Fast Facts When a drug is granted priority review, the FDA has six months to decide whether to approve or reject the drug application. For more information, read Novartis To Lobby Health Plans To Cover Glivec. In the United States, Glivec is known generically as imatinib mesylate. Outside of the United States it is known generically as imatinib. "CML is like a timebomb, and what we are hoping is that Glivec may be able to prevent it occurring, by containing the disease in the chronic stage, long-term" — Professor Kerry Taylor, director of cancer services at Brisbane's Mater Hospital in Australia, where Novartis is also seeking rapid government approval for prescription use.

EAST HANOVER, N.J., March 26, 2001 — Novartis Oncology today announced that Glivec* [pronounced GLEE-vek] has been designated priority review by the U.S. Food and Drug Administration (FDA) for possible use as treatment of patients with chronic myeloid leukemia (CML) in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy. The FDA grants priority reviews for products that may offer a significant improvement compared to marketed products.

Novartis submitted the new drug application (NDA) for Glivec on February 27, 2001. Submissions have taken place also in the European Union, Switzerland and other countries, and the filing for Japan is expected shortly as well. In addition, priority reviews have been granted in other countries.

"Novartis is pleased by the FDA's decision to grant priority review of Glivec," said David Epstein, President, Novartis Oncology. "We will continue to work closely with the Agency so that Glivec can get to the market and be available to patients as quickly as possible."

The filing application is based on study results from approximately 1,230 patients in 32 centers located in five countries. In fewer than three years since the initiation of clinical trials, Glivec has been studied in more than 5,000 patients in 30 countries. Based on early study results, the FDA had designated Glivec fast track status during development for the myeloid blast crisis phase indication of CML. In addition, Glivec was granted Orphan Drug designation by the United States, European Union and Japan. CML is one of the four most common types of leukemia. Worldwide, the disease is responsible for 15 to 20 percent of all adult leukemias.

In clinical trials, Glivec has been generally well tolerated, with side effects including nausea, muscle cramps, edema, skin rash, diarrhea, heartburn, and headache, which have been largely mild or moderate in intensity. Fewer than three percent of patients have experienced serious side effects such as the potential for liver toxicity, fluid retention syndrome, and hemorrhages.

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 "will," "significant improvement," "quickly," or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of a new product, Glivec, for which the company has filed global marketing applications, and anticipated customer demand for such products. 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, performance or achievements of Glivec to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to unexpected regulatory delays, future clinical trial results, government regulation or competition in general, as well as factors discussed in the company's Form 20F 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.

About Novartis

Novartis Oncology is a business unit under Novartis AG. It has operations within Novartis Pharma AG in Switzerland as well as Novartis Pharmaceuticals Corporation in the United States. Novartis (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 67,600 people and operates in over 140 countries around the world.

Source: Novartis Oncology

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