Termination of Co-Promotion and Takeda's Distribution of 'Xeljanz® Tablets 5 mg' in Japan

Tokyo and Osaka, Japan, December 18, 2017— Pfizer Japan Inc. (Headquarters: Shibuya-ku, Tokyo, President & CEO Akihisa Harada, “Pfizer”) and Takeda Pharmaceutical Company Limited (TSE: 4502, Headquarters: Chuo-ku, Osaka, President & CEO Christophe Weber, “Takeda”), today announced the  termination of co-promotion of the oral JAK inhibitor rheumatoid arthritis product 'Xeljanz^® Tablets 5 mg' (generic name: tofacitinib citrate, “Xeljanz”) as of March 31, 2018. Accordingly, Takeda will cease distribution of Xeljanz and Pfizer, the manufacturer of the product, will become the sole marketer as of April 1, 2018.

Since its launch in Japan in July 2013, Xeljanz has been co-promoted by Pfizer and Takeda, with Takeda responsible for distribution under a co-promotion agreement between the two companies. Due to changes in the business environment, Pfizer and Takeda have decided to terminate the co-promotion and Takeda's distribution of the product. The financial terms of this termination are not disclosed. 

The two companies will continue to co-promote the rheumatoid arthritis product Enbrel^® (generic name: etanercept), with Takeda continuing to distribute it under the co-promotion agreement.

Pfizer and Takeda will continue to contribute to better health by proceeding with the seamless transfer of Xeljanz and by providing important products to rheumatoid arthritis patients and the medical community.

Reference material

Summary of XELJANZ in Japan

Trade Name	XELJANZ® Tablets 5mg
Generic Name	tofacitinib citrate
Date of Marketing Approval	March 25, 2013
Date of Listing in the NHI Reimbursement Price	May 24, 2013
Date of Initial Marketing	July 30, 2013
Indications	Rheumatoid arthritis in patients that have had an inadequate response to conventional treatment.
Dosage and Administration	The recommended dose is 5mg twice daily, administered orally as tofacitinib.

About Rheumatoid Arthritis (RA)

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 700,000 - 800,000 people in Japan¹ and 23.7 million people worldwide.² Although multiple treatments are available, many patients do not adequately respond. Specifically, up to one-third of patients do not adequately respond and about half stop responding to any particular disease-modifying anti-rheumatic drug (DMARD) within five years.^3,4,5,6,7,8

Because RA requires long-term treatment, it is of utmost importance to continue treatment along with reducing the mental and physical burden of patients

About XELJANZ (generic name: tofacitinib citrate)

XELJANZ is a Janus kinase (JAK) inhibitor and the first oral therapy ever approved for the treatment of RA. Unlike biologic drugs that target cytokines outside the cell, XELJANZ targets signal transduction inside the cell. It is specifically designed to inhibit the JAK pathways, which are signaling pathways inside the cell that play a key role in the inflammation involved in RA.

XELJANZ is approved in more than 80 countries and regions around the world, including Japan, for the treatment of moderately to severely active RA. Since it was first approved in the United States in 2012, XELJANZ has been prescribed to more than 90,000 patients worldwide.

About ENBREL (generic name: etanercept (gene recombination))

ENBREL is the longest-used biologic medicine for the treatment of rheumatism around the world, as well as the standard medicine for patients with RA who have had an inadequate response to conventional treatment. Since it was first approved in the United States in 1998, the drug has been approved in over 100 countries and regions worldwide. In Japan, it was launched in March 2005. A syringe-type and a pen-type that allows patients to administer easily and safely with one click also became available in June 2008 and June 2013, respectively.

ENBREL reduces RA inflammation by binding with and inhibiting the activity of Tumor Necrosis Factor (TNF), which is a cytokine* that plays a key role in the process of developing RA inflammation, as well as with Lymphotoxin α (LTα), which is another cytokine considered to be a factor related to RA symptoms. It is the only TNFα receptor medicine, and issues such as a reduction in efficacy due to the production of neutralizing antibodies are few.

* A generic term for a protein factor that is released from the cell and mediates the interaction with the cells. It plays an important role in immunity, inflammation and biophylaxis.

1.Report from Study Committee on Rheumatoid Arthritis and Allergy Accessed on 13 March 2013.

http://www.mhlw.go.jp/stf/houdou/2r9852000001nfao-att/2r9852000001nfdx.pdf

2.World Health Organization, “The Global Burden of Disease, 2004 Update.” Accessed 13 March 2012. Available at http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.

3.Klareskog L, Van der Heijde D, de Jager J, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomized controlled trial. The Lancet 2004. 363: 675-681

4.Keystone, E, Kavanaugh A, Sharp J, et al. Radiographic, clinical and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy. Arthritis & Rheumatism 2004. 50: 1400-1411

5.Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in the treatment of rheumatoid arthritis. The New England Journal of Medicine 2000. 1594-1602.

6.Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor necrosis factor blockers in daily practice in 770 rheumatic patients. J Rheumatol 2006; 33:2433-8.

7.Maradit-Kremers H, Nicola PJ, Crowson CS, et al. Patient, disease, and therapy-related factors that influence discontinuation of disease-modifying antirheumatic drugs: a population-based incidence cohort of patients with rheumatoid arthritis. J Rheumatol 2006; 33(2):248-55.

8.Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and adherence to biologics for rheumatoid arthritis: a systematic review. Clin Ther 2011;33(7):901-913. 

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Takeda Pharmaceutical Company Limited
Ryoko Omichi  
TEL：+81-3-3278-2665 
E-mail：[email protected]

Kazumi Kobayashi 
TEL： +81-3-3278-2095 
E-mail：[email protected]

Pfizer Japan Inc.

Communications Team 2, Oncology/Inflammation and Immunology/Rare Disease Communications and Country Manager Office

Koki Kadowaki
TEL：+81-80-5501-9396 
E-mail：[email protected]

Yuko Ueda
TEL：+81-80-6605-9005 
E-mail：[email protected]