Elan expects to return to profitability in 2005 with the potential launches of Antegren for multiple sclerosis and Crohn's disease and Prialt for chronic pain.

Elan and Antegren partner Biogen Idec plan an earlier-than-expected mid-2004 BLA filing for natalizumab in multiple sclerosis based on one year of data from two Phase III studies.

The companies also plan to present FDA with Phase III data on Antegren use as maintenance therapy in Crohn's disease.

Elan will also file an amendment to its Prialt NDA in the second quarter and anticipates launching the product no later than the first quarter of 2005.

Based on FDA approval timelines, "we think it's fair guidance to say...that sometime in the second half of 2005 we would return to profitability," CEO Kelly Martin said during a Feb. 18 earnings call.

"That would be subject to change if for any reason the regulatory timelines slip or there are other things that we have to do," Martin acknowledged. "But we have two products, Antegren and Prialt, three indications, severe pain, Crohn's and MS, which we believe we will be participating in on both cost and revenue through 2004 then into 2005."

Elan began a restructuring and divestiture program in 2002 that included the sale of its primary case business - the sleep aid Sonata and muscle relaxant Skelaxin - to King Pharmaceuticals last year (¹ Also see "King/Elan Deal Proceeds; Skelaxin Royalties Will Offset Lower Purchase Price" - Pink Sheet, 26 May, 2003., p. 14).

The company remains in the red, reporting a net loss after discontinued operations of $529.4 mil. in 2003, compared to a $2.4 bil. loss in 2002.

A mid-2004 BLA filing for Antegren in MS could mean FDA approval in early to mid-2005.

The BLA filing decision was made "after discussing the data from two Phase III trials with the FDA" on Feb. 17, Elan Exec VP Lars Ekman, MD/PhD, said.

"No other MS therapy on the market has been approved with less than two years worth of data," Ekman noted. "However, after our discussion with the FDA, we believe that our one-year data is sufficient to support the filing."

Ekman declined to describe the degree of FDA's support for a BLA filing on the limited data. "I think you have to draw your own conclusion" based on the companies' decision to file, Ekman said. "I think that that information speaks for itself."

Biogen and Elan are committed to completing the two-year MS studies, Martin said.

"We would have done nothing to damage or potentially harm the MS work," Martin said. "We had very full, deep, thorough discussions between ourselves and the agency, and this was the conclusion that we came to based on those discussions."

Ekman said it would be premature to speculate on an indication for Antegren. "The label will be driven" by data from the Phase III trials, which are studying Antegren as monotherapy and as a combination therapy.

The 900-patient AFFIRM trial is evaluating the ability of natalizumab to slow the progression of disability and reduce the rate of clinical relapses.

SENTINEL is a study of 1,200 patients with relapsing-remitting MS. The trial is evaluating the effect of Antegren in combination with Biogen's Avonex (interferon beta-1a) compared with Avonex alone in slowing the progression of disability and reducing the clinical relapse rate.

Both protocols included data analysis at one year with relapse rate as the primary endpoint.

Elan and Biogen Idec submitted the one-year data to FDA at the end of 2003; two-year data will be available in the first quarter of 2005.

Elan is also eyeing a 2005 approval for Antegren in Crohn's disease. Elan and Biogen Idec plan to present FDA with data from two Phase III studies evaluating use of natalizumab as continuous therapy in Crohn's disease.

Antegren failed to meet the primary endpoint of disease response in the Phase III ENACT-1 induction trial last year (² Also see "Biogen Amevive Revival Strategy Includes Shorter Time To Reimbursement" - Pink Sheet, 28 July, 2003., p. 25).

However, the companies obtained more positive results from the ENACT-2 maintenance therapy trial.

Patients who achieved a 70-point decrease in the Crohn's Disease Activity Index after three months of treatment in ENACT-1 were re-randomized to either Antegren or placebo. The primary endpoint was maintenance of response with a sustained CDAI score below 220 after six months of treatment.

"We were pleased to see a significant treatment difference of greater than 30% in favor of Antegren as compared to placebo," Ekman said.

"The totality of the data from this Phase III study and from the early ENACT-1 Phase III induction study...clearly indicates that Antegren is both biologically and clinically active."

"We will meet with the U.S. and European regulatory authorities to present the data of these two pivotal studies and to determine the most appropriate path forward for Antegren in the treatment of Crohn's disease," Ekman said.

The companies also expect to begin a Phase II trial by July studying Antegren use in rheumatoid arthritis.

The randomized, prospective, double-blind study will evaluate 250 patients with moderate to severe RA who are currently being treated with methotrexate.

The primary endpoint of the six-month study will be the percentage of patients that achieve a 20% improvement in swelling of joints and pain scores.

Elan also is optimistic about its chances of bringing Prialt (ziconotide) to market in the 2004-2005 time frame despite its lengthy regulatory history.

The product has been "approvable" since June 2000. Elan subsequently conducted a long-term study in patients with chronic severe pain (³ Also see "Elan Prialt NDA Awaits Longer-Term Data In Chronic Pain" - Pink Sheet, 11 February, 2002., p. 30).

"In the double-blind, placebo-controlled trial, patients treated with Prialt displayed a statistically significant improvement at week three in the Visual Analog Scale of Pain Intensity (VASPI) score, as compared to placebo," Elan said.

Elan Pinning 2005 Profitability Hopes On Antegren, Prialt Launches

More from Archive

More from Pink Sheet