BIOWORLD TODAY

BIOWORLD TODAY
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THE DAILY BIOPHARMACEUTICAL NEWS SOURCE
BIOTECH’S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS
MARCH 23, 2015
VOLUME 26, NO. 55
IPO PACE QUICKENS IN EUROPE
READY FOR ‘PRIME’ TIME?
Aducanumab, AD still golden for
Biogen Idec in updated phase I findings
Malin, Nordic Nanovector
raise $415M in upsized
Dublin, Oslo offerings
By Marie Powers, News Editor
By Cormac Sheridan, Staff Writer
It’s increasingly difficult to generate a big move in shares of a big biotech, but
Alzheimer’s disease (AD) did the trick again for Biogen Idec Inc., which continued
to report upbeat findings for aducanumab (BIIB037) at the 12th International
Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological
Disorders in Nice, France. The human recombinant monoclonal antibody, in-licensed
in 2007 from Zurich, Switzerland-based Neurimmune Therapeutics AG, showed a
dose- and time-dependent reduction of amyloid plaque in the brain in a pre-specified
DUBLIN – Investor appetite for European
biotech shows no sign of relenting, as
Malin Corp. plc and Nordic Nanovector
ASA priced their respective IPOs
Friday, which will take in $415 million
in total. Dublin-based Malin set a new
benchmark for a European biotech IPO,
See Biogen, page 2
See IPOs, page 4
DEALS AND M&A
REGULATORY
IN THE CLINIC
Lilly strikes $456M
oncology deal with
China’s Innovent
Court: BPCIA ‘patent
dance’ merely an
optional safe harbor
By Michael Fitzhugh, Staff Writer
By Mari Serebrov, Regulatory Editor
Eli Lilly and Co. is tapping China’s
Innovent Biologics Inc. to develop and
manufacture a strategic portfolio of
potential cancer therapies in one of the
largest biotech collaborations between a
The patent dance laid out in the
Biologics Price Competition and
Innovation Act (BPCIA) is merely a
temporary safe harbor that biosimilar
sponsors may opt out of, a federal
THE BIOWORLD BIOME
BITE ME
No free lunch between
mosquitoes and GMOs
By Anette Breindl, Senior Science Editor
BioWorld Science Editor Anette
Breindl takes a closer look at
translational medicine
Read this week’s edition
Protein shake-up in PD:
Anti-synuclein’s phase I
results boost Prothena
By Randy Osborne, Staff Writer
Unlike Alzheimer’s disease (AD), which
took much of the spotlight Friday,
“there’s not another gene to argue over”
in Parkinson’s disease (PD), said CEO
See Prothena, page 7
See BPCIA, page 6
See Innovent, page 5
BENCH PRESS
SINGLE DOSE DATA ‘DRAMATIC’
Genetically modified foods have the
dubious distinction of being the scientific
topic with the widest opinion gap
between scientists and the lay public.
In a report on “Public and Scientists’
See Mosquitoes, page 8
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CHINA
Ascletis’ triple therapy
HCV drug nails phase II
trial in Chinese patients
By Shannon Ellis, Staff Writer
SHANGHAI – Upstart domestic biotech
Ascletis Inc., with offices in the U.S.
and China, is a step closer to realizing
its dream of having the first effective
hepatitis C virus (HCV) treatment on the
See Ascletis, page 9
MONDAY, MARCH 23, 2015
BIOWORLD™ TODAY
Ascletis
Continued from page 1
market in China. But it is facing a race against time, going up
against much heavier hitters such as Gilead Sciences Inc., of
Foster City, Calif.
A protease inhibitor, ASC08 (or dapovenir), was licensed from
Basel, Switzerland-based Roche AG in April 2013, giving
Ascletis the Greater China rights. At the time, Roche had data
in Caucasians and proof of concept, but no data existed in Asian
patients.
“When we saw the Caucasian data we predicted in Chinese
patients that SVR [sustained viral response] should be better
than 90 percent, but we wanted the data,” Jinzi Wu, CEO and
president of Ascletis, told BioWorld Today.
Now with phase II results on hand from a trial in noncirrhotic
patients in Taiwan, Wu said investigators have observed a cure
rate (SVR12) of 94 percent after 12 weeks of treatment.
“Basically, we have a huge step here. After we saw these data, it
is a big relief and better than what we predicted,” said Wu.
Ascletis presented its data at the Annual Asian Pacific
Association for the Study of Liver (APASL) meeting where
it shared the event’s top honors, known as the Choice of
President’s, with Gilead Science’s sofosbuvir and Bristol-Myers
Squibb Co.’s beclabuvir.
A direct-acting antiviral agent (DAA), ASC08 is considered a
triple therapy working in conjunction with the current standard
of care to speed up and improve efficacy, especially in Asian
patients. Currently, there is no DAA on the market in China.
“The study results indicate that ASC08, in combination with peginterferon alfa 2a plus ribavirin, can deliver better cure rate in
Chinese patients where genotype 1b predominates, as compared
to Caucasian patients where genotype 1a predominates,” said
Jinhoang Kao, professor and director of the clinical research
institute at Taiwan University, who presented the results at the
meeting.
In particular, the ASC08 trial showed that in genotype 1
Taiwanese patients the SVR12 rate was 94 percent but in
genotype 1b, which accounts for 57 percent of all genotype
patients in Mainland China, the SVR12 rate was 100 percent
in noncirrhotic Taiwanese patients. The treatment showed
comparable side effects to the current standard of care (peginterferon plus ribavirin).
According to Wu, during China’s national liver day on March
18, the government released new numbers, which showed the
enormity of the problem in China: It is now estimated there
are 40 million people in China living with HCV. Estimated is an
operative word since doctors lack understanding of HCV and it
remains highly underdiagnosed. The China numbers dwarf the
extent of the problem in the U.S., where there are 3.2 million
sufferers. Moreover, the China numbers of HCV patients can
change rapidly with rates rising due to modern lifestyle habits
and better diagnosis capabilities and awareness.
PAGE 9 OF 14
A DOMESTIC ADVANTAGE
Although the trial was conducted in Taiwan, Ascletis’ goal is
clearly the huge patient population in China. However, like
many companies, there are greater regulatory uncertainties
about timelines on the mainland.
Wu emphasized the company’s aim is to have the treatment
on the market as soon as possible in China, but is vague on
the details about when, perhaps not wanting to give away too
much to the competition.
Having such strong data on Chinese patients he hopes will help
to improve the case with the local regulators who view having
data on Chinese patients a priority.
“First, our confidence is increased that this drug works in
China in Chinese patients, even better than in Caucasians,”
Wu said. “Second, [the data] will help us to accelerate clinical
development in China.”
Another factor when Ascletis looks over the shoulder at the big
boys is that Wu, as a member of the 1,000 talents programs,
a government program to lure top level returnees back to the
mainland, and his company is considered a local company.
“We are all competing for the China market,” said Wu, “but we
have certain advantage as a domestic company.”
Before Ascletis, Wu was vice president of global HIV drug
discovery at Glaxosmithkline plc, based in Research Triangle
Park, N.C. Ascletis has offices in Research Triangle Park as well
as in Hangzhou and Shaoxing, both in Zhejiang province. Last
fall, the firm announced the construction of a cGMP facility in
Shaoxing.
Wu and his team’s global contacts have helped to sign Chinafocused deals with a nice roster of big pharma, including an
HIV protease inhibitor deal with Johnson & Johnson-owned
Janssen Biotech Inc., an agreement for a liver cancer drug
targeting VEGF and KSP from Cambridge, Mass.-based
Alynlam Pharmaceuticals Inc. and, most recently, a deal for
another HCV candidate, an NS5A inhibitor from Presidio
Pharmaceuticals Inc., of San Francisco. (See BioWorld Today,
Nov. 19, 2014.)
In describing how the two HCV candidates work together, Wu
said, “we put the two together to have synergy. The objective
is to have an oral interferon-free regimen. . . . Our two drugs
together offer an interferon-free regimen. We have two drugs
for patients with different needs in China.” //
Prothena
Continued from page 7
limelight – and with a major pharma partner – “we think there
could be a renewed interest in Prothena, and there is lots of
room to go, as it is still only a $1.3 billion market cap (not to
mention there is a third antibody for psoriasis that is starting
phase I [trials] shortly, in the first half of this year,” Yee wrote in
a research report. //
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