(Source: PrimeNewswire)
DANBURY, Conn., CHADDS FORD, Pa., and ALISO VIEJO, Calif., June 9, 2009 (GLOBE NEWSWIRE) -- Penwest Pharmaceuticals Co. (Nasdaq:PPCO), Endo Pharmaceuticals (Nasdaq:ENDP) and Valeant Pharmaceuticals (NYSE:VRX) today announced that Endo has signed an exclusive license with Valeant allowing it to market OPANA ER in Canada, Australia and New Zealand. OPANA ER, the extended release formulation of oxymorphone, was jointly developed by Penwest and Endo.
This agreement is the first one resulting from the collaborative work Penwest and Endo began late last year to license OPANA ER in territories outside the U.S. Under the terms of the collaboration agreement between Penwest and Endo, the two companies have agreed to share equally in the proceeds received from Valeant for OPANA ER under the terms of the licensing agreement.
The agreement with Valeant also includes rights to OPANA(r), the immediate release formulation of oxymorphone developed by Endo.
The terms of the licensing agreement call for a payment of C$2 million upfront and payments totaling up to C$1 million when certain sales milestones are reached in Canada and A$1.1 million when certain regulatory and sales milestones are met in Australia. In addition, Valeant has agreed to pay royalties ranging from 10% to 20% of net sales of the OPANA products in each of the three countries, subject to royalty reductions upon patent expiry or generic entry.
Jennifer L. Good, President and Chief Executive Officer of Penwest, said, "We are very pleased with the agreement with Valeant to license OPANA ER in Canada, Australia and New Zealand, all of which are regions where Valeant has a strong regulatory and commercial presence. As the first licensing agreement for OPANA ER outside the U.S., this deal represents the achievement of one of the deliverables we committed to our shareholders in optimizing the value of this important asset for them. We continue to work toward achieving additional licensing deals for OPANA ER in other territories outside the U.S."
"We are pleased to be able to add a successful product such as OPANA ER to our current product portfolios in Canada, Australia and New Zealand," stated J. Michael Pearson, Chairman and Chief Executive Officer of Valeant. "The addition of this product will extend our successful pain franchise in Canada, while providing Valeant with an opportunity to broaden our therapeutic scope in Australia and New Zealand."
Demand for analgesic narcotics in Canada, a market that includes long-acting opioids, such as versions of oxycodone, morphine, fentanyl and hydromorphone, has been growing at double digit rates annually over the past several years. In 2008, analgesic narcotics in Canada represented approximately a C$400 million market.
OPANA ER received FDA approval in June 2006, and is currently marketed by Endo as a treatment for moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
As recently reported by Endo, combined net sales for the OPANA franchise increased 31 percent to $52.8 million for the first quarter 2009, compared with $40.3 million in the same period a year ago, while prescription volume for OPANA ER and OPANA increased 58 percent in the first quarter 2009, compared with the first quarter of 2008.
Indication
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. OPANA ER is not intended for use as an as needed analgesic. OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of oversedation and respiratory depression requiring reversal with opioid agonists. OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.
OPANA ER has a boxed warning as follows:
WARNING: OPANA ER contains oxymorphone, which is a morphine-like opiod 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 an as needed 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.
