(Repeats story from Wednesday to additional subscribers.)
By Bill Berkrot
NEW YORK Feb 8 Tetraphase Pharmaceuticals Inc
Chief Executive Guy Macdonald said annual sales of the
company's lead experimental antibiotic for serious bacterial
infections could climb as high as $700 million if approved.
The antibiotic, eravacycline, is being studied in a pivotal
450-patient Phase III trial for intra-abdominal infections.
Tetraphase expects to have the data in the fourth quarter after
which it will apply for U.S. approval that could come in 2018.
"The FDA has been very supportive of getting new antibiotics
approved, so clearly we have a fast-track agreement with them
once we get the positive data," Macdonald told Reuters.
He said he believes eravacycline could garner annual sales
that would take it at least halfway to blockbuster status.
"If you have a successful gram negative drug like
eravacycline, you're looking at somewhere in the
$500-to-$700-million range. I think that's certainly reachable,"
Eravacycline is a synthetic tetracycline derivative for
drug-resistant bacterial infections administered intravenously
The company is also enrolling for a 1,000-patient
eravacycline trial in complicated urinary tract infections.
Tetraphase is developing the drug with the help of a $80
million grant from the Biomedical Advanced Research and
Development Authority (BARDA), a division of the U.S. Department
of Health and Human Services. It currently has enough funding to
take it through the second half of 2018, the CEO said.
Antibiotic resistance and the emergence of so-called super
bugs, caused by widespread antibiotic overuse and the ability of
bacteria to evolve, is seen as a global health threat.
The U.S. government has been very helpful in funding for new
antibiotics, Macdonald said.
In September, Medicines Co and Roche
received significant funding from BARDA to help develop
Many major drugmakers abandoned antibiotic development
because they are not nearly as profitable as other medicines,
such as cancer drugs, and marketing them aggressively would
likely only exacerbate the overuse problem.
Tetraphase expects to also apply for European approval late
this year, and hopes to find a partner to sell the drug outside
the United States.
"We can do it in the U.S. on our own," Macdonald said.
"For us to be able to provide the growth we need and keep
our investor base happy, that's a much better business model to
do it ourselves," he added. "If you want to commercialize it
worldwide, we're not capable of doing that."
The 75-employee company with a market value under $200
million will build a small sales force for eravacycline,
Tetraphase already has someone with commercial experience
from Merck & Co and Cubist to oversee the eravacycline
launch, once approved.
"We just need the data," Macdonald said.
(Reporting by Bill Berkrot, editing by G Crosse)