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

To: SDR-SI who wrote (756)	10/5/1998 6:12:00 PM
From: Harold Engstrom	Read Replies (1) \| Respond to of 1686

Biogen conference call notes (earnings were in line with $0.49 estimates, although Avonex sales exceeded expectations). Approx 40,000+ patients in US 2,000 more patients in Europe 11,000 total patients in Europe $38MM in Royalties - lower than expected R&D spending higher and remain relatively level 33% tax - averaging 34% over last year 5,000 MS patients in Japan - Genzyme to distribute Avonex sales of $107MM. Rebif argument that 3.5-5.5 EDSS is beyond Biogen's data has apparently been rejected by FDA. Rebif final decision will be delayed until the middle of next year (or so Serono has apparently said). Canada - approval and reimbursement in 3 provinces. Expect reimbursement in all by end of year. Novatrone. Good trial results. But is chemo drug and has drastic effects. Will have application in fringes on market. CBM release. Odds of running a successful indication on renal indication seem pretty slim. Pipeline: Hirulog - The Medicines Company appears before FDA on Oct 23 for Angioplasty indication. LFA3TIP - Called Amavive? Kinder, gentler T-cell inhibitor. Safety data well received from Phase IIA. Broader Phase IIA is ongoing and Phase IIB proceeding very rapidly. Results by end of Q2, '99. Late 2001, early 2002 lauch. Will need to run Phase III, but expect to be able to lauch right in after Phase IIB completion. 5C8 - Called Antova? Phase I in ITP (autoimmune reaction to own platelets). Patients rolled into extended Phase IIA safety trials with increasing doses. Phase II hemophilia trial to start next quarter. Kidney and eyelet cell transplants and MS indications to be tested next year. Excellent results so far. Biogen very high on this drug. Interest shared by community at large including NIH. Phase II for Lupus will be complete early in 2001 due to slow accrual and long term follow-up requirements. CVT124. Still in Phase IIB. Phase II data to presented in November. Avonex - trials in Glioma ongoing. VLA4 - Trials with Merck going very smoothly. Merck is pursuing trials with 2 VLA4 compounds out of Biogen's labs. Phase IIA to start later this year (IND filed with FDA in June). Biogen working on another IND for trials in 2000 with a new compound that positively affects dendritic cells. Indications for rheum arthritis, inflammatory bowel disease and psoraisis. Jim Tobin says LFA3TIP is a product he would bet the farm on (if he had to choose one) - excellent safety and efficacy data to date. CD40L looks pretty great as well, but not as far along in the clinic. Higher SG&A are likely in the future. R&D likely to rise to roughly $200MM next year. Think total MS market in US is 325,000 patients. Thinks new MRI tools will help diagnose MS earlier and with more certainty - will help grow market as well. Biogen seeing later and later and earlier and earlier stage patients.