Anthony Almada BSc, MSc07.01.03
Back in the 16th century both the fisherman and the physician arose to the sun in the East and retired to its western departure. To virtually all this confirmed an earth-centered universe: the sun revolved around the earth. But to a brilliant young man studying medicine, the lure of mathematics and experimentation compelled him to paint a different picture and thus launched a revolution anchored in science. Not unlike Galileo the man, married only to his experimentation, Galileo Pharmaceuticals (GP), formerly known as Galileo Laboratories, is semi-novel in its application of rigorous scientific experimentation to identify and develop over-the-counter (OTC) and prescription products by harnessing Mother Nature's voluminous library of molecules.
The first strike was on nutraceuticals. Dr. Miller stated, "We are no longer a nutraceutical company. We have a renewed and keen focus." He attributed the investment community's disenchantment and second degree burns from holding onto nutraceutical companies to the failure of Benecol, 9/11 and the dot com bubble rupturing. These events heralded the "end of the infinite bubble for the dietary supplement market," which, in effect, "sent ripples through the spines of CEO's," eliciting embarrassment and creating failure portfolios. (Note: GP raised $31 million in equity financing [its eighth round] earlier this year, with participants including Bay City Capital, Johnson & Johnson (J&J) Development Corp., Nestl/Inventages Venture Capital, North American Nutrition and Agribusiness Fund and Novartis BioVenture Fund. However, this close required about 18 months of effort and was accompanied by a notable reduction in GP's valuation.)
So where is GP pointing its telescope? Dr. Miller pointed out three target areas: medical foods, companion animal health and consumer and prescription dermatologicals. (This latter category took on a dominant position in the discussions that ensued. Presumably the pursuit of pharma was not expanded upon because of it being outside of the scope of the intended audience.) The compositions that evolve into these different application areas are being matured through use and composition patents, trade secrets and "clinical and perceived benefits" obtained through clinical trials.
1. Consumer nutraceuticals didn't work so GP will pursue consumer dermatologicals;
2. The "toolbox approach didn't work, so GP will pursue pharmacophores (chemical units or segments that can interact with a specific pathologic molecule(s)) for inflammation; and
3. Neuro-inflammatory diseases and bioenergetic inflammation will work. These include medical events and conditions like stroke, Alzheimer's, multiple sclerosis, amyotrophic lateral sclerosis (Lou Gehrig's disease), Duchenne's muscular dystrophy and peripheral neuropathy. Included in this are redox-based (leveraging oxidation and reduction events within cells) and pharmacophores for ischemic (compromised blood flow) diseases. (Note: an example of a redox-based pharmacophore for inflammation is the napthoquinone unit, which is present in certain forms of vitamin K.)
Dr. Miller believes the biotech toolbox business model (genomics, functional genomics, proteomics) "fell apart" and that there "is a need for phenotypic screening," the outward metabolic or physiological manifestation of a specific genetic handprint each individual is dealt.
Clinical Trials and the Big Five. In the previous article it was stated that Galileo did not appear to begin and complete the five clinical trials that had been declared in a Wall Street interview. However, Dr. Miller stated that they had completed five clinical trials, "all of which contained significant positive data in cardiovascular disease, end-stage renal disease [mentioned in the March article], exercise and performance, diabetes [type 2] and premenstrual syndrome/premenstrual dysphoria disorder (PMS/PMDD)." None of the trials employed an active control e.g. Serafem brand of fluoxetine for PMS/PMDD and it is still unclear whether all of these trials employed a placebo control. Dr. Miller stated there was no need to disclose the results of the studies to the public (Agreed. Especially given the existence of strategic alliances and partnerships in place). Indeed, GP has become quite a quiet entity, with its own website having a 13 month respite between press releases.
Patent-A-Month Club. Another prophecy offered by Dr. Miller in his Wall Street interview was that the company was filing one patent a month. When queried about this he stated that Galileo had come close to, if not exceeding, that target. However, tracking patents filed both domestically and internationally, and the international nature of most of GP's filings, they do not appear to have been filed at a one a month pace (OK, who cares). Rather, a lot of catch up work has been undertaken. What is far more intriguing is to see how these patents endure in the marketplace, and when challenged, given that GP is playing in the sandbox of the "muscle-bound" multinationals. GP's partnerships will likely provide guidance in the patent litigation war, a most expensive one at that, even under the tutelage of a J&J, Novartis or Nestl.
Skin Game. As mentioned previously, Dr. Miller did dedicate a notable emphasis on consumer and prescription dermatologicals as a business development opportunity for GP. He cited both sides of the regulatory fence in this class of goods as being "under assault by private label," and that "competitor erosion of the innovator" being commonplace. So how does GP plan to circumnavigate this "Sea of Siege?" When asked, "Can we expect to see any nutritionals from GP appearing on the consumer shelf?" Dr. Miller said the company has plans for "broad benefit skin redox consumer products, like a soap or a cream, an oral supplement and a prescription oral or topical product."
Let's put these in perspective, given the alliances GP has established: J&J owns Neutrogena (soaps and cream); Nestle has partnered with L'Oreal to form the Inneov (a cosmetic dietary supplement joint venture) "beauty from within" brand for skin health and appearance and J&J has a strong place in prescription dermatologicals e.g. Ortho-McNeil. Galileo's objective is to create familiarity with a branded product and offer a clinical benefit-a consumer experience cemented upon an evidence base, derived from phase IIb-style clinical trials using surrogate markers for establishing efficacy.
Claim Game. Dr. Miller offered early in the interview a perspective regarding large consumer products companies and their need to have conventional claims providing a freedom to operate. The aforementioned objective in dermatologicals gives Dr. Miller and GP the freedom to operate within the realm and eyes of the FDA. This signals GP's reliance on the FDA as a governor of how they will and can move in the market. On the notion of the FTC auditing claims that enter into consumer ads, Dr. Miller bristled, "The FTC as the arbiter of claims of efficacy, that is preposterous! This is an indictment of our current system."
Honing in on what brand would appear on any claimed product with claims, citing an abundance of companies sporting the Galileo moniker, Dr. Miller audibly smiled and acknowledged that he and his board will likely need to cross that bridge some day. As to what will be the first commercialization bridge that GP's first scion traverses is a lofty bet. However, given the passion of the double doctor, his impressive partners and board, and his celestial aspirations it will likely be a memorable one. To Dr. Miller and GP the power of an X-ray telescope is wished to tease out the magic molecules from their Herculean natural bioactives library and bring real "lab-to-sky," evidence-based and enduring innovations to the consumer.NW
About the author:
Anthony Almada is chief scientific officer and founder of Imaginutrition and MetaResponse Sciences, Laguna Niguel, CA. He can be reached at 949-489-0229; Fax: 949-363-1758; E-mail: anthony@imaginutrition.com; Website: www.imaginutrition.com.
The first strike was on nutraceuticals. Dr. Miller stated, "We are no longer a nutraceutical company. We have a renewed and keen focus." He attributed the investment community's disenchantment and second degree burns from holding onto nutraceutical companies to the failure of Benecol, 9/11 and the dot com bubble rupturing. These events heralded the "end of the infinite bubble for the dietary supplement market," which, in effect, "sent ripples through the spines of CEO's," eliciting embarrassment and creating failure portfolios. (Note: GP raised $31 million in equity financing [its eighth round] earlier this year, with participants including Bay City Capital, Johnson & Johnson (J&J) Development Corp., Nestl/Inventages Venture Capital, North American Nutrition and Agribusiness Fund and Novartis BioVenture Fund. However, this close required about 18 months of effort and was accompanied by a notable reduction in GP's valuation.)
So where is GP pointing its telescope? Dr. Miller pointed out three target areas: medical foods, companion animal health and consumer and prescription dermatologicals. (This latter category took on a dominant position in the discussions that ensued. Presumably the pursuit of pharma was not expanded upon because of it being outside of the scope of the intended audience.) The compositions that evolve into these different application areas are being matured through use and composition patents, trade secrets and "clinical and perceived benefits" obtained through clinical trials.
Hedges Funded
1. Consumer nutraceuticals didn't work so GP will pursue consumer dermatologicals;
2. The "toolbox approach didn't work, so GP will pursue pharmacophores (chemical units or segments that can interact with a specific pathologic molecule(s)) for inflammation; and
3. Neuro-inflammatory diseases and bioenergetic inflammation will work. These include medical events and conditions like stroke, Alzheimer's, multiple sclerosis, amyotrophic lateral sclerosis (Lou Gehrig's disease), Duchenne's muscular dystrophy and peripheral neuropathy. Included in this are redox-based (leveraging oxidation and reduction events within cells) and pharmacophores for ischemic (compromised blood flow) diseases. (Note: an example of a redox-based pharmacophore for inflammation is the napthoquinone unit, which is present in certain forms of vitamin K.)
Dr. Miller believes the biotech toolbox business model (genomics, functional genomics, proteomics) "fell apart" and that there "is a need for phenotypic screening," the outward metabolic or physiological manifestation of a specific genetic handprint each individual is dealt.
Clinical Trials and the Big Five. In the previous article it was stated that Galileo did not appear to begin and complete the five clinical trials that had been declared in a Wall Street interview. However, Dr. Miller stated that they had completed five clinical trials, "all of which contained significant positive data in cardiovascular disease, end-stage renal disease [mentioned in the March article], exercise and performance, diabetes [type 2] and premenstrual syndrome/premenstrual dysphoria disorder (PMS/PMDD)." None of the trials employed an active control e.g. Serafem brand of fluoxetine for PMS/PMDD and it is still unclear whether all of these trials employed a placebo control. Dr. Miller stated there was no need to disclose the results of the studies to the public (Agreed. Especially given the existence of strategic alliances and partnerships in place). Indeed, GP has become quite a quiet entity, with its own website having a 13 month respite between press releases.
Patent-A-Month Club. Another prophecy offered by Dr. Miller in his Wall Street interview was that the company was filing one patent a month. When queried about this he stated that Galileo had come close to, if not exceeding, that target. However, tracking patents filed both domestically and internationally, and the international nature of most of GP's filings, they do not appear to have been filed at a one a month pace (OK, who cares). Rather, a lot of catch up work has been undertaken. What is far more intriguing is to see how these patents endure in the marketplace, and when challenged, given that GP is playing in the sandbox of the "muscle-bound" multinationals. GP's partnerships will likely provide guidance in the patent litigation war, a most expensive one at that, even under the tutelage of a J&J, Novartis or Nestl.
Skin Game. As mentioned previously, Dr. Miller did dedicate a notable emphasis on consumer and prescription dermatologicals as a business development opportunity for GP. He cited both sides of the regulatory fence in this class of goods as being "under assault by private label," and that "competitor erosion of the innovator" being commonplace. So how does GP plan to circumnavigate this "Sea of Siege?" When asked, "Can we expect to see any nutritionals from GP appearing on the consumer shelf?" Dr. Miller said the company has plans for "broad benefit skin redox consumer products, like a soap or a cream, an oral supplement and a prescription oral or topical product."
Let's put these in perspective, given the alliances GP has established: J&J owns Neutrogena (soaps and cream); Nestle has partnered with L'Oreal to form the Inneov (a cosmetic dietary supplement joint venture) "beauty from within" brand for skin health and appearance and J&J has a strong place in prescription dermatologicals e.g. Ortho-McNeil. Galileo's objective is to create familiarity with a branded product and offer a clinical benefit-a consumer experience cemented upon an evidence base, derived from phase IIb-style clinical trials using surrogate markers for establishing efficacy.
Claim Game. Dr. Miller offered early in the interview a perspective regarding large consumer products companies and their need to have conventional claims providing a freedom to operate. The aforementioned objective in dermatologicals gives Dr. Miller and GP the freedom to operate within the realm and eyes of the FDA. This signals GP's reliance on the FDA as a governor of how they will and can move in the market. On the notion of the FTC auditing claims that enter into consumer ads, Dr. Miller bristled, "The FTC as the arbiter of claims of efficacy, that is preposterous! This is an indictment of our current system."
In the End
Honing in on what brand would appear on any claimed product with claims, citing an abundance of companies sporting the Galileo moniker, Dr. Miller audibly smiled and acknowledged that he and his board will likely need to cross that bridge some day. As to what will be the first commercialization bridge that GP's first scion traverses is a lofty bet. However, given the passion of the double doctor, his impressive partners and board, and his celestial aspirations it will likely be a memorable one. To Dr. Miller and GP the power of an X-ray telescope is wished to tease out the magic molecules from their Herculean natural bioactives library and bring real "lab-to-sky," evidence-based and enduring innovations to the consumer.NW
About the author:
Anthony Almada is chief scientific officer and founder of Imaginutrition and MetaResponse Sciences, Laguna Niguel, CA. He can be reached at 949-489-0229; Fax: 949-363-1758; E-mail: anthony@imaginutrition.com; Website: www.imaginutrition.com.
