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This is getting boring...
DNAP can release a pr about a community college visiting their facility (how freakin' ridiculous is that)
There was no such PR...you're obviously confused. A PR is a publicity piece issued by the company, usually through a service such as PR Newswire, or some such service.
A newspaper article is NOT a PR and newspaper articles are written by newspapers, usually reporters or reporterettes, not companies.
As to the second part of your post, per SEC regulations, a company is only required to announce the signing of a material agreement (which they did). You will also have noted that Gabriel and Gomez have been added to the Biofrontera BOS:
http://www.biofrontera.com/company/supervisory_board.html
Irrespective of the language alluding to February 7th, the fact that an additional PR was not issued is not evidence one way or the other as to the status of the agreement. I would remind you, moron, that the company didn't even issue a PR when they signed the Orchid distributorship agreement, although the agreement was made public by Orchid. That caused many here great concern as well, but it had no bearing on whether the agreement was signed. It was.
Lastly, there is another quite significant milestone date coming up in February. Care to venture a guess? (and I don't mean Valentine's Day, sweetheart...xo...xo...xo) Maybe you can get your info guru to PM you again...lol
Later,
W2P
You don't understand the information that IS available...now you're asking me to explain information that ISN'T. You're a HOOT!
Like I said before...you go girl!
Later,
W2P
My, my, easybake...all I tried to do was help. Your link is obviously out-of-date information...BTW, Luchese hasn't been a Director for over two years as well.
And not trying to put words in your mouth...it's obvious there are plenty there that shouldn't see the light of day.
And I did address your facts...which are not facts at all, BTW.
But you go girl...let us have it! lol
Later,
W2P
easybake...I can see that you are a relative novice to investing. And I too wish the person who PM'd you would speak up. It would be interesting to find out which idiot you are relying on for your misinformation. lol
And a word to the wise. You have absolutely NO IDEA as to the status of the Biofrontera deal. I suggest you include the JMHO disclaimer in your testimonials, lest people rely on your affirmative statement and sue your azz when they find out you had no idea what you were talking about.
But of course, that's JMHO.
Later,
W2P
Let me s p e a k r e a l s l l l l o o o w f o r y o o o o uuuuuuuuuu....
T h e r e a r e n o t 5 0 o r 4 5 o r e v e n 5! B O D m e m b e r s.
T h e r e a r e 3, a n d s o o n t o b e 4.
B O d o e s n o t s t a n d f o r B O D.
G r o w a b r a i n.
T h e K n o b i a s s i t e y o u g a v e t h e l i n k t o i s o u t o f d a t e.
I n c a s e y o u h a d n' t n o t i c e d, T o n y F r u d a k i s h a s n' t b e e n C E O f o r n e a r l y t w o y e a r s.
L a t e r,
W 2 P
Aussie...and if you think there are 50 BOD members, you had best get your information from a source other than the board idiot...he knows not of which he speaks...lol
Later,
W2P
DougS...Then "ideal" it is...lol This post from mingwan0 confirms it:
http://ragingbull.lycos.com/mboard/boards.cgi?board=CLB01189&read=3892
Later,
W2P
Doug...seems to me I read somewhere that Wicks' AncestryByDNA grant ran until June 2005...I'll try to find that and post it later.
Later,
W2P
Someone was asking about the status of the Kondragunta civil action. You can't view the images, but this is the record of events to date:
http://www.clerk.co.sarasota.fl.us/srqapp/civdetail.asp?tb_searchby=Company&tb_searchfor=2003+CA...
Later,
W2P
Anybody see that George Frudakis' action has been dismissed?
http://www.clerk.co.sarasota.fl.us/oprapp/cache/2004246843.pdf
Later,
W2P
gunnabeoneday...Personally, I like this statement a little later in the document under Career History:
Career History
1. InfoValley Sdn. Bhd.
A development stage, specialized bioinformatics and domain consulting company. The company develops and provides total informatics based software solutions, technology transfer and expert consulting for life sciences, pharmaceuticals, medical and clinical informatics.
Chief Executive Officer June 2002 – Current
Achievements:
· Installed country ’ s first bioinformatics solution at The National Institute for Genomics and
Molecular Biology – BioValley.
2. DNA Phenomics Sdn. Bhd.
A development stage company focused on the emerging field of phenomics and the discovery of genomic based diagnostics test. A joint venture with DNA Genomics Inc, USA.
Vice President - Business Development October 2002 – Current
Seems that DNAPhenomics has been in the works for quite some time.
Later,
W2P
Sorry Arch, tried to post this at RB...what a piece of chit that board is...
Anyway, here's the link to your post:
http://ragingbull.lycos.com/mboard/boards.cgi?board=CLB01189&read=3714
And here's my response:
And don't think we don't have anything to do with this:
http://64.233.167.104/search?q=cache:idvtZSTvEOwJ:www.guardian.co.uk/crime/article/0,2763,1208113,00... COLOR="FF0020">LGC+DNAPrint&hl=en
And LGC, mentioned in your article stands for "Laboratory of the Government Chemist", a UK agency. They are WELL aware of DNAPrint's work. This is a link to the paper mentioned in the article above. Scroll through this paper down to Section 7:
http://www.police-foundation.org.uk/Publications/GENETIC%20MARKERS.pdf
You're right, sounds like fun to me TOO!
Later,
W2P
They must be target marketing to the Native American community. I've seen this link all over the NA sites. Here's another one from January 12, 2005:
http://64.233.167.104/search?q=cache:zUvauvosoqIJ:www.dealtime.co.uk/xMPF-Sacred-Dance-Pow-Wows-Of-T...
And this one is VERY COOL!
http://www.lumbee.homestead.com/DNAarticles.html
Anyway, you get the picture...
Later,
W2P
Looks like they're making a real effort to increase their advertising and promotion:
http://64.233.167.104/search?q=cache:CgoAv--30rIJ:www.computergenealogy.com/articles_dna.html+Ancest...
http://64.233.167.104/search?q=cache:aDnYE4Ppk0EJ:www.onescrappysite.com/article368.html+AncestrybyD...
http://www.dnaconsultants.com/commerce2/index.php?main_page=index&cPath=1&zenid=10e35cb88b06...
Even at Amazon.com:
http://64.233.167.104/search?q=cache:479q4B--Cu4J:www.amazon.com/exec/obidos/ASIN/0816053677/+Ancest...
http://64.233.167.104/search?q=cache:T9cXeWM3eCQJ:www.amazon.com/exec/obidos/tg/detail/-/0911797971%...
This one from 12/14/04:
http://64.233.167.104/search?q=cache:VYBv0JAibJYJ:www.dailygenealogynews.com/default_details.asp%3Ff...
This one from 12/25/04:
http://64.233.167.104/search?q=cache:s8ygEH2UReoJ:www.clues2you.com/links.html+AncestrybyDNA&hl=...
This one from 12/30/04:
http://64.233.167.104/search?q=cache:OxBmb_gP_DkJ:www.epinions.com/musc_mu-263730+AncestrybyDNA&...
Same site, January 8, 2005:
http://64.233.167.104/search?q=cache:6UAmQlNqzJUJ:www.epinions.com/mags-All-American_Indian_Art_Maga...
This one's very cool, January 15, 2005:
http://64.233.167.104/search?q=cache:Udc5-f-j4DAJ:www.ancestornews.com/family-tree/ancestry_by_dna.h...
Interesting.....
Later,
W2P
This is VERY interesting. Mentions specifically Affymetrix, and the limitations of their mass array technology in gene expression. Scroll down the page, however, and you will see mention of Biofrontera:
BOBERG: I would say that few companies have the same high technological ability of gene expression as Global Genomics, although many companies do compete with Affymetrix in the microarray space. In the open system competitive space, there is one company called Biofrontera that uses their technology for in-house development, but have chosen not to market their technology for strategic reasons. There are few open gene expression systems with similar sensitivity and reliability as tangerine profiling.
Sounds like there is a market for the DEPD technology itself if Biofrontera/DNAPrint wish to pursue it.
Interesting audio interview on the subject, done on April 6, 2004 at this link:
http://64.233.167.104/search?q=cache:cFSCbA57X30J:www.wallstreetreporter.com/linked/GlobalGenomics.h....
Later,
W2P
ann...Thanks, this is helpful in filling in the timelines.
Later,
W2P
frog...One of the key questions for me has been deciding just when Gabriel actually became "involved" with DNAP.
I can document that Gabriel's association with Gomez goes back, at least, to January 2002 because that's when he and Gomez formed the Genbiomics consultancy business. Of course, Gomez soon after became a member of DNAPrint's BOD, and DNAPrint entered into a consulting contract with Genbiomics. So in essence, Gabriel's association with respect to DNAPrint dates back to early 2002.
As you are also aware, I attended the National Managed Healthcare Congress in September 2002 in Chicago and sat in on a 2 hour roundtable discussion with Dr. Frudakis, Dr. Moskowitz, Dr. Michael Lehman of U of Pennsylvania, and several others. Something I don't know that I ever mentioned was the discussion concerning Dr. Frudakis' belief that there needed to be a new model for drug development. It was his belief that they needed to find a generic drug maker that would be willing to add a research capability to their operation, because big pharma was clearly bucking the personalization of medicine, preferring, for obvious reasons, the blockbuster model. I never discussed it here because it didn't seem relevant.
As I look at Biofrontera, I see a sort of flip side to Dr. Frudakis' idea. In other words, rather than find a generic manufacturer willing to do research, they seem to have found a pure research type of Biopharmaceutical company that outsources the manufacturing. Gabriel has said on more than one occasion that the manufacturing process is easily outsourced.
I think Biofrontera fits DNAPrint's needs quite well, and given Gabriel's prior association, and his relationship to Gomez, I think it's very reasonable to speculate that it may have been Gabriel's association with Biofrontera that got him in the door at DNAPrint to begin with. "I can make this happen, but in order to do that, I have to be in charge."
So I would agree with your view that the driving force for this agreement originated with Gabriel, and undoubtedly before he became the CEO, but he was already working under contract with Genbiomics FOR DNAPrint and this may have been part of his charge all along.
As for the "hard part" of the question, I guess it's possible, but I have a different view. It is my view that DNAPrint may have been silently collaborating with Biofrontera since Gabriel arrived at DNAPrint. I mean, don't you find it odd that DNAPrint silently dissolves their skin cancer research collaboration with Penn State in February 2004, and then Biofrontera suddenly comes out with a "dermatology" product in MARCH of 2004?
What strikes me as I go through the PR page on Biofrontera's website is that from their beginning they have been specialized in CNS disorders. ALL of the PR's emphasized work in Parkinson's, Alzheimers, and neuropathic pain. All of the pharmaceutical collaborations - Janzen, Shering, Kiadis, dealt with CNS disorders. So when we arrive at the March 30, 2004 PR announcing that Biofrontera's Uticaria drug was highly effective in Stage II clinical trials, I find myself asking WHERE the Hell did THAT come from...lol
Not only is there no mention of them working on dematology products up until that point, but shortly after the DNAPrint investment is announced they in-license another dematology product and change their "About Biofrontera" text to this:
About Biofrontera AG
Biofrontera is aiming to become a specialty pharma business, initially in the field of dermatology, with internal research capacity to extend its drug pipeline. Major shareholders of Biofrontera include Heidelberg Innovation and the 3i group. DNAPrint genomics Inc., a genomics-based company based in Sarasota, FL, recently also agreed to acquire a significant stake in Biofrontera.
Say what? Dermatology? I thought they specialized in CNS disorders. So where did this Uricaria drug come from, and what is it that caused them, after years, to change their focus to "dermatology"?
I think, and this is my speculation only, that the answer to both of these questions is the same as the answer to the question, why would Biofrontera and their investors allow DNAPrint to step in and purchase majority interest in their company? And why would Dutchess agree to put up $35 Million by purchasing shares at 96% of market?
I don't have even a hint of evidence to support this theory, but my intuition is that DNAPrint had something to do with the development of that Uticaria drug already, and it is that science and perhaps some other discoveries made along the way that caused them to also in-license the basal cell carcinoma drug.
Pretty wild, huh? Think I need to go take my meds...lol
Later,
W2P
Easyman/Aries...A couple of items I meant to include in the list of 2003 items was that from the instant that Gabriel was first announced as CEO, he and Gomez began talking about acquiring a pipeline of drugs. And, July 2003 was also the month that Tony gave the interview to TWST, wherein he talked about them transitioning to a pharma company.
The TWST article provides a sketchy timeline for that process. I'll leave it to everyone individually to draw their own conclusions as to where (if anywhere) we are in that process.
Later,
W2P
frog...It appears to me that this post hits the nail on the head. I would, again, direct people to the DNAPrint Investment Agreement and the listing of (pre-DNAPrint) Biofrontera shareholders.
The Preferred A and B Shares were created as a result of the two previous rounds of financing. It looks to me as if the "Common" Shares were the original investors. If we accept that as a premise, and look at the list of common shareholders alone we get this:
Shareholder Number of Shares
Prof. Dr. Hermann Lubbert 403,200 Common Shares
Dr. Montserrat Foguet-Lubbert 25,200 Common Shares
Richard Gabriel 12,600 Common Shares
Monica Tamborini 12,600 Common Shares
Dr. Peter Engels 784 Common Shares
Armin Ollig 420 Common Shares
Dr. Stefan Zwilling 308 Common Shares
Inga Engels-Kunz 196 Common Shares
PD Dr. Christine Stichel-Gunkel 140 Common Shares
Christian Schramm 70 Common Shares
Dr. Barbara Welters 70 Common Shares
Dr. Beate Schmitz 56 Common Shares
Regina Hiltawsky 14 Common Shares
Ulrike Ebel 14 Common Shares
Own Shares 756 Common Shares
The parties acknowledge that under the current ESOP 4,217 convertible bonds have been issued, which may require the issuance of another 59,038 Shares. Furthermore, there are further 13,734 convertible bonds which have not been issued yet under the ESOP and which cannot be issued anymore since the empowerment elapsed.
I would guess that the very small shareholders received theirs as a result of the ESOP that is referenced in the above paragraph. Talk about dilution! How would you like to be the guy/gal with 14 shares, knowing there are about to be something over 4,000,000 issued...lol
Anyway, IMO, this lends much credence to your argument.
And I wish to go on record as saying that I DON'T share slopster/wishbone/Hopeful/...'s opinion regarding PharmEco Labs. I haven't seen anything to suggest that they are invested in Biofrontera.
Johnson Matthey, however, is a different story (and of course, Johnson Matthey owns PharmEco). The following text is a footnote to the list of Biofrontera investors. In it, it reveals the fact that Johnson Matthey played a role in the sequence of events leading to this agreement. Whether Johnson Matthey continues to have a role is a matter for speculation. For purposes of clarity, "Parties 3 and 4", that are excluded from the events of July 2003, are Gabriel and Tamborini, but as becomes clear, they enter the picture at a later date:
The parties named in (1) and (2), (5) to (27) and Johnson Matthey Pharmaceuticals Materials Inc. (hereinafter referred to as Johnson Matthey) entered into (i) a "Shareholders' Agreement" dated 3 July 2003, (ii) in July 2003 into an "Amendment to Shareholders' Agreement dated 3 July 2003" and (iii) and an "Investment Agreement" dated 3 July 2003. The parties named in (1), (2) and (5) to (27) entered into (iv) an "Amendment to Investment Agreement dated 3 July 2003" dated 31 December 2003. In May 2004 the parties named in (3) and (4) acquired the shares of Johnson Matthey and took over its rights and obligations under the agreements named in (i), (ii) and (iii) and became party to the agreement named in (iv). The agreements named in (i) and (ii) are collectively referred to as the Shareholders' Agreement. The agreements named in (iii) and (iv) are collectively referred to as the Investment Agreement.
Remember, this was all happening in the summer of 2003 against the backdrop of DNAPrint's success and media exposure in the LA Serial case; Biofrontera making the acquisition of Bioleads; Biofrontera completely revamping it's Supervisory Board; DNAPrint starting their clinical projects with Moffitt in November 2003; and in December 2003 (coinciding with the December 31, 2003 "Amendment to Investment Agreement dated July 3, 2003") DNAPrint consummated the La Jolla Funding Agreement.
Conveniently, in April 2004, Gabriel and Tamborini receive the first installment of the executive tax "bonus". Then in May 2004, they "acquire" the rights and obligations from Johnson Matthey, and become Party to the Amendment to the Investment Agreement that was executed in December 2003. Quite a series of events, which of course, all lead up to DNAPrint taking the role as the lead investor in October of this year.
Pardon my conjecture, but I'd say this has been in the works for the better part of two years, and it appears to me that the group of companies has orchestrated quite a number of events to bring us to this point in time. Given Gabriel's prior association with Johnson Matthey, and his sudden appearance at DNAPrint in the spring of 2003, their participation in this deal is certainly not a coincidence.
And given what has all the appearances of a great deal of planning and execution, I doubt very highly that these companies are relying solely on DNAPrint's market price as THE determining factor for successfully completing this venture.
How did Doctor Frudakis put it, "We have some tools in our belt to help us complete his deal..." Should be interesting to see how it all plays out.
Later,
W2P
frog...In the Biofrontera agreement, Gabriel and Tamborini are listed as owning 12,600 common shares each. Given that prior to DNAPrint coming to the table (and that's where we currently stand) there were approximately 1,870,000 shares outstanding (the exact number is in the filing I'm just too lazy to look it up right now...lol), their combined 25,200 shares of Biofrontera would equate to about 1.3% of the total.
Their ownership interest in terms of share ownership would appear to me to be consistent with the <1% each statement.
That's all I can tell from the filing...and I agree it seems odd that they would be listed as "major investors" based on such little interest.
Later,
W2P
retro...Don't know. I just threw that out as a possible explanation. And I'm not suggesting that DNAPrint and the Execs took the step to eliminate the conflict. Perhaps they didn't consider it a conflict since it was less than 1% of the company. But perhaps the Regulators had different ideas about the situation.
I've seen it suggested on one of the boards that the loan is some sort of downpayment on the $25 million. I don't buy that argument at all. If that were the case, DNAPrint would not be entitled to receive additional shares, as they will be by this loan agreement.
Gabriel and Tamborini currently own shares of Biofrontera. This would be one way of transferring that interest to DNAPrint itself. But it's JMHO.
Later,
W2P
ice...Did DNAPrint perhaps just purchase Gabriel and Tamborini's interest in Biofrontera? We "loan" Biofrontera $195K. They use the proceeds to buy out Gabriel and Tamborini's interest. We now own their interest. That would explain why the "loan" can be repaid to DNAPrint in Preferred B Shares.
Eliminates any potential conflict of interest in the eyes of SEC or outside investment community...JMHO, but might offer one possible explanation.
Later,
W2P
MattG...I believe they are aware of that and are attempting to correct by way of the WSG, Inc. Check my posts on the Nap Heads II Board. Here's a couple of good links:
http://ragingbull.lycos.com/mboard/boards.cgi?board=CLB01189&read=3522
http://ragingbull.lycos.com/mboard/boards.cgi?board=CLB01189&read=3525
Later,
W2P
money4nothin...It's right here:
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FP...
[0001] This application claims the benefit of priority under 35 U.S.C. .sctn. 119(e) of U.S. Ser. No. 60/404,357, filed Aug. 19, 2002, and U.S. Ser. No. 60/467,613, filed May 2, 2003, and is a continuation-in-part of U.S. Ser. No. 10/156,995, filed May 28, 2002; a continuation-in-part of U.S. Ser. No. 10/188,359, filed Jul. 1, 2002; and a continuation-in-part of International Application PCT/US02/38345, filed Nov. 26, 2002 (Intl. Publ. No. WO 03/045227A, Jun. 5, 2003), the entire content of each of which is incorporated herein by reference.
Later,
W2P
Doug/frog...According to this article in Pharmalive Magazine, very few pharmaceutical companies have the core competencies necessary to develop pharmacogenomic tests to accompany their drugs. It is the opinion of the author, that they will likely partner with medical-diagnostics companies to accomplish their ends:
http://www.pharmalive.com/magazines/randd/view.cfm?articleID=1534
...The diagnostic industry is working independently of pharmaceutical companies to bring theranostics to market. Emerging pharmacogenomics technologies are presenting drug-discovery and development companies with the promise of targeted therapies and potential new revenue streams and are creating new opportunities for diagnostic companies to develop tests that can be used to determine patient response to a drug and screen out inappropriate candidates. The increasing interest in theranostics is likely to prompt more pharmaceutical companies to develop diagnostics divisions or acquire diagnostic companies. Future progress in theranostics will draw on developments in pharmacogenomics.
"There’s not an extreme urgency to develop companion diagnostics," Dr. Dorner says. "This has to be done in the next year or so and we have to hurry up and get something on the market. The whole pharmaceutical industry at this point is asking not how urgent is the need but that the need is there. Everyone believes that this is the future for the pharmaceutical industry and the questions are, ‘How can it be practically implemented? What are the technologies, and what are the time lines within the drug development pathway for accomplishing this?’ As health-care costs continue to escalate, as our drugs become more sophisticated and targeted to specific populations of patients, the need for companion diagnostics to direct therapy will become greater and greater."
FDA’s guidance on pharmacogenomic data submission will accelerate the development of theranostics. The guidance specifies when to submit pharmacogenomic data to the agency, what data to submit, and how to submit the data. These data must be focused on diagnostic tests used in conjunction with drugs and show how responses to the drug vary from person to person.
In November 2003, FDA issued a draft guidance to the pharmaceutical industry advising the companies about when to submit pharmacogenomic data to the agency during the drug’s development and review process, what formats may be used for submissions, and how the data will be used in regulatory decision making. The guidance defines pharmacogenomics as the use of a pharmacogenomic test in conjunction with therapy — an assay intended to study interindividual variations in whole-genomic or candidate gene single-nucleotide polymorphism maps, haplotype markers, and alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response.
The regulatory agency acknowledges that the promise of pharmacogenomics lies in its potential to individualize therapy, making it more effective while reducing its risk. FDA says the pharmacogenomic field is in its early-development stage and pharmaceutical companies are reluctant to conduct pharmacogenomic testing during the drug-development stages because they do not know how the agency will use these data in drug-application review process. The guidance was written to clarify the agency’s policy.
FDA envisions that pharmaceutical companies will begin to use pharmacogenomic tests to support drug development and/or to guide therapy. Most pharmacogenomic data are of an exploratory or research nature and are not required to be submitted. Although the submission of pharmacogenomic data is not required under FDA regulations, the agency is encouraging the voluntary submission of these data. The data can be submitted to an investigational drug application, a new drug application, or a biologics drug application. The data can be submitted to support scientific content related to dosing, safety, or efficacy. The agency will not use the information submitted for regulatory decision making but only for scientific and informational purposes.
The agency recommends joint development of the pharmacogenomic tests and the drug, and submission of complete information on the test to the agency. The agency plans to issue another guidances on joint development of pharmacogenomic tests and drugs in the near future.
Many pharmaceutical companies are using biomarkers during Phase I and Phase IIa clinical studies to predict and monitor safety and efficacy outcomes. Few pharmaceutical companies have the core capabilities, however, that would allow the development of those biomarkers into clinically validated and regulator-acceptable surrogate markers of disease outcomes, thus time and costs savings are not yet realized in Phase IIb and Phase III registration studies. Pharmaceutical companies, with their access to large numbers of patients who have undergone therapy with proprietary medicines, represent a resource that can be used to validate biomarkers. In collaboration with a medical-diagnostics company, they can jointly develop these validated biomarkers into a medical-diagnostic test.
Right now, only a few pharmacogenomic tests for certain drug-metabolizing enzymes are considered valid biomarkers in humans. FDA is encouraging pharmaceutical companies to develop pharmacogenomic tests that predict which subpopulations will have a positive response to therapy. Regulators point to the trend that has emerged in the past few years of drug labels becoming more narrow in their indications. The shift has become apparent in the HIV-drug-therapy field, which evolved from broad indications to narrow indications when the drug-resistance tests became available.
The agency is particularly interested in receiving pharmacogenomic data that distinguish patients at greater risk for a serious adverse event, and exploring the correlation in the appropriate populations. For pharmaceutical companies interested in developing the drug solely for populations that exclude the high-risk patients based on pharmacogenomic testing, the agency recommends that the company jointly develop a diagnostic and the drug because the agency would be unable to prove a drug for which the safety profile was predicated on a pharmacogenomic test that was unavailable.
FDA envisions that in the future, pharma-cogenomic markers that predict drug toxicity will be identified and developed on a parallel path with overall drug development. The medicine would be developed in a conventional manner with a parallel effort to identify appropriate predictors of toxicity. If the drug’s risk-benefit profile were acceptable, the drug could be approved before the completion of efforts to refine and develop the relevant pharmacogenomic tests. When the predictive value of a diagnostic test is to be established and the test is to become commercially available, the drug label could be changed to reflect the data.
FDA is countering the perception that pharmacogenomic testing is likely to give very definitive answers about safety and effectiveness in subpopulations. This may happen sometimes, as it happens in oncology, and in these cases the rapid development of a diagnostic test is highly encouraged. This is unlikely, the agency says, to be the ordinary case. In most instances, the gene expression profile is likely to be one of a number of factors.
"FDA had a workshop in March on the concept of how to codevelop a diagnostic assay for pharmacogenomics or pharmaco-
genetics data and a drug and a companion diagnostic should be developed simultaneously, but I am not sure that is possible," Dr. Dorner says. "In most cases, biomarkers for the diagnostic will be identified or will be discovered in a Phase II clinical trial because many times the Phase I clinical trial is healthy volunteers and it isn’t always a diseased population that is going to be targeting in the later-stage trials. In many cases, we will be discovering biomarkers in Phase II to put together an assay to be validated in Phase III and then go to the FDA for registration of the drug as well as some information on what the companion diagnostic should be.
"At this point, we are going to have to develop, perhaps, new paradigms of how to jointly develop a diagnostic that can be used in the label to determine patient-therapeutic options. That is something that FDA is very interested in, understanding how to do this."
Industry observers say the era of the blockbuster market is over. Although there will be more blockbusters, there are not enough blockbusters left to fuel the entire pharmaceutical industry. The innovation in the industry has been more and more in targeted therapies.
"This is a good trend," Dr. Cohen says. "Targeted therapies will allow for many indications and will allow us as physicians to offer better and safer medications over time. We will not have personalized medicine tomorrow, but during the next decade there will be an explosion in the number of drug-development programs that utilize pharmacogenetic-companion tests. This is a natural evolution of molecular medicine."
BTW, isn't that a most interesting definition of Pharmacogenomics:
The guidance defines pharmacogenomics as the use of a pharmacogenomic test in conjunction with therapy — an assay intended to study interindividual variations in whole-genomic or candidate gene single-nucleotide polymorphism maps, haplotype markers, and alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response.
Later,
W2P
ifida...They should show up here when they are released:
http://www.fda.gov/cber/guidelines.htm#04
Later,
W2P
ifida...This is the article:
http://www.englewoodheraldtribune.com/apps/pbcs.dll/article?Date=20041001&Category=BUSINESS&...
Article published Oct 1, 2004
DNAPrint buying stake in drugmaker
By MARGARET ANN MIILLE
SARASOTA -- DNAPrint Genomics Inc. is tapping into a drug development pipeline by becoming the majority owner of a German pharmaceutical company.
DNAPrint announced this week that it has agreed to acquire 51.77 percent of Biofrontera AG, a company based in Keverkusen and Heidelberg. The money for the deal will come from the Dutchess Private Equity Fund, which will buy up to $35 million of DNAPrint's stock over two years.
DNAPrint has agreed to invest about $25 million during the same length of time in Biofrontera shares, representing a 51.77 percent equity interest.
"This is what I have been waiting for for the past four years, to reach this stage of legitimacy," said Tony Frudakis, the company's founder and chief science officer. "From the very beginning, we've wanted to become a drug company, not just a data company that makes neat genetic tests."
DNAPrint, which has developed genetic tests that genealogists and forensic experts use to determine a person's racial mix, said the Biofrontera deal will give DNAPrint access to drugs already under development and allow the two companies to share technology.
The focus will be on "theranostics," which blend genomics tests with drugs to yield the best results in specific groups of people.
Biofrontera's lead candidate for development is a drug called "BF-Derm1," which is in clinical trials for treating chronic itching and scratching. Frudakis said that drug so far has shown a 40 percent improvement when compared with a placebo in reducing clinical symptoms in all patients.
Biofrontera, which focuses on developing treatments for inflammation and central nervous system diseases, also is in the early stages of developing a drug to treat and prevent migraines.
DNAPrint said it will continue selling its ancestry tests, called DNAWitness when marketed to the forensics market and ANCESTRYbyDNA2.5 when sold to the public.
But it intends to wrap up its research and market diagnostic tests for determining what existing drugs work the best for certain patients.
"Most of our efforts in the future will focus on developing our pipeline of new drugs," Frudakis said.
The two companies plan to eventually seek out a manufacturer when their drugs reach the production stage.
DNAPrint said the agreement with Dutchess, a limited partnership based in Boston, was arranged by Athena Capital Partners Inc., a private merchant bank in Tampa.
Frudakis said the acquisition eventually should boost investor confidence and buying activity in his company's over-the-counter stock.
At the close of trading Thursday, shares were selling for 1.9 cents, down from 2.2 cents the previous day.
"Investors value data companies, basic science companies, much lower than they do pharmaceutical companies," Frudakis said. "The money in this business is in selling medicine."
Later,
W2P
ifida...I did, in fact anyone that wants to see it can follow this link. When you get there, select the Health 2005 story:
http://www.cbsnews.com/sections/i_video/main500251.shtml?channel=i_video&clip=/media/2004/12/29/...
Later,
W2P
Hummer...quite a network of companies you've built. I think you've been holding out on me! lol
Later,
W2P
aries...Probably for the same reason that DNAPrint doesn't tell it's shareholders or the investing public when they expand their network of marketing partners...in other words, I haven't got a clue! lol
Later,
W2P
Don't remember seeing this, but it's interesting in retrospect. I'd say some of the critics in this story have a bit of egg on their faces:
http://www.lineofduty.com/blotterstory.asp?StoryID=61536
Later,
W2P
All of DNAPrint's tests now being offered by GeneTree. This is the first I've seen offering EuroDNA 1.0, AncestryByDNA 2.5, DNAWitness 2.5, and Eye Color testing:
http://www.genetree.com/product/population-assessment-dna-test.asp
http://www.genetree.com/product/dna-detective.asp
They're charging $1,000 for DNAWitness 2.5, and $500 for the Retinome test.
Lastly, check out their affiliates:
http://www.genetree.com/about/genetree-partners.asp
Actually, this is the second time today that I've seen Sorenson Molecular show up in a search for DNAPrint information.
Later,
W2P
Another one of our partners (scroll down):
http://64.233.167.104/search?q=cache:6Ujq7B55GWkJ:www.tracegenetics.com/aboutus.html+DNAPrint+genomi...
Later,
W2P
Nice new article on DNAPrint that discusses AncestryByDNA and provides pricing and ordering information:
http://64.233.167.104/search?q=cache:3mK0p-sy5NkJ:www.tolerance.org/news/article_tol.jsp%3Fid%3D1121...
Later,
W2P
gunnabe/grateful...Lifecodes was the paternity testing and forensics testing company Orchid acquired when they began to transition their business:
http://www.ctinnovations.com/news/69.php
Later,
W2P
DRCAL...Don't be too quick to apologize! lol In the first place, that 400,000,000 represents 150% of the shares that would be issued at the then current price (by regulation, that's the way they have to present it in the filing - it is so stated in the notes to the table). Secondly, the actual number that would be issued is share price dependent, just as are the Dutchess shares. If the price appreciates, not nearly that many would be issued. Thirdly, I stand by my earlier argument, that if I'm Dutchess, I'm not going to purchase $35 million worth of shares at 96% of market, knowing that LJ can convert and sell immediately, thereby undercutting my investment.
Of course, this is purely my speculative judgement after looking at the various deals from a business perspective. Just don't see how any of this works without a rise in the share price (so that's what I'm expecting), and don't see how that happens if the La Jolla financing remains as is (so I'm expecting it to go away). But again, it's JMHO.
Later,
W2P
He's no lightweight either. Came from a position as CEO and Board Director of Miraibio, a Division of Hitachi:
http://www.miraibio.com/
Later,
W2P
Reliagene taking a page from the DNAPrint playbook? Looks like they recently added an experienced business executive as CEO, leaving the founder to focus on scientific and R&D efforts:
http://www.reliagene.com/index.asp?content_id=102804
October 28, 2004– In a move anticipated to significantly enhance company growth, ReliaGene Technologies, Inc. has announced the appointment of Leonard Klevan, Ph.D., as Chief Executive Officer.
Later,
W2P
gunnabeoneday...Nicely reasoned post. As for this statement:
Also, the Dutchess commitment at ONLY a 4% discount to market is a very positive factor in my assessment.
For me, this is THE key piece of information. At 4% discount, it is, IMO, unreasonable to assume that Dutchess intends to do anything but buy and hold or place the shares with others who intend to do the same. To do otherwise would quickly drive the price down into a losing transaction for Dutchess.
Again, JMHO and I welcome plausible alternative suggestions.
Later,
W2P
DR DOLITTLE...Better do some more DD. Plenty of potential connections to DNAP in that article...lol
Later,
W2P