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, including 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.
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