Healthcare Industry News: Barr Laboratories
News Release - July 5, 2007
Women's Menstrual Cycles Can Be Seasonal with SEASONALE(TM): First Extended-Cycle Oral Contraceptive Approved by Health Canada
MONTREAL, QUEBEC--(Healthcare Sales & Marketing Network)--Jul 5, 2007 -- Paladin Labs Inc. (Toronto:PLB.TO ) announced today that it has obtained Health Canada's approval for SEASONALE(TM) - 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.SEASONALE, (levonorgestrel and ethinyl estradiol 0.15mg/0.03 mg 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.
A recent survey by Ipsos Camelford Graham shows that almost three out of four Canadian women are open to the idea of reducing the number of their periods. When given a choice regarding how often they could have a period, the most popular alternative was four times a year (almost 40 per cent of respondents), while only one out of five felt comfortable with complete suppression of their periods.
"SEASONALE is an excellent new option for women who are eligible to take oral contraceptives, particularly those who have busy and active lives and wish to have fewer periods each year," says Dr. Amanda Black, Obstetrician/Gynecologist, The Ottawa Hospital and Assistant Professor, University of Ottawa. "SEASONALE may also be helpful for women who experience physical symptoms during their period, such as cramping, heavy bleeding, or headaches."
SEASONALE is designed to reduce the number of periods from 13 to four 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.
"It is a myth that women need to have a period every month," says Dr. Melissa Mirosh, Staff Obstetrician/Gynecologist, High River General Hospital and a contributor to the Society of Obstetricians and Gynaecologists of Canada (SOGC) guidelines on extended/continuous use contraception. "Women currently using traditional oral contraceptives do not have a true monthly menstrual period, but more accurately have a 'hormone withdrawal bleed.' With SEASONALE, women have the choice to safely have their period just four times a year and still prevent conception."
Who May Use SEASONALE?
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.
"As an active woman with a busy life, I am excited about SEASONALE," says Caroline Fortin, a teacher from Cornwall, Ontario. "Being able to limit the number of periods will be a tremendous advantage for me. I'll have the freedom to do the activities that I enjoy like camping and hiking without calculating when I'll get my period. I am also hoping that it will ease some of the physical symptoms I experience such as menstrual migraine."
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.
On September 30, 2005, Paladin licensed Seasonale from Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE:BRL ) and filed a New Drug Submission (NDS) with the Therapeutic Products Directorate (TPD) of Health Canada on behalf of Duramed. Duramed markets SEASONALE® in the United States.
About the Survey
The survey was conducted by Ipsos Camelford Graham on behalf of Paladin from June 20 to June 28, 2007. For this research a total of 988 interviews were conducted nationally among Canadian females aged 18 to 45 years of age. Interviews were held via the Ipsos Reid Canadian Online Omnibus. Results are considered accurate to within +/- 3.1%, 19 times out of 20 had the entire Canadian 18-45 year old female population been interviewed. These data were weighted to ensure that the sample's regional composition reflects that of the actual Canadian population according to census data.
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 www.paladinlabs.com.
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, 2006. 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 www.sedar.com
SEASONALE is a trademark of Barr Laboratories, Inc.
Source: Paladin Labs
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