EXTON, Pa., July 21, 2004 (PRIMEZONE) -- Highlighting the great need for a well tolerated and effective treatment for cytomegalovirus (CMV), a panel of transplant clinicians and ViroPharma (Nasdaq:VPHM) scientific leaders today provided analysts and investors with an overview of CMV infection, CMV disease and the treatments currently available to patients at risk of CMV disease. In addition, the Company provided an overview and update on maribavir, ViroPharma's leading clinical candidate molecule that inhibits CMV.
Dr. Ravi Vij, the Assistant Professor of Medicine at Washington University, in Medical Oncology, Division of BMT and Leukemia, in St. Louis, Missouri provided an overview of the virus and CMV disease, an introduction to the large number of patients at risk of morbidity and mortality associated with the disease, and a review of the therapies currently available to patients at risk of disease:
-- Cytomegalovirus is a commonly latent herpes virus, infecting up to
80 percent of the population; it can reactivate and cause
significant disease in an immunocompromised host;
-- CMV is a cause of mononucleosis in healthy people; causes severe
congenital/perinatal disease in newborns often resulting in
deafness and severe retardation; and causes a variety of
significant diseases in patients with suppressed immune systems,
such as organ and bone marrow transplant patients, and patients
with HIV;
-- In the U.S., there are approximately 91,000 patients at high risk
of CMV disease, including organ and bone marrow transplant
patients, children born with congenital CMV disease, HIV patients
with clinical manifestations of CMV, and cancer patients
undergoing rigorous courses of chemotherapy;
-- In transplant patients, CMV disease can be severe or fatal;
-- Published sources cite mortality rates between 50% and 100% from
CMV pneumonia;
-- Available therapies can suppress the virus in many high-risk
patients for significant periods of time;
-- An improved safety profile from future products is needed.
Dr. Finn Bo Petersen, a Professor of Medicine and Pediatrics, and Program Director in the Division of Hematology/BMT at the University of Utah, Salt Lake City, Utah, presented a clinician's "view from the trenches" in treating patients at high risk of CMV disease. Dr. Petersen provided insight into life threatening infections with CMV, the direct and indirect effects of infection, the challenges associated with CMV patient support and treatment, and a clinician's opinion of the need for new therapies targeting the disease. Included in Dr. Petersen's presentation were the following points:
-- Morbidity and mortality from viral infections remains a
significant problem in at risk patient populations, despite major
advances in prophylaxis and treatment;
-- The consequences from harboring the CMV virus become
life-threatening in at risk patients;
-- Patients can acquire CMV disease by viral reactivation,
transfusions, transplants, and transmission through bodily fluids;
-- Direct effects of CMV disease include, among others, CMV
pneumonia, gastroenteritis, hepatitis, and myocarditis;
-- Indirect effects of CMV disease include increased risks of fungal
and bacterial infection, and acute and chronic graft rejection;
-- There is great need for new therapies due to the toxicity and
logistical limitations associated with the currently available
options;
-- Among the attributes required of a successful new CMV product are
an improved toxicity profile; improved ease of administration and
long-term use; and effectiveness as a prophylactic in high-risk
patients.
Colin Broom, M.D., ViroPharma's Vice President and Chief Scientific Officer then provided an introduction and overview of the clinical progress with maribavir, ViroPharma's leading anti-CMV clinical candidate.
-- Maribavir, a potent anti-CMV benzimidazole compound, was acquired
from GlaxoSmithKline in August 2003;
-- Maribavir targets UL97, a viral protein kinase involved in
processes including DNA elongation and viral capsid exit from the
nucleus of an infected cell, both of which are necessary for CMV
to replicate and spread to uninfected cells;
-- Maribavir is additive or synergistic in vitro with other anti-CMV
drugs, and is active in vitro against CMV strains resistant to
other anti-CMV agents;
-- Preclinical data show that maribavir appears to be significantly
more active in vitro against CMV than other currently available
agents;
-- ViroPharma conducted two Phase 1 clinical trials with the
compound, one to assess the potential of the product to interact
with other common drugs, the other to assess the safety of the
product in patients with increasing levels of renal impairment.
The outcomes of those trials support the initiation of the Phase 2
program;
-- The imminent Phase 2 program will study the safety, tolerability,
pharmacokinetics, and anti-CMV activity in CMV seropositive
recipients of allogeneic stem cell transplant;
-- ViroPharma expects that, if the Phase 2 data support development,
a Phase 3 program could begin in mid-2005, and lead to the filing
of a New Drug Application (NDA) with the FDA in late 2006;
-- The company believes that, to date, maribavir appears to be a
potent, selective, orally available antiviral agent targeting CMV,
with a compelling safety and tolerability profile.
"Thus far in its development cycle, we feel that maribavir possesses all of the qualities needed from an excellent compound targeting CMV, and I believe it to be one of the most promising anti-CMV agents currently being developed," commented Dr. Broom of ViroPharma. "Maribavir came to ViroPharma with a wealth of supportive data, and we continue to build on that data set. As we enter into Phase 2 testing with the product, maribavir appears to be a potent, specific, and, perhaps most importantly, well tolerated antiviral agent. There is great need among physicians and patients for a new treatment targeting CMV with these attributes."
Viropharma is providing an audio archive of the meeting, which will be available today, Wednesday July 21, 2004, at 8:00 P.M. Eastern Time. Windows Media or Real Player will be needed to access the archive of the audio presentation. The audio archive and a downloadable version of the slides from the event can be accessed via the ViroPharma corporate website, www.viropharma.com. The archive of the event will be available until August 20, 2004.
CMV is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50% and 85% of adults in the U.S. by 40 years of age. In most individuals with intact immune systems, CMV causes little to no apparent illness. However, in immunocompromised individuals, CMV can lead to serious disease or death. Before the availability of potent anti-HIV therapy, CMV associated retinitis was commonly seen in patients with HIV/AIDS. Currently, patients who are immunosuppressed following hematopoietic stem cell (e.g., bone marrow) or solid organ transplantation remain at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ.
ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma is currently focused on drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV).
The information contained in this document is as of July 21, 2004 and will not be updated as a result of new information or future events. Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties, including those relating to:
-- ViroPharma's belief that maribavir has the potential to inhibit
CMV;
-- ViroPharma's belief that maribavir may be more active against CMV
than other currently available agents;
-- ViroPharma's plans to initiate the maribavir Phase 3 program in
mid-2005, and to file a New Drug Application (NDA) with the FDA
in late 2006;
-- ViroPharma's belief that maribavir is a potent, selective, orally
bioavailable antiviral agent targeting CMV, with a compelling
safety and tolerability profile; and
-- ViroPharma's belief that maribavir is one of the most promising
anti-CMV agents currently being developed.
Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. There can be no assurance that that any of the forward-looking statements identified in this press release will occur. Conducting clinical trials for investigational pharmaceutical products are subject to risks and uncertainties. There can be no assurance that planned clinical trials can be initiated, that planned or ongoing clinical trials can be successfully concluded or concluded in accordance with ViroPharma's anticipated schedule, or that maribavir will achieve proof of concept or become a marketed product. These factors, and other factors, including, but not limited to those described in ViroPharma's most recent annual report on Form 10-K and registration statements on Forms S-3 and S-4 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 may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.