Vasogen and privately held IntelliPharmaCeutics (IPC) inked a merger agreement to create a publicly traded firm called IntelliPharmaCeutics International. IPC’s shareholders will own 86% of the new entity, which will retain Vasogen’s intellectual property but likely focus solely on IPC’s strategy of developing and manufacturing new and generic controlled-release pharmaceutical products.
Vasogen has been trading below $1 since March 2008 due to delays with the FDA regarding the design of a clinical trial to support an application for U.S. market approval of Celacade, a device designed to treat heart failure. Vasogen also has intellectual property related to immune system modulation to treat inflammatory disorders.
Regulatory hurdles and a lack of capital forced Vasogen to restructure, dropping over 86% of its workforce, and to subsequently halt development activities to look for alternatives. The company’s pipeline was in the preclinical stage. As of May 31, Vasogen had $5.8 million in cash.
To help the merger with IPC, Vasogen entered into an arrangement with Cervus that will provide gross proceeds to Vasogen of approximately $7.5 million in nondilutive capital. Isa Odidi, Ph.D., and Amina Odidi, Ph.D., shareholders of IPC, will together own approximately 55.3% of the combined company. IPC's second largest shareholder, Par Pharmaceutical, which acquired an equity interest in 2007 when it inked a development and commercialization deal for four product candidates, will own approximately 3.6% of the new entity.
The merged company will take on the 15 candidates in IPC’s development pipeline, several of which are partnered with third parties, the companies note. IPC's lead product is dexmethylphenidate XR, a generic version of Focalin XR®, indicated for attention deficit hyperactivity disorder. Along with Par Pharmaceutical an ANDA was filed in August 2007. Additionally, IPC’s generic version of Coreg CR, a high blood pressure medication, called Carvedilol CR is ready for entry into bioequivalence studies.
One of IPC's nongeneric products is an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation. This product is covered by pending patent applications for its novel ReXista™ abuse- and alcohol-resistant drug delivery technology.