Betaseron® by Berlex Laboratories, the brand name for Interferon beta-1b, has as its active ingredient a modified human protein produced by the Escherichia coli bacteria that acts like the body's natural interferon. Treatments consist of subcutaneous (under the skin) injections every other day for relapsing forms of MS and the reduction of MRI lesions. Betaseron® does not need to be refrigerated and can be stored at room temperature, unlike the other interferon-based medications. 

Biogen Idec’s Avonex® is the brand name for Interferon beta-1a. Avonex was the first treatment indicated for relapsing forms of MS to both reduce physical disability progression and decrease the frequency of clinical exacerbations. Approved by the FDA for marketing in the US on May 17, 1996, it is made up of exactly the  same amino acids (major components of proteins) as the interferon beta naturally found in the human body. Treatment is a once-a-week intramuscular (IM) injection, usually in the large muscles of the thigh, upper arm, or hip. This October, Biogen said that sales of Avonex®, its flagship product, grew worldwide by 16 percent to $US 346 million for the third quarter.

Although Avonex® sales for the past several quarters has been more or less steady with a running rate about $US 349 million per quarter, the year-over-year revenue growth has been on a decline. This issue has raised some concerns on Wall Street regarding the expectation of Avonex® sales and valuation of Biogen Idec's share price.

Chemically identical to Avonex® is Rebif®, a Interferon beta-1a drug from Serono, Inc. Approved by the FDA in 2002 for relapsing forms of MS to decrease the frequency of clinical exacerbations and to delay the accumulation of physical disability, Rebif is taken by subcutaneous injection three times a week. Rebif® is the fastest growing MS disease modifying drug and has overtaken Betaseron® in terms of new prescriptions share since July 2004 in the USA. 

Also from Serono is Novantrone®, brand name for Mitoxantrone, an immune system suppressor that was FDA approved in 2000 for treatment of worsening relapsing-remitting MS and for progressive-relapsing or secondary-progressive MS. Novantrone® is usually administered four times a year by IV infusion in a medical facility and can be given for a limited time only to avoid possible side effects to the heart. Novantrone® reduces new lesions, decreases attacks or relapses, and slows the rate of increasing disability. Novantrone® sales in Q3 2004 were just $US 10.2 million, compared to $US 6.6 million in Q3 2003.

Teva Pharmaceutical Industries, Israel’s top drug firm, is the developer of Copaxone, brand name for glatiramer acetate formerly known as copolymer-1, a synthetic compound that is a mixture of four amino acids. Copaxone is in a different class of drug used to treat MS as it is a non-interferon medication. FDA approved in 1996 for the treatment of relapsing-remitting MS, Copaxone is a subcutaneous injection drug that is taken daily to reduce new brain lesions and the frequency of relapses by targeting the site of the lesion and reducing inflammation. We estimate that the annualized sales of Copaxone® in 2004 could exceed $US 940 million with over 30 percent year-over-year growth next year.

New Drugs and Treatments in the Pipeline - Dublin, Ireland-based Elan Corp (NYSE ADS: ELN) jointly developed Antegren, a treatment for autoimmune disease, with Biogen Idec. Antegren, the brand name for natalizumab, is a selective adhesion molecule (SAM) inhibitor and is designed to inhibit the migration of immune cells into chronically inflamed tissue where they may cause or maintain inflammation. 

Antegren is a potential treatment in patients with MS, bowel disorder Crohn’s disease, and Rheumatoid Arthritis (RA). Results of a final Phase III study into its use against Crohn's disease will appear in the first half of 2005 while Phase II rheumatoid arthritis trial data for Antegren should be published by the middle of next year, Elan CEO Kelly Martin said. 

Earlier this year, Elan and Biogen Idec applied to the FDA for approval for use of the drug as an MS treatment based on the first year of results from two clinical trials, one year ahead of schedule. Antegren is expected to be approved by the FDA for MS treatment in late November 2004. Some analysts expect the Antegren drug to reach $US 3 billion in annual sales if approved. Biogen Idec Inc. has said Antegren can expand the current multiple sclerosis market to $US 6 billion from $US 3.6 billion over time.        

According to the National MS Society, at two scientific meetings (American Academy of Neurology Annual Meeting and Experimental Biology 2002), results of studies were presented suggesting that Pfizer’s Lipitor, brand name for atorvastatin, and other “statins,” drugs used to lower cholesterol, can treat experimental animal models of MS. This research adds to previous basic studies suggesting that statins can alter immune responses in a way that may hold promise in treating human MS. If the drug proves effective in human trials, statins, which can be taken in pill form, would offer an attractive alternative or complement to existing therapies for MS.

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