Ortho Women's Health & Urology Celebrates 75 Years Of Partnering With Women

RARITAN, N.J., July 25 /PRNewswire/ -- With the introduction 75 years ago of the first prescription contraceptive, Ortho Women's Health & Urology, a Division of Ortho-McNeil Pharmaceutical, Inc., has been a pioneer in advancing reproductive health. Today, the company begins a year-long celebration to commemorate the 75th anniversary of its continued partnership with women.

In conjunction with the anniversary, the Guttmacher Institute will carry out a retrospective analysis of the Female Attitudes and Contraceptive Trends Study (FACTS), conducted annually by Ortho Women's Health & Urology for the last 40 years, to gather women's views about health and birth control.

"The average woman has a span of some three decades during which she may consider birth control options," says Michelle Brennan, general manager, Ortho Women's Health & Urology. "Over this time, she must be well-informed about the advancements in birth control methods and about the benefits and risks of each. Since our earliest days, Ortho Women's Health & Urology has been a partner with women in this process. We've built our legacy on offering not only innovative products, but on providing assistance to women and to the healthcare professionals who help women. As we celebrate our 75th year, we're proud to reaffirm our commitment to generations of women."

Ortho undertook the first FACTS Birth Control Study in 1965, about five years after The Pill became available in the United States. The study was intended to better understand women's views on health, lifestyle and birth control. The company has continued the study annually since then, sharing the information with the public and healthcare community at different intervals.

"The 75th anniversary of Ortho's partnership with women offers an ideal time to engage in a retrospective analysis to highlight women's evolving views about their health and the integral role birth control plays in their lives," Ms. Brennan says. "Working with Guttmacher, the leading analytic and policy institute on reproductive health, we are confident that the analysis will be both thorough and enlightening."

The results of the retrospective analysis will be published in 2007.

A Legacy of Innovation

FACTS is just one example of Ortho's response to the changing needs of women. Among its many "firsts" was the development of the first prescription contraceptive vaginal jelly, the first contraceptive diaphragm, and the first test to detect cervical and uterine cancer, widely known today by women as the Pap Smear; and RhoGAM(R) Rho (D) Immune Globulin (Human), the first medication used to prevent life-threatening hemolytic disease of the newborn, currently marketed by Ortho-Clinical Diagnostics.

The company's later research efforts focused on hormone combinations that could prevent pregnancy -- new insights that helped pave the way for the introduction of The Pill in 1960. This important research was recognized in 1966 when Ortho scientist, Carl Hartman, M.D., was named the first recipient of the Margaret Sanger Award in Medicine.

As the use of The Pill expanded widely in the 1970s, Ortho embarked on research to meet the contraceptive needs of women in all stages of life. Nursing mothers became the first beneficiaries with the introduction of ORTHO MICRONOR(R) (norethindrone), the first progestin-only birth control pill appropriate for nursing mothers. More than 20 years later, progestin-only contraception remains an excellent option for mothers who breast feed.

In the 1980s, Ortho scientists used their growing knowledge to develop the first multiphasic birth control pills, ORTHO NOVUM(R) 10/11 (norethindrone/ethinyl estradiol) and ORTHO NOVUM(R) 7/7/7 (norethindrone/ethinyl estradiol). These pills mimicked the natural hormonal rhythms of a woman's menstrual cycle. Today, multiphasic pills are the #1- prescribed birth control pill in the United States.

Expanding the Value of Contraception

By the 1990s, as 30% of American women using contraception chose The Pill as their method of choice, Ortho continued to investigate ways to innovate The Pill. In 1997, ORTHO TRI-CYCLEN(R) (norgestimate/ethinyl estradiol) became the first birth control pill to receive an indication to treat moderate acne (for women ages 15 years and older, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menstruation, and are unresponsive to topical anti-acne medications).

As the 21st century emerged, Ortho Women's Health & Urology sought to meet the contraceptive needs of the active and health-conscious woman and to address physician concerns regarding patient compliance. The company introduced a new delivery system to appeal to women seeking more convenience in their contraceptive choice - ORTHO EVRA(R) (norelgestromin/ethinyl estradiol), the first and only weekly transdermal birth control patch.

Most recently, the company introduced ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol), a unique triphasic birth control pill that delivers three different levels of progestin and 25 micrograms of estrogen throughout a woman's menstrual cycle. ORTHO TRI-CYCLEN(R) LO offers high efficacy in preventing pregnancy with a low incidence of common side effects.

"Ortho Women's Health & Urology is proud of our heritage of innovation," says Ms. Brennan. "During our 75-year history, we've continued to listen to women and their healthcare professionals and have responded by introducing new developments and improvements in contraception and reproductive health. We're committed to building on this legacy in the future as we seek new solutions to advance the state of reproductive health."

About Ortho Women's Health & Urology

Ortho Women's Health & Urology, a Division of Ortho-McNeil Pharmaceutical, Inc., is a leader in the fields of women's health and urology and is committed to providing patients with products that help them to live healthier lives. Ortho Women's Health & Urology, a trusted partner of healthcare professionals, is committed to meeting the needs of providers and patients with products such as ORTHO EVRA(R) (norelgestromin/ethinyl estradiol), ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol), DITROPAN XL(R) (oxybutynin chloride), and ELMIRON(R) (pentosan polysulfate sodium). For more information on these products, birth control, bladder health or general women's health issues, please visit http://www.orthowomenshealth.com.

About the Guttmacher Institute

The Guttmacher Institute - http://www.guttmacher.org - advances sexual and reproductive health worldwide through an interrelated program of social science research, policy analysis and public education, designed to generate new ideas, encourage enlightened public debate, promote sound policy and program development, and, ultimately, inform individual decision-making.

About Ortho Women's Health & Urology Hormonal Contraceptives

ORTHO EVRA(R), ORTHO TRI-CYCLEN(R), ORTHO TRI-CYCLEN(R) LO, ORTHO MICRONOR(R), ORTHO NOVUM(R) 10/11, and ORTHO NOVUM(R) 7/7/7 are hormonal contraceptives and are not for everybody. Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke and heart attacks. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use hormonal contraceptives are strongly advised not to smoke. Hormonal contraceptives do not protect against HIV or sexually transmitted diseases.

The pharmacokinetic (PK) profile for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations (60% higher) and lower peak concentrations (25% lower) of ethinyl estradiol (EE) compared with an oral contraceptive containing EE 35 micrograms. In general, increased estrogen exposure may increase the risk of adverse events. However, it is not known whether there are changes in the risk of serious adverse events based on the differences in pharmacokinetic profiles of EE in women using ORTHO EVRA compared with women using oral contraceptives containing 35 micrograms of EE. (See CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives, BOLDED WARNING in the Package Insert).

ORTHO MICRONOR(R) is a progestin-only pill. Women using these products may be more likely to experience ovarian cysts or an ectopic pregnancy.

For full Prescribing Information visit http://www.thepill.com or http://www.orthoevra.com.

About RhoGAM(R) Rho (D) Immune Globulin (Human)

Important Safety Information

RhoGAM(R) and MICRhoGAM(R) Ultra-Filtered are made from human plasma. Because these products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. RhoGAM and MICRhoGAM are intended for maternal administration. Do not inject the newborn infant. Local adverse reactions may include redness, swelling, and mild pain at the site of injection and a small number of patients have noted a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. RhoGAM and MICRhoGAM contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Patients who receive RhoGAM or MICRhoGAM for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.

For full Prescribing Information visit http://www.rhogam.com.

Ortho Women's Health & Urology

CONTACT: Julie Keenan, Director, Communications, Office: +1-908-704-4564,Mobile: +1-609-240-8590, jkeenan2@ompus.jnj.com, or Gloria Vanderham,Manager, Communications, Office: +1-908-927-3756, Mobile: +1-862-686-0606,gvanderh@ompus.jnj.com, both of Ortho Women's Health & Urology

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