It’s an indication of how desperate Amgen Inc. investors are these days that what normally would have been considered disappointing results from a study of its leading anemia drug was perceived as good news last week, sending share prices upward.
At least the drug, Aranesp, hadn’t killed anybody, Wall Street may have been thinking.
The Thousand Oaks company had hoped that the study, released April 19, would show that Aranesp improved survival rates by making a type of lung cancer more vulnerable to chemotherapy. That outcome would have enabled the company to make stronger claims for the drug currently only approved by Food and Drug Administration for treating chemotherapy-related anemia, which weakens cancer patients.
The study, however, didn’t show a measurable benefit. But on the bright side, the study didn’t indicate that Aranesp increased risks for death, blood clots, strokes and heart attacks, something that other studies in recent months have suggested.
In addition, the lung cancer patients experienced few adverse side effects and a significantly lower risk of blood transfusions.
That conclusion is a silver lining may alleviate recent safety concerns over the entire class of Amgen drugs, which includes Aranesp’s predecessor Epogen.
Those concerns began with a study released in January that showed giving Aranesp at higher-than-recommended levels to cancer patients not undergoing chemotherapy may promote tumor growth.
FDA staff last month added warnings to the labels of both Arnesp and Epogen after various studies showed using too much of the drugs increased risks for chronic kidney failure patients. The warning label called for doctors to use the lowest possible dose of the drug.
An FDA expert panel is scheduled to review the drugs next month, which could result in further restrictions.
Amgen closed at $62.32 on April 19, up 4 percent on news of the latest study after jumping 6 percent earlier in the day. However, Amgen shares have been so battered by bad news this year that the company long considered the world’s largest biotech by market cap recently ceded the title to South San Francisco rival Genentech Inc.
Next up for investors is how all the negative news has impacted Amgen’s financials, with the company is scheduled to announce first quarter earnings on Monday. Aranesp and Epogen accounted for nearly half of the company’s $13.9 billion revenues last year.
Further FDA restrictions will impact potential sales growth for both Aranesp and Epogen, though the first quarter impact could be minor. Joel Sendek at Lazard Capital Markets is forecasting a 3 percent decline in Aranesp sales compared to the fourth quarter, according to his survey of physicians.
Abraxis Loses Civil Suit
A Santa Monica jury has awarded a tiny Netherland Antilles-based licensing company $2.6 million in fees and interest that it ruled a subsidiary of Abraxis Bioscience Inc. owes for licensing a piece of drug delivery technology first developed at UCLA.
The case dates from the late 1990s, when a predecessor company of Los Angeles-based Abraxis was a struggling drug developer years away from FDA approval for its first cancer drug, Abraxane. Abraxis was formed from the 2006 merger of two companies controlled by former UCLA researcher Dr. Patrick Soon-Shiong.
Bioquest Venture Leasing Co. contends that VivoRx, a subsidiary of Soon-Shiong’s American BioScience Inc., still owed $960,000 in licensing fees when it stopped making payments in 1999.
The technology, developed by another UCLA researcher, involved a way to deliver therapies via biomanufactured antibodies, and is not used in any current Abraxis product. But Bioquest contends VivoRx sublicensed the intellectual property to another company, which is using the technology in its products today. It also contends that American BioScience siphoned revenue from VivoRx to cover some unrelated legal battles it was fighting, a contention the company denied.
Attorneys handing the case for Abraxis were traveling and could not be reached for comment, a company spokeswoman said. The Los Angeles Superior Court judge in the case is scheduled to hold a May 24 hearing to confirm whether Abraxis, as the surviving parent company, is the “alter ego” entity liable for the damages.
Precision Dynamics Divests
San Fernando-based Precision Dynamics Corp. has sold its medical writing instrument division to Caledonia, Mich.-based Aspen Surgical Products Inc. for an undisclosed sum. The division makes markers and pens used in hospitals and medical offices. Precision in recent years has been concentrating on cutting-edge bar code and radio frequency identification systems and less on traditional wristband products. The deal is scheduled to close in May.
Staff reporter Deborah Crowe can be reached at (323) 549-5255, ext. 232, or at
[email protected]
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