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4-Traders Homepage  >  Equities  >  Swiss Exchange  >  Roche Holding Ltd.    ROG   CH0012032048

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FDA Approves Breast-Cancer Drug

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02/22/2013 | 06:05pm CEST

--Drug packs Roche's Herceptin with chemotherapy agent

--Drug approved for use as a first-line, or initial treatment for advanced breast cancer

WASHINGTON--The U.S. Food and Drug Administration Friday approved a powerful new type of drug that will be marketed by Roche Holding AG (ROG.VX, RHHBY) to treat breast cancer.

The drug called, Kadcyla, combines Roche's existing cancer drug, Herceptin, with a powerful chemotherapy agent, and is meant to treat certain types of breast cancer that have spread to other parts of the body.

Herceptin targets a protein called HER2 found on tumors in about 20% to 25% of breast-cancer patients. The two other components of Kadcyla, both developed by ImmunoGen Inc. (>> ImmunoGen, Inc.), are a chemotherapy agent called emtansine that is too potent to be delivered as a conventional medicine, and a linker that connects the two drugs. Herceptin then delivers the package to the tumor cell, where it releases the toxic cargo to kill the cancer.

The FDA's approval of Kadcyla, which was previously known as T-DM1, triggers a $10.5 million payment to ImmunoGen by Roche. ImmunoGen will also receive royalties on sales of up to 5%.

Analysts said the approval was broader than expected. The drug can be marketed for initial treatment rather than just in patients who've tried other therapies, creating a "significantly larger patient population," said Simos Simeondis, an analyst at Cowen and Company.

Roche's Genentech unit said Kadcyla will be available to patients in about two weeks. The drug will be priced at $9,800 a month. The company said there will be a patient-assistance program to help pay for the product.

Agents like Kadcyla are called antibody-drug conjugates and they are the focus of intense interest in the pharmaceutical industry. Roche's Genentech unit has 25 such agents under development for different cancers, including eight in human studies.

The first such agent to gain FDA approval was Seattle Genetics Inc.'s (>> Seattle Genetics, Inc.) Adcetris, for Hodgkin's Lymphoma and another rare cancer. That company and ImmunoGen are each collaborating with big pharmaceutical firms including Bayer AG (BAYRY, BAYN.XE), Eli Lilly & Co. (>> Eli Lilly & Co.), GlaxoSmith Kline PLC (GSK, GSK.LN), Pfizer Inc. (>> Pfizer Inc.), Sanofi (>> Sanofi SA) to develop several types of new cancer drugs.

The approval of Kadcyla was based on a study of about 1,000 women with HER2-positive breast cancer who had been treated previously with Herceptin and a traditional chemotherapy drug. About half of the women were then treated with T-DM1 and the other half were treated with a combination of Xeloda, another Roche drug, and GlaxoSmithKline's Tykerb. The study showed women receiving Kadcyla lived for an average of 31 months, which was about six months longer than women being treated with Xeloda and Tykerb.

However, like other cancer drugs Kadcyla has the potential to cause serious and life-threatening side effects from liver damage or heart problems. The drug can also cause severe birth defects so doctors need to make sure women of child-bearing age aren't pregnant before administering the product.

--Joseph Walker contributed to this story.

Write to Jennifer Corbett Dooren at [email protected]

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

Stocks mentioned in the article
ChangeLast1st jan.
ELI LILLY AND COMPANY 1.74% 82.55 Delayed Quote.-5.17%
GLAXOSMITHKLINE 1.74% 1436.8 Delayed Quote.6.78%
IMMUNOGEN, INC. 1.54% 10.52 Delayed Quote.55.85%
ROCHE HOLDING LTD. 0.16% 218.1 Delayed Quote.-11.66%
SANOFI 0.67% 66.31 Real-time Quote.-8.32%
SEATTLE GENETICS, INC. 1.52% 48.86 Delayed Quote.-8.82%
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Financials ( CHF)
Sales 2018 55 182 M
EBIT 2018 18 555 M
Net income 2018 11 868 M
Debt 2018 4 203 M
Yield 2018 3,97%
P/E ratio 2018 15,26
P/E ratio 2019 14,54
EV / Sales 2018 3,53x
EV / Sales 2019 3,34x
Capitalization 191 B
Duration : Period :
Roche Holding Ltd. Technical Analysis Chart | ROG | CH0012032048 | 4-Traders
Technical analysis trends ROCHE HOLDING LTD.
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 29
Average target price 258  CHF
Spread / Average Target 19%
EPS Revisions
Severin Schwan Chief Executive Officer & Executive Director
Christoph Franz Chairman
Alan Hippe Chief Financial & Information Technology Officer
John Irving Bell Non-Executive Director
Andreas Oeri Independent Non-Executive Director
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ROCHE HOLDING LTD.-11.66%193 904
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PFIZER2.32%220 455
NOVARTIS-8.69%202 567
AMGEN-1.13%114 902