Biotech investors are unusually quiet for this time of year. Over the past few years the biotech sector has dominated the news coming out of the annual American Society of Clinical Oncology (ASCO) meeting, the world's most important cancer conference. And their stocks typically start moving a week or two ahead of the meeting in anticipation of those headlines.
But if there's a spotlight to steal at ASCO this year, it's likely to be nabbed by big pharmaceutical companies. When some 25,000 cancer specialists, investors, and reporters gather in Atlanta from June 2-6, few major announcements are expected, and the most highly anticipated of those will come from Bristol-Myers Squibb, GlaxoSmithKline (GSK), and Pfizer (PFE).
BREAKING THROUGH. So the traditional pre-ASCO bump is nowhere to be seen in biotech stocks this year. And because oncology drugs form only a small portion of the sales of large pharmaceutical makers -- very few cancer drugs ever hit blockbuster status, defined as $1 billion in annual sales -- they aren't getting an uptick, either. Preconference stock rallies or no, patients and cancer specialists are very interested in the ASCO data, particularly any studies of drugs for patients who have grown resistant to existing medicines, a common problem in cancer treatment.
In that vein, Bristol-Myers Squibb's Sprycel will be one of the most closely watched drugs at the meeting, and UBS Investment Research recently issued a report saying it expects ASCO to be a positive for Bristol's stock. Sprycel is an experimental drug aimed at patients with chronic myeloid leukemia (CML) who have grown resistant to Gleevec, Novartis's (NVS) breakthrough cancer drug.
Gleevec heralded a new age in cancer drugs when it was approved five years ago. The drug targets a specific cellular mechanism that causes deadly CML, with few side-effects. But a large percentage of patients eventually develop resistance. Bristol plans to present results of a head-to-head trial comparing Sprycel to Gleevec.
TARGETING GENETIC FLAWS. But the drug will gain even more attention as the focus of a Food & Drug Administration advisory panel meeting held at the site of the ASCO meeting on June 2. The FDA has already said it will ask the committee to consider whether a dose of Sprycel lower than the 70 milligrams studied in clinical trials would be appropriate in order to reduce side-effects. A vote to accept the drug would be good news to holders of Bristol, which filed for FDA approval of the drug in December, 2005.
While Bristol tries to eclipse Gleevec, Glaxo will attempt to do the same to Genentech's (DNA) Herceptin, a best-selling breast cancer drug. Glaxo's Tykerb targets the same genetic flaw as Herceptin, but it is a pill, making it easier to administer than Herceptin, which must be given by infusion. Some 13 studies on Tykerb will be presented at ASCO.
One to watch: A Phase 3, or late-stage, trial of Tykerb in Herceptin-resistant women. Enrollment in the trial was stopped in April ahead of schedule because a sufficiently large number of women receiving Tykerb combined with standard chemotherapy did better than those receiving chemo alone. Glaxo should also score points at the meeting with updates on its cervical-cancer vaccine Cervarix, for which it plans to seek FDA approval this year. As promising as Cervarix may be, the drug is lagging behind Merck's Gardasil, another cervical-cancer vaccine expected to win approval in June.
LAST YEAR'S STAR.Genentech dominated ASCO the past two years with data on Avastin and Tarceva, two of the most advanced cancer drugs on the market. Although Genentech will present no major new data at the meeting, there will be some 160 presentations on Avastin, Tarceva, Rituxan, Herceptin, and others in its pipeline. Celgene (CELG), another biotech firm, should also gain attention with data on its two drugs for blood cancer, Thalomid and Revlimid. Thalomid just won FDA approval for multiple myeloma, and Revlimid is widely expected to gain an FDA nod by the end of June.
Data will be presented this year on another one of last year's stars, Pfizer's Sutent. The data will look at the drug's efficacy against other types of cancer, most prominently lung cancer. The FDA approved Sutent in January for kidney cancer and a rare type of stomach tumor, but Pfizer is hoping to expand the drug's indications to other forms of cancer. Oncologists will be particularly interested in how the new data on Sutent stack up against Nexavar, a rival drug from Onyx Pharmaceuticals (ONXX) and Bayer (BAY).
Of course, there's a chance of breakthroughs on drugs that have been little noticed in the run-up to the conference. Given that many new drug test results will be presented on Saturday and Sunday, news over the weekend could prompt big buying -- or selling -- come Monday.