It looks like the ASCO floodgates have busted wide open, based on yesterday’s biotech’s wild ride. The momentum all started last week with Genentech’s (DNA | Quote | Chart | News | PowerRating) release of positive phase III data on its new anti-angiogenesis drug. The instigator yesterday was ImClone (IMCLE | Quote | Chart | News | PowerRating), with a news release before the opening bell. The company stated it would receive a $6 million milestone payment from its European partner Merck KGaA related to the upcoming release of phase III data on its new drug Erbitux in patients with metastatic colorectal cancer. The full data will be presented at the upcoming ASCO meeting, data eagerly awaited by investors. ImClone was a big winner yesterday and seems to continue the momentum in the biotech sector leading up to the ASCO meeting this weekend. Momentum all started by Genentech last week.
Since my May 19 article on the companies with the most to gain at this meeting, the so-called “Big Four,” ImClone has performed the best, up 32%. The others, Genentech (up 20%), Millennium Pharmaceuticals (MLNM | Quote | Chart | News | PowerRating) (up 7%), and OSI Pharmaceuticals (OSIP | Quote | Chart | News | PowerRating) (up 6%) have also performed well. I believe there is still much more to come once the ASCO meeting gets started on Friday.
The FDAWith all the excitement surrounding the influence of the upcoming cancer meeting on stock prices, one would think the FDA might feel a little left out. Well, it doesn’t appear that way for long. On Thursday, May 29, the FDA will show its muscle. The FDA’s Circulatory System Devices Advisory Committee will make a decision on the pre-market approval application of Cardima’s (CRDM | Quote | Chart | News | PowerRating) new minimally invasive treatment approach to atrial fibrillation. This company has developed a catheter system called REVELATION that will allow cardiologists to treat this common heart arrhythmia with minimally invasive techniques and potentially avoid major surgery.
Atrial fibrillation is commonly treated with
medication, including blood thinners. However, this medication can have
significant side effects and does not work in a number of patients. In those
patients, major open-heart surgery is an option. Surgery is effective in
destroying the abnormal heart tissue responsible for this arrhythmia. However,
the operation is very invasive and carries with it some morbidity and
mortality. Cardima’s technology allows for a minimally invasive approach to
treat patients with atrial fibrillation who do not respond to medication. The
technology is already approved in Canada. Look for this stock to be in play.
In addition, the FDA’s Cardiovascular and Renal Drugs Advisory
Committee will also meet on Thursday to discuss Bayer AG and
GlaxoSmithKline’s (GSK | Quote | Chart | News | PowerRating)
new drug Levitra for the treatment of erectile dysfunction. Specifically, the
FDA will discuss the cardiac risks potentially associated with the use of this
drug. Levitra is one of the major potential competitors to
Pfizer’s (PFE | Quote | Chart | News | PowerRating) blockbuster Viagra, along with
ICOS (ICOS | Quote | Chart | News | PowerRating) and Eli Lilly’s
(LLY | Quote | Chart | News | PowerRating) Cialis. Any potentially negative news coming out of this meeting on Thursday
will have an immediate impact on all the companies in the erectile dysfunction
space.
Good Luck,
Paul Ruggieri, MD, FACS