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RESPIRATORY SYNCYTIAL VIRUS

Respiratory Syncytial Virus (RSV) – the virus and market

Respiratory Syncytial Virus (RSV) is the cause of one-fifth of all lower respiratory tract infections worldwide and is increasingly recognized as representing a serious threat to patient groups with poorly functioning or immature immune systems.

The primary patient groups affected by Respiratory Syncytial Virus (RSV) are the following:

Infants under two years. Three percent of infants under one year old are hospitalised each year as a result of RSV Respiratory Syncytial Virus infections. There is also growing evidence and a belief in the medical community linking severe RSV in infancy to the occurrence of childhood asthma.
Elderly adults: studies are showing that RSV Respiratory Syncytial Virus is as significant as influenza in causing excess morbidity and mortality in this group.
Chronic obstructive pulmonary disease (COPD) and asthma patients - exacerbations can be particularly severe in congestive heart failure (CHF) and COPD patients.
Immuno-compromised individuals such as stem cell transplant patients and chemotherapy patients. Approximately 10% of all bone marrow/stem cell transplant patients annually are infected with RSV. Half of these infected patients develop pneumonia and of these, between 45-80% die.

Unlike influenza, which tends to have severe epidemics every 10 to 15 years with a short peak period, RSV Respiratory Syncytial Virus incidence is regular and substantial occurring every year during the winters in both the Northern and Southern Hemispheres and virtually year round in equatorial regions. RSV is a major factor in infant mortality in developing countries. Healthcare costs associated with RSV are significant, with estimated total direct medical costs for RSV-associated infant hospitalisations in the US (emergency department visits and in-patient stays) alone averaging approximately $750 million per year.

The only significant product currently sold for RSV is a monoclonal antibody (‘Synagis' from Medlmmune) sales of which exceeded US $1 billion in 2005. This product is used for prevention of RSV infection in premature and other high risk babies only, and so accesses a single sub-segment of just one of the potential markets for an RSV product. The only therapeutic product approved for treatment of RSV infection is ribavirin, which is now little used as clinical trials have shown inconsistent results and the product has an undesirable side effect profile. There are very few competitors in development and no vaccine exists despite many attempts.

Arrow’s RSV Respiratory Syncytial Virus programme

RSV604: Arrow has developed a first-in-class small molecule antiviral therapy for RSV (RSV604 – previously known as A-60444) with the ultimate aim of treating all patients from infants to the elderly. Early data indicated an excellent safety profile and once-a-day oral dosing. The compound has a novel mechanism of action, through inhibition of one of the proteins involved in viral replication (the N protein). Phase I trials are complete and Phase II trials are currently underway in stem cell transplant patients infected with RSV in Europe, Australia and the US.

In June 2005, Arrow announced a global licensing deal with Novartis, involving the development and commercial sale of RSV604. Under the terms of the agreement Novartis will undertake most of the further development and all commercialisation activity for the compound. All future work on the project will be funded by Novartis.

Follow-up compounds: Arrow also continues its independent efforts to discover further new RSV therapeutics with different chemistry. This follow-up programme is currently at the lead optimisation stage.

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PRODUCT PIPELINE

Arrow: Novartis RSV Collaboration

30 June 2005 - Arrow announced deal with Novartis for the treatment of RSV

Under the terms of the deal Arrow received an upfront payment of $10 million in addition to milestone payments of up to $217 million for success in the ongoing and future development and commercialisation of RSV604, and royalties on product sales appropriate for a compound in Phase IIa trials.

RSV Publications

RSV Benzodiazepine Inhibitors
J Med Chem March 2006

RSV604 Phase I Pharmacokinetics poster
ICAAC 2005