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Going Against The Grain In Life Sciences Research
Rolf Kletzien and Jerry Colca are doing research they could not do when they were employed by the big pharmaceutical companies. If their project succeeds, it could have a worldwide impact on health, with a potential monetary value so "extreme" that "the lawyers don't like us to talk about that," according to Colca.
Kletzien and Colca, who were employed at Pfizer until 2005 and have many years of research experience there and at other major pharmaceutical companies, pooled their money in 2006 to form Metabolic Solutions Development Co. to address the growing global threat of Type 2 diabetes and related metabolic disorders.
With initial investment and managerial help from Grand Rapids firm Hopen Therapeutics, the company has made significant progress — which led to a big boost in January when the Southwest Michigan First Life Science Fund in Kalamazoo announced it was making a significant investment in the firm.
The strength of Metabolic Solutions’ “discovery pipeline” drew the attention of the Southwest Michigan First Life Science Fund, according to the fund's general partner and CEO Ron Kitchens. The amount of the investment was not disclosed, but it is “going to allow us to do our initial Phase 2 trials," said Colca. The investment will also fund additional long-term studies that will eventually bring those studies to the critical registration trials. They hope to have a drug ready for production in 2012.
"This was an idea that Rolf and I had for a number of years," said Colca. "We were never able to pursue it within the big pharma companies. … It runs contrary to their standard way of thinking," he said.
Their idea is focused on insulin-sensitizing thiazolidineiones, or TZDs, which were discovered more than 25 years ago by scientists at Takeda Pharmaceutical Co. There are side effects, but Kletzien and Colca believe they now understand the mechanism of action of insulin sensitizers. Because of a general failure to understand those mechanisms, there have been no new insulin-sensitizing drugs developed since the first TZDs were produced almost 20 years ago — in spite of considerable attempts to do so, according to the company’s Web site, www.msdrx.com
"The basic thing is that our idea of how these drugs work runs counter to what everybody else believes," said Colca.
Before they even formed Metabolic Solutions, Colca and Kletzien went to Hopen Therapeutics with their idea, but Hopen was "not too excited about it at first," said Colca. Once they began to get some initial results, Hopen made an investment in their company and linked it to other companies in West Michigan, all of which "allowed us to open an IND (investigational new drug)," said Colca.
Hopen Therapeutics is a private equity investment firm formed in 2005 in Grand Rapids that focuses on helping early- to mid-stage life sciences projects achieve commercial success. It looks for promising pharmaceutical and health care concepts, and offers the owners of those concepts funding, development and managerial expertise, along with a broad network of industry relationships.
Mark Olesnavage, a former Perrigo executive and now president of Hopen Therapeutics, said Hopen was skeptical at first because "these guys are counter to what the scientific community thinks, on how this class of drugs works." But Hopen also realized the two men had many years of experience and enough "interesting knowledge in their area to at least make us want to explore further."
Olesnavage said Hopen did some homework and came to the conclusion that if the two men were right, the market opportunity would be incredible. Hopen offered its support because of the "tremendous market opportunity, and … the depth of knowledge and the history that these two have" in research involving the TZD class of drugs.
According to the World Health Organization’s Web site, WHO estimates that more than 180 million people worldwide have diabetes, and the number is likely to more than double by 2030.
In 2005, an estimated 1.1 million people died from diabetes. That number could be as high as 2.9 million deaths per year if deaths in which diabetes was a contributing factor were also taken into account.
WHO projects that deaths from diabetes will increase by more than 50 percent in the next 10 years without urgent action. Diabetes deaths are projected to increase by over 80 percent in upper-middle-income countries between 2006 and 2015.
"All I can say is, the existing market for Type 2 diabetes oral meds are in the billions of dollars. And that's just the U.S.," said Olesnavage.
He noted that Metabolic Solutions’ could also apply to the complications of diabetes. Colca said he and Kletzien hope to do more than treat diabetes: They want to prevent it.
In addition to initial financing, Hopen's resource network of small life sciences companies in West Michigan helped the two men develop a pre-clinical package and file an investigational new drug application, required by the U.S. Food and Drug Administration. Metabolic Solutions also has applied for four new drug patents.
On its Web site, the company lists its "key development partnerships," which includes a variety of research laboratories and business services, such as legal, regulatory affairs and management consultants. Almost all the firms are located in either the Kalamazoo or Grand Rapids areas.
While a concerted effort such as this was once considered possible only for large pharmaceutical companies, it is now possible for small area companies "because there are lots of resources here in West Michigan that are left over from the large pharma companies," said Olesnavage.
One of those resources is professional people with years of experience, such as those who were employed in R&D at the large drug companies and stayed behind when those companies left West Michigan. “There's a really unique collection of expertise that exists here now," said Colca.
"There actually exists within the community enough expertise to build an entire drug company around this, and just take off." HQX