P R O H O S T   O n l i n e The Newsletter of Biotechnology Insight and Investment

ImClone meets with FDA for C-225 Pre-BLA

girls13481

From: orring
Date: March 31, 2006
Time: 04:27 PM

From: Backlash
Date: August 11, 2000
Time: 06:36 PM

Comments

Good article on ImClone. Opinions??

The Trials of Adolescence by James Baker back

Soon it will grow into adulthood and this New York company has garnered some much-deserved attention from wall street. Whispers are starting to focus on this company as the realization sets in as to their future potential. ImClone Systems Incorporated (NASDAQ: IMCL) meets with the FDA today for a pre-BLA meeting on their C225 drug.

A BLA (Biologics License Agreement) is similar to an NDA (New Drug Application) license for pharmaceutical drugs but specifically for biotechnology applications. ImClone has submitted its schedule for the pre-BLA meeting, which covers each component of the complete BLA filing. This schedule and the corresponding data will be reviewed at the pre-BLA meeting for a recommendation to continue on with the BLA submission or to continue on with further testing. Upon recommendation to continue the BLA processing, the company will submit each component of the BLA and pay the user fee for the application. The FDA then has 60 days to approve the BLA for filing.

C225 is being reviewed for its efficacy and safety aspects for fighting colorectal cancer in a phase II program. Results of this meeting may not be known for several days or more.

It appears ImClone is likely to step up the timetable to profitability. In a Prudential briefing notice, research analyst Robert Toth commented, "Our $165 target assumes a 26 times multiple on our projected 2002 revenues of $208 Million, discounted back at 25%. This target implies that, as C225 advances through its final phases of human testing and attains commercial status early next year, we believe that revenues associated with the drug can be appropriately valued in line with the industry average." He also noted, "New data from the first 3 patients treated with refractory pancreatic cancer is extremely compelling and is incrementally positive to our investment thesis. While the formal results of this phase II refractory study are not expected to be available by the anticipated BLA filing in 2H00, it could provide the impetus for off-label usage that is not currently accounted for in our revenue forecast".

Colorectal and pancreatic cancers are not the only indications for C225. C225 is in a phase III trial of radiotherapy for head and neck cancer, a phase III trial in combination with Cisplatin for head and neck cancer, and a phase II trial in combination with Gemcitabine for pancreatic cancer, and a phase II trial for renal cell carcinoma.

ImClone's cancer vaccine BEC2 has been in a phase III multinational study with Merck KgaA for a little over two years of the five year study timetable.

Their IMC-1C11anti-angiogenesis drug has entered a phase I trial recently and their pipeline is growing more depth with multiple pre-clinical candidates with most centered around cancer indications.

This company is growing up fast. Time to look this one over before it becomes an adult.

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