Paladin Labs Inc.: Canadian Women To Be Granted Easier Access To Emergency Contraception

Main Category: Women's Health / Gynecology
Also Included In: Pharmacy / Pharmacist
Article Date: 15 Apr 2008 - 14:00 PDT

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Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, today announced that the National Drug Scheduling Advisory Committee (NDSAC) has recommended Paladin's application to move Plan B® from Behind-the-Counter status to full Over-the-Counter (OTC) status to the National Association of Pharmacy Regulatory Authorities (NAPRA).

NDSAC's decision to recommend the scheduling change to NAPRA means that Canadian women are one step closer to easier access through full OTC status. If approved by NAPRA, Canadian women would no longer need to request Plan B® from the pharmacist and would be able to purchase Plan B® just like any other OTC product.

"We are thrilled with NDSAC's decision," says Madeleine Boscoe, nurse with the Women's Health Clinic in Winnipeg. "Due to the nature of emergency contraception, it needs to be taken as soon as possible within a maximum of 72 hours after unprotected intercourse or a contraceptive failure. Better access and use of emergency contraception may significantly reduce the incidence of unintended pregnancy in Canada."

Plan B® is a safe, effective and easy-to-use emergency contraceptive pill that is 95 per cent effective in preventing unintended pregnancy when taken within 24 hours of unprotected sex, but does not have any impact on an already established pregnancy.

"Plan B® meets all the relevant criteria for Schedule III listing," says Dr. Colleen Metge, Assistant Professor of Pharmacy, University of Manitoba, and a former chairperson of the National Drug Scheduling Advisory Committee. "The drug is safe, easy to use, does not require personal instruction or any examination by a doctor, and the active ingredient, levonorgestrel, has a long history of safe and effective use both as an oral contraceptive and emergency contraceptive. It is great news that Plan B® will now be available Over-the-Counter in pharmacies."

Studies have demonstrated that the labelled directions on Plan B® were followed accurately by women without counselling or evaluation by a health professional. And moving Plan B® to Schedule III status will still allow women the option of speaking to a pharmacist if desired.

"This decision is a step forward for women," says Madeline Boscoe, nurse with the Womens Health Clinic in Winnipeg. "Whether due to condom failure or forgetting to take a birth control pill, the reality is that the morning after pill is a safe and effective way to prevent unintended pregnancies, and over the counter availability is the best way to guarantee women timely access to emergency contraception."

Many leading Canadian health organizations, including the Society of Obstetricians and Gynecologists of Canada, the Canadian Federation of Medical Women and the Canadian Association for Adolescent Health, are supportive of making Plan B® available on pharmacy shelves as a schedule III drug as it is a safe and effective emergency method to prevent unintended pregnancy.

About Paladin Labs

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Company's web site at http://www.paladinlabs.com.

Plan B® is a registered trademark of Duramed Pharmaceuticals, Inc.
This news release may contain forward-looking statements or predictions.

This news release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiary may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report as well as in the Company's Annual Information Form for the year ended December 31, 2007. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether a result of new information, future events, or except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly fillings, annual report and Annual Information Form and other fillings found on SEDAR at http://www.sedar.com.

Paladin Labs