Sciele Pharma, Inc. has signed an exclusive agreement with Addrenex Pharmaceuticals, Inc. to market, upon approval by the US Food and Drug Administration (FDA), Clonicel, a patented, sustained-release formulation of clonidine hydrochloride for the treatment of hypertension and attention deficit and hyperactivity disorder in North America. Sciele will also have the right of first refusal for other Addrenex products focused on paediatrics, women's health, and cardiovascular/metabolic diseases.
Under the terms of the agreement, Sciele has purchased a $6 million equity stake in Addrenex and will have the right to increase its equity stake in Addrenex by an additional 10 per cent. Sciele will also make regulatory milestone payments of up to $11 million and royalty payments to Addrenex on product sales.
Clonidine hydrochloride is an alpha-2 agonist approved for the treatment of hypertension. During the past year, approximately 11.7 million prescriptions were dispensed for clonidine hydrochloride tablets and approximately 1.8 million prescriptions were dispensed for clonidine patches, according to IMS Health's National Prescription Audit Plus data. Clonicel is a 12-hour, sustained-release formulation of clonidine hydrochloride, which currently is in pivotal clinical trials for hypertension. A 505 NDA filing with the FDA is expected in the second half of 2007. A phase III clinical trial utilizing Clonicel for ADHD is expected to begin in the second half of 2007.
Patrick Fourteau, chief executive officer of Sciele Pharma, said, "This agreement with Addrenex provides us with the opportunity to further expand both our cardiovascular and paediatric product lines. We continue to execute on our strategy to diversify our product portfolio and expand our late-stage product pipeline through the licensing and acquisition of products."
Moise Khayrallah, PhD., CEO of Addrenex, said, "We are very happy that a successful company such as Sciele sees the potential of our lead compound Clonicel. We look forward to a rewarding partnership that will allow Addrenex to develop and commercialize this product as well as future compounds in our adrenergic regulation portfolio."