MAIDENHEAD, England,
March 25, 2013 /PRNewswire/ --
-
Cinryze shown to treat and prevent attacks in rare and life
threatening genetic disorder -
- First and only C1 inhibitor
licensed* for routine prevention in patients with severe and
recurrent HAE attacks now available for use by
NHS Wales -
Adults and adolescents in Wales
living with hereditary angioedema (HAE) - a rare and life
threatening genetic disorder - now have access to ViroPharma's
Cinryze® (C1 inhibitor [human]), through NHS
Wales, following the approval from the All Wales Medicines Strategy
Group (AWMSG).[1] Cinryze is the first and only C1
inhibitor approved in Wales for
the treatment and pre-procedure prevention of angioedema attacks in
adults and adolescents with hereditary angioedema, and routine
prevention of angioedema attacks in adults and adolescents with
severe and recurrent attacks of hereditary angioedema who are
intolerant to or insufficiently protected by oral prevention
treatments or who are inadequately managed with repeated acute
treatment.[1]Cinryze is also
recommended for the treatment of acute attacks.[2]
HAE is a rare, debilitating and potentially life-threatening
genetic disorder affecting around 10,000 people across Europe.[3] Based on an incidence of
one in 50,000, it is estimated to affect 50 - 60 people in
Wales.[4] People living
with the condition suffer from recurrent and disabling attacks of
swelling that can affect the larynx, abdomen, face, extremities and
urogenital tract.
"The impact of HAE can cause significant disruption to a
patient's life. HAE attacks are usually very unpredictable and can
be life threatening if untreated" said Dr. Tariq El-Shanawany,
University Hospital of Wales. "The
availability of a new product approved in Wales for routine prevention as well as
treatment of acute attacks is very much welcomed."
Patients deemed eligible for routine prevention therapy by their
physician may also be 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 Wales. This 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 therapy.
"HAE UK are delighted that
Cinryze has now been included in the list of medications available
to patients in Wales," said
Ann Price from HAE UK. "The disease profile in HAE varies
from patient to patient, and it is important that the specialists
and the patients have access to the full range of routine
prevention and acute attack medications in order to set up the most
effective HAE management program for each individual patient."
"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 Wales with a label
that includes routine prevention of attacks, in addition to
treating the attacks as they occur," commented Thierry Darcis, ViroPharma General Manager for
Europe. "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 the 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.[5],[6]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. [5]
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.
[6]
About Cinryze®(C1
inhibitor [human])
Cinryze is a highly purified, pasteurised and nanofiltered
plasma-derived C1 inhibitor product.
[2] 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 HAE, who are intolerant to or insufficiently protected by oral
prevention treatments or patients who are inadequately managed with
repeated acute treatment. [2]
Cinryze is for intravenous use only.
[2]
Hypersensitivity reactions to Cinryze may occur.
[2] Thrombotic events have
occurred in patients receiving off-label high dose C1 inhibitor
therapy. [2] Patients with known
risk factors for thrombotic events (including indwelling catheters)
should be monitored closely. [2]
With any blood or plasma derived product, there may be a risk of
transmission of infectious agents, e.g. viruses. Standard
measures to prevent infections resulting from the use of medicinal
products prepared from human blood or plasma include selection of
donors, screening of individual donations and plasma pools for
specific markers of infection and the inclusion of effective
manufacturing steps for the inactivation/removal of viruses.
[2]
The only common adverse reactions in clinical trials associated
with Cinryze was rash. [2]Uncommon
adverse reactions include headache, nausea, erythema, phlebitis and
local reactions at the injection site.
[2] 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.[7] There are estimated to be at least 10,000
people in Europe with
HAE,[3] with approximately 50 - 60
people in Wales living with the
disease.
For more information on HAE, please visit HAE UK's website at http://www.haeuk.org/.
About Libertas
Plus™ Home Care Service
The Libertas Plus Home Care Service is a complementary new
service that has been specifically devised to help families with
HAE increase control of their HAE therapy and gain independence, by
providing patients, friends and family training to confidently and
successfully self-administer treatment at home. Libertas Plus
service provides individualised self-administration training by a
specialist nurse and ongoing support to individuals who are
receiving routine prevention therapy.
Recommendation
from the AWMSG
Cinryze is the first and only C1 inhibitor approved in
Wales for the treatment and
pre-procedure prevention of angioedema attacks in adults and
adolescents with hereditary angioedema, and routine prevention of
angioedema attacks in adults and adolescents with severe and
recurrent attacks of hereditary angioedema who are intolerant to or
insufficiently protected by oral prevention treatments or who are
inadequately managed with repeated acute
treatment.[1]
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 Wales. There can be no
assurance that our commercial launch of Cinryze in the EU,
including Wales, will be
successful. The commercial success of Cinryze in the EU, including
Wales, will depend on a number of
factors including, the actual number of HAE patients in the EU and
Wales, physician and patient
acceptance of Cinryze, the timing and level of pricing approvals
obtained in EU member states, including Wales, and the level of manufacturing and
supply of Cinryze produced by third party manufacturers. In
addition, there can be no assurance that we will be successful in
our efforts to continue to deliver important solutions that address
critical gaps in care for patients living with few, if any,
clinical treatment options in the future. 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, 2012 and 10-Q filings for the
quarters ended March 31, 2012,
June 30, 2012, and 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.
*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 HAE, who are intolerant to or insufficiently protected by oral
prevention treatments, or patients who are inadequately managed
with repeated acute treatment.
References
1. All Wales Medicines Strategy Group.
AWMSG Recommendations. Available at:
http://www.wales.nhs.uk/sites3/Documents/371/C1%20inhibitor%20%28Cinryze%29%20FAR.pdf
[http://www.wales.nhs.uk/sites3/Documents/371/C1 inhibitor
%28Cinryze%29 FAR.pdf ] Last accessed 25
March 2013
2. Cinryze European Summary of Product
Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001207/WC500108895.pdf.
Last accessed March 2013.
3. 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.
4. ViroPharma Pricing and
Reimbursement Dossier. Cinryze. Data on file.
5. Zuraw BL, et al. Nanofiltered C1
Inhibitor Concentrate for Treatment of Hereditary Angioedema. N
Engl J Med 2010; 363:513-522.
6. Zuraw B, Kalfus I, et al. Safety
and Efficacy of Prophylactic Nanofiltered C1-inhibitor in
Hereditary Angioedema. Am J
Med. 2012; 125(9):938
7. Cicardi M, Agostini A. Hereditary
angioedema. N Engl J Med. 1996;334:1666-1667.
ViroPharma Incorporated Contacts:
Thierry Darcis
General Manager, ViroPharma Europe
Phone +44(0)20-7572-1222
Emma White (Media
Enquiries)
PR, Advocacy and Communications Manager, Europe
Phone +44(0)1628-582732