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Monday, 02/09/2009 1:54:54 AM

Monday, February 09, 2009 1:54:54 AM

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Important CEO Q&A from the company's web site:

Question: Good Morning.

What is the specific supporting strategy for the
statement: "This will be a very lucrative company indeed." In re: GenoDrugDiscovery.

Answer:

It currently requires $1 billion in investment, and 12 years of work, to bring a single new drug to market.

Most biotech companies focus on bringing a single drug to market. The hope is that theirs will be a "blockbuster" drug and earn $1-3 billion dollars a year for 5-8 years. The classic example is Amgen, whose drug EPOGEN revolutionized the dialysis industry, doubling Medicare's cost the first year it was introduced. Amgen remains the most successful biotech company in history, although it's currently in trouble because EPOGEN has competitors.

Even giant research pharmaceutical companies like Pfizer and Merck are thrilled if they can bring 1 or 2 new drugs to market every year. Like Amgen, big pharmaceutical companies are also in trouble because their pipelines are dry.

Now consider our position: since our last investment of roughly $1 million in early 2004, GenoMed has discovered about three thousand (3,000) genes for each of six common cancers. Each of these genes is a separate target. Each target could generate several new drugs. In other words, we have more targets than the entire pharmaceutical industry has ever made drugs against. That number is supposed to be something like 500. All the existing drugs target only 500 genes.

The human genome has 25,000 genes. So there are a lot more drugs to be made.

There are many other companies who boast lots of cancer targets. Anybody can use an Affymetrix chip to interrogate all 25,000 genes. But our SNPs operate upstream of the tumor-expressed genes that everybody else has. Because of the "cascades" in biology, blocking an upstream step is much more effective clinically than blocking downstream steps.

Put differently, it's a lot easier to stop the Mississippi River at its source at Lake Itasca, than to dam it in New Orleans.

So our targets trump everyone else's in terms of clinical efficacy. That means we should have no problems showing that our drugs stop the cancer. We've already shown this with one class of drugs, namely ACE inhibitors.

But that's not why 99.9% of new drugs fail. They fail mostly because of toxicity.

Here's another crucial GenoMed advantage.

Because we have so many thousands of high-quality targets, we can afford to throw most of them away. We can throw out the 99.9% of our initial drug leads that are toxic, and just focus on the 0.1% that are safe as well as effective.

No other drug discovery company can boast this.

Let me put this into numbers. We already have 3,000 gene targets for each of the following cancers: breast, colon, lung, ovary, pancreas, and prostate. Let's say we find 3 drug structures per gene target (or protein). That will give us 9,000 drugs for each cancer. Now, let's throw out 99.9% of them because they fail toxicity assays, which will be the first thing we run on any of these drugs. That still leaves us with 9 drugs per cancer.

It's no wonder that biotech investing has been so disappointing. Historically, biotech companies have focussed on mechanism, like the NIH. They've pursued drugs that were effective, but they only had the resources to pursue a single drug. But 99.9% of effective drugs fail because of unacceptable toxicity. So 99.9% of biotech companies, being one-trick ponies, fail.

GenoMed can beat these horrible odds, since we start with thousands of great targets, and can afford to discard most of them.

Large numbers: "that's the power of genomics(tm)."

To summarize, and just to make sure I answer your question: 9 new cancer chemotherapy drugs for each of six cancers (54 drugs), times $500 million per year per drug--let's be conservative here--adds up to a lot of revenue ($27 billion a year). Even if we produce only one new drug for each of six cancers, we'll still earn 6 x $500 M = $3 billion a year.

GenoMed investors will own a substantial piece of each drug, despite the $1 billion in dilutional investment required for each drug. With a little bit of luck, we'll be able to bring the new drugs to market for less time and money than currently. Genomics has forced us to create a new business model for the pharmaceutical industry-- the "peer-reviewed virtual pharmaceutical company(tm)" of collaborating scientists in academic labs, coordinated by GenoMed, and funded by financial institutions which have until now just been on the sidelines of the pharmaceutical industry.

Best regards,
Dave Moskowitz MD
CEO
GenoMed, Inc.

Quote from another Q&A session:

"We used the $1.1 million investment from 2004 to find about 5,000 single nucleotide polymorphisms for each of the 6 most common cancers in whites, namely breast, colon, lung, ovary, pancreas, and prostate. These SNPs, occurring in about 2,000 genes, are the basis of the next generation of cancer diagnostics and therapeutics. Although billions of dollars, and hundreds of groups, are trying to find disease-causing genes, we're the only group so far that has succeeded. We're currently looking for more investment to carry on the fight against cancer."

Use and importance of SNPs (per wikipedia):

Variations in the DNA sequences of humans can affect how humans develop diseases and respond to pathogens, chemicals, drugs, vaccines, and other agents. SNPs are also thought to be key enablers in realizing the concept of personalized medicine.[3] However, their greatest importance in biomedical research is for comparing regions of the genome between cohorts (such as with matched cohorts with and without a disease).


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