*

Lilly's weight-loss pill beats Novo's in trial

*

Test results boost Lilly's GLP-1 market lead

*

Global filings planned as Lilly eyes rapid rollout of oral

obesity drug

By Maggie Fick and Mrinalika Roy

VIENNA, Sept 17 (Reuters) - Eli Lilly's ( LLY ) bid for

approval for an experimental weight-loss pill got a boost on

Wednesday with new clinical trial data, but company executives

said it was too soon to assume the drug will be part of a new

U.S. speedy review program.

Lilly's shares rose 0.8% on Wednesday. The company is

developing the pill as an alternative to its injectable drugs

Mounjaro and Zepbound, which already lead sales among diabetes

and weight-loss treatments. Lilly has been trying to widen its

lead in the fast-growing market for GLP-1 drugs over Danish

rival Novo Nordisk

Lilly said that in a head-to-head trial of 1,698 adults

with type 2 diabetes, its orforglipron lowered average blood

sugar and weight more effectively than Novo Nordisk's oral

semaglutide Rybelsus.

"The data strengthens our conviction that Eli Lilly ( LLY ) is well

positioned to maintain leadership in the GLP-1 market," said

Daniel Barasa, portfolio manager at Gabelli Funds. He said

orforglipron not only shows superior efficacy but also

advantages in dosing convenience in the trial against Rybelsus.

Lilly, the world's most valuable drugmaker by market value,

is expanding U.S. and international manufacturing capacity to

meet soaring demand for GLP-1 treatments, as it races with rival

Novo to get an oral version first to the market.

However, executives at the Indianapolis company signalled

caution on the U.S. Food and Drug Administration's new priority

voucher program designed to shorten reviews for certain

therapies that address major public health needs.

"There is very little knowledge about this national priority

voucher today. I would not assume we will submit with a national

priority voucher, because we do not fully understand what it

contains," Patrik Jonsson, president of Lilly International,

told Reuters in an interview on Wednesday.

Kenneth Custer, president of Lilly Cardiometabolic Health, said

the company views the initiative positively and supports efforts

to speed up regulatory review, but emphasized that it is too

early to know how the program might apply to the company's

pipeline.

Several Wall Street analysts told Reuters this week that

orforglipron could be a prime candidate for the program.

Analysts forecast orforglipron could generate peak annual

sales of $10 billion and are expecting it to secure FDA

fast-track approval by the end of 2025.

Jonsson said Lilly is obliged to study regulatory options but

stressed the company's base plan does not depend on the

yet-to-be-defined voucher program. He added that Lilly plans to

file for approval of orforglipron with regulators in the United

States, Britain, European Union, Japan and China "within weeks"

of each other.

Jonsson declined to specify locations for pill manufacturing

outside the U.S., but confirmed non-U.S. production is planned.

Orforglipron is designed to mimic the appetite-suppressing

GLP-1 hormone targeted by Lilly's blockbuster injection

tirzepatide, sold under the brand names Mounjaro and Zepbound.

Novo expects U.S. regulatory approval for its oral obesity

drug later this year.