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Eflornithine

Eflornithine (α-difluoromethylornithine or DFMO) is a drug manufactured by Sanofi-Aventis which has various uses. It was initially developed as a cancer medication; and while it has no significant effects on cancerous malignancies, it was found to be very effective in combatting African trypanosomiasis (sleeping sickness), in particular the West African form¹ of the disease. It is hoped that eflornithine will replace the relatively toxic melarsoprol. more...

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Supplies of Eflornithine are limited as it is not very cost effective to manufacture. Aventis stopped making eflornithine in 1995 because of this very reason. The drug company gave the rights to manufacture the drug to the World Health Organization, who attempted to find a new supplier. Eflornithine is also an effective hair removal agent and is the active ingredient in Vaniqa brand hair removal cream.

Eflornithine appears to work by inhibiting ornithine decarboxylase (ODC), an enzyme that regulates cell division.

Sleeping Sickness Treatment

In 2001, Aventis made a 5-year agreement with the WHO to manufacture eflornithine, melarsoprol and pentamidine, in sufficient amounts to cover existing needs. The yearly value of the drugs donated by Aventis under this agreement is US$5 million. Medecins Sans Frontieres, or Doctors Without Borders, the non-profit international medical group, assisted in the creation of the new agreement. MSF will work to distribute the drugs. In addition, under the agreement, Bristol-Myers Squibb, the manufacturer of Vaniqua, will pay for part of the eflornithine. The 5-year agreement will expire in 2006. In 2004, Aventis merged with Sanofi-Sythélabo to form Sanofi-Aventis.

The trade name of eflornithine as manufactured for the treatment of sleeping sickness is Ornidyl®.

As of September 2005, the World Health Organization's eflornithine page is reporting that the India Institute of Chemical Technology in Hyderabad, India and ILEX Oncology in Texas, United States are both working on new ways of making eflornthine more cheaply. The WHO goes on to say that ILEX is experimenting with an oral formulation of the drug as a treatment for cancer and that trials of the new oral formulation for efficacy against sleeping sickness are underway.

Hair Removal Cream

As a topical application, the drug has been shown to be an effective hair growth retardant in some patients, and is sold under the brand name Vaniqa® (eflornithine hydrochloride 13.9%). Efficacy data submitted to FDA observed about 58% of women using it on facial hair had improvement². This study suggested it may be particularly effective in postmenopausal women. One large published study on safety found the product rarely caused significant side effects such as acne, follicle irritation, itching or dryness³. This corroborates unpublished data submitted to FDA showing about 2% of subjects discontinued use due to adverse reactions.

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Barrier Acquires Vaniqa Canadian Distribution Rights
From Worldwide Biotech, 8/1/05

Barrier Therapeutics, Inc. (NASDAQ: BTRX), Princeton, N.J., a pharmaceutical company developing products in the field of dermatology, has acquired the right to distribute VANIQA(r) (eflornithine hydrochloride) Cream, 13.9% in Canada from Shire Pharmaceutical Contracts Limited. VANIQA(r) is currently the only prescription product approved by Health Canada for slowing the growth of unwanted facial hair in women.

Under the terms of the agreement, Barrier is the exclusive distributor for VANIQA(r) in the Canadian territory and is responsible for all sales, marketing, regulatory and distribution activities. Shire Pharmaceuticals is the supplier of finished goods for Barrier.

"Having acquired the rights to sell VANIQA(r) in Canada, along with our existing product Solag(r), we will immediately begin to build our own sales and marketing organization in Canada," commented Al Altomari, chief commercial officer. "We view Canada as an important market in our global commercialization plans, as it provides us an opportunity to leverage our existing commercial infrastructure."

About VANIQA(r) (eflornithine hydrochloride) Cream, 13.9% VANIQA(r) is the only prescription product approved by Health Canada for slowing the growth of unwanted facial hair in women. VANIQA(r) works during the growth phase of the hair cycle by blocking an enzyme that is necessary for hair growth. VANIQA(r) does not remove facial hair; instead, it is designed to reduce the rate of growth of facial hair and increase the interval between periods of hair removal when used together with traditional hair removal methods such as shaving, waxing and tweezing. Clinical trials have shown results from the use of VANIQA(r) in four to eight weeks from initial application, with continued improvement over time.

VANIQA(r) is approved for sale in 39 countries, including the United States, Canada, the European Union, and major Latin American countries.

About Barrier Therapeutics, Inc.

Barrier Therapeutics, Inc. is a pharmaceutical company focused on the discovery, development and commercialization of pharmaceutical products in the field of dermatology. The company currently markets Solag(r) (mequinol 2%, tretinoin 0.01%) Topical Solution in the U.S. and Canada for the treatment of solar lentigines, a common condition also known as "age spots" or "liver spots," and for the broader indication including related hyperpigmented lesions in Canada. Barrier has eight product candidates in various stages of clinical development. The four most advanced product candidates include one for the treatment of diaper dermatitis complicated by candidiasis, which is in registration, and three products, which are in or entering Phase 3 clinical trials for the treatment of seborrheic dermatitis, fungal infections, including vaginal candidiasis and onychomycosis, and congenital ichthyosis. Barrier has product candidates in earlier stages of clinical development for the treatment of acne, psoriasis and fungal infections. The company is headquartered in Princeton, New Jersey and has wholly owned subsidiaries in Geel, Belgium and Ontario, Canada.

For more information, call 212/845-4274 or visit http://www.barriertherapeutics.com.

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