Proquin® XR for Uncomplicated UTIs

Proquin® XR (ciprofloxacin hydrochloride) is a once-daily, extended release formulation of ciprofloxacin for the treatment of uncomplicated urinary tract infections (UTIs).* Proquin XR is available in 3-tablet blister packs and 50 count bottles.

Formulated with AcuForm™ 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. Additionally, because of the extended release made possible with AcuForm, Proquin XR has been shown to result in less peak concentrations of ciprofloxacin hydrochloride than what is commonly seen with immediate release formulations of the drug. 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.

Proquin XR was approved in the United States on May 19, 2005. A Marketing Authorization Application is currently under review in Sweden.

Commercialization and Partnering Update

U.S. commercialization of Proquin XR commenced in the fourth quarter of 2005.  In July 2007, Depomed and Watson Pharmaceuticals entered into a co-promotion agreement relating to the product.  Under the agreement, Depomed has granted Watson a co-exclusive right to promote Proquin XR for the urology and long-term care specialties in the United States and its possessions, including Puerto Rico.  In September 2007, the agreement was expanded to grant Watson the right to promote to the Ob/Gyn specialty as well.

With regard to ex-U.S. commercialization, in November 2005 Depomed and Madaus S.RL (now Rottapharm) entered into a distribution and supply agreement for Proquin XR. Under the terms of the agreement, Depomed has granted exclusive rights to Rottapharm for the commercialization of Proquin XR in Europe and has agreed to supply Rottapharm with commercial quantities of Proquin XR tablets in bulk form. In exchange, Rottapharm will pay Depomed for Proquin XR tablets at a pre-specified percent of Rottapharm's wholesale ex-factory price, net of packaging costs. Madaus is obligated to obtain regulatory approvals necessary to market Proquin XR within the various European jurisdictions.