Elan will pursue development of Antegren (natalizumab) humanized monoclonal antibody for chronic treatment of multiple sclerosis, the company announced July 26.

Preliminary results from a Phase II study of Antegren for the treatment of acute exacerbation of MS suggest that Antegren "may have a beneficial effect in suppressing new lesion formation if administered chronically," Elan said.

However, data do not show a benefit in treatment of acute exacerbation, and Elan plans to discontinue that program in favor of Phase II chronic studies, to begin this quarter. The firm noted that chronic treatment has "stronger data and market potential." Phase II trials are also in progress for Antegren for the treatment of inflammatory bowel disease.

Elan may also explore other uses for the anti-(4 integrin monoclonal antibody; the firm's 1998 annual report cites work in animal models for asthma, rheumatoid arthritis and transplantation rejection. Elan anticipates a three year development timeline for Antegren.

The firm has a number of other products higher up in the pipeline, and predicts five new product launches by December 2000.

Miguard for migraine treatment, Neurobloc for cervical dystonia, Zelpar for Parkinson's disease, ziconotide for acute and severe pain and Zonegran are all expected to reach the market in the next 18 months.

The anti-epilepsy compound Zonegran is farthest along with "approvable" status since March 19, 1998. FDA is still waiting for "analyses and information on the previously completed clinical studies and refinement of the draft labeling," Elan said.

The company also anticipates submitting an IND before year-end for AN-1792, a beta-amyloid peptide for Alzheimer's treatment. In pre-clinical trials, AN-1792 reduced pre-existing amyloid plaque and prevented further plaque formation, Elan says.

Elan's drug development program emphasizes the company's move away from drug delivery towards innovative pharmaceuticals.

In the second quarter, product sales increased 71%, accounting for 55.1% of the company's total revenues for the quarter. Overall, revenues climbed 50% to $234.4 mil., while net income advanced 34% to $80.1 mil.

Elan highlighted the strong performance of Skelaxin, a musculoskeletal pain reliever with U.S. sales of $17 mil. for the quarter versus $11 mil. the year earlier.

Naprelan, sustained-release naproxen, followed with U.S. sales of $11 mil., up from $8 mil. in second quarter 1998. Permax, a Parkinson's treatment, rounded out the highest product sales with $9 mil. in the second quarter.

The gross margin on product sales increased to 64% compared with 54% in the second quarter of 1998. "These second quarter results represent...the continuing transition of Elan's business to a company deriving its revenues primarily from product sales," the company said.

Elan said its business previously was dependent on applying its technologies to generic or proprietary drugs through licensing agreements.

While Elan is now emphasizing its drug development programs, the company continues to also pursue licensing opportunities. Elan announced a second technology transfer and license agreement with Merck July 27, expanding Merck's access to Elan's NanoCrystal drug delivery technology. The agreement calls for payments to Elan of up to $30 mil. as well as fees and royalties.

Elan also announced a $22 mil. investment in Targeted Genetics which will help fund a Targeted Genetics subsidiary to develop technologies for the enhanced delivery of therapeutic genes.

Expected to be named Emerald Gene Systems, the partnership, which will last at least three years, will focus initial efforts on combining the companies' technologies. The agreement centers on two technologies- a nano-particle formulating technology and an attached ligand system which together allow for particle uptake and binding. Targeted Genetics hopes the collaboration will focus on oral delivery gene therapy which would be applied to specific organs and cells.

Elan Developing Antegren For Chronic MS; Quarterly Sales Up 50%

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