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ViroPharma Incorporated (Nasdaq: VPHM) announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy.

Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for round prophylaxis in anticipation of hereditary angioedema (HAE) attacks in adults and adolescents. Cinryze is not approved in the European Union or any of its member states.

“We are honored to be presenting HAE data at this important meeting,” commented Peter Wijngaard, senior counsellor, clinical development and European medical affairs, ViroPharma Europe. “ViroPharma is committed to raising awareness of HAE and educating healthcare professionals that may not have had any experience diagnosing and treating this rare disease.”

The following abstracts from studies supported through Lev Pharmaceuticals, now ViroPharma Biologics, Inc., a fully-owned subsidiary of ViroPharma, were presented:

Poster Session 22: Phase 3 Results of Cinryze as Prophylactic and Acute Treatment of HAE

— In some abstract entitled, ‘Safety and Efficacy of Nanofiltered C1 Inhibitor Concentrate on this account that Acute and Prophylactic Treatment of Hereditary Angioedema suitable to C1 Inhibitor Deficiency,’ Dr. Joshua Jacobs described couple double-blind randomized placebo-controlled multi-center studies to determine the efficacy and safety of nanofiltered C1 inhibitor (C1-INH; Cinryze);

— One essay evaluated preventive treatment with C1-INH to preclude attacks. The promote trial examined the practice of C1-INH as far as concerns the treatment of shrewd attacks of hereditary angioedema fit to C1 inhibitor deficiency;

— Cinryze is not approved for acute attacks of HAE.

Poster Session 23: Prophylactic Therapy Considerations in Hereditary Angioedema

— In an abstract entitled, ‘When Should Prophylactic Therapy exist Considered for Hereditary Angioedema?’, Dr. Richard Gower described how a literature review, guideline dissection from other countries, one expert array meeting, and consensus development were conducted in order to perform the operations indicated in therapy considerations for prophylaxis of HAE in the U.S.;

— The outline suggested that patients through frequent HAE attacks, severe attacks, past laryngeal attacks, excessive loss of work or school, significant anxiety and of little use trait of time from birth to death could have being considered despite prophylaxis therapy, especially for those that fail, are bigoted, have adverse events or are not candidates for androgens;

— This abstract was the result of a consensus group on the method of treating considerations for patients with HAE, which was paid for and organized by Lev Pharmaceuticals.

About Cinryze™ (C1 esterase inhibitor [sympathetic])

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA notwithstanding course prophylaxis against angioedema attacks in adolescent and adult patients by HAE. C1 inhibitor therapy has been used acutely on this account that in greater numbers than 35 years in Europe to treat patients with C1 inhibitor deficiency.

The most inferior adverse reactions observed accept been upper respiratory infection, sinusitis, rash and headache. No drug-related staid hostile events (SAEs) esteem been observed in clinical trials. Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving ostentatious drench off-label C1 inhibitor therapy profitable above the approved treatment dosage food. With a single one blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD operator. The risk has been reduced by screening patients for foregoing exposing. to existing virus infections and by manufacturing steps to reduce the risk of viral transferrence including pasteurization and nanofiltration.

Cinryze is for the sake of intravenous use merely. A dose of 1000 Units of Cinryze can subsist administered each 3 or 4 days as being practice prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at any injection rate of 1 mL per diminutive.

About Hereditary Angioedema (HAE)

HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a weak side of C1 inhibitor, a human plasma protein. This class is the termination of a abandon allegiance in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural arrangement 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 period of life minatory attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital disquisition. Patients with HAE experience not fa from 20 to 100 days of incapacitation per year. There are estimated to be at minutest 6,000 population by HAE in the United States.

About ViroPharma Incorporated

ViroPharma Incorporated is an between nations biopharmaceutical company committed to developing and commercializing innovative products for physician specialists to capacitate the maintain of patients with serious diseases for which there is any unmet of medicine need, and providing rewarding careers to employees. ViroPharma commercializes Cinryze(TM) (C1 esterase inhibitor [human]) on this account that order prophylaxis against angioedema attacks in growing and adult patients by hereditary angioedema (HAE). ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by the agency of Staphylococcus aureus, including methicillin-resistant strains. ViroPharma currently focuses its unsalable article progressive growth activities in diseases including C1 esterase inhibitor deficiency and C. difficile.

Source: ViroPharma Incorporated

View drug information upon Cinryze.

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