Preventing acute rejection, and maintaining pulmonary function, is a major unmet medical need in lung transplantation. Described as a "proliferation inhibitor", Certican™ has been shown to target many of the underlying causes of chronic allograft dysfunction or late graft loss, including acute rejection and vascular remodelling.
In one of the largest global trials of its kind, over 200 patients from 33 centres in nine countries took part in the randomised, double-blind phase III study which is planned to last three years. Results at 12 months showed:
- 22% of patients receiving Certican™ 1.5mg/bid reached the composite primary study endpoint (>15% decline in pulmonary function, graft loss or patient death) compared with 34% of patients receiving azathioprine (1.0 - 3.0 mg/kg/day) (p 0.0455)
- Certican™ was superior to azathioprine in terms of the number of acute rejection episodes requiring treatment (8% with Certican™; 32% with azathioprine; p <0.001)
- Certican™ was superior to azathioprine in terms of the single endpoint of more than 15% reduced pulmonary function (16% of patients vs 28% respectively; p 0.034 )
All patients received standard immunosuppressive therapy with full dose Neoral® (cyclosporin for microemulsion) with or without corticosteroids.
Lead investigator, Associate Professor Gregory Snell commented: "Decline in pulmonary function is a common and problematic occurrence after lung transplantation. Principal causes include acute rejection and chronic allograft dysfunction, which manifests in lung transplant patients by obliteration and loss of the small bronchioles. There is an urgent need for immunosuppressive regimens with the capacity to address this complication and the impressive performance of Certican™ in this regard is very encouraging."
At the same meeting, 24 month results of adjunctive Certican™ versus azathioprine in a major international trial of over 600 heart transplant patients were presented. These data confirmed the superiority of Certican™ over azathioprine in terms of all-cause efficacy failure, acute rejection rates and cardiac allograft vasculopathy which is known to contribute to late graft loss or chronic allograft dysfunction.
It is conceivable that these attributes of Certican™ could have a major impact on both health-related quality of life for transplant patients and on medical care resource utilisation by decreasing morbidity, graft loss and the expense associated with prolonged hospitalisation and/or re-transplantation.
This release contains certain "forward-looking statements," relating to the Company's business, which can be identified by the use of forward-looking terminology such as "new", "novel", "investigational … drug", "final stages of development", "conceivable", "could have", or similar expressions, or by express or implied discussions regarding the potential approval or marketing of Certicanä. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There can be no guarantees that Certican™ will be commercialised in any market. Any such commercialisation can be affected by, among other things, uncertainties relating to the product development and clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, 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 materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of CHF 32.4 billion (USD 20.9 billion) and a net income of CHF 7.3 billion (USD 4.7 billion). The Group invested approximately CHF 4.3 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72 900 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
NOTES TO EDITORS