Commercialization Strategy
We have established and intend to pursue future strategic alliances and licensing agreements with pharmaceutical companies to enhance our ability to develop and commercialize our product candidates.
Alliance for Aversion® opioid analgesic products in the U.S., Canada, and Mexico
In October 2007, we entered into a License, Development and Commercialization Agreement, or the Pfizer Agreement, with King Pharmaceuticals Research and Development, Inc., now a subsidiary of Pfizer covering the United States, Canada, and Mexico. Under the Pfizer Agreement, Pfizer will manufacture and commercialize Oxecta® in the United States and develop and commercialize three additional opioid analgesic products utilizing our proprietary Aversion Technology, including hydrocodone / acetaminophen, oxycodone / acetaminophen and an undisclosed opioid analgesic tablet product.
As of September 30, 2011 we have received an aggregate of $78.5 million in payments from Pfizer, in the form of a $30.0 million upfront cash payment, milestone payments, option fees and reimbursement for research and development expenses, including a $20.0 million milestone fee relating to the receipts of FDA approval of the New Drug Application, or NDA, for Oxecta. In addition, we are eligible to receive milestone payments based on future regulatory events and product sales achievements, reimbursement for certain research and development expenses and tiered royalties of 5 – 25% on combined annual net sales of all products commercialized under the Pfizer Agreement. Royalty payments commence one year after the first commercial sale of Oxecta.
Product Portfolio Overview
Our lead product, Oxecta® (oxycodone HCI, USP) Tablets CII, or Oxecta (formerly Acurox®), was approved for marketing by the United States Food and Drug Administration, or FDA, on June 17, 2011. Oxecta is an immediate-release oxycodone hydrochloride, or HCl, tablet utilizing our proprietary Aversion® Technology. Oxecta represents the first immediate-release oxycodone product approved by the FDA that applies our Aversion® technology. Aversion® is a mixture of inactive ingredients incorporated into pharmaceutical tablets and capsules designed to address some common methods of product tampering. Oxecta will be manufactured and is being commercialized by Pfizer under our October 2007 license agreement with a subsidiary of Pfizer. We are eligible to receive tiered royalties ranging from 5% to 25% on net sales of Oxecta. The royalties commence on the first anniversary of the first commercial sale of Oxecta which we do not expect to occur during 2011. The trademark Oxecta® is owned by Pfizer or its affiliate.
In addition to Oxecta, we have licensed to Pfizer the rights to develop, manufacture and commercialize three other immediate-release opioid products utilizing our Aversion Technology in the United States, Canada and Mexico, including:
- hydrocodone bitartrate / acetaminophen tablets;
- oxycodone HCl / acetaminophen tablets; and
- an undisclosed opioid analgesic tablet product.
We believe our Aversion Technology can also be used to develop and commercialize unique formulations of non-opioid pharmaceutical products associated with abuse and intentional misuse. Our initial non-opioid product candidates are a benzodiazepine product for the treatment of anxiety disorders and a stimulant product for the treatment of attention deficit disorder.
We are also developing an over-the-counter, or OTC, immediate-release pseudoephedrine HCl tablet, utilizing our proprietary Impede™ Technology (“Nexafed” formerly referred to as Impede PSE). Pseudoephedrine HCl, or PSE, is a widely-used nasal decongestant available in many non-prescription and prescription cold, sinus and allergy products, including Johnson & Johnson’s Sudafed®. Our Impede Technology is a proprietary mixture of inactive ingredients designed to limit or impede extraction of pseudoephedrine from tablets for use as a starting material in producing methamphetamine.
