Endo receives FDA approval for pain drug Opana; revises 2006 estimates

By E. Janene Geiss

Philadelphia, June 23 - Endo Pharmaceuticals Inc. said Friday that the Food and Drug Administration has granted final approval of the company's New Drug Applications for its extended-release and immediate-release formulations of oxymorphone hydrochloride.

These products are now known under the trade names Opana ER tablets and Opana tablets, according to a company news release.

A new oral extended-release opioid analgesic option for patients, 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 and is not intended to be used on an as-needed basis.

This is the first time oxymorphone will be available in an oral, extended-release formulation, officials said.

Opana ER will be available in 5 mg, 10 mg, 20 mg and 40 mg tablets. Opana (the immediate release version) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate and will be available in 5 mg and 10 mg tablets.

Both products are expected to be commercially available in the United States in the coming weeks.

Endo said it also plans to relaunch its oxymorphone hydrochloride injection under the new trade name in the hospital setting.

The company said the clinical program for Opana includes more than 15 clinical trials enrolling more than 3,000 patients.

Opana ER will compete in the $3.2 billion market for long-acting, strong opioid analgesics.

Its clinical profile demonstrates it can be dosed consistently on a twice-daily basis and is well-tolerated when titrated effectively, officials said.

Opana ER also has demonstrated maintenance of effective pain control at a stable dose over the three-month period of the pivotal clinical trials, which the company believes highlights the durability of its analgesic effect.

Guidance revised

Endo said it is revising its guidance for 2006 and expects net sales in 2006 to be about $880 million to $910 million.

Combined net sales of Opana ER and Opana are expected to be about $20 million to $30 million, substantially comprised of Opana ER.

Net sales of Lidoderm in 2006 continue to be estimated at about $530 million to $540 million, officials said.

Over the next few weeks, Endo said it plans to expand its current 370-person sales force by about 220 sales representatives to promote all formulations of Opana as well as its existing portfolio of branded products, including Lidoderm and Frova.

Additionally, Endo said it will substantially increase its investment in the Opana franchise and, accordingly, expects to incur a loss for this product franchise in 2006 in connection with this launch.

But the company said it believes this launch provides another significant growth opportunity to complement its existing portfolio.

At this time, Penwest Pharmaceuticals Co., Endo's development partner, continues to elect not to fund Opana ER; therefore, Endo said it will recognize 100% of the losses attributable to Opana ER during its launch phase.

Endo said it expects to recover Penwest's share of these losses from the future profits of Opana ER, which will be recognized as an increased share of the profits at that time.

As such, the impact of the launch of Opana ER and Opana is expected to reduce Endo's 2006 adjusted diluted earnings per share by about $0.20.

The company said it now estimates adjusted diluted earnings per share for 2006 to be about $1.55 to $1.60. This excludes estimated upfront and milestone payments to partners, stock compensation charges related to the adoption of SFAS 123(R) - estimated to be about $0.05 per diluted share - and compensation expense and related employer payroll taxes funded by Endo Charmane LLC.

Endo is a Chadds Ford, Pa., specialty pharmaceutical company.

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