ViroPharma Incorporated to Host Analyst and Investor Seminar on September 21, 2012
EXTON, Pa., Sept. 18, 2012 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) announced today that the company will provide a live audio and slide webcast of its analyst and investor seminar, focusing on the company's commercial product projections and future growth opportunities on Friday, September 21, 2012. Lectures will be provided by a number of ViroPharma representatives.
The seminar, entitled "Broadening Horizons," will be held from 9:00 A.M. until 12:45 P.M. Eastern Time on Friday, September 21, 2012. Among the topics ViroPharma will discuss are: plans and opportunities for furthering Cinryze® (C1 esterase inhibitor [human]) growth in North America; updates on launch progress and projections for Cinryze, Buccolam® (midazolam, oromucosal solution),and Plenadren® (hydrocortisone, modified release tablet) in the European Union; development pipeline updates including interim data from select clinical studies; and a financial overview, including longer term financial guidance.
"We are excited to be in position to not only provide continued growth with our cornerstone product, Cinryze, here in North America and in Europe, but also to be moving ahead on numerous other commercial products and development opportunities to deliver sustained growth well into the back half of the decade and beyond," commented Vincent Milano, ViroPharma's president and chief executive officer. "We look forward to this event and sharing our plans with the investment community as they can begin to share in our vision of both the short and long term milestones in the path forward for ViroPharma."
A live webcast of the meeting may be accessed via the investor section of the ViroPharma corporate website, http://www.viropharma.com. The archive of the meeting will be available through October 31, 2012.
About Cinryze® (C1 esterase inhibitor [human])
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. In the E.U., the product is approved by the EMA for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment. Cinryze is for intravenous use only.
Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze, and in patients receiving off-label high dose C1 inhibitor therapy. Monitor patients with known risk factors for thrombotic events. With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been reduced by screening donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.
The most common adverse reactions in clinical trials associated with Cinryze were rash, headache, nausea, erythema, phlebitis and local reactions at the injection site. Adverse events of sinusitis and upper respiratory infection also were observed in clinical trials. No drug-related serious adverse events (SAEs) were reported in clinical trials.
Please visit http://www.viropharma.com/products/cinryze.aspx for the full U.S. Prescribing Information; the prescribing information for other countries can be found at www.viropharma.com.
About Buccolam® (midazolam, oromucosal solution)
Buccolam is oromucosal midazolam provided in an individual dose formulation for buccal delivery. It is provided as convenient, portable, ready to use, pre-filled oral syringes containing age-specific doses. Buccolam is approved throughout the European Union and the EEA for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from three months to less than 18 years of age.
Buccolam must only be used by parents/carers where the patient has been diagnosed to have epilepsy. For infants between 3-6 months of age, treatment must be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Hypersensitivity to midazolam, benzodiazepines or to any of the excipients may occur. Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration. Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.
The most common adverse reactions in clinical trials associated with oromucosal midazolam were sedation, somnolence, depressed levels of consciousness, respiratory depression, and nausea and vomiting. No severe adverse events were reported. The safety profile was similar to rectal or intravenous diazepam in the comparative clinical trials.
About Plenadren® (hydrocortisone, modified release tablet)
Plenadren is the first true innovation in over 50 years in the treatment of adrenal insufficiency.
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 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, cytomegalovirus (CMV); 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, and the risk factors included in our periodic filings with the Securities and Exchange Commission for more information on ViroPharma and our business.
SOURCE ViroPharma Incorporated