Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Abgenix, Inc. (ABGX) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (216)	6/2/2003 8:24:49 AM
From: mopgcw	Read Replies (1) \| Respond to of 590

From GS: Stock rating: In-Line Coverage view: Neutral Small-Cap Growth Price: US$10.64 June 2, 2003 ABGX (IL/N): Encouraging interim PII ABX-EGF data in colorectal cancer 52-Week Range US$13-5 YTD Price Change 44.37% Market Cap US$933.7mn Interim data from a Phase II study with ABX-EGF, in development with Amgen, were reported at the American Society of Clinical Oncology meeting in Chicago on 5/31/03. Although a relatively small study, we regard the data as encouraging so far, with an approximate 10% response rate with ABX-EGF as monotherapy in advanced patients who had failed other regimens. This study is continuing to enroll as are four other studies. We expect additional data will help map the course for potential pivotal studies. ABX-EGF is the company's lead candidate. With the recent approval of Astra Zeneca's Iressa and encouraging data on Bristol/ImClone/Merck KGA's Erbitux, we think that there is strong interest in the EGF class. Further, we believe that ABX-EGF may have potential side effect advantages relative to other antibodies. We maintain In-Line rating and Neutral coverage view. Key risks include potential clinical failures, long development timeframes and volatility in the biotech sector. INVESTMENT OUTLOOK: We believe that Abgenix represents an attractive opportunity for long term oriented investors with a high risk tolerance. Abgenix is distinguished by its ability to make fully human antibodies to a broad range of targets, a platform technology that can fuel an expansive, diversified pipeline. Abgenix has established a blue chip partner list and has the potential to develop a growing roster of proprietary therapeutic antibodies. Over the next several years, we expect a range of new antibodies to enter the clinic on a proprietary and partnered basis. The main clinical data to be presented over the course of 2003 and 2004 will be Phase II results with cancer antibody ABX-EGF. I. Encouraging interim Phase II data in colorectal cancer ABX-EGF is a fully human antibody to the EGF receptor, which is over- expressed in a range of cancers. Abgenix and partner Amgen, are developing ABX-EGF in a number of different oncology applications. A series of Phase II studies are underway in renal, colorectal, prostate cancer and non-small cell lung cancer. Interim colorectal cancer data presented at ASCO Data were reported from an interim analysis of one of two open-label trials with ABX-EGF ongoing in colorectal cancer. This study includes patients who are refractory to chemotherapy, including the Saltz regimen. Some patients were also refractory to oxaliplatin. Data were reported on 40 patients evaluable for efficacy (having had at least 5 EGF doses) and on 44 patients on an intent to treat basis. The study will include 150 patients (expanded from 100 to get more data on oxaliplatin treated patients) who will receive monotherapy intravenous infusions of 2.5 mg/kg of ABX-EGF weekly over an 8- week treatment cycle, for up to 6 cycles. The endpoints of the trial are tumor response rates and time to progression. At 8 weeks, 4/40 patients had partial responses (RECIST criteria -greater or equal to 30% tumor shrinkage) and 22 patients had stable disease. We regard a 10% response with ABX-EGF in such advanced patients who had failed other therapies as an encouraging start. Similar response rates have been observed with optimized chemotherapy in second line patients. As expected, the most common adverse events were mild to moderate skin rash. Skin rash is a common side effect of the class and may be correlated with response. No patients reported allergies or experienced anaphylaxis or antibody formation. To date, diarrhea has not been observed as it has with some of the oral agents. Lack of infusion reaction and anaphylaxis could potentially differentiate ABX-EGF from some of the other antibodies. II. Other EGF studies underway. In the second trial in colorectal cancer, initiated in January 2002, up to 84 patients will receive weekly intravenous infusions of 2.5 mg/kg of ABX- EGF in combination with standard doses of irinotecan, leucovorin, and 5- fluorouracil (Saltz regiment) over a 6-week treatment cycle, for up to eight cycles. prostate cancer In January 2002, Abgenix initiated a 50-patient, multi-center, open-label Phase II study of ABX-EGF in prostate cancer patients who are failing hormone replacement therapy. In this trial, patients will receive intravenous infusions of 2.5 mg/kg of ABX-EGF weekly over an 8-week treatment cycle, for up to 5 cycles. The primary efficacy endpoint of the study will be measured by prostate specific antigen (PSA) response rates (decrease of PSA level by >50% compared to baseline). This study is intended to be a proof of principle study as PSA levels are not an accepted primary endpoint. renal cancer Positive initial Phase II data on ABX-EGF as monotherapy in 88 advanced kidney cancer patients were reported at ASCO in May, 2002. At 8 weeks, stable disease was achieved in 50% of the patients. We believe this is a strong start given the severity of the patients studied, and the fact that ABX-EGF was studied as monotherapy. The second part of this study will assess less heavily treated pretreated patients and has enrolled 115 new patients. Competition Several companies are pursuing anti-EGF approaches to cancer, some of which are further ahead than Abgenix. However, we believe that the market is large enough to support multiple players. Further, until the relative risk/benefit of each candidate is determined, it will be difficult to predict the ultimate winners. Advanced programs include Astra Zeneca's Iressa, approved, Bristol Myers Squibb/ImClone's Erbitux, (NDA application not accepted) and Genentech/Roche/OSI's Tarceva, an oral EGFr inhibitor in Phase III studies. Abgenix is also developing an antibody to epidermal growth factor receptor version 3 (EGFrvIII), which could be a more selective target. === 2003 milestones === * Phase II data for ABX-EGF monotherapy in second and third line colon cancer at ASCO - Fremont manufacturing facility to come on line === 2003/2004 milestones === - Phase II ABX-EGF monotherapy time-to-progression data in renal cancer - Phase II data for ABX-EGF monotherapy in prostate cancer - Phase II data for ABX-EGF combination therapy in non-small cell lung cancer - Phase II data for ABX-EGF combination therapy in first-line colon cancer - Phase I data for ABX-MAI in cancer * Milestone attained I, Meg Malloy, hereby certify ..

To: Icebrg who wrote (216)	6/2/2003 6:00:14 PM
From: Icebrg	Read Replies (2) \| Respond to of 590

Puncturing The ImClone Hype Matthew Herper, 06.02.03, 10:14 AM ET [I will park this here, as Erbitux future has a lot of relevance for ABX-EGF] NEW YORK - Could ImClone Systems' Erbitux be a powerful cancer fighter after all? Maybe. A new study presented June 1 at a meeting of oncologists seems to boost that contention. But there are still reasons to doubt that Erbitux will be approved soon or that it will eventually be a blockbuster. Wall Street bid ImClone (nasdaq: IMCLE - news - people ) shares up 20% today on positive results from the study, but the party is premature. A comparison with Genentech's (nyse: DNA - news - people ) Avastin, another medicine against colon cancer that's being studied, reveals how full of hype the Erbitux story still is. Merck KGaA, which has the rights to sell Erbitux in Europe, conducted the new trials, which were presented at the annual meeting of the American Society of Clinical Oncology in Chicago. In this large, randomized study, Erbitux shrank colon cancer tumors by at least half in 23% of patients when used with chemotherapy, and 11% when used alone. Those numbers mirror the results ImClone boasted of in 2001, before the U.S. Food and Drug Administration rejected a new drug application on the grounds that the data were not sufficient to prove that Erbitux worked. Merck KGaA, which is distinct from the U.S. company of the same name, will use this new data to try to get Erbitux approved in Europe. ImClone and its U.S. partner, Bristol-Myers Squibb (nyse: BMY - news - people ), issued a statement saying they will talk with the FDA about trying to get U.S. approval as well. The new data do offer proof that Erbitux has a role in fighting colon cancer, but that does not necessarily mean the FDA will be satisfied. One doctor who has been involved with clinical studies of both Erbitux and Avastin says there is reason to be doubtful. "Is this a potentially effective drug for cancer patients? Absolutely," says Alan Venook, a professor of clinical medicine at the University of California at San Francisco. "But I'm not sure this data is enough to get a drug approved." Richard Evans, a pharmaceuticals analyst at Bernstein, made a similar point in a note to investors this morning. "Merck KGaA's European Erbitux trial is strong enough to demonstrate that Erbitux works," Evans wrote, "but the poor trial design will likely render Merck KGaA's trial insufficient for Bristol-Myers to file with the FDA." Evans still forecasts that the drug will be approved after more clinical trial data becomes available, and he projects 2007 sales of $400 million. One problem: The Erbitux trial lacks a control group or a comparison to conventional chemotherapy, so the study does not show clear survival benefit. Venook will be heading up a clinical trial with Erbitux and chemotherapy in previously untreated patients for Bristol and ImClone, and that could help further answer questions about the drug's effectiveness. In the meantime, Venook says the real star right now is Avastin, the first cancer drug to work by inhibiting blood flow to tumors by blocking a protein called the vascular endothelial growth factor (VEGF). When added to chemotherapy, Avastin improved the survival of untreated colon cancer patients by 50%; patients who took Avastin lived 20.3 months, six months longer than those who received only chemotherapy. Venook says Avastin is a "monumental" advance, while Erbitux is merely "incremental." He was on an independent committee that Genentech formed to monitor the data coming from its tests of the drug, and he was impressed by how conservative the company was. "Genentech is to be credited for really good drug development," he says. "They're not overstating what they have right now, nor have they raised expectations. This is really an example of doing it right." In contrast, ImClone's development plan--not least its relationship with the FDA--has been seriously botched so far. Moreover, the company is in near total disarray. Former Chief Executive Samuel Waksal is awaiting sentencing in New York; his brother Harlan took up the CEO mantle and then dropped it. Companies like Millennium Pharmaceuticals (nasdaq: MLNM - news - people ) and Novartis (nyse: NVS - news - people ) have received approval for cancer drugs without proving that they extend survival, but those efforts have involved carefully crafted messages. They also involved evidence at the molecular level that the drugs reduced cancer--something ImClone doesn't really have. In the meantime, there are still other scientific dragons to slay. Doctors will no doubt want to test Avastin and Erbitux in combination and may even add other drugs like AstraZeneca's (nyse: AZN - news - people ) Iressa or a new VEGF pill being developed by Novartis. Amgen (nasdaq: AMGN - news - people ) and Abgenix (nasdaq: ABGX - news - people ) are developing their own drug, which is similar to Erbitux. None of the medicines are cure-alls. "With all of these agents, the real problem is that patients benefit, but it's really only 10% or 20% of patients who benefit," says Venook. "Can't we figure out who benefits and who doesn't?" That will be the next step: using genetic tests and other methods of separating those patients who will be helped from those who will not.