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Highly anticipated new drugs wait in the wings from Microbio
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Microbio Co., Ltd.
(By David Silver)
25 April, 2009
Changing the lives of diabetic patients, forever. A company in Taiwan is developing a product that might just do that, with its WH-1 new drug candidate for diabetic patients who suffer from painful, difficult-to-heal ulcers.
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Founder and Chairman of Microbio, Mr. William Lu (left), with Microbio subsidiary Oneness Biotech's head of new drug development, Dr. Liming Shen, at the company's headquarters in Taipei, Taiwan. |
Although Taipei-based Microbio is still young, its achievements are stacking up rapidly. Starting off as an offshoot in 2000 of founder, chairman and health foods proponent William Lu and his growing business in imported pure foods, the company has morphed over the years from being primarily a dietary supplement company into a successful consumer health products and herbal supplements developer and manufacturer, and on to its most recent focus -- discovering and developing new drugs for a host of unmet medical needs.
At the same time, its business in supplements has gone from strength to strength, with a catalogue now of more than 70 products making up its 'Lee Herbs' brand. LeeHerb products are available from over 1,200 traditional Chinese medicine stores nationwide, and have over the years become a common household brand in Taiwan. Microbio recently received recognition from the Department of Health with LeeHerb Herbiron- the first product to be awarded DOH Health Food Certificate for improvement of nutrition-deficient anemia.
Recognizing that majority of dietary supplements worldwide are sold via multi-level marketing, Microbio established its own wholly owned MLM company- Microsoy International Inc., in 2006. In 2008, Microbio further strengthened its retail business unit through the acquisition of a chain of organic specialty stores under the name of 'Oneness Organic' aka 飈ottonLand.' Cottonland is one of the longest running, most reputable organic specialty stores in Taipei. With over 17 years of experience, CottonLand operates 11 organic specialty stores throughout Taipei with national expansion next on its agenda. Strengthening of Microbio's retail and dietary supplement business units is helping to fund Microbio's core activity in new drug development.
At the core of Microbio's new drug development is the company's proprietary fermentation platform technology, where researchers have recreated conditions found in human intestine. This unique fermentation platform allows for the growth and isolation of new compounds with therapeutic properties from botanical extracts, with the technology being incorporated as part of Microbio's wholly owned, GMP and ISO-certified manufacturing facility, with a larger plant currently under construction in Shanghai.
Microbio's first drug candidate breakthrough came in oncology, with its MS-20 drug candidate. MS-20 is derived from the fermentation of organic, non-GM soybeans using Microbio's proprietary fermentation platform. The process utilizes over 20 strains of intestinal bacteria to create a concentrated soybean fermentation metabolite solution. MS-20 has proven effective in enhancing intestinal beneficial bacteria and is currently undergoing US FDA and Taiwan DOH recognized Phase II and III human clinical trials respectively. Intended indications being studied include: enhancement of natural killer cell activity, suppression of neutropenic fever, enhancement of quality of life and survival of liver cancer patients.
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A sampling of Microbio's LeeHerbs dietary supplements.
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Microbio's MB-6 drug candidate is currently under development as an adjunct therapy for colorectal cancer. MB-6 utilizes materials grown under Good Agricultural Practice (GAP) conditions fermented using Microbio's proprietary fermentation platform.
Recognizing the importance of intellectual property protection in new drug development, both MS-20 and MB-6 are protected by a family of strategic international patents.
To concentrate on furthering its achievements in new drug discovery, Microbio recently spun off a new company, Oneness Biotech Co., Ltd., solely focusing on the development of new drugs. Oneness Biotech is currently working on Microbio's most exciting product to date: its WH-1 drug candidate, a topical diabetic wound healing agent currently undergoing FDA-approved Phase II clinical trials.
Whilst it is commonly known that diabetic patients suffer from neuropathy (poor circulation of the peripheral limbs) that can result in painful, difficult to heal wounds, and in cases, amputation of affected areas, the absence of effective, convenient and affordable treatments was the reality for such patients.
This may be about to change. Microbio scientist, and now Oneness Biotech's head of new drug development, Dr. Liming Shen explains.
"Up until now, patients with diabetes have had limited options towards the effective treatment of hard-to-heal foot ulcers. This has been further exacerbated by the recent FDA announcement that Regranex [a protein drug for the treatment of diabetic skin ulcers made by J&J] must carry box labels warning of increased risk of cancer mortality. WH-1, in comparison is a much safer, more convenient, cheaper product with comparable effectiveness," said Shen.
Microbio is confident that WH-1 will move rapidly along the commercialization pipeline and be approved for the market both locally and internationally. The company is encouraged by the fact that the only other botanically-derived prescription drug in the world to receive US FDA approval is also a topically applied product, Veregen (derived from green tea extract), used to treat genital warts. If WH-1 is so approved, it will be a milestone not only for Microbio and Taiwan's fledging biotech industry, but also for the global botanical drug development industry as a whole.
As for Microbio's therapeutic focus, it is mostly in the field of chronic conditions including cancer, anti-inflammatory diseases and metabolic disorders. Microbio is continually looking for partners with shared synergy to further strengthen its development portfolio.
Microbio is also hard at work on the development of numerous drug screening platform technologies from natural products and continue to collaborate with two of Taiwan's leading research institutes, the Development Center for Biotechnology (DCB), and Academia Sinica, on the discovery of new compounds with exciting therapeutic potential.
But the measure of Microbio's success is perhaps best summed up in the fact that it is the only company in Taiwan so far to have received recognition from the FDA for Phase II clinical trials on three of its drug candidates.
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