We are disappointed with the delay in the approval of Johnson & Johnson’s (JNJ) injectable drug Yondelis (trabectedin). The company is seeking the US Food and Drug Administration (FDA) approval to use Yondelis in combination with its cancer drug Doxil (doxorubicin HCl liposome injection) for the treatment of women with relapsed ovarian cancer. Yesterday, Centocor Ortho Biotech Products, L.P, a unit of J&J, received a Complete Response Letter (CRL) on Yondelis from the FDA regarding the New Drug Application (NDA) submitted in November last year.

In the CRL, the agency has asked for more information regarding the treatment Incorporatedluding overall survival rates from its ongoing clinical trial. The company is reviewing the letter and expects to respond at the earliest. Earlier in July, an advisory panel of the FDA voted 14-1 against the drug based on its potential side effects which included blood toxicity, anemia and heart problems. Yondelis has been developed by Ortho Biotech in collaboration with Spanish drugmaker PharmaMar. While PharmaMar holds marketing rights in Europe and Japan, Ortho Biotech holds rights for the rest of the world.

According to the National Cancer Institute, more than 15,000 women in the US died of ovarian cancer last year. Johnson & Johnson aims to develop its relatively small oncology platform, an area of increased focus recently for the company and one that offers high potential. In May 2009, in order to expand its oncology platform, Johnson & Johnson acquired Cougar Biotechnology, a company targeting the oncology market for $43 per share, or about $893 million.

We have a Neutral recommendation on the stock.

Zacks Investment Research
View original at: Zacks.com News Feed

1. (JNJ) Johnson & Johnson Responds to FDA Questions on Antibiotic Drug TrialsWe are pleased to hear that the US Food and Drug Administration (FDA) has accepted...
2. (JNJ) Johnson & Johnson’s Cypress Study Enrollment BeginsYesterday, Johnson & Johnson (JNJ) announced the initiation of enrollment in the Cypress study (CYPherR...
3. (JNJ) Twin FDA Problems for Johnson & JohnsonIn a major disappointment for Johnson & Johnson (JNJ), the US Food and Drug Administration...
4. (ALKS) Alkermes Notified Johnson & Johnson Intends to Stop Development of RisperidoneOn Wednesday, Alkermes, Inc. (ALKS) disclosed that it has received notification from Johnson & Johnson’s...
5. (AMGN) Amgen’s Kidney Drug Fails Phase III StudyYesterday, Amgen (AMGN) said that Aranesp failed in a large, randomized, double-blind, placebo-controlled, phase III...
6. (MRK) Drug Companies: A Powerhouse of Profitsby The Investment U Research Team A couple of interesting news items came out in...

Search Posts by Tag: JNJ | Johnson & Johnson | Drug Manufacturers - Major | Healthcare

RSS Feeds by Tag: JNJ | Johnson & Johnson | Drug Manufacturers - Major | Healthcare |

Other Posts by: vitalstocks | RSS Feed for this author