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Company Information |
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Genomed, Inc. |
Symbol: GMED |
Exchange: OTC |
Sector: Preventive Medicine |
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Share Related |
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S/O: 221,170,711 |
Float: NA |
52 Wk: .0011 - .017 |
Recent: .005 |
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Contact Information |
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Contact: David W. Moskowitz |
Phone: (314) 983-9933 |
Fax: NA |
E-mail:
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Company Profile
 Editor's Comments
President Obama sponsored the Genomics and Personalized Medicine Act of 2007 - a bill which was aimed at accelerating genetic research and regulating DNA testing. Saving money in heathcare is a top priority for Obama and 2009 should be an interesting year for the sector.
Here's an excerpt from Obama's introductory remarks to the bill:
"We know that all human beings are 99.9 percent identical in genetic makeup, but differences in the remaining 0.1 percent hold important clues about the causes of disease and response to drugs. Simply put, the study of genomics will help us learn why some people get sick and others do not, and use this information to better prevent and treat
disease.
The relatively new field of genomics is key to the practice of personalized medicine. Personalized medicine is the use of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, and help determine a patient''s predisposition to a particular disease or condition. Personalized medicine represents a revolutionary and exciting change in the fundamental approach and practice of medicine.
Pharmacogenomics, or the study of how genes affect a person's response to drugs, is a critical component of personalized medicine. Currently, so-called blockbuster drugs are typically effective in only 40 to 60 percent of patients who take them. Other studies have found that up to 15 percent of hospitalized patients experience a serious adverse drug reaction, causing an estimated 100,000 deaths each year. Pharmacogenomics has the potential to dramatically increase the effectiveness and safety of drugs, both of which are major health care concerns."
from: Genomics and Personalized Medicine Act (S.976)
According to Ricardo Alonso-Zaldivar of the Associated Press, "Now the pursuit of "personalized medicine" is expected to get a major push from the incoming administration of President-elect Barack Obama." (see article)
According to Ken Powell of the GLG Group, "Obama's election bodes well for diagnostic test manufacturers and commercial reference labs that provide "personalized medicine" diagnostics that link the right patient with the right therapy. Obama supports advancing personalized medicine and increased funding for research. The clinical diagnostics market will be transformed by new developments in molecular diagnostic tests that deliver this treatment critical information and in return will reward diagnostic test developers with higher margins."
And a report issued recently by the Deloitte Center for Health Solutions, showed "significant opportunities for the adoption of personalized medicine to produce a positive return on investment across key stakeholders in the U.S. health care system."
"Personalized medicine is not a promise of the future; it is fast emerging as the current state in diagnostics and therapeutics," said Terry Hisey, vice chairman and U.S. industry leader for Deloitte LLP's Life Sciences industry group.
The continued trend toward M&A and partnerships may also pick up as personalized diagnostic companies may become prime investments or acquisition targets. New strategies to integrate marketing, sales and distribution with companion diagnostics will need to be considered to improve the cost effectiveness of these activities." (see article)
The Company
GenoMed is a Next Generation DMtm company that uses medical genomics to improve patient outcomes. GenoMed is working to translate knowledge of medical genomics--the study of which genes cause disease--into clinical practice. GMED combines biotechnology with Disease Management (DM). The Company develops new and better drugs, uses existing drugs for new disease indications, and uncovers disease before symptoms arise. By studying disease genes, GMED hopes to make medicine more proactive and disease prevention more effective.
Business Segments
Drug discovery: Once GenoMed identifies a disease gene without any existing therapy, the company pursues strategic alliances with large, research-oriented pharmaceutical companies to develop new drugs against the target.
Using existing drugs for new clinical indications: Occasionally, knowing a disease gene can make an existing drug more effective. For example, GenoMed has demonstrated that a proprietary regimen of an existing ACE inhibitor can dramatically delay the progression of end-stage kidney disease due to Type 2 diabetes or hypertension in both African American and Caucasian men, as well as the progression of peripheral vascular disease, and even emphysema. This is the first time an ACE inhibitor has been found to be useful for emphysema.
Gene-based diagnostic tests: Knowing the genes which cause a disease allows a physician to diagnose that disease before symptoms ever become visible. In clinical medicine, the earlier the diagnosis, the better the clinical outcome.
Competitive Position
Like the science of genomic medicine, GenoMed takes a targeted and efficient approach to finding and commercializing disease genes. GMED's past experience in medical genomics has helped the Company to identify a class of single nucleotide polymorphisms (SNPs) that it believes has strong associations with all common diseases. GMED uses the least expensive, fastest throughput genotyping currently available in the world. The Company's ability to move much more quickly than larger, more bureaucratic corporations maximizes its intellectual property produced per dollar spent.
History
GenoMed was inspired by Dr. David Moskowitz's research on the angiotensin I-converting enzyme (ACE) gene during the mid 1990s. His lab discovered that ACE was a "master" disease gene. ACE was found to be associated with about 160 common, serious diseases such as type 2 diabetes, common cancers (except for prostate and breast), and psychiatric diseases. Moskowitz, a nephrologist, treated 1,000 of his own patients based on his knowledge of diseases caused in part by ACE. His early efforts produced dramatic results -- the rate of progression of kidney disease due to high blood pressure was reduced by an average of 300% in both African American and Caucasian male patients. Through this new treatment, patients who normally reached dialysis in 4 years were not predicted to reach end-stage kidney disease for 16 years. Patient outcomes for kidney failure due to type 2 diabetes, atherosclerotic peripheral vascular disease, and emphysema (COPD) were equally exciting. In February 2001 Moskowitz founded GenoMed with the help of industry veterans Jerry White, Richard Kranitz and Peter Brooks.
Patents and Patent Applications
Issued:
Patent number: 6,998,404
Treatment or prevention of acute renal failure
Patent number: 6,939,534
Method to treat pulmonary hypoplasia in the newborn
Pending Patents:
Patent application#: 20020197632
Method to find disease-associated SNPs and genes
Patent Appliaction #: 20030040509
Methods and compositions for treating diseases associated with excesses in ACE
Patent Application#: 20060135422
Use of angiotensin receptor blockers (ARBs) to treat diseases associated with excess ACE
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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