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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): April 11, 2000
VIROPHARMA INCORPORATED
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(Exact name of issuer as specified in charter)
DELAWARE 0-021699 23-2789550
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation or file Identification
Organization) number) Number)
405 EAGLEVIEW BOULEVARD
EXTON, PENNSYLVANIA 19341
(Address of principal executive offices)
(610) 458-7300
(Registrant's telephone number, including area code)
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Item 5 - Other Events.
As is more fully described in the attached press release that is
incorporated herein by reference, on April 11, 2000, ViroPharma Incorporated
("ViroPharma") announced the results of three Phase 3 clinical studies of
pleconaril in two disease indications: viral respiratory infection (VRI) in
adults and viral meningitis in adults and children.
This report, including the press release attached hereto, contains
forward-looking statements, including statements relating to the Company's
anticipated schedule for conducting clinical trials and for the submission of a
New Drug Application to obtain regulatory approval for pleconaril. Pleconaril
currently is in clinical trials. There can be no assurance that planned or
ongoing clinical trials can be successfully concluded or concluded in accordance
with the Company's anticipated schedule. The conduct of clinical trials and
acquiring regulatory approval for investigational pharmaceutical products are
subject to risks and uncertainties. Neither the FDA nor any other regulatory
authority has approved pleconaril or any of ViroPharma's other product
candidates for commercialization. There can be no assurance that FDA or other
regulatory authority approval for pleconaril or any other product candidate
under development by ViroPharma will be granted on a timely basis or at all.
Even if approved, there can be no assurance that pleconaril will achieve market
acceptance. These factors, and other factors that could cause future results to
differ materially from the expectations expressed in this press release,
include, but are not limited to, those described in ViroPharma's 1999 Annual
Report on Form 10-K filed with the Securities and Exchange Commission. The
forward-looking statements contained in this press release may become outdated
over time. ViroPharma does not assume any responsibility for updating any
forward-looking statements.
Item 7 - Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits
Exhibit No. Description
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99 ViroPharma Press Release dated April 11, 2000
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Signatures
Pursuant to the requirements of the Securities and Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, hereunto duly authorized.
VIROPHARMA INCORPORATED
Date: April 11, 2000 By: /s/ Claude H. Nash
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Claude H. Nash
President and Chief Executive Officer
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Index to Exhibits
Exhibit No. Description
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99 ViroPharma Press Release dated April 11, 2000
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Exhibit 99
ViroPharma Announces Results of
Viral Respiratory Infection and Viral Meningitis Studies
Clinical Benefit Seen in Adult Patients with Confirmed Picornavirus Infections
Exton, PA, April 11, 2000 - VIROPHARMA INCORPORATED (Nasdaq: VPHM) today
announced results from its three Phase 3 clinical studies of pleconaril in two
disease indications: viral respiratory infection (VRI) in adults and viral
meningitis in adults and children. As expected, clinical benefits were generally
greater in patients with confirmed picornavirus infection. The adult patients in
both indications showed improved time to resolution of disease based on various
objective and subjective assessments of illness when compared to placebo-treated
patients.
In the VRI study, the time to resolution of illness, as measured by the primary
endpoint (absence of runny nose and reduction of other symptoms), was reduced
from 9.4 days to 7.7 days (p = 0.07) in picornavirus-infected patients receiving
pleconaril compared to placebo-treated patients. A greater treatment benefit was
seen in picornavirus-infected patients receiving pleconaril who did not take
concomitant cold medications, where illness duration was reduced from 9.0 days
to 6.75 days (p = 0.033). Objective assessments of VRI illness in all
picornavirus-infected patients, such as mucus production as measured by facial
tissue use (p = 0.03) and sleep disturbance (p = 0.025), were substantially
reduced. Reductions in cold medication use, middle ear pressure and virus
shedding were also seen in these patients. In all randomized patients, generally
less pronounced treatment benefits were seen in this study.
"In the VRI study, we observed a treatment benefit in picornavirus-infected
patients treated with pleconaril who presented to the clinic with symptoms of a
cold," said Claude Nash, VIROPHARMA's Chief Executive Officer. "We are confident
in pleconaril's ability to help these patients. Our timeline for the completion
of our clinical program and filing for regulatory approval for VRI is
unchanged."
VIROPHARMA plans to conduct additional large studies of pleconaril in adult
patients with VRI during the summer and fall months of this year using
information gained from this study. If the results of these studies are
favorable, the Company plans to submit a new drug application for regulatory
approval.
Pleconaril also was evaluated for the treatment of viral meningitis in two
studies, one in adult patients and a second in pediatric patients. The time to
complete resolution of headache was the primary endpoint in the study. While a
significant effect of pleconaril was not observed in this endpoint for all
randomized patients with confirmed picornavirus infection, significant effects
were seen in adult patients with the most severe disease. As observed in the
last adult viral meningitis study, the treatment effect was most pronounced in
adult patients who presented with severe headache and vomiting. In these
patients, the time to complete resolution of headache, the primary endpoint in
the study, was reduced by 3 days (10 days in the placebo group to 7 days in the
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pleconaril-treated group, p = 0.039). The time to return to work or school also
was reduced by 3 days in these patients (10 days in the placebo group to 7 days
in the pleconaril-treated group, p = 0.015).
In children with viral meningitis, the duration of illness observed in this
study was considerably shorter than noted in the previous study of this patient
group. Many children showed resolution of headache symptoms following lumbar
puncture on study day one. As a result, a significant effect of pleconaril was
not observed. Nonetheless, the illness was shortened from 4 days to 3 days in
children receiving pleconaril therapy within 24 hours of symptom onset.
"VIROPHARMA plans to discuss the data from these studies in viral meningitis
with the FDA," said Claude Nash. "We will determine the next steps to be taken
for the use of pleconaril to treat viral meningitis, as well as the timing of
those activities. We may have to revise our timeline for filing a new drug
application for this indication."
In all studies, adverse events were reported at a similar rate in pleconaril and
placebo-treated patients, except mild nausea which was slightly higher in the
pleconaril-treated patients. The frequency of nausea in the pleconaril-treated
group compared to the placebo group in VRI was 7% versus 3%, in adult meningitis
was 27% versus 20% and in pediatric meningitis was 1% in both groups.
ViroPharma will hold a teleconference call today at 10:00 a.m. (EST) to discuss
these results. To participate in the call, please dial: 1-800-288-8968 and
identify the ViroPharma conference call.
Viral Respiratory Infection (VRI)
Viral respiratory infection, or VRI, is an upper respiratory viral infection
that causes inflammation of the mucous membranes lining the nose and throat, and
in more serious forms, the lower respiratory tract. VRI can be a more serious
illness in many individuals. Symptoms of viral respiratory infection include
nasal discharge, nasal obstruction and congestion, sneezing, sore or "scratchy"
throat, cough and shortness of breath. The distinguishing features of VRI from
other respiratory infections are the systemic (whole body) manifestations,
including headache, muscle aches and malaise (a general feeling of illness or
poor health). If the infection progresses to the sinuses or lower respiratory
tract, sinusitis, otitis media (ear infection), respiratory distress, croup,
bronchitis, bronchiolitis and pneumonia may result.
The majority of viral respiratory infections are caused by picornaviruses, in
particular the closely related picornaviruses called rhinoviruses and
enteroviruses. Picornaviruses are small (pico means very small) RNA-containing
(RNA means ribonucleic acid) viruses and are one of the largest and most
important groups of human pathogens.
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Rhinoviruses infect principally the upper respiratory tract and are the single
most important cause of the common cold. Rhinoviruses can also infect the lower
respiratory tract. There are 101 distinct rhinoviruses. Enteroviruses cause
systemic infections and affect a variety of organ systems including the
respiratory tract, the gastrointestinal tract, the heart and the central nervous
system (CNS). Enteroviruses contribute to an estimated 15% of all viral
respiratory disease and are the most prevalent infectious agent of the CNS.
There are 66 distinct enteroviruses.
VRI has a significant impact on society in terms of medical and productivity
costs. VRI is responsible for more than 34 million physician visits each year in
the U.S. and contributes to the more than $6 billion spent annually on over the
counter and prescription medicines. On average, severe colds are responsible for
26 million missed school days, or 30 percent of all absences, and 23 million
lost work days, or 40 percent of all lost time, annually. Currently, there is no
specific antiviral treatment for VRI.
Viral Meningitis
Viral meningitis is caused predominantly by enteroviruses and is characterized
by a severe headache, stiff neck, fever, muscle pain, nausea, vomiting and
malaise. It has been estimated that there are over 500,000 cases of viral
meningitis annually in the U.S. Patients with viral meningitis often require
emergency care and hospitalization. In about 25% of viral meningitis patients,
the illness continues for more than 2 weeks. The cost of care for a patient with
viral meningitis often exceeds $5,000. Currently, there is no specific antiviral
treatment for viral meningitis.
Pleconaril
Pleconaril is a novel orally acting small molecule with broad anti-picornavirus
activity that is being developed by VIROPHARMA for treatment of certain
picornavirus diseases. Pleconaril works by specifically inhibiting the function
of the picornavirus capsid. The capsid is the protective protein shell of the
virus and is essential for virus infectivity and transmission. The drug
integrates within the viral capsid at a specific site that is common to the
majority of all rhinoviruses and enteroviruses. In doing so, pleconaril disrupts
several stages of the virus infection cycle. Pleconaril currently is being
evaluated in patients with viral respiratory infection (VRI) and viral
meningitis. Pleconaril also is being provided in an ongoing compassionate use
program for patients with serious degenerative and life-threatening picornavirus
diseases such as chronic meningoencephalitis, neonatal enteroviral disease,
polio and myocarditis.
VIROPHARMA INCORPORATED is committed to the commercialization, development and
discovery of antiviral pharmaceuticals. The Company is focused on drug
development and discovery activities in viral diseases including viral
respiratory infection (VRI, a severe form of the common cold), viral meningitis,
hepatitis C and RSV disease.
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This press release contains forward-looking statements, including statements
relating to the Company's anticipated schedule for conducting clinical trials
and for the submission of a New Drug Application to obtain regulatory approval
for pleconaril. Pleconaril currently is in clinical trials. There can be no
assurance that planned or ongoing clinical trials can be successfully concluded
or concluded in accordance with the Company's anticipated schedule. The conduct
of clinical trials and acquiring regulatory approval for investigational
pharmaceutical products are subject to risks and uncertainties. Neither the FDA
nor any other regulatory authority has approved pleconaril or any of
VIROPHARMA's other product candidates for commercialization. There can be no
assurance that FDA or other regulatory authority approval for pleconaril or any
other product candidate under development by VIROPHARMA will be granted on a
timely basis or at all. Even if approved, there can be no assurance that
pleconaril will achieve market acceptance. These factors, and other factors that
could cause future results to differ materially from the expectations expressed
in this press release, include, but are not limited to, those described in
VIROPHARMA's 1999 Annual Report on Form 10-K filed with the Securities and
Exchange Commission. The forward-looking statements contained in this press
release may become outdated over time. VIROPHARMA does not assume any
responsibility for updating any forward-looking statements.
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