Paladin Labs Inc. and Procter & Gamble (P&G) Pharmaceuticals Canada, Inc. announced that the companies have entered into a Canadian co-promotion agreement for Seasonaletm - the first and only extended-cycle oral contraceptive available in Canada. With Seasonaletm, Canadian women have an oral contraceptive option that will allow them to have just four periods per year.

Seasonaletm (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 Seasonaletm and will continue to support Seasonaletm 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 Seasonaletm.

"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 Seasonaletm 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 Seasonaletm is an exciting new option for Canadian women that will help meet this need."

Seasonaletm 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 Seasonaletm to be an attractive contraceptive option.

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

Seasonaletm is an extended-cycle oral contraceptive designed to reduce the number of periods from 13 to 4 per year. Seasonaletm 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.

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