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Molecular Design International’s Bill Purcell with UT researchers Jena Steinle and Duane Miller.

UT Researchers Target Diabetes
Compound has potential to be “billion-dollar drug”

2011 The Memphis Business Journal

By Michael Sheffield

A new compound being developed at the University of Tennessee Health Science Center could be the link to preventing blindness in diabetic retinothropy patients.  It has already received $1 million in research grants from the Juvenile Diabetes Research Foundation and the National Institutes of HealthFollowing the lengthy process of clinical trials and approval, the research could lead to “billion-dollar drug.”  The compound currently known as 49b, was developed by Jena Steinle, associate professor at UTHSC, and Duane Miller, chair and professor of the department of pharmaceutical services at the UT College of Pharmacy.

Duplicate diabetic conditions in animals were found without making the animals diabetic, a process that would have taken years to accomplish.  In the Type I diabetes model, 90 percent of people with the disease go blind because the glucose kills the nerves,” Purcell says.  “If we fix the nerves, we may not have these problems.”  Steinle and Miller have connected with Molecular Design International, a company that helps shepherd compounds such as 49b to market. A eye drop has been developed that is taken once a day by patients.  In lab animals, the treatment is shown to prevent diabetic retinothopy. So far, the work has resulted in a $1 million grant from the Juvenile Diabetes Research Foundation and $100,000 from NIH.  The project has received an $80,000 grant from UT, which is being used to help bring the compound into the pharmaceutical market.  Molecular Design International has worked with companies suchas Glaxo SmithKlineMerck & Co. Inc. and  Eli Lilly and Co. in bridging drugs to the market in the past, and currently has two obesity and oncology drugs in development.

MDI is also working on the development of a wound care product.  Bill Purcell, chairman of Molecular Design International, says the drug’s reach could be limitless because of the prevalence of diabetic retinothropyin diabetes patients. “If you have diabetes and you live long enough, you’ll probably get diabetic retinothophy, and if you have that, you will go blind,”Purcell, says.  “This could stop that, reverse the process of blindness and help people see that wouldn’t be able to see. It could be a billion-dollar drug.”  Miller who has more than 450 patents to his credit, says the process began with 30 drugs that were narrowed down and eventually manipulated as they showed progress. “It’ll be a real challenge going from animals to humans, but the only way to really test it is to actually test it in humans,” Miller says. “This has high potential.”  While the process could take up to eight years and “between $50 million and $100 million,” Purcell believes the science of 49b is sound enough to move forward, however, moving from the research phase is complex, says Jan Bouton, a partner with Memphis based early stage biotechnology investment company, Innova.  Compounds that are designed to prevent a condition rather than cure a disease face challenging trials, she says.”  They just need to get to the point where it’s attractive to someone big enough to pick it up and get the results,” Bouton says, “Diabetes is a growing problem and blindness as a result is growing as well.  This would be a really good one if they can figure it all out.”

Market BioNext Wound Product in U.S.
Friday, October 23, 2009
Memphis Business Journal – by Michael Sheffield

 

Memphis-based Molecular Design International has secured U.S. distribution rights to Bionext’s wound protection product, a biocellulose device that creates a physical barrier and helps prevent infection to wounds.

BioNext is a Brazil-based company that manufactures the product and has sold it in five other countries, including China and Italy. The product is gas permeable and impermeable to bacteria. Also, it only needs to be applied once, where other wound care products must be applied multiple times over the duration of the wound, says Bill Purcell, MDI’s founder and chairman. Once the wound is healed, the film can simply be washed away.

BioNext’s biocellulose device can work on stage one and two wounds, which typically include bedsores, diabetic ulcers and first- and second-degree burns. The healing process for burns has been clinically proven to happen in a week with the product. Its limits would be battlefield wounds, which are considered stage three wounds.

Despite that, BioNext’s usefulness in the healing of bedsores is one reason Purcell is exploring the possibility of offering it to the VA Medical Center at Memphis. MDI is working with Huntsville, Tenn.-based S&L Products and Services, a disabled veteran-owned medical equipment and supply distributor.

Molecular Design International Receives Research Grant
April 2008

The Daily News

Molecular Design International Inc. of Memphis has received a competing continuation grant $599,008 for pharmacological research.  The National Institute of General Medical Sciences, a division of the Department of Health and Human Services, awarded the grant.  The funds would permit MDI president and lead scientist, Dr. William Purcell, to continue his current research on the wound-healing properties of a particular chemical compound that he developed, which he calls “9-cis Retinoid Acid Derivative.”  The compound has been used effectively to treat common skin conditions such as acne and psoriasis, but also has shown promise in its ability to fight skin cancer.  Purcell funded MDI in1975.  The company mostly focuses on discovery and out-licensing of new pharmaceutical compounds.  MDI has worked on pharmaceutical compounds in the fields of oncology, dermatology, female sexual dysfunction and obesity.

Chemist’s Thickening Compound Lands $1 Million Federal Grant
March 7, 2005
The Memphis Business Journal article by Scott Shepard 

Dermatologists know that a class of drugs called retinoids can promote skin growth and possibly healing.  But the also know that retinoids will have their patients climbing the walls from the irritation.

A Memphis scientist thinks he’s fixed the problem, and the feds like it so much that they’re giving him $1 million to further the idea.  A dutch company is so impressed that it has already asked to help commercialize it when the time comes.

“Aging makes the skin extremely thin,” says chemist Bill Purcell, a retired UT professor and founder of Molecular Design International.  “All retinoids are irritating.  You don’t want to take an elderly person and slap something on them that turns them red and makes their skin peel.”  His compound stimulates collagen production and thickens the skin.  It may also have applications in wound healing.  Phase I results were so promising that the National Institutes of Health awarded the grant under its Small Business Innovation Research Program, which began in 1982 to encourage small business biotech.

Topical retinoids have demonstrated efficacy in the treatment of photo-aging; their use is often limited by their potential to induce irritation,” says Alan Moshell, director of the NIH Skin Disease Program.  “A non-irritation topical retinoid would be of value in the treatment of aging skin and potentially other conditions such as acne.”

In creating his drug, Purcell started with a retinoid used to treat Kaposi’s sarcoma, a form of skin cancer often appearing in AIDS patients.  “It looked like an exotic molecule, so I said let’s use some baling wire and see if we could fix the fence,” Purcell says.

He’s worked with immunologist James Varani in the Department of Pathology at the University of Michigan to build the molecule and study it.  Much of the grant money will fund two more years of animal studies in Varani’s lab.  Another collaborator is California’s Stanford Research Institute, where the drug’s toxicology profile will be developed.

Both aspects are needed before Purcell can approach the FDA with an Investigational New Drug application, which allows Phase III human trials.

Both Varani and Stanford have contractual arrangements, but no stake in the drug.  Purcell over the years has seen many enthusiastic scientists gradually cede control of their ideas, a few percentage points at a time, in the quest for funding.

Only his name and his company’s name appear on the patent, and he likes it that way.  Whatever drug company might eventually distribute the compound, Purcell says he will maintain ownership – except for one long string that will always be attached.  “When the federal government funds your research they retain royalty-free rights,” he says.  “So if they want to make an ointment out of this and give it to the troops, it’s theirs to do so.”

Dr. William Purcell

Biotech Leaders Explore Funding Options

Sept. 10, 2004
The Daily News

Memphis, Tennessee,at the University of Memphis, with  program managers from 14 federal agencies.  The purpose of the seminar was to inform potential grant applicants about the funds and opportunities available through the federal SBIR and STTR programs.   Because MDI has had tremendous success within the federal grant program, Dr. Purcell was interviewedwed for this article.”Putting SBIR to use”.
Dr. William Purcell, president and chief executive officer of Molecular Design (Intl.) Inc., knows firsthand the benefits of applying for an SBIR grant.  MDI has been submitting applications for the grants since 1985, Purcell said.  The company has a full pipeline of drugs in discovery and development in the categories of cancer, obesity, dermatology and sexual dysfunction.

Currently, MDI is at phase two of the application process for work on a skin restoration compound that combats thinning of the skin that occurs during the aging process.  ‘This compound restores skin to its healthy condition.’  Purcell said.  What sets the product apart from others on the market are the dual properties of the compound, he added.  ‘While it restores aged skin to a very healthy condition, it does not irritate the skin,’ he said, adding that a lot of products can do one or the other, but not both.  Right now, it’s a waiting game for Purcell as he anticipates word on funding.  But he’s optimistic.  ‘We got very good reviews and a very good score,’ he said.

Molecular Design International - Memphis Business Journal

MDI Makes “The List” in The Memphis Business Journal

Emphasis:  Biotechnology, List Makers, A look beyond the numbers,

Memphis Business Journal, July 9-15, 2004, page 21

The Memphis Business Journal interviewed MDI’s Dr. William P. Purcell in its coverage of the growing Biotechnology market in Memphis.

What has been your most successful personal or business investment?
Investing in myself and my company; believing in my ideas; and making personal commitments and monetary investments to inventing drugs, which has been my most successful investment.

What do you consider your greatest accomplishment?
Predicting the biological activity of a molecule before it was discovered.

How do you enjoy spending time outside of work?
Playing tennis, fishing, hunting and playing with my grandchildren.

What are your business goals for the coming year?
To drive our obesity drug candidate to the clinic.  Before we administer the drug to humans, we will evaluate the drug in an obese baboon model.  If we can get to the clinic in the coming year, the primary goal of MDI will be achieved.

What is the biggest challenge you face in meeting these goals?
Regulatory affairs and the costs of conducting the studies.

August 25, 2003
Experts: World Facing Diabetes Catastrophe
By Emelia Sithole

PARIS (Reuters) – More than 300 million people worldwide are at risk of developing diabetes and the disease’s economic impact in some hard-hit countries could be higher than that of the AIDS (news – web sites) pandemic, diabetes experts warned on Monday.

In a report released at the International Diabetes Federation conference in Paris, experts estimate the annual healthcare costs of diabetes worldwide for people aged 20 to 79 are at least $153 billion.  “In some countries with a higher incidence, diabetes has a higher economic impact than AIDS,” Williams Rhys, professor of clinical epidemiology at the University of Wales, told a news conference.  According to the Diabetes Atlas report, total direct healthcare spending on the disease worldwide will be between $213 billion and $396 billion by 2025, if predictions are correct that the number of people with diabetes will rise to 333 million by 2025 from 194 million.
Diabetes occurs in two basic forms: type I, which occurs in children and adolescents and accounts for five-10 percent of all diabetes cases, and the more common type II, or adult onset diabetes.  Patients with type I diabetes do not produce enough insulin while those with type II produce insulin but cannot use it effectively. Adult onset diabetes can often be prevented or controlled in its early stages with careful diet and exercise, but patients often need a range of drugs to control it.  Diabetes can lead to blindness, kidney failure, heart disease, disability and death.

HEALTHIER FOODS

More than 75 percent of diabetes cases are expected to be in developing countries by 2025 because of rapid culture and social changes as well as increasing urbanization. This is expected to further burden healthcare systems already stretched by the AIDS pandemic.  “What AIDS was in the last 20 years of the 20th century, diabetes is going to be in the first 20 years of this century,” said Paul Zimmet, foundation director of the International Diabetes Institute.  Zimmet and other experts say the diabetes epidemic will be fueled by an estimated 314 million people with impaired glucose tolerance (IGT) or higher than normal blood glucose levels — a high risk condition for developing type II diabetes.  They also warn that type II diabetes was increasing in children and adolescents in many countries and is linked to rising obesity. They urged food companies — especially those who make fast foods — to produce healthier foods and governments to set up national campaigns to combat diabetes.  “We are running out of time,” IDF President-elect Pierre Lefebvre warned during a news conference.  “If action is not taken now to stop the rise in diabetes, there is a significant risk that governments and social security (news – web sites) systems may fail to ensure the appropriate care to the millions who will be affected by diabetes in 2025,” he said.

April 24, 2003
American Cancer Society Study of Cancer Deaths Shows Obesity Link
Obesity Is Linked to Cancer Deaths , by David Armstrong,  Wall Street Journal, April 24, 2003, Page D3. 

“Americans worried about their weight can add this to their list of concerns:  A new study has been found that obesity significantly increases the risk of dying from Cancer.  The study from the American Cancer Society also warns that the more overweight a person is, the greater the risk of dying from cancer.  For the heaviest Americans, the death rate from all cancers was 52% higher for men and 62% higher for women. The study authors estimate 90,000 cancer deaths a year in the country are linked to obesity.  The study, published in this week’s New England Journal of Medicine, is the most sweeping yet to analyze the link between overweight Americans and cancer.  The data were culled from a mortality study of just over 900,000 Americans who were traced from 1982 through 1998.”

The article goes on to describe various types of cancers which seem to be the most  affected by obesity.  “While the dangerous connection between obesity and cardiovascular disease is well-known, there is less awareness of the cancer link even though prior studies have pointed to the relationship.  In a survey conducted last year by the American Cancer Society, only 1% of the people questioned listed obesity as a risk factor for cancer.  The study doesn’t answer the question of why there is a link between obesity and death from cancer… so far, investigators have been unable  to pinpoint a biological mechanism clearly linking obesity to most forms of cancer.

Eugenia E. Calle, the lead study author and the director of analytic epidemiology at the cancer society, said the drastic increase in cancer deaths among the overweight population may provide incentive for some patients to control their weight.  But she added the problem of obesity is so ingrained and widespread that there needs to be a societal change in eating habits.  “Every year there is an increase in the prevalence of obesity in this country,” she said. “Every year it goes up and we are nowhere near controlling this.  “The article goes on to describe the obesity evaluation process and stated that severely obese persons were most at risk.
Molecular Design International - Dr. William P. Purcell

February 27, 2003
MDI Is Featured in The Memphis Business Journal
Molecular Design sets Sights on Making Drugs, and Money
by Scott Shepard,
Memphis Business Journal,
February 21-27, 2003, Page 3.

The Memphis Business Journal focused on MDI this month in an in-depth article written by veteran reporter, Scott Shepard.

January 14, 2003
Use of Cosmeceuticals Is on The Rise
The Skinny on Wrinkle Creams , by Robert J. Davis,  Wall Street Journal, January 14, 2003,
Page D4. 

“Department stores, drug stores and even doctors are selling a growing array of products, often called ‘cosmeceuticals,’ that seem to claim they can reverse the aging process.”

Mr. Davis goes on to name some of the products currently on the market.  “While none can get rid of deep wrinkles, some products may firm the skin and reduce the appearance of fine lines.  But you have to know what you’re buying and use it carefully.  Wrinkles occur as we age because the body produces less collagen and the skin loses its elasticity.  Smoking and overexposure to the sun can hasten the process.  many products contain alpha hydroxy acids, or AHAs, which may help boost collagen production.  The problem is that they can increase sensitivity to the sun and the risk of sunburn.  As a result, the Food and Drug Administration recommends that users wear sunscreen and avoid the sun.   To minimize skin irritation, many experts suggest sticking to weaker solutions of AHAs – those with concentrations of 10% or less and a pH of 3.5 or higher – which tend to be less effective.

Another common ingredient, retinol, is a derivative of vitamin A.  It’s a weaker version of the active compound in the prescription anti-wrinkle drug Retin-A and Renova, which have been shown to build collagen, get rid of skin blotches, and possibly even prevent skin cancer.  But the effectiveness of over-the-counter retinol is less clear-cut.   Despite the claims of manufacturers, many experts say most retinol products are too weak to do much good.  Some experts are similarly skeptical when it comes to antioxidants like vitamins C and E and coenzyme Q-10.  These compounds are believed to counteract free radicals, which damage cells and cause aging.  But there’s no definitive evidence that antioxidants, when applied to the skin, have anti-aging effects.  However, there are some dermatologists who believe, for different reasons, that antioxidants may increase collagen production.  As for other ingredients, there’s even less proof that they work.  The cost of cosmeceuticals varies widely – from less than $10 an ounce to more than $100.”

Mr. Davis goes on to give consumers advice about choosing a product that is right for them.

January 2, 2003
Obesity Epidemic Growing

Obesity, Diabetes Continue to Increase in U.S., Associated Press,  Wall Street Journal, January 2, Page D4.

“The twin epidemics of obesity and diabetes still are on the rise in the U.S.”

More than 44 million U.S. residents were obese and 16.7 million people had diagnosed diabetes during 2001, according to a study by the federal Centers for Disease Control and Prevention.  The researchers found the U.S.’s obesity rate climbed to 21% during 2001 from 20% the year before, and the rate of diagnosed diabetes rose to 7.9% from 7.3%.  The study appeared in yesterday’s Journal of the American Medical Association.  The study’s findings are based on telephone surveys with a nationally representative sample of 195,005 adults.  The study used self-reported data to calculate body-mass index, a height-to-weight ration.  A BMI of 30 or higher was considered obese in the study.  Researchers believe the real  rates are even higher, partly because people tend to underestimate their weight.”

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