ViroPharma
Encyclopedia
ViroPharma Incorporated, a pharmaceutical company
, develops and sells drugs that address serious diseases treated by physician specialists and in hospital settings. The company focuses on product development activities on virus#Viruses and human disease, including those caused by cytomegalovirus
(CMV) and hepatitis C
virus (HCV) infections.
The company has strategic relationships with GlaxoSmithKline
, Schering-Plough
, and Sanofi-Aventis
.
ViroPharma acquired Lev Pharmaceuticals in a merger on 10/21/2008.
ViroPharma is a member of the NASDAQ Biotechnology Index
and the S&P 600
.
None of the founders are still with the company.
: licensed from Eli Lilly
in 2004. Oral Vancocin is an antibiotic
for treatment of staphylococcal enterocolitis
and antibiotic
associated pseudomembranous colitis
caused by Clostridium difficile
.
is an oral
antiviral drug
candidate licensed from GlaxoSmithKline
in 2003 for the prevention and treatment of human cytomegalovirus
disease in hematopoietic stem cell/bone marrow transplant
patients. In February 2006, ViroPharma announced that the United States Food and Drug Administration
(FDA) had granted the company fast track
status for maribavir.
In March 2006, the company announced that a Phase II study with maribavir demonstrated that prophylaxis with maribavir displays strong antiviral activity, as measured by statistically significant reduction in the rate of reactivation of CMV in recipients of hematopoietic stem cell/bone marrow transplant
s. In an intent-to-treat analysis of the first 100 days after the transplant, the number of subjects who required pre-emptive anti-CMV therapy was statistically significantly reduced (p-value
= 0.051 to 0.001) in each of the maribavir groups compared to the placebo
group (57% for placebo
vs. 15%, 30%, and 15% for maribavir 100 mg twice daily, 400 mg daily, and 400 mg twice daily, respectively).
ViroPharma conducted a Phase III clinical study to evaluate the prophylactic use for the prevention of cytomegalovirus disease in recipients of allogeneic
stem cell
transplant patients. In February 2009, ViroPharma announced that the Phase III study failed to achieve its goal, showing no significant difference between maribavir and a placebo in reducing the rate of CMV disease.
pleconaril was ViroPharma's first compound, licensed from Sanofi
in 1995. Pleconaril is active against viruses in the picornavirus
family. ViroPharma's first indication was for enteroviral
meningitis
, but that indication was abandoned when the clinical trial
s did not demonstrate efficacy.
In 2001, ViroPharma submitted a New Drug Application of pleconaril to the FDA for the common cold
. On 2002-03-19, the FDA Antiviral Advisory Committee recommended that the company had failed to show adequate safety, and the FDA subsequently issued a not-approvable letter. After the Advisory Committee meeting the stock price fell from 22 USD at the beginning of 2002 to an all time low of 0.87 USD on 2002-10-28. (The stock price recovered in 2005.)
In November 2003, ViroPharma licensed pleconaril to Schering-Plough
, who are developing an intranasal formulation for the common cold
and asthma
exacerbations. (Schering-Plough Development Pipeline). In August 2006, Schering-Plough started a Phase II clinical trial.
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
, develops and sells drugs that address serious diseases treated by physician specialists and in hospital settings. The company focuses on product development activities on virus#Viruses and human disease, including those caused by cytomegalovirus
Cytomegalovirus
Cytomegalovirus is a viral genus of the viral group known as Herpesviridae or herpesviruses. It is typically abbreviated as CMV: The species that infects humans is commonly known as human CMV or human herpesvirus-5 , and is the most studied of all cytomegaloviruses...
(CMV) and hepatitis C
Hepatitis C
Hepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus . The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years...
virus (HCV) infections.
The company has strategic relationships with GlaxoSmithKline
GlaxoSmithKline
GlaxoSmithKline plc is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom...
, Schering-Plough
Schering-Plough
Schering-Plough Corporation was a United States-based pharmaceutical company. It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. In 1971, the Schering Corporation merged with Plough to form Schering-Plough. On November 4, 2009 Merck & Co...
, and Sanofi-Aventis
Sanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
.
ViroPharma acquired Lev Pharmaceuticals in a merger on 10/21/2008.
ViroPharma is a member of the NASDAQ Biotechnology Index
NASDAQ Biotechnology Index
The NASDAQ Biotechnology Index includes securities of NASDAQ-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals.- Criteria :...
and the S&P 600
S&P 600
The S&P 600 SmallCap Index, more commonly known as the S&P 600, is a stock market index from Standard & Poor's. It covers roughly the small-cap range of US stocks, using a capitalization-weighted index...
.
History
ViroPharma Incorporated was founded in 1994 by Claude H. Nash (Chief Executive Officer), Mark A. McKinlay (Vice President, Research & Development), Marc S. Collett (Vice President, Discovery Research), Johanna A. Griffin (Vice President, Business Development), and Guy D. Diana (Vice President, Chemistry Research.)None of the founders are still with the company.
Board of directors
- Michel de RosenMichel de RosenMichel de Rosen is the CEO of Eutelsat Communications and is a non-executive member of the board of directors of ABB Ltd. He was Chief Executive Officer and Chairman of the Board of Directors of ViroPharma Incorporated from August 2002 to May 2008...
Chairman since September 2002, President and Chief Executive Officer since August 2000, Director since May 2000 - Vincent J. Milano President and Chief Executive Officer since March 2008, Director since March 2008
- Paul A. Brooke Director since February 2001
- William D. Claypool Director since December 2003
- Michael R. Dougherty Director since January 2004
- Robert J. Glaser Director since August 1997
- John R. Leone Director since January 2006
- Howard H. Pien Director since 2006
Management team
- Vincent J. Milano President and Chief Executive Officer
- Daniel B. Soland Vice President, Chief Operating Officer
- Thomas F. Doyle Vice President, Strategic Initiatives
- Colin Broom Vice President, Chief Scientific Officer
- Robert G. Pietrusko Vice President, Global Regulatory Affairs and Quality
- J. Peter Wolf Vice President, General Counsel
Marketed products
Vancocin Pulvules HClVancomycin
Vancomycin INN is a glycopeptide antibiotic used in the prophylaxis and treatment of infections caused by Gram-positive bacteria. It has traditionally been reserved as a drug of "last resort", used only after treatment with other antibiotics had failed, although the emergence of...
: licensed from Eli Lilly
Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States...
in 2004. Oral Vancocin is an antibiotic
Antibiotic
An antibacterial is a compound or substance that kills or slows down the growth of bacteria.The term is often used synonymously with the term antibiotic; today, however, with increased knowledge of the causative agents of various infectious diseases, antibiotic has come to denote a broader range of...
for treatment of staphylococcal enterocolitis
Enterocolitis
Enterocolitis is an inflammation of the colon and small intestine. However, most conditions are categorized as one or the other of the following:* Enteritis is the inflammation of the small intestine...
and antibiotic
Antibiotic
An antibacterial is a compound or substance that kills or slows down the growth of bacteria.The term is often used synonymously with the term antibiotic; today, however, with increased knowledge of the causative agents of various infectious diseases, antibiotic has come to denote a broader range of...
associated pseudomembranous colitis
Pseudomembranous colitis
Pseudomembranous colitis, a cause of antibiotic-associated diarrhea , is an infection of the colon. It is often, but not always, caused by the bacterium Clostridium difficile. Because of this, the informal name C. difficile colitis is also commonly used. The illness is characterized by...
caused by Clostridium difficile
Clostridium difficile
Clostridium difficile , also known as "CDF/cdf", or "C...
.
Pipeline
MaribavirMaribavir
Maribavir is an experimental oral antiviral drug candidate licensed by ViroPharma from GlaxoSmithKline in 2003 for the prevention and treatment of human cytomegalovirus disease in hematopoietic stem cell/bone marrow transplant patients...
is an oral
Route of administration
A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body.-Classification:Routes of administration are usually classified by application location...
antiviral drug
Antiviral drug
Antiviral drugs are a class of medication used specifically for treating viral infections. Like antibiotics for bacteria, specific antivirals are used for specific viruses...
candidate licensed from GlaxoSmithKline
GlaxoSmithKline
GlaxoSmithKline plc is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom...
in 2003 for the prevention and treatment of human cytomegalovirus
Cytomegalovirus
Cytomegalovirus is a viral genus of the viral group known as Herpesviridae or herpesviruses. It is typically abbreviated as CMV: The species that infects humans is commonly known as human CMV or human herpesvirus-5 , and is the most studied of all cytomegaloviruses...
disease in hematopoietic stem cell/bone marrow transplant
Bone marrow transplant
Hematopoietic stem cell transplantation is the transplantation of multipotent hematopoietic stem cell or blood, usually derived from bone marrow, peripheral blood stem cells, or umbilical cord blood...
patients. In February 2006, ViroPharma announced that the United States Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) had granted the company fast track
FDA Fast Track Development Program
The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration that accelerates the approval of investigational new drugs undergoing clinical trials with the goal review time of 60 days...
status for maribavir.
In March 2006, the company announced that a Phase II study with maribavir demonstrated that prophylaxis with maribavir displays strong antiviral activity, as measured by statistically significant reduction in the rate of reactivation of CMV in recipients of hematopoietic stem cell/bone marrow transplant
Bone marrow transplant
Hematopoietic stem cell transplantation is the transplantation of multipotent hematopoietic stem cell or blood, usually derived from bone marrow, peripheral blood stem cells, or umbilical cord blood...
s. In an intent-to-treat analysis of the first 100 days after the transplant, the number of subjects who required pre-emptive anti-CMV therapy was statistically significantly reduced (p-value
P-value
In statistical significance testing, the p-value is the probability of obtaining a test statistic at least as extreme as the one that was actually observed, assuming that the null hypothesis is true. One often "rejects the null hypothesis" when the p-value is less than the significance level α ,...
= 0.051 to 0.001) in each of the maribavir groups compared to the placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
group (57% for placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
vs. 15%, 30%, and 15% for maribavir 100 mg twice daily, 400 mg daily, and 400 mg twice daily, respectively).
ViroPharma conducted a Phase III clinical study to evaluate the prophylactic use for the prevention of cytomegalovirus disease in recipients of allogeneic
Tissue engineering
Tissue engineering is the use of a combination of cells, engineering and materials methods, and suitable biochemical and physio-chemical factors to improve or replace biological functions...
stem cell
Stem cell
This article is about the cell type. For the medical therapy, see Stem Cell TreatmentsStem cells are biological cells found in all multicellular organisms, that can divide and differentiate into diverse specialized cell types and can self-renew to produce more stem cells...
transplant patients. In February 2009, ViroPharma announced that the Phase III study failed to achieve its goal, showing no significant difference between maribavir and a placebo in reducing the rate of CMV disease.
Failed products
OralRoute of administration
A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body.-Classification:Routes of administration are usually classified by application location...
pleconaril was ViroPharma's first compound, licensed from Sanofi
Sanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
in 1995. Pleconaril is active against viruses in the picornavirus
Picornavirus
A picornavirus is a virus belonging to the family Picornaviridae. Picornaviruses are non-enveloped, positive-stranded RNA viruses with an icosahedral capsid. The genome RNA is unusual because it has a protein on the 5' end that is used as a primer for transcription by RNA polymerase...
family. ViroPharma's first indication was for enteroviral
Enterovirus
Enteroviruses are a genus of ssRNA viruses associated with several human and mammalian diseases. Serologic studies have distinguished 66 human enterovirus serotypes on the basis of antibody neutralization tests. Additional antigenic variants have been defined within several of the serotypes on the...
meningitis
Meningitis
Meningitis is inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. The inflammation may be caused by infection with viruses, bacteria, or other microorganisms, and less commonly by certain drugs...
, but that indication was abandoned when the clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s did not demonstrate efficacy.
In 2001, ViroPharma submitted a New Drug Application of pleconaril to the FDA for the common cold
Common cold
The common cold is a viral infectious disease of the upper respiratory system, caused primarily by rhinoviruses and coronaviruses. Common symptoms include a cough, sore throat, runny nose, and fever...
. On 2002-03-19, the FDA Antiviral Advisory Committee recommended that the company had failed to show adequate safety, and the FDA subsequently issued a not-approvable letter. After the Advisory Committee meeting the stock price fell from 22 USD at the beginning of 2002 to an all time low of 0.87 USD on 2002-10-28. (The stock price recovered in 2005.)
In November 2003, ViroPharma licensed pleconaril to Schering-Plough
Schering-Plough
Schering-Plough Corporation was a United States-based pharmaceutical company. It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. In 1971, the Schering Corporation merged with Plough to form Schering-Plough. On November 4, 2009 Merck & Co...
, who are developing an intranasal formulation for the common cold
Common cold
The common cold is a viral infectious disease of the upper respiratory system, caused primarily by rhinoviruses and coronaviruses. Common symptoms include a cough, sore throat, runny nose, and fever...
and asthma
Asthma
Asthma is the common chronic inflammatory disease of the airways characterized by variable and recurring symptoms, reversible airflow obstruction, and bronchospasm. Symptoms include wheezing, coughing, chest tightness, and shortness of breath...
exacerbations. (Schering-Plough Development Pipeline). In August 2006, Schering-Plough started a Phase II clinical trial.
Further references
- The Long Road Ahead for ViroPharma Motley Fool 29 September 2006
- McDonald LC, Killgore GE, Thompson A, et al. 2005 Emergence of an epidemic, toxin gene variant strain of Clostridium difficile responsible for outbreaks in the United States between 2000 and 2004. N Engl J Med 353:2433-2441 http://content.nejm.org/cgi/content/abstract/353/23/2433?andorexacttitleabs=and&search_tab=authors&tmonth=Dec&searchtitle=Authors&sortspec=Score+desc+PUBDATE_SORTDATE+desc&excludeflag=TWEEK_element&hits=20&author2=Killgore+&tyear=2005&author1=McDonald+&andorexactfulltext=and&fyear=1995&fmonth=Dec&sendit=GO&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
- U.S. Centers for Disease Control and PreventionCenters for Disease Control and PreventionThe Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
Report on Severe Clostridium difficile—Associated Disease in Populations Previously at Low Risk --- Four States, 2005 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5447a1.htm - Lu H, Thomas S. 2004. Maribavir (ViroPharma). Curr Opin Investig Drugs 5:898-906