Full Description

K-V Pharmaceutical Company (KV), incorporated in 1971, is a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets branded and generic/non-branded prescription pharmaceutical products. The Company has a range of dosage form capabilities, including tablets, capsules, creams, liquids and ointments. KV conducts its branded pharmaceutical operations through Ther-Rx Corporation (Ther-Rx) and its generic/non-branded pharmaceutical operations through ETHEX Corporation (ETHEX). Through Particle Dynamics, Inc. (PDI), the Company also develops, manufactures and markets value-added raw material products for the pharmaceutical, nutritional, personal care, food and other markets. The Company has developed a variety of drug delivery and formulation technologies, which are primarily focused in four principal areas: SITE RELEASE; tastemasking; oral controlled release, and oral quick dissolving tablets.

In May 2007, KV acquired the United States marketing rights to Evamist, an estrogen replacement therapy product delivered with a metered-dose transdermal spray system, from VIVUS, Inc. In May 2007, the Company received the United States Food and Drug Administration (FDA) approval to market the 100 milligram and 200 milligram strengths of metoprolol succinate extended-release tablets, the generic version of Toprol-XL (marketed by AstraZeneca). KV received FDA approval to market the 25 milligram and 50 milligram strengths of metoprolol succinate extended-release tablets in March 2008 and May 2008, respectively. As a result of the recent 50 milligram approval, KV offers the complete line of all four dosage strengths of metoprolol succinate extended-release tablets: 200 milligram, 100 milligram, 50 milligram and 25 milligram. During the fiscal year ended March 31, 2008 (fiscal 2008), the Company had a 69.1% and 72.5% share of the generic market place according to IMS Inc. for the 200 milligram and 100 milligram strengths, respectively.

In July 2007, the Company entered into an additional licensing arrangement to market Clindesse in the People's Republic of China. KV has previously entered into licensing arrangements for the right to market Clindesse in Spain, Portugal, Andorra, Brazil, Mexico, five Scandinavian markets and 18 Eastern European countries. In January 2008, the Company entered into a definitive asset purchase agreement with CYTYC Prenatal Products and Hologic, Inc. (CYTYC) to acquire the United States and worldwide rights to Gestiva (17-alpha hydroxyprogesterone caproate). The new drug application (NDA) for Gestiva is before the FDA, pending approval for use in the prevention of preterm birth in certain categories of pregnant women. The proposed indication is for women with a history of at least one spontaneous preterm delivery (that is less than 37 weeks), who are pregnant with a single fetus.

KV operates principally in three industry segments, consisting of branded products marketing, specialty generics marketing and specialty raw materials marketing. The Company derives revenues primarily from directly marketing its own brand-name and generic/non-branded products and products marketed under joint development agreement with other companies. Revenues may also be received in the form of licensing revenues and/or royalty payments based upon a percentage of the licensee's sales of the product, in addition to manufacturing revenues, when marketing rights to products using its drug delivery technologies are licensed.

Ther-Rx Corporation (Ther-Rx)

The Company established Ther-Rx to market brand name pharmaceutical products, which incorporate its technologies. Ther-Rx has introduced 11 products into two principal therapeutic categories: women's health and oral hematinics. KV established its women's healthcare franchise through its acquisition of PreCare, a prescription prenatal vitamin, from UCB Pharma, Inc. In May 2007, the Company acquired from VIVUS, Inc. the United States marketing rights to Evamist, a transdermal estrogen therapy delivering a low-dose of estradiol in a once-daily spray. In January 2008, KV entered into a definitive asset purchase agreement with CYTYC to acquire the United States and worldwide rights to Gestiva (17-alpha hydroxyprogesterone caproate).

ETHEX Corporation (ETHEX)

The Company established ETHEX, its largest business segment, to utilize its portfolio of drug delivery systems to develop and market hard-to-copy generic/non-branded pharmaceuticals. In May 2007, it received FDA approval to market the 100 milligram and 200 milligram strengths of metoprolol succinate extended-release tablets, the generic version of Toprol-XL (marketed by AstraZeneca). ETHEX primarily focuses on the therapeutic categories of cardiovascular, women's health, pain management and respiratory, leveraging its capability in developing and manufacturing products in these areas.

ETHEX markets over 70 products in its cardiovascular line, including products to treat angina, arrhythmia and hypertension, as well as for potassium supplementation. ETHEX markets over 30 products in its pain management line. Included in this line are several controlled substance drugs, such as morphine, hydromorphone and oxycodone. During fiscal 2008, ETHEX marketed approximately 30 products in its respiratory line, which consisted primarily of cough/cold products. ETHEX markets over 20 products in its women's healthcare line, all of which are prescription prenatal vitamins. In addition to its core therapeutic lines, ETHEX markets over 40 products in the gastrointestinal, dermatological, anti-anxiety, digestive enzyme and dental categories.

Particle Dynamics, Inc. (PDI)

PDI develops and markets specialty raw material products for the pharmaceutical, nutritional, food, personal care and other industries. Its products include value-added active drug molecules, vitamins, minerals and other raw material ingredients. PDI is also a supplier of value-added raw materials for the development and manufacture of both existing and new products at Ther-Rx and ETHEX.