Physicians' Financial News: March 2008

By Matthew Mahady
Published: Monday, Jun 21, 2010
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Novartis Leverages Formidable Size and Pipeline to Maintain Strong Oncology Position

Novartis—listed on New York, Swiss, and London stock exchanges—was formed in March 1996 by the combination of Sandoz and Ciba-Geigy, two Swiss-based chemical and life sciences giants. The company, which employs more than 99,000 people in 140 countries around the world, has major production sites in eight countries (Switzerland, Germany, United States, United Kingdom, France, Austria, Turkey, and Ireland) and six major research and development centers spread out over three continents (Switzerland, England and Austria in Europe; Massachusetts, United States in North America; and Japan and China in Asia).

The international corporation is composed of a number of business units or divisions. In broad organization terms, Novartis can be broken down into four separate major components: Pharmaceuticals, Vaccines and Diagnostics, Sandoz (which focuses on generic medications), and Consumer Health.


â–º Novartis Pharma

Within the pharmaceuticals division of Novartis, the company concentrates on the following seven major therapeutic areas: cardiovascular and metabolism; oncology and hematology; neuroscience; respiratory; infectious diseases, transplantation, and immunology; ophthalmics, dermatology, gastrointestinal, and urinary; and arthritis and bone.

Novartis Pharmaceuticals has received 15 new product approvals in the United States since 2000, which, according to the company, is the most of any pharmaceutical company. The current product portfolio of Novartis Pharmaceuticals includes more than 45 marketed products. Its product development pipeline involves nearly 140 projects—including potential new product candidate compounds as well as potential new indications or formulations for existing products—in various stages of clinical development.

In 2007, Novartis increased its level of research and development investment by 19% (over 2006) to $5.1 billion, 21% of net sales. Last year also marked the creation of the Novartis biologics unit, which the company’s 2007 annual report defines as “a dedicated innovation unit with a strong biotech culture in the areas of discovery and development unique to biologics.” Currently, biologics make up roughly 25% of Novartis’s preclinical research pipeline.

A wealth of strategic alliances and research and development partnerships augment Novartis in-house product development efforts. Currently, Novartis is involved in more than 400 collaborations in 20 countries. About 120 of these partnerships are with biotechnology concerns and more than 280 are with academic centers.

Key Novartis products include Diovan (valsartan) and Lotrel (amlodipine besylate and benazepril HCl), two high-selling hypertension treatments; Gleevec (imatinib mesylate), an oncology product indicated to treat chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST); Lamisil (terbinafine HCI), an antifungal agent; and Zometa (zoledronic acid), an intravenous infusion utilized in the treatment of bone metastasis in a variety of tumor types (including multiple myeloma, breast, lung, and prostate cancers).

â–ºNovartis Oncology

Novartis currently offers seven oncology therapies to American patients. In addition to the aforementioned Gleevec and Zometa, Novartis’ oncology and hematology division has five other products that have attained FDA approval and are currently being marketed in the United States.

The rest of the Novartis cancer care portfolio includes: Newly approved (as of fourth quarter 2007) Tasigna (nilotinib), a Philadelphia chromosome– positive (Ph+) CML treatment indicated for patients who are resistant or intolerant to Gleevec; Femara (letrozole), a breast cancer therapy that a company spokesperson claims is the only aromatase inhibitor approved as adjuvant therapy, extended adjuvant therapy, and advanced (metastatic) breast cancer; Sandostatin (octreotide acetate), indicated for long-term maintenance therapy in patients with acromegaly and in the treatment of symptoms related to carcinoid syndrome and vasoactive intestinal peptide tumors; Exjade (deferasirox), indicated for the treatment of chronic iron overload caused by blood transfusions, particularly in cases of myelodysplastic syndrome and thalassemia; and Proleukin (aldesleukin), an injectable therapy indicated for the treatment of metastatic renal cell carcinoma and metastatic melanoma.

The late 2007 Tasigna approval, which was based on data which demonstrated that Tasigna produced responses in 40% of patients with Ph+CML resistant or intolerant to prior treatment, represented one of the watershed events in recent Novartis oncology history. Commenting on the event, David Epstein, President and CEO, Novartis Oncology, stated, “Tasigna represents an important advance for the small number of patients who are resistant or intolerant to prior therapy. This approval means we can offer physicians a comprehensive treatment approach with effective medicines to treat their Ph+CML patients.”


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