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Biotech / Medical : HuMAB companies -- Ignore unavailable to you. Want to Upgrade?


To: Icebrg who wrote (497)2/20/2003 11:48:46 PM
From: Miljenko Zuanic  Respond to of 1022
 
Erik,

Majority of your comments were correct. ABGX is today different story than street believed (or hoped) two-three years ago However, I will put few slightly different views in perspective.

Timeframe for ABX-EGF approval (IF at all) is hard to predict. Frame should be from 2005 second half and up to 2007 first half. Significant rule will have IMCL patent and how will monotherapy data look. As you observed they didn’t said single word about ongoing combination trials (NSCLC and CC).

Regards the pipeline and IND generation, I hope that it is clear to anyone who follow sector, that +80% candidates failed (regardless when) because of the poor target selection, and > 20% because of the candidates itself. ABGX paid its price, as did AVERY bios that we know (and many will continue to pay high price). So, as long as they can form 50-50 collaborations where partners will contribute knowledge and money in selection and confirmation of the targets, I see as move forward not backward. Preclinical models and studies, if done throughfully and completely, is 80% of the work necessary to generate drug. Bit of the luck and doing clinical studies may be just time and money consuming, not sleepless time.

Second, one does not invest +150 millions in process science and manufacturing if he is not confident that it will need this part of the business. For this money it can generate three candidates in PII and let partner do and pay for rest.

Miljenko



To: Icebrg who wrote (497)2/27/2003 6:01:30 PM
From: Icebrg  Read Replies (1) | Respond to of 1022
 
Medarex's todo list for 2003.

At today's BIO presentation DD presented what he hopes MEDX will be able to achieve during the current year. Like last year the list isn't short. Let's hope that they succeed better in its implementation.

H1 2003
Expects to have data available at ASCO from phase II MDX-010 combination trial with GP 100 vaccine.

Expects to file:

IND for MDX-010 in breast cancer indication.

IND for MDX-010 in HIV indication

IND for MDX-067 which is cancer product developed in 50/50 partnership with OGS.

IND for MDX-214 which is an EGF-r targeted fusion protein.

Plus expects to enter into a number of corporate partnerships.

H2 2003.
Expects to initiate first phase III trial for MDX-010.

Expects to initiate multiple phase II trials for MDX-010.

Expects filing of IND for Colon Cancer product.

Expects at least 3 INDs from corporate cash and carry partners.

And to top it off. Even more corporate partnerships.

Erik