BASEL, Switzerland, June 30, 2005 (PRIMEZONE) -- Novartis (NYSE:NVS)announced today that it has signed an exclusive global license agreement with Arrow Therapeutics, Ltd. for A-60444 a first-in-class therapy in development for the treatment of respiratory syncytial virus (RSV) infections. RSV is the most common respiratory virus in infants.
Under the terms of the agreement, Novartis obtains the rights to develop, manufacture and commercialize A-60444 as well as rights to back-up compounds and a right of first negotiation on follow-up compounds. A-60444 is in Phase I/II clinical trials and is the industry's most advanced small molecule in development for RSV. Arrow completed a Phase I dose escalating pharmacodynamics, safety and tolerability study in healthy volunteers last year.
RSV is an area of high unmet medical need as current treatment options are limited. No RSV-specific anti-virals are currently available, and the only commonly used treatment option is used to prevent infection in high-risk infants and has limited efficacy.
"Our development portfolio, especially in infectious disease is focused on products that are highly differentiated and have the potential to meet significant unmet medical needs," said Thomas Ebeling, CEO of Novartis Pharma AG. "RSV leads to hospitalization of 125,000 infants in the U.S. each year and 2,500 deaths, which points to the public health issues yet to be addressed. As the most advanced RSV-specific antiviral in development, A-60444 has the potential to offer a more effective and safer treatment option than currently available therapies."
About RSV
RSV is a virus that causes infection of the lungs and breathing passages. It infects 50-70% of all infants during the first year of life and is the leading cause of infant hospitalization, bronchiolitis and pneumonia. RSV can also cause severe lower respiratory tract disease at any age, especially among the elderly, patients with chronic obstructive pulmonary disease and immuno-compromised persons, such as transplant and cancer patients. RSV can cause long-term health problems, such as asthma, and, in severe cases, RSV infection can be fatal.
Infection with RSV typically causes lower respiratory tract infections (bronchiolitis, pneumonia) and middle ear infections (otitis media). Hospitalization is necessary in 3% of otherwise healthy infants who contract RSV in the U.S., and the majority of these children are under 6 months of age. Infants born prematurely and infants with chronic lung conditions or congenital heart disease are at increased risk for more severe or life-threatening disease. RSV is highly contagious and can be spread through close contact with infected persons or through contact with nonporous surfaces, such as a crib or countertop.
The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "pipeline", "potentially", or similar expressions, or by express or implied discussions regarding the potential development, regulatory approvals and commercialization or potential future sales of A-60444. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any of these products will be approved for sale in any market, or that any of them will achieve any particular level of sales. Any such commercialization can be affected by, among other things, uncertainties relating to product development and clinical trials, including unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; as well as factors discussed in the Company's Form 20-F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
About Novartis
Novartis AG (NYSE:NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.