June 19, 2009

Dainippon Sumitomo Pharma Co., Ltd.

Acquisition of an additional indication of AmBisome
®
, a therapeutic agent
for systemic fungal infection
Dainippon Sumitomo Pharma Co., Ltd. (Headquarters: Osaka, Japan; President: Masayo Tada) has obtained as of June 17 a Japanese

approval for an additional
indication and new dosing regimen of
“
AmBisome
®
50mg for intravenous drip infusion”,
a therapeutic agent for systemic fungal infection, relating to treatment of infections caused by
Mucor
species and species of a few other genera as well as treatment of
visceral leishmaniasis. AmBisome
®
, discovered by Gilead Sciences, Inc. of the U.S., is an agent to mitigate the
side-effects of amphotericin B while retaining its efficacy with regard to treatment of fungal infections by intercalating amphotericin B into a liposomal membrane formulation. This agent is sold in 46 countries outside of Japan, including the U.S., the U.K., Germany and France. In Japan, this agent, developed by the company was launched in June 2006 with indications of “systemic mycosis, respiratory mycosis, fungal meningitis, and disseminated visceral mycosis caused by
Aspergillus
species,
Candida
species or
Cryptococcus
species” and “febrile neutropenia suspected to be caused by fungal
infection”. As a result of the additional indication, this agent can be more widely used than ever to cure systemic mycosis due to addition of
Mucorymycosis
,
Histoplasmosis
and a few
others to the three major kinds of fungus covered by the previously approved indication. Cases of infections by imported fungus such as
Histoplasmosis
are feared to increase in
number as international intercommunion becomes more active in the future. Visceral leishmaniasis can be treated by AmBisome
®
under the newly added indication,
though the same has already been allowed outside of Japan. Visceral leishmaniasis is a zoonotic infection of protozoal origin prevalent in the semitropical-to-tropical zone. There is no approved drug in Japan. This agent is thought to be an extremely important medicine as a means to cure visceral leishmaniasis particularly because of its actual medical achievements overseas. The company expects that as a result of the additional indication and new dosing regimen AmBisome
®
will be able to meet the needs in medical practice more than before
and contribute to furtherance of medical services. [Please see the separate sheet for an outline of AmBisome
®
.]

(Reference)
Profile of
“
AmBisome
®
for Intravenous Drip Infusion 50 mg”
[Brand name]
AmBisome
®
for Intravenous Drip Infusion 50 mg

[Generic Name]
Amphotericin B
[Indications] (The underline indicates the added part.)
1.Fungal infections
The following infections caused by
Aspergillus
species,
Candida
species or
Cryptcoccus
species,
Mucor

species,
Absidia
species,
Rhizopus
species,
Rhizomucor
species,
Cladosporium
species,
Cladophialophora
species,
Fonsecaea
species,
Phialophora
species,
Exophiala
species,
Coccidioides
species,
Histoplasma

species, and
Blastomyces
species:
Systemic mycosis, respiratory mycosis, fungal meningitis, and disseminated visceral mycosis
2. Febrile neutropenia suspected to be caused by fungal
infection
3. Visceral Leishmaniasis
[Dosage and Administration] (Addition only)
3. Visceral Leishmaniasis
A dose of 2.5 mg (potency)/kg (body weight) of amphotericin B is administered once daily on 1
st
day
-5
th
day, 14
th
day and 21
st
day by intravenous drip
infusion over 1-2 hours to a patient with normal immune capacity. In the case of an immunodeficient patient, a dose of 4.0 mg (potency)/kg (body weight) of amphotericin B is administered once daily on 1
st
-5
th

day, 10
th
day, 17
th
day, 24
th
day and 38
th
day by
intravenous drip infusion over 1-2 hours.

[Manufacturer and Distributor]
Dainippon Sumitomo Pharma Co., Ltd.