Novartis has today taken steps to strengthen its primary care product portfolio with the acquisition of Pfizer’s M3 antagonist, Enablex (darifenacin). Pfizer is to divest the product to comply with regulatory requirements surrounding its planned merger with Pharmacia.
Under the terms of the agreement, Novartis has agreed to pay up to $225 million, part of which is conditional on certain marketing approvals being obtained in the US and EU.
The new drug application was filed in December 2002 and, if approved, Enablex is expected to reach the US market in 2004, where an estimated 17 million patients suffer from bladder control problems. European approval is expected in 2004.
Worldwide, it is estimated that 50 to 200 million people are affected by the condition, and Novartis will seek approvals to bring this new therapeutic option to patients in other countries.