NovaMedica Signs Distribution Agreement with Aptalis Pharma to Develop and Commercialize Gastrointestinal Pharmaceutical Products in Russia

Moscow. December, 05, 2013 - NovaMedica LLC, a Russian pharmaceutical company, has signed a partnership agreement with Aptalis Pharma, a leading specialty pharmaceutical company, providing innovative, effective therapies for unmet medical needs, to develop and commercialize a portfolio of three of Aptalis Pharma’s novel gastrointestinal pharmaceutical products in Russia.

One of these medicines, Pylera®, is indicated for the eradication of Helicobacter Pylori in patients with gastric or duodenal ulcer in Europe and the United States. During clinical trials, the product has demonstrated proven clinical superiority in comparison to triple therapy with omeprazole, amoxicillin and clarithromycin in managing H. Pylori infection. The 3-in-1 patented unique capsule technology simplifies traditional multi-therapy treatment, which may result in better patient compliance.

Lacteol®, a product derived from a unique strain of Lactobacillus LB of human origin, is widely used for adults, children and infants with diarrhea. Available in convenient sachets, Lacteol is used by millions of patients and marketed in more than 40 countries.

Panzytrat® is a formulation of pancreatic enzymes indicated for maldigestion due to exocrine pancreatic insufficiency, e.g. related to cystic fibrosis, chronic pancreatitis, major pancreatic resection, gastric resection. A novel formulation of micronized coated microtablets ensures the release of the enzymes at the optimum pH into the duodenum. Unique range of different forms allows precise dosing for children and infants.

Under the agreement, NovaMedica will work towards to completing the requirements for regulatory approval of the products in Russia.   Subject to obtaining approvals, Aptalis’ pharmaceutical products are expected to come to market in 2014-2015.

"Gastrointestinal diseases are one of the most common and socially significant medical issues in Russia. Creating a strategic partnership with Aptalis will be a key success factor to offer to doctors and patients new treatment opportunities in this essential therapeutic area,” said Fabrice Egros, COO of NovaMedica. "All of these Aptalis proven therapies have properties that are new to the Russian market; Panzytrat and Lacteol are suitable for all age groups of patients, including children, while Pylera is only indicated for children 9 years old and older. With this new alliance, NovaMedica will gain considerable experience on the market place which is in line with our long-term strategy".

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NovaMedica is a Russian pharmaceutical company established in 2012 by DRI Holdings Limited, a portfolio company of Domain Associates LLC, and Russian investment corporation RUSNANO, which implements government policy on the development of hi-tech industries. The company’s strategy is aimed at localizing production of a wide range of new medicines and technologies on the Russian market, including screening and registration, and the creation of innovative GMP-standard manufacturing facilities. www.novamedica.com

Aptalis Pharma is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, RECTIV®, VIOKACE™, ULTRESA®, LACTEOL®, DELURSAN®, PANZYTRAT®, and SALOFALK®. Currently, the company markets more than 40 products and dosage strengths worldwide in the field of gastroenterology, including several that hold a leading market position. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations. www.aptalispharma.com.