To: software salesperson who wrote (1976 ) 12/18/2003 2:03:01 AM From: Miljenko Zuanic Respond to of 3044 Sales, THANK YOU SO MUCH for posting your communication with FDA. Erick, 3 years addition in exclusivity for second orphan indication sound right to me. Simple put, two or three orphan indications and you may have market size that is more than non-orphan indication. Peter, 10K:<<If the FDA approves any of these indications for THALOMID(Reg. TM), we will be granted a seven-year period of exclusivity during which time the FDA is prohibited, except under certain conditions, from approving another version of thalidomide for the approved indication.>> Funny how CELG use FUTURE to describe PASS. T is approved on July 16, 1998, and ENL orphan status was granted early. From the some 10K: “We have received from the FDA orphan drug approval for thalidomide for the treatment of ENL. We also have received orphan drug designations for thalidomide: for the treatment of multiple myeloma;…>> Regards the patent protection from STEPS, let me say clearly that STEPS is nothing more than BRAIN WASH approach. It is due to liability and US legal system. Completely corrupted and FA**-UP! Thalidomide is extremely dangerous for fetus and developed baby in first few months of pregnancy. This know every oncologist. After that it is not more toxic than other chemos or bio-agents. BTW, what cancer drug does not have label restriction and warning for pregnant women? That system is f***-up, in near future we will have LEGAL and OTC drug that are nothing less than DEADLY WEPON, in more that 90% cases that will be use. So, in one way we are legalazing and promoting KILLING and on the other (to be protected from LAYERS) protecting the babies from toxic drugs, by brain washing MDs and Pts. Or,another example, person at 18 years of age can give his life for this Contry but can not have in public alcoholic drink. From the Layers and legal standpoint I do not know how strong is STEPS patent protection. Did STEPS protected or suppressed T black market in US? Bottom line, as hmpa indicated and from Orange book statement, T exclusivity (from ODE) expire on June-2005. At that time (or 6 months early) generic are free to file aNDA for T in ENL, regardless what is status of the other orphan designation. Will they be able to still market share is question to discuss. However, current T market price and cost of the therapy suggest that generic will be more than welcome. Maybe the answer is generic STEPS program, or whatever... Sales << miljenko, (i) why do you believe that T will be a $ 400 m drug? Growth in mm? Solid tumors? (ii) How do you think Velcade will impact T revenues in mm? >> Currently T sale is at $60-65 M/Q. Sales is still growing (mostly due to MM market), but there is opportunity for several solid tumors. The problem is label and marketing, in addition to STEPS “brain wash” approach. So, another 30% growth is not far away. Near term V will not impact T sale for MM, mostly. As the V move into early use it will reduce T penetration for early MM indications (unless this two drug combination show superiority from all others combination, which is open and one of the likely scenario), but T will continue to have chance as second and third line options. I do not think nor believe that Remivid will be as effective as T in MM, or some other solid tumors It will be interesting to see who will got first EU MM approval, Thalidomide (NDA submitted on 4-2002) or Velcade (1-2003)? Miljenko