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Irish Examiner
Elan starts to produce new MS drug

By Conor Keane, Business Correspondent
ELAN has started production of Antegren, its multiple sclerosis (MS) drug, in advance of a possible launch in 2005.

Elan gave a detailed briefing to stockbroking analysts on Monday. They were told the company anticipates approval for Antegren from the US Food and Drug Administration to permit sales to start by early 2005.

Merrion's Peter Frawley said, in a note to clients, Elan's greatest concern is not the approval process but rather managing the demand and supply curve.

"At launch, the group will have capacity to meet the needs for 70,000 patients and the group is currently in pre-launch production to stockpile supplies.

"Late next year, the group plans to have IDEC's Oceanside facility up and running which will meet the demand of a further 70,000 patients. To meet the demand beyond that, the group hopes to improve the yield at its existing facilities and in tandem is looking at ways of expanding its production capacity, hence Monday's announcement of a $35m proposed investment in Elan's Athlone facility," Mr Frawley said.

Elan is still under investigation by the US Securities and Exchange Commission but this is now regarded as a side issue.

Mr Frawley said: "On the SEC, the group maintained its guidance for a resolution by Q3 2004 and interestingly, the group hopes to simultaneously resolve the class action litigation."

Davy's Jack Gorman said: "Frustratingly, the Securities and Exchange Commission process drags on, not through any fault of Elan's.

"Nothing new or different has been asked for by the agency since it completed the investigation at the end of Q1. By the end of Q3 management now hope to have it, and potentially the civil suits, resolved."

Mr Gorman said it was very much a case of looking forward rather than back.

"The newsflow momentum that we can anticipate over the rest of 2004 looks very positive and supports a trading buy opportunity for the shares," he said.

Shares in Elan fell one cent to €17.79.

I thought Biogen made antegren. I am now confused.

It's a collaborative effort between Elan and Biogen IDEC. It looks like Elan will handle the European side and Biogen will handle the US. My point in posting that article was to show how confident they are that it will be approved and reach the market early next year.

The wall street journal wrote an article last week about antegren- it was pretty enthusiastic about the drug and ms. I hope it's as good as many people are thinking it will be.

jicepf, do you have an electronic copy of the article? We'd love to see it.

My sister is supposed to be mailing it to be- when I get it, I will type it out and email it to you.

I hope this isn't illegal.

BOSTON -- Although investors sold when Biogen Inc. and Idec Pharmaceuticals Corp. first announced their merger last year, the newly constituted Biogen Idec Inc. is now riding a wave of euphoria. Its stock is up 71% this year, giving it $20.9 billion in market value -- about 11 times total sales.

What is behind the reversal? Optimism about Antegren, a new therapy for multiple sclerosis under joint development with Elan Corp.

Rarely has so much been riding on a drug not yet approved by the Food and Drug Administration.

If the FDA clears it, forecaster Sagient Research estimates world-wide Antegren sales will peak at more than $2 billion by 2011. Biogen Idec expects that over the next few years, Antegren could help expand the MS drug market to $6 billion from $3.6 billion today. Even competitors see a gain. "It will grow the market, no question," said James Pusey, executive vice president of neurology for Serono Inc., the U.S. division of Serono SA, which makes the rival MS drug Rebif.


Since Antegren works differently than other drugs on the market, doctors looking for a more powerful therapy could prescribe it in combination with other medicines. Antegren also may fill a gap for some of the large number of MS patients who don't respond to existing treatments.

Biogen Idec sought FDA approval for the drug last month in an unusual application based on the first year of results from two clinical trials. In the past, the FDA has considered MS therapies only after two years of study. The early filing signaled to many investors that the yet-to-be-disclosed trial results were much better than those for therapies already on the market -- a suggestion that Biogen Idec has done little to dispel.

"The one-year data are obviously very positive," said Burt A. Adelman, the company's executive vice president of development. A decision by the FDA could come before the end of the year, following the company's request for an accelerated review.

"One hopes that the optimism this most recent announcement has generated is well considered and appropriate," said Stephen Reingold, vice president for research programs at the National Multiple Sclerosis Society.

Dr. Reingold said some of the optimism is warranted because Antegren is a new class of drug and because of promising data from an earlier, Phase II trial that involved fewer people for a shorter duration than the later trials under current FDA review. In the earlier trial, there was a reduction of 50% in the number of patients experiencing a relapse of symptoms related to MS, such as tingling, muscle weakness and double vision.

The drug also is being studied as a treatment for Crohn's disease, a fairly common condition that causes inflammation in the small intestine. U.S. approval as a Crohn's disease treatment is less promising, because of disappointing trial results, but the company has filed for European approval as a Crohn's medicine.

Biogen Idec has no other drug with similar blockbuster potential close to approval. Many of its most exciting candidates are still in early development and are years from market. At the same time, recently approved drugs from the company have been disappointing.

Amevive, a treatment for psoriasis approved by the FDA last year, is beset by poor sales and increased competition from other new psoriasis treatments, such as Genentech Inc.'s Raptiva. Zevalin, a treatment for non-Hodgkin's lymphoma approved in 2002, hasn't widely established itself and posted sales last year of $20 million.

Nearly all of Biogen Idec's $1.85 billion in revenue last year came from two drugs. Avonex, the market-leading MS therapy, reaped $1.17 billion. Rituxan, a cancer drug under testing as a treatment for several autoimmune diseases, generated $493 million -- the company's share of sales under an agreement with Genentech.

Biogen Idec is testing Antegren two ways. In one trial, Antegren is being compared with placebo. In a second test, the drug is combined with Avonex and compared with placebo.

If the combined drug therapy is better than Antegren alone, Biogen Idec could see a double benefit. But if not, sales of Avonex could fall as doctors and patients switch to Antegren. Avonex has 42% of the U.S. market for MS drugs, according to data from IMS Health Inc.

Analysts expect Antegren to cost as much as or more than current therapies, which can run as much as $14,000 a year. Unlike current treatments, the most popular of which are self-administered with a daily or weekly shot, Antegren is given as a once-a-month infusion in the doctor's office.

Avonex and rival Rebif are beta-interferons, synthetic versions of naturally occurring human proteins that appear to modulate the immune system. But Antegren is one of a new class of drugs called selective adhesion molecule inhibitors. The drug attaches to potentially damaging immune cells to block them from migrating from the bloodstream into the brain, where they cause inflammation and kill nerve cells.

My neuro is concerned that the extremely high cost of antegren will be difficult for insurance companies to deal with. Anyone have thoughts on how the insurance companies are likely to handle this? Will it be available for any confirmed RRMS case or perhaps only cases with special circumstances?

Does anyone know if Antegren is available in any other country? I have a 19 year old daughter with MS. We have done high doses of steroids, blood plasma exchange and even 2 chemo treatments. Things went well for a while but now the flare ups have started again, 3 in 2 months. Can't wait for this new medication. Willing to travel if necessary.

Hsan,

To my knowledge Antegren won't be available for general use until early into 2005 and that's if the FDA in the US gives it approval. After that, each country's drug approval agency would have to approve Antegren for that country as well.

We haven't seen any clinical trial data on Antegren as yet and can only go by what Biogen and Elan have indicated so far...and that it has had good results in their trials. They are rushing the approval process and I hope that is being done because it is a promising drug as opposed to generating a lot of revenue for the drug companies.

Harry