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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?


To: kendall harmon who wrote (280)8/30/1999 9:38:00 PM
From: Bharat H. Barai  Read Replies (1) | Respond to of 666
 
The data about response rates to Bexaar are simply superb. Even with best chemotherapy we rarely see 70% complete remissions.

Rituxan is a non radio labeled monoclonal antibody. In patients with Non Hodgkin's Lymphoma-low grade, who have been previously treated with chemotherapy, Rituxan produced 6% complete remissions and 36% partial remissions. Bexxar data if duplicated in real life, would be exceptional and would push the drug to 1st line use.

Idec, maker of Rituxan has gone from 30 to 130 in 12-18 months.

What FDA has asked is nothing but routine inquiries and I doubt it would delay the approval by more than few weeks at the best. It is possible that if revised data and analysis are submitted in next few weeks, the drug may still be approved by end of the year. FDA knows life of thousands of patients are at stake.

Radio active I 131 has been used for years in treatment of Thyroid cancer, without any significant harmful effects on the rest of the body. I 131 labeled monoclonal antibody should have similar safety profile.

Those who are willing to weather temporary turbulence, this may be a great entry point. You rarely get such opportunity. I was looking to buy into this company for sometime. I did buy some on Friday and a lot today morning. Make your own research and judgement.

Bharat H. Barai MD
Hematologist-Oncologist



To: kendall harmon who wrote (280)8/30/1999 9:56:00 PM
From: kendall harmon  Respond to of 666
 
CLTR--Prudential comments from today, excerpts:

We would point out that the preclinical data package and the manufacturing package from the Bexxar license application were not questioned, and at no point did the FDA raise issues with regard to Bexxar's safety, or with the endpoints used to measure its efficacy.

Regardless of how minor the FDA's issues may appear, the refusal to file letter is certainly negative to our investment thesis on CLTR shares. Most of the impact is attributable to a timing slip in our expectations for a potential approval and launch by partner SmithKline Beecham. We had earlier expected the Agency to make a ruling on Bexxar's approvability before the end of 1999; however, the letter has essentially stopped the FDA's approximately 6-month review clock from ticking and it will not start again until CLTR resubmits the Bexxar application. We have conservatively projected this event
as occurring in mid- to late October. Although CLTR can readily address the FDA's issues within 2-3 weeks, it will taken
an additional 2-3 weeks to prepare the filing for electronic submission, or 4-6 weeks total. Given that 2 months have
passed since the original filing date of June 30, the setback should be approximately 4 months (from the end of December 1999 to the end of April 2000), Due to the timing slip, we are reducing our Bexxar sales estimates, our EPS estimates for CLTR, and our price target on
the stock. Our worldwide Bexxar numbers are reduced in 2000 from $85M to $59M, in 2001 from $169M to $146M, and in 2002 from $268M to $250M. Our EPS estimate for 1999 is uchanged at ($2.12); in 2000 it goes from ($0.95) to ($1.49), in 2001 from $0.88 fully taxed to $0.53 fully taxed, and in 2002 from $2.23 to $1.93 fully taxed. Our corresponding price target is reduced from $42 to $36 based on a 35 PE multiple applied to our 2002 fully taxed EPS of $1.93 discounted back 25%. However, we do not see this recent event as increased the remaining development risk in the Bexxar program, or weakening its potential commercial value despite the fact that the Street may have perceptions along those lines and we anticipate a fairly dramatic reduction today in CLTR share price. We continue to assert that Bexxar has a greater than 50% probability of approval and that it will play an important role in the treatment of low-grade non-Hodgkin's lymphoma.

While it may have lost several months' lead time over IDEC Pharmaceuticals Zevalin (launch expected in early 2001), we
remain undaunted in our view that Bexxar will secure significant market share, particularly in the estimated 15,000 patients
who did not respond adequately to Rituxan, and presently have limited treatment options.

Even with a modestly reduced price target, we still see CLTR shares as having the potential to out-perform the general market over the next 12 months and are therefore retaining our Strong Buy rating. We view today's unfortunate news as a timing issue and not an approvability issue. We would therefore view the expected weakness in the stock today as an opportunity to purchase CLTR shares.