EXTON, Pennsylvania, May 7, 2012 /PRNewswire/ -- ViroPharma Incorporated (NASDAQ: VPHM) today announced that three posters relating to long term data on Plenadren« (hydrocortisone, modified release tablet) were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology (ICE/ECE), held May 5 through 9, in Florence, Italy.
Plenadren is the first true innovation in over 50 years in the treatment of adrenal insufficiency (AI), a rare and potentially life-threatening disease caused by insufficient cortisol production by the adrenal glands. In November 2011, the European Commission (EC) granted European Marketing Authorization for Plenadren« (hydrocortisone, modified release tablet), an orphan drug for treatment of adrenal insufficiency in adults. ViroPharma anticipates commercial launch of Plenadren in the EU in the fourth quarter of 2012. Plenadren is not approved in the United States. However, it has received orphan drug designation status in the United States and has maintained orphan status in Europe upon approval.
ICE/ECE Poster Presentations
A poster entitled 'An Open, Multi-Centre, Phase IIIb, Long-Term Follow-up Study to Assess the Safety, Tolerability and Efficacy of Once-Daily Oral Dual-Release Hydrocortisone in Patients with Adrenal Insufficiency' (#P78) described data from a long-term follow-up study in 71 patients with AI showing that the beneficial effects on blood pressure and body weight reported in an initial randomized controlled clinical study were maintained over 18 months follow-up. Moreover, in patients with concomitant diabetes mellitus, HbA1c (a laboratory test showing the average amount of sugar in the blood as a measure of disease control) was decreased from 6.95 percent to 6.58 percent. No safety signals were observed in this long-term open prospective study. After 18 months, 94.6 percent of patients were still in the study
In a poster entitled, 'Intercurrent Illness Dose Regimen in Adrenal Insufficiency with a Dual-Release Hydrocortisone Formulation Derived from Population Pharmacokinetic Modeling' (#P50), additional data were presented on the use of Plenadren during intercurrent illness such as low grade infection or fever, and physical stress situations. In a healthy individual, the body responds to these types of stress with an overall increase in serum cortisol concentrations. During these episodes, patients with AI need an increased dose of hydrocortisone to increase their cortisol levels. The authors report that, during these types of intercurrent illnesses, a Plenadren dosing regimen designed to increase the total daily dose by administering the maintenance dose two to three times daily (the regimen used in the clinical trial) resulted in higher total exposure and extended cortisol cover during the 24 hour period after administration as compared to standard immediate release hydrocortisone.
In a poster entitled, 'Dosing Regimens for Glucocorticoid Replacement Therapy - A Worldwide Patient Survey of Patients with Adrenal Insufficiency' (#P76), data from a worldwide survey of 1245 patients with AI were presented. Of these, 84 percent had primary AI. A wide range of treatment regimens was reported, which may reflect the absence of evidence-based guidelines and the variability in the clinical approach to glucocorticoid replacement therapy for patients with AI.
About Plenadren« (hydrocortisone, modified release tablet)
Plenadren is indicated for the treatment of adrenal insufficiency in adults.
Hypersensitivity to the active substance of Plenadren or to any of the excipients may occur. During acute adrenal insufficiency, parenteral administration of hydrocortisone in high doses, together with physiological sodium chloride solution for injection, must be given. Use of Plenadren with potent CYP 3A4 inducers and inhibitors may merit an adjustment of hydrocortisone dosage. High (supra-physiological) dosages of cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Long-term treatment with higher than physiological hydrocortisone doses can lead to clinical features resembling Cushing's syndrome with increased adiposity, abdominal obesity, hypertension and diabetes, and thus result in an increased risk of cardiovascular morbidity and mortality. All glucocorticoids increase calcium excretion and reduce the bone remodeling rate. Patients with adrenal insufficiency on long term glucocorticoid replacement therapy have been found to have reduced bone mineral density. Psychiatric adverse events may occur with systemic glucocorticoids.
The most common adverse reactions observed in clinical studies have been fatigue, gastroenteritis, upper respiratory tract infection, sedation, vertigo and dry eyes.
About Adrenal Insufficiency
Adrenal insufficiency (AI) is a disorder caused by dysfunction of the adrenal gland resulting in low levels of the hormone cortisol, which normally follows a circadian rhythm and regulates many critical body functions. To survive, AI patients need replacement therapy with glucocorticoids (usually hydrocortisone). Because it is a chronic condition, they require this life-saving therapy throughout their lives. Primary AI is referred to as Addison's disease, which affects up to 14 in every 100,000 people. Common symptoms of Addison's disease include fatigue, muscle weakness, fever, weight loss, difficulty in standing up, changes in personality, and gastrointestinal involvement. Severe adrenal insufficiency, which can manifest as shock (very low blood pressure with loss of consciousness), dehydration, and imbalance of sodium and potassium levels, can be life threatening. These cases of adrenal crisis (sometimes called 'adrenal or Addisonian crisis') can occur after a significant stress such as infection or trauma, and can be fatal if not promptly diagnosed and treated with glucocorticoid therapy. Secondary adrenal insufficiency is caused by impairment of the pituitary gland or hypothalamus, often caused by exogenous steroid use or surgical removal of benign tumors of the pituitary gland.
About ViroPharma Incorporated
ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing novel solutions for physician specialists to address unmet medical needs of patients living with diseases that have few if any clinical therapeutic options. ViroPharma is developing a portfolio of therapeutics for rare and Orphan diseases including C1 esterase inhibitor deficiency, Friedreich's Ataxia, and adrenal insufficiency; and recurrent C. difficile infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are treated, and to build international partnerships with the patients, advocates, and health care professionals we serve. ViroPharma's commercial products address diseases including hereditary angioedema (HAE), seizures, adrenal insufficiency and C. difficile-associated diarrhea (CDAD); for full U.S. prescribing information on our products, please download the package inserts at http://www.viropharma.com/Products.aspx; the prescribing information for other countries can be found at www.viropharma.com.
ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.
Forward Looking Statements
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events. There can be no assurance that that the data presented during the 2012 joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology (ICE/ECE) regarding Plenadren is predictive of how Plenadren will perform in commercial usage. Plenadren is currently only approved in Europe. We cannot assure that current or future studies with Plenadren in the patient populations described in the ICE/ECE presentations will demonstrate the same or similar safety and efficacy profile of Plenadren as described in the data presented during the 2012 ICE/ECE meeting. These factors, and other factors, including, but not limited to those described in our annual report on Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release are made as of the date hereof and may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements. These forward looking statements should not be relied upon as representing our assessments as of any date subsequent to the date of this press release.
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