Anthony Almada, BSc03.01.03
In the April 2000 and June 2001 issues of Nutraceuticals World, "Industry Innovators" profiled a suite of companies and individuals endowed with industrial prescience. Although the profiled consumer brand companies continue to thrive (e.g. Tropicana, Stonyfield, Quaker Oats and General Mills), less has been broadcast about the ingredient and R&D companies showcased. Two of the more research-intensive companies mentioned were Galileo Laboratories, Santa Clara, CA, and GalaGen, Minnetonka, MN.
At the axis of this Northern California-based life sciences company is the energetic, intelligent and charismatic Guy Miller. This personality mix has likely played an important part in the successful courting of the investment community, coupled with his MD/PhD degree combo. [Note: Much of Dr. Miller's excellent chemistry research (and PhD dissertation) in free radical-mediated DNA damage with an antitumor antibiotic (bleomycin) was published under the name of Guy Ehrenfeld.] Additionally, Dr. Miller's personality has served Galileo well in developing a large stable of partnerships. These have ranged from the National Stroke Association (education campaign describing the relationship between nutrition and stroke risk reduction) to the Florida Department of Citrus (FDOC) (FDOC agreed to fund research on citrus derived bioactives for cardiovascular diseases) to Procter & Gamble (with Iams pet health products).
Due to several controllable and uncontrollable forces, there do not appear to be any collaborative research and development partnerships that have generated any revenues of note (assumption: such partnerships would likely be the subject of a press release). Galileo did undertake some in vitro/pre-clinical research for DMV on some proprietary glutamine-centric peptide (GPX) derived from wheat. However, this did not appear to mature into human proof of concept studies or materialize into a robust marketing campaign. Galileo's partnerships with Warner-Lambert (now part of Pfizer) and P&G/Iams also have yet to bear commercially ripe fruit.
The application areas that Galileo announced to the world it would be pursuing were cardiovascular disease, bioenergetics and oxidative stress/redox targets. In the April 2000 issue of Nutraceuticals World, Galileo reported that it was filing patents at the rate of one per month. Over the intervening 35 months (assuming the interview transpired in February of 2000), Galileo has had eight patent applications publish, collectively in the U.S. and internationally. Four of these eight were U.S. applications that published in January of this year, describing pyruvate derivatives (many of them being suited for drug regulatory status). This class of compounds appears widely in the patent literature and thus it will be of interest to watch Galileo's prosecution success in the U.S. Patent Office.
Galileo was awarded a U.S. patent in July of 2002, describing compositions comprised of individual vitamers of non-alpha tocopherols, e.g. gamma-, beta-, or delta-tocopherol, plus a flavonoid and lactoferrin. This combination suggests that Galileo's alliances with FDOC and DMV may have had some influence on the invention (citrus being a rich source of flavonoids and lactoferrin being a dairy bioactive). Two related U.S. patent applications by Galileo were published in September and October of last year describing the use of non-alpha-tocopherols or their metabolites, with or without a flavonoid, for the treatment of conditions associated with impaired blood delivery to a certain tissue (ischemia).
The gamma-tocopherol aspect of the issued patent appears to have been licensed to Encore Pharmaceuticals Inc., based in Riverside, CA, in a technology transfer deal that was completed late last year. Encore is led by Dr. William Wechter, a former professor of medicine at Loma Linda University. Encore filed and received a suite of patents on gamma-tocopherol and one of its metabolites, and was working on this resurrected vitamin E isomer even before Galileo closed its first round of funding. Encore is vigorously pursuing the use of this vitamer, specifically in conditions related to disordered sodium excretion (e.g. hypertension and kidney disease).
One of Galileo's early partners (since 1998), the Worcester, MA-based Phytera, sold its marine microbe and cultured plant cell libraries, and its R&D partnerships to Galileo in March 2002. Phytera operated Phytera Ltd. in the U.K., which posted sales of less than $2 million in fiscal year 2002 and now has been named Galileo Laboratories Ltd. Probing the oceans on the left continent, Dr. Miller is also listed as a co-inventor on an international patent filed with co-authors from the University of California, Santa Cruz (about 30 miles away from Galileo's headquarters in Silicon Valley), through a collaboration with Dr. Phil Crews. Crews' lab routinely ventures into the South Pacific searching for new sponges and characterizing new bioactive molecules, especially as anti-tumor agents. This new source of marine natural products further expands Galileo's library of novel compounds. The subject of the patent is marine sponge-derived compounds exhibiting potent inhibitory effects on the pro-inflammatory enzyme lipoxygenase.
In a May 2001 Wall Street CEO Interview, Dr. Miller stated that they were aiming to initiate five or so nutraceutical clinical trials in the next 18 months. Eighteen months later the only one that has been publicly described is one with sixty type II diabetics. Dr. Miller stated the results would be available in the third quarter 2001 but no mention of the results has been made public. Did the trial fail or are the results on ice? Galileo did recently announce the results of a clinical trial with its proprietary compound GLI-8545. It was shown to significantly reduce the concentrations of a circulating marker of inflammation, C-reactive protein (CRP) in persons requiring dialysis for end stage kidney disease. It is not clear if this is a natural product or a synthetic derivative thereof, or if it was compared to another drug and/or placebo.
The fascination of the investment community with nutraceuticals, as a near term means of revenue generation, has waned dramatically. This may be due, in part, to the absence of any blockbuster or even "successful" nutraceutical product introductions using drug discovery tools. Thus, Galileo may be retooling its resources to focus its discovery "tool box" upon drug development. A continued scrutiny of the stars with an innovation telescope will unveil Galileo's true trajectory.
The other gal, the northern gal from Minnetonka, MN, enjoyed a big splash in the world of nutraceuticals several years after its birth in 1987. Starting as a subsidiary of the Land O' Lakes cooperative (which also ended up renting a building to GalaGen), it was first led by president and COO Blair Mowery, who also was the co-founder and president of Procor Technologies. Procor was exploring the innovations and intellectual property of bovine bioactive proteins in the late 1980's-early 1990's and was the direct predecessor of GalaGen. Joining Mr. Mowery was Eileen Bostwick, who obtained her PhD from the University of Minnesota as a bovine immunologist and apparently was much of the brains behind GalaGen's bioactives. After Mr. Mowery, human amino acid metabolism expert Robert Hoerr (who trained under the expert eye of Dr. Vernon Young at MIT) took the helm, making the shift from amino acids to proteins. GalaGen's business centered around harnessing engineered bioactive proteins derived from bovine mammary secretions. Indeed, chairman and chief technology officer (and former CEO) Bob Hoerr, also an MD/PhD (like Guy Miller), made a scientific presentation at the 1996 annual meeting of The American Association for the Advancement of Science titled, "The Cow as a Bioreactor."
In the June 2001 Nutraceuticals World interview with Dr. Hoerr, he stated, "I thought early on that the nutraceutical path would be similar to that for dietary supplements; after all, we had an ingredient backed by a lot of science." Indeed, science alone does not a successful company make. A more pointed question is did they have the right science? GalaGen, a public company, was first delisted from the NASDAQ Small Cap Market in January 2001 and then filed for Chapter 7 bankruptcy in February 2002. And its collective assets were on the block over the last few months, with companies like dairy bioactive-centric DMV making a bid as low as $30 thousand. NuSkin's subsidiary, Pharmanex, snatched some or all of those assets up this January for a sum just north of $100 thousand.
Similar to Galileo, GalaGen forged a number of strategic alliances with industrial partners. With its lead nutraceutical ingredient Proventra®, a proprietary (and relatively very expensive) bovine colostrum ingredient (which was produced through contract manufacturing relationships), GalaGen aligned with Hormel HealthLabs (a division of Hormel Foods, another Minnesota-based company), Estee Lauder (supply agreement), GNC (dietary supplements), Wyeth (antibacterial infant formulas), Tropicana (refrigerated juices), Rhodia (for its unique NCFM strain of Lactobacillus acidophilus), Metagenics (a sublicense to patents for beverage compositions that combine a probiotic with an immunoglobulin source, like colostrum) and Lifeway Foods (refrigerated beverages incorporating both a probiotic and an immunoglobulin source).
The last three alliances were interwoven, with GalaGen providing the Proventra-derived immunoglobulins, Rhodia providing the probiotic and Metagenics allowing the practice of combining the two and the promise not to sue for patent infringement. The product, Basics Plus™, a slightly effervescent, creamy fruit drink that was introduced in late 1997, continues to sell at a modest pace in the specialty natural retail channel. It has been labeled as a dietary supplement since its launch.
Another alliance that was unknown to many was with Biocine, a venture of Chiron, Emeryville, CA-part of "Biotech Bay." The 1995 alliance involved the licensing of Chiron's MF-59 adjuvant technology (used in its vaccine development projects), and a collaborative research and development agreement, to explore passive immune therapies using bovine antibodies against Helicobacter pylori (H. pylori). H. pylori is closely linked to the development of stomach ulcers and cancers. This technology was applied to GalaGen's Sporidin-G oral antibody preparation. Chiron had an option for exclusive worldwide marketing rights for products resulting from the collaboration.
Sporidin-G designed for a different gut infection elicited excitement in the investment community after a preliminary, open-label (no placebo control group) study in AIDS patients infected with the gut parasite Cryptosporidium parvum. The early results were very promising (well tolerated and a significant reduction in diarrhea-associated stool weight) and were published (J AIDS, 1996) but the follow-up randomized placebo-controlled trial (RCT) yielded disappointing results.
GalaGen then co-sponsored an open label clinical study with H. pylori-targeted Sporidin-G, orally administered for two days to 15 H. pylori-infected subjects. This Baylor College of Medicine-based study met the same fate as the AIDS RCT: non-significant results. The findings appeared in a 1999 paper (Aliment Pharmacol Ther), which also found recombinant human lactoferrin and a special carbohydrate to be ineffectual. The authors of this paper- giants in the field of clinical gastroenterology-did suggest that perhaps a longer duration of supplementation might have yielded a positive outcome.
During its life, GalaGen filed a number of U.S. and international patents, covering both methods of production of colostrum and bovine immunoglobulins and their use. Five U.S. patents were issued, two being the prime jewels in the recent acquisition of assets by Pharmanex. These patents describe a method to filter whey and colostrum. The European patent with very similar claims was issued last December. One U.S. patent that departed from GalaGen's core technology was a liquid amino acid enteral nutrition composition that also claimed a peptide form of glutamine. No bovine proteins were claimed as part of the patent. An unappreciated international patent application that never issued described a composition comprised of an active immunoglobulin (e.g. appropriately prepared colostrum) and soy (e.g. as soy isoflavones or soy protein). This could have become a product for Lifeway Foods with its Soy Treat™ kefir products. Its international patent filing for treating H. pylori never entered the European phase of patent prosecution, nor the national phase in Canada. Its fate in the U.S. Patent and Trademark Office is unknown.
GalaGen's demise is unfortunate for the nutraceuticals industry at large in that it will likely discourage outside investment in true research plus intellectual property (IP)-driven business plans and entities. GalaGen's seminal efforts in putting colostrum on the map, this time with a much bigger footprint, fostered a left shift in the success curve of numerous other colostrum ingredient manufacturers and marketers, and colostrum finished goods marketers. [Note: colostrum enjoyed an evanescent stint in the mid to late 1980's, primarily as a sports nutrition supplement claimed to have anabolic effects, by virtue of the then questionable presence of insulin-like growth factors (IGFs).] An interesting experiment in a parallel universe would have been installing a management team with prior dietary supplement success at GalaGen, coupled with GalaGen's former research and IP savvy group. Perhaps Proventra preceded its time in the mass market, or could it have fared better in gut health-conscious markets like the EU or Japan? Sadly, we may never know.NW
Galileo Laboratories
At the axis of this Northern California-based life sciences company is the energetic, intelligent and charismatic Guy Miller. This personality mix has likely played an important part in the successful courting of the investment community, coupled with his MD/PhD degree combo. [Note: Much of Dr. Miller's excellent chemistry research (and PhD dissertation) in free radical-mediated DNA damage with an antitumor antibiotic (bleomycin) was published under the name of Guy Ehrenfeld.] Additionally, Dr. Miller's personality has served Galileo well in developing a large stable of partnerships. These have ranged from the National Stroke Association (education campaign describing the relationship between nutrition and stroke risk reduction) to the Florida Department of Citrus (FDOC) (FDOC agreed to fund research on citrus derived bioactives for cardiovascular diseases) to Procter & Gamble (with Iams pet health products).
Due to several controllable and uncontrollable forces, there do not appear to be any collaborative research and development partnerships that have generated any revenues of note (assumption: such partnerships would likely be the subject of a press release). Galileo did undertake some in vitro/pre-clinical research for DMV on some proprietary glutamine-centric peptide (GPX) derived from wheat. However, this did not appear to mature into human proof of concept studies or materialize into a robust marketing campaign. Galileo's partnerships with Warner-Lambert (now part of Pfizer) and P&G/Iams also have yet to bear commercially ripe fruit.
The application areas that Galileo announced to the world it would be pursuing were cardiovascular disease, bioenergetics and oxidative stress/redox targets. In the April 2000 issue of Nutraceuticals World, Galileo reported that it was filing patents at the rate of one per month. Over the intervening 35 months (assuming the interview transpired in February of 2000), Galileo has had eight patent applications publish, collectively in the U.S. and internationally. Four of these eight were U.S. applications that published in January of this year, describing pyruvate derivatives (many of them being suited for drug regulatory status). This class of compounds appears widely in the patent literature and thus it will be of interest to watch Galileo's prosecution success in the U.S. Patent Office.
Galileo was awarded a U.S. patent in July of 2002, describing compositions comprised of individual vitamers of non-alpha tocopherols, e.g. gamma-, beta-, or delta-tocopherol, plus a flavonoid and lactoferrin. This combination suggests that Galileo's alliances with FDOC and DMV may have had some influence on the invention (citrus being a rich source of flavonoids and lactoferrin being a dairy bioactive). Two related U.S. patent applications by Galileo were published in September and October of last year describing the use of non-alpha-tocopherols or their metabolites, with or without a flavonoid, for the treatment of conditions associated with impaired blood delivery to a certain tissue (ischemia).
The gamma-tocopherol aspect of the issued patent appears to have been licensed to Encore Pharmaceuticals Inc., based in Riverside, CA, in a technology transfer deal that was completed late last year. Encore is led by Dr. William Wechter, a former professor of medicine at Loma Linda University. Encore filed and received a suite of patents on gamma-tocopherol and one of its metabolites, and was working on this resurrected vitamin E isomer even before Galileo closed its first round of funding. Encore is vigorously pursuing the use of this vitamer, specifically in conditions related to disordered sodium excretion (e.g. hypertension and kidney disease).
One of Galileo's early partners (since 1998), the Worcester, MA-based Phytera, sold its marine microbe and cultured plant cell libraries, and its R&D partnerships to Galileo in March 2002. Phytera operated Phytera Ltd. in the U.K., which posted sales of less than $2 million in fiscal year 2002 and now has been named Galileo Laboratories Ltd. Probing the oceans on the left continent, Dr. Miller is also listed as a co-inventor on an international patent filed with co-authors from the University of California, Santa Cruz (about 30 miles away from Galileo's headquarters in Silicon Valley), through a collaboration with Dr. Phil Crews. Crews' lab routinely ventures into the South Pacific searching for new sponges and characterizing new bioactive molecules, especially as anti-tumor agents. This new source of marine natural products further expands Galileo's library of novel compounds. The subject of the patent is marine sponge-derived compounds exhibiting potent inhibitory effects on the pro-inflammatory enzyme lipoxygenase.
In a May 2001 Wall Street CEO Interview, Dr. Miller stated that they were aiming to initiate five or so nutraceutical clinical trials in the next 18 months. Eighteen months later the only one that has been publicly described is one with sixty type II diabetics. Dr. Miller stated the results would be available in the third quarter 2001 but no mention of the results has been made public. Did the trial fail or are the results on ice? Galileo did recently announce the results of a clinical trial with its proprietary compound GLI-8545. It was shown to significantly reduce the concentrations of a circulating marker of inflammation, C-reactive protein (CRP) in persons requiring dialysis for end stage kidney disease. It is not clear if this is a natural product or a synthetic derivative thereof, or if it was compared to another drug and/or placebo.
The fascination of the investment community with nutraceuticals, as a near term means of revenue generation, has waned dramatically. This may be due, in part, to the absence of any blockbuster or even "successful" nutraceutical product introductions using drug discovery tools. Thus, Galileo may be retooling its resources to focus its discovery "tool box" upon drug development. A continued scrutiny of the stars with an innovation telescope will unveil Galileo's true trajectory.
GalaGen
The other gal, the northern gal from Minnetonka, MN, enjoyed a big splash in the world of nutraceuticals several years after its birth in 1987. Starting as a subsidiary of the Land O' Lakes cooperative (which also ended up renting a building to GalaGen), it was first led by president and COO Blair Mowery, who also was the co-founder and president of Procor Technologies. Procor was exploring the innovations and intellectual property of bovine bioactive proteins in the late 1980's-early 1990's and was the direct predecessor of GalaGen. Joining Mr. Mowery was Eileen Bostwick, who obtained her PhD from the University of Minnesota as a bovine immunologist and apparently was much of the brains behind GalaGen's bioactives. After Mr. Mowery, human amino acid metabolism expert Robert Hoerr (who trained under the expert eye of Dr. Vernon Young at MIT) took the helm, making the shift from amino acids to proteins. GalaGen's business centered around harnessing engineered bioactive proteins derived from bovine mammary secretions. Indeed, chairman and chief technology officer (and former CEO) Bob Hoerr, also an MD/PhD (like Guy Miller), made a scientific presentation at the 1996 annual meeting of The American Association for the Advancement of Science titled, "The Cow as a Bioreactor."
In the June 2001 Nutraceuticals World interview with Dr. Hoerr, he stated, "I thought early on that the nutraceutical path would be similar to that for dietary supplements; after all, we had an ingredient backed by a lot of science." Indeed, science alone does not a successful company make. A more pointed question is did they have the right science? GalaGen, a public company, was first delisted from the NASDAQ Small Cap Market in January 2001 and then filed for Chapter 7 bankruptcy in February 2002. And its collective assets were on the block over the last few months, with companies like dairy bioactive-centric DMV making a bid as low as $30 thousand. NuSkin's subsidiary, Pharmanex, snatched some or all of those assets up this January for a sum just north of $100 thousand.
Similar to Galileo, GalaGen forged a number of strategic alliances with industrial partners. With its lead nutraceutical ingredient Proventra®, a proprietary (and relatively very expensive) bovine colostrum ingredient (which was produced through contract manufacturing relationships), GalaGen aligned with Hormel HealthLabs (a division of Hormel Foods, another Minnesota-based company), Estee Lauder (supply agreement), GNC (dietary supplements), Wyeth (antibacterial infant formulas), Tropicana (refrigerated juices), Rhodia (for its unique NCFM strain of Lactobacillus acidophilus), Metagenics (a sublicense to patents for beverage compositions that combine a probiotic with an immunoglobulin source, like colostrum) and Lifeway Foods (refrigerated beverages incorporating both a probiotic and an immunoglobulin source).
The last three alliances were interwoven, with GalaGen providing the Proventra-derived immunoglobulins, Rhodia providing the probiotic and Metagenics allowing the practice of combining the two and the promise not to sue for patent infringement. The product, Basics Plus™, a slightly effervescent, creamy fruit drink that was introduced in late 1997, continues to sell at a modest pace in the specialty natural retail channel. It has been labeled as a dietary supplement since its launch.
Another alliance that was unknown to many was with Biocine, a venture of Chiron, Emeryville, CA-part of "Biotech Bay." The 1995 alliance involved the licensing of Chiron's MF-59 adjuvant technology (used in its vaccine development projects), and a collaborative research and development agreement, to explore passive immune therapies using bovine antibodies against Helicobacter pylori (H. pylori). H. pylori is closely linked to the development of stomach ulcers and cancers. This technology was applied to GalaGen's Sporidin-G oral antibody preparation. Chiron had an option for exclusive worldwide marketing rights for products resulting from the collaboration.
Sporidin-G designed for a different gut infection elicited excitement in the investment community after a preliminary, open-label (no placebo control group) study in AIDS patients infected with the gut parasite Cryptosporidium parvum. The early results were very promising (well tolerated and a significant reduction in diarrhea-associated stool weight) and were published (J AIDS, 1996) but the follow-up randomized placebo-controlled trial (RCT) yielded disappointing results.
GalaGen then co-sponsored an open label clinical study with H. pylori-targeted Sporidin-G, orally administered for two days to 15 H. pylori-infected subjects. This Baylor College of Medicine-based study met the same fate as the AIDS RCT: non-significant results. The findings appeared in a 1999 paper (Aliment Pharmacol Ther), which also found recombinant human lactoferrin and a special carbohydrate to be ineffectual. The authors of this paper- giants in the field of clinical gastroenterology-did suggest that perhaps a longer duration of supplementation might have yielded a positive outcome.
During its life, GalaGen filed a number of U.S. and international patents, covering both methods of production of colostrum and bovine immunoglobulins and their use. Five U.S. patents were issued, two being the prime jewels in the recent acquisition of assets by Pharmanex. These patents describe a method to filter whey and colostrum. The European patent with very similar claims was issued last December. One U.S. patent that departed from GalaGen's core technology was a liquid amino acid enteral nutrition composition that also claimed a peptide form of glutamine. No bovine proteins were claimed as part of the patent. An unappreciated international patent application that never issued described a composition comprised of an active immunoglobulin (e.g. appropriately prepared colostrum) and soy (e.g. as soy isoflavones or soy protein). This could have become a product for Lifeway Foods with its Soy Treat™ kefir products. Its international patent filing for treating H. pylori never entered the European phase of patent prosecution, nor the national phase in Canada. Its fate in the U.S. Patent and Trademark Office is unknown.
GalaGen's demise is unfortunate for the nutraceuticals industry at large in that it will likely discourage outside investment in true research plus intellectual property (IP)-driven business plans and entities. GalaGen's seminal efforts in putting colostrum on the map, this time with a much bigger footprint, fostered a left shift in the success curve of numerous other colostrum ingredient manufacturers and marketers, and colostrum finished goods marketers. [Note: colostrum enjoyed an evanescent stint in the mid to late 1980's, primarily as a sports nutrition supplement claimed to have anabolic effects, by virtue of the then questionable presence of insulin-like growth factors (IGFs).] An interesting experiment in a parallel universe would have been installing a management team with prior dietary supplement success at GalaGen, coupled with GalaGen's former research and IP savvy group. Perhaps Proventra preceded its time in the mass market, or could it have fared better in gut health-conscious markets like the EU or Japan? Sadly, we may never know.NW
