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.
for the full U.S. Prescribing Information; the prescribing information for other countries can be found at
About Enhanze™ Technology
Enhanze is Halozyme's proprietary drug delivery platform based on the Company's patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 acts by removing traditional limitations on the volume of drugs that can be delivered subcutaneously (just under the skin). By using Enhanze, some drugs that are administered intravenously may instead be delivered subcutaneously. Enhanze may also benefit subcutaneous drugs by reducing the need for multiple injections. This improved delivery may improve patient convenience and reduce overall costs to the healthcare system.
About Hereditary Angioedema (HAE)
HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. This condition is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unregulated, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. Patients with HAE experience approximately 20 to 100 days of incapacitation per year. There are estimated to be at least 6,500 people with HAE in
the United States
and at least 10,000 people in the European Union.
For more information on HAE, visit the HAEi's (International Patient Organization for C1 Inhibitor Deficiencies) website at
and the U.S. HAE Association's website at:
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, including C1 esterase inhibitor deficiency, pediatric epilepsy and
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) and CDI; for prescribing information on our products, please download the package inserts at
ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's website,
. The company encourages investors to consult these sections for more information on ViroPharma and our business
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets HYLENEX
recombinant (hyaluronidase human injection) and has partnerships with Roche,
, ViroPharma and Intrexon. Halozyme is headquartered in
San Diego, CA.
For more information on how we are innovating, please visit our corporate website at
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, including the therapeutic indication and use, safety, efficacy, tolerability, convenience of subcutaneous administration, and potential of Cinryze and our focus, goals, strategy, research and development programs, and ability to develop pharmaceutical products, commercialize pharmaceutical products, and execute on our plans including clinical development activities with Cinryze related to subcutaneous administration. There can be no assurance that that our clinical program with Cinryze utilizing subcutaneous administration in combination with rHuPH20 will yield positive results, be viewed by patients as more convenient than IV administration, or support further development of Cinryze for subcutaneous administration in combination with rHuPH20. The FDA or EMA may view the data regarding subcutaneous administration of Cinryze in combination with rHuPH20 as insufficient or inconclusive, request additional data, require additional clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, or deny the approval of Cinryze for subcutaneous administration in combination with rHuPH20. 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, 2010
and 10-Q filings for the quarters ended
March 31, 2012
June 30, 2012
September 30, 2012
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.
SOURCE ViroPharma Incorporated; Halozyme Therapeutics