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26.145.137 von Cashlover am 13.12.06
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Bad news ...
NeoPharm takes turn for worse
Brain cancer drug tests a major disappointment
December 12, 2006
BY FRANCINE KNOWLES Business Reporter
The brain cancer drug that Waukegan-based NeoPharm Inc. banked on
being its first commercial product failed in a late-stage clinical
trial, which sent the shares plummeting 68 percent Monday and
leaves the company's fate up in the air.
The survival rates for patients on NeoPharm's drug cintredekin
besudotox were not significantly different than the survival rates
of patients on MGI Pharma Inc.'s Gliadel Wafer treatment, the
company said Monday.
Median survival was 36.4 weeks for patients treated with
cintredekin besudotox, compared with 35.3 weeks for those treated
with the Gliadel Wafer.
NeoPharm is placing all future trials of its drug on hold while it
conducts more analysis of the trial data, Chief Executive Officer
Guillermo Herrera told analysts after announcing the results.
"The Neopharm board of directors and senior management created a
task force to evaluate company options going forward," he said.
Those options include advancement of the other products in its
pipeline, which are much less further along in development. Among
them are drugs to treat breast cancer, colorectal cancer and other
advanced forms of cancer. The products use a liposome-based drug
delivery system to deliver anti-cancer drugs to tumors. Liposomes
are microscopic membrane-like structures created from fats.
"This doesn't leave the company with much other than early stage
products," said Jonathan Aschoff, an analyst with Brean Murray
Carret & Co. "It's nowhere near as exciting for the
company."
"It's really bad news," said Robert W. Baird analyst Christopher
Raymond. "They made a conscious decision to put all their other
pipeline products on the back burner. They allowed those to
diminish in value as they bet everything on this."
Raymond said the competitive landscape for the other cancer
treatment products in NeoPharm's pipeline has changed to NeoPharm's
detriment.
"There are other companies that have products in trials," he said.
"NeoPharm has lost its place in line."
First Albany Capital Managing Director David Webber responded to
the news by downgrading the stock to neutral from buy. He said in a
research note the market for NeoPharm's breast cancer drug product
is already crowded, and while its colorectal product shows promise,
it's "moving slowly in an academic trial."
Regarding the future fate of cintredekin besudotox, he said, "we
think it would be difficult to obtain approval without another
trial, but the apparent shrinking of cintredekin besudotox to the
size of Gliadel's $35 million argues against that expense."
Earlier this year, NeoPharm released results from a study that
showed patients with glioblastoma, or brain tumors, treated with
its drug had a median survival time of 44 weeks, compared with 28
weeks with the Gliadel Wafer.
The latest trial results showed patients on cintredekin besudotox
had a survival rate of 35.1 percent vs. 30.1 percent for patients
on Gliadel Wafer at 12 months, 20 percent vs. 14.5 percent at 18
months and 14.4 percent vs. 14.5 percent at 24 months.
Herrera said the company will continue to work with its scientific
advisory board and the FDA to determine the best path forward for
the drug.
The company expects to have $35 million in cash on hand at the end
of the year, and doesn't anticipate having to go to the market to
raise more financing for two years or more, Herrera said, noting
there is sufficient cash to fund its liposome projects.