High-density lipoprotein cholesterol (HDL-C) has been consistently documented as being inversely correlated with the incidence of cardiovascular atherosclerosis and coronary heart diseases. HDL-C clears LDL-C (low-density lipoprotein cholesterol) from the blood circulation and helps reduce the blood level of LDL-C, which has the tendency to adhere to the wall of arteries, causing inflammation and ultimately atherosclerosis. The world’s best selling class of drugs, statins, reduce the level of LDL-C and therefore significantly reduce the risk of cardiovascular atherosclerosis. It seems a logical idea that HDL-C could also be used as a therapeutic agent for lowering LDL-C. Has this avenue been ... Read more

Over the last several years, U.S. pharmaceutical companies have been aggressively investing in new drug discovery technologies such as high-throughput screening machinery, and relying on their application for the discovery of new drugs. In the long run, this may turn out to be productive but the approach has not yet yielded the expected results.

Japanese companies, however, continue to rely heavily on human talent in drug discovery research and have so far shunned away from large-scale dependency on machinery. This approach may have paid off at least for the time being. In the past five years, drugs discovered by Japanese companies ... Read more

“Science requires greater modesty. Our experience with AIDS underscores the importance of basic research, which gave us the technical and conceptual tools to find the cause in less than three years after the disease was first described… It has also become clear that finding the cause of an infectious disease is the alpha but not the omega of its eradication.”

Robert C. Gallo, M.D., and Luc Montagnier, M.D., Director of Institute of Human Virology, University of Maryland, Baltimore (R.C.G); World Foundation AIDS Research and Prevention, Paris (L.M.). In “The Discovery of HIV as the cause of AIDS.” N Engl J Med ... Read more

After a long drought since 2000, the IPO pipeline has seen some increased flow-through. In the third quarter of this year (2003), 21 companies became public entities, raising a combined $4.08 billion. There were only 5 IPOs in each of the first and second quarters.

The renewed interest coincides with a rising stock market. Amex has risen –% from its low on March — to the end of the third quarter. Some biotech companies seized the euphoric sentiment and filed IPOs. In the third quarter, there were 46 IPOs filed, including 32 filed after the beginning of August. Among the third ... Read more

Due to limited revenue potentials, drug development programs for rare diseases lack the vigor in drug programs for more prevalent diseases such as heart diseases and cancer. Nonprofit biotechnology companies are coming to the rescue.

It was reported in Nature Medicine (9:981, Aug. 2003) that a small nonprofit biotechnology outfit, The ALS Hope Drug Discovery Center (ALS-HDDC), has developed two drugs, ritonavir and hydroxyurea, for the treatment of amytrophic lateral sclerosis (ALS), a rare neurodegenerative disease of peripheral muscles. They are among six new drugs for ALS that are ready to enter human trials.

The concept of ALS-HDCC, formed two years ago, ... Read more

Biogen and IDEC to Merge, Confronting Slower Growth. Biogen IDEC is Third Largest Biotech Company

On June 23, 2003 Biogen, Inc. of Cambridge, MA and IDEC Pharmaceuticals, San Diego, CA announced plans to merge with a combined capitalization of $12 billion. IDEC shareholders will hold 50.5% and Biogen shareholders 49.5% of the combined companies. The combined company named Biogen IDEC will be headquartered in Cambridge, MA with current IDEC chairman and CEO William H. Rastetter, Ph.D. as Executive Chairman and current Biogen Chairman and CEO James C. Mullen as the CEO. Biogen IDEC will be the third largest biopharmaceutical company after Amgen ... Read more

In recent months, the U.S. FDA has shown its willingness to work closer with the pharmaceutical industry to bring drugs to market faster. Since Dr. Mark McClellan assumed the commissionership on Nov. 14, 2002, FDA has approved a number of new drugs with style and speed.

Dr. McClellan took heart from the awesome responsibility of the U.S. FDA, which regulates about 20% of all U.S. economic activities. The following are several aspects of the regulatory activities that the FDA is implementing:

-FDA has taken the initiative to include cancer specialists with hands-on patient care expertise such as clinicians from National Cancer Institute, ... Read more

If you have been skeptical about targeting one molecule as a therapeutic means to treat a complex disease with unknown etiology, then you’ll be pleasantly surprised. Drugs that treat rheumatoid arthritis by targeting tumor necrosis factor a (TNF-α) are such examples. We know that inflammation causes the pathology of the disease. It is widely known that autoimmune responses lead to the avalanche of inflammatory responses in rheumatoid arthritis. But we know little for sure about what incited the autoimmune reactions. In addition, dozens of molecules are involved in distinct pathways in the inflammation process. TNF-α is an important factor but ... Read more

Equity markets declined from December to January. Pharmaceutical companies faired better than the biotechs and the overall market. Pharmaceutical companies had a dismal 2002 (DRG index down 22%) as far as their stock prices are concerned. Recently, investors read the tea leaves again and realized that drug firms’ business wasn’t so bad after all. Prescription drug sales grew a still respectable 12% in 2002 compared to 17% in 2001.

Equity market contractions since March 2000 continue to constrain severely the capital flow into research and development stage biotech companies. Venture capital is scarce. The market remains very hostile to public offerings. ... Read more

Johnson & Johnson announced on Feb. 10, 2003 that it will acquire Scios Inc., Sunnyvale, CA in stock transactions worth about $2.4 billion. Scios’ lead marketed product, Natrecor, is a recombinant form of human B-type natriuretic peptide for treating acute heart failure and had total sales of $107 million in 2002. Scios also has an oral small molecule drug, SCIO-469, currently in phase II trial for treating rheumatoid arthritis. The compound is an inhibitor of p38 mitogen-activated protein kinase, which participates in the production of pro-inflammatory tumor necrosis factor-a. With Scios’ 2002 annual revenue of just $111 million, Johnson & Johnson ... Read more