We don’t have much interest in Big Pharma here. Big pharmaceutical companies simply don’t yield really dramatic returns. Usually, it takes a small-cap or start-up to do that. Until recently, the odds were stacked against small companies, due to the costs of drug approval, which have become enormous.

Regulators may have the right motives, but bureaucracies are necessarily risk averse. Approving a drug that ends up killing a few dozen people unexpectedly will end a career. Refusing to allow a drug onto the market that could save thousands of lives has little career risk. As a result, it has become increasingly difficult and expensive to get a drug to market.

In the last few months, however, we’ve seen a number of new drug treatments based on the convergence of nanotech and biotech. These drugs haven’t come from giant companies, however. They’ve come from small labs and companies thinking outside the traditional pharma box. This trend may help sidestep the FDA barrier while providing remarkable investment opportunities.

The basic strategy being exploited is to use a nanotech structure to increase the efficiency of an existing drug. Contrary to the common misperception, not all nanotech structures are complex or metallic. Many researchers, in fact, prefer the term “molecularly precise.”

One molecularly precise structure of interest is the polymeric micelle. Many of these molecularly precise structures are made of common, benign components that self-assemble under the right controlled conditions. Researchers have found ways to use them to enclose other drug molecules for a variety of purposes. These micelles are not pharmaceutically active themselves, so they offer little biological hazard.

Researchers at Children’s Hospital Boston have used the technique to resurrect TNP-470, one of the first drugs tested that blocks angiogenesis. Angiogenesis is the unnatural growth of blood vessels that enable, among other things, tumor growth. TNP-470 is known to be effective against a broad range of cancers. The problem with the drug is that the body breaks it down easily, requiring high doses that may cause neurological side effects.

New tests on mice of the drug encapsulated in polymeric micelles have shown extraordinary effectiveness. The nanoparticles protect the TNP-470, taken orally and absorbed intact. Once the nanoparticles reach the tumor, they break down, slowly releasing the drug. Because angiogenesis is also involved in macular degeneration and other diseases, the drug and basic technology is of serious interest. Currently, the rights to the convergent drug, lodamin, are held by SynDevRx Inc., which is not yet traded. We’ll be watching as it and similar ventures approach IPO.

Yours for transformational profits,

Patrick Cox
July 24, 2008

The Start to the Convergence Revolution was originally featured in the Penny Sleuth.