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Biotech Sage Subscription BioTech Stock Report - Picking Up the Trial

March 31st 2003 Since February, ImClone System’s (NASDAQ:  IMCL) share price has forged ahead based on renewed interest in its cancer drug, Erbitux (a chimeric anti-EGFr [epithelial growth factor receptor], antibody for colorectal cancer. The sudden raise is due to ImClone's European partner, Merck KgaA (Merck), which has been conducting its own trials of Erbitux.

Meanwhile, Abgenix’s/NASDAQ:  ABGX share price has benefited from the renewed interest in ImClone. Abgenix is in collaboration with Amgen, in a 50/50 cost and profit sharing agreement in developing ABX-EGF, a monoclonal antibody EGF-receptor to treat cancers. The results of the Phase II trial of ABX-EGF in colorectal cancer are expected at the upcoming American Society of Clinical Oncology (ASCO) meeting, which will start on May 31st in Chicago. Overall, five trials of ABX-EGF in four indications are under way; colorectal cancer, renal cell cancer, non-small cell lung cancer and prostate cancer.

Potential catalysts for Abgenix share price appreciation include presentation of Phase II data for ABX-EGF in colorectal and renal cancer at ASCO, and the initiation of a pivotal Phase III clinical trial for ABX-EGF in mid-2003. The company also expects to file one or two investigational new drugs each year. The key to Abgenix’s profitability is the potential success of ABX-EGF. ABX-EGF has two advantages over Erbitux. First, ABX-EGF is a fully human monoclonal antibody, while Erbitux is a chimeric (contains some mouse) humanized antibody. And second, ABX-EGF has a better safety profile than Erbitux. These advantages could help ABX-EGF even if Erbitux receives FDA approval first. 

Risks for Abgenix include unfavorable results from the Phase II clinical trials for ABX-EGF, and to a certain extent, unfavorable results from competitors’ anti-EGFr candidates in clinical trials, which could be negative in terms of the perception of anti-EGFr therapy. Some 14 anti-EGFr drugs are in development, including ImClone’s Erbitux, AstraZeneca’s Iressa (the PDUFA date is May 5th), and OSI Pharmaceuticals’s Tarceva, so competition abounds for ABX-EGF.

Despite reports of pulmonary toxicities and deaths associated with Iressa in Japan, the FDA is likely to grant approval for Iressa in relapsed/refractory non-small cell lung cancer. Such news would validate the EGF receptor inhibitor class.

Nonetheless, Abgenix’s ABX-EGF has the potential to become a good drug. All ABX-EGF needs is convincing clinical data to support it. We’ve been looking for evidence that the drug is on course with its development, but it appears Wall Street is picking up the scent. Judging by Abgenix’s trading volume, interest is starting to rise. So, we’ll say the market must know something.

While Abgenix’s share price has risen about 50% and ImClone’s 67% over the past 2 months, Abgenix book value is about $7.00 compared to ImClone that is basically nothing. Additionally, both Abgenix and ImClone’s one year price target is $13. Abgenix, whose stock is trading around $8, looks certainly like a better deal than ImClone, which trades at around $16. Finally, Abgenix is involved in more than 30 collaborations with Big Pharma, biotech and genomics companies. Thus far, two of its collaborators, Pfizer and Amgen, have advanced antibodies to the clinic. So, rather than add more partnerships, Abgenix would like to expand existing partnerships. It intends to bring targets forward at a slower pace, clear out a preclinical backlog of candidates, and reduce cash burn so that it has 3 years of cash on hand by the end of 2003. The company also plans to partner product candidates earlier in the process, mostly at the preclinical stage. Abgenix is building a future.

 

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