New products rejuvenate our pharmaceutical portfolio
Renewal of the portfolio is accelerating as new medicines expand options for patients in fields where Novartis already is a leader, such as oncology and cardiovascular medicine, as well as in other diseases with unmet medical need.
"In the long run, the pharmaceutical industry is about innovation," said Joe Jimenez, CEO of the Pharmaceuticals Division. "Our research and development investment is at the high end of the industry, and we expect that to continue, to create a best-in-class pipeline over the next five years."
Novartis achieved 30 major regulatory approvals in 2009. New drugs launched since 2007 generated net sales of USD 4.7 billion in 2009, providing eight percentage points of the 12% growth (in local currencies) in Pharmaceuticals.
Delivering on innovation’s promise
The Pharmaceutical division achieved excellent progress during 2009, gaining 25 regulatory approvals in the United States, European Union and Japan. Since 2000 the US Food and Drug Administration approved more new molecular entities from Novartis than any other major pharmaceutical company. Novartis currently has 145 projects in clinical development.
Among major recent launches and approvals for Pharmaceuticals:
Afinitor, a novel new approach to treatment of cancer, for kidney cancer (EU, US and Japan)
Tekturna/Rasilez, the first new class of high blood pressure medicines in recent years (Japan)
Combination products to improve hypertension outcomes, including Exforge HCT (US and EU), Valturna (US) and Co-Dio and Exforge (Japan)
Lucentis, a biotechnology eye therapy for age-related macular degeneration (Japan)
Onbrez Breezhaler, for chronic obstructive pulmonary disease (EU)
Ilaris, a fully human monoclonal antibody that blocks IL-1 beta inflammatory protein (EU and US)
Extavia, for relapsing forms of multiple sclerosis (EU and US)
Fighting cancer with new therapiesOncology, the largest therapeutic franchise, continues to expand as new therapies from the R&D pipeline build upon the double-digit growth of Gleevec/Glivec, a pioneering targeted treatment for chronic myeloid leukemia (CML).
In 2009, Novartis launched Afinitor in the US, EU and Switzerland for the treatment of advanced renal cell carcinoma in patients whose disease progressed on or after standard therapy. In January 2010, Afinitor also was approved in Japan.
Afinitor is being studied in many cancer types, including neuroendocrine tumors, breast, gastric and lymphoma, as well as a genetic disorder called tuberous sclerosis, with more submissions planned in 2010 and beyond.
Tasigna, an important advance for CML patients resistant or intolerant to prior treatment including Gleevec/Glivec, more than doubled in net sales in 2009. After new clinical data, Tasigna was submitted in December for US and EU approval for first-line use in newly diagnosed CML patients.
Managing high blood pressure and diabetesNew medicines for high blood pressure and diabetes are strengthening the Cardiovascular and Metabolism franchise, amid slowing sales growth for Diovan, the flagship high blood pressure medicine.
Tekturna/Rasilez, the first new class of high blood pressure medicines in more than a decade, has grown rapidly since its 2007 launch in the US and EU. In 2009, the product won approval in Japan. In addition, US regulatory authorities approved a broader indication for Tekturna HCT, a single-pill combination with a diuretic. Tekturna HCT is also approved in the EU.
“Our research and development investment is at the high end of the industry, and we expect that to continue,”
said Joe Jimenez, CEO of the Pharmaceuticals Division.
Other single-pill combination therapies are under development. In 2009, Novartis submitted the combination of aliskiren and amlodipine to regulatory authorities. In 2009, US authorities approved Valturna, a single-pill combination of Tekturna/Rasilez and Diovan that offers significantly greater blood pressure reduction than either agent alone.
Novartis is actively developing an array of combination products to improve outcomes in the management of high blood pressure, since up to 65% of patients do not have the condition under control. If left untreated, they face increased risk of stroke, heart attack and heart failure.
Galvus and Eucreas, oral treatments for type 2 diabetes, are expanding rapidly in Europe, Latin America and Asia-Pacific markets. Galvus was approved in Japan under the name Equa.
Increasing product portfolio diversity
Novartis Pharmaceuticals is making a difference in many disease states by launching innovative new products to fulfill unmet needs. Among the other milestones in 2009:
Ilaris was approved for a debilitating auto-inflammatory disease, cryopyrin-associated periodic syndrome (CAPS). Studies are ongoing in other diseases linked to the protein IL-1 beta, including painful hard-to-treat gout, systemic juvenile idiopathic arthritis (SJIA) and type 2 diabetes.
Onbrez Breezhaler, a new once-daily maintenance bronchodilator treatment of chronic obstructive pulmonary disease (COPD), was launched in the EU.
To help patients better manage multiple sclerosis (MS), Novartis launched Extavia in the EU and US as a new branded version of interferon beta-1b, the standard of care for relapsing forms of MS. The company also submitted FTY720, a breakthrough with potential to transform the treatment of MS.