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Growth Strategies for the Pharmacogenomic Market
By leveraging our proprietary technologies, we are positioned to serve the growing compliance and operational needs of pharmaceutical companies. We will continue to seek product and market relationships that expand and enhance our ability to apply our technology to existing medications or new medications, improving drug efficacy and reducing patient side effects by testing the patient. We believe the future of drug development and drug approval as outlined by recent FDA writings will force the industry to recognize smaller market opportunities with higher efficacy profiles and significantly reduced or diminished side effects. No drug available today is free of side effects on a broad population from around the world. All drugs have side effects, some more deadly than others, but the side effects are often balanced against the potential benefit. For example most cancer treating medicines are lethal to the patient if administered at a higher dose, but more lethal to the cancer cells at lower doses. However, these anti-cancer drugs kill healthy cells as well as cancer cells, creating a dilemma -- treat the cancer and harm the patient, do not treat the cancer and the patient dies. In medicine, there are no miracle cures; each drug appears to have a specific and narrow range of application to certain groups of individuals and may or may not provide a benefit to each and every patient and may in fact kill some patients. The power of pharmacogenomic testing or the testing of patient populations for genetic markers and other inherited traits can be seen in the recent treatment of a particular form of cancer.
An article in MedAd News in June 2003 titled, "From Blockbusters to Multibusters" highlighted the first successful use of pharmacogenomics to obtain the approval of a drug. Genetech's Herceptin(TM), according to IMS Health sources, would not have made it to the market had not the company's scientists discovered the HER-2 receptor which is found in 15-20% of the population. The overall success rate of the drug in metastatic breast cancer in combination with Taxol is just 6%. But with the HER-2 test to identify the patient, the drug's efficacy is now nearly 100%. Sales of the drug are projected to approach $400 million in 2003. Additionally, nearly all the female patients diagnosed for metastatic breast cancer are tested for the HER-2 receptor, generating additional sales for a pharmacogenomic test procedure not included in the $400 million in drug sales for 2003. We have located no reported figures specifically for the size of the diagnostic test market for HER-2.
This article highlights the potential explosion of pharmacogenomics and drug approval within the pharmaceutical industry. If drugs are approved faster, the current 400 drug targets that represent about $380 billion in potential sales could leap to 4,000 targets with sales approaching $1 to $2 trillion by 2020. We have no assurance, however, that the FDA and foreign governments would accelerate their drug approval processes to accommodate such a high projection. The FDA regularly reports on the drugs approved from year to year, and industry watchers continue to expect the FDA to increase its rate of New Drug Approvals from the current 40-50 per year to several hundred per year. However, there are no corresponding increases in funding to accommodate this exceptional projected growth. Therefore, we believe a more conservative approach to the potential drug market would include a review of the effect of pharmacogenomics on drug approval. Price-Waterhouse-Coopers recently issued a report titled `Personalized Medicine - The Emerging Pharmacogenomics Revolution' (February 2005). The report focuses on the high failure rate of drugs after an Investigational New Drug ("IND") is filed with the FDA -- nearly 79% of the drugs fail in clinical trials. The report suggests that better patient understanding and mechanisms of action within patient groups might help bring the failure rate down. Additional information indicates what physicians across the globe have been reporting for years, that blockbuster drugs or drugs that have worldwide sales of more than a billion dollars per year only work in 40 to 60 percent of the patients treated with the drugs. If these drugs express failures in sub-populations, then if enough fatalities are the result, the drug is voluntarily pulled from the market by the company or forcibly by the FDA. The net result is a large number of patients that have had positive experience with a drug are denied its benefits.
The Price-Waterhouse-Coopers report goes on to say that by stratifying the market opportunities for drugs; `pharmacogenomics could expand markets and revenues by defining new uses or targets for existing drugs, "rescuing" drugs in development, managing product life-cycles, and dominating niche markets.' The article goes on to point out some of the immediate demands for pharmacogenomic products in the clinical laboratory for determining a patient's response to medications earlier, rather than waiting several weeks to months and diagnosing diseases earlier. Additional improvements are being made in the third-party payers segment of the market, crucial to gaining acceptance for pharmacogenomics in clinical development, testing and practice. Many of the large third-party payers are drafting policies and procedures for a pharmacogenomics approach to drug applications once drugs are approved. Pharmacogenomics is not just about developing new drugs but also testing patients for potential side effect risks, emerging diseases and other potential disorders. Third-party payers would be remiss to pursue exclusionary practices with their subscriber populations as that will surely bring governmental oversight, punishment and new legal procedures that could be counter productive to the benefit of improving the overall health and efficacy of the drugs that their subscribers will all eventually use.
Additionally, the report highlights that the first likely application of a pharmacogenomics drug will continue to be the oncology area since by definition of the disease automatically places patients in disease categories which appear to be treatable by either a cocktail of chemotherapy agents or specific chemotherapy agents and practices. Further segmentation depending upon a patient's ability to absorb or metabolize medicines or to form chemotherapy resistant cancer cells are all pharmacogenomic targets and will help to more narrowly focus a patient's treatments. It is unlikely, according to the report, that blockbuster drugs will disappear, but it is likely that large pharmaceutical companies will gravitate toward more of the global marketing, sales and channel dominations that they are currently controlling and less likely to continue the high capital expenditures on research and development.
We can, through research and development, and over time, identify the genes involved with a patient's positive response to a drug. Once the genes have been identified, researchers are then able to find the receptors coupled to those genes; thereby providing a predictive test to determine those patients who will respond positively to the drug. In addition, we can identify the genes that are involved with the rejection of the drug and from that find the receptors coupled to those genes. Both choices open new opportunities for drug development and the treatment of existing diseases. To date, best estimates put the time somewhere between one and two years and at a cost of $500,000 to $750,000 per gene set. Perlegen, one of our competitors through one of its sponsored research affiliates, has recently announced at the March 2-6, 2005 American Society of Clinical Pharmacology and Therapeutics meeting in Orlando, Florida that using their technology platform, SNP or Single Nucleotide Polymorphism identifications of disease genes can be accomplished for about $250,000 to $500,000 per gene. Another scientist at the meeting, James Watters, PhD; Washington University:
PGRN Member reiterated the earlier presentation and pointed out the isolation of 6 candidate genes sets for poor patient response to Docetaxel treatment. However, neither Watters nor McLeod were able to acknowledge a validation of their work and hinted that the six isolated genes, might in fact, not be the correct genes associated with drug metabolism. They are continuing their work using the Perlegen/Affymetrix system.
Once gene sets are identified and blind study trials are completed, additional benefits and future growth potential can result from:
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Enhanced Drug Marketing- By using our products and services, pharmaceutical companies may enhance the effectiveness of their marketing campaign resulting in improved profitability. The overlap of demographic segments and genetic predispositions offers a compelling opportunity for focused drug marketing. Armed with studies that indicate a drug is most effective within certain demographic segments, pharmaceutical companies can more effectively engage in target marketing. Although we do believe that pharmaceutical companies may enhance the effectiveness of their marketing campaign by using our products and services, as of December 31, 2004, no pharmaceutical companies have used our products or services with respect to demographic segments, genetic predispositions and drug marketing and achieved such results.
Expanded Drug Patent Life - There is also potential that packaging a drug with a genomic diagnostic test may extend the drug's patent life. Pharmaceutical companies that are struggling to find replacements for their aging drugs could benefit from a patent extension. Although we do believe that pharmaceutical companies can prepare a genomic diagnostic test and extend a drug's patent life, as of December 31, 2004, no pharmaceutical companies have used our products or services for such purpose or achieved such results. Our current technologies and services could be utilized by a pharmaceutical company to identify and develop a genomic diagnostic test. Alternatively, we could work with generic drug manufacturers and assist them in developing a genetic diagnostic test for off patent drugs. Our greatest, and possibly the most immediate, market potential is to create a testing service for physicians and patients that will allow them to determine if a particular medicine is right for the disease that has been diagnosed.
Increased Drug Development Success Rates - By incorporating genomic variation, clinical trials can be designed to include those patients most likely to benefit from the proposed therapeutic product. The use of a genomics strategy has the potential to yield improved response rates. While the number of clinical trial participants may not be reduced, drug trial efficacy would be greatly enhanced.
Rescue Failed Drugs - A pharmaceutical company may choose to initiate new clinical trials on drug candidates that previously failed. The failure of the earlier trial could have been because the earlier trial was conducted on a broad patient population. We could design a genetic test to predict patient response which would allow a smaller, more clearly defined group of patients to be identified for the new clinical trial; thereby enhancing the drug's efficacy and compliance and improving the likelihood of approval within a targeted group. Although we do believe that pharmaceutical companies can utilize our genetic test to predict patient response, as of December 31, 2004, no pharmaceutical companies have used our products or services for such purpose or achieved such results. Approval may require a physician to use the test to determine if a patient would be within the response group prior to prescribing the drug. We believe that this strategy will lead to more drug approvals and longer product life cycles, improving the return on capital for the pharmaceutical company and increasing the use of our tests.
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Growth Strategy in Forensics
We provide a potential suspect's genetic heritage with DNAWitness(TM) 2.5. We are investigating avenues to encourage federal, state and local governments, crime laboratories and law enforcement agencies to use DNAWitness(TM) to help solve cold cases, current serial killer cases and other violent crimes. We believe DNAWitness(TM) could help revolutionize investigative procedures. By using DNAWitness(TM) on a regular basis, witness information can be corroborated, and where no witness is present, DNAWitness(TM) can provide a "fuzzy sketch" of the donor, possibly reducing the cost of examining a large donor pool and shortening the investigation.
During 2004 we added new sales agents that included Orchid Biosciences and Reliagene, Inc. and we are seeking to expand our list to other forensic testing laboratories across the world. Nevertheless, to date no appreciable sales have been derived from our developing base of sales representatives.
We anticipate an increase in marketing and sales costs throughout 2005 as we implement our marketing and sales plan to increase product awareness. We expect to incur costs for additional sales personnel, the expenses associated with trade shows and promotions, and our planned seminars and training programs.
Our future plans also include seeking or acquiring American Society of Crime Laboratory Directors or "ASCLD" accreditation of our laboratory for forensics work tied to court testimony. Once accredited, either through acquisition of another forensic operation or development of our own operation, we will also be able to offer conventional DNA testing to our clients. Accreditation would allow us to capture a portion of this market and to offer a full range of services to our clients.
It is our intention, over time, to broaden our forensics product line. Additional tests that we hope to add to our product line include hair color, and skin shade. Other tests that we could develop in the future include bone mass, to predict body size, height, and detached and attached ear lobes. We have added nearly 3,000 hair samples to our hair color research and as with eye color service, RETINOME(TM); we are in the early stages of researching and developing the necessary marker combinations in order to be able to validate the test. We do not expect validation to be completed in 2005 but perhaps in early 2007 a hair color version will be beta tested.
We introduced RETINOME(TM), our eye color test, to the forensics community, and the test have thus far has not been used on any cases. We have, however performed over 20 pro bono tests and we are not permitted to discuss the results due to confidentiality. The service was introduced in late 2004, and we are working on developing a kit format for the test as well. We do not anticipate that this kit to be available until late 2005. Earlier in the year, we introduced our EUROWitness(TM) 1.0 test to the forensics community, and to date, this new service has been used on three cases. This test helps narrow the field of investigation by providing investigators with more detailed information on the potential inherited genes. We have expanded our database to include markers from four major ancestry groups to eight. The total number of markers now represent Sub Saharan African, Indo European, East Asian, Native American, Northern European, Middle Eastern, Mediterranean, and Indo. Combining this with our RETINOME(TM) test, a DNA sample obtained at a crime scene could describe a person of interest in much greater detail. Although to date, no agency has used the combined test to describe a person of interest.
Over the course of 2004 we have also added nearly 1,500 volunteers to our photo database and eye color database arrays. These volunteers have received a free ANCESTRYbyDNA(TM) 2.5 report for providing their DNA and photos of their faces and eyes. We now have nearly 3.000 individual donors in our database covering a wide diversity of individuals from around the world. We expect the database to continue to grow through 2005 as we add new service and product features. Our goal is to provide the investigators with as much information as possible on the crime scene DNA samples so that they may narrow the focus of their investigations, corroborate eye witness reports or develop a `person of interest' description from the scientific data that we supply.
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Patent Applications
We have filed claims for international and domestic patent protection. The patents, if issued, will help ensure protection of our bioinformatics platforms, analytical software, genome maps and genetic classifiers in forensic, consumer products, and pharmacogenomics applications. The most significant patent applications cover the bioinformatics platforms and genome maps. Other applications describe the mathematical process of finding complex genetic information and the actual processes that find the gene variants responsible for specific complex genetic traits.
Two of our patent applications, 'Compositions...Pigmentation' and 'Compositions...Statin', have entered National Phases and are pending review and we believe, approval in the U.S. and designated countries. The pigmentation patent is important because it includes the methods and compositions for determining skin shade, eye color or any other pigmentation application. Our Statin patent application includes the use of method for determining a person's ability to respond favorably to a particular Statin. We have covered all Statins and the use of our AIMs and any assay developed that might use those markers in the development of the assay.
Additional national phases will began for the other patents during the second quarter of 2004 and will likely run through 2005. As discoveries warrant, we will continue to apply for future additional patents. Listed below is our current patent pending applications.
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Pending Patent Applications
Efficient Methods and Apparatus for High-Throughput Processing of Gene Sequence Data US2003/0171875A1
Methods for the Identification of Genetic US2003/0171878A1
Features for Complex Genetics Classifiers WO 03/048318
Methods and Apparatus for use in Genetics Classification Including Classification Tree WO 03/048999
Analysis
Methods and Apparatus for use in Complex Genetics Classification WO 03/048372
Based on Correspondence Analysis and Linear-Quadratic Analysis
Composition and Methods for the Inference US10/156,995
Of Pigmentation Traits PCT/US02/16789
AU2002/312112
CA2,448,569
EP02739467.5
JP2003/500216
Compositions and Methods for Inferring US10/188,359
A Response to a Statin PCT/US02/20847
AU2002/316485
EP02746794.3
JP2003/509083
Single Nucleotide Polymorphisms and Combinations Thereof Predictive of PCT/US02/38345
Paclitaxel Responsiveness in Cancer Patients
Compositions and Methods for Inferring US10/644,594
Ancestry PCT/US03/26229
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We continue our work in forensics to expand the physical descriptors that can be derived from crime scene DNA samples. Our research also continued in hair color, skin shade, and we carried on work to improve our recently introduced eye color predictor model. Additionally, we have collected nearly 1,500 volunteer photo database samples and will incorporate those new samples into our forensic photo database array in the near future.
Oops, 10k again http://biz.yahoo.com/e/050331/dnap.ob10ksb.html
More naked shorting news... http://www.faulkingtruth.com/Articles/Investing101/1022.html
Bring it on......
I wouldn't mind holding my butt for a moon shot
Yeah and then he tells you to hold onto your butt... whatsup with that?
That's funny frog.
Good one bag8ger..... I hate to sound like a blond but now I know there are indians in Indiana
Agreed frog.
frogdreaming,
It is the tactics used to achieve that goal that determine the classification of the investor, not the actual transactions.
Who can know whom & when these tactics are used by a investor?
Some people are so lost when it comes to investing that they call that pump & dump.... believe it or not!
Thanks for responding easymedicine.... and I hope Kentucky wins today!
GOOOOOOOOOOOO SEC
I wonder if easymedicine is part of the conspiracy to bring DNAP down.... C'mon fess up bashers.
Arizona had a 14/15 point lead with a little over 4 minutes left.. WOW, great games!!!
Congrats Louisville
Congrats Illinois
Amen gag8ger, the truth is out there.... now if TD and others would honestly fess up?
cosmiclifeform, now how can I spin that to say someone else or some other Co. created that technology?
RETINOME was that a DNAP discovery or was I dreaming?
Amen I've had to come to grips with that in the last few years.
Adverse drug reactions are reaching epidemic proportions:
http://biz.yahoo.com/bw/050323/235124_1.html
TonyTox just posted info on RB that shows Big Pharma has held these FDA guidelines back for as long as they can.... if you get a chance please read it and form your own opinion.
Thank you very much.
infida do you have a link to that article?
Amen altarboy4!
DNAP is a member.... GNSC speaks out: http://biz.yahoo.com/prnews/050322/nytu107_4.html
The party started: http://biz.yahoo.com/prnews/050322/netu022_1.html
Thanks ExtremeSport!
Hey.... we may have to start praying the way they have been acting
Tomorrow if not cancelled
Good Friday this week isn't it?
You're quite welcome.
NIH to Spend $3M on Research into Genomics of Transplantation in FY '06
By a GenomeWeb staff reporter
NEW YORK, March 21 (GenomeWeb News) - The National Institutes of Health plans to fund genomic studies in clinical transplantation, NIH said on Friday.
Under the RFA, entitled "Genomics of Transplantation Cooperative Research Program," NIH plans to fund two or three applications with $3 million in total in fiscal year 2006 to expand its existing research program in this area. Applicants can request up to $700,000 per year in direct costs for up to five years.
Examples of eligible research projects include determination of gene-expression profiles of donor organs and recipients, development of surrogate biomarkers of acute and chronic graft rejection, identification of SNPs, haplotypes, and microsatellite polymorphisms in donors and recipients, determination of gene polymorphisms and expression patterns associated with race, age, and gender in graft rejection, and development of diagnostic tests based on gene expression that will predict rejection.
Do you get the basic info on their web pages or that canned response that they give everyone?
Please calm down investors.... I don't know of a Co that I can call and get the kind of attention you are asking for.
I,I,I,I,I,I,I,I,I,I,I,I,I..........
me,me,me,me,me,me,me,me,me,me,me.........
and futhermore about me,me,me,me,me,me,me....
I told you, I told you, I told you, I told you, I told you,............