"Par is very pleased to have been the first to demonstrate the substantial food effect that exists with the original megestrol acetate oral suspension 800 mg/20 mL. The recognition and understanding of this food effect by health care providers is essential to their successful treatment of cachectic patients," said Shankar Hariharan, Ph.D., executive vice president and chief scientific officer. "For those AIDS patients with a lack of appetite who may have difficulty eating without the help of medication, Megace ES meets a critical need."
In 2005, the U.S. Food and Drug Administration (FDA) approved Megace ES for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of AIDS. Megace ES can be taken without regard to meals and is dosed at one-fourth the volume of the original product. Megace ES represents the first branded pharmaceutical product developed by Par to be approved for marketing by the FDA. Introduced in July 2005, Megace ES now holds a 20.3 percent share of new prescriptions in the U.S. market for megestrol acetate oral suspension products, according to the IMS Health national prescription audit of retail and mail order trade outlets for the week ending August 25, 2006.
"We are pleased to be granted this new patent surrounding our NanoCrystal Technology that recognizes the benefit the reduced food effect provides to cachectic patients. This new patent further strengthens our patent estate protecting our key technology," commented Paul V. Breen, president and chief operating officer, Elan Pharma International Ltd.
* NanoCrystal® Technology is a registered trademark of Elan Pharma International Limited, Ireland.
Par Discontinues Phase III Clinical Trial Par today also announced that, due to slow patient enrollment, it has decided to discontinue a Phase III clinical trial of megestrol acetate concentrated suspension in cancer-induced anorexia. Par intends to discuss alternate clinical development options with the FDA. Par is also pursuing the development of new formulations or dosage forms of megestrol acetate concentrated suspension that potentially offer greater patient benefits and that could be available as soon as 2008 or 2009.
Important Information About Megace ES
Megace ES and megestrol acetate oral suspension 800 mg/20mL are contraindicated in patients with a history of hypersensitivity to megestrol acetate or any component of the formulation, or patients with known or suspected pregnancy.
Evidence of adrenal suppression has been observed in patients receiving megestrol acetate oral suspension. The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated.
Clinical cases of new onset diabetes mellitus, exacerbation of pre- existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate.
The most common adverse events associated with Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are impotence, flatulence, rash, hypertension, fever, decreased libido, insomnia, dyspepsia, and hyperglycemia.**
Women who participated in studies reported breakthrough bleeding; however, it is unknown if these events are drug- or disease-related. For complete prescribing information, visit http://www.MegaceES.com.
** Adverse events > placebo derived from the comprehensive adverse events table (greater than or equal to 5%) in Megace ES and megestrol acetate oral suspension prescribing information.
About Par Pharmaceutical Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced the appetite stimulant Megace ES, its first branded pharmaceutical product. Par's Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. Par manufactures, markets or licenses more than 110 generic drugs. For press release and other company information, visit http://www.parpharm.com.
About NanoCrystal Technology and Elan Drug Technologies
Elan's NanoCrystal technology is a proven, robust, drug optimization technology enabling solubility easily and effectively for many poorly water- soluble compounds. The technology which can offer enhanced commercialization opportunities is covered by 1,077 U.S. and foreign patents and patent applications and is part of a suite of technologies which Elan's Drug Technologies business offers to third party clients. The drug in nano-form can be incorporated into common dosage forms, including tablets, capsules, inhalation devices, and sterile forms for injection, with the potential for substantial improvements to clinical performance.
The NanoCrystal Technology is part of a suite of capabilities available through Elan Drug Technologies (EDT). With over 30 products launched in 40 countries, EDT has a proven track record of collaborating with pharmaceutical companies. For more information about Elan Drug Technologies please visit http://www.elan.com/EDT.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Source: Par Pharmaceutical Companies, Inc.
