Feeling No Pain - Pharmaceutical Executive


Feeling No Pain
Endo is nicely poised to grab a big piece of the rapidly expanding pain-management market.

Pharmaceutical Executive

From 1997 to 2003, the Percocet franchise enjoyed steady annual growth, rising from $40 million in sales to $214 million, despite the fact that it had no patent protection. But generic competition in 2004 led to a decline in the product's sales. "They've had a difficult 2004," says one analyst. "But what they've done during the year has strengthened the outlook for 2005, and the negatives of 2004 won't apply." In fact, Endo's lull this year will be fully compensated by next year's busy schedule.

Launch Year In fact, Endo sales reps should have their bags full of new products by the end of 2005. The first new product is Frova (frovatriptan), a treatment that has been marketed in the United States since mid-2002 for acute migraine in adults. It was launched by Endo this September after the company acquired the North American marketing rights from UK-based Vernalis. The second new product, DepoDur, is launching now. The sustained-release morphine injection, which was licensed by Endo for North American distribution in late 2002, was developed by London-based SkyePharma and approved by FDA this past May for pain following major surgery."

"SkyePharma is currently validating and preparing launch quantities," Ammon says. "But we just kicked off a dedicated hospital force. We started with 25 reps and will add another 45 after the first of the year when we commercialize the product. We are now in the hospital with these reps, building advocacy, teaching anesthesiologists how to use the product, and working with pharmacists to understand what the product is about and to get it onto formulary. We will begin shipping by the end of this year."

For abdominal surgeries, C-sections, and hip and knee replacements, anesthesiologists can now inject DepoDur into the epidural space (before or during the surgery) and give their patients 48 hours of postsurgical pain relief. Ammon believes the product has the potential to change the standard of post-surgical care. Some analysts concur with that potential but believe it will take some time for physicians to "get comfortable" with long-acting morphine.

Oxymorphone. Presently under FDA review, this product is one that "we are very excited about," says Ammon. The compound was originally developed in the 1960s but never really received much attention as other opioids came on the market. Now Endo, in a co-development deal with Penwest, has reformulated the product as an extended-release tablet for patients who need around-the-clock pain relief for extended periods of time. Endo has also developed an immediate-release tablet for acute pain.

"Because we already have an injection and suppository on the market [Numorphan], this will be the only controlled-release, oral opioid with four different formulations—injection, suppository, oral-controlled release, and an immediate release for breakthrough pain," says Ammon. "What's nice about that is that patients can be started in the hospital environment on the injection and can be sent home to use the controlled release. And in end-of-life situations, a suppository can be used. We feel it's going to be a very useful product in terms of all the different patient needs."

FDA issued Endo an approvable letter last October and then asked the company to do another study. Two of the Phase III studies had been done with opioid-naive patients, and there was a significant number of dropouts because of side effects, which is common with opioids. Endo has met with FDA about the design of a new study, and it expects to begin the trial soon.

Extended-release oxycodone. This generic version of Purdue's OxyContin received FDA's green light in March, but Endo is waiting for a final court ruling before it launches the product.

"We were the first to file on the 10-, 20-, and 40-mg strengths of OxyContin, which we were very pleased about," Ammon says. "If we choose to wait for the appeal, the exclusivity stays with us. After looking at several different factors, we decided to wait for the appeal. We are confident about our case, and if that appeal is ruled in our favor, then our exclusivity kicks in that day and we'll launch immediately after."


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