Agreement grants Quadri Pharmaceuticals Store exclusive promotional, commercialization, and distribution rights in Bahrain, Kuwait, Qatar, Saudi Arabia, the United Arab Emirates, and Oman for human indications of crofelemer approved in the U.S., including future target indications
SAN FRANCISCO, CA / ACCESSWIRE / March 31, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the company has entered an agreement (the "Agreement") with Quadri Pharmaceuticals Store LLC (Quadri Pharma) that grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for specified human indications of crofelemer in Bahrain, Kuwait, Qatar, Saudi Arabia, the United Arab Emirates (UAE), and Oman following regulatory approval to market crofelemer in these countries for the specified indications, including the indication currently approved in the U.S. for HIV-related diarrhea, and cancer therapy-related diarrhea, for which crofelemer is currently in a pivotal Phase 3 clinical trial. In addition, the Agreement grants Quadri Pharma exclusive rights to distribute crofelemer in these countries in the immediate future under Named Patient Programs.
According to the UNAIDS 2020 global report, the HIV epidemic is growing in the Middle East and North Africa (MENA) region, with an estimated 20,000 new infections in 2019 - a 25% increase over new infections in 2010, and an estimated 170,000 to 400,000 adults and children in the region lived with HIV in 2019. Data from this report indicates that 52% of people living with HIV in the MENA region knew their status in 2019, 38% were accessing antiretroviral therapy, and less than one third were virally suppressed.1
"Our collaboration with Quadri Pharma is a welcome and important step towards making crofelemer's novel mechanism of action available to patients in need in global markets," said Karen Brunke, PhD, Jaguar Health's Executive Vice President of Corporate and Business Development. "We look forward to a close relationship with Quadri Pharma and their team of experienced professionals."
Crofelemer is Jaguar Health's antidiarrheal drug product that is approved, under the name Mytesi (crofelemer 125 mg delayed-release tablets), in the U.S. by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. The indications specified by the Agreement include Mytesi's approved U.S. indication in HIV/AIDS patients as well as any other human indication of the tablet form of crofelemer that receives approval in the U.S. during the term of the Agreement, which may include cancer therapy-related diarrhea (CTD) and inflammatory bowel disease (IBD).
"We are very pleased to enter into this strategic transaction with Jaguar Health," said Dr. Hesham Elbakr, Chief Executive Officer of Quadri Pharma. "We expect crofelemer to be an important treatment option for patients in need in Bahrain, Kuwait, Qatar, Saudi Arabia, the UAE, and Oman, and we have knowledge and experience in the distribution of pharmaceutical products throughout the Middle East, including the servicing of requests for a particular medicine in markets where that medicine does not have marketing approval - such as requests related to Named Patient Programs, which provide revenue-generating products approved in a major market country to individual patients ("named" patients) through physician requests in a country without marketing approval."
Based in Abu Dhabi and Dubai in the UAE, Quadri Pharma provides services related to the registration, marketing, and distribution of pharmaceutical products in the MENA region in compliance with local and international regulatory standards.
Mytesi (crofelemer) is an antidiarrheal indicated in the U.S. 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.
About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals, & Napo Therapeutics
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Animal Health is a tradename of Jaguar Health. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe.
For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo Therapeutics, visit www.napotherapeutics.com.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that crofelemer will be an important treatment option for patients in need in Bahrain, Kuwait, Qatar, Saudi Arabia, the UAE, and Oman. 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 several 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.
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