ALNY » Topics » Competing Drugs for RSV

This excerpt taken from the ALNY 10-K filed Feb 26, 2010.
Competing Drugs for RSV
 
The only product currently approved for the treatment of RSV infection is Ribavirin, which is marketed as Virazole by Valeant. This is approved only for treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. While it is also used to treat RSV infection in lung transplant patients, no randomized controlled trials of Ribavirin have been conducted in the lung transplant patient population. Ribavirin has been reported to have limited efficacy and limited anti-viral activity against RSV. Moreover, administration of the drug is complicated and requires elaborate environmental reclamation devices because of


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potential harmful effects on health care personnel exposed to the drug. According to published reports by Valeant, sales of Virazole were $12.3 million in 2008.
 
Other current RSV therapies consist of primarily treating the symptoms or preventing the viral infection by using the prophylactic drug Synagis (palivizumab), which is marketed by MedImmune. Synagis is a neutralizing monoclonal antibody that prevents the virus from infecting the cell by blocking the RSV F protein. Synagis is injected intramuscularly once a month during the RSV season to prevent infection. According to published reports by MedImmune and AstraZeneca PLC, which acquired MedImmune during 2007, worldwide Synagis sales were approximately $1.1 billion in 2009. MedImmune is also developing motavizumab (formerly known as Numax®), a humanized monoclonal antibody, which is being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of contracting RSV disease. MedImmune submitted a biologic license application for motavizumab to the FDA in early 2008 and received a complete response letter from the FDA in November 2008 requesting additional information. MedImmune submitted a response to the FDA in December 2009. MedImmune has also initiated a Phase I/IIa clinical trial of a live, attenuated intranasal vaccine in development to help prevent severe RSV infections and has several ongoing Phase I trials to evaluate a second live, attenuated intranasal vaccine in development to help prevent severe lower respiratory tract disease caused by RSV or parainfluenza virus 3. In addition, Novartis has a small molecule drug, RSV604, licensed from Arrow Therapeutics Ltd, which was last reported as being in Phase II clinical trials. RSV604 is an oral drug that targets the viral N protein.
 
These excerpts taken from the ALNY 10-K filed Mar 2, 2009.
Competing Drugs for RSV
 
The only product currently approved for the treatment of RSV infection is Ribavirin, which is marketed as Virazole by Valeant. This is approved only for treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. However, Ribavirin has been reported to have limited efficacy and limited anti-viral activity against RSV. Moreover, administration of the drug is complicated and requires elaborate environmental reclamation devices because of potential harmful effects on health care personnel exposed to the drug. According to published reports by Valeant, sales of Virazole were $14.3 million in 2007. Other current RSV therapies consist of primarily treating the symptoms or preventing the viral infection by using the prophylactic drug Synagis (palivizumab), which is marketed by MedImmune, Inc. Synagis is a neutralizing monoclonal antibody that prevents the virus from infecting the cell by blocking the RSV F protein. Synagis is injected intramuscularly once a month during the RSV season to prevent infection. According to published reports by MedImmune and AstraZeneca PLC, which acquired MedImmune during 2007, worldwide Synagis sales were greater than $1.2 billion in 2008. MedImmune is also developing motavizumab (formerly known as Numax®), a humanized monoclonal antibody, which is being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of contracting RSV disease. MedImmune submitted a biologic license application for motavizumab to the FDA in early 2008. MedImmune has also recently initiated a Phase I/IIa clinical trial of a live, attenuated intranasal vaccine in development to help prevent severe RSV infections. In addition, Novartis has a small molecule drug, RSV604, licensed from Arrow Therapeutics Ltd, which is in Phase II clinical trials. RSV604 is an oral drug that targets the viral N protein.
 
Competing
Drugs for RSV



 



The only product currently approved for the treatment of RSV
infection is Ribavirin, which is marketed as Virazole by
Valeant. This is approved only for treatment of hospitalized
infants and young children with severe lower respiratory tract
infections due to RSV. However, Ribavirin has been reported to
have limited efficacy and limited anti-viral activity against
RSV. Moreover, administration of the drug is complicated and
requires elaborate environmental reclamation devices because of
potential harmful effects on health care personnel exposed to
the drug. According to published reports by Valeant, sales of
Virazole were $14.3 million in 2007. Other current RSV
therapies consist of primarily treating the symptoms or
preventing the viral infection by using the prophylactic drug
Synagis (palivizumab), which is marketed by MedImmune, Inc.
Synagis is a neutralizing monoclonal antibody that prevents the
virus from infecting the cell by blocking the RSV F protein.
Synagis is injected intramuscularly once a month during the RSV
season to prevent infection. According to published reports by
MedImmune and AstraZeneca PLC, which acquired MedImmune during
2007, worldwide Synagis sales were greater than
$1.2 billion in 2008. MedImmune is also developing
motavizumab (formerly known as
Numax®),

a humanized monoclonal antibody, which is being evaluated for
its potential to prevent serious lower respiratory tract disease
caused by RSV in pediatric patients at high risk of contracting
RSV disease. MedImmune submitted a biologic license application
for motavizumab to the FDA in early 2008. MedImmune has also
recently initiated a Phase I/IIa clinical trial of a live,
attenuated intranasal vaccine in development to help prevent
severe RSV infections. In addition, Novartis has a small
molecule drug, RSV604, licensed from Arrow Therapeutics Ltd,
which is in Phase II clinical trials. RSV604 is an oral
drug that targets the viral N protein.


 




These excerpts taken from the ALNY 10-K filed Mar 10, 2008.
Competing Drugs for RSV
 
The only product currently approved for the treatment of RSV infection is Ribavirin, which is marketed as Virazole by Valeant. This is approved only for treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. However, Ribavirin has been reported to have limited efficacy and limited anti-viral activity against RSV. Moreover, administration of the drug is complicated and requires elaborate environmental reclamation devices because of potential harmful effects on health care personnel exposed to the drug. According to published reports by Valeant, sales of Virazole were $14.3 million in 2007. Other current RSV therapies consist of primarily treating the symptoms or preventing the viral infection by using the prophylactic drug Synagis (palivizumab), which is marketed by MedImmune, Inc. Synagis is a neutralizing monoclonal antibody that prevents the virus from infecting the cell by blocking the RSV F protein. Synagis is injected intramuscularly once a month during the RSV season to prevent infection. According to published reports by MedImmune and AstraZeneca PLC, which acquired MedImmune during 2007, worldwide Synagis sales were greater than $1.0 billion in 2007. MedImmune is also developing motavizumab (formerly known as Numax®), a humanized monoclonal antibody, which is being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of contracting RSV disease. Phase I and II studies have been reported showing that motavizumab appears to have a similar safety and pharmacokinetic profile to Synagis in infants. In addition, Novartis has a small molecule drug, RSV604, licensed from Arrow Therapeutics Ltd, which is in Phase II clinical trials. RSV604 is an oral drug that targets the viral N protein.
 
Competing
Drugs for RSV



 



The only product currently approved for the treatment of RSV
infection is Ribavirin, which is marketed as Virazole by
Valeant. This is approved only for treatment of hospitalized
infants and young children with severe lower respiratory tract
infections due to RSV. However, Ribavirin has been reported to
have limited efficacy and limited anti-viral activity against
RSV. Moreover, administration of the drug is complicated and
requires elaborate environmental reclamation devices because of
potential harmful effects on health care personnel exposed to
the drug. According to published reports by Valeant, sales of
Virazole were $14.3 million in 2007. Other current RSV
therapies consist of primarily treating the symptoms or
preventing the viral infection by using the prophylactic drug
Synagis (palivizumab), which is marketed by MedImmune, Inc.
Synagis is a neutralizing monoclonal antibody that prevents the
virus from infecting the cell by blocking the RSV F protein.
Synagis is injected intramuscularly once a month during the RSV
season to prevent infection. According to published reports by
MedImmune and AstraZeneca PLC, which acquired MedImmune during
2007, worldwide Synagis sales were greater than
$1.0 billion in 2007. MedImmune is also developing
motavizumab (formerly known as
Numax®),
a humanized monoclonal antibody, which is being evaluated for
its potential to prevent serious lower respiratory tract disease
caused by RSV in pediatric patients at high risk of contracting
RSV disease. Phase I and II studies have been reported
showing that motavizumab appears to have a similar safety and
pharmacokinetic profile to Synagis in infants. In addition,
Novartis has a small molecule drug, RSV604, licensed from Arrow
Therapeutics Ltd, which is in Phase II clinical trials.
RSV604 is an oral drug that targets the viral N protein.


 




This excerpt taken from the ALNY 10-K filed Mar 12, 2007.
Competing Drugs for RSV
 
The only product currently approved for the treatment of RSV infection is Ribavirin, which is marketed as Virazole® by Valeant. This is approved only for treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. However, Ribavirin has been reported to have limited efficacy and limited anti-viral activity against RSV. Moreover, administration of the drug is cumbersome and requires elaborate environmental reclamation devices because of potential harmful effects on health care personnel exposed to the drug. According to published reports by Valeant, sales of Virazole were $16.6 million in 2006. Other current RSV therapies consist of primarily treating the symptoms or preventing the viral infection by using the prophylactic drug Synagis® (palivizumab), which is marketed by MedImmune, Inc. Synagis is a neutralizing monoclonal antibody that prevents the virus from infecting the cell by blocking the RSV F protein. Synagis is injected intramuscularly once a month during the RSV season to prevent infection. According to published reports by MedImmune, Synagis sales were $1.1 billion in 2006.
 
This excerpt taken from the ALNY 10-K filed Mar 16, 2006.
Competing Drugs for RSV
 
The only product currently approved for the treatment of RSV infection is Ribavirin, which is marketed as Virazole® by Valeant Pharmaceuticals International. This is approved only for treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. However, Ribavirin has been reported to have limited efficacy and limited anti-viral activity against RSV. Moreover, administration of the drug is cumbersome and requires elaborate environmental reclamation devices because of potential harmful effects on health care personnel exposed to the drug. According to published reports by Valeant Pharmaceuticals, sales of Virazole were $15.3 million in 2005. Current RSV therapies consist of primarily treating the symptoms or preventing the viral infection by using the prophylactic drug Synagis®, which is marketed by MedImmune, Inc. Synagis is a neutralizing monoclonal antibody that prevents the virus from infecting the cell by blocking the RSV F protein that is used to infect lung cells. Synagis is injected intramuscularly once a month during the RSV season to prevent infection. According to published reports by MedImmune, Synagis sales were $1.1 billion in 2005.
 
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