ST. LOUIS, Feb. 4, 2011 /PRNewswire/ -- K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company"), a specialty pharmaceutical company, announced today that it has been informed by Hologic, Inc. that the U.S. Food and Drug Administration (FDA) granted approval for Makena™ (hydroxyprogesterone caproate injection). Makena, commonly referred to as "17P," is the first and only FDA-approved treatment indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered < 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
"The communities of healthcare providers and advocacy organizations who are on the front lines of this issue now have access to the benefits of an FDA-approved product," said Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation. "The approval of Makena is not only a milestone for the Company; more importantly, it represents a significant step forward for the thousands of women whose families have been impacted by preterm birth."
According to the March of Dimes, preterm birth, or the birth of a baby at less than 37 completed weeks of pregnancy, affects one in eight babies born in the United States. Additionally, the rate of preterm birth has increased more than 35 percent in the last 25 years, and late preterm births – babies born at 34 to 36 weeks of pregnancy – account for nearly three quarters of all preterm births in the United States. In 2005, preterm birth was estimated to cost the nation more than $26 billion. According to a study published in Obstetrics and Gynecology, although the causes of spontaneous preterm birth are often unknown, a leading risk factor for preterm birth is a history of prior preterm birth. Makena is approved to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth, which is a subset of the overall population of women at risk for preterm birth.
"Preterm birth is a national healthcare crisis. The approval of this new treatment is a breakthrough in our fight against preterm birth," said Alan R. Fleischman, M.D., Medical Director, March of Dimes. "Although the United States has made great progress in caring for premature babies, there is no greater advance than allowing a baby to mature in a mother's womb."
Makena is a prescription hormone (progestin) medicine used in women who are pregnant and who have delivered a baby too early (preterm) in the past. Makena is used in these women to help lower the risk of having a preterm baby again. The approval of Makena was based on a study of 463 women who had experienced a previous singleton spontaneous preterm birth. The study, sponsored by the National Institutes of Health, showed that compared to controls, treatment with Makena reduced the proportion of women who delivered preterm at less than 37 weeks. After adjusting for time in the study, 7.5 percent of Makena-treated subjects delivered prior to 25 weeks compared to 4.7 percent of control subjects. Makena is administered by a healthcare provider via a weekly intramuscular injection (every 7 days) beginning between 16 and 20 weeks of pregnancy and continuing until 37 completed weeks or until delivery, whichever comes first.In partnership with the Society for Maternal-Fetal Medicine, the American College of Obstetricians and Gynecologists issued a written opinion in October 2008 stating that, "Progesterone supplementation for the prevention of recurrent preterm birth should be offered to women with a singleton pregnancy and a prior spontaneous preterm birth due to spontaneous preterm labor or premature rupture of membranes." Makena is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
"As an obstetrician specializing in high risk pregnancies and a mom of two, I know that every week of pregnancy counts," said Ashley Roman, M.D., MPH, Clinical Assistant Professor, Department of Obstetrics and Gynecology, NYU Langone Medical Center. "I have confidence in the safety and efficacy profile of Makena to reduce the risk of another preterm birth for women who are eligible for therapy."
Important Safety InformationMakena should not be used in women with any of the following conditions: current or history of thrombosis or thromboembolic disorders; known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy; liver tumors, benign or malignant, or active liver disease; or uncontrolled hypertension.
Makena should be discontinued if thrombosis or thromboembolism occurs. Consider discontinuing Makena if allergic reactions occur. Women receiving Makena should be monitored if they are prediabetic or diabetic; have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction; develop hypertension; or have a history of clinical depression. Makena should be discontinued if depression recurs.
Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (i.e. low amniotic fluid levels; 3.6% vs. 1.3%).
The most common adverse reactions reported in ≥ 2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions (pain [35%], swelling [17%], pruritus [6%], and nodule[5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%).
Asset Purchase AgreementUnder the terms of an existing asset purchase agreement between Hologic, Inc. and K-V, worldwide rights to Makena will be transferred to K-V subject to the satisfaction of certain terms and conditions, all of which K-V anticipates will be satisfied within 5 business days. Following the asset transfer from Hologic to K-V, Makena will be marketed by K-V's branded drug subsidiary, Ther-Rx Corporation. After a short stock-in period, Makena will be available through specialty pharmacies and distributors by prescription only and is subject to all U.S. guidelines applicable to dispensing an FDA-approved prescription product. In conjunction with the approval of Makena, Ther-Rx Corporation is launching the Makena Care Connection™, a comprehensive program for patients and healthcare providers that provides administrative, financial, and treatment support for Makena in one single point of contact. More information about the Makena Care Connection™ will be available soon at www.makena.com. To view the Makena Prescribing Information, please visit http://www.kvpharmaceutical.com/pdf/Makena_PI.pdf.
Conference Call InformationK-V Pharmaceutical will host an investor conference call on Monday, February 14, 2011 at 10:00 a.m. EST to discuss the FDA approval of Makena™ and provide a general update on other company matters. Participants can listen to the conference call by dialing 412-317-6789. To access the live web cast of the conference call, please go to the investor relations portion of the Company's website at www.kvpharmaceutical.com. Please log-in or dial-in at least 10 minutes prior to the start time to ensure a connection.
A replay of the call will also be available for seven days by dialing 412-317-0088 and citing code 445162. An archived version of the web cast will be accessible for 30 days at www.kvpharmaceutical.com.
About Ther-Rx CorporationTher-Rx Corporation is committed to advancing the health of women across all the stages of their lives. To help ensure patients are educated about their health care, Ther-Rx collaborates with leading patient advocacy groups and professional organizations who share this common mission of advancing women's health.
About K-V Pharmaceutical CompanyK-V Pharmaceutical Company is a fully-integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded prescription pharmaceutical products. The Company markets its technology-distinguished products through Ther-Rx Corporation, its branded drug subsidiary.
For further information about K-V Pharmaceutical Company, please visit the Company's corporate Website at www.kvpharmaceutical.com.
Cautionary Note Regarding Forward-looking StatementsThis press release contains various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 (the "PSLRA") and that may be based on or include assumptions concerning the operations, future results and prospects of the Company. Such statements may be identified by the use of words like "plan," "expect," "aim," "believe," "project," "anticipate," "commit," "intend," "estimate," "will," "should," "could," "potential" and other expressions that indicate future events and trends.
All statements that address expectations or projections about the future, including without limitation, statements about product development, product launches, regulatory approvals, governmental and regulatory actions and proceedings, market position, acquisitions, sale of assets, revenues, expenditures, resumption of manufacturing and distribution of products and the impact of the recall and suspension of shipments on revenues, and other financial results, are forward-looking statements.
All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the PSLRA's "safe harbor" provisions, the Company provides the following cautionary statements identifying important economic, competitive, political, regulatory and technological factors, among others, that could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions.
Such factors include (but are not limited to) the following:
This discussion is not exhaustive, but is designed to highlight important factors that may impact the Company's forward-looking statements. Because the factors referred to above, as well as the statements included under the captions Part I, Item 1A—"Risk Factors," Part II, Item 7—"Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the Form 10-K, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by the Company or on the Company's behalf, you should not place undue reliance on any forward-looking statements.
All forward-looking statements attributable to the Company are expressly qualified in their entirety by the cautionary statements in this "Cautionary Note Regarding Forward-Looking Statements" and the risk factors that are included under Part I, Item 1A – "Risks Factors" in the Form 10-K , as supplemented by the Company's subsequent SEC filings. Further, any forward-looking statement speaks only as of the date on which it is made and the Company is under no obligation to update any of the forward-looking statements after the date of this release.
New factors emerge from time-to-time, and it is not possible for the Company to predict which factors will arise, when they will arise and/or their effects. In addition, the Company cannot assess the impact of each factor on its future business or financial condition or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.Media Contact: Jennifer Forst502.firstname.lastname@example.orgInvestor Relations Contact:Cathy Biffignani314-645-6600 x3307CBiffignani@kvph.com
|SOURCE K-V Pharmaceutical Company|
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