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Aiming to Become a “Sharp”


Specialty Pharmaceuticals
Supplier
Pharmaceuticals Business
FY 2008 - 2010
Medium-Term Management Plan

July 2, 2008
Tomoyasu Toyoda
President, Pharmaceuticals Company
Ajinomoto Co., Inc.
Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.
Page 2

Contents

1. Management Philosophy/Management Vision


and Business Strategies
2. Strengthening Pipeline with R&D of In-house
Plus In-licensed Products
¾An in-licensed gastrointestinal treatment
3. Measures to Strengthen the Medical Foods Business
¾Strengthening sales promotion by establishing
AJINOMOTO NUTRITION FOODS Co., Ltd.
¾New product launch plans
4. Performance and Targets

Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.


Page 3

Management Philosophy/Management Vision


of Pharmaceuticals Company

zManagement Philosophy
9 Contribute to health and a better quality of life for the people of
the world through unique pharmaceuticals that only the
Ajinomoto Group can develop

zManagement Vision
9 Aim to become the number one specialty pharmaceuticals
supplier based on TNC (Total Nutrition Care*) and a focus on
large-scale, field-specialized drugs

Greater strategic concentration of resources on themes that are


targeting the global market and that Ajinomoto can market by itself in
Japan

*TNC = Total Nutrition Care. TNC means to recognize nutritional therapy as the base of every therapy and direct
diagnosis (and preventive care), care, prevention of recurrence and improvement of prognosis performed by
medical practitioners toward improvement of QOL of both patients and presymptomatic patients.

Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.


Page 4

Pharmaceuticals Business:
Review of FY 2005 – 2007

(¥ billion)
FY 2007
FY 2004 FY 2005 FY 2006 FY 2007 Initial targets

Net sales 80.7 83.2 83.3 84.1 100.0


Operating income 11.4 12.6 15.8 14.9 20.0
OP margin 14.1% 15.1% 18.9% 17.8% 20.0%
In a challenging environment with ongoing measures to restrain healthcare costs in Japan,
Ajinomoto’s sales and operating income in the pharmaceuticals business increased every
year supported by roughly constant sales of products sold by Ajinomoto itself and the
contribution of existing products sold through business tie-ups and one-off payments
from licensing out developed products. However, the initial target was not achieved mainly
due to stronger-than-expected impact of NHI* price revision, the government’s healthcare
expenditure containment policy that advanced faster than expected and delay in launch of
some new products.
*National Health Insurance

Main Products
Products Sold by Ajinomoto : LIVACT, SOLITA-T, ELENTAL, etc.
Products Sold through Business Tie-ups : ATELEC, ACTONEL, FASTIC, etc.
Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.
Page 5

Pharmaceuticals Business Strategies

Strengthen the pharmaceuticals business as a specialty pharmaceuticals supplier

Products Sold by Ajinomoto R&D


(Mainly in the infusion, clinical nutrition and dialysis, Invest proactively for future growth
and gastrointestinal fields) 1. Strengthen R&D and licensing activities
Aim to become a specialty pharmaceuticals supplier ¾ Strengthen pipeline with R&D of in-house
based on TNC plus in-licensed products for early launch of
1. Thoroughly strengthen fields where Ajinomoto is new pharmaceuticals
competitive (liver, gastrointestinal) ¾ Steadily advance existing themes (AJM300,
2. Establish a presence in nursing care and home AJD101)
care markets ¾ Introduce new medical food products each
¾ Strengthen sales and marketing: Established a year
sales promotion company, AJINOMOTO
NUTRITION FOODS Co., Ltd., in April 2008
¾ FY 2010 sales target in medical foods
business: ¥10.0 billion
Cost Reductions
Products Sold through Business Tie-ups 1. Promote cost reduction
(Mainly in the lifestyle-related disease field)
¾ Cost reductions: FY 2010 vs. FY 2007
Aim to become a specialty pharmaceuticals supplier approx. ¥1.8 billion
with focus on large-scale, field-specialized drugs
1. Promote life cycle management (LCM) for ¾ Raise capacity utilization rate, carefully
existing products select investment and renovation items,
2. Secure one-off payments by licensing out improve expenditure management
developed products
Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.
Page 6

Progress of Development Themes

Field Name Indication Note Phase I Phase II Phase III NDA filed

Colon preparation Additional indication /


NIFLEC ●
for barium enema Combination use with mosapride citrate
Gastrointestinal Inflammatory bowel
AJM300 ●
diseases*1 disease
AJG501 Ulcerative colitis In-licensed from Dr. Falk Pharma GmbH
(Salofalk )
Additional indication /
FASTIC Diabetes ●
Combination use with insulin-sensitizing agent
Additional indication / ●
Nateglinide*3 Diabetes
Impaired glucose tolerance (Overseas)
Additional indication /
ACTONEL Paget's disease of bone ●
Lifestyle-related Orphan drug designation
diseases*2 ●
(Overseas)
AJD101 Diabetes

(Japan)

SGLT2 inhibitor*4 Diabetes ●


(Overseas)

Other AC-7700 (AVE8062)*5 Solid tumor ●


(Overseas)
*1 Ajinomoto’s research and development in the field of gastrointestinal diseases is centered on liver diseases and
inflammatory bowel disease (IBD).
*2 Ajinomoto's research and development in the field of lifestyle-related diseases is centered on diabetes.
*3 Clinical studies are being conducted by Novartis Pharma AG (exclusive licensee outside Japan and Korea
for the rights to develop, manufacture and sell the drug).
*4 Clinical studies are being conducted by Boehringer Ingelheim (worldwide exclusive licensee for the rights to develop,
manufacture and sell the drug). Ajinomoto retains a co-promotion right in Japan.
*5 Clinical studies are being conducted by Sanofi-Aventis SA (worldwide exclusive licensee for the rights to develop,
manufacture and sell the drug).

Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.


Page 7

What Is the Specialty Pharmaceuticals Supplier That


Ajinomoto Pharma Co., Ltd. Aims to Become?

Ajinomoto Pharma Co., Ltd. aims to become a specialty


pharmaceuticals supplier in each of the fields of liver diseases,
gastrointestinal diseases and dialysis—the fields where the company
has strength on the basis of TNC!

Strong Gastro-
Liver Dialysis
fields intestinal

Infusions Medical foods

TNC

Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.


Page 8

Further Growth through In-Licensing

Ajinomoto In-Licenses Ulcerative Colitis Product from Dr. Falk Pharma

Ajinomoto Co., Inc. (“Ajinomoto”, Chuo-ku, Tokyo, Japan) today announced


that Ajinomoto has agreed with Dr. Falk Pharma GmbH (“Falk”, Freiburg,
Germany) on in-license to Falk’s once-a-day formulation of 5-aminosalicylic
acid (5-ASA).

The license agreement gives Ajinomoto the exclusive rights to develop,


manufacture and market the product in Japan. In return Ajinomoto will make
upfront, milestone and royalty payments to Falk. The product will be marketed
by Ajinomoto Pharma Co., Ltd. for the Japanese market. The license agreement
also provides Ajinomoto the right of first negotiation with respect to rights to
develop, manufacture and market the product for additional indications as well
as certain additional Falk’s 5-ASA products in Japan.

Excerpted from Ajinomoto’s press release on April 8, 2008

Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.


Page 9

Market Size of Gastrointestinal Field


(NHI Price Basis)
(¥ billion)
AJP=Ajinomoto Pharma Co., Ltd.

食道
Esophagus


Stomach

Liver
肝臓 膵臓
Pancreas
IBD : 33.0
ELENTAL 7.2 (AJP)
5-ASA preparation 18.0
Steroids 1.5
Immunoregulatory drugs 2.0 Small
小腸intestine
Remicade 4.0
Other 0.3
Large
大腸 Colonoscopy : 5.0
intestine
Blind gut
NIFLEC 2.5 (AJP)
盲腸
Lactobacillus preparation : 13.0 MAGCOROL P 1.0
Enteronon-R (AJP) Anus
肛門 MUBEN 1.0
Hemorrhoidal diseases : 13.0 Other 0.5
Proctosedyl (AJP)Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.
Page 10

Inflammatory Bowel Disease (IBD)

IBD
Both are incurable diseases that cause ulcers
in the gastrointestinal tract (There is a patient registration system),
and IBD patients have been increasing steadily since 1970s in Japan

Patients
Crohn's Disease Patients Ulcerative colitis

Currently about 25,700 Currently about 90,627


patients in Japan patients in Japan

Increasing by 1,500 Increasing by 4,500


patients annually patients annually

Primary indication In-licensed


of ELENTAL AJG501 (Salofalk)
Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.
Page 11

AJG501 (Salofalk )

Similar drug approved in Japan : Pentasa


AJG501 (Salofalk) (Nisshin Kyorin Pharmaceutical Co., Ltd. & Kyorin
Pharmaceutical Co., Ltd.)

■Drug characteristics • Once daily dosing ■Drug characteristics • Dosings 3 times per day
• 1.5-3.0g per dose • 2-3 tablets per dosing
• Formulation: granules • Formulation: tablets
■ Indication: ulcerative colitis Diameter: 9.6mm
Thickness: 4.6mm
¾ 80% of physicians prefer reduced dosing
frequency ■ Indication: ulcerative colitis and Crohn’s disease
(Aminosalicylic acid Pentasa is a basic treatment in
¾ Over 60% of physicians prefer granules
Japan.)
⇒Aiming for over 30% prescription share
■Sales: ¥17.0 billion (NHI price basis)
■Status overseas (once daily dosing) ■ Share of prescriptions: Over 75%
¾ Germany: NDA filed (Approval expected in 2008)
¾ UK: Approved
¾ USA: NDA filed (Approval expected in 2008)

Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.


Page 12

Establishment of
AJINOMOTO NUTRITION FOODS Co., Ltd.
New Company Profile
Company name AJINOMOTO NUTRITION FOODS Co., Ltd.
Head office 1-1, Irifune 2-chome, Chuo-ku, Tokyo
Established April 1, 2008

Position of New Company


A sales promotion company funded by Ajinomoto Pharma Co., Ltd. with a goal of
developing the nursing care and home care markets and strengthening sales of
medical foods
Ajinomoto Co., Inc.

Establish an earnings base in


health and nutrition business

Market prescription drugs Develop sales channels for


and medical foods Establish a new business model for medical foods and
nursing care and home care markets foods for nursing care

Ajinomoto Pharma Co., Ltd. AJINOMOTO NUTRITION FOODS Co., Ltd.

A specialty pharmaceuticals Develop the nursing care


supplier with the base in TNC Strengthen medical food and home care markets and
sales promotion strengthen sales of medical foods

Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.


Page 13

Sales Targets for Medical Foods

Market size of liquid foods (for tube feeding/oral ingestion) (¥ billion)


70.0
・Importance of nutritional management Æ
63.0
60.0
increase in oral ingestion and enteral feeding Sales target
・ Aging society Æ Increased number of 57.0
people using enteral nutrition at ¥10.0 billion in FY 2010 through
50.0 nursing homes 50.0 collaboration between Ajinomoto Pharma
44.0 Co., Ltd. and AJINOMOTO NUTRITION
40.0 38.7 FOODS Co., Ltd.

30.0 Sales Initiatives

20.0
Reinforce Ajinomoto Co., Inc.’s ongoing
TNC activities and proposals for nutritional
10.0 management by collaboration between
Ajinomoto Pharma Co., Ltd. (covering
0.0 mainly hospitals/clinics) and AJINOMOTO
FY 2006 FY 2007 FY 2008 FY 2009 target FY 2010 target NUTRITION FOODS Co., Ltd. (covering
forecast mainly nursing homes and direct sales to
home care patients).
Establishment of AJINOMOTO NUTRITION FOODS Co., Ltd.

Core products
MEDIF bag
MEDIF PUSH CARE
MEDIF AMINO PLUS
PEMVest
MEDIF
IMPACT
Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.
Page 14

Development of Medical Foods


New Product Development Plan
Centered on liquid foods for tube
feeding and oral ingestion, offer
new/improved products that fit needs in
healthcare, featuring combination of
original components and highly nce
ie
functional package. ven
C on

Market Development with Novel Products for healthcare facilities


Products and nursing homes

Go beyond the scope of inpatient-


oriented products to develop new Products for patients Pathological
products covering nutrition management condition-specific
at healthcare facilities
ranging from healthcare products
facilities/nursing homes to home care.
Products for home care

Development System Me
eti
The “medical foods section” was clin ng ne
ica eds
l si
established in the Pharmaceutical tes in
Research Laboratories as of April 1,
2008 as part of efforts to strengthen the
development system for enteral nutrition.
Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.
Page 15

Performance of Pharmaceuticals Business


(FY 2001-2007)
Ajinomoto Pharma Co., Ltd. was established in December 1999, and we acquired Shimizu
Pharmaceutical Co., Ltd. in December 2002. Their production and logistics functions
were integrated in April 2005 to establish Ajinomoto Medica Co., Ltd.
Sales and operating income have been firm.

Net sales Operating


(¥ billion) income
Net sales Operating income (¥ billion)
100.0 20.0
80.7 83.2 83.3 84.1
79.0
80.0
15.0
62.7 15.8
14.9
60.0 53.5
12.6 10.0
11.4
40.0 10.3
8.9
5.0
20.0 6.5

0.0 0.0
FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007

Shimizu Pharmaceutical Co., Ltd. Ajinomoto Medica Co., Ltd.

Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.


Page 16

Targets of Pharmaceuticals Business (FY 2008~)

Ajinomoto aims to become a “sharp” specialty pharmaceuticals supplier and


achieve sales of ¥100 billion and operating income of ¥20 billion in this business
within 5 years.

Net sales Operating


(¥ billion) income
Net sales (¥ billion)
Operating income 30.0
100.0
100.0
84.1 87.0 87.0 25.0
83.2 83.3
80.0 20.0
20.0
15.8
60.0 14.9
14.0 12.5 15.0
12.6

40.0
10.0

20.0 5.0
(OP margin) (15.1%) (18.9%) (17.8%) (16.0%) (14.4%) (20.0%)

0.0 FY 2005 FY 2006 FY 2007 FY 2008 FY 2010 Target within 0.0


Actual Actual Actual Forecast Target 5 Years
Copyright © 2008 Ajinomoto Co., Inc. All rights reserved.

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