Pharmaceutical Business

Noriaki Okubo President, Pharmaceutical Business

Noriaki Okubo
President,
Pharmaceutical Business

In the pharmaceutical business, JT will continue to build world-class, unique R&D capabilities and reinforce its market presence through innovative drugs by devoting efforts to increasing and advancing compounds in a late phase of clinical trial and enhancing the R&D pipeline, so that it can pursue a high-value added business based on the development of world-class innovative drugs.

FY 3/2010 Business Performance Summary

  • Net sales: ¥44.1 billion down ¥12.7 billion
  • EBITDA: –¥9.7 billion down ¥14.5 billion
  • Operating loss: –¥13.6 billion down ¥14.6 billion

Net sales and profits in FY 3/2010 declined due to the absence of the upfront fee revenue and milestone revenue that boosted the results of FY 3/2009.

One-time revenues in FY 3/2009

  • Upfront fee revenue related to anti-osteoporosis drug JTT-305, which was licensed to Merck & Co. of the United States in FY 3/2009
  • Milestone revenue associated with progress in the development of anti-dyslipidemia compound JTT-705, which was licensed to Roche of Switzerland in FY 3/2005

Torii Pharmaceutical Co., Ltd. posted a rise in both net sales and profits.

  • Sales of the Futhan® protease inhibitor declined.
  • Sales of REMITCH® CAPSULES, an anti-pruritus drug for hemodialysis patients, started in March 2009
  • Sales of anti-HIV drug Truvada® and anti-emesis drug Serotone® grew.

Pharmaceutical Business - Net Sales

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Pharmaceutical Business - EBITDA

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R&D Status

Some progress was made in the reinforcement of the R&D pipeline in the first year of JT-11.

Anti-hepatitis C drug JTK-853 advanced to the clinical development stage abroad, bringing the number of drugs under clinical development to 10, and one more drug moved to a higher stage.

Clinical Development (as of April 28)

Code

Key Indication

Stage

Rights

JTT-705(oral)

Dyslipidemia

Phase 2
(Japan)

Roche(Switzerland) obtained the rights to develop and commercialize the compound worldwide, with the exception of Japan.(Development stage by Roche: Phase 3)

JTT-130(oral)

Dyslipidemia

Phase 2
(Japan)
Phase 2
(Overseas)

 

JTK-303(oral)

HIV infection

Phase 1
(Japan)

Gilead Sciences(US) obtained the rights to develop and commercialize this compound worldwide, with the exception of Japan.(Development stage by Gilead Sciences: Phase 3)

JTT-302(oral)

Dyslipidemia

Phase 2
(Overseas)

 

JTT-305(oral)

Osteoporosis

Phase 2
(Japan)

Merck(US) obtained the rights to develop and commercialize this compound worldwide, with the exception of Japan.

JTS-653(oral)

Pain Overactive bladder

Phase 1
(Japan)

 

JTT-654(oral)

Type 2 diabetes mellitus

Phase 1
(Japan)
Phase 2
(Overseas)

 

JTK-656(oral)

HIV infection

Phase 1
(Overseas)

 

JTT-751(oral)

Hyperphosphatemia

Phase 2
(Japan)

JT obtained the rights to develop and commercialize this compound in Japan from Keryx Biopharmaceuticals(US)(Developed jointly with Torii)

JTK-853(oral)

Hepatitis C

Phase 1
(Overseas)

 

Strategies and Specific Measures

To strengthen the capability for clinical development, including late-stage development, and the capability for drug discovery research

  • To strengthen the capability for clinical development in order to keep up with the progress in clinical development
  • To enhance the capability for drug discovery research in order to reinforce the R&D pipeline
    ・To continue concentrating R&D resources mainly on the following four areas: glucose and lipid metabolism; virus research; immune disorders and inflammation; and bone metabolism

To enhance licensing activity and strengthen relationships with foreign partners

  • To explore strategic opportunities for licensing agreements in order to rapidly increase the value of the pharmaceutical business.

To further develop Torii Pharmaceutical´s expertise in its areas of strength

  • To further expand sales of REMITCH® CAPSULES and Truvada® Tablets
  • To develop expertise in the field of allergens.

Out-Licensing Deals

FY

Code

Company

3/2005

JTT-705(anti-dyslipidemia drug)

Roche(Switzerland)

3/2005

JTK-303(anti-HIV drug)

Gilead Sciences(US)

3/2007

Pre-clinical trial stage new compound

GlaxoSmithKline(UK)

3/2007

Pre-clinical trial stage anti-body drug candidate

Medlmmune(US)

3/2009

JTT-305(anti-osteoporosis drug)

Merck(US)

In-Licensing Deals

FY

Code

Company

3/2004

Three anti-HIV drugs

Gilead Scienses(US)

3/2008

JTT-751(anti-hyperphosphatemia drug)

Keryx Biopharmaceuticals(US)

Pursuit of Innovative Drugs

We are engaged in an unceasing quest to develop innovative and globally competitive drugs, which we regard as the most critical mission for our pharmaceutical business. The development of new drugs is a tough challenge, which we are tackling with a sense of pride and high motivation. We are endeavoring to make the kind of achievements that we alone can realize and make available drugs that we alone can offer, so that we may deserve the respect and appreciation of patients and medical staff around the world.