13 innovative drugs included for the first time in approved procurement list, expanding care for major illnesses

QINGDAO, 19 December 2014 – The Qingdao municipal government today released an expanded reimbursement list for drugs treating major illness. The approved list includes 13 new drugs from 9 leading domestic and international companies, including Remicade? and Velcade? - two leading compounds from Xian Janssen Pharmaceuticals.

Today’s announcement marks the second time that the Qingdao drug reimbursement list has been expanded since the approval of the Urban Major Illness Support System in 2012, and the first time that many innovative medicines have been approved for public reimbursement in China. The 2012 announcement initiated the “Qingdao Model”, under which the government, pharmaceutical companies, and individuals share the burden of elevated costs for specialized medicines.

The announcement is an example of the commitment of the government and pharmaceutical companies to work together to address the needs of patients suffering from rare and complex diseases.

“The inclusion of Remicade? and Velcade? in the drug reimbursement list is a major development for patients suffering from cancer and immunological disorders. We share a responsibility to work together with the regulators to make our drugs available to those in need, and today’s announcement will come as great news to patients and their families,” said Dr. Avery Ince, Vice President of Xian Janssen Pharmaceutical Ltd.

Ms. Zheng Lei said: “Qingdao is providing a potential solution for all parties to come together to address the gap between health resources and public health need. “We look forward to the success of this model and hope to see further approval of innovative medicines here in Qingdao and across China.”

Hospitals in Qingdao that will benefit from this program are青島大學(xué)附屬醫(yī)院, 青島市市立醫(yī)院, 青島市海慈醫(yī)療集團(tuán), 解放軍第四〇一醫(yī)院, 青島市中心醫(yī)院. The drugstore included in this program is 青島惠友大藥房有限公司，青島市閩江二路15號乙，電話：0532-85773562。

Since its establishment in 1985, Xian Janssen has been committed to providing Chinese patients with high-quality, innovative products that fulfill unmet medical needs in psychiatry, neurology, oncology, immunology, and gastrointestinal and fungal diseases.

Based on the company’s Credo and spirit of caring, Xian Janssen has been an active corporate citizen, conducting more than 50 cooperative projects in the areas of medicine, public health, medical R&D, and corporate social responsibility.

About REMICADE? (Infliximab)
REMICADE? is the only anti-TNF-alpha treatment approved in three different therapeutic areas in China: gastroenterology, rheumatology and dermatology.

REMICADE? was launched in China for use in the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS), moderately to severely active Crohn’s disease, and fistulizing Crohn’s disease in May, 2006. Psoriasis was the fifth indication of REMICADE? to be approved in China.

Launched in 103 countries, REMICADE? has been used for 19 years globally. More than 1.6 million patients treated worldwide have benefited from this biological treatment, reinforcing the efficacy and safety profile of REMICADE?.

REMICADE^? was the first anti-TNF-alpha treatment approved in the United States in August 1998 and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  REMICADE^? has demonstrated broad clinical utility with indications in Crohn's disease, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis (UC), pediatric Crohn’s disease, psoriasis, and pediatric UC.  The safety and efficacy of REMICADE^? have been well established in clinical trials over the past 17 years and through commercial experience with more than 1.5 million patients treated worldwide.

In the U.S., REMICADE^? is approved for the following indications:

• Reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA, when administered in combination with methotrexate.

• Reducing signs and symptoms in patients with active ankylosing spondylitis.

• Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.

• Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease.

• Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy.

• Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis.

• Treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

REMICADE^? is unique among available anti-TNF-alpha biologic therapies.  It is the only anti-TNF-alpha biologic administered directly by caregivers in the clinic or office setting.  REMICADE^? is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6.  As a result, REMICADE^? patients may require as few as six treatments each year as maintenance therapy.

Janssen Biotech, Inc. discovered and developed REMICADE^? and markets the product in the United States.  The Janssen Pharmaceutical Companies market REMICADE^?in Canada, Central and South America, the Middle East, Africa, and Asia Pacific.

In Japan, Indonesia, and Taiwan region, Janssen Biotech, Inc. licenses distribution rights to REMICADE^? to Mitsubishi Tanabe Pharma Corporation.  In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE^? to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co, Inc.

About VELCADE? (bortezomib)
Velcade? was approved in China five years ago for treatment of multiple myeloma mantle cell lymphoma, and approximately 30,000 people with these life-threatening diseases were treated with Velcade? since its launch in China.

• Patients who have not been treated before and who are not suitable for high-dose chemotherapy (medicines to treat cancer) with a blood stem-cell transplant. In these patients, VELCADE is used in combination with melphalan and prednisone (other medicines for MM)

• Patients who have not been treated before and who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant. In this group of patients, VELCADE is used in combination with dexamethasone, or with dexamethasone plus thalidomide

• Patients whose disease is progressive (getting worse) and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a blood stem-cell transplant. VELCADE is either used on its own in these patients or in combination with CAELYX (pegylated liposomal doxorubicin) or dexamethasone

VELCADE contains an active substance called bortezomib and is the first in a specific class of medicines known as proteasome inhibitors. Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with other cells around them. Bortezomib reversibly interrupts the normal working of cell proteasomes, causing myeloma cancer cells to stop growing and die.²

VELCADE has a predictable safety profile and a favourable benefit-risk ratio. The most common side effects reported with VELCADE (bortezomib) include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy.²

VELCADE is the market leader in the treatment of frontline, non-transplant eligible MM. It is co-developed by Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, and Janssen Pharmaceutical Companies. Millennium: The Takeda Oncology Company is responsible for commercialisation of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialisation in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 550,000 patients worldwide.
 
For more information, please contact:
Richard Jinglei Zhang, MD, MBA
Xian Janssen Pharmaceutical Ltd.
Tel: 010-5821 8310
Cell: 1370-129-0270
E-mail: jzhan236@ITS.JNJ.COM