St. Louis, MO – January 21, 2014 – K-V Pharmaceutical Company (KV) announced today it has enrolled 677 women in its ongoing international Phase 3B safety and efficacy trial of Makena® (hydroxyprogesterone caproate injection), the only FDA-approved medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The latest trial enrollment figures make this study the largest randomized controlled trial to date assessing the impact of progestogen therapy on reducing the risk of recurrent singleton preterm birth.
“While the prior NICHD MFMU network trial demonstrated that this drug should be used for women with this obstetrical history, it is important that further research is done to understand the potential neonatal benefits” said Sean C. Blackwell, MD, Chair, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Texas Health Science Center in Houston, Texas. “The vast amount of data collected through the new trial will also provide a robust platform for extensive secondary analyses.”
“We look forward to partnering with leading external researchers to maximize the scientific value of this data” said Michael Jozwiakowski, Vice President of Research and Development for KV Pharmaceutical. “Not only will this trial satisfy important commitments made when FDA approved Makena, but we sincerely believe that the data from this study will help further advance women’s healthcare.”
As with the original trial conducted by the NICHD MFMU Network on 463 women (Meis et al, NEJM 2003), this randomized controlled trial sponsored by KV will evaluate the impact of Makena, hydroxyprogesterone caproate injection made under Good Manufacturing Practices (GMP), on reducing the rate of preterm birth in women pregnant at high risk for recurrent preterm delivery. The new trial will enroll more than 1,700 women, a sufficient sample size to detect improvements in overall newborn health in high-risk pregnancies in addition to assessing the surrogate marker of preterm birth less than 35 weeks of gestational age. Previously, the largest trial comparing a progestogen to placebo for recurrent preterm birth was O’Brien et al. (Ultrasound Obstetrics and Gynecology 2007), which enrolled 659 women.
Preterm birth – defined as birth prior to 37 weeks – is a significant cause of morbidity and mortality and ranks among the top 10 global causes of burdens of disease. Women who have delivered prematurely at any gestational age, including 34-37 weeks, are at increased risk for a subsequent preterm birth.
The FDA approval of Makena is based on the surrogate marker of effectiveness, namely the improvement in the proportion of women who delivered before 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. One of the primary endpoints of this ongoing trial is to determine the impact of Makena on neonatal health. While there are many risk factors for preterm birth, the safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. Makena is not intended for use in women with multiple gestations or other risk factors for preterm birth. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
In addition to investing in this trial, KV is also sponsoring a companion follow-up study to evaluate children between 23 and 25 months of age born to women enrolled in this trial. The Company will also complete a definitive pharmacokinetic trial of hydroxyprogesterone caproate and its metabolites in 2014 with collaboration from a number of prominent researchers.
About Makena® (hydroxyprogesterone caproate injection)
Makena® is a progestin 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.
Limitation of use: 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.
For full Makena prescribing information, visit www.makena.com.
Important Safety Information for Makena (hydroxyprogesterone caproate injection)
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.
Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
About K-V Pharmaceutical Company
K-V Pharmaceutical Company is a specialty branded pharmaceutical company with a primary focus in the area of women’s healthcare. The company is committed to advancing the health of women across the stages of their lives. For further information about K-V Pharmaceutical Company, please visit www.kvph.com.
Cautionary Note Regarding Forward-Looking Statements
This release contains various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 (the “PSLRA”) and which may be based on or include assumptions concerning our future operations, future results and prospects. 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, although not all forward-looking statements contain these words.
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, we provide the following cautionary statements with regard to KV, 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):
1) KV’s ability to execute its business plan;
2) KV’s ability to achieve revenue from the sale of Makena® consistent with its business expectations, including as a result of competition from approved and unapproved products;
3) unfavorable resolutions of private and governmental litigation and governmental inquiries and other risks and costs associated with litigation;
4) disruptions in the supply of raw materials or finished product;
5) risks, costs and delays associated with clinical trials;
6) issues associated with KV’s intellectual property rights, licenses and exclusivity;
7) extensive industry regulation;
8) KV’s ability to meet its obligations under the Credit and Guaranty Agreement dated September 16, 2013 or other indebtedness; and
9) the ability of KV and its affiliates to maintain contracts that are critical to their operation, including the ability to obtain and maintain normal terms with their vendors, customers and service providers and to retain key executives, managers and employees.
This discussion is not exhaustive, but is designed to highlight important factors that may impact our forward-looking statements.
Because the factors referred to above as well as additional factors and assumptions not identified above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. All forward-looking statements attributable to us are expressly qualified in their entirety by the cautionary statements in this “Cautionary Note Regarding Forward-Looking Statements. ” Further, any forward-looking statement speaks only as of the date on which it is made and we are 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 us to predict which factors will arise, when they will arise and/or their effects. In addition, we cannot assess the impact of each factor on our 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.
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