EXTON, Pa., Aug. 1, 2013 /PRNewswire/ -- ViroPharma
Incorporated (NASDAQ: VPHM) today announced that following
discussion with the Center for Biologics Evaluation and Research
(CBER) division of the U.S. Food and Drug Administration,
ViroPharma is going to discontinue this Phase 2 study. The
discontinuation of the study is a precaution related to the
emergence of an unexpected incidence and titer of non-neutralizing
anti-rHuPH20 antibodies in a number of patients with the
formulation being used in this study. These antibodies have not
been associated with any adverse clinical effects and are of
unknown clinical significance.
The study was fully enrolled and 41 patients completed at least
one dosing arm of study drug with a total of 20 patients having
completed both dosing arms. These data will be informative for
design of future subcutaneous administration studies.
In parallel with the conduct of this Phase 2 study, we have
developed an optimized, low-volume subcutaneous formulation of
Cinryze. As a result, ViroPharma expects to conduct a Phase 3
subcutaneous registration study with this alternative formulation
in the same time frame that had been anticipated previously for the
combination product.
ViroPharma will be conducting a conference call to discuss the
second quarter financial results and other business this morning
and will provide additional information related to the subcutaneous
administration development program.
Cinryze is approved in the United
States as intravenous (IV) administration for routine
prophylaxis against angioedema attacks in adolescent and adult
patients with hereditary angioedema (HAE), and in Europe for routine prevention, pre-procedure
prevention and acute treatment of angioedema attacks in adolescent
and adult patients with HAE.
Conference Call and Webcast
ViroPharma is
hosting a live teleconference and webcast with senior management to
discuss the financial announcement, guidance, and all other
operational results of the first quarter on August 1, 2013 and discuss developments in the
subcutaneous Cinryze clinical development program at 9:00 a.m. Eastern. To participate in the
conference call, please dial (800) 874-4559 (domestic) and (302)
607-2019 (international). After placing the call, please tell
the operator you wish to join the ViroPharma investor conference
call.
Alternatively, the live webcast of the conference call can be
accessed via ViroPharma's website at
http://www.viropharma.com. Windows Media or Real Player will
be needed to access the webcast. An audio archive will be
available at the same address until August
15, 2013.
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 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 healthcare
professionals we serve.
ViroPharma routinely posts information, including press
releases, which may be important to investors in the investor
relations and media sections of our company's website,
http://www.viropharma.com/. The company encourages investors to
consult these sections for more information on ViroPharma and our
business.
ViroPharma 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 the
therapeutic indication and use, safety, efficacy, tolerability and
potential of Cinryze and our focus, goals, strategy, research and
development programs, and ability to develop pharmaceutical
products, commercialize pharmaceutical products, and execute on our
plans including clinical development activities with Cinryze
related to subcutaneous administration in combination with rHuPH20
or alternatively as a standalone low volume formulation. There can
be no assurance that clinical investigation of Cinryze in
combination with rHuPH20 will resume. We may also experience delays
in commencing a Phase 3 study of the subcutaneous administration of
low volume Cinryze as a standalone therapy. Additionally,
future studies with low volume Cinryze as a standalone therapy may
not yield positive results or support further development of
Cinryze for subcutaneous administration. The FDA or EMA may view
the data regarding subcutaneous administration of low volume
Cinryze as a standalone therapy as insufficient or inconclusive,
request additional data, require additional clinical studies, delay
any decision past the time frames anticipated by us, limit any
approved indications, or deny the approval of Cinryze for
subcutaneous administration. 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 Form 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