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Teva Invests in Potential Type 1 Diabetes Therapy Once Rejected by Sanofi

December 20, 2011
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Teva Pharmaceutical Industries Ltd.'s Headquarters

Teva Pharmaceutical Industries Ltd.’s Headquarters

Teva Pharmaceutical Industries Ltd.'s Headquarters

Adam Reynolds/Bloomberg

The entrance to Teva Pharmaceutical Industries Ltd.’s headquarters in Jerusalem.

The entrance to Teva Pharmaceutical Industries Ltd.’s headquarters in Jerusalem. Photographer: Adam Reynolds/Bloomberg

Teva Pharmaceutical Industries Ltd. (TEVA),
the world’s largest generic-drug maker, is seeking to transform
a compound once rejected by Sanofi into the first treatment to
succeed insulin for Type 1 diabetes.

The therapy, DiaPep277, is made from a human protein that
stops the immune system from destroying the pancreatic beta
cells that secrete insulin, a hormone needed to convert sugar,
starches and other food into energy. The drug also helps control
sugar levels in the blood, a late-stage study showed last month.

Type 1 diabetes develops early in life and robs people of
their ability to make insulin, according to the World Health
Organization
. Teva, based in Petach Tikva, Israel, and its
partners are aiming to find a drug that preserves the ability to
make insulin after companies including Eli Lilly Co. (LLY) and
Johnson Johnson (JNJ) have failed. If the product is approved, peak
sales (TEVA) may be between $500 million and $1 billion, Ronny Gal, an
analyst at Sanford C. Bernstein, wrote in a Dec. 2 note.

“Type 1 has a huge unmet need, with no other treatment
other than insulin,” Aharon Schwartz, vice president of
innovative ventures at Teva, said in an interview. “We believed
the risk-benefit ratio was worthwhile.”

Diabetes is a chronic illness in which the body either
doesn’t produce enough insulin or fails to use insulin
effectively. About 346 million people worldwide have diabetes,
of which 90 percent have the Type 2 form of the disease, often
the result of excess body weight and lack of physical activity,
according to the Geneva-based WHO.

Beta Cells

While the exact cause of Type 1 is unknown, scientists
believe it occurs when the immune system attacks the pancreatic
beta cells that produce insulin. By the time most patients are
diagnosed with Type 1, 80 percent of their beta cells have been
destroyed, Shlomo Dagan, chief executive officer of Teva’s
partner, Andromeda Biotech Ltd., said in an interview.

“Right now the only treatment for Type 1 diabetes are
insulin injections,” Dagan said. “This is not a therapy; it’s
a replacement.”

Lilly and partner MacroGenics Inc. last year said their
experimental Type 1 diabetes drug teplizumab wasn’t effective in
slowing the progression of the disease in a pivotal trial.
Diamyd Medical AB (DIAMB) terminated an agreement with a Johnson
Johnson unit to develop a Type 1 diabetes treatment in June
after the medicine failed to preserve beta cell function after
15 months, the primary goal in a late-stage trial.

No Competition

“When we started we thought, even if the results are
positive, we would have competition,” Schwartz said. “Now we
are the only game in town.”

DiaPep277, which modulates the immune system to prevent the
destruction of insulin-secreting cells, was invented by Irun
Cohen of the Weizmann Institute of Science in Rehovot, Israel.
Since then it has been under development by Peptor Ltd. and its
successor companies: DeveloGen AG, which merged with Peptor in
2003, and Evotec AG, which bought DeveloGen last year. Aventis
SA, which later became Sanofi (SAN), licensed the drug from Peptor in
2002 and returned the rights two years later.

DeveloGen sold the drug to Andromeda Biotech in June 2007.
Teva licensed worldwide rights to DiaPep277 from Andromeda
Biotech in June 2009, and invested $170 million in the company
last year to fund a clinical trial to confirm earlier results
for DiaPep277.

Teva’s Stake

Bernstein’s Gal estimates the market for the medicine to be
about 50,000 patients a year at a price point of between $5,000
and $10,000 annually. The product is a “nice asset” for Teva,
which will probably get 20 percent of sales as a royalty rate,
Gal said.

“It sounds like a drug that could provide value to
patients who don’t have a lot of options,” he said in an
interview. “The question is, does it stop the deterioration of
the pancreas or just slow it down?” If patients lose the
ability to produce any insulin, then DiaPep277 wouldn’t help, he
said.

The drug met both the main and secondary goals of a study
in the last of three stages of human testing generally needed
for regulatory approval, Andromeda Biotech, a unit of Ramat Gan,
Israel-based Clal Biotechnology Industries Ltd. (CBI), said on Nov.
22. Patients taking the medicine had stable C-peptide levels,
which meant pancreatic cells secreted insulin on their own,
while there was a decline in those levels among patients taking
the placebo.

Glucose Control

Patients taking DiaPep277 also maintained “good diabetic
control” compared with those taking the placebo. That means
patients need fewer daily insulin doses, delaying or reducing
complications from diabetes, which include heart disease and
stroke, according to Andromeda Biotech.

The trial included 457 Type 1 diabetes patients between the
ages of 16 and 45 in Europe, Israel and South Africa. Patients
were newly diagnosed and received one subcutaneous injection
every three months, on top of their regular insulin injections,
Dagan said.

Enrollment in the second late-stage trial, which includes
450 patients in the U.S., Canada, Europe, Israel and Argentina,
will probably be completed during the first half of 2012. Data
from the two-year study is due out in 2014, and the company will
use it to apply for approval in the U.S. and Europe, Dagan said.

“Type 1 diabetes has been notoriously difficult to
treat,” Cord Dohrmann, the chief scientific officer of Evotec
who oversaw early trials of the drug as CEO of DeveloGen, said
in an interview. “A number of other applications have failed in
late-stage development. There’s a lot of hope riding on
DiaPep277.”

To contact the reporter on this story:
Allison Connolly in Frankfurt at
aconnolly4@bloomberg.net.

To contact the editor responsible for this story:
Phil Serafino at pserafino@bloomberg.net.

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Article source: http://www.bloomberg.com/news/2011-12-20/teva-invests-in-potential-type-1-diabetes-therapy-once-rejected-by-sanofi.html

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