Positive Top Line Results from Phase III Study (MARVEL) of anti-influenza Virus Agent 'CS-8958'
TOKYO, Japan (August 10, 2009) - Daiichi Sankyo Company,
Limited announced today the top line results from a Phase III study
of the anti-influenza virus agent 'CS-8958' (generic name;
laninamivir).
This study, named MARVEL (Multinational Asian
Clinical Research for Influenza Virus
Extermination on Long-Acting Neuraminidase-Inhibitor
study), was performed as a randomized, double-blind, and
active-controlled study in order to confirm the efficacy and safety
of CS-8958 administered as a single inhaled dose of 20 or 40 mg
compared to oseltamivir phosphate 75 mg (Tamiflu® capsule)
orally administered twice daily for 5 days (total of 10 times) in
adult patients with influenza A or B virus
infection. According to the results, non-inferiority to
oseltamivir phosphate was confirmed in both the 20 mg group and 40
mg group of CS-8958 in terms of the primary endpoint, which was the
time to alleviation of influenza illness. In the
comparison between the dose groups of CS-8958, 40 mg group was
superior to 20 mg group in efficacy. Both 20 mg and 40
mg of CS-8958 were well tolerated.
In addition, Daiichi Sankyo conducted a randomized, double-blind,
active-controlled Phase II / III study for pediatric use
in parallel with MARVEL study, and the efficacy and safety of
CS-8958 administered as a single inhaled dose of 20 or 40 mg was
compared to oseltamivir phosphate (Tamiflu® for oral
suspension) as well. According to the results, both the
20 mg group and 40 mg group of CS-8958 were better than oseltamivir
phosphate group in efficacy. Both 20 mg and 40 mg of
CS-8958 were well tolerated in pediatric patients.
Daiichi Sankyo is now preparing to file its NDA for a treatment
indication in fiscal year 2009. Furthermore, Daiichi Sankyo is also
preparing to start a clinical study for a prophylaxis indication in
autumn of 2009.
(1) About CS-8958
CS-8958 (generic name; laninamivir) is an anti-influenza
virus agent, originated by Daiichi Sankyo Co.,Ltd., and is expected
to be effective after a single dose due to its long action as a
neuraminidase inhibitor. After inhalation, CS-8958 is
retained for a long time in the target organ.Non-clinical studies
conducted so far have shown that this agent was effective not only
against seasonal influenza, but also against new type influenza
(swine A/H1N1) in-vitro and in-vivo (Y. Itoh,et al,
Nature, 2009). Additionally, CS-8958 shows efficacy
against H5N1 avian influenza virus in non-clinical tests.
(2) About phase III study in adult patients
?MARVEL study (Multinational Asian Clinical
Research for Influenza Virus Extermination on
Long Acting Neuraminidase Inhibitor)
Study design :
A randomized, double-blind, active-controlled, multi-center study
to confirm the efficacy and safety of CS-8958 20 mg and 40 mg
compared to oseltamivir phosphate in approximately 1,000 adult (age
? 20 yr) patients with influenza A or B virus
infection. It was conducted as a multinational study in
Japan, Taiwan, Hong Kong, and Korea.
Efficacy :
To confirm the non-inferiority of CS-8958 to oseltamivir phosphate
in terms of the primary endpoint, which was the time to alleviation
of influenza illness
Safety :
To make between-group comparisons with regard to incidence of
adverse events and other safety measures
Secondary objective :
To evaluate the optimum dosage of CS-8958 based on the efficacy and
safety of single inhaled doses of 20 mg and 40 mg
(3) About phase II/III study in pediatric
patients
Study design :
A randomized, double-blind, active-controlled, multi-center study
for the evaluation of efficacy and safety of CS-8958 20 mg and 40
mg compared to oral formulation of oseltamivir phosphate 2 mg/kg
(Tamiflu® for oral suspension) administered twice daily for 5
days in approximately 180 pediatric (age ? 9 yr) patients with
influenza A or B virus infection
Efficacy :
To evaluate by the primary endpoint, which was the time to
alleviation of influenza illness
Safety :
To make between-group comparisons with regard to incidence of
adverse events and other safety measures
Secondary objective :
To evaluate the optimum dosage of CS-8958 based on the efficacy and
safety of single inhaled doses of 20 mg and 40 mg.
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Takashi Shoda, President and Representative
Director
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock
Exchanges)
Please address inquiries to Toshiaki Sai, General Manager,
Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/
Posted: August 2009
