Foresee Pharmaceuticals announced that it has entered into an exclusive license agreement with Intas Pharmaceuticals ("Intas") for the US commercialization of Foresee's novel FP-001 program, Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous 6-month and 3-month depot formulations ("Camcevi®"). The application for the 3-month indication of Camcevi® has not yet been filed with the US Food and Drug Administration (FDA) and is under development by Intas and Foresee, the Section 505(b)(2) New Drug Application for the 6-month Camcevi® indication, is currently under review by the FDA.

Under the terms of this partnership, Foresee, a Taiwan and US-based biopharmaceutical company, will receive 10 million US Dollars upfront, along with certain regulatory milestones and sales milestones payments having a combined value totaling up to 207 million US dollars, plus a share of the product revenue in the territory. Intas' US affiliate, Accord BioPharma, Inc. will be commercializing the Camcevi® products in the US market. Intas, a global biopharmaceutical company, will cover all costs of commercialization in the territory.

Dr. Ben Chien, Founder and Executive Chairman of Foresee commented: "We are very pleased to have entered into this license agreement with Intas for commercialization of Camcevi® in the US; it allows us to build on our existing partnership with Intas, where they have demonstrated strong commitment to the success of this complex and promising product. We look forward to successfully leveraging Intas' US commercial platform together."

Chrys Kokino, President US Specialty at Accord Healthcare Inc., said "Intas and its US specialty arm, Accord BioPharma, Inc., is very committed to bringing complex and accessible, added value medicines to the US market, improving the standard of care and ultimately the lives of patients and the public health in general. This agreement will contribute another key therapy to our fast-growing US business. We look forward to continuing our successful collaboration with Foresee."

About Foresee Pharmaceuticals Co. Ltd.

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs.

Foresee's product portfolio includes late stage and early stage programs. FP-001 – stable, ready-to-use versions of leuprolide mesylate for injection, for which regulatory approval reviews are currently underway in US and EU for the 6-month product and regulatory submissions for 3-month product are in preparation. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia. FP-004 – a novel, subcutaneously injectable product in development for the treatment of opioid use disorder and pain. www.foreseepharma.com

About Intas Pharmaceuticals

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. It has been growing at approximately 26% CAGR over the last five years and crossed the $2 billion revenue milestone in the past fiscal year. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, Canada, South Africa, Australia, Asia Pacific, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of EU and the US.

Currently ranked 8th (as per IQVIA TSA MAT September 2020) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Gastroenterology, Urology and Oncology in India, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US.

Intas' success and growth is a direct influence of Intas' extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are located in India, and the rest in the U.K. and Mexico. Between them, the facilities are accredited by top global regulators such as US FDA, EMA, MHRA, TGA, and others. Every year, the company invests ~6-7% of its revenues in R&D. Currently; Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products.

For more information, visit www.intaspharma.com

 

Source: prnewswire.com

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