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Biotech / Medical : VD's Model Portfolio & Discussion Thread

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To: Andrew H who wrote (537)	5/14/1997 2:41:00 AM
From: Vector1	of 9719

Andrew more on CRO's and GZTC More and more small biotech companies and even some of the larger companies are outsoucing product testing and development services. For many companies the setting up of the infrastructure or obtaining the expertise to bring a compound to be ready for clinical testing is prohibitively expensive.The development cost of for an individual drug can exceed 100 million. GZTC by providing a comprehensive set of services through its respected laboritories can reduce cost and overall time. This business will continue to grow. Whether it will be sufficient to fully fund the transgenic development, I doubt it although deep pocket GENZ has supplied a 6 million undrawn working capital facility and the company has about 9 million in cash.. In response to q4 whether they will need to raise more money depends on the partnership deals they develop with pharma or whether they decide to go it alone and ramp up the production by themselves. What is clear is that once trangenic production is accepted and they get FDA approval the sky is the limit. Your first question was,Regarding the AT-111 trials. I understand that P1 tested only safety and P2 is testing only dosage. Is that true? Do you think there will be some hints of efficacy in the P2 results? What do you think the chances are for successful completion of P2 and prompt initiation of P3 trials? Is there any reason this transgenic version of AT-111 should not be successful? This drug has been in use for many years, already, no? But not the transgenic version. My understanding is that the purpose of the phase II is to confirm the safety of the product. I do believe they will get some sence of efficacy albeit not in a group that is statistically significant. ATIII is already on the market in Japan and Europe. I'm not sure but don't think it is approved in the US. ATIII is a plasma protein that helps regulate blood clotting and is a 200 million sales market wordwide. The phase II involves patients undergoing open heart surgery which would create a large additional market for the product because it would reduce the need for blood transfusions during surgery. The company has stated that transgenically produced ATIII is superior to the current plasma version because it is safer as well as more cost effective. There of course is the key cost effective protien production. If Transgenics works this company has a method to cost effectively transgenically produce virtually every major protein based drug. This will be especially important as some key patents lapse. Maybe this is why the company has signed 10 agreements with pharma and biotec companies to produce for them in the milk of transgenic animals monoclonal antibodies and other protiens that are cost prohibitive using traditional methods. As for other advice I think this company should be a core position in a quality biotec portfolio. However ther is some risk so I would keep the position at no more than 15% of my total biotec portfolio. Hope thats helpful. The company has more going on such as vaccines and and other trangenic plasmas but I am to tired. V1

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