Lumara Health™ Launches With Focus on Women’s Health
ST. LOUIS, May 29, 2014 – K-V Pharmaceutical Company today announced a new corporate name, Lumara Health Inc., which reflects the fundamental changes the Company has made since emerging from Chapter 11 bankruptcy protection last year to align with its core mission of helping women achieve healthier lives.
“With new ownership, a new Board of Directors with a strong and diverse background in healthcare, new members of our leadership team who bring deep expertise that complement our current capabilities, and the recapitalization of our finances, we are in a stronger position today to deliver on our core mission,” said Greg Divis, CEO of Lumara Health. “We’re excited about the direction the Company is headed and our ability to contribute to advancements in women’s healthcare.”
Lumara Health, headquartered in St. Louis, is a specialty pharmaceutical company committed to advancing the health of women throughout the stages of their lives, with a particular focus on maternal health. As part of a recent reorganization of its operations, the Company created a Maternal Health Division, which specializes in addressing preterm birth. Lumara Health’s flagship product, Makena® (hydroxyprogesterone caproate injection), is the only FDA-approved product to reduce the risk of recurrent preterm birth in certain at-risk women. Since Makena’s approval by the FDA, tens of thousands of these patients have been prescribed Makena to help reduce their risk for recurrent preterm birth.
“Whether it’s a new partnership to provide patients and healthcare providers the option of home administration of Makena, or spearheading the largest randomized controlled trial to date assessing the impact of progestogen therapy, there are good things happening within the Company,” said Joseph M. Mahady, who was appointed Chairman of Lumara Health’s Board of Directors in October of last year. Mahady previously served as Senior Vice President of Wyeth and President of Wyeth Pharmaceuticals, Inc.
In addition to its Maternal Health Division, Lumara Health has also created a Women’s Healthcare Division. The Company’s FDA-approved products in this division help treat a number of women’s health issues, including vaginal infections and menopausal symptoms.
As part of the Company’s new direction, it is concentrating on three core principles: collaborate with healthcare providers to advance patient care, contribute to women’s healthcare through research and development, and support the women’s healthcare community through partnerships and education.
“The Company’s recent reorganization demonstrates its focus on maternal health as a core element of its contribution to the women’s healthcare space. The new leadership of the Company speaks to the commitment they have towards positively shaping the future of women’s health, particularly in preterm birth,” said Roger Newman, MD, Professor and Maas Chair for Reproductive Sciences, Department of Obstetrics and Gynecology, Medical University of South Carolina.
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 .
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 Lumara Health
Lumara Health™ is a specialty pharmaceutical company committed to advancing the health of women throughout the stages of their lives, with a particular focus on maternal health. At the heart of Lumara Health is our mission to help women achieve healthier lives. For more information on Lumara Health and our FDA-approved products, please visit www.LumaraHealth.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 Lumara Health, 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) Lumara Health’s ability to execute its business plan;
2) Lumara Health’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 Lumara Health’s intellectual property rights, licenses and exclusivity;
7) extensive industry regulation;
8) Lumara Health’s ability to meet its obligations under the Credit and Guaranty Agreement dated September 16, 2013 or other indebtedness; and
9) the ability of Lumara Health 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.