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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): January 9, 2001
ViroPharma Incorporated
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(Exact name of issuer as specified in charter)
DELAWARE 0-021699 23-2789550
(State or Other (Commission (I.R.S. Employer
Jurisdiction file Identification
of Incorporation or number) Number)
Organization)
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.
ViroPharma Incorporated ("Viropharma") is filing a set of "Frequently Asked
Questions" and the answers to these questions. The "Frequently Asked Questions"
reflect information that experience has demonstrated to be often requested by
analysts and investors.
ViroPharma Incorporated
Frequently Asked Questions
See "Important Information Regarding the Answers to
these Frequently Asked Questions" below.
(Revised through January 2001)
Pleconaril and Picornavirus Diseases
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What are picornaviruses and what diseases do they cause?
Picornaviruses are a large, very prevalent group of RNA viruses that are
responsible for a significant portion of all human viral disease. These
viruses, particularly the rhinovirus and enterovirus members of the
picornavirus family, cause a diverse range of illnesses. They are the
predominant cause of the common cold, viral respiratory infection (VRI),
myocarditis, encephalitis, bronchitis, otitis media, neonatal enteroviral
disease and viral meningitis. Infections by these viruses can also lead to
acute disease exacerbations in individuals with asthma and chronic
obstructive pulmonary disease (COPD). Immunocompromised patients,
including transplant patients and patients receiving chemotherapy, are
extremely susceptible to severe and life-threatening diseases caused by
picornavirus infections.
Currently, there are no antiviral medicines available to treat picornavirus
infections.
What is pleconaril?
Pleconaril is a proprietary, orally administered small molecule inhibitor
of picornaviruses that was discovered by scientists currently with
ViroPharma. Pleconaril has been demonstrated to inhibit picornavirus
replication in vitro by a novel, virus-specific mode of action. Pleconaril
works by inhibiting the function of the viral protein coat, also known as
the viral capsid, which is essential for virus infectivity and
transmission. Laboratory studies have shown that pleconaril integrates
within the picornavirus capsid at a specific site that is common to a
majority of picornaviruses, including rhinoviruses and enteroviruses, and
disrupts several stages of the virus infection cycle. Based on these
laboratory studies, our clinical trials completed to date, and pleconaril's
broad spectrum anti-picornavirus activity, we believe that pleconaril may
be useful in treating a number of picornavirus diseases. There are
currently no antiviral medicines available to treat these diseases.
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How do the current VRI Phase III studies differ from the studies reported
in April 2000?
In April 2000, we reported the results of an 875 patient trial in adults
with VRI. The results showed that 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). In all randomized patients, generally less pronounced
treatment benefits were seen in the study.
After carefully reviewing the April 2000 VRI results with several leading
infectious disease experts, we identified elements of the trial design that
may have affected the outcome of the study. Most notable was the extent of
variability in the patients who enrolled in the study. Based on this
review, we redesigned our current trials to decrease the variability of the
patient population.
For example, we have excluded from our current VRI trials patients who have
active or recent allergic rhinitis (runny nose and sneezing due to
allergies). These allergic symptoms are similar to those of VRI but will
not respond to treatment with an antiviral drug like pleconaril, so the
inclusion of such patients could mask the effect of pleconaril. We also
are enrolling only patients who have a moderate to severe runny nose before
entering the study, since these symptoms are indicative of patients with
picornavirus infections. We are requiring patients to enroll into the
study within twenty-four hours after first developing symptoms because we
believe that the earlier a viral infection is treated, the larger the
impact of an antiviral drug on the severity and duration of the symptoms.
We have restricted enrolled patients' use of cold/cough treatments to only
the analgesic acetaminophen and the cough suppressant dextromethorphan so
that the varying effects of these medicines on cold symptoms will not
interfere with our ability to detect the effects of pleconaril. We also
have ensured that smokers are evenly distributed between the drug and
placebo treated groups to reduce the confounding effects of smoking on VRI
symptoms and endpoints. Finally, each of the two studies being conducted
in the fall of 2000 is larger than last year's study. We hope that these
study modifications will provide a more controlled environment for the
evaluation of pleconaril for treatment of VRI.
When will you announce the Phase III data for VRI?
We have completed enrollment in our ongoing VRI Phase III studies, and
currently we expect to announce preliminary results from these studies
sometime during April 2001.
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Are you conducting any other studies to support an NDA for pleconaril?
Yes. In addition to various drug interaction and pharmacokinetic studies,
we are conducting a study designed to assess the safety of pleconaril in
the pediatric population. We expect that the results from this study will
be available sometime in the second quarter of 2001.
Are you planning any additional pleconaril studies?
Yes. We plan to continue clinical research with pleconaril in order to
explore its utility in pediatric patients suffering from VRI, as well as in
other diseases associated with picornavirus infections. For example, if the
results from our pediatric safety study and our current VRI studies in
adults are positive, we may commence pivotal studies in the pediatric
population in the third quarter of 2001. Also, we may initiate a VRI
transmission study in the third quarter of 2001.
When will you file an NDA for pleconaril?
If the results from our Phase III studies in adult patients with VRI are
positive, and if we complete all of the required components for filing, we
anticipate submitting in mid-2001 an NDA (new drug application) to the
U.S. Food and Drug Administration (FDA) requesting permission to market
pleconaril for the treatment of VRI in adults.
What will be the primary indication for pleconaril?
Pleconaril currently is not approved for use in any indication. A number of
clinical trials with pleconaril have been completed and still others are
ongoing and planned to evaluate the safety and effectiveness of pleconaril
in various clinical situations. To date, pleconaril has been administered
to over 3,000 individuals and has been found to have a safety and
tolerability profile similar to that of placebo. If the results of our
current Phase III studies in adult patients with VRI are positive, then we
plan to submit an NDA (new drug application) to the FDA requesting
permission to market pleconaril for the treatment of viral respiratory
infection in adults. However, the details of the final indication as
described in pleconaril's labeling will depend on FDA's review of the NDA,
and on our discussions with FDA.
How will you commercialize pleconaril?
In order to penetrate the VRI marketplace, we intend to identify a
strategic partner to help us target primary care physicians. We hope to
engage a commercial partner for pleconaril during the first half of 2001.
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Hepatitis C Program
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What is hepatitis C?
Hepatitis C virus (HCV) is recognized as a major cause of chronic hepatitis
worldwide. The World Health Organization (WHO) estimates that 170 million
people are infected throughout the world. According to the Centers for
Disease Control and Prevention (CDC), there are nearly 4 million people
infected with HCV in the United States. Approximately 85 percent of persons
infected with HCV develop chronic hepatitis, of which 20 percent progress to
liver cirrhosis. Chronic HCV infection can also lead to the development of
hepatocellular carcinoma and liver failure. There are no vaccines or
specific antiviral treatments available for hepatitis C, and current
treatments are effective in only 10% to 40% of patients.
Do you have a product candidate to treat hepatitis C?
Yes. ViroPharma, with its HCV partner American Home Products Corporation, is
committed to finding and developing antiviral treatments for hepatitis C.
Toward this end, the ViroPharma-AHP team is pursuing a broad research and
development program. Our lead candidate is a small molecule virus inhibitor
that was originally discovered by ViroPharma scientists. This hepatitis C
product candidate is a member of a novel group of small molecule compounds
that has been shown in laboratory studies to specifically inhibit a key
replication activity of HCV.
Is your hepatitis C product candidate in human clinical trials?
Yes. We initiated Phase II studies with our first HCV product candidate in
adult patients infected with HCV during the fourth quarter of 2000. These
initial Phase II studies are designed to evaluate the safety and
pharmacokinetics of the compound, but will also assess the effect of the
product candidate on virus load in patients.
. What is the patient population for these HCV trials?
We expect to evaluate our HCV product candidate both in adult patients who
are treatment naive and in patients who are non-responders to standard
therapies.
When will you announce results from your Phase II studies in HCV?
Currently, we expect to announce preliminary results from our Phase IIa HCV
clinical program by mid-2001.
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RSV (Respiratory Syncytial Virus) Program
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What is RSV and RSV disease?
RSV, or respiratory syncytial virus, is a major viral respiratory tract
pathogen that often causes pneumonia and bronchiolitis. Yearly RSV disease
epidemics in the U.S. typically begin in November and continue through
April. The virus is highly contagious and infects individuals of all ages,
generally causing respiratory symptoms that include runny nose, cough and
wheezing. More than 90% of children throughout the world are infected
during the first two years of life. However, previous RSV infection does
not protect against subsequent infection. Consequently, symptomatic RSV re-
infections are very frequent events throughout life. Infants and young
children that are premature or have various heart or lung diseases are at
great risk of serious RSV morbidity and mortality.
RSV can also cause serious disease in adults and the elderly.
Epidemiological data indicate that the impact of RSV in older adults may be
similar to that of influenza. Hospitalization costs due to RSV in infants
and the elderly are estimated up to $1 billion annually in the U.S. Other
individuals at risk of serious and life-threatening complications arising
from RSV infections include bone marrow transplant patients and patients
with chronic obstructive pulmonary disease (including bronchitis and
emphysema) and asthma. More than 42 million Americans fall into these
groups.
There currently are no vaccines available for the prevention of RSV disease.
Immunoglobulin products are available for prophylactic use in certain high
risk infants with RSV infections. Supportive care is the principle therapy
for the disease, although more severe cases may require oxygen therapy or
mechanical ventilation. Ribavirin, administered by aerosol to minimize the
drug's adverse effects, is occasionally used for treatment of cases of RSV
pneumonia and bronchiolitis.
Do you have a product candidate to treat RSV disease?
Yes. Scientists at ViroPharma have discovered a novel antiviral product
candidate for the potential treatment of RSV disease that has proven to be
extremely potent and very selective in laboratory studies. The product
candidate, designated VP14637, is a member of a novel small molecule
compound series that has been shown in laboratory studies to inhibit RSV
replication by affecting functions of the viral F (fusion) protein, a highly
conserved RSV protein that is essential for virus reproduction.
We are developing VP14637 as part of our broader RSV antiviral program.
Currently we are developing this compound for administration by inhalation
using drug delivery device technology that we licensed from Battelle
Pulmonary Therapeutics. We believe that this technology is well suited for
VP14637 and can efficiently administer the drug directly to the primary site
of virus infection, the lungs.
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Is your RSV product candidate in human clinical trials?
Yes. During the fourth quarter of 2000, we initiated human clinical trials
with VP14637. These studies are designed to evaluate the safety and
pharmacokinetics of the compound in healthy human volunteers. If the drug
exhibits a favorable safety, tolerability and pharmacokinetic profile in
these initial studies, we would expect to initiate Phase II trials in
patients infected with RSV sometime during the second half of 2001.
Corporate Information
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When will you announce operating results?
ViroPharma's practice is to announce results for the first three calendar
quarters during the last week of the month following the close of the
applicable quarter, and to announce fourth quarter and year-end operating
results by the end of February.
Important Information Regarding the Answers to these
"Frequently Asked Questions"
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The answers to these "Frequently Asked Questions" contain forward-looking
statements that involve a number of risks and uncertainties, including those
relating to our estimated timeframes for the release of clinical data for
pleconaril and other product candidates, engaging a commercialization partner
for pleconaril, filing an NDA for pleconaril and our expected initial approved
indication for pleconaril, the initiation of clinical trials for pleconaril and
our other product candidates, as well as expected patient populations for our
HCV and RSV clinical trials. There can be no assurance that:
. we can initiate clinical trials for pleconaril or for our other product
candidates during the timeframe that we expect;
. the patient populations for our HCV and RSV clinical trials will be the
populations that we expect;
. clinical data for any of our clinical trials will be released during the
timeframe that we expect;
. we can file an NDA for pleconaril during the timeframe that we expect;
. FDA or other regulatory authority approval for any product candidate
that we have under development will be granted on a timely basis or at
all;
. even if approved, pleconaril will be indicated initially for the
treatment of adults suffering from viral respiratory infection;
. even if approved, pleconaril or any of our other product candidates will
achieve market acceptance; or
. we will be able to engage a commercialization partner for pleconaril
during the timeframe that we expect.
Investigational pharmaceutical products, such as all of our product candidates,
require significant time and effort for research and development, laboratory
testing and clinical testing prior to
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regulatory approval and commercialization. As a result, all of the activities
described in the answers to the "Frequently Asked Questions" are subject to
risks and uncertainties. These factors, and other factors that could cause
future results to differ materially from the expectations expressed answers to
the "Frequently Asked Questions", include, but are not limited to, those
described in our most recent Registration Statement on Form S-3 filed with the
Securities and Exchange Commission. The forward-looking statements contained in
the answers to the "Frequently Asked Questions" may become outdated over time.
ViroPharma does not assume any responsibility for updating any forward-looking
statements. From time-to-time, statements made by ViroPharma may modify or
replace prior statements found in the "Frequently Asked Questions" or other
releases and investors should refer to the most recently dated material
available. Presenting information in the "Frequently Asked Questions" or
updating this information from to time should not be deemed an acknowledgement
that such information is material or otherwise required to be disclosed.
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: January 9, 2001 By: /s/ Michel de Rosen
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Michel de Rosen
President and Chief Executive Officer
