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Biotech / Medical : TITAN PHARMACEUTICAL (TTP) -- Ignore unavailable to you. Want to Upgrade?


To: NeuroInvestment who wrote (139)9/26/2000 9:41:17 PM
From: Miljenko Zuanic  Respond to of 362
 
Dr Harry,

Thanks for thoughts.

I definitely agree that it is to early for champagne, but nice glass of red vine is appropriate at this time.

We do have long way to go. However, news on Zomaril (with NVS permission to release more data) indicate that ZEUS program progressed very well and that NDA can be expected shortly. Long term trials are for additional drug label and promotion/marketing. At this point only extreme skepticism can question *high probability* (nothing is for sure) that NDA will be brief and clean. Market penetration and revenue growth is another story.

Few layman thought on point 1. and 2.

1. From PII trials results (8 mg/d dose arm, 10 days, 35 pts) drug have statistical significant PANSS negative subscale score results; P<0.025, and trend in preliminary first PIII trial data (4 and 8 mg, short treatment duration, while second PIII should be 8 and 16 mg /day dose, three months), as well as Ilo receptor binding profile (strong 5TH- 1A/2A) one can with good probability extrapolate or assume statistical significance on Negative sx. Nothing is for granted, but it was much less granted two years ago.

2. Risperdal is one of the arm in third PIII trial. This is to evaluate QTc safety issue (if any) as well as comparison between two atypical antipsychotic. If their pivotal trials results are comparable to data reported for Risperdal and Zyprexa, than going after Zyprexa isn’t imperative. IMO, at this time more important are long-term studies (with additional end points). Another opportunity is refractory and non-respond chizo population (~40% of market which is Clozaril’s field), and this is where Ilo may have good chance to penetrate. Some data from animal model and similarity with Clozaril indicate that Ilo may be active in this population. I will like to see that they do run refractory pts trials.

Like you I am also looking forward for additional data with hope that Ilo will continue to show good promise and reliable data.

Miljenko