Press Release

<p>NATIONAL SURVEY OF NURSE PRACTITIONERS REVEALS SERIOUS TOLL OF HEAVY MONTHLY PERIODS</p>
<p><b>Common Condition Affects Health, Lifestyle and Finances But Patients Delay Reporting Symptoms</b></p> <p>Washington, DC &ndash; March 21, 2011 &ndash; Millions of American women suffer from cyclic heavy menstrual bleeding (HMB), and a recent national survey of more than 1,600 nurse practitioners revealed that this condition has a considerable negative impact on patients&rsquo; health, lifestyle and even employment. Yet very few patients report their symptoms or request professional help, or they delay reporting their HMB to a medical professional from five months to more than one year, according to 82 percent of nurses. </p> <p>The survey, <i>Nurse Practitioners&rsquo; Assessment of Heavy Menstrual Bleeding: Communication and Lifestyle Implications</i>, was conducted online in June 2010 by the National Association of Nurse Practitioners in Women&rsquo;s Health (NPWH) and supported by Ferring Pharmaceuticals Inc.</p> <p>&ldquo;Heavy menstrual bleeding has long been a condition in which many women opt to suffer in silence,&rdquo; said Susan Wysocki, president and CEO, NPWH. &ldquo;The results of this survey point to a dire need to educate women that cyclic HMB is not normal and that the healthcare professional community needs to be armed with the proper tools to help identify women who may be needlessly suffering from this condition.&rdquo;</p> <p>The survey found that the most common lifestyle effect of HMB was its negative impact on social, leisure and physical activities. Other significant effects included the inability to work one or more days during menses, the inability to maintain daily activities, HMB&rsquo;s impact on relationships, interference with sexual intimacy, and the inconvenience of sanitary protection issues.</p> <p>Other key findings of the <i>Nurse Practitioners&rsquo; Assessment</i> include:</p> <ul> <li>HMB is a common problem for patients. Most respondents (90%) indicated 10-30% of their patients experience cyclic HMB.</li> <li>The vast majority (97%) of nurses thought there may be more patients who suffer from cyclic HMB but consider it normal, so they do not raise it as a topic of discussion.</li> <li>Almost 70% of nurses reported that 10-30% of their HMB patients have been unable to work one or more days during menses due to HMB symptoms. Nearly 86% reported HMB patients take a significant number of sick days. Another 23% said their HMB patients limit their work hours. A striking 5% of nurses reported that HMB patients have been terminated from their jobs due to symptoms.</li> <li>HMB affects patients&rsquo; ability to perform routine household chores, according to 63% of respondents. Activities such as cleaning, cooking, driving and paying bills were limited in 10-30% of HMB patients.</li> <li>Nearly 75% of nurses reported that up to 50% of their HMB patients reduce or eliminate social, leisure and/or physical activities during their period.</li> <li>About two-thirds of nurses reported that 10-30% of HMB patients experience complications of this condition such as iron-deficiency anemia. </li> <li>A large majority of nurses (82%) would appreciate a tool to help identify patients with cyclic HMB.</li> </ul> <p><b>HMB Treatment</b></p> <p>Traditional treatments have been limited to pain relievers like ibuprofen and most hormonal contraceptives, which are not FDA-approved for HMB, as well as surgery such as hysterectomy. The only two FDA-approved products available to treat cyclic HMB are a hormonal intrauterine system (IUS), which is not appropriate for women who wish to become pregnant, and LYSTEDA&trade; (tranexamic acid) tablets, the only oral non-hormonal and non-surgical prescription medicine indicated specifically for cyclic HMB. In clinical studies, LYSTEDA was shown to lower the amount of blood lost during monthly periods by about one third. LYSTEDA pills are taken only during the monthly period for up to five days, and have been shown to work across all treatment cycles studied and as early as the first cycle of use. LYSTEDA has not been studied in adolescents under age 18 with cyclic HMB.</p> <p><b>Survey Methodology</b></p> <p>The research was undertaken by NPWH using an online survey conducted in June 2010. The survey was emailed to members of NPWH. Nearly all (99.6%) of the 1,628 respondents were female. Almost two-thirds (63%) were over 45 years old and 63% have been in practice for more than 10 years. </p> <p>Approximately 41% of respondents practice in private offices, 35% practice in clinics, and the remainder practice in a variety of settings, such as community health centers and hospitals. Several types of nurse practitioners are represented: most (64%) are women&rsquo;s health nurse practitioners (WHNPs) or OB/GYNs, another 25% are Family Nurse Practitioners (FNPs), and the rest are Adult Nurse Practitioners (ANPs), Pediatric Nurse Practitioners (PNPs) and other types. Forty-five percent of the nurse practitioners see more than 51 patients per week, and 29% see 31-50 patients per week.</p> <p><b>About HMB</b></p> <p>It is estimated millions of women in America may suffer from cyclic HMB,<sup>1,2</sup>. Of these women with HMB, one in four wait more than five years before seeking treatment.<sup>3</sup> Signs and symptoms include heavy menstrual flow that interferes with regular lifestyle, feeling tired or short of breath (the symptoms of anemia), using double sanitary protection to control menstrual flow, and soaking through one or more tampons or pads per hour.<sup>4</sup></p> <p>In women with normal menstruation, the body&rsquo;s healthy blood-clotting process helps to manage the rate of blood flow. In contrast, women with HMB experience a breakdown of blood clots, or fibrinolysis, which occurs more rapidly than normal, causing excessive bleeding during menstruation. </p> <p>In some cases, the cause of HMB is unknown. However, a number of conditions may result in heavy menstrual flow, including a hormonal imbalance, ovarian dysfunction, uterine fibroids and polyps, and other complications.<sup>4</sup></p> <p><b>About LYSTEDA&trade;</b></p> <p>LYSTEDA&trade; is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. LYSTEDA does not contain any hormones and is taken only during your period. It does not treat premenstrual symptoms, does not affect your fertility, and cannot be used as birth control. It does not protect against sexually transmitted diseases. </p> <p>LYSTEDA has not been studied in adolescents younger than 18 years of age.</p> <p><b>Important Safety Information</b></p> <p>You should not take LYSTEDA if you currently have or have ever had a blood clot, have been told you are at risk for having a blood clot, or are allergic to LYSTEDA or tranexamic acid.</p> <p>LYSTEDA can cause serious side effects, including:</p> <ul> <li>The risk of serious blood clots may be increased when LYSTEDA is taken with hormonal contraceptives, especially if you are taking higher than your normal dose of birth control, are overweight, or if you smoke cigarettes. Risk of serious blood clots may also be increased if you take LYSTEDA with medicines used to help your blood clot or some medicines used to treat leukemia. Be sure to tell your health care provider if you take any of these medicines.</li> <li>Stop taking LYSTEDA if you experience any eye changes, and promptly report any eye problems to your healthcare provider.</li> <li>If you have an allergic reaction (have shortness of breath and your throat feels tight), stop taking LYSTEDA and get medical help right away.</li> </ul> <p>The most common side effects of LYSTEDA include: headaches, sinus and nasal problems, back pain, pain in your abdomen, pain in your muscles or joints, anemia, and fatigue.</p> <p>If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition.</p> <p>You are encouraged to report side effects of prescription drugs. Contact Ferring at 1-888-FERRING (1-888-337-7464) or call 1-800-FDA-1088 or visit <a href="http://fda.gov/medwatch" target="_blank">fda.gov/medwatch</a>.</p> <p><b>About The National Association of Nurse Practitioners in Women&rsquo;s Health (NPWH)</b></p> <p>The National Association of Nurse Practitioners in Women&#8217;s Health was founded in 1980. NPWH&rsquo;s mission is to assure the provision of quality health care to women of all ages by nurse practitioners. NPWH defines quality health care to be inclusive of an individual&#8217;s physical, emotional, and spiritual needs.</p> <p>NPWH recognizes and respects women as decision-makers for their health care. NPWH&#8217;s mission includes protecting and promoting a woman&#8217;s right to make her own choices regarding her health within the context of her personal, religious, cultural, and family beliefs.</p> <p>NPWH represents nurse practitioners that provide care to women in the primary care setting as well as in women&#8217;s health specialty practices.</p> <p>NPWH is a trusted source of information on nurse practitioner education, practice, and women&#8217;s health issues. NPWH works with a wide range of individuals and groups within nursing, medicine, and the women&#8217;s health community.</p> <p><b>About Ferring Pharmaceuticals Inc.</b></p> <p>Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market. They include: BRAVELLE<sup>&reg;</sup> (urofollitropin for injection, purified), MENOPUR<sup>&reg;</sup> (menotropins for injection, USP) and REPRONEX<sup>&reg;</sup> (menotropins for injection, USP), NOVAREL<sup>&reg;</sup> (chorionic gonadotropin for injection, USP), ENDOMETRIN<sup>&reg;</sup> (progesterone) Vaginal Insert, FIRMAGON<sup>&reg;</sup> (degarelix for injection), PROSED<sup>&reg;</sup> DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA<sup>&reg;</sup> (1% sodium hyaluronate).</p> <p>Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For more information, call 1-888-FERRING (1-888-337-7464) or visit <a target="_blank" href="http://www.FerringUSA.com">www.FerringUSA.com</a>.</p> <p>Please visit <a target="_blank" href="http://www.lysteda.com">www.lysteda.com</a> for full prescribing information for LYSTEDA.</p> <tr><td valign="top" class="number"><sup>1</sup></td><td>U.S. Census Bureau, 2006-2008 American Community Survey. Available at: http://factfinder.census.gov/. Accessed April 7, 2010. </td></tr><tr><td valign="top" class="number"><sup>2</sup></td><td>Tufts Medical Center website. Heavy Menstrual Bleeding. Available at: http://tufts-nemc.org. Accessed April 7, 2010. </td></tr><tr><td valign="top" class="number"><sup>3</sup></td><td>National Women&rsquo;s Health Resource Center. Survey of Women Who Experience Heavy Menstrual Bleeding. 2005. </td></tr><tr><td valign="top" class="number"><sup>4</sup></td><td>Mayo Clinic. Menorrhagia (heavy menstrual bleeding). Available at: www.mayoclinic.com/health/menorrhagia/ds00394. Accessed May 27, 2010.</td></tr>