Eli Lilly Meets Target For Sepsis Treatment
By Matt Paolucci
Drug maker Eli Lilly and Co. (LLY) announced Thursday that it
is stopping enrollment in a 1,520-person Phase III trial of
recombinant human activated protein C in treating severe
sepsis after the trial met goals for lowering death rates.
The decision to stop enrollment of new patients in the PROWESS
trial (Recombinant Human Activated Protein C Worldwide
Evaluation in Severe Sepsis) follows a favorable
recommendation by an independent Data and Safety Monitoring
Board (DSMB), which met on June 28 to conduct a regularly
scheduled interim analysis of the study.
The PROWESS trial began in July 1998 and has been conducted at
clinical sites in 11 countries worldwide.
"There is a serious unmet medical need for more than 1.5
million people worldwide annually who have sepsis, since there
are currently no pharmacological agents approved to treat this
often fatal disease," said Dr. August Watanabe, executive vice
president, science and technology for Lilly.
Sepsis is a disease characterized by an overwhelming systemic
response to infection, which can rapidly lead to organ failure
and ultimately death. Sepsis can strike anyone, and can be
triggered by events such as pneumonia, burns, trauma, surgery,
or by conditions such as cancer and AIDS.
Aside from heart disease, Sepsis is the leading cause of death
in the United States. The disease most often occurs among
hospitalized patients. Each year, 700,000 new cases of sepsis
are diagnosed in the U.S., killing an average of 1,400 people
worldwide every day.
Sepsis has a 30 to 50 percent mortality rate.
Lilly said it is encouraged with the interim analysis and is
hopeful the results of the full evaluation of the data will
support a submission to regulatory authorities for approval of
Zovant. The study started in 1998 and spanned 11 nations.
The Company, based in Indianapolis, Indiana, said it plans to
market recombinant human activated protein C as Zovant, if it
receives regulatory approval.
Protein C is a protein in the body that appears to be severely
low in sepsis patients. When protein C levels are low, it
cannot be converted in sufficient quantities to the activated
form, APC. As a result, coagulation (clotting) and
inflammation go unchecked, resulting in serious complications.
Zovant is believed to have three important roles: preventing
clot formation, breaking up clots already in existence, and
reducing the inflammation that occurs in blood vessels.
The estimated costs associated with the treatment of patients
with sepsis range from $10 billion to $25 billion annually in
the U.S. alone, Lilly said. Annual sales estimates for Zovant,
if approved, range from $5 billion to $10 billion worldwide,
rivaling AstraZeneca's blockbuster hypertension drug Prilosec.
Prilosec is the top selling frug in the world with $5.9
billion in sales last year.
Many attempts at finding a treatment for sepsis have rendered
little success in the past. "More than 30 clinical trials of
investigational compounds have failed to offer an effective
and safe treatment," said PROWESS lead investigator Gordon
Bernard, M.D., associate director of the Division of Allergy,
Pulmonary and Critical Care Medicine, Vanderbilt University
Medical Center.
With Lilly's anti-depressant drug Prosac patent expiring in
the next 2-3 years, Zovant would help fill any holes in the
Company's pipeline.
Lilly has 12 drugs in Phase II or III clinical trials, eight
of which are currently in Phase III and two more destined to
enter Phase III by year-end.
Further results of the PROWESS trial should be revealed in
about a year.
Shares of Eli Lilly closed up $15.38 to $102.50 on the NYSE.
