SOURCE: ViroPharma Incorporated

November 09, 2010 08:00 ET

ViroPharma Announces Six Upcoming Presentations of Cinryze™ (C1 Esterase Inhibitor (Human)) Data at 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI)

Presentations on Safety and Efficacy Profile of Cinryze in a Range of Patient Populations

EXTON, PA--(Marketwire - November 9, 2010) -  ViroPharma Incorporated (NASDAQ: VPHM) today announced the schedule of its upcoming Cinryze (C1 esterase inhibitor [human]) hereditary angioedema (HAE) presentations during the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), November 11 through 16 in Phoenix, Ariz. Cinryze is the first and only FDA-approved therapy indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE, a rare, debilitating and potentially fatal disease. Cinryze is not approved by the FDA to treat acute angioedema attacks, nor has the safety and effectiveness of Cinryze been established in pediatric patients with HAE. Cinryze should be used in pregnant women only if clearly needed.

"Since the approval of Cinryze for the prevention of HAE attacks two years ago, the HAE therapy landscape has changed dramatically as patients and physicians now have a prophylactic option to help manage this incapacitating and potentially life-threatening disease," said Colin Broom, ViroPharma's vice president and chief scientific officer. "These data reflect our commitment to physicians and patients to expand the body of scientific data for Cinryze and to continue to improve care for patients with HAE."

Embargoed until Saturday, November 13, 12:30 MST

Poster Presentation
Title:
Open-Label Use of Nanofiltered C1 Esterase Inhibitor (human) (Cinryze™) for the Prophylaxis of Hereditary Angioedema (HAE) Attacks
Presenter: Ira Kalfus, M.D., M2G Consulting New York, NY
ID: 262
Date and Time: Saturday, Nov. 13, 12:30-1:30 p.m. MST; Sunday, Nov. 14, 12:00-1:00 p.m. MST
Location: Phoenix Convention Center, Halls A-D

Poster Presentation
Title:
Open-Label Use of Nanofiltered C1 Esterase Inhibitor (human) (Cinryze™) for the Prophylaxis of Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects
Presenter: David Hurewitz, M.D., Allergy Clinic of Tulsa, Tulsa, Okla.
ID: 263
Date and Time: Saturday, Nov. 13, 12:30-1:30 p.m. MST; Sunday, Nov. 14, 12:00-1:00 p.m. MST
Location: Phoenix Convention Center, Halls A-D

Poster Presentation
Title:
Open-Label Use of Nanofiltered C1 Esterase Inhibitor (human) (Cinryze™) for Treatment of Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects
Presenter: William Lumry, M.D., University of Texas Southwestern Medical School, Dallas, Texas
ID: 264
Date and Time: Saturday, Nov. 13, 12:30-1:30 p.m. MST; Sunday, Nov. 14, 12:00-1:00 p.m. MST
Location: Phoenix Convention Center, Halls A-D

Poster Presentation
Title:
Site of Care of Nanofiltered C1 Esterase Inhibitor (human) (Cinryze™) in Patients with Hereditary Angioedema (HAE)
Presenter: Ladonna Landmesser, Pharm.D., ViroPharma Incorporated, Exton, Pa.
ID: 315
Date and Time: Saturday, Nov. 13, 12:30-1:30 p.m. MST; Sunday, Nov. 14, 12:00-1:00 p.m. MST
Location: Phoenix Convention Center, Halls A-D

Embargoed until Sunday, November 14, 1:30 p.m. MST

Oral Presentation
Title:
Open-Label Use of Nanofiltered C1 Esterase Inhibitor (human) (Cinryze™) for Treatment or Prophylaxis of Acute Attacks of Hereditary Angioedema (HAE) in Pregnant Subjects
Presenter: James Baker, M.D., Allergy, Asthma, and Dermatology Associates, Lake Oswego, Ore.
ID: Concurrent Session D, 27
Date and Time: Sunday, Nov. 14, 1:30 p.m. MST
Location: Phoenix Convention Center, Room 224AB

Embargoed until Sunday, November 14, 1:45 p.m. MST

Oral Presentation
Title:
Open-Label Use of Nanofiltered C1 Esterase Inhibitor (human) (Cinryze™) for the Treatment of Hereditary Angioedema (HAE) Attacks
ID: Concurrent Session D, 28
Presenter: Marc Riedl, M.D., Department of Medicine, UCLA-David Geffen School of Medicine, Los Angeles, Calif.
Date and Time: Sunday, Nov. 14, 1:45 p.m. MST
Location: Phoenix Convention Center, Room 224AB

About Cinryze™ (C1 esterase inhibitor [human])
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency.

Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze for routine prophylaxis, 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 observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials.

Cinryze is for intravenous use only. A dose of 1000 Units of Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at an injection rate of 1 mL per minute.

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.

For more information on HAE, visit the U.S. HAE Association's website at: www.haea.org.

About ViroPharma Incorporated
ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing innovative products for physician specialists to enable the support of patients with serious diseases for which there is an unmet medical need, and providing rewarding careers to employees. ViroPharma commercializes Cinryze™ (C1 esterase inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information on ViroPharma's commercial products, please download the package inserts at http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including C1 esterase inhibitor deficiency and C. difficile infection.

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 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) regarding Cinryze is predictive of how Cinryze will perform in commercial usage. Cinryze is not approved in the U.S. for acute treatment of attacks nor has the safety and effectiveness of Cinryze been established in pediatric patients with HAE. We cannot assure that current or future studies with Cinryze in the patient populations described in the ACAAI presentations may demonstrate the safety and efficacy profile of Cinryze, For example, in June 2009, the U.S. FDA issued a complete response letter and requested an additional clinical study, due to their opinion that the placebo controlled study submitted in support of the sBLA for acute treatment of HAE lacked robustness. 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, 2009 and 10-Q filings for the quarters ended March 31, 2010, June 30, 2010 and September 30, 2010 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.