Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

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

SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets

FDA Approves Breast-Cancer Drug

share with twitter share with LinkedIn share with facebook
share via e-mail
0
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

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on ROCHE HOLDING LTD.
10/23 ASTRAZENECA : among backers as Swiss cancer biotech raises $200 million
10/23 ROCHE : Chugai Pharmaceutical Co. Ltd. - F. Hoffmann La Roche Announces Third Qu..
10/20 ROCHE : 66-- Notice of Intent-Sole Source IDIQ Roche laboratory supplies
10/20 INOVIO PHARMACEUTICALS : Begins Phase 1b/2 Cancer Efficacy Trial Combining Its T..
10/19 PTC THERAPEUTICS : Spinal Muscular Atrophy Program Advances into Pivotal Study i..
10/19 FOUNDATION MEDICINE : Appoints Tom Civik as Chief Commercial Officer
10/19DJEuropean Corporate Roundup for Thursday
10/19DJEuropean Corporate Roundup for Thursday
10/19 ROCHE : Swiss biotech group Roche sees 5 pct rise in 9-month sales
10/19DJROCHE : 3Q Sales Increase on Strong Performance of Recently Launched Drugs
More news
News from SeekingAlpha
10/20 The Market Is Skeptical About Roche Ahead Of Major Trial Read-Outs
10/20 YOUR DAILY PHARMA SCOOP : Johnson & Johnson's Mixed Signals, Celgene's Mongersen..
10/20 Tracking Ken Fisher's Fisher Asset Management Portfolio - Q3 2017 Update
10/19 Roche Holding's (RHHBY) CEO Dr. Severin Schwan on Q3 2017 Results - Earnings ..
10/19 Roche Holding ADR (RHHBY) Updates On 3Q17 Sales - Slideshow
Financials ( CHF)
Sales 2017 53 411 M
EBIT 2017 18 409 M
Net income 2017 11 152 M
Debt 2017 9 884 M
Yield 2017 3,67%
P/E ratio 2017 17,46
P/E ratio 2018 15,97
EV / Sales 2017 4,00x
EV / Sales 2018 3,78x
Capitalization 204 B
Chart ROCHE HOLDING LTD.
Duration : Period :
Roche Holding Ltd. Technical Analysis Chart | ROG | CH0012032048 | 4-Traders
Technical analysis trends ROCHE HOLDING LTD.
Short TermMid-TermLong Term
TrendsBearishBearishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 30
Average target price 272  CHF
Spread / Average Target 16%
EPS Revisions
Managers
NameTitle
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
Sector and Competitors
1st jan.Capitalization (M$)
ROCHE HOLDING LTD.0.77%207 116
JOHNSON & JOHNSON23.60%382 202
NOVARTIS13.97%226 404
PFIZER12.13%216 886
MERCK AND COMPANY8.51%174 223
AMGEN25.14%133 501