Pharmaceutical companies are racing to get new drugs on the market to treat breast cancer. Picture: THINKSTOCK
Pharmaceutical companies are racing to get new drugs on the market to treat breast cancer. Picture: THINKSTOCK

NOVARTIS is hot on the heels of Pfizer in developing a promising new type of breast-cancer drug that represents a targeted approach to fighting the dread disease.

Analysts believe the drug could generate billions of dollars in annual sales.

The Swiss drug maker, which has previously kept its research programme under wraps, revealed on Friday that its experimental pill LEE011 was set to enter final-stage Phase III clinical trials next month.

Pfizer’s rival drug Palbociclib — the first in the class — is already in Phase III testing, but Novartis’s rapid progress means the US group could face competition sooner than expected.

Both drugs are pills and work by blocking two enzymes known as cyclin-dependent kinases (CDK) 4 and 6.

The significance of the new approach to fighting cancer was highlighted in April when US regulators granted a "breakthrough therapy" designation to Palbociclib, based on impressive results seen in mid-stage trials.

Palbociclib is widely seen by investors as Pfizer’s most valuable compound in late-stage development and the company has started several new clinical trials to maximise its potential.

Analysts currently expect annual Palbociclib sales of $1.9bn by 2019, according to consensus estimates compiled by Thomson Reuters Pharma, and some think it could eventually sell $5bn if it is approved for multiple cancer types.

Because Novartis has not previously revealed mid-stage clinical trial data for LEE011, analysts have not yet modelled sales forecasts for that product.

Stealthy advance

LEE011’s rapid advance suggests that Novartis has stealthily accelerated its development programme and "snuck up from behind," according to Bernstein analyst Tim Anderson.

"Investors should therefore be aware that Palbociclib could face competition sooner than anticipated," he wrote in a research note.

Eli Lilly also has a CDK 4/6 inhibitor in development but it is further behind the other two drug companies.

Novartis disclosed that LEE011 would progress into Phase III clinical testing in a statement ahead of an investor presentation last week, in which it announced a $5bn share buyback programme and highlighted the potential of several research projects.

Like Palbociclib, LEE011 will be tested in combination with a standard drug, Letrozole, in postmenopausal women undergoing treatment for advanced or metastatic breast cancer.

A total of 500 women are expected to be enrolled into the Phase III study of LEE011 and the trial is due to be completed in November 2016, according to the US National Institutes of Health’s ClinicalTrials.gov website.

Also like Pfizer, Novartis is hoping to use its drug beyond breast cancer. The website reveals a total of 11 clinical trials for LEE011 at various development stages, four of which are in breast cancer. Other earlier-stage studies with LEE011 are looking at melanoma, lymphoma and paediatric cancers.

Advances in understanding the molecular and genetic basis of cancer means the disease is now a top priority for research teams at many pharmaceutical companies.

Cancer drugs are expected to be the top-selling therapy area in the coming years, with sales in developed markets forecast to reach between $74bn and $84bn by 2017, according to pharmaceutical information firm IMS Health.

Experts point out that breast cancer is one form of the disease that has a high survival rate if caught early enough, making detection key. In the US, more and more women are undergoing breast magnetic resonance imaging (MRI) scans to screen for cancer, according to two new studies.

There are still concerns, however, that expensive MRI scans are not being used among the groups of women who would benefit most from the tests.

"It’s a great new test but no one had looked at how and if it was really used," Natasha Stout, who led one of the new studies, says. "These are the first studies to really document the use and rates of use for breast MRIs."

Dr Stout is an assistant professor in the department of population medicine at the Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston.

In addition to not exposing women to radiation, Dr Shelley Hwang says MRI scans are known to be more sensitive and show more small abnormalities than traditional mammograms. But that also means more false alarms that result in biopsies.

Dr Hwang, chief of breast surgery at Duke University in Durham, North Carolina, co-wrote an editorial accompanying the new studies in Jama Internal Medicine.

Both the American Cancer Society and the National Comprehensive Cancer Network recommend breast MRIs be used in conjunction with mammograms among women with a lifetime breast cancer risk of 20% or higher, usually due to their family history.

Reuters with Marika Sboros