Allergan announced that it has completed its acquisition of Oculex Pharmaceuticals, Inc., a leader in developing treatments for sight-threatening diseases of the eye.
The United States Federal Trade Commission notified Allergan that it had granted early termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to the acquisition. Oculex’s shareholders approved the acquisition on November 17, 2003.
Allergan paid approximately $230 million for the Oculex business in an all cash transaction pursuant to a definitive merger agreement announced on October 14, 2003. It is estimated that as much as 75 per cent to 90 per cent of the purchase price will be expensed by Allergan as in-process research and development in the fourth quarter of 2003, with the balance being allocated to other tangible net assets, core technology and goodwill. An independent valuation is being performed by a major accounting firm to determine the final allocation of the purchase price.
Key to the transaction was the acquisition of Posurdex, a bioerodable, extended release implant that Oculex was developing to deliver dexamethasone to the targeted disease site at the back of the eye. According to new preliminary clinical trial data presented at the American Academy of Ophthalmology, patients treated with the investigational Posurdex technology showed significant improvement in signs and symptoms of macular edema (swelling of the retina) compared with patients who did not receive the treatment.
The Phase 2 study, which precedes the formal Phase 3 trials, followed 306 patients who were diagnosed with macular edema associated with four conditions: diabetes, retinal vein occlusions, uveitis, and post-cataract surgery. The safety and efficacy of the Posurdex delivery system was tested in this controlled Phase 2, prospective, randomized multicenter study in which patients were randomly assigned to one of three treatment arms: a single Posurdex implant containing a 350µg dose of dexamethasone, a single Posurdex implant containing 700µg of dexamethasone, or observation without drug therapy.
"We are pleased and encouraged about the initial six-month data from the Phase 2 study of Posurdex, showing that the 700 µg implant resulted in a significant increase in the percentage of patients achieving an equal to or greater than three-line improvement in visual acuity," said Scott Whitcup, MD Allergan's vice president and head of the ophthalmology therapeutic area.
"We are now looking forward to beginning Phase 3 trials of Posurdex to further test it as a potential new treatment for this sight-threatening condition that affects more than 2.5 million people worldwide," Dr Whitcup said.
Posurdex is a proprietary, bioerodable extended release implant that delivers dexamethasone to the targeted disease site at the back of the eye. Allergan currently intends to initiate Phase 3 clinical trials for Posurdex, for the treatment of macular edema, in early 2004. The Phase 3 clinical trials will focus on macular edema associated with diabetes and other conditions. If these Phase 3 clinical trials are successful, Allergan anticipates potential FDA approval for Posurdex in the late 2006 or 2007 timeframe.
Macular edema is a sight-threatening condition that results from the swelling of the central retina, or macula, and is associated with diseases such as diabetic retinopathy, retinal vein occlusion and uveitis. Macular edema is a major cause of visual disabilities and blindness among individuals with diabetes. Allergan estimates that macular edema affects more than 750,000 people in the United States, and over 2.5 million people worldwide. A significant share of these patients has persistent macular edema that has failed to respond to the current standard of care. Allergan currently believes the annual market potential for this indication could be over $500 million.