IDM Pharma initiated with "buy"
Friday, May 25, 2007 6:04:59 AM ET
Cantor Fitzgerald
NEW YORK, May 25 (newratings.com) - Analyst Pamela Bassett of Cantor Fitzgerald initiates coverage of IDM Pharma Inc (ticker: IDMI) with a "buy" rating. The target price is set to $11.
In a research note published this morning, the analyst mentions that the company is likely to receive the FDA’s approval or approvable letter for the Junovan drug by August 26 and EMEA’s approval by the end of 1Q08. IDM Pharma is likely to launch Junovan in the US by the end of 2007, and the drug has the potential to become a widely used immunotherapeutic treatment for metastatic disease in multiple cancers going forward, the analyst says.
[One of the more surprising opinions of the year, considering...]
IDM Pharma cancer drug data rejected by FDA
Advisory panel said clinical study results unclear, hard to interpret.
May 9 2007: 6:45 PM EDT
SILVER SPRING, Md. (Reuters) -- Data for IDM Pharma Inc.'s drug Junovan failed to show it effectively treats osteosarcoma, a rare bone cancer that often affects teenagers, a U.S. advisory panel said Wednesday.
Shares of the small biotechnology company fell closed down $1.30, or 32.5 percent, at $2.70 Wednesday after the decision by the Food and Drug Administration's panel of outside experts.
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IDM Pharma (Charts) is seeking FDA approval for Junovan, called Mepact in Europe, to treat newly diagnosed cases of the cancer after patients undergo surgery in combination with chemotherapy.
But panel members, in a 12 to 2 vote, said a single clinical study of the drug, also known as mifamurtide, was unclear and difficult to interpret.
"I don't think we have the evidence we need," said panel member Dr. Gregory Reaman, a pediatrician at George Washington University in Washington, D.C.
The FDA will make the final decision on whether to approve the treatment, but it usually follows panel recommendations.
While the agency generally requires two clinical trials before a drug is considered for approval, IDM Pharma completed just one study that agency reviewers said was flawed.
Company representatives said its study of more than 700 registered patients proved the drug was effective and proved it would save about 50 lives a year.
"In the context of this benefit, side effects are trivial," Dr. Eugenie Kleinerman told the panel on behalf of the company. She added patients experienced mild to moderate, mostly flu-like side effects.
Still, panel members agreed with FDA staff reviewers who argued that the company's data failed to prove the medicine was effective.
Agency staff cited problems with IDM Pharma's data collection and analysis, saying the company failed to follow up properly with many patients. It also decided how to analyze its results after the study was completed rather than selecting goals ahead of time.
Panelists said they were left struggling to decide what the company's data meant for doctors and patients.
"I have no idea how to use it, and I have no idea why some patients benefit and some patients don't," said panelist Dr. Lee Helman, a scientific director for clinical research at the National Cancer Institute.
In a statement, IDM Pharma's President and Chief Executive Officer Jean-Loup Romet-Lemonne said the company was disappointed by the panel's vote.
"We will focus on working with FDA in the coming weeks to address the issues raised," he said. |
