EXTON, Pa., May 28, 2013 /PRNewswire/ -- ViroPharma
Incorporated (Nasdaq: VPHM), an international biopharmaceutical
company committed to developing and commercializing innovative
products that address unmet medical needs and rare diseases, today
announced results of new data analyses from the randomized,
placebo-controlled and open label clinical trials of Cinryze® (C1
esterase inhibitor [human]), the first and only C1 esterase
inhibitor therapy approved for routine prevention of angioedema
attacks in patients with HAE. Since neither of these clinical
trials excluded patients who were on anabolic androgens (AA;
attenuated androgens), analyses were conducted to evaluate how the
use of AA impacted the outcome of subjects while on Cinryze.
In the randomized, placebo-controlled trial, 36.4 percent of
subjects (8 of 22) were using AA for prophylaxis with a mean
historical attack rate of 13.88 per 12 weeks. Five of these eight
patients discontinued AA use prior to randomization. Among these
five, the mean number of attacks over the 12-week placebo period
was 15, compared to 6.8 attacks during the Cinryze treatment
period; this represents a 54.7 percent decrease in attack rate
which is similar to the reduction in attack rate (52 percent) from
the overall study population.
In the open label study, 28.8 percent of subjects (42 of 146)
were using AA for prophylaxis at screening and 23 of them
discontinued AA during the study. The median number of
attacks/month in subjects who discontinued AA was 3.00 (1.25, 11;
interquartile range, IQR) at study entry which decreased to 0.00
(0.00, 0.31) during an average of 257 days in the study while
taking Cinryze. Eight subjects continued on a stable dose of AA
during open label treatment. The attack frequency/month of those
subjects went from 3.5 (2.75, 4) at study entry to 0.26 (0.06,
0.71) after treatment with open label Cinryze. The other 11
subjects reduced but did not stop using AA; their median monthly
attack frequency went from 2 (2, 3) to 0.24 (0, 0.67) at study
completion. No drug interaction studies of Cinryze and AA have been
conducted.
Lead author Bruce L. Zuraw,
Professor of Medicine, Chief of the Section of Allergy and
Immunology, and Director of the Allergy and Immunology Training
Program at the University of California
School of Medicine, San Diego
delivered these findings during an oral platform presentation at
the 8th C1 Inhibitor Deficiency Workshop in Budapest, Hungary.
"While clinical trials have demonstrated the efficacy and safety
of Cinryze for the long-term prevention of HAE, these data
demonstrate that Cinryze is an important option, even in patients
who have been managed on anabolic androgens and continue to
experience multiple attacks of HAE," said Dr. Zuraw. "It
reinforces current evidence based guidelines for the management of
HAE, especially given the long-term risk/benefit of anabolic
androgens."
The abstract 'Anabolic androgen experience and response to
CINRYZE (C1 esterase inhibitor [human]) in the prevention trials in
patients with HAE' will be published in the May edition of The
Journal of Angioedema.
About Cinryze® (C1 esterase inhibitor
[human])
Cinryze is a highly purified, pasteurized and
nanofiltered plasma-derived C1 esterase inhibitor product. In
the U.S., Cinryze is approved by the FDA for routine prophylaxis
against angioedema attacks in adolescent and adult patients with
HAE. In the E.U., 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. Cinryze is for intravenous use only.
Severe hypersensitivity reactions to Cinryze may occur.
Thrombotic events have occurred in patients receiving Cinryze, 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 in clinical trials associated
with Cinryze were rash, headache, nausea, erythema, phlebitis and
local reactions at the injection site. Adverse events of
sinusitis and upper respiratory infection also were observed in
clinical trials. No drug-related serious adverse events (SAEs)
were reported in clinical trials.
Please visit http://www.viropharma.com/products/cinryze.aspx for
the full U.S. Prescribing Information; the prescribing information
for other countries can be found at www.viropharma.com.
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 and at least 10,000 people in
the European Union.
For more information on HAE, visit the U.S. HAE Association's
website at www.haea.org and the HAEi's (International
Patient Organization for C1 Inhibitor Deficiencies) website
at 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. ViroPharma is developing a portfolio of therapeutics
for rare and Orphan diseases including C1 esterase inhibitor
deficiency, Friedreich's Ataxia, and adrenal insufficiency; and
recurrent 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), seizures
and C. difficile-associated diarrhea (CDAD); for full U.S.
prescribing information on our products, please download the
package inserts at http://www.viropharma.com/Products.aspx; the
prescribing information for other countries can be found at
www.viropharma.com.
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.
Forward-looking statements in this press release include statements
regarding the therapeutic use and effectiveness of Cinryze in
patients on anabolic androgens. Our actual results could differ
materially from those results expressed in, or implied by, these
forward-looking statements. The commercialization of pharmaceutical
products is subject to risks and uncertainties. The data that were
discussed in this presentation and The Journal of Angioedema
article are subject to different interpretations and may not be
predictive of the results of any individual's results or of how
Cinryze performs in commercial usage. 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 for the quarter ended
March 31, 2013 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.
SOURCE ViroPharma Incorporated