January 17, 2008

INCREASED USAGE OF MIFEPREX® HELPS SLOW DECLINE IN ABORTION PROVIDERS ~80% OF CLINICS NOW OFFER MIFEPREX®

New York, NY - The Guttmacher Institute announced today that use of Mifeprex® (the brand name for mifepristone) for early medication abortion increased substantially between 2000 and 2005. According to the report, approximately 78-81% of clinics now offer Mifeprex®. The report also found that more than half of all known abortion providers are offering Mifeprex®, a 70% increase from the first half of 2001. Additionally, these findings show that the increased number of Mifeprex® providers has helped to slow the overall decline in abortion providers. Since FDA approval of Mifeprex® in September 2000, more than 840,000 women in the United States have chosen Mifeprex® as a safe and effective, private option for ending early pregnancy.

Nearly 90% of abortions in the U.S. occur during the first trimester. In more recent years women having an abortion are able to do so earlier and earlier in the first trimester. According to Guttmacher, the proportion of providers offering very early medication or surgical abortions grew from 7% in 1993 to 40% in 2005. Mifeprex® allows women to act early, up to 7 weeks from the beginning of their last menstrual period. Currently, more than six in 10 abortions occur within the first 8 weeks of pregnancy.

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex® use. No causal relationship between the use of Mifeprex® and misoprostol and these events has been established. A high index of suspicion is needed to rule out serious and rarely fatal infections (e.g. Clostridium sordellii) and sepsis that can present without fever, bacteremia or significant findings on a pelvic exam, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

Danco Laboratories, LLC is a women’s health pharmaceutical company that has been granted an exclusive license from the Population Council to manufacture, market and distribute Mifeprex® in the United States.

For Prescribing Information, or more information about Mifeprex®, please access the Mifeprex® web site, or call the Mifeprex® hotline at 1-877-4 Early Option (1-877-432-7596).

The Guttmacher Institute’s study, “Abortion in the United States: Incidence and Access to Services, 2005” is the most complete available data on the number of abortions and abortion providers in the U.S.

July 18, 2005

New York, NY – Danco Laboratories announced today that it is modifying the labeling for Mifeprex® to include updated safety information.

Mifeprex® has been available in the U.S. for almost 5 years, and more than 460,000 women in this country have chosen it for early abortion since FDA approval in September 2000. During that time period, Danco has received reports of five deaths from serious bacterial infection and sepsis following treatment with Mifeprex and misoprostol. “All of these cases had atypical presentations of infection, and in the first three cases, the bacteria were identified as a very rare anaerobic, gram-positive, spore forming species known as Clostridium sordellii,” said Richard Hausknecht, M.D., Medical Director, Danco Labs. One of these cases occurred during a clinical trial in Canada in 2001. The other four cases were reported from California – two in late 2003, one in early 2004, and a recent one in mid 2005. No causal relationship between these events and the use of Mifeprex and misoprostol has been established.

Childbirth, menstruation and abortion, whether spontaneous, surgical or medical, all create conditions that can result in serious and sometimes fatal infection, and there is no evidence that Mifeprex and misoprostol present a special risk of infection¹. Clostridium sordellii is a common soil and enteric bacterium that has presented in a very small number of obstetric and gynecologic cases, including following childbirth (vaginal delivery and caesarian section), medical abortion, and in other gynecologic and non-gynecologic conditions.²

Women who are undergoing a medical abortion with the Mifeprex® and misoprostol regimen should contact their provider or an emergency room right away if they experience abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea), with or without fever, more than 24 hours after taking misoprostol.

Danco Laboratories, LLC exclusively markets Mifeprex® (mifepristone) in the United States.

1. Grimes, D. Risks of mifepristone abortion in context. Contraception, 2005; 71: 161.

2. e.g. Bitti, A. et al. A fatal postpartum Clostridium sordellii associated toxic shock syndrome. Journal of Clinical Pathology, 1997; 50:259-260. McGregor, J.A. et al., Maternal deaths associated with Clostridium sordellii infection. American Journal of Obstetrics and Gynecology, 1989; 161(4): 987-995. Rorbye, C. et al. Postpartum Clostridium sordellii infection associated with fatal toxic shock syndrome. Acta Obstet Gynecol Scand, 2000; 79(12): 1134-1135.

September 24, 2002

MORE THAN 100,000 U.S. WOMEN HAVE CHOSEN MIFEPREX FOR THEIR NON-SURGICAL ABORTION

Danco Laboratories releases use data for Mifeprex® (Mifepristone), Tablets 200 mg

New York, NY – Today, Danco Laboratories reports that more than 100,000 U.S. women have used Mifeprex*, the early option pill, since FDA approval in September 2000 and product availability in November 2000. Sales in the United States are 36 percent higher for the first eight months of this year compared to last year, indicating increased use of Mifeprex by American women. Nearly one million women worldwide, excluding China, have used mifepristone over the last decade. Mifepristone is now approved in 26 countries including major European countries and the United States.

Taken orally, the early option pill provides women with a non-surgical method for early abortion, up to seven weeks after the beginning of their last menstrual period. Mifeprex offers women the freedom to make the best decisions for themselves and their families.

Where can Women get Mifeprex?

Mifeprex is available in almost every state and from a variety of health care providers.

• Current sales information reveals that clinics, such as those affiliated with Planned Parenthood Federation of America and National Abortion Federation (NAF) as well as independent clinics represent 83 percent of Mifeprex sales. Private practices represent 17 percent of sales. At launch, virtually all sales and use of Mifeprex were in clinics.
• Current account information reveals that clinics represent 37 percent of accounts, while private practices represent 63 percent.
• Physicians in 47 states, the District of Columbia, Guam and Puerto Rico offer Mifeprex to their patients.
• Where can Women get Information about Mifeprex?
• http://www.earlyoptionpill.com - The Mifeprex website has been a source of information for women and health care providers throughout the year. Not only can women use this site to access information and provider referrals, but providers can learn more about the product, how to prescribe it, and how to order it.
• 1-877-4 Early Option (1-877-432-7596) – The toll free Mifeprex hotline is also available for those seeking information. Providers can have their medical questions answered by a physician with experience providing Mifeprex, 24 hours a day/ 7 days a week. Prospective patients can access information on Mifeprex and provider referrals.

"We've seen a steady increase in clinics and physicians providing this service to their patients over the last two years," said Dr. Richard Hausknecht, Associate Clinical Professor of OB/GYN at Mt. Sinai School of Medicine and Medical Director of Danco Laboratories. "We are confident that this trend will continue, providing more American women with an early non-surgical option when it comes to their reproductive health."

"As a family practitioner, I feel medical abortions are an important part of offering my patients the comprehensive care they may need," said Dr. Ruth Lesnewski. "One of my goals as a physician is to help women avoid procedures they do not want to have if non-invasive alternatives are available."

More Information about Mifeprex.

Mifeprex blocks a hormone that is needed for pregnancy to continue. When followed by another medicine, misoprostol, Mifeprex ends the pregnancy.

Mifeprex followed by misoprostol is approximately 92–95 percent effective. Bleeding and cramping are a normal part of the process; women can expect bleeding or spotting for an average of 9–16 days. In the case of heavy bleeding, some women may require a surgical procedure. Side effects that may occur include nausea, headache, vomiting, diarrhea, dizziness, fatigue and back pain.

A woman makes three visits to a doctor's office or clinic over a two-week period. During the first visit, she must read and sign a statement that she has decided to end her pregnancy. Health care providers will give their patients a number to call if they have any questions, and, a number to call if emergency care is needed.

Before Mifeprex received final FDA approval, every aspect of the drug regimen was rigorously tested and thoroughly reviewed. Over 2,000 women participated in clinical studies in the United States. The results were published in The New England Journal of Medicine and the American Medical Association's Archives of Family Medicine.

Danco Laboratories, LLC is a women's health pharmaceutical company that has been granted an exclusive license from the Population Council to manufacture, market and distribute Mifeprex in the United States.

For more information about Mifeprex, visit the website at

www.earlyoptionpill.com. Or call the Mifeprex hotline at 1-877-4 Early Option (1-877-432-7596).

B-roll footage is available upon request.

High-resolution images of the product are available to download on the Mifeprex web site.

* Mifeprex is a registered trademark of Danco Laboratories, LLC.

September 24, 2001

Danco Laboratories’ One Year Anniversary of FDA Approval for MIFEPREX™ (Mifepristone), Tablets 200 mg First Year Sales and Use of “The Early Option Pill” Have Increased Access for Women

New York, NY – One year after the FDA approval of Mifeprex*, Danco Laboratories, LLC, reports increasing sales of the drug, providing greater access to this important health care option for American women. Taken orally, the early option pill provides women with a non-surgical method for early abortion, up to 7 weeks after the beginning of their last menstrual period. Mifeprex offers women the freedom to make the best decisions for themselves and their families.

Where can Women get Mifeprex?

Mifeprex is available in almost every state and from a variety of health care providers.

• Current sales information reveals that non-profit clinics, such as Planned Parenthood Federation of America, and other clinics associated with the National Abortion Federation (NAF), represent 70 percent of Mifeprex sales. Private practices and independent clinics represent 30 percent of sales.
• Current account information reveals that non-profit clinics and clinics associated with NAF represent 35 percent of accounts, while private practices and independent clinics represent 65 percent.
• Physicians in 45 out of 50 states and the District of Columbia offer Mifeprex to their patients.

“We are encouraged to see more and more physicians deciding to add Mifeprex to their practice,” said Dr. Richard Hausknecht, Associate Clinical Professor of OB/GYN at Mt. Sinai School of Medicine and Medical Director of Danco Laboratories. “Mifeprex is now offered in most states, and we are working to increase access so that every woman has the option of Mifeprex if she chooses it.”

Where can Women get Information about Mifeprex?

• http://www.earlyoptionpill.com - The Mifeprex website has been a source of information for women and health care providers throughout the year. Not only can women use this site to access information and provider referrals, but providers can learn more about the product, how to prescribe it, and how to order it.
• 1-877-4 Early Option – The toll free Mifeprex hotline is also available for those seeking information. Providers can have their medical questions answered by a physician with experience providing Mifeprex, 24 hours a day/ 7 days a week.

“When we started offering Mifeprex, the demand was huge and it has not waned,” said Lorie Spear, Director of Surgical Services, Planned Parenthood Chicago Area. “Women from different cultures, socio-economic backgrounds, ages, and religions are choosing Mifeprex for the same reasons: because it feels more private and it allows them to take the process out of a surgical environment and into their own hands.”

Where can Women get Information about Mifeprex?

• Danco has applied for, and received, Medicaid coverage for Mifeprex. New York State, California and a number of other states now have policies in place to cover the drug under state Medicaid laws.
• Mifeprex is generally covered by health care plans if they offer coverage for surgical abortions. Aetna US Healthcare, many regional Blue Cross and Blue Shield plans, regional United Healthcare, and regional Oxford plans among others have finalized reimbursement policies for Mifeprex.

"New York State Medicaid has been critical in making Mifeprex a viable option for all women, regardless of their socio-economic status," said Eric Schaff, MD, Professor of Family Medicine at the University of Rochester. "The legislation in New York allows for reimbursement for medical abortion and helps ensure that women have access to this safe and effective option."

More Information about Mifeprex.

Mifeprex blocks a hormone that is needed for pregnancy to continue. When followed by another medicine, misoprostol, Mifeprex ends the pregnancy.

Mifeprex followed by misoprostol is approximately 92–95 percent effective. Bleeding and cramping are a normal part of the process; women can expect bleeding or spotting for an average of 9–16 days. Side effects that may occur include nausea, headache, vomiting, diarrhea, dizziness, fatigue and back pain.

A woman makes three visits to a doctor’s office or clinic over a two-week period. During the first visit, she must read and sign a statement that she has decided to end her pregnancy. A few women who take Mifeprex will need a surgical procedure to stop heavy bleeding. The type of surgical procedure used in these cases is identical to the procedure for miscarriage. Health care providers will give their patients a number to call if they have any questions, and, if different, a number to call if emergency care is needed.

Before Mifeprex received final FDA approval, every aspect of the drug regimen was rigorously tested and thoroughly reviewed – a five-year process. Over 2,000 women participated in clinical studies in the United States. The results were published in The New England Journal of Medicine and the American Medical Association’s Archives of Family Medicine. Government regulatory agencies in France, Great Britain and Sweden approved mifepristone approximately a decade ago. Almost 700,000 women in Europe have chosen this safe and effective early option. It has now been approved in twenty-three countries worldwide.

Danco Laboratories, LLC is a women’s health pharmaceutical company that has been granted an exclusive license from the Population Council to manufacture, market and distribute Mifeprex in the United States.

For more information about Mifeprex, please access the Mifeprex website, or call the Mifeprex hotline at 1-877-4 Early Option (1-877-432-7596).

November 16, 2000

DANCO LABORATORIES, LLC ANNOUNCES AVAILABILITY OF MIFEPREX™ (Mifepristone) Tablets, 200 mg

New York, NY – Danco Laboratories announced today the availability of Mifeprex* - the early option pill - a safe and effective non-surgical method for ending early pregnancy.

Shipments of Mifeprex to physicians begin on Monday, November 20, 2000. Danco is also sending informational materials to health care professionals.

"After having successfully used mifepristone in U.S. clinical trials, I am excited that Mifeprex has been approved by the FDA and is now available to women," said Paul D. Blumenthal, MD, MPH, Associate Professor, Department of GYN/OB at Johns Hopkins University School of Medicine. "The availability of Mifeprex creates an important new set of choices for both women and their health care providers. I am enthusiastic about being able to offer Mifeprex to my patients and am certain it will help me to better meet their needs."

Health care providers interested in purchasing Mifeprex for their patients can do so by accessing the website or by calling the Mifeprex hotline at 1-877- 4 Early Option (1-877-432-7596).

Mifeprex is a medical breakthrough in the United States. Taken orally, the early option pill is non-invasive and, for most women, does not involve surgery or anesthesia. Mifeprex can be taken to end a pregnancy from the time a woman knows she is pregnant up to seven weeks after the beginning of her last menstrual period. A woman using this option makes three visits to a doctor's office or clinic over a two-week period.

Mifeprex followed by misoprostol is approximately 92-95 percent effective for ending a pregnancy. Bleeding and cramping are a normal part of the process. Women may experience bleeding similar to or greater than a heavy period and can expect bleeding or spotting for an average of 9-16 days. In some cases, women may have severe bleeding and need to contact their doctor right away. Side effects that may occur include nausea, headache, vomiting, diarrhea, dizziness, fatigue and back pain. A few women who take Mifeprex will need a surgical procedure to end the pregnancy or to stop heavy bleeding. Health care providers will communicate to their patients how they have planned to handle this possibility and will give their patients a name and number to call if they have any questions and, if different, a name and number to call in an emergency.

More than 2,000 women participated in clinical studies in the United States. The results were published in The New England Journal of Medicine and the American Medical Association's Archives of Family Medicine. Government regulatory agencies in France, Great Britain and Sweden approved mifepristone nearly a decade ago. More than half a million women in Europe have chosen this safe and effective early option. It has now been approved in eighteen countries worldwide.

"We're pleased to bring Mifeprex to the U.S. marketplace," said Heather O'Neill, Danco spokesperson. "Women can now finally access this important reproductive health option."

Danco Laboratories, LLC is a women's health pharmaceutical company that has been granted an exclusive license from the Population Council to manufacture, market and distribute Mifeprex in the United States.

Additional press materials are available via fax by calling 1-888-796-3683.

September 28, 2000

THE EARLY OPTION PILL FOR WOMEN

First FDA-Approved Non-Surgical Option To End Early Pregnancy

MIFEPREX™ (Mifepristone), Tablets 200 mg

New York, NY - The Food and Drug Administration (FDA) today approved Mifeprex*, a safe and effective non-surgical method for ending early pregnancy. Mifeprex gives women an early option in pill form.

Mifeprex is a medical breakthrough in the United States. Taken orally, the early option pill is non-invasive and, for most women, does not involve surgery or anesthesia.

"It is an important day in women's health care. With FDA approval of Mifeprex, American women have a safe and effective early option for ending pregnancy," said Dr. Richard Hausknecht, Associate Clinical Professor of OB/GYN at Mt. Sinai School of Medicine and Medical Director of Danco Laboratories, LLC, the pharmaceutical company that brought Mifeprex to the United States. "We and our partners in the women's health community have worked long and hard for this day. I am excited and very proud to be part of this."

Mifeprex blocks a hormone that is needed for pregnancy to continue. When followed by another medicine, misoprostol, Mifeprex ends the pregnancy.

Mifeprex followed by misoprostol is approximately 92-95 percent effective for ending a pregnancy. Bleeding and cramping are a normal part of the process. Women may experience bleeding similar to or greater than a heavy period and can expect bleeding or spotting for an average of 9-16 days. In some cases, women may have severe bleeding and need to contact their doctor right away. Side effects that may occur include nausea, headache, vomiting and diarrhea. A pain reliever can be taken to alleviate discomfort.

Mifeprex can be taken to end a pregnancy from the time a woman knows she is pregnant up to seven weeks after the beginning of her last menstrual period. A woman using this option makes three visits to a doctor's office or clinic over a two-week period. At the first visit, she receives a Medication Guide (which explains how the early option works), is counseled and takes three tablets, each containing 200 milligrams of Mifeprex. Two days later she returns and takes two tablets, each containing 200 micrograms of misoprostol. A follow up visit approximately 12 days later checks that the pregnancy has ended. A few women who take Mifeprex will need a surgical procedure to end the pregnancy or to stop heavy bleeding. Health care providers will communicate to their patients how they have planned to handle this possibility. Health care providers will also give their patients a telephone number to call if they have any questions, concerns or problems.

"I think most women to whom I have given this treatment in a clinical trials setting found it very acceptable. It gave them more sense of control; they felt it was a more private approach to pregnancy termination," said Dr. Carolyn Westhoff, Professor of OB/GYN and Public Health at Columbia University. "One thing that is really important about Mifeprex is that it offers women the choice of an early approach to use. I think this is very valuable to women."

More than 2,000 women participated in clinical studies in the United States. The results were published in The New England Journal of Medicine and the American Medical Association's Archives of Family Medicine. Government regulatory agencies in France, Great Britain and Sweden approved mifepristone nearly a decade ago. More than half a million women in Europe have chosen this safe and effective early option. It has now been approved in eighteen countries worldwide.

Mifeprex is provided directly to doctors' offices or clinics and is not available through pharmacies. "As with any new reproductive health option, patient counseling and information is very important," said Dr. Richard Hausknecht. Mifeprex will be available to physicians in approximately 4 weeks.

"FDA approval of the drug mifepristone is an historical moment, comparable to the arrival of the birth control pill forty years ago," said Gloria Feldt, President of Planned Parenthood Federation of America. "We are overjoyed that with today's announcement from the FDA, Planned Parenthood will soon be able to offer American women the same early option that has been available in Europe for a decade."

Danco Laboratories, LLC is a women's health pharmaceutical company that has been granted an exclusive license from the Population Council to manufacture, market and distribute Mifeprex in the United States.

For more information about Mifeprex, please access the Mifeprex website or call the Mifeprex hotline at 1-877- 4 Early Option (1-877-432-7596).

* Mifeprex is a trademark of Danco Laboratories, LLC