Home Pharmaceutics Renexxion Ireland Ltd. announces licensing and collaboration agreement with Dr. Falk...

Renexxion Ireland Ltd. announces licensing and collaboration agreement with Dr. Falk Pharma GmbH

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ROSCREA, Ireland and FREIBURG, Germany, Oct. 5, 2021 / PRNewswire / – Renexxion Ireland Ltd., a private biopharmaceutical company committed to providing innovative medicines to patients with high unmet need for gastrointestinal (“GI”) disorders, announced today that it has entered into a licensing and collaboration agreement with Dr Falk Pharma GmbH to jointly develop and commercialize Naronapride, a single advanced stage GI prokinetics, initially for gastroparesis.

  • Renexxion Ireland and Dr Falk Pharma have entered into an exclusive licensing and collaboration agreement to advance Naronapride into late stages of development in Greater Europe (including UK), Russia, the Central Asian Republics and some Australasian countries.
  • As part of the licensing and collaboration agreement, Dr Falk Pharma made an upfront payment and committed to significant development funding, clinical, regulatory and commercial milestone payments, as well as double-digit tiered fees in addition to clinical and operational support.
  • Renexxion Ireland retains the remaining rights to Naronapride worldwide, including Greater China, the United States and Japan, and this collaboration with Dr Falk Pharma will serve as an important catalyst for Renexxion to advance Naronapride with patients. with gastrointestinal motility disorders worldwide.
  • Renexxion Ireland will manage its obligations under the License and Collaboration Agreement, including additional research from its base of operations in Roscrea, Ireland.

Naronapride is an advanced clinical drug candidate that possesses a unique combination of serotonin 5HT4 receptor agonist and dopamine D2 receptor antagonist properties, both of which are clinically validated targets and act both in the tract. upper and lower gastrointestinal.

“Dr Falk Pharma is a leader in the development and commercialization of GI drugs in Europe and has the in-depth clinical and business knowledge, experience and insight that will be a transformational collaboration for Renexxion Ireland, leading to inflection points keys in the company’s growth trajectory, ”said Peter Milner MD, FACC, President and CEO.

Roland Greinwald, PhD, Managing Director of Medicine and Pharmacy at Dr Falk Pharma GmbH, said: “Naronapride, a gastrointestinal prokinetics with a unique target profile, has the potential to be the first-order treatment for gastroparesis, a disorder that currently has no approved treatments. “

According to Prof. Jan Tack as Expert in Gastrointestinal Disorders and Head of Clinic, Department of Gastroenterology, University Hospitals of Leuven, Belgium, “Naronapride is a perfect candidate with first-rate potential expected, for s ‘suitable for the treatment of gastroparesis because of its dual mode of action, namely its pro-kinetic effect as a very potent 5-HT4 agonist and its antiemetic properties as a dopamine D2 antagonist. At the same time, due to its rapid metabolism, Naronapride is expected to work primarily only topically and therefore a very good safety profile is expected. “

About Unmet Gastrointestinal Motility Disorders and Gastroparesis

No safe and effective GI motility agent is currently available to patients. The last such agents approved were cisapride (Propulsid®) and tegaserod (Zelnorm®), which each sold for over $ 1 billion per year and were withdrawn over 10 years ago due to issues cardiac safety.

Gastroparesis is a serious chronic disease characterized by delayed gastric emptying resulting in upper gastrointestinal symptoms such as nausea, vomiting, or bloating. The estimated prevalence of gastroparesis has been reported at 24.2 per 100,000 in the United States; however, because gastroparesis is underdiagnosed, the actual prevalence has been estimated at 50.5 per 100,000. Gastroparesis is frequently associated with significant impairment in social and occupational functioning. Despite the high unmet medical need, there is no approved drug available in this indication.

About Naronapride – Best-in-Class Potential Blockbuster for Unmet GI Indications

Naronapride is an advanced clinical drug candidate that possesses a unique combination of 5HT4 agonist and D2 antagonist properties and acts in both upper and lower GI. It is locally active in the intestinal lumen, designed to be poorly absorbable, its side effect profile cannot be distinguished from a placebo. Four positive phase 2 studies have been completed in upper and lower gastrointestinal indications and are ready for phase 3 in CIC (chronic idiopathic constipation) and GERD (gastroesophageal reflux disease). Naronapride has been designed to avoid any risk of cardiac safety. Its oral formulation responds to significant unmet needs for CIC, IBS-c, PPI resistant GERD and gastroparesis.

About Renexxion:

Renexxion Ireland Ltd. is a privately held biopharmaceutical company committed to delivering new drugs to patients with gastrointestinal motility disorders through its Ireland-based drug development and operations team. For more information, see http://www.rnexltd.ie.

About Dr. Falk Pharma GmbH

Dr. Falk Pharma GmbH has been developing and marketing innovative medicines for over 60 years to treat a wide range of gastrointestinal disorders such as inflammatory bowel disease or eosinophilic esophagitis as well as hepato-biliary disorders such as primary biliary cholangitis. As international experts in digestive and metabolic medicine, the company brings together physicians, scientists and patients to design new and powerful approaches to patient care. Dr Falk Pharma engages in preclinical and clinical research aimed at significantly improving therapeutic practice and the health and well-being of patients. A family business with a global presence, Dr. Falk Pharma has ten subsidiaries in Europe and Australia and continues to grow. The company is headquartered and R&D facilities in Freiburg, Germany, its pharmaceutical products are manufactured in Europe, primarily at sites in Germany, France and Switzerland. Dr. Falk Pharma GmbH employs around 990 people worldwide, including 214 in Freiburg.

More information about Dr. Falk Pharma is available online: https://drfalkpharma.com

Contact:

Catherine PearsonChief Operating [email protected]+353 61 539121.

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SOURCE Renexxion Ireland Ltd. ; Dr. Falk Pharma GmbH


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