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GLIVEC, GLEEVEC
Novartis points to strong pipeline, growth areas
By Nancy Weil
IDG News Service, Boston Bureau
20-11-2003
At a time when the era of blockbuster drugs, with annual sales of US$1 billion, is said to be on the wane, Novartis AG has seven potential blockbusters that could be on the market by 2008, executives said Wednesday during the company's annual research and development day in New York.
In the pipeline are 78 development projects, with 63 in Phase II, III or at the regulatory registration process. Sixteen of the projects are in cancer treatments and nine are in cardiovascular drugs, which are among the main growth areas targeted by the company.
Gleevec, used to treat chronic myeloid leukemia (CML) and gastrointestinal tumors, will reach blockbuster status before this year is out, said Thomas Ebeling, chief executive officer of Novartis' pharmaceuticals division during a session with reporters that was webcast.
The drug, marketed under the name Glivec outside of the U.S., was first released to treat patients with CML in May 2001 after fast-track approval by the U.S. Food and Drug Administration (FDA). When it was approved, Gleevec was hailed by Richard Klausner, who then was director of the National Cancer Institute as "proof that molecular targeting works in treating cancer, provided that the target is correctly chosen." Phase II clinical trials are under way, investigating the drug's use to treat other diseases, including as a combination therapy in prostate and breast cancers.
Zometa, or zoledronic acid, is expected to reach the blockbuster level next year, he said. Zometa is an injectable drug used to treat hypercalcemia, or excess calcium in the blood, caused by the destruction of bone tissue in patients with cancer that has spread to their bones. Femara, for advanced breast cancer, also has a "strong growth outlook," with an improved four-year disease free survival rate among those using the drug, according to Novartis, based in Basel, Switzerland.
Joerg Reinhardt, the company's head of pharmaceutical development, highlighted 10 of the company's projects that are in Phase II and Phase III development, including two compounds for treating osteoporosis and one each for cancer, iron overload, transplantation, Hepatitis B, type 2 diabetes, high blood pressure, neurodegeneration, asthma and chronic obstructive pulmonary disease.
By 2010, there will be 50 million people worldwide with osteoporosis, and 15 million of them will be receiving treatment for the disease, double the number now being treated, Reinhardt said. Osteoporosis causes bones to become fragile and more likely to break. Although women, particularly those who are post-menopausal, are four times as likely as men to develop osteoporosis, men also get osteoporosis, according to the National Osteoporosis Foundation Web site.
Zoledronic acid, administered in one annual injection, is a promising Novartis compound for treating the disease, Reinhardt said. It is currently in Phase III trials, with a second compound, AAE581 in Phase II. AAE581, taken once daily, performs dual action by inhibiting bone resorption and improving bone production, he said.
Another compound in the pipeline is PTK787, which is an angiogenesis inhibitor, meaning it prevents the growth of blood vessels that provide nourishment to cancer cells. PTK787 is in Phase III development as a possible treatment for colorectal cancer.
"There is a huge medical need in colorectal cancer with 30,000 new cases of metastatic colorectal cancer in the U.S. per year," and a low five-year survival rate among patients, Reinhardt said.
Besides drugs in development for treating cancer, Novartis is also stepping into the Hepatitis B market, "a totally new field for us," Reinhardt said. Worldwide, there are 500 million long-term carriers of the disease, with 250 million of those in the Asia-Pacific region. One million people die worldwide each year from Hepatitis B infection, a virus transmitted by blood and bodily fluids that attacks the liver.
Novartis' LDT600 compound is at Phase III development and shows potential to be "best-in-class treatment" for Hepatitis B, the company said. Existing therapies "leave major room for improvement," Novartis said in a slide presentation accompanying executives' remarks.
The same is true for type 2 diabetes treatments. Some 300 million people worldwide will have type 2 diabetes by 2025, double the number today, Reinhardt said. Diabetes causes the pancreas to either be unable to make the hormone insulin or the body does not use insulin properly, so glucose, which is the main energy source from food, builds up in the blood.
There is a need for treatments that provide lasting control of glucose for disease prevention among those at risk, as well as long-term treatment options, he said. Risk factors for type 2 diabetes include obesity and lack of exercise. The company's LAF237 is in Phase II development and shows promise as "the first in a highly attractive new class of compounds," for controlling hemoglobin A1c, or HbA1c, Novartis said.
Hemoglobin is the compound in red blood cells that transports oxygen. Glucose binds to hemoglobin A and that is what forms the A1c subtype. Decomposition of glucose happens slowly, so buildup will remain for several weeks. People with diabetes have a higher level of HbA1c in their blood.
"We are quite excited by Phase II data" from of LAF237 trials, Reinhardt said.
Also in Phase II development is the compound SPP100 for treating high blood pressure and vascular disease. "If successful, SPP100 would be the first new treatment for high blood pressure in 10 years," he said.
While the pipeline was focused on during the presentation, those compounds will either make it to market or be discarded along the way, so Novartis has to also keep up with drug discovery project, said Mark Fishman, president of the Novartis Institutes for Biomedical Research. That global discovery arm of the company has as its mission "to discover new medicines reliably and predictably, not serendipitously, as it happens far too often now," he said.
Of course, future drug development will involve tapping into what is known, and will become known, about the human genome. "The genomic universe has not been fully captured for pharmaceutical discovery," Fishman said, "but it will be."