MGI Aloxi Oral Dose, Post-Operative Indications To Enter Phase III In 2004

MGI Pharma plans to commence Phase III trials for an oral formulation of the intravenous anti-emetic Aloxi (palonosetron), as well as studies supporting a post-operative indication.

The programs are "an extension of our initial license agreement with Helsinn Healthcare, and we anticipate both of those being in Phase III trials later this year," CEO Lonnie Moulder said at the J.P. Morgan conference in San Francisco Jan. 15.

Aloxi was approved by FDA as an I.V. formulation for the prevention of delayed and acute nausea and vomiting associated with chemotherapy July 25 (¹ (Also see "MGI Aloxi Launch Set For September; Indications Include Delayed Nausea" - Pink Sheet, 4 Aug, 2003.), p. 34).

Aloxi is the first 5-HT3 antagonist approved for both delayed and acute stages of vomiting and nausea; GlaxoSmithKline's Zofran (ondansetron), Roche's Kytril (granisetron) and Aventis' Anzemet (dolasetron) are approved only for the acute phase.

Like Aloxi, Merck's oral substance P antagonist Emend (aprepitant) is also indicated for both acute and delayed nausea; a post-operative indication would help differentiate Aloxi from Emend. The three other 5-HT3 antagonists are approved for post-operative nausea.

Since Aloxi's launch in September, more than 30,000 doses have been administered, Moulder said. "We're on the type of trajectory that is quite pleasing, and we're getting outstanding feedback from the field."

At an average wholesale price of $324, Aloxi is priced at a premium to other anti-emetics in the 5-HT3 class. For example, Anzemet is $76.24 per 100 mg dose. Aloxi is more on par with Emend, which has an AWP of $312.50.

Aloxi is on track to double MGI Pharma's consolidated sales within the first 12 months of launch.

MGI expects to generate overall sales of $37 mil.- $39 mil. in 2003, including $5 mil.-$10 mil. in sales for Aloxi. In the first 12 months on the market, Aloxi will bring in $50 mil.-$55 mil.

The launch was enthusiastically received by investors; the stock gained 468% during 2003, the biggest gain on the F-D-C Index of NASDAQ-traded biopharma stocks.