DNAPrint Product Pipeline - July 2006
DNAPrint Genomics - PRODUCTS PIPELINE – July 2006
MILESTONES FOR FORENSICS AND CONSUMER MARKETS
ANCESTRYbyDNA 2.0….R/D 2000-01…4Q 2002 market…Mar2004*replaced w/ V2.5
ANCESTRYbyDNA 2.5….R/D 2003….Feb2004 market…Feb2005 Laptop Biochip System
ANCESTRYbyDNA 3.0….R/D 2005.…Test kit.- 2006 market?
EURO-DNA 1.0…..R/D 2003.....4Q 2004 market
DNAWitness 2.0….R/D 2002……2003 market… 2004*replaced w/ V2.5
DNAWitness 2.5 …R/D 2003...July 2004 market…Test kit - late 2005 ...global sales 2006
DNAWitness 3.0………R/D 2005 (3.0 to include eye color)…market 2006?
DNAWitness-Y…added to DNA Witness product…Aug 2005 market
DNAWitness-Mito…added to DNA Witness product…Aug 2005 market
EURO Witness 1.0……………..R/D 2004…….Feb2005 market
RETINOME 1.0 Eyecolor …R/D 2003....4Q 2004 market…Test kit - late 2005…global sales 2006
RETINOME HA Haircolor…….R/D 2004….2005-06 validate…..2007 beta test……..2008 market?
SKIN SHADE………………… R/D 2005-07……2008 market?
AMERIND 1.0…………………R/D 2005-06……2007 market?
Genetic Family Tree DB……… R/D 2004…….online 2005
Searchable Ancestry Genealogy DB…… R/D 2003….online 2004…expand 2005/06
Searchable PhotoAncestryDB (Forensics)… R/D 2003….. online 2004…expand 2005/06
DNA Database for Native Americans…develop 2003/2004….expand 2005/06
DNA Database for African-Americans…. develop 2005…expand 2006
3D Biometrics Imaging System for DNA fuzzy photo - Forensics –…Jun 2005
MILESTONES FOR PHARMACOGENOMICS - DIAGNOSTICS AND THERANOSTICS
Diagnostic Products - Predictive Drug Classifier Tests
1) Ovanome - Taxol/Carboplatin efficacy for Ovarian Cancer
* R/D 1998…Announced Mar 2000…Validation Studies 2002-2004
* Diagnostic Phase II - 2005…FDA-PMA 2Q06…Launch 2006
* Market Potential - $50 Million Dollars
2) PONV - Ondansetron – Chemo-nausea (DNAPrint/Moffitt)
* R/D 2003…Diagnostic Phase II - 2005/06…..FDA-PMA 4Q06…Launch 2007
* New - October 15, 2006 – Abstract/Presentation - Anesthesiology 2006; 105: A402
Single Nucleotide Polymorphisms Associated with Postoperative Nausea/Vomiting and Zofran Response
Jinhong Liu, M.D., Ph.D., Keith A. Candiotti, M.D., Tony Frudakis, Ph.D., Barbara L. Handelin, Ph.D., Hector Vila, M.D.
Department of Anesthesiology, H Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida
* Market Potential - $500 Million Dollars
3) Statinome - Lipitor, Zocor, efficacy, liver, muscle adverse myalgia response
* R/D 1998/2004…Diagnostic Phase II - 2005/06…FDA-PMA 2Q07...Launch 2008
* Market Potential - $1 Billion Dollars
4) Melphalan/Topotecan – Multiple Myeloma (DNAPrint/Moffitt)
* R/D 2003…Diagnostic Phase I - 2005/08….FDA-PMA 1Q08…Launch 2009
* Market Potential - $50 Million Dollars
5) Acenome – Ace Inhibitors - Enalapril, Lisinopril efficacy, muscle, adverse cough
* R/D 1998/2004…Diagnostic Phase I - 2005/08 …FDA-PMA 2Q08...Launch 2009
* Market. Potential - $750 Million Dollars
6) BC-LOH – Breast Cancer (DNAPrint/Moffitt)
* R/D 2003… Diagnostic Phase I - 2004/08…FDA-PMA 3Q08…Launch 2009
* Market Potential - $400 Million Dollars
7) Xeliri/Xelox – Colon Cancer (DNAPrint/Moffitt)
* R/D 2003… Diagnostic Phase I - 2005/08…FDA-PMA 4Q08…Launch 2009
* Market Potential - $200 Million Dollars
8) Diabetes – Pre-Diabetes and Diabetic Complications
* R/D 2005... Diagnostic Phase I – 1Q06… FDA-PMA 1Q09…Launch 2010
* DNAPrint licensed diabetes diagnostics test from Harvard Medcal School – Jan 26, 2006
* Market Potential - $5 Billion Dollars
* Feb 14, 2006 - DNAPrint Pharmaceuticals Retains DOCRO for Development of Immunoassay to Better Detect Diabetic Vascular Complications. DOCRO will perform technical and clinical assistance and provide guidance on the regulatory requirements associated with the design of clinical trials necessary to commercialize DNAPrint's recently in-licensed intellectual property relating to glycated CD59. "DOCRO is a leading CRO specializing in the commercialization of diagnostic technologies," commented Dr. Hector J. Gomez, MD, PhD…"DOCRO's proven formula for success has resulted in an unparalleled track record at the FDA with over seventy consecutive successful FDA submissions."
Theranostics Products – Drug and Drug Test Combinations
9) PT-201 – Opthalmic Allergies
* Phase II – 2Q06…FDA-NDA 4Q07…Launch 2008
* Market Potential - $50 Million Dollars
10) PT-202 – Nasal Allergies
* Phase I – 2Q06…FDA-NDA 4Q07…Launch 2008
* Market Potential - $50 Million Dollars
11) PT-301 – Atopic Dermatitis
* Phase I – 2Q06…FDA- NDA 2Q08…Launch 2009
* Market Potential - $600 Million Dollars
12) PT-401 - Super EPO Anemia Drug – Renal Failure
* License Apr 2005…Pre-clinical 4thQ 2005/2006…FDA-NDA 2009…Launch 2010
* Market Potential - $2.5 Billion Dollars – Revised 3/14/06 - $11 Billion Dollars
* DNAPrint exclusive worldwide license to develop a Super EPO anemia drug for renal failure
* Consulting contract with Super EPO inventor/patent-holder to help DNAPrint develop Super EPO drug
* Contract for CRO to manufacture Super EPO drug for pre-clinical testing, ready Fall 2005 (completed)
* Sept 2005 – Super EPO drug begins pre-clinical testing. Production schedule remains on track
* TWST – “We expect to file a New Drug Application (NDA) by 2009 and a product launch somewhere around 2010.”
* Mar 14, 2006 – DNAPrint™ Genomics Pharmaceuticals Division Announces That Research on Development of Super EPO Drug for Anemia Market Shows Promising Early Results
* May 16, 2006 - DNAPrint Pharmaceutical Completes Computational Model to Guide Preclinical Development on Anemia Drug. DNAPrint announced that DNAPrint Pharmaceuticals, Inc.'s Computational Biology Division completed a pre-clinical, first generation computational model of the characteristics and mechanisms of its PT-401 drug under development for the treatment of anemia.
13) PT-501 – ADHD - Methylphenidate – Ritalin-like Compounds
* License Oct 2005….Pre-clinical 2005…FDA-NDA 2009…Launch 2010
* Market Potential - $4.6 Billion Dollars
* Oct 25, 2005 -- DNAPrint genomics, Inc. today announced it has licensed a series of methylphenidate analogs or Ritalin(TM)-like compounds targeting the clinical development of enhanced pharmaceuticals for the treatment of drug addiction, attention deficit hyperactivity disorder (ADHD), and depression. This is the second drug project that will be developed by DNAPrint Pharmaceuticals. Inc., the Company's wholly owned, recently formed pharmaceutical subsidiary focused on personalized medicine….Ritalin(TM) or methylphenidate analogs represent a $4.6 billion dollar market opportunity by 2014, (Decision Resources, Inc)….
*Dr. Froimowitz and DNAPrint genomics are working with the National Institute for Drug Abuse (NIDA) in identifying compounds that offer potential relief to the craving usually associated with drug abuse.
* TWST - Drug addiction compound has actually been selected by the National Institute of Drug Abuse (NIDA) for further study.
* Mar 3, 2006 - DNAPrint announced that it has entered into a Research Sponsorship Agreement with the Massachusetts College of Pharmacy and Health Sciences for the potential development of Ritalin(TM)-like compounds as possible medications for drug abuse, attention deficit hyperactivity disorder (ADHD) and depression. “In fact, the National Institute of Drug Abuse has selected one of Dr. Froimowitz's compounds for their pre-clinical drug addiction development program. We will be supplying purified compounds to NIDA for further development."
14) PT-502 – Drug Addiction - Methylphenidate – Ritalin-like Compounds
* License Oct 2005…. Pre-clinical 2005…FDA-NDA 2010…Launch 2011
* Market Potential - $500 Million Dollars
15) PT-503 – Depression - Methylphenidate – Ritalin-like Compounds
* License Oct 2005….Pre-clinical 2005…FDA-NDA 2011…Launch 2012
* New – July 17, 2006 - DNAPrint Genomics Selects PT-502 Lead Research Compound for Development of Drug for Treating Depression. DNAPrint Genomics, Inc. today announced it has confirmed positive results in an animal model for anti-depressant activity for its PT-502 lead compound being developed with the Massachusetts College of Pharmacy and Health Sciences.
* Market Potential - $7 Billion Dollars
16) Cancer Compounds – **TI inhibitors in-licensed, closing imminent…4Q05 (Khandaker Report)
Biofrontera’s Drug Pipeline:
17) BF 200 ALA - 5-aminolevulinic acid - for actinic keratosis – in Clinical Phase III 2006…Market 2008
18) BF-Derm1 - for antihistamine-refractory urticaria – in Clinical Phase II 2006…Market 2009
19) BF 37 - Atopic Dermatitis - for eczema skin rash - Clinical Phase II….Sept 2005…Market 2010
20) BF 200 ALA – Kondyloma – for epidermotropic human papillomavirus (HPV)…in Clinical Phase II…Market 2009
21) BF 200 ALA – VIN III – for vulvar intraepithelial neoplasia …in Clinical Phase II…Market 2009
22) 5-HT2B receptor antagonist - for migraine prophylaxis - in Preclinical 2005…Market ?
Other DNAPrint Studies
23) Immune System Deficiencies and Suppressants - Sirolimus, Tacrolimus, Mycophenolate
* R/D 2001…NYU?…. Fall 2005 - Elipsis Biotherapeutics – Crohn’s Disease and other immune system disorders
24) Acute Lymphocyte Leukemia (ALL)
* R/D 2005…Joint Publication late 2005….DNA Screening Test 2006?…..
25) Cervical Cancer and Environmental Tobacco Smoke
* FAMRI Grant Feb 2003….2 year grant….Publication 2006?....
PARTNERS
* Forensics and Consumer Genealogy - Lynn Peavey, Orchid Biosciences, and ReliaGene Technologies
* Forensics – DNAPrint working with defense industry consultant, Defense Life Sciences, towards defense and homeland security applications…Aug 2005
MERGERS, ACQUISITIONS, and SUBSIDIARIES
* DNAPrint Pharmaceuticals Subsidiary – DNAPrint Genomics forms wholly owned pharmaceutical subsidiary focused on personalized medicine, DNAPrint Pharmaceuticals…Oct 12, 2005
* "We are at the forefront in the development of personalized medicines and genomics-based pharmaceuticals, the Company's main focus," stated Hector J. Gomez, M.D., Ph.D., DNAPrint's Chairman and Chief Medical Officer, who will head the new subsidiary's day-to-day operations. "We believe that test/drug combinations called 'theranostics' are the wave of the future and that our new DNAPrint Pharmaceuticals subsidiary affirms the Company's commitment to the development of these products." Data Monitor and the Pharmaceutical Manufacturer's Association expect the worldwide pharmaceutical market to more than triple over the next 10-15 years to an estimated trillion dollars a year.
* DNAPrint ACQUISITION – Trace Genetics…Acquired Jun 2005
* Trace Genetics – diagnostics specialists in genetic identity DNA analysis, with expertise in genetic genealogy, forensics, molecular diagnostics and population genetics
* Trace Genetics will do product testing, production, and sales for forensics and consumer genealogy while DNAPrint continues core drug discovery research and clinical trials for DNAPrint’s growing drug pipeline.
* DNAPrint ACQUISTION…Biofrontera AG…July 13, 2005
* DNAPrint Genomics Acquires 18% Interest In Biofrontera AG, a Small German Pharmaceutical Company
* Biofrontera has proprietary programs for gene expression analysis and has 3 drugs already in their pipeline
* Biofrontera just acquired a new drug (Sept 2005) and now has 4 drugs in their pipeline
* Biofrontera milestone: Biofrontera stated intentions to do an IPO stock offering in Europe.
* Sept 2005 – Biofrontera completes bond funding for $20 million euro. Biofrontera’s new IPO stock offering is on track within 9 months
* Sept 2005 – Biofrontera acquires new drug for Atopic Dermatitis for it’s drug pipeline
* DNAPrint ACQUISITION – Kenna Technologies, Inc…Acquired Oct 25, 2005
Kenna Technologies, Inc., expertise in computational biology. Kenna is an in-silico drug discovery company developing proprietary biological simulations that will improve and accelerate drug discovery and development. Kenna’s platform provides a new rationale for selecting drug targets, evaluating the activity of candidate compounds, and planning clinical trials for promising drug compounds.
* DNAPrint ACQUISITION – Elipsis Biotherapeutic Corporation…Acquired Dec 22, 2005
SARASOTA, Fla., Dec. 22, 2005 -- DNAPrint Genomics, Inc. today announced the completion of its previously announced acquisition of Ellipsis Biotherapeutics Corporation, which will operate as a drug and diagnostic subsidiary. Ellipsis will retain its existing personnel and continue to be managed by Dr. Laurence Rubin, who is also the Director of the Division of Rheumatology at St. Michael's Hospital in Toronto. His research has focused on the genetic determinants of osteoporosis, rheumatoid arthritis and other inflammatory diseases. In addition, Ellipsis has acquired a diverse portfolio of genetic data and intellectual property from unique patient populations, specifically with Inflammatory Bowel Disease (Crohn's disease) including last year's publications of the discovery of a gene for Crohn's disease. Diagnostic applications are currently under development in this and related areas of autoimmune inflammatory disorders.
* Feb 21, 2006 - Ellipsis Biotherapeutics Completes Four Contracts for High Through-Put Genotyping Services For Record Quarter Of Revenues
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* DNAPrint - Research Sponsorship Agreement with Mass.College of Pharmacy and Health Sciences - 8-K Jan 31, 2006
On January 31, 2006, the Registrant entered into a Research Sponsorship Agreement with the Massachusetts College of Pharmacy and Health Sciences for sponsored research in connection with the synthesis and testing of certain (Ritalin) compounds as possible human medications for drug abuse, attention deficit hyperactivity disorder, and depression. The research will be conducted under the supervision of Dr. Mark Froimowitz. The Registrant had previously licensed exclusive rights to the compounds from Dr. Froimowitz on October 19, 2005 under an Exclusive Licensing Agreement. The sponsored research payments total $300,000 and will be paid in monthly installments of $25,000 over one (1) year.
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All drugs, projects, acquisitions, and other data listed in this DNAPrint pipeline may or may not be inclusive of all possible drugs, projects or acquisitions that DNAPrint may presently be involved in. Milestone dates are subject to change by DNAPrint Genomics.
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