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Carson City biopharma firm using botanical products to take on infectious diseases

Mike Sion

Legere Pharmaceuticals Ltd. based in

Carson City has a breakthrough product

aimed right at consumers’ guts.

More specifically at the frequent

culprit of chronic stomachaches, including

the piercing pangs of indigestion,

ulcers and worse:

Helicobacter pylori a form of bacteria

experts believe causes most of the

upset stomachs or gastritis among the

estimated 60 million cases a month in

which Americans take something to

relieve a constant bellyache.

Legere (which is doing business as

Lectin Labs Ltd.) has developed an overthe-

counter powder, NutraLec, based on

proteins known as lectins naturally found

in most plants and animals (in

NutraLec’s case, wheat). Lectins are

weapons against H. pylori (as it is more

commonly called by scientists), which

seems to be quite the terrorist among

human pathogens.

H. pylori (pronounced pie-LOR-ee)

was discovered in 1983 by two Australian

researchers. Until then, scientists

believed that stress, poor diet or too

much alcohol caused ulcers. Now

researchers know that H. pylori is the

culprit, and that chronic infection can

lead to stomach cancer which trails

only lung cancer as the most fatal human

malignancy on the planet, according to

the World Health Organization.

H. pylori thrives in the stomach’s

highly acidic environment, colonizing

and spreading and ranks as the most

common human pathogen in the world.

H. pylori infects half of all Americans

and two-thirds of the world population,

according to the WHO and the U.S.

Centers for Disease Control.

The market for a product such as

NutraLec would seem to be huge. Lectin

Labs has been developing the antipathogen

since 1992 and set up shop in

Carson City in 1996. Carson proved to

have the best price for land and facilities

compared to next-door California, Reno

and Sparks, says Howard C. Krivan, company

president and chief scientific officer.

The company has filed for patents on

NutraLec and now is bringing it to market.

The first order for bulk shipments to

a distributor which will sell the powder

to retailers, who will package the

supplement under their own brand

names is expected by October, says

company chairman/CEO Bruce F. Rose.

NutraLec will hit northern Nevada store

shelves before the end of the year,

offered either in pouches or plastic

bottles, Rose says. Consumers either

on their own in response to chronic

stomach troubles, or on the recommendation

of their physicians as an alternative

to prescribing antibiotics are

directed to take 20 grams daily of the

powder, mixing it in tea, water or other

beverage to absorb NutraLec’s mildly

mocha-like taste.

Rose and Krivan are two of three officers

in the company, which has six fulltime

employees at its 10,000-square-foot

facility at 3123 Research Way. There are

corporate offices, laboratories and a pilot

plant to produce NutraLec and a range of

other lectin-based products the company

is in various stages of developing.

The officers bring a range of experience

to the company:

* Rose, with 40 years in the pharmaceutical/

healthcare industry, help led two

companies VLI Corporation, Inc.

(maker of the TODAY contraceptive

Sponge) and UltraFEM, Inc. (maker of

the INSTEAD Female Sanitary

Protection Device) each to $100

million capitalization and listing on

the Nasdaq.

* Krivan is a microbiologist with an

extensive resume in the public and private

sectors. He was a staff fellow at the

National Institutes of Health. He also

founded the vaccine-maker MicroCarb,

Inc. (now called Antex Biologics, Inc.)

and helped lead it to an initial public

offering. Krivan holds 14 U.S. patents.

* Richard C. Potter, executive vice

president/chief operating officer, is a

chemical engineer who developed such

products as the No-Pest Strip and the

Hartz Flea Collar.

Legere plans to package and market

NutraLec under its own label in addition

to meeting orders for a distributor with

whom Legere has signed a multimilliondollar

contract to last three to five years.

The company forecasts $80,000 in

sales of NutraLec in 2002, $2.5 million

in 2003 and $36.8 million by 2006.

“The global marketplace for NutraLec

is estimated to be in excess of $5 billion

and consists of 5,500 U.S. health food

stores, 55,000 U.S. pharmacies, mass merchandisers

such as Wal-Mart, network

marketing companies, e-commerce and

international retail outlets,” Rose says.

The company expects to have up to 50

full-time employees by 2006 the same

year Legere anticipates U.S. Food &

Drug Administration approval of a far

more advanced form of NutraLec to be

available by prescription. The current

version falls under the federal Dietary

Supplement and Health Education Act

as a supplement, and did not need FDA

approval, Rose says.

Clinical trials have shown that

NutraLec relieves stomach pain and also

arrests the infection of H. pylori, Krivan

says. This means that NutraLec should

be taken daily as with standard vitamins

and mineral supplements by

those who suffer from frequent gastric

discomfort. Depending on the retailer’s

price, NutraLec can cost $20 to $50 a

month far less expensive than an

antibiotic treatment, Krivan says.

Someone suffering an upset stomach

perhaps after eating at a restaurant

may reach for an over-the-counter product

such as Tums or Zantac. But recurring

pain should signal a trip to a physician

for a test to reveal whether H. pylori

is in a patient’s stomach, Krivan says.

And those who suffer gnawing gastritis

may suspect that the bacterium is at work

and seek to medicate themselves with

NutraLec without initially seeing a doctor,

he says.

The battle between lectins and H.

pylori is conducted on the molecular

level. Carbohydrates bristling with various

chemical receptors cloak living cells.

The receptors bind with different molecules

to transfer chemicals that keep the

cell alive. H. pylori and other pathogens

have surface proteins that can attach to a

cell’s receptor and wreak havoc. That

beachhead is the beginning of a battle

that can result in infection that can

spread to other cells.

Lectins, however, can bind with and

destroy many types of pathogens, such as

H. pylori, and thus ward off disease.

Not only is reaching for a bottle of

Maalox not a cure for the cause of indigestion

or ulcers (as opposed to the

symptoms), but even mega-doses of

antibiotics aren’t always effective, since

H. pylori is known to resist certain

antibiotics, Krivan says.

Legere also is developing a range of

microbicides (bacteria-killers) to use in

pharmaceuticals or over-the-counter

nutraceuticals to treat skin disorders such

as acne and body odor, digestive ailments

and sexually transmitted diseases.

“The company has several core technology-

based products in varying degrees

of the development,” Krivan says. “The

company intends to introduce other

nutraceutical, dermaceutical (skin carebased)

and RX products. For example,

lectins have been found to specifically

target bacteria that cause acne and body

odor; lectins also have been found to

arrest infection of the Type I herpes

virus, which is responsible for cold sores.

And a vaginal microbicide is under

development to prevent STDs in women,

such as chlamydia, gonorrhea and

HIV/AIDS,” he says.

“This lectin technology has endless

applications in fighting microbial disease

and the company has a long pipeline

of exciting product opportunities.”


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