Tasigna filing brought forward

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Novartis:

Tasigna filing brought forward

July 2006

By Fleur Pijpers

Following the approval of Bristol-Myers Squibb's Sprycel in June,

Novartis

has brought forward its intended filing date for Tasigna to late 2006.

Both

drugs are capable of overcoming Gleevec resistance, marking a

significant

breakthrough for cancer patients. Given this, and the fact that Novartis

has

relevant market experience thanks to Gleevec, Tasigna could prove a

worthy

opponent for Sprycel.

Novartis has brought forward the intended filing date for approval of

its

next-generation Gleevec product, which will be marketed as Tasigna

(nilotinib) and is known as the 'son of Gleevec'. The company planned to

file for both US and European approval in early 2007, but, following the

recent approval of Bristol-Myers Squibb's similar product Sprycel

(dasatinib), Tasigna's regulatory filing is now set to occur in late

2006.

Tasigna is an orally available inhibitor of Bcr/Abl, c-Kit and

platelet-derived growth factor (PDGF). The drug retains half the

chemical

make-up of Gleevec, with the added capability of tighter binding with

Bcr/Abl to prevent cell proliferation and induce apoptosis, otherwise

known

as cell death. This has the effect of increasing the potency of Tasigna,

with the potential to overcome Gleevec resistance in patients.

Gleevec, known as Glivec outside the US, is a key drug in Novartis'

portfolio, having generated sales of $1.2 billion in the first half of

2006.

In addition, the drug is currently the gold standard for the treatment

of

chronic myeloid leukemia (CML) and gastrointestinal stromal tumors

(GIST).

However, despite Gleevec's numerous advantages, weaknesses have begun to

emerge, namely in the form of resistance. It is estimated that

approximately

4% of newly diagnosed CML patients already have Gleevec resistance,

while up

to 20% develop resistance over time.

In clinical trials, both Sprycel and Tasigna have demonstrated the

ability

to overcome Gleevec resistance, thus representing a significant

development

for patients. However, given Sprycel's first-to-market status, it is

likely

that Bristol-Myers Squibb's drug will dominate, claiming a significant

proportion of market share.

Nevertheless, Novartis has gained extensive experience in the CML and

GIST

markets with Gleevec, and the company's well-established sales and

marketing

capabilities will undoubtedly prove invaluable upon Tasigna's launch.