NovaMedica to distribute Aptalis products in Russia

06 December 2013

The Pharma Letter

Russian drugmaker NovaMedica, a joint enterprise between the Russian high-technology investment fund RusNano and the American venture health care fund Domain Associates set up last year (The Pharma Letter March 7, 2012), has signed a partnership agreement with privately-held US firm Aptalis Pharma, to develop and commercialize a portfolio of three of Aptalis Pharma’s novel gastrointestinal pharmaceutical products in Russia.

Under the agreement, financial terms of which were not disclosed, 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.

Drug details

One of these drugs, Pylera (bismuth subcitrate potassium), is indicated for the eradication of Helicobacter pylori in patients with gastric or duodenal ulcer in Europe and the USA. 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, eg, 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.

“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, chief operating officer of NovaMedica, adding: “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 nine 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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