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Richter signed a licensing agreement with Pharmanest to commercialize its proprietary pain relief product for gynaecological use in certain territories

19/10/2017

Budapest, Stockholm – 12 October 2017 – Gedeon Richter Plc. (‘Richter’) and Pharmanest AB (‘Pharmanest’) today announced that Richter will commercialise Pharmanest’s SHACT (Short Acting Lidocaine) technology, a novel innovative proprietary pain relief pharmaceuticalformulation, in Europe, in Latin America and in certain other markets.

Under the terms of the agreement Richter shall make an upfront payment upon signature of the contract. In addition, further milestone payments and sales related double digit royalties will become payable to Pharmanest subsequent to the launch of the product.

SHACT is a novel delivery technology that provides pain relief on mucosal tissue. In a clinical study conducted in Sweden, SHACT treatment was associated with significant reduction of pain and discomfort in women undergoing gynaecological interventions without causing bothersome side effects. In the 218-patient study, women treated with SHACT experienced
significantly less pain during intrauterine device (IUD) placement compared to those treated with placebo (p<0.0001).

Globally, about 165 million women are using IUDs and millions of women experience pain and discomfort during placement.

“The partnership with Richter will be of great value during the continued commercialization of SHACT in Europe and other significant markets. Richter is a leading women’s health company with an outstanding reputation, and their know-how and expertise will accelerate the launch of the SHACT product,” according to Gunilla Lundmark, CEO of Pharmanest.

“For years, we have tried to find medications to reduce insertion pain and SHACT has the potential to reduce pain all along the path – not only in the cervix, but within the uterus itself. Other procedures may also be rendered less painful – such as endometrial sampling and hysteroscopy. I am excited by SHACT’s potential and look forward to the US study,” said Anita L. Nelson, professor & Chair OB-GYN, Western University of Health Sciences, Pomona, California, USA.

“We remain committed to the development and commercialization of Women’s Healthcare products aiming towards the improvement of the quality of life for the female population in all age groups. This agreement is considered as a further step to enhance our existing Women’s Healthcare franchise worldwide, being a paramount strategic initiative for our Company,” stated Erik Bogsch, Managing Director of Gedeon Richter Plc.

Pharmanest intends to accelerate the clinical development program for SHACT for North America during 2018.

About Gedeon Richter Plc
Gedeon Richter Plc. (www.richter.hu), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. Having reached a market capitalisation of EUR 3.7 billion (US$ 3.9 billion) by the end of 2016, Richter’s consolidated sales were approximately EUR 1.3 billion (US$ 1.4 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women’s Healthcare, Central Nervous System, and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter’s original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women’s healthcare field worldwide. Richter is also active in biosimilar product development.

About Pharmanest AB
Pharmanest AB (www.pharmanest.se) is a Swedish privately-held pharmaceutical company focused on new products for pain relief in the gynecology and obstetrics field. Pharmanest AB was founded by scientists at Karolinska Institute and the idea to develop mucosal analgesia is based on identification of sensory nerves in the reproductive tract. Pharmanest’s major shareholders include Östersjöstiftelsen (The Foundation for Baltic and East European Studies) which was founded by the Swedish Government in 1994. Its mission is to support research and doctoral studies at Södertörn University and the foundation currently manages a portfolio worth close to SEK 6 billion, Recipharm Venture Fund, part of Recipharm, a leading (CDMO) within the pharmaceutical industry and Praktikerinvest, an investment company within the Praktikertjänst Group, Sweden’s biggest provider of private health and dental care, owned and run by dentists, doctors and other therapists.

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Patient safety is the most important value for the Gedeon Richter Group. Thus monitoring adverse drug events occurring during pharmacotherapy is especially important for us. We offer to patients and physicians current medical information as well as  we answer all questions regarding the safety of medicinal products.

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