Biotechs To Soothe The Heart
Since February has been designated “Heart Month,â€
I feel obligated to shed some light on two biotechs with some very exciting
drugs in the developmental pipeline. There are attractive qualities of these two
companies that will garnish a significant amount of investor attention as their
drugs approach the FDA.
The first is that both companies are developing drugs that approach the targeted
disease in a very unique way. When a company’s new drug is described as a
“novel approach†to treating a disease, this always
raises an investor eyebrow. Any new drug that works and acts in a unique way,
different from today’s drugs on the market, has the potential to be watched very
closely by investors and doctors as it proceeds through human clinical
trials. If this “novel drug†happens to be successful and pass the FDA’s
decision board, most often the company’s stock reaction will be
significant. Both companies talked about in this article have drugs that are
“novel†in their approach to their specific targeted disease.
In addition to a “novel approach,†investors also like to see new drugs in
development targeted at big disease markets. The number one disease market today
is cardiovascular or heart disease. Cardiovascular disease remains the number
one killer of people in this country today and this will not change in the
foreseeable future. Cancer still runs a close second, followed by cerebral
vascular accidents or stroke. Companies hoping to develop blockbuster new drugs
need to aim for one of these large disease targets in order to be financially
successful. Well, both companies that I am about to discuss follow this
“big market†rule with their “novel†drugs, with
both aimed at the multibillion-dollar cardiovascular market. With their drugs
exploiting new approaches to treat cardiovascular disease, both companies are
developing a recipe for strong long-term gains.
CV Therapeutics
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CV Therapeutics is a
company developing new drugs to treat heart disease, specifically chronic angina
and common heart arrhythmias. The company’s lead drug, Ranexa (Ranolazine), is
designed to treat patients with chronic angina due to coronary artery
atherosclerotic buildup. Chronic angina affects more than 7 million people in
this country at a rate of 400,000 per year. The disease is common over the age
of 55 and costs the system billions in health-care dollars. This is one of the
biggest disease markets for any new drug and CV Therapeutics has the edge.
The unique aspect about Ranexa is its mechanism of action. The drug acts in a
“novel way,†unlike any drugs on the market today. It partially inhibits fatty
acid oxidation and the subsequent buildup of atherosclerotic plaque in the
coronary arteries. No drugs currently on the market do this and Ranolazine is
the first new class of anti-anginal therapy (called pFOX inhibitors) to come
along in more than 20 years.
CV Therapeutics filed its New Drug Application for Ranolazine with FDA on
December 30, 2002. It has been extensively studied in thousands of patients and
so far, the clinical data looks good. In talking to cardiologists, this drug has
all the earmarking of a potential blockbuster if it gets approved. So far,
nothing I have seen about it has convinced me otherwise. Knowing the FDA
timeline, the FDA should act on this drug sometime by the end of the year.
In addition to having a potential blockbuster drug in front of the FDA, CV
Therapeutics also has a pipeline of new drugs, all aimed at big market
diseases. The company has a drug in phase three clinical trials (Tecadenosen) to
treat atrial arrhythmias commonly observed in the elderly population. Look for
the release of data on this “novel therapy†sometime this year. In addition, CV
Therapeutics is developing a new drug with Biogen (Adentri) to treat acute and
chronic congestive heart failure. One can only see Scios Corporation’s
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success with its new congestive heart failure drug to appreciate the potential
of CV Therapeutics’ Adentri.
On a final note, CV Therapeutics will present several abstracts at this year’s
annual meeting of the American College of Cardiology at the end of March. The
bottom line here is that there are a lot of investor (including big brokerage
houses) eyes focused on this company. I believe the company has a lot to look
forward to this year and beyond. Â
Atherogenics
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Unlike CV Therapeutics,
Atherogenics does not have a new drug on the verge of potentially getting
approved by the FDA. However, I believe it has something better. The company’s
lead product is a new drug (AGI-1067) aimed at the huge coronary artery disease
market. The drug acts by reducing inflammation in the wall of blood vessels,
inflammation that has been strongly linked to the buildup of atherosclerotic
plaque. The entire concept of inflammation being a major factor in the buildup
of plaque in the coronary arteries has only recently been brought to the
forefront.
To support this, it was only a few short months ago that the medical
establishment touted a new and strong predictor of heart disease, the C-reactive
protein (CRP). The C-reactive protein is a known player in the inflammatory
process often seen in other diseases such as rheumatoid arthritis. Now, this
protein is linked to heart disease and the buildup of plaque in the coronary
arteries. This is supported by a recent study just published confirming that
people with rheumatoid arthritis are at increased risk for a myocardial
infarction. The C-reactive protein can be simply measured through a blood test
in order to predict your risk for a heart attack.
Atherogenics, with its new drug, may hold the key to this entire
inflammation-heart disease puzzle. If this drug does turn out to be the key,
then watch out because it has all the characteristics of being a blockbuster. It
is a “novel way†to treat a “big market†disease with potential overlap to other
inflammatory-associated diseases. The drug is currently in phase three clinical
trials (called the ARISE trials) and the company is keeping a tight lid on the
timeline to release any data. I don’t see it happening anytime in the next six
months.
In
addition to AGI-1067, Atherogenics also has drugs in the clinical pipeline
(phase II) to treat rheumatoid arthritis and to prevent organ rejection. Like CV
Therapeutics, Atherogenics has a lot of investor eyes watching its growth and
development. Both companies remind me of a vintage year harvest cabernet that
needs to be put to cellar for a while to mature to its full potential.
On a final note, the company I alluded to at the end of
my last piece is unfortunately a private company and inaccessible to public
investors as it approaches an FDA decision on Feb. 28. The public company I had
researched is also developing a new technique to treat wrinkles (Isolagen-ILO).Â
However, its turn in front of the FDA will come later in the year, and not on
Feb. 28.
Paul Ruggieri, MD, FACS
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