deshalb der Kurssprung bei ELN
Pharmaceutical Announces FDA Approval of Megace(R) ES for Anorexia, Cachexia, or an Unexplained, Significant Weight Loss in Patients With a Diagnosis of AIDS
WOODCLIFF LAKE, N.J., July 6, 2005 /PRNewswire-FirstCall via COMTEX/ -- Par
Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Megace(R) ES (megestrol cetate), a concentrated oral suspension for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). The approval of Megace ES represents the first branded pharmaceutical product developed by Par to be approved for marketing by the FDA. New Megace ES is an advanced formulation of megestrol acetate oral
suspension, the appetite stimulant most commonly prescribed by physicians.
Megace ES can be taken without regard to meals and is dosed at one-fourth the
volume of the original product.
"Unintended weight loss and cachexia, also known as wasting, have been shown to
be determining factors in progression of disease in AIDS patients," said Lynn
Kramer, MD, senior vice president, clinical development and medical affairs.
"For patients who have difficulty swallowing a large dose, or those with a lack
of appetite who cannot eat without the help of medication, the approval of
Megace ES is a crucial advance."
Megace ES utilizes Elan's NanoCrystal(R) Technology delivery system* to improve the rate of dissolution and bioavailability of the original megestrol acetate oral suspension. Recent data have shown that the bioavailability of the original formulation is reduced substantially when taken on an empty stomach. With Megace ES, this reduction in bioavailability is minimized in the fasted state, resulting in improved bioavailability in patients who have not eaten. Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are bioequivalent in a fed state.
Patients taking Megace ES will be able to take a one-teaspoon (625 mg/5 mL)
daily dose, or one-fourth of the volume of the original product. Previously,patients had to drink one 20 mL cup (800 mg/20 mL) of megestrol acetate oral suspension daily to receive the drug's full benefit. Megace ES also is 16 times less viscous (10 cP versus 163 cP) than the original formulation.
"Par Pharmaceutical is committed to the science of improving treatment solutions for patients," said Scott Tarriff, president and chief executive officer. "It is gratifying to be able to offer patients this advanced product. Improved bioavailability and reduced volume per dose of Megace ES should allow patients to receive the complete benefit of the therapy."
Efficacy of Megace ES
The FDA approval of Megace ES was based on pharmacokinetic studies demonstrating
bioequivalence between 625 mg of Megace ES and 800 mg of megestrol acetate oral
suspension when dosed in a fed state. The clinical benefits of megestrol acetate
oral suspension in treating patients with anorexia, cachexia, or an unexplained, significant weight loss have been clearly demonstrated in patients with AIDS. In one of two placebo-controlled, randomized efficacy trials in patients with AIDS,
megestrol acetate oral suspension effectively stimulated appetite in nine out of 10 patients, increased mean caloric intake by 646 calories per day, and increased mean weight gain by 10.7 pounds versus placebo in 12 weeks. Patients also reported an improved sense of well being. In a second placebo-controlled study, seven out of 10 patients experienced improved appetite, mean caloric intake was increased by 464 calories a day, and mean weight increased by 13.3 pounds versus placebo.
Moreover, a bioavailability study directly comparing the rate and extent of
absorption of Megace ES and megestrol acetate oral suspension revealed that the
Cmax** level with the original formulation was 1,364 ng/mL in fed patients and
187 ng/mL in unfed patients. In contrast, the Cmax level with Megace ES was
1,517 ng/mL in fed patients and 1,041 ng/mL in unfed patients. Further, in unfed
patients Megace ES achieved 5 times greater peak plasma levels than megestrol
acetate oral suspension. Additionally, the study demonstrated that a lower
volume of Megace ES achieved maximum blood concentration more rapidly than the
currently available oral suspension products.
About Unintended Weight Loss
Anorexia (a persistent lack of appetite), unintended weight loss, and cachexia
(significant weight loss that involves depletion of both fat and lean body mass)
represent a serious risk in patients with AIDS. Significant weight loss and
cachexia are associated with worsening illness, physical impairment, decreased
tolerance of some therapeutic agents, and increased susceptibility to infection.
Important Safety Information About Megace ES
Megace ES and megestrol acetate oral suspension 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 (less than or equal to 1% and > than placebo)
associated with Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800
mg/20 mL are impotence, flatulence, rash, hypertension, insomnia, fever,
decreased libido, dyspepsia and hyperglycemia.
Women who participated in studies (n=10) reported breakthrough bleeding;
however, it is unknown if these events are drug -- or disease-related. For more information on Megace ES, or for complete prescribing information, visithttp://www.MegaceES.com.
About NanoCrystal Technology
Megace ES was developed with NanoCrystal Technology, a nanoparticulate drug
delivery system of Elan Pharma International Limited, a subsidiary of Elan
Corporation, plc (NYSE: ELN). NanoCrystal Technology is applied exclusively to poorly water-soluble drugs, and has been applied successfully to several dosage forms to overcome many of the problems created by low levels of water
solubility. An extensive patent estate protects Elan's NanoCrystal Technology.
More information about Elan's NanoCrystal Technology is available athttp://www.elan.com/EDT.
About Par Pharmaceutical Companies
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic
pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and
its recently acquired subsidiary, Kali Laboratories, Inc. The company also is
developing an additional line of branded pharmaceutical products for specialty
markets, the first of which is Megace ES. Par currently manufactures, markets or
licenses 90 prescription drugs. The trade name Megace was licensed from
Bristol-Myers Squibb Company. For press releases and other company information,
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.
* NanoCrystal Technology is a trademark of Elan Pharma International
Limited. Page 2
** Cmax: Maximum drug concentration in blood plasma.
Cecelia C. Heer
SOURCE Par Pharmaceutical Companies, Inc.
CONTACT: Stephen Mock, +1-201-802-4000, firstname.lastname@example.org, or Cecelia C. Heer,
+1-201-802-4000, email@example.com, both of Par Pharmaceutical Companies, Inc.
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