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MarketScreener Homepage  >  Equities  >  Tokyo  >  Chugai Pharmaceutical Co., Ltd.    4519   JP3519400000

CHUGAI PHARMACEUTICAL CO., LTD.

(4519)
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Chugai Pharmaceutical : Files for Additional Indication for Anti-HER2 Antibody Drug Conjugate Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer

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09/02/2019 | 10:52am EDT

TOKYO - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has filed an application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for an additional indication for anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla (generic name: trastuzumab emtansine), as adjuvant therapy in patients with HER2-positive early breast cancer.

'There is still a high unmet medical need for the development of treatment methods when pathologic complete response (pCR) is not obtained by neoadjuvant therapy. This application is the first step in providing patients with Kadcyla as a new treatment option of adjuvant therapy,' said Dr. Yasushi Ito, Chugai's Executive Vice President, Co-Head of Project & Lifecycle Management Unit. 'Our HER2 franchise, consisting of Herceptin, Perjeta and Kadcyla has contributed to improving the outcomes of HER2-positive breast cancer. In this indication, we will continue to discuss with the regulatory authorities for the early approval of Kadcyla.'

This application is based on results from an open-label, randomized, global phase III clinical study (the KATHERINE study), evaluating efficacy and safety of Kadcyla adjuvant therapy compared to Herceptin in almost 1,500 people with HER2-positive early breast cancer who had invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy including Herceptin. The primary endpoint of the study was invasive disease-free survival (IDFS) Based on the results of the study, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Kadcyla as adjuvant therapy and gave regulatory approval on May 3, 2019, which is just over 12 weeks after submission under the FDA's Real-Time Oncology Review pilot program.

The main results from the KATHERINE study are as follows

According to the first interim analysis of the primary endpoint, the superiority of Kadcyla over Herceptin in IDFS has been confirmed (unstratified hazard ratio: 0.50 [95% confidence interval: 0.39-0.64, log-rank test, p

(C) 2019 Electronic News Publishing, source ENP Newswire

Stocks mentioned in the article
ChangeLast1st jan.
CHUGAI PHARMACEUTICAL CO., LTD. -0.24% 8300 End-of-day quote.34.30%
ROCHE HOLDING AG 0.35% 288.2 Delayed Quote.19.97%
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Financials (JPY)
Sales 2019 636 B
EBIT 2019 171 B
Net income 2019 127 B
Finance 2019 261 B
Yield 2019 1,25%
P/E ratio 2019 35,5x
P/E ratio 2020 29,5x
EV / Sales2019 6,74x
EV / Sales2020 6,22x
Capitalization 4 543 B
Technical analysis trends CHUGAI PHARMACEUTICAL CO.,
Short TermMid-TermLong Term
TrendsBullishBullishBullish
Income Statement Evolution
Consensus
Sell
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Mean consensus HOLD
Number of Analysts 13
Average target price 7 812,50  JPY
Last Close Price 8 300,00  JPY
Spread / Highest target 18,1%
Spread / Average Target -5,87%
Spread / Lowest Target -21,7%
EPS Revisions
Managers
NameTitle
Tatsuro Kosaka President, CEO & Representative Director
Osamu Nagayama Chairman
Itagaki Toshiaki CFO, Manager-Information Technology & Accounting
Hisafumi Okabe Senior Executive Officer & Head-Research
Hisanori Takanashi Executive Officer & GM-Clinical Development
Sector and Competitors
1st jan.Capitalization (M$)
CHUGAI PHARMACEUTICAL CO., LTD.34.30%41 970
JOHNSON & JOHNSON-1.05%337 021
ROCHE HOLDING AG18.88%250 869
MERCK AND COMPANY10.82%216 813
PFIZER-16.47%201 662
NOVARTIS15.10%198 751