Novartis News Release on

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Hi everyone -

I thought this 12/08/09 news release on Tasigna would be of interest.

Tasigna Prevents Leukaemia Progression

http://www.clinicaspace.com/news_story.aspx?NewsEntityId=164845 & source=news-emai\

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EAST HANOVER, N.J., Dec. 8 /PRNewswire/ -- In a large Phase III clinical trial,

Tasigna® (nilotinib) 200 mg capsules demonstrated greater efficacy over

Gleevec® (imatinib mesylate) tablets* in the treatment of adult patients with

newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+

CML) in chronic phase(1).

In the first head-to-head comparison of these two oral therapies as initial

treatment for this life-threatening blood cancer, Tasigna results showed

statistically significant improvement over Gleevec in every measure of efficacy,

including major molecular response (MMR), complete cytogenetic response (CCyR)

and prevention of progression to accelerated or blastic phase(1). The new data

were presented as a late breaker abstract at the 51st annual meeting of the

American Society of Hematology (ASH), held in December, in New Orleans, USA.

" The outstanding rates of response observed with Tasigna, combined with the very

low rate of disease progression, strongly indicate that patients who begin their

treatment with Tasigna may have long-term improvement of progression-free

survival, " said Giuseppe Saglio, University of Turin, San Luigi Hospital,

Orbassano-Torino, Italy, a member of the study management committee. " The

efficacy results and tolerability of Tasigna should support its use in newly

diagnosed Ph+ CML patients. "

MMR was defined in the study as reduction in the level of the abnormal Bcr-Abl

protein to less than or equal to 0.1% of the pre-treatment level based on an

internationally agreed standard(1). This can be interpreted to mean that for

every 1,000 cells containing Bcr-Abl that were present in the blood at the start

of therapy, only one cell was present at the 12-month follow-up. CCyR indicates

that no CML cells containing the diagnostic Ph chromosome can be seen in a

sample of bone marrow taken from the patient.

Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes

production of cancer cells in Ph+ CML(2,3). Upon initial reports of resistance

in the Gleevec registration trials, Novartis scientists created a new molecule,

Tasigna, just a year after the launch of Gleevec. The first clinical trials

began just 21 months after discovery. The drug received its first regulatory

approval in the second-line indication in 2007.

Here is the Bloomberg story on the financial end of this.

Novartis's Tasigna Beats Gleevec, May Be Blockbuster

By Dermot Doherty

http://www.bloomberg.com/apps/news?pid=20601124 & sid=a8aD2x2pHwmo

Dec. 8 (Bloomberg) -- Novartis AG's Tasigna, which ranks outside the Swiss

drugmaker's top 20 products after two years on the market, may turn into a $1

billion seller after tests showed it was better at treating newly diagnosed

leukemia than Gleevec.

Combined peak sales from the treatments could exceed $5 billion, said

Epstein, Novartis's head of oncology, in an interview. Gleevec, also sold as

Glivec, is Novartis's second- biggest drug with $3.67 billion in 2008 revenue.

A study presented today at the American Society of Hematology in New Orleans

showed that Tasigna reduced levels of a protein linked to chronic myeloid

leukemia in twice as many patients as Gleevec. Novartis will use the data to ask

regulators to expand the use of Tasigna, which is approved in more than 80

countries as a treatment for patients who didn't respond to at least one prior

therapy. The medicine had sales of $144 million in the first nine months of this

year.

" I think that Tasigna will become one of our top products over time based upon

the data that we showed here at ASH as well as more than four other ongoing

clinical trials, " Epstein said. " Based on these data it should become a

blockbuster. "

Epstein said he would be " very disappointed " if 2010 revenue from the product

was " at the low end " of a $300 million to $400 million range. Sales at the upper

end " would be better. "

CML, which accounts for 10 percent to 15 percent of all leukemia cases in

adults, strikes one to two people per 100,000 a year, Novartis said.

`Outstanding'

The data presented at the medical meeting focused on Tasigna and Gleevec's

ability to cut the level of a protein called Bcr-Abl in the blood. The protein,

an indicator for CML, causes malignant white blood cells to multiply.

Tasigna lowered levels of the protein to less than or equal to 0.1 percent of

pre-treatment levels in 44 percent of patients, compared with 22 percent in

those given Gleevec.

" The outstanding rates of response observed with Tasigna, combined with the very

low rate of disease progression, strongly indicate that patients who begin their

treatment with Tasigna may have long-term improvement of progression-free

survival, " said Giuseppe Saglio, a researcher at the University of Turin's San

Luigi Hospital who was involved in the study, in a statement.

Fewer patients on Tasigna discontinued treatment because of adverse events and

there were no sudden deaths among those receiving either drug, said Novartis,

which announced initial results from the trial in October.

Novartis fell 20 centimes, or 0.4 percent, to close at 56.65 Swiss francs. The

stock has risen 7.5 percent this year.

Epstein also said Novartis may seek regulatory approval next year for a new

treatment, called LBH589, for Hodgkin's lymphoma. The compound is a so-called

Pan-DAC inhibitor and may also treat cancers such as breast and prostate tumors.

To contact the reporter on this story: Dermot Doherty in Geneva at

ddoherty9@...

Last Updated: December 8, 2009 11:53 EST

There are several other stories as well. Fascinating!

Pat Elliott

Phoenix, AZ