Sprycel and Tasigna

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Analysis: BMS` Sprycel shows promise

By Steve

Jun 14, 2006, 19:00 GMT

WASHINGTON, DC, United States (UPI) -- Bristol-Myers Squibb`s Sprycel

may get a boost from a study released Wednesday that indicates the

experimental drug improves symptoms in chronic myeloid leukemia

patients who failed to respond to the standard treatment Novartis`

Gleevec.

Novartis, however, may have its own contender for this subset of

patients. A phase 1 study also released Wednesday shows its candidate

Tasigna appears to benefit CML patients who are Gleevec resistant.

Physicians are excited about the prospects of both Sprycel and

Tasigna, saying they offer hope to patients who do not respond or

develop resistance to Gleevec.

Dr. Sawyers, a professor of hematology/oncology at the

University of California, Los Angeles` Jonsson Cancer Center and lead

author of the study, called Sprycel \'spectacularly successful in

treating patients with resistance to Gleevec.\'

Sawyers told United Press International the drug could have a \'huge

impact\' on the treatment of CML and could save many people`s lives.

There had been concerns about Sprycel`s safety and tolerance going

into the study, but Sawyers said the side effect profile is

\'surprisingly great.\' He noted that a significant number of patients

went off of Gleevec because they couldn`t tolerate it, but yet didn`t

have a problem with Sprycel.

Sprycel will likely remain a second-line therapy for CML, but the

questions now are should it be used up front, in combination with

Gleevec or in combination with Tasigna, Sawyers said. \'Those kinds of

questions will take time to play out,\' he added.

The Food and Drug Administration`s oncology drug advisory committee

recommended earlier this month that Sprycel be approved and the agency

is expected to issue its decision soon.

Analysts, however, are split on the potential of Sprycel, with some

predicting the drug will not pose much of a threat to Gleevec while

others think it could find a niche among patients with resistance or

tolerance to Novartis` drug.

In the Sprycel study, which appears in the June 15 issue of the New

England Journal of Medicine, 94 patients were treated with the drug.

This included 40 patients with chronic phase CML, 11 with a worse form

of the disease called accelerated phase CML and 23 with CML in blast

crisis, the most serious form of the disease. In addition, 10 patients

with acute lymphoblastic leukemia and the Philadelphia chromosome, the

mutation Sprycel targets, also were treated in the study.

Approximately 45 percent of the chronic phase patients and 43 percent

of the other CML and ALL patients showed a major response to Sprycel.

The responses persisted for up to two years and some patients are

still taking the drug.

Prudential analyst Dr. Tim said in a recent research report

that \'Sprycel poses little-to-no risk for Gleevec\' as front-line

therapy.

Approximately 15 percent to 30 percent of patients discontinue

Gleevec, which provides an opportunity for Sprycel. \'But just how far

(Sprycel) will penetrate this subset of patients is still unclear,\'

stated.

\'One very real possibility is that both second-line regimens --

Sprycel and high-dose Gleevec -- will be used in the same failing

patient at some point, but in what order is unclear,\' he wrote.

\'This will be an important variable in determining how much Gleevec

erodes by.\'

projected Sprycel could achieve global sales of $150 million

in 2007 and increase up to nearly $500 million by 2010, compared with

expected Gleevec sales of $2.6 billion this year. He projected Tasigna

could generate sales of $15 million in 2007, increasing to $330

million by 2010.

However, Moskowitz, an analyst with Friedman, Billings and

Ramsey, said in a recent note that Sprycel is positioned to capture

patients who develop resistance or intolerance to Gleevec and could

work its way into being used earlier in some cases.

\'The company plans to exploit the use of cytogenetic and molecular

testing to identify a lack of response to Gleevec, hence an

opportunity to fuel earlier use of Sprycel,\' Moskowitz stated.

Another advantage working in BMS` favor is the company \'could price

Sprycel at a premium to Gleevec, given that the drug offers higher

value, but will likely be used in a smaller market,\' he added.

In the Tasigna study, which appears in the same issue of NEJM, 119

patients with CML or ALL with the Philadelphia chromosome who had

failed on Gleevec were treated with the drug.

The drug improved outcomes in all three forms of CML, but only 2 of 13

ALL patients showed a response. Tasigna was well tolerated and side

effects included a reduction in the ability of the bone marrow to

produce blood cells and heart arrhythmia. One patient died after the

trial concluded, but the cause of death is unknown.

Novartis thinks Tasigna, rather than Sprycel, offers a better

alternative for patients who fail on Gleevec.

\'Clearly, we think Tasigna is looking like a very promising therapy

for patients who need treatment options,\' Geoffrey Cook, spokesman

for Novartis, told UPI. The company plans to file a new drug

application with the FDA for Tasigna, which is currently in phase 2

studies, later this year.

Regarding the potential of Sprycel, Cook said, \'Any product that`s

going to want to compete with Gleevec is going to need to show high

response rates, a good tolerability profile and long-term durable

responses and that`s going to be a very tough combination for any

product to meet.\'

He added, \'The data on Sprycel is relatively limited and it`s being

looked at in patients who have failed Gleevec and need new treatment

options.\'

Copyright 2006 by United Press International