Another settlement: Diazepam [DIASTAT(R)]

Valeant’s DIASTAT(R) and DIASTAT(R) AcuDial(TM) [diazepam rectal gel] are indicated for the management of selected, refractory, patients with epilepsy, on stable regimens of anti-epileptic medications (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity. This franchise had combined US sales of approximately $75 million for the twelve months ended August 2007, based on IMS sales data.

Valeant was in a patent litigation on Orange Book listed US5462740 with Kali Laboratories Inc. (now acquired by Par) and PLIVA Inc. (now acquired by Barr) at U.S. District Court for the District of New Jersey. This is a formulation patent for a viscous gel. Under the terms of an earlier agreement between PLIVA and Kali, Kali developed the generic formulation and PLIVA assumed responsibility for the litigation and its associated costs.

Valeant Pharmaceuticals North America has now entered into a settlement agreement with both the parties - Par and Barr, pursuant to a settlement conference held in June, 2007.

Under the terms of the settlement:

a) Barr will have the right to launch generic versions of both the products on or after September 1, 2010, or earlier in certain circumstances. This is approximately three years prior to the expiration of the patent, which otherwise is due to expire on Sep. 17, 2013.

b) Barr will market, sell and distribute generic diazepam rectal gel in the U.S., and will split profits from the sales of the product with Par.

Par news release.

Barr news release.