Release Details
News Release Details
Jaguar Health Secures an Additional $3 Million Payment from Future Pak for Mytesi and Canalevia-CA1
As announced, Jaguar received an up-front payment of
Under the terms of the agreement, Future Pak became the exclusive marketer for Mytesi (crofelemer), Jaguar's FDA-approved novel prescription drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy, and Canalevia-CA1, Jaguar's crofelemer prescription drug for the treatment of chemotherapy-induced diarrhea in dogs. Jaguar was provided with
"As announced, the agreement has a buy-back option that provides Jaguar with the unilateral right to repurchase all of the licensed rights from Future Pak starting five years after the agreement effective date, provided that certain regulatory milestones are met," said
"Our agreement with Future Pak is fully aligned with our strategy to concentrate Jaguar's crofelemer development efforts on human rare-disease indications, particularly intestinal failure, where we continue to advance business development discussions with additional potential partners," Conte said.
Crofelemer continues to advance as a potential treatment for rare forms of intestinal failure, including intestinal failure due to short bowel syndrome (SBS-IF) and microvillus inclusion disease (MVID). Multiple investigator-initiated and company-sponsored studies of crofelemer are ongoing in the
Jaguar's intestinal failure program is expected to continue to provide clinical proof-of-concept milestones, and the company is targeting Breakthrough Therapy designation for crofelemer for the indication of MVID, with a planned filing of an NDA (New Drug Application) with the
Intestinal failure is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute PS. Many intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day. While crucial for intestinal failure patients, PS is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, and liver and kidney function problems. These symptoms may emerge at any time in intestinal failure patients and often become life-threatening.
About Crofelemer
Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest.
About the Jaguar Health Family of Companies
For more information about:
Napo Therapeutics, visit napotherapeutics.com
About Mytesi®
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.
Important Safety Information About Canalevia®-CA1
For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling.Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.
See full Prescribing Information at Canalevia.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that its intestinal failure program will continue to provide clinical proof-of-concept milestones, Jaguar's expectation that the company will apply for Breakthrough Therapy designation for crofelemer for the indication of MVID, and Jaguar's expectation that it will file an NDA with the
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SOURCE:
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