Endo plans to boost its sales force by 33% to support the re-launch of Frova after in-licensing the triptan migraine therapy from Vernalis.

The company will increase its sales force by "about a third, so that's somewhere in the 70-80 range on the existing 230 base we have," Endo said July 15 during an earnings call.

A day earlier, Endo announced it had in-licensed Frova (frovatriptan) from Vernalis. Under terms of the agreement, Endo picks up North American sales and marketing rights in exchange for $60 mil. in unconditional payments over two years and a $50 mil. loan.

Vernalis retains the right to co-promote Frova in the U.S. with up to 25 reps.

The agreement also calls for up to $255 mil. in sales milestone payments to Vernalis, with an initial milestone of $10 mil. on $200 mil. in sales; milestone payments will increase to a maximum of $75 mil if product revenues reach $1.2 bil.

Endo also will make a $40 mil. milestone payment upon FDA approval of a supplemental indication for prophylactic treatment of menstrually associated migraine, with "tiered royalties of 20% and higher" on sales following approval of the indication.

The upfront payments Vernalis receives will more than offset the $55 mil. it paid Elan to re-acquire the product in March (¹ Also see "Elan Sells Back Frova Rights; Vernalis Plans Menstrual Migraine Filing In 2005" - Pink Sheet, 30 March, 2004.).

Frova was approved in November 2001 for acute treatment of migraines. Sales of the product were $37.5 mil. in 2003.

The triptan is in Phase III for the MAM indication. A long-term safety study is underway, and a confirmatory efficacy trial is expected to begin in the second half of 2004, the companies said.

Endo predicts the MAM indication will be filed in 2005, with approval anticipated in 2006.

The company is optimistic the MAM indication will help drive Frova's growth.

"Frova's potential future application for the treatment of menstrually associated migraine makes it one of Endo's most promising products," Chief Operating Officer Peter Lankau said.

In the meantime, Endo intends to differentiate Frova from other triptans by highlighting its longer half-life and reduced rate of migraine recurrence.

Endo will detail the drug to a targeted group of specialists.

"Our intent is to promote Frova to a targeted group of neurologists, pain specialists and other physicians that we believe are the appropriate audience for the clinical benefits of Frova," Lankau said. "We will create an advocacy base" of specialty care physicians, he added.

Targeting the specialty care market allows Endo to avoid competing with large pharma companies - including Pfizer( Relpax ) and GlaxoSmithKline ( Imitrex ) - in the primary care setting, the company said.

Endo is hoping Frova, as well as the upcoming launch of DepoDur (morphine extended-release injection), will help offset the negative impact of generic competition to Percocet . Sales of the acetaminophen/oxycodone combination were $13.6 mil. for the quarter, down from $52.4 mil. a year ago.

Endo's total sales for the quarter declined 5% to $144 mil.

- Lee Kalowski

Endo To Boost Sales Force Following Frova In-Licensing Deal With Vernalis

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