Napo EU S.p.A., Jaguar Health’s Italian Subsidiary, Provides Updates on Plans to Pursue Conditional Marketing Authorization in the EU
Jaguar & Dragon SPAC announce initial funding of
Napo EU to focus initially on conditional approval for an important orphan indication, short bowel syndrome (SBS), a condition leading to intestinal failure
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Equita Group S.p.A., a leading Italian based investment bank, advising Dragon SPAC;
Napo EU was formed with the mission to expand access to crofelemer to
Napo Pharma previously received orphan‑drug status for crofelemer from the Office of
The FDA is committed to advancing rare disease therapies through the Orphan Drug Act (ODA) of 1983, providing financial and other incentives for innovation to treat rare diseases. Since this groundbreaking legislation went into effect, more than 300 orphan products for treatment of rare diseases have been approved in the
"For SBS patients who suffer from the catastrophic loss of their bowel, the resulting excessive intestinal fluid output and lifelong restriction and adjustment of oral intake of food and liquids leads to the requirement that patients receive intravenous fluids for most of every day - a treatment called parenteral support ("PS"). This challenges their ability to carry out activities of daily living, or to attend school or work, and has a significant impact on their daily quality of life. Furthermore, lifelong PS leads to potentially life-threatening complications like sepsis,"
According to the Crohn's &
It is estimated that the direct costs of inpatient PS in
A treatment that can delay or reduce an SBS patient's reliance on PS will offer significant value to the patient in terms of disease management and quality of life and offer significant cost savings to the healthcare system. The global SBS market exceeded
"We are quite pleased that Napo EU is the named target of Dragon SPAC and that Dragon SPAC has completed a first funding for the benefit of Napo EU," stated
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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%).
More information and complete Prescribing Information are available 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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Napo EU's plans to pursue conditional marketing authorization for SBS, Napo Pharma's intention to pursue regulatory approval to commercialize a new formulation of crofelemer in the
3Aatmani TDK, et al. Gastroenterol Clin Biol 2006;30:574-79
4Arhip L, et al. Clin Nutr. 2019;38(4):1945-51
5Howard L. Gastroenterology. 2006;130(2 Suppl 1):S52-9