Last month, investors waxed poetic about IDM Pharma Inc., an Irvine-based drug company, over its bone cancer candidate.
Now, it’s the Food and Drug Administration’s turn.
IDM officials and the FDA’s Oncologic Drugs Advisory Committee are scheduled to meet Wednesday to discuss its application for Junovan. The drug treats osteosarcoma, a form of bone cancer, following surgical resection,removal of part of an organ or structure,in combination with chemotherapy.
IDM shares jumped 167% to $7.63 on the news in early April. IDM shares since have traded around $7, giving it a recent market value of $126 million.
IDM licensed Junovan from Novartis SA, the Swiss drug maker.
The company’s goal is to develop therapies that stimulate a patient’s immune system. The hope is that by stimulating the immune system it will be able to destroy cancer cells left over after chemotherapy and radiation therapy, or prevent tumors from returning.
IDM, which counted 32 local workers last year, has four other drug candidates in clinical development besides Junovan.
Three are in second-phase clinical trials for conditions such as bladder cancer and melanoma, a common form of skin cancer.
IDM has co-developed Uvidem, a melanoma treatment, with French drug maker Sanofi-Aventis.
The company has its subsidiary, IDM SA, in Paris. The company also has several facilities there.
IDM’s history dates back to 1993, when Immuno-Designed Molecules SA was established as a “soci & #233;t & #233; anonyme,” or public company.
In August 2005, IDM combined with Epimmune Inc., a publicly traded company that was based in San Diego, in an all-stock deal, creating IDM Pharma Inc.
The company is led by Chief Executive Jean-Loup Romet-Lemonne, who founded Immuno-Designed Molecules.
Earlier this year, IDM raised $12.8 million in a funding round led by Palo Alto Investors, with existing investor Alta Partners of San Francisco.
It saw a 64% rise in sales to $11.1 million last year. The company posted a net loss of $23.4 million, up 40% from a year ago.
Separately, IDM said that Edward Penhoet, a director of several venture capital funds at Alta, is a new member of the company’s board.
Penhoet’s experience includes serving as a director and cofounder of Chiron Corp., a biotech company that he spent 17 years at as its chief executive.
TriZetto Earnings
TriZetto Group Inc., a Newport Beach healthcare software company, posted first-quarter net income that exceeded an earlier forecast, though it was down from a year ago.
TriZetto posted a profit of $5.9 million in the first quarter, 13.2% lower than a year ago. The company said its earnings were affected by a $4.1 million tax-related charge. Sales rose 33% to $113.5 million.
Analysts expected TriZetto to earn $5 million, with $107.2 million in sales.
Earlier this month, TriZetto said it expected a profit of $3.6 million to $5.4 million, and for sales to come in at $100 million to $110 million.
The company also reaffirmed its guidance for the year. TriZetto expects $17.6 million to $22.6 million in profit in 2007. Sales should come in at $425 million to $445 million.
Wall Street’s looking for $22.6 million in profit and sales of $442.3 million this year.
I-Flow Boost
A clinical study gave a boost to I-Flow Corp., a Lake Forest device maker.
I-Flow’s stock shot up in mid-April after it said a study of its On-Q medical device reduced the rate of surgical site infections and the length of hospital stays. The study included 120 colorectal surgery patients. I-Flow’s stock rose 13% to $16.50 on the news earlier last month.
On the same day, Alexander Arrow, a medical technology analyst for Lazard Capital Markets LLC, maintained a “buy” rating on I-Flow.
The price rise “implies the market is assigning more significance to these infection rate data than we are,” he said in a research note.
“Infection rates are an important metric by which hospitals are judged,” Arrow said. “We don’t, however, see these data as a company-transforming event, and we don’t think the company will be seen by clinicians as ‘wound management’ instead of pain management, as some (including I-Flow’s management) have suggested it might.”
Bits and Pieces:
Endologix Inc., an Irvine medical device maker, recently got approval from the FDA to make the material to cover its Powerlink abdominal aortic aneurysm device. An abdominal aortic aneurysm occurs when the aorta, the body’s largest blood vessel that runs from the heart, balloons out and threatens to rupture. The Powerlink is a tubelike device that is placed in the aorta to keep it from rupturing Cogent Healthcare Inc., which is leaving Irvine for Nashville, is among several companies named in a lawsuit by Brookdale University Hospital and Medical Center against Health Insurance Plan of Greater New York. The suit alleges that millions of dollars of costs to the hospital were shifted and should have been paid by the managed care organization. Cogent denied the allegations and said it plans to possibly file a counterclaim Cortex Pharmaceuticals Inc., an Irvine drug maker, said it sent a toxicology data package for its Ampakine CX717 drug candidate to the FDA Orange Coast Memorial Medical Center in Fountain Valley said that it now is offering Johnson & Johnson’s Cordis Carotid medical device for treating patients who are at risk of stroke from carotid artery disease.
