Paladin Labs Inc.

Paladin Labs Inc.

January 04, 2008 08:00 ET

Paladin Labs Announces SEASONALE Launch

MONTREAL, QUEBEC--(Marketwire - Jan. 4, 2008) - Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, today announced the Canadian launch of SEASONALE™, the first and only extended-cycle oral contraceptive available in this country. With SEASONALE™, Canadian women now have a new contraceptive option that will allow them to have just four periods per year.

"We are very pleased to have strengthened our Women's health franchise with the addition of SEASONALE™. With approximately 3,600 physicians writing 50% of the prescriptions in Canada, SEASONALE™ is a clear therapeutic fit for Paladin. As such, we are very excited to be bringing this exclusive product to Canadian women and believe that this next-generation oral contraceptive option will be the preferred choice of many," said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc.

SEASONALE™, (levonorgestrel and ethinyl estradiol 0.15mg/0.03mg tablets), is a safe and effective contraceptive option for women, striking a balance between the benefits of having fewer periods with the reassurance of still having some periods. SEASONALE™ will appeal most to busy women who do not want to deal with the inconveniences of a monthly period and to women who suffer from period-related symptoms such as cramping, heavy bleeding and headaches.


SEASONALE™ is designed to reduce the number of periods from 13 to 4 per year. SEASONALE™ is a 91-day regimen taken daily as 84 active tablets followed by seven inactive tablets, during which time a woman would have her period. By contrast, oral contraceptive products currently on the market are based on a 28-day regimen, with 21 active pills and seven inactive tablets.


SEASONALE has been used by over half a million women in the U.S. since its approval in 2003, and studies have shown no increased health risks with the medication compared to traditional birth control pills.

SEASONALE is suitable for anyone who can safely and effectively take oral contraceptives, but may appeal most to women with busy, active lives who would prefer not to deal with the inconvenience of a monthly period. Women who suffer from period-related symptoms such as cramping, heavy bleeding and headaches may also find relief in SEASONALE.

Clinical Data

The clinical data supporting Health Canada's approval of SEASONALE tablets resulted from a randomized, open-label, multi-center trial that ended in March 2002. The trial involved 1,400 patients between the ages of 18 to 40 at 47 sites across the U.S. An extension trial with 300 patients was performed for an additional two years.

In the trials, SEASONALE was found to have a comparable safety and efficacy profile to traditional oral contraceptives. As with other oral contraceptives, the most common adverse events were nasopharyngitis, headache and intermenstrual bleeding or spotting.

Oral contraceptives are one of the most widely researched drugs prescribed by physicians and have been studied for over 40 years. SEASONALE has been formulated using well-established ingredients, long recognized as safe and effective and extensively used in 28-day regimens.

About Paladin Labs Inc.

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. For more information, please visit the Company's web site at

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 Companies consider the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding the future events, many of which are beyond the control of the Companies and their subsidiaries, 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 reports, as well as in the Companies' Annual Information Forms for the year ended December 31, 2006. The Companies disclaim 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 Companies' ongoing quarterly filings, annual reports and Annual Information Forms and other filings found on SEDAR at

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