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

To: William Partmann who wrote (1153)	10/22/1999 8:30:00 AM
From: pfierb	Respond to of 1686

Well that's two in a row for me yesterday it was IBM today BGEN they could have given me a few days to lick my wounds, at least IBM is up a few in after hours.Hate when this happens.

To: William Partmann who wrote (1153)	10/22/1999 2:13:00 PM
From: Beltropolis Boy	Respond to of 1686

i realize that we're not the myopic mr. mcgoo types, but for what it's worth, this is via today's Thomsons Investor Watch. ----- BGEN -- Biotechnology -- Healthcare 22-Oct-99 11:56:44 News that Biogen (BGEN) halted several trials of Anti-CD40 Antibody (Antova) due to 'adverse events" sent the stock 12%, or $8 7/16, lower to $64 1/8. Biogen's shareholders tend to be aggressive growth and momentum type investors who have been attracted to the stock by its impressive price momentum - year-to-date the firm's price has appreciated 75%. Biogen's announcement has cast a shadow of uncertainty over the stock in the near-term as it awaits further information on whether or not Antova's development will need to be halted completely. The aggressive Big Money investors have no patience for this type of uncertainty, and as a result are dumping the stock today. Of the 12.6 million shares exchanged, about 60% stemmed from a block trade which is evidence of a heightened institutional presence. Recent I-Watch data shows sell super messages have retreated while new super bids seek to establish support at $64. While current pre-trade data favors buyers, the sellers are expected to continue to call the shots today.

To: William Partmann who wrote (1153)	10/31/1999 11:11:00 PM
From: Beltropolis Boy	Read Replies (2) \| Respond to of 1686

for what it's worth, following are comments via Goldman (no analyst cited). Q4 estimate is $0.41. ----- October 22, 1999 Biogen, Inc.: Setback in Phase II Trials on Antova. Maint. Est. MO [Market Outperformer] Biogen stopped several Phase II studies on Antova due to clotting side effect. We expect the program to be delayed by several months if ongoing analysis show the side effect to be unrelated to Antova or can be managed. Development may be halted completely if clotting is caused by Antova, which is 1 of 3 products in Phase II trials w/market potential over $0.5B. We maintain our 1999 & 2000 est. because product launch is not expected until 2002. However, the delay can be negative for long term growth & put pressure on the shares until the cause of clotting is defined. Continue to rate market outperformer for long term investors based on Avonex growth & potentially higher royalties in 2000. 1. HALTED SEVERAL PHASE II TRIALS ON ANTOVA. CD40 ligand is a receptor on T-lymphocytes that is involved in interaction with B-lymphocytes, and blood vessel cells. Antova is a humanized anti-CD40 ligand monoclonal antibody that can potentially block inappropriate immune responses, such as in autoimmune diseases and in transplant rejection. Biogen started Phase II trials on Antova in six indications: (1) kidney transplantation, (2) immune thrombocytopenic purpura (ITP, a clotting disorder), (3) lupus (an autoimmune disorder), (4) pancreatic islet cell transplantation, (5) multiple sclerosis, and (6) factor VIII inhibitor syndrome in hemophilia A (a bleeding disorder). Last night, the company announced that it has halted the Phase II trials on the latter four indications. Patients currently treated with Antova in the kidney transplantation trial as well as ITP patients that have benefited from therapy will continue to receive the drug. Biogen is in discussions with the FDA to continue the lupus trial. Management indicated that the decision to halt the trials was initiated by the company, not the FDA. Biogen's decision was triggered by increasing incidence of clotting complications. Apparently, over 100 patients have been treated with Antova, most of whom were in the kidney transplantation and ITP trials. Less than 10 have developed clotting complications thus far. 2. CAUSE OF CLOTTING COMPLICATIONS UNKNOWN. Biogen is analyzing the Phase II data to determine whether the clotting complications are related to treatment with Antova. It may take several months for the analysis to be completed. The company indicated that clotting complications were not observed in studies of animals, including primates. The development of clotting complications did not seemed to be correlated with dosage or repeated treatment. There is some evidence showing that activated platelets express CD40 ligand. We believe that theoretically, cross-linking of platelets by Antova could lead to clotting. However, there is no clinical data to support this hypothesis yet. 3. LIMITED FINANCIAL IMPACT IN 1999 AND 2000. If the ongoing analysis show that Antova therapy is unrelated to the clotting complications or if the complications can be managed to balance the potential clinical benefit of Antova, then the program may be restarted in full scale in the next three to six months. In the worst case, Antova treatment is related to unpredictable clotting, then all the indications may have to be dropped. We do not expect commercialization of Antova until 2002 assuming successful development. Therefore, the delay in Antova development would not result in any change in our 1999 and 2000 estimates of $1.43 and $1.72, respectively. However, the delay may reduce the long-term growth rate. It also highlights the risk in drug development and the need of having a robust pipeline in order to maximize the probability of success. 4. PHASE II TRIALS ON AMEVIVE AND ADENTRI WILL CONTINUE. Biogen has two other products in Phase II development. Amevive is a recombinant fusion protein for blocking the activity of T- lymphocytes. The initial indication is moderate to severe psoriasis. Biogen announced initial positive Phase II results in May 1999, but details will be released in March 2000 at a scientific meeting. Phase III studies on the intravenous and other formulations should start by year-end. Studies in other autoimmune diseases are planned for 2000. Adentri is a small molecule antagonist of the adenosine A1 receptors in the kidney. It is being developed as a therapy for acute and chronic congestive heart failure (CHF). Three small Phase I/II studies have been completed. Another Phase II trial with 640 patients with moderate to severe CHF has just completed enrollment. Other Phase II studies may be performed in 2000.