Here's another release giving an analyst's projections for Thalomid sales:
$4-5m this year, $50m next year. Drug cost for cancer patients is $18k per year, so less than 3k cancer patients projected for next year - seems conservative to me.
Peter
Headline: (UPDATE) EntreMed Licenses Thalidomide To Celgene To Focus On
Cancer
Drug
======================================================================
ROCKVILLE, Md. -(Dow Jones)- Biotechnology firm EntreMed Inc. said
Thursday it agreed to sublicense its rights to thalidomide to Celgene
Corp., and will use royalty payments to develop an experimental cancer
drug that received widespread attention earlier this year.
EntreMed (ENMD) plans to use revenues from the agreement to develop
endostatin, which it is preparing for clinical trials in people for the
first time next year.
For Celgene, the deal avoids a patent fight with EntreMed on the uses
of thalidomide, which Celgene already sells for one rare disease, and
gives it a lock on use of the drug for other uses, such as cancer.
EntreMed set off a wave of buying in biotechnology stocks earlier
this year after press reports said endostatin caused large tumors in
mice to shrink and lie dormant, and that this plus a second agent called
angiostatin can make such tumors vanish. The drugs are believed to work
by cutting off or halting the blood supply to tumors.
The company was forced to defend the two experimental drugs last
month after some researchers said they haven't been able to duplicate
the company's findings.
The exclusive agreement gives Celgene EntreMed's patents on
thalidomide, related technology and Food and Drug Administration orphan
drug designation, which gives a company financial and marketing
incentives to develop treatments for rare diseases.
In July, Celgene received FDA to use its version of the controversial
drug thalidomide, called Thalomid, to treat erythema nodosum leprosum,
an inflammatory complication of leprosy.
The drug was originally sold in the 1950s as a sedative and to treat
nausea in pregnant women in Europe and Canada. It was pulled from those
markets in 1962 after it was discovered it caused severe birth defects.
The drug is available only with heavy restrictions.
Celgene also is developing Thalomid for the treatment of a number of
autoimmune and inflammatory diseases and several oncological
indications, including multiple myeloma, and in HIV/AIDS-related
conditions and Crohn's disease.
For Celgene, the deal is significant because it means any fights with
EntreMed over patents for thalidomide will be avoided.
Stephen G. Brozak, an analyst who follows Celgene for Vanguard
Capital, said getting the EntreMed licenses was a huge step for Celgene.
"They've locked up every cancer application and every other
meaningful application out there," Brozak said.
He projects Celgene's thalidomide sales will be between $4 million
and $5 million this year. For next year, Brozak said sales should be
about $50 million.
About 90% of the prescriptions written next year will be for uses not
approved by the FDA, Brozak projects. Once the agency approves a drug
for sale in the U.S., doctors can prescribe it to treat other ailments,
which is called off-label use. However, companies cannot promote drugs
for unapproved uses.
John Jackson, Celgene's chairman and chief executive, said the
agreement with EntreMed will speed up research on thalidomide for
treating cancers.
"By working together we should be able to get approval from the FDA
quicker than if we had been working separately," Jackson said.
Jerry Treppel, an analyst who follows Celgene for Warburg Dillon
Read, said the company's thalidomide sales will jump next year as more
research is published detailing the drug's benefits for certain cancers.
Caroline Copithorne, senior biotechnology analyst at Prudential
Securities Inc., said the deal with EntreMed gives Celgene the dominant
position in the cancer market for the drug.
Copithorne said the payments will be money well spent for Celgene.
Although Celgene isn't disclosing the amount of payments, Copithorne
said the amount isn't substantial.
Copithorne also said cancer patients are more valuable to Celgene.
Leprosy patients take 50 mg of thalidomide daily, which costs $2,300 a
year, Copithorne said. For cancer, daily doses are 400 mg to 800 mg
daily, costing $18,000 per patient, per year, she said.
EntreMed recently broadened the scope of its thalidomide clinical
trials to include new investigational studies in non-small cell lung
cancer, metastatic renal cell cancer, and head and neck cancer. The drug
also is in trials for primary brain cancer, prostate cancer, Kaposi's
sarcoma, and breast cancer.
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