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Antigenics Inc. has spent between $400 million and $500 million to conduct two Phase 3 trials on its potential cancer vaccine. But the Lexington-based company never plans to send it to the U.S. Food and Drug Administration for approval.
“Not unless the agency significantly changes. The Western regulatory bureaucracies are too rigid to know how to deal with our product,” CEO Garo Armen said.
So Antigenics’ revenue expectations for its key product, Oncophage, excludes U.S. revenue, far from typical for a small public biotech. Russian authorities approved Oncophage, a therapeutic vaccine, for the treatment of kidney cancer in April 2008 and patients are just beginning therapy. But the European Medicines Agency, known as the EMEA, rejected the vaccine target in October. The company is currently in talks with the European regulators to determine a way forward.
In all, eight late-stage clinical trials in a variety of cancer indications — either Phase 2 or Phase 3 — have been conducted on Oncophage since 1998. The company has raised $700 million since its launch in 1994. On Sept. 30, Antigenics had $29 million in cash on hand, according to documents filed with the U.S. Securities and Exchange Commission. The company booked revenue of $2.8 million in the first nine months of 2009 and burned through $20.6 million in the same time period.
Antigenics cut its staff by almost one-third in 2009, to 62 workers.
The story of Antigenics speaks to the unwavering determination of scientists to bring products to market that could significantly impact patients’ health. It is also an illustration of the huge losses that are commonplace in the high stakes world of cancer research.
“The easiest thing for us right now would be to abandon Oncophage, but we have a moral responsibility,” Armen said.
Armen says that too much of modern cancer research has focused on extending life for the sickest patients by just a few months, or even a few weeks. But he said trials that focus on earlier-stage cancer take longer, are more expensive and make investors nervous.
It is fair to say that Antigenics may have been, up until recently, a company ahead of its time. After all, cancer vaccines have largely been the stuff of dreams over the past decade.
But in the next few months, Seattle-based Dendreon Corp. is likely to win FDA approval for its prostate cancer vaccine, and several other late-stage vaccines are in the pipeline at other companies. Similarly, the field of personalized medicine, in which patients with different types of the same disease receive different drugs, is still in its infancy.
Oncophage goes one step further — individualized medicine. With Oncophage, each patient undergoes surgery to have a piece of the tumor removed. The piece is then purified of cells, and the empty molecules are injected back into the patient to create an immune response to that particular, unique tumor.
Investors have grown impatient with Oncophage’s progress. The share price has remained under $1 on every day but one since Nov. 9. On Dec. 30, the Nasdaq Stock Exchange sent the company a letter saying the stock would be delisted if the company did not come under compliance by June.
Armen said the company has to control costs. Antigenics is currently not conducting any clinical trials and is looking to bring in a partner that could help continue to develop Oncophage.
Antigenics has a revenue-producing asset, a vaccine adjuvant called QS-21. Adjuvants help vaccines work better, and Antigenics is used in 14 vaccine targets in the pipeline of one of its partners, U.K.-based GlaxoSmithKline.
Armen said another strategy would be to acquire some small specialty cancer products, such as medicines that help ameliorate the side effects of chemotherapy. The goal would be to bring in a steady, if small, stream of revenue, and raise the profile of the company. Antigenics also has an early-stage vaccine target for herpes that could attract a partner or acquirer.
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