Eisai CEO Sees 'Huge' Medical Need for New Diet Drug
Last Update: 8/14/2012 3:56:18 PM
By Peter Loftus
Japan's Eisai Co. (ESALY, 4523.TO) will target a "huge unmet medical need" with
its plan to begin selling the new diet drug Belviq in the U.S. in early 2013, the
company's leader said Tuesday.
Chief Executive Haruo Naito said Eisai will market the drug by aiming to enhance
disease awareness, collaborate with patient groups and seek insurance coverage of
Belviq.
Obesity is "obviously a huge unmet medical need in this country," Mr. Naito said
in an interview Tuesday. "It's a major medical expenditure and social cost."
Eisai obtained rights to market Belviq in the U.S. and certain other countries
from Arena Pharmaceuticals Inc. (ARNA), which developed the drug and will
manufacture it.
The U.S. Food and Drug Administration approved Belviq in June, marking the first
new weight-loss drug in more than a decade. Less than a month later, in July, the
FDA approved a second diet drug, Qsymia from Vivus Inc. (VVUS), setting up a
competitive race to capture share of what is expected to be a multibillion-dollar
market, as obesity rates have soared.
Eisai expects an early 2013 launch of Belviq because it's awaiting a U.S. Drug
Enforcement Administration determination on how Belviq will be classified; it's
expected to be a DEA "scheduled" drug because of its potential for abuse. A
scheduled drug is subject to certain DEA regulations.
Mr. Naito said Eisai already has a sufficient sales and marketing infrastructure
in place to promote Belviq. Last week, Arena said Eisai is expected to have a
sales force of about 190 representatives to promote Belviq to doctors. An Eisai
spokeswoman said the final number hasn't been determined.
Mr. Naito said Eisai won't promote Belviq as a "general antiobesity drug," in
contrast to previous diet drugs. He said the drug is intended for "committed
patients" who also make an effort to lose weight through diet and exercise.
Mr. Naito said it was too soon to discuss pricing for Belviq, which some analysts
have estimated could range from $3 to $4 a day. Cowen's Simos Simeonidis
estimates Vivus's new diet drug will cost about $3.50 a day.
These drugs may not get wide insurance reimbursement initially, as insurers
assess the costs and benefits. Mr. Naito said Eisai will work to persuade
health-care payers that Belviq provides value because it could mitigate medical
costs associated with obesity.
"We'll be working very hard to try to have reimbursement possible for Belviq in
this country," he said.
Belviq was shown in studies to lead to average weight loss of 3% to 3.7%, and
some patients with diabetes lost at least 5% of their weight, according to the
FDA. The drug is associated with certain safety risks, including a condition
called serotonin syndrome and disturbances in attention or memory. The FDA
required post-marketing studies to assess potential cardiovascular risks of the
drug.
Some analysts view Vivus's Qsymia as being more efficacious than Belviq, and it's
likely to hit the market first, in the fourth quarter of this year. An Eisai
spokeswoman said the company couldn't comment specifically on the competitive
landscape, but said the drugs have different target audiences.
Mr. Naito was speaking by phone from a ceremony to open a new manufacturing plant
outside Philadelphia by Eisai's Morphotek unit. The plant will supply
biologic-based drugs for early-stage clinical trials.
Eisai acquired Morphotek in 2007 for about $325 million. Morphotek is conducting
a late-stage clinical trial of an experimental ovarian cancer drug, farletuzumab,
and studying other potential new drugs, said Morphotek CEO Nicholas Nicolaides.
Mr. Naito said Eisai isn't interested in "big acquisitions" but would consider
deals similar to Morphotek, which enhance Eisai's technological capabilities and
research in drugs for oncology, neuroscience and immunology.
Eisai also is studying a potential new treatment for Alzheimer's disease, which
the company hopes to submit for regulatory approval in 2016 or 2017, assuming
later-stage studies are successful, Mr. Naito said. The experimental drug has a
different mechanism than bapineuzumab, a drug co-developed by Pfizer Inc. (PFE)
and Johnson & Johnson (JNJ), which recently failed to show a benefit in
late-stage studies. |
