CHADDS FORD, Pa., Aug. 17 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. , has commented on Penwest Pharmaceuticals’ announcement that it intends to initiate the formal dispute resolution process provided for under the terms of the contract that governs the companies’ agreement for Opana(R) ER. While Penwest in its press release acknowledges that it owes to Endo Penwest’s share of the development costs relating to Opana(R) ER from the pre-launch period, the companies hold different interpretations of the contract for the post-launch period. Penwest is Endo’s development partner for Opana(R) ER (oxymorphone HCl) extended-release tablets CII, an opioid analgesic that was approved by the U.S. Food and Drug Administration on June 22, 2006.
In particular, Penwest views that it has no obligation to reimburse Endo for any of the losses that will be incurred during the launch phase of Opana(R) ER. Since March 2003, when Penwest opted out of funding its share of the development of Opana(R) ER, as was its right under the agreement, Endo has funded all of the product’s development costs and expects to recover those costs as a reduction in future royalty payments to Penwest. In addition, as previously disclosed, Endo will recognize 100% of the losses attributable to Opana(R) ER during its launch phase but expects to recover Penwest’s share of these losses from the future profits of Opana(R) ER, which will be recognized as an increased share of the profits at that time. As a result, as announced on June 23, 2006, Endo reduced its 2006 adjusted diluted earnings per share guidance by approximately $0.20 to reflect the impact of the launch of Opana(R) ER and Opana.
After reviewing the matter and consulting with its outside legal counsel, Endo believes the agreement supports the position that both partners should share equally in not only the profits but also any losses that may be incurred from the up-front costs associated with launching the product prior to its achieving profitability. While the company anticipates that the mediation process will facilitate further discussion, and the company believes that its position will prevail, there is no assurance that the parties will reach an acceptable conclusion to this issue without resorting to arbitration.
Meanwhile, Endo continues to strongly support the ongoing launch of this important new product. “Whatever the outcome of this issue, we believe Opana(R) ER represents a significant marketing opportunity as well as an important new option for physicians and patients,” said Endo President and Chief Executive Officer Peter A. Lankau. “Toward this end, we are committed to making significant investments in marketing and responsibly promoting the product to ensure its commercial success.”
About Opana(R) ER and Opana(R) Tablets
Oxymorphone hydrochloride, the active ingredient in Opana(R) ER and Opana(R), is a semisynthetic, pure opioid agonist that has been formulated as a 12-hour extended-release (ER) tablet and as an immediate-release tablet. Opana(R) ER has been studied in a wide range of chronic pain conditions, including low back pain, osteoarthritis pain, and cancer pain. Opana(R) has been studied as a treatment for acute pain conditions, such as post-surgical pain. Endo developed Opana(R) ER using Penwest Pharmaceuticals’ proprietary time-release technology, TIMERx(R). The two companies provided funding for the Opana(R) ER studies. Immediate-release Opana(R) is a proprietary product developed by Endo.
Important Safety Information
Opana(R) ER and Opana(R) are opioid agonists and Schedule II controlled substances with an abuse liability similar to morphine. Opana(R) ER and Opana(R) can be abused in a manner similar to other opioid agonists, legal or illicit.
WARNING:
OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
OPANA ER is NOT intended for use as a prn analgesic.
OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.
Opana(R) ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery), or if pain is mild or not expected to persist for an extended period of time.
Opana(R) ER and Opana(R) are contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of Opana(R) ER and Opana(R); in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated.
Respiratory depression is the chief hazard of Opana(R) ER and Opana(R), particularly in elderly or debilitated patients.
The most common adverse drug reactions (greater than or equal to 10%) in clinical trials for Opana(R) ER were nausea, constipation, dizziness, vomiting, pruritus, somnolence, headache, increased sweating, and sedation. The most common adverse drug reactions (greater than or equal to 10%) reported in clinical trials for Opana(R) were nausea and pyrexia.
For full prescribing information, visit http://www.opana.com.
About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo Pharmaceuticals Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products. The company researches, develops, produces and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at http://www.endo.com.
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management’s beliefs and assumptions, current expectations, estimates and projections. Statements that are not historical facts, including statements which are preceded by, followed by, or that include, the words “believes,” “anticipates,” “plans,” “expects” or similar expressions and statements are forward-looking statements. Endo’s estimated or anticipated future results, product performance or other non- historical facts are forward-looking and reflect Endo’s current perspective on existing trends and information. Many of the factors that will determine the Company’s future results are beyond the ability of the Company to control or predict. These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The Company undertakes no obligation to update any forward-looking statements whether as a result of new information, future events or otherwise. Several important factors, in addition to the specific factors discussed in connection with these forward-looking statements individually, could affect the future results of Endo and could cause those results to differ materially from those expressed in the forward-looking statements contained in this press release. Important factors that may affect future results include, but are not limited to: market acceptance of the Company’s products and the impact of competitive products and pricing; dependence on sole source suppliers; the success of the Company’s product development activities and the timeliness with which regulatory authorizations and product launches may be achieved; successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions; the availability on commercially reasonable terms of raw materials and other third party manufactured products; exposure to product liability and other lawsuits and contingencies; dependence on third party suppliers, distributors and collaboration partners; the ability to timely and cost effectively integrate acquisitions; uncertainty associated with pre- clinical studies and clinical trials and regulatory approval; uncertainty of market acceptance of new products; the difficulty of predicting FDA approvals; risks with respect to technology and product development; the effect of competing products and prices; uncertainties regarding intellectual property protection; uncertainties as to the outcome of litigation; changes in operating results; impact of competitive products and pricing; product development; changes in laws and regulations; customer demand; possible future litigation; availability of future financing and reimbursement policies of government and private health insurers and others; and other risks and uncertainties detailed in Endo’s filings with the Securities and Exchange Commission, including its Registration Statement on Form S-3 filed with the SEC on March 21, 2006. Readers should evaluate any statement in light of these important factors.
Endo Pharmaceuticals Inc.
CONTACT: Bill Newbould of Endo Pharmaceuticals, +1-610-558-9800
