BioWorld International Correspondent

For analysts eagerly anticipating developments with Antegren, Elan Corp. plc's multiple sclerosis drug, the news last week that Prialt, its first pain product, gained a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use was a pleasant sideshow.

The FDA's imminent ruling on Antegren is the main event.

"[Prialt's recommendation] is a positive. It's going to be a very nice niche product for them," said analyst David Marshall at Dublin, Ireland-based NCB Stockbrokers. Prialt, originally developed by Neurex Inc., which Elan acquired in a $741 million stock swap in 1998, was recommended for approval in severe, chronic pain in patients requiring intrathecal analgesia. Dublin-based Elan said European Commission marketing authorization should follow in three months.

It seems FDA approval for Prialt also is close at hand. Elan disclosed positive Phase III trial data in January. In June, it submitted an amended NDA, incorporating additional efficacy and safety data.

"Certainly the approval should come by year-end in the U.S.," said analyst Peter Jackson, of Bloxham Stockbrokers in Dublin. (See BioWorld International, Jan. 14, 2004.)

Prialt has orphan drug status in the EU, although Jackson said the main sales effort will focus on the U.S. initially, in which there is greater penetration of intrathecal pumps. Those devices, supplied by Medtronic Inc., of Minneapolis, are implanted subcutaneously and deliver the drug directly into the cerebrospinal fluid. Prialt, a non-opioid synthetic derivative of a peptide isolated from the venom of the marine snail Conus magus, acts by blocking a neuron-specific N-type calcium channel. Elan initially plans to target three groups: patients who have become refractory to or intolerant of morphine, those with advanced AIDS who are experiencing severe pain, or those with cancer and pain.

As it is a niche area, the market, Marshall said, is "circumspect" about Prialt's potential. He has put a peak sales estimate of $150 million on the product.

"There's certainly scope for it to do double that, if it can gain any kind of traction," he said.

Antegren, which is in development with Biogen Idec Inc., of Cambridge, Mass., remains the main driver of Elan's share price. Once it obtains approval, which is expected, Jackson said the company's share ownership will undergo substantial rotation, as speculative investors who bought in earlier this year take profit on the stock. More conservative institutional investors will not buy in, he said, until the SEC probe is finally settled - Elan disclosed a provisional agreement last month - and Antegren has gained approval.

Elan also has settled a shareholder class-action suit and last week raised about $1.2 billion in a debt offering that should enable it to clear its last remaining off-balance sheet debt vehicle and to fund its imminent product launches.

"The finances are very strong," Jackson said. Revenues from both products are expected to start flowing early next year.

"They're saying cash-flow positive in the second half of 2005 - that seems reasonable," Marshall said.