Depomed’s ProQuin(R) XR Achieves First Marketing Authorization in Europe
Depomed, Inc. (NASDAQ:DEPO) and Rottapharm/Madaus announced today that the Marketing Authorization (MA) for ProQuin XR has been received from the Medical Products Agency in Sweden. Depomed’s ProQuin XR is exclusively licensed to Rottapharm/Madaus for Europe and is a once-daily extended-release formulation of ciprofloxacin hydrochloride for the treatment of uncomplicated urinary tract infections.
“We are glad to see ProQuin XR be approved in Sweden as reference member state which is a first step to make it commercially available in Europe. We feel confident that our partner Rottapharm/Madaus with their strong market presence and local expertise in individual European countries will realize ProQuin XR’s commercial potential in Europe. We anticipate the commercial rollout and pricing in other European countries will progress through next year,” noted Carl A. Pelzel, president and chief executive officer of Depomed.
Antonino Santoro, corporate business development and regulatory affairs director of Rottapharm/Madaus, added, “ProQuin XR complements our product portfolio and strengthens our position in urology. ProQuin XR’s approval in Sweden paves the way for further regulatory approvals in other European countries through the mutual recognition procedure; we expect to launch the product under the trade-mark UTIMINX(TM) starting in 2009 in different countries and in some of them we are planning to co-market the product under the secondary trade-mark URITENT(TM).”
About ProQuin(R) XR
ProQuin XR is a once-daily extended-release formulation of ciprofloxacin hydrochloride and is intended to treat uncomplicated urinary tract infections (UTIs). UTIs are bacterial infections frequently caused by E. coli and are typically treated with antibiotics. Patients should not take ProQuin XR if they are allergic to, or have ever had a severe reaction to, ciprofloxacin or to any other “quinolone” antibiotics. Proquin XR is generally well tolerated. The most common side effects with Proquin XR include vaginal yeast infection and headache. UTIs are the second-most common type of bacterial infection, after those of the respiratory tract, with more than 35 million medically treated infections across the seven major markets each year. This translated into sales in excess of $1.1billion across key markets.
Formulated with AcuForm(TM) delivery technology, Proquin XR is delivered over a six-hour period to the upper gastrointestinal (GI) tract where ciprofloxacin is best absorbed. This controlled, targeted delivery allows for nearly 87 percent of the active ingredient to enter into the blood stream and less unabsorbed drug to pass through to the lower GI tract where it can cause irritation and give rise to side effects. Proquin XR is the first version of ciprofloxacin with nausea and diarrhea listed as “uncommon” adverse events in its label, rather than “common” adverse events.
Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuForm(TM) drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Glumetza(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus in the United States. Proquin(R) XR (ciprofloxacin hydrochloride) extended release tablets are approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and is marketed in the United States within the urology, Ob/Gyn and long-term care specialties by Watson Pharmaceuticals. Product candidate Gabapentin GR(R) is currently in clinical development for the treatment of neuropathic pain and for menopausal hot flashes. Additional information about Depomed may be found on its web site, www.depomedinc.com.
Rottapharm/Madaus is an Italian multinational pharmaceutical company, headquartered in Monza, with more than 2,000 employees, branches in over 85 countries worldwide and seven manufacturing sites located in Europe and India. Since its inception, the company has been primarily focused on research: R&D activities are currently engaged in different therapeutic areas such as gastroenterology, bronchopneumology, psychiatry, rheumatology, urology, gynecology, cardiovascular, oncology. The group also boats a leading position in the personal care and nutraceutical segments.
After the acquisition of the German pharmaceutical group Madaus in August 2007, Rottapharm has combined its well-known brands such as DONA(R), EXTRANASE(R), FORTILASE(R), EPINITRIL(R), ESTROMINERAL(R) and SAUGELLA(R) with new leading brands including AGIOLAX(R), REPARIL(R), LEGALON(R), TROMALYT(R) and BEN-U-RON(R). This acquisition has represented an important turning point for the new Rottapharm/Madaus group in terms of R&D synergies and marketing growth.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995.
Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. The inclusion of forward-looking statements, including those related to the commercialization of ProQuin(R) XR should not be regarded as a representation that any of our plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation, risks and uncertainties related to: our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; our ability to successfully commercialize our products; the success of our collaborative arrangements with development and commercialization partners; and other risks detailed in our filings with the Securities and Exchange Commission filings, including our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. We undertake no obligation to revise or update this release to reflect events or circumstances that occur after the date of this release.