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Biotech / Medical : Biogen -- Ignore unavailable to you. Want to Upgrade?

To: Harold Engstrom who wrote (1160)	10/30/1999 9:33:00 PM
From: Mark Bong	Read Replies (2) \| Respond to of 1686

Horold, this press release from the Diabetes Research Institute at the University of Miami adds a little more clarity to the Antova issue. I believe that Antova is very important to BGEN, and I hope that the concerns about this drug can be overcome. drinet.org Last night we learned of the Biogen decision to halt some of the trials with anti-CD40 ligand (anti CD-154), including the islet trial. We learned of this decision from the press release, as many of you did. The concerns on thrombo-embolic side effects resulted from observations in other trials and we have not observed such problems in association with islet transplantation. In general, there are disease states in which there is a strong predisposition to thrombo-embolic events (i.e., Lupus or following major surgery). Unlike kidney transplantation, islet transplantation consists of an infusion of cells in the portal vein and there is no surgery involved in it. In addition, experimental evidence indicates that, if anything, treatment with anti-CD40 ligand should actually inhibit clotting (thrombosis), but it is still too early to know all potential biologic effects of the drug. We understand the company decision and we will continue to work with Biogen and the FDA to make sure all necessary safety steps are taken in a timely fashion, so that we can resume the trials as soon as possible. We are concerned about the delay in this trial, as we still strongly believe that this drug is the best agent we have tested so far in islet transplantation, but we agree that patient safety must be an absolute priority. The Institute will continue pilot trials with other drug combinations that have been already approved by FDA, including the infusion of donor bone marrow stem cells and other emerging anti-rejection strategies. Camillo Ricordi, M.D.

To: Harold Engstrom who wrote (1160)	10/31/1999 4:43:00 PM
From: Beltropolis Boy	Respond to of 1686

appreciate the reply, harold; not familiar with the following webrag, but her comments seem to echo yours. btw, is there some corporate secret behind the 'A'-named product line or have i been slipped a two-year-long mickey? ----- Biotech Stocks Insider: A Buying Opportunity in Biogen October 28, 1999 6:22 AM EDT By Nadine Wong Columnist worldlyinvestor.com Biogen (BGEN: Nasdaq) has been badly battered lately, most recently because it halted testing of a widely anticipated drug that was expected to have broad applications. But investors selling the stock may be losing track of the fact that Biogen has many important products undergoing clinical trials. This may be a good time to buy the stock cheaply. Biogen was a star performer most of the year, more than doubling in price through September. The company reported earnings just above expectations on October 7th; investors started taking profits and have been doing so over since. But in addition, bad news hit the stock shortly after. News that Biogen had halted several trials of Antova, or Anti-CD40 Antibody, due to potentially life-threatening blood clots, sent the stock tumbling 12% on October 21st. Biogen's announcement casts a shadow of uncertainty over the stock for the near-term, as the market must await further information on whether or not Antova's development will be halted completely. For investors, the big question is how important Antova is to the inherent value of Biogen's product pipeline? The answer is that Biogen's development pipeline is pretty impressive. Riding High on Avonex Prior to the Antova setback, Biogen had been riding high on a wave of accelerating sales of its lead product Avonex, a therapy for delaying the progression to disability in multiple sclerosis patients. Since its 1996 launch, Avonex has been gaining share in a market that has been expanding as a result of earlier diagnosis and prescribing trends. Sales are on track to reach or even exceed our $589 million estimate for 1999. Biogen forecasts that over 100,000 patients will be treated with Avonex within the next few years, a feat that, if achieved, represents a billion-dollar market. Avonex is available in most countries and continues to expand into new smaller markets. But in 2003, Avonex will lose its "orphan drug status" and sales are expected to plateau. Biogen is viewed as a one-product company, and so needs at least another major product on the market. Not Just a One Product Company Biogen had anticipated that its new drug, Antova, would treat a large target population. It could have been a blockbuster. But there are other strong contenders in development; progress is being made with new products anticipated to hit the market in late 2001 or early 2002. Amevive, which is in late-stage trials for treating individuals with severe psoriasis (autoimmune skin disorder), is geared towards a large unmet market. It is believed that Amevive is capable of targeting over 300,000 patients in the US alone. Amevive is the most advanced drug in the pipeline. It is a recombinant human fusion protein, which works by binding to CD2 (a protein on the surface of T cells, key to autoimmune systems), thereby preventing T-cell activation. Biogen plans to release results in December 1999. So far, the drug is on track for launch in the second half of 2001. Biogen is collaborating with CV Therapeutics on the development of Andentri, a novel diuretic for the treatment of congestive heart failure (CHF). A Phase II trial, which began in the second quarter of 1998, will evaluate the drug alone or in combination with Lasix, currently the standard form of treatment for CHF. Results are expected by year-end. In addition to these new products in development, Biogen is conducting three Phase III trials to expand the Avonex label in MS (monosymptomatic, secondary progressive and double-dose Avonex). Results are expected in mid-2000. Other indications include Phase II trials in glioma (a form of brain cancer), and in IPF (Idiopathic Pulmonary Fibrosis), a disease marked by scarring of the lungs. Biogen also is collaborating with Inhale Therapeutics (INHL: Nasdaq) to develop an inhaled version of Avonex. Inhale will develop the formulation and Biogen will do the clinical trials and commercialize the new form. Biogen also stands to benefit in the near term from incremental royalties on increased sales of Intron A for Hepatitis C. The Future Earnings could slow due to reduced royalty income in 2000-2001 if Avonex sales weaken and Biogen's foreign patents on hepatitis B antigens and Intron A expire. But the company is on very sound financial footing, with continued earnings and plenty of cash on hand. In addition, the management team is strong and scientific talent is abundant. It is unrealistic to expect all of its drugs to work, but Biogen still won't know whether Antova will be dropped or not. There are many questions to be answered and many alternatives to be analyzed before any firm decisions about Antova's future can be made. Meanwhile, there is lot more than Antova driving this biotech giant. Nadine Wong is editor of BioTech Navigator, a newsletter that provides investors with strategic information for investing in biotechnology stocks. Her Biotech Stocks Insider column appears every Thursday.