ViroPharma Introduces New Reconstitution System for Cinryze™ (C1 Esterase Inhibitor [Human])

EXTON, Pa., May 17 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that it has begun packaging Cinryze™ (C1 Esterase Inhibitor [Human]), its product proven to prevent attacks of hereditary angioedema (HAE), with West Pharmaceutical Services, Inc.'s (NYSE: WST) Mix2Vial® needle-less reconstitution system. This simple-to-use reconstitution device and accompanying training materials will be widely available in the coming weeks.

Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against hereditary angioedema (HAE) attacks in adolescents and adults.  

"Since the launch of Cinryze, patients with HAE who are managed prophylactically with Cinryze - whether they have been trained by their healthcare provider to utilize our unique self administration option or have their physician administer their doses - have been empowered to take control of their lives," commented Daniel Soland, ViroPharma's chief operating officer.  "Among our goals since the launch of Cinryze is that of continuously improving the entire Cinryze experience for our patients and physicians, and we have listened closely to their feedback. We believe that the use of the Mix2Vial in combination with Cinryze offers patients, care givers and physicians a needle-less system to encourage independence and simplify the reconstitution process."

"We are pleased that ViroPharma has chosen Mix2Vial for reconstituting Cinryze," said Fran DeGrazio, vice president, marketing and strategic business development, West. "Convenience and simplicity are of the utmost importance for patients and health care providers; our reconstitution system addresses both of these for Cinryze."

The Mix2Vial transfer device offers a needle-less reconstitution and transfer system and an asymmetrical vial skirt to help achieve new levels of simplicity in reconstituting Cinryze.

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.  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.

Important Information About Cinryze™

INDICATION

CINRYZE™ is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

CONTRAINDICATIONS

CINRYZE™ is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product. 

IMPORTANT SAFETY INFORMATION

Severe hypersensitivity reactions may occur.  Because hypersensitivity reactions and HAE attacks may have similar symptoms, distinguishing between the two is important.  Epinephrine should be immediately available to treat any acute severe hypersensitivity reaction and CINRYZE™ should be discontinued. 

Thrombotic events have been reported in association with C1 esterase inhibitor products when used off-label at high doses. Monitor patients with known risk factors for thrombotic events.

CINRYZE™ is made from human plasma.  Products made from human plasma may contain infectious agents (e.g. viruses and, theoretically, the Creutzfeldt-Jakob Disease agent).  The risk that such products will transmit an infectious agent has been reduced by screening donors, testing for the presence of infections, and by inactivating or removing a broad range of viruses during the manufacturing process. 

In the clinical trial, the most common adverse reactions observed by greater than or equal to 5% of the 24 evaluable subjects after receiving CINRYZE™ were upper respiratory tract infection, sinusitis, rash, and headache. 

Before prescribing CINRYZE™, please read the Full Prescribing Information.

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 6,000 people with HAE in the United States.

For more information on HAE, visit the U.S. HAE Association's website at: http://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(TM) (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, http://www.viropharma.com/. The company encourages investors to consult these sections for more information on ViroPharma and our business.

About West

West is the world's premier manufacturer of components and systems for improving the safety and effectiveness of therapeutic and diagnostic health care delivery systems. This includes ready-to-sterilize and ready-to-use stoppers and seals for vials, plungers and other prefillable syringe components and an assortment of safety, reconstitution and delivery system capabilities and services. The Company also provides products with application to the personal care, food and beverage markets. West's customers include the world's leading pharmaceutical, biotechnology, generic drug and medical device producers. Headquartered in Lionville, Pennsylvania, West supports its partners and customers from 50 locations throughout North America, South America, Europe, Mexico, Japan, Asia and Australia. For more information, visit West at westpharma.com.

Mix2Vial® is a registered trademark of Medimop Medical Projects, Ltd. in the United States and other jurisdictions.

SOURCE ViroPharma Incorporated