Cinryze®▼ (C1 Inhibitor [Human]) Now Available in the UK for Routine Prevention of Hereditary Angioedema (HAE) Attacks

MAIDENHEAD, England, February 29, 2012 /PRNewswire/ --

- New treatment shown to prevent and treat rare and life threatening genetic disorder -

- Therapeutic option is first and only licensed for routine prevention in patients with severe and recurrent HAE attacks, pre-procedure prevention and acute attacks of HAE*-

Adults and adolescents in the UK living with hereditary angioedema (HAE) - a rare and life threatening genetic disorder - now have access to ViroPharma's Cinryze^® (C1 inhibitor [human]), a new treatment option for the condition. Cinryze is the first and only C1 inhibitor approved in the UK for routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of HAE who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.^[1]It is also available for the treatment of acute attacks and pre-procedure prevention.^[1]

HAE is a rare, debilitating and potentially life-threatening genetic disorder affecting around 10,000 people across Europe, with up to 1,850 cases in the UK.^[2] People living with the condition suffer from recurrent and disabling attacks of swelling that can affect the larynx, abdomen, face, extremities and urogenital tract.

"HAE attacks are unpredictable and vary in frequency, severity, and duration. Patients can experience a significant number of days of incapacity each year if the disease is not well managed," commented Dr. Hilary Longhurst, Consultant Immunologist and Clinical Lead at Barts and the London Children's Hospital. "The availability of a licensed product in the UK to both prevent and treat HAE attacks will provide physicians and patients with another important therapeutic option to help better manage the condition and alleviate the burden of disease."

Eligible patients are able to self-administer Cinryze giving doctors and patients the ability to better manage the condition. To support this ViroPharma provides eligible patients with the Libertas Plus™ Home Care Service in the UK. This new service provides direct-to-home delivery of the medicine, individualised self-administration training by experienced, specially trained nurses, and ongoing guidance and support to individuals who are receiving routine prevention therapy.

"We are pleased that patients with HAE will not only now have an additional treatment option, but also a dedicated support program to help them better live with and manage their condition," commented Ann Price, Patient Support Contact, HAE UK. "Being able to proactively reduce the frequency or severity of attacks, in addition to self-administering treatment at home, should help patients to regain a sense of normality in their daily lives."

"HAE is a disabling and potentially life threatening condition, with the unpredictability of attacks causing many patients significant anxiety. We are excited to offer the only C1 inhibitor approved in the UK with a label that includes routine prevention of attacks, in addition to treating the attacks as they occur," commented Matt Mason, ViroPharma's General Manager, UK and Ireland.  "At ViroPharma, we are committed to delivering important solutions that address critical gaps in care for patients living with few, if any, clinical treatment options. We will be working closely with physicians to help and support patients through prevention and treatment of their HAE attacks."

Clinical trials

Clinical trials have demonstrated that Cinryze can significantly reduce the duration and frequency of HAE attacks and the time to symptom reliefcompared to placebo.^[3,4] In a pivotal Phase III study involving patients experiencing acute attacks, Cinryze demonstrated symptom relief in less than half the time compared to placebo, from a median of more than four hours to symptom relief with placebo, to two hours with Cinryze. In the second pivotal study, which examined routine prevention, patients experienced an average reduction from four attacks per month on placebo to two attacks per month on Cinryze.^[1] Furthermore, in an open label study for routine prevention, Cinryze reduced the frequency of attacks by 93 percent, from a median of three attacks per month at baseline to 0.2 per month.^[1]

About Cinryze^®(C1 inhibitor [human])

Cinryzeis a highly purified, pasteurized and nanofiltered plasma-derived C1 inhibitor product.^[1] In the EU, 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.^[1] Cinryze is for intravenous use only.^[1]

Severe hypersensitivity reactions to Cinryze may occur.^[1] Thrombotic events have occurred in patients receiving Cinryze, and in patients receiving off-label high dose C1 inhibitor therapy.^[1] Monitor patients with known risk factors for thrombotic events.^[1] With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease (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.^[1] 

The most common adverse reactions in clinical trials associated with Cinryze were rash, headache, nausea, erythema, phlebitis and local reactions at the injection site.^[1] Adverse events of sinusitis and upper respiratory infection were also observed in clinical trials. No drug-related serious adverse events (SAEs) were reported in clinical trials.

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, and 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 10,000 people in Europe with HAE, with up to 1,850 cases in the UK.^[2]

For more information on HAE, please visit the HAEi's (International Patient Organization for C1 Inhibitor Deficiencies) website at http://www.haei.org/.

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, treatment of seizures in children and adolescents, adrenal insufficiency, and 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), CDI and treatment of seizures in children and adolescents.

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 our regulatory filings in Europe related to Cinryze, including without limitation statements related to physician and patient acceptance of Cinryze and the estimated number of HAE patients in the United Kingdom.  There can be no assurance that our commercial launch of Cinryze in the EU, including the UK, will be successful. The commercial success of Cinryze in the EU, including the UK, will depend on a number of factors including, the actual number of HAE patients in the EU and the UK, physician and patient acceptance of Cinryze, the timing and level of pricing approvals obtained in EU member states, including the UK, and the level of manufacturing and supply of Cinryze produced by third party manufacturers. 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 Quarterly Report on Form 10-Q for the period ended September 30, 2011 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.

Cinryze is a registered trademark of ViroPharma Biologics, Inc.

*Treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with

hereditary angioedema (HAE).

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.

ViroPharma Contacts:    

Matt Mason
General Manager, ViroPharma UK and Ireland
Phone +44-1628-509-644

Kristina M. Broadbelt (Media)
Associate Director, PR & Advocacy
Phone +1-610-321-2358

References

1.  Cinryze European Summary of Product Characteristics.15 June 2011.

2.  Agostoni A, Aygoren-Pursun E, Binkley KE, et al. Hereditary and acquired angioedema: problems and progress: proceedings of the third C1 esterase inhibitor deficiency workshop and beyond. J Allergy Clin Immunol 2004;114(3 Suppl):S51-131.. Last accessed on February 6, 2012.

3.  Zuraw BL, et al. Nanofiltered C1 Inhibitor Concentrate for Treatment of Hereditary Angioedema. N Engl J Med 2010; 363:513-522.

4.  Zuraw BL, et al. Open-label use of nanofiltered C1 esterase inhibitor (human) (CINRYZETM) for the prophylaxis of hereditary angioedema (HAE) attacks. Ann Allergy, Asthma & Immunol. 2010; 105(5 Suppl 1):A100. Abstract P262.