Some thoughts on IDMI and Junovan from Dr. Garren (Biotech Insight).
IDM Pharma (IDMI) shot up on large volume. They announced a May 9th date for an FDA panel meeting to discuss Junovan. This is an immunomodulator (acts via the Nod2 receptor) that looks promising in patients with non-metastatic osteosarcoma post surgery/chemotherapy. The problem is that the single very large Phase III trial (reported March 2005 in the Journal of Clinical Oncology) was so complex that it is hard to really see a clear signal. The study had to be analyzed by the article authors as a four-arm protocol because of an interaction between two of the agents --- the original design was not powered for that kind of analysis. The problem was that the combining ifosfamide and Junovan showed some form of interaction that was unexpected-I am just not sure this data makes sense and I don't buy into the scientific hand-waving to explain it. The company's interpretation of this trial data is more optimistic than was that of the authors of the journal article. The FDA again faces the problem of coming to grips with a therapy that may help but with less than ideal trial results. This trial will never be repeated because of the large size and the long follow-up of the original trial. In my mind the FDA is in a predicament-approval of cancer therapies without very significant evidence of efficacy is not a good solution especially in light of the costs of new cancer therapies. With a relatively modest market cap and a small number of shares there is lots of leverage in this play-a positive FDA panel would send this stock way up. I have no position in IDMI.
Medarex wrote the following about the company's financial interest in IDMI in its most recent 10-K.
During the second half of the 1990s, the focus of our business shifted from humanized and murine monoclonal antibody-based products to fully human antibody development. As a result, in July 2000, we entered into an agreement with Immuno-Design Molecules, S.A., or IDM, whereby we licensed to IDM certain of our humanized and murine antibodies in exchange for equity units in IDM. In August 2005, IDM completed a share exchange with Epimmune Inc., a Delaware corporation traded on the NASDAQ Global Market, whereby IDM shareholders exchanged their IDM shares for shares of Epimmune. Epimmune subsequently changed its name to IDM Pharma, Inc., or IDM Pharma. As a result of the exchange and a subsequent private placement in February 2007, we currently hold an approximate 14.6% equity position in IDM Pharma. IDM Pharma’s most advanced product candidate, Junovan™, has completed Phase III clinical trials for the treatment of osteosarcoma, a bone cancer affecting adolescents, and is under review for market approval by the FDA and the European Agency for the Evaluation of Medicinal Products, or EMEA. |
