Paladin Labs Inc.

Paladin Labs Inc.
Procter & Gamble Pharmaceuticals Canada Inc.

Procter & Gamble Pharmaceuticals Canada Inc.

July 02, 2008 17:00 ET

Paladin Labs and Procter & Gamble Pharmaceuticals Enter Into Canadian Co-Promotion Agreement for Seasonale™: First and Only Extended-Cycle Oral Contraceptive Available in Canada

MONTREAL, QUEBEC--(Marketwire - July 2, 2008) - Paladin Labs Inc. (TSX:PLB) and Procter & Gamble (P&G) Pharmaceuticals Canada, Inc., today announced that the companies have entered into a Canadian Co-Promotion Agreement for SEASONALE™ - the first and only extended-cycle oral contraceptive available in Canada. With SEASONALE™, Canadian women have an oral contraceptive option that will allow them to have just four periods per year.

SEASONALE™ (levonorgestrel and ethinyl estradiol 0.15mg/0.03 mg tablets) is an effective new contraceptive option for Canadian women, striking a balance between the benefits of having fewer periods with the reassurance of still having some periods.

Under this Co-Promotion Agreement, Paladin will maintain regulatory and supply responsibilities for SEASONALE™ and will continue to support SEASONALE™ using its national specialty sales force. P&G Pharmaceuticals Canada will provide marketing, promotion, trade distribution and will deploy a national sales force in support of SEASONALE™.

"P&G is the world's largest consumer product company and offers the pharmaceutical expertise and proven alliance management capabilities that made it our preferred partner for helping to grow SEASONALE™ in Canada" said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc.

"We are pleased to partner with Paladin and share their passion to make a positive impact in the lives of patients," said Andy McClenaghan, General Manager, P&G Pharmaceuticals Canada. "At P&G, we have a deep consumer understanding and a long history of successful women's health products. We understand that many women want to manage their periods and SEASONALE™ is an exciting new option for Canadian women that will help meet this need."

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 SEASONALE™ to be an attractive contraceptive option.

Paladin acquired the Canadian license to SEASONALE™ from Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE:BRL), in September 2005. At that time, Paladin filed on behalf of Duramed the New Drug Submission (NDS) for SEASONALE™ with the Therapeutic Products Directorate (TPD) of Health Canada. SEASONALE™ received TPD approval in July 2007 and was subsequently launched by Paladin in January 2008.


SEASONALE™ is an extended-cycle oral contraceptive 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.

Clinical Data

The clinical data supporting Health Canada's approval of SEASONALE™ tablets resulted from a randomized, open-label, multi-centre 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. 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

About P&G Pharmaceuticals Canada

Procter & Gamble Pharmaceuticals (P&GP), a division of Procter & Gamble Health Care, has successfully developed and marketed a wide range of trusted leading prescription brands in Canada including Actonel®, Asacol®, Dantrium®, Didrocal®, and Macrobid®. Through an innovative Connect & Develop model, P&GP exclusively licenses, partners or acquires all its new product development candidates from academia, biotech and pharmaceutical industry relationships. P&GP is dedicated to delivering innovations to patients in need in areas of gastrointestinal, musculoskeletal, and women's health. The P&GP community consists of more than 3,000 employees working in over 22 countries worldwide.

Three billion times a day, P&G brands touch the lives of people around the world. P&G has one of the strongest portfolios of quality, leadership brands in consumer health and wellness, including Align®, Always®, Crest®, Metamucil®, Oral-B®, Pepto-Bismol®, Prilosec OTC®, Scope®, Tampax®, and Vicks®, in addition to its trusted consumer brands, including Ariel®, Braun®, Bounty®, Charmin®, Dawn®, Downy®, Duracell®, Folgers®, Gillette®, Head & Shoulders®, Iams®, Lenor®, Mach3®, Olay®, Pantene®, Pampers®, Pringles®, Tide®, Wella®, and Whisper®. The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit for the latest news and in-depth information about P&G and its brands.

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, 2007. 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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