Making headlines in the biotech world are Chiron/NASDAQ: CHIR which is a targeted by Novartis to become a buyout candidate and Protein Design Labs/NASDAQ: PDLI, who recently announced its heart drug ularitide may work better and have fewer safety concerns than an existing treatment. As a result, both companies’ share prices had a nice gain.
On our radar screen is Atherogenics/NASDAQ: AGIX and its cardiovascular drug AGI-1067, which has the potential to treat coronary artery disease, a leading killer in the U.S., causing a million deaths every year. Given the frequency and seriousness of coronary artery disease, and the risk factors that are associated with cardiovascular disease such as high blood pressure, high cholesterol levels, smoking, and diabetes, which all lead to inflammation in the arteries; a treatment aimed at reducing inflammation would be very valuable. Inflammation is believed to be responsible for the formation of atherosclerotic plaques, and AGI-1067 is designed to block the inflammatory process.
The company expects to submit the final CART-2 data with AGI-1067 to a peer-review journal this year. However, publication will not occur until the end of 2005 or early 2006. The CART-2 data will provide a comprehensive look at AGI-1067’s Phase II results, including safety and impact on cholesterol and other inflammation factors in coronary artery disease. This could provide critical validation for AGI-1067 and credibility for management.
Meanwhile, the ARISE trial appears to be on track with the release of data expected in the second quarter of 2006. The results of the ARISE trial should determine whether or not AGI-1067 reaches the market. The ARISE trial seeks to show an improvement in-patient outcome as measured by cardiovascular events (number of deaths, heart attack, stroke and angina) vs. CART-2, which is designed to show a reduction in plaque volume. Thus, the ARISE trial has a higher hurdle to clear than CART-2. If the ARISE trial is successful, expect blockbuster potential for AGI-1067 since the strategy is to use the drug as a chronic therapy in combination with standard of care therapies, such as statins.
In our opinion, Atherogenics is a gamble, but if AGI-1067 can hit its clinical endpoints, it could be worth the risk. Remember, all of Atherogenics’ fortune is tied to AGI-1067 and with positive data its share price could increase significantly. In the interim, Atherogenics needs to sign a partnership to prepare for AGI-1067 commercialization.
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