Log in
Forgot password ?
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Equities  >  Nasdaq  >  ImmunoGen, Inc.    IMGN

News SummaryMost relevantAll newsSector newsTweets 

FDA Approves Kadcyla, Breast-Cancer Drug from Roche, ImmunoGen

share with twitter share with LinkedIn share with facebook
share via e-mail
02/22/2013 | 05:26pm CET
   By Jennifer Corbett Dooren 

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.

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.

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.

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 PLC's (GSK, GSK.LN) Tykerb. The drugs were administered every three weeks until the disease progressed or patients experienced unmanageable side effects.

The study was designed to measure progression-free survival, which is a measurement of the time from the start of treatment until the disease gets worse or the patient dies, and overall survival, which is a measurement of time from the start of treatment until death.

The median progression-free survival for patients receiving T-DM1 was 9.6 months, compared with 6.4 months in the group receiving Xeloda and Tykerb, a difference considered statistically significant. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months for Xeloda and Tykerb group.

Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com.

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

Stocks mentioned in the article : ImmunoGen, Inc.
share with twitter share with LinkedIn share with facebook
share via e-mail
Latest news on IMMUNOGEN, INC.
02/17 IMMUNOGEN : reports 2Q loss
02/17 IMMUNOGEN INC : Results of Operations and Financial Condition, Financial Stateme..
02/17 IMMUNOGEN : Reports Recent Progress and Operating Results for Six-Month Period a..
02/02 IMMUNOGEN : Announces Webcasts of Presentations at Upcoming Investor Conferences
01/27 IMGN Marches Forward, FDA Nod For ZLTQ, Knight Lends Shine To PLX
01/26 IMMUNOGEN : Announces First Patient Dosed in FORWARD I Phase 3 Study of Mirvetux..
01/25 IMMUNOGEN : Announces Conference Call to Discuss its Results for Six-Month Perio..
01/25 IMMUNOGEN,INC. (NASDAQ : IMGN) Files An 8-K Departure of Directors or Certain Of..
01/23 IMMUNOGEN INC : Change in Directors or Principal Officers, Financial Statements ..
01/23 IMMUNOGEN : Announces Departure of Sandra Poole
More news
Sector news : Biotechnology & Medical Research - NEC
02/16 How Sanofi lost out to J&J in $30 billion battle for Actelion
02/14 Gilead challenges GSK with strong HIV drug data
02/13 TEVA PHARMACEUTICAL INDUSTRIES : seeks CEO with pharma background to lead recove..
02/09DJAppeals Court Allows Sanofi, Regeneron to Continue Selling Cholesterol Drug
02/08 Weak pound buoys GSK but drugmaker warns on 2017 generic threat
More sector news : Biotechnology & Medical Research - NEC
News from SeekingAlpha
02/17 ImmunoGen's (IMGN) CEO Mark Enyedy on Q2 2017 Results - Earnings Call Transcr..
02/17 ImmunoGen revenues off 23% in FQ2; updates guidance
02/17 ImmunoGen, Inc. 2016 Q4 - Results - Earnings Call Slides
02/17 ImmunoGen misses by $0.01, misses on revenue
02/16 Notable earnings before Friday?s open
Financials ($)
Sales 2017 61,0 M
EBIT 2017 -97,7 M
Net income 2017 -127 M
Debt 2017 146 M
Yield 2017 -
P/E ratio 2017 -
P/E ratio 2018
EV / Sales 2017 5,86x
EV / Sales 2018 5,95x
Capitalization 212 M
More Financials
Duration : Period :
ImmunoGen, Inc. Technical Analysis Chart | IMGN | US45253H1014 | 4-Traders
Full-screen chart
Technical analysis trends IMMUNOGEN, INC.
Short TermMid-TermLong Term
Technical analysis
Income Statement Evolution
More Financials
Mean consensus OUTPERFORM
Number of Analysts 9
Average target price 4,00 $
Spread / Average Target 65%
Consensus details
EPS Revisions
More Estimates Revisions
Mark J. Enyedy President, Chief Executive Officer & Director
Stephen C. McCluski Chairman
David B. Johnston Chief Financial Officer & Executive Vice President
Richard J. Gregory Chief Scientific Officer & Executive VP
Joseph J. Villafranca Independent Director
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
IMMUNOGEN, INC.19.12%212
CELLTRION, INC.--.--%10 747
LONZA GROUP AG1.87%10 368
More Results