Thanks to a recent court ruling, a former Celgene sales rep's off-label marketing lawsuit will go forward. The rep, Beverly Brown, claims the company pushed its multiple myeloma drugs Thalomid and Revlimid for uses not approved by the FDA--and a judge says she's produced enough evidence to justify a trial.
Seattle's NanoString Technologies stands to make up to $45 million if it can come up with a successful companion diagnostic test to screen for a subset of lymphoma patients who will benefit from Celgene's blockbuster drug Revlimid.
When it comes to selling big, cancer drugs have a lot going for them. Their targets--deadly diseases that in many cases can kill quickly--put them in high demand, even as they continue to redefine...
Celgene is working to expand its portfolio of drugs, but for now its growth is primarily driven by extending the uses of its megablockbuster Revlimid. As successful as the myeloma drug has been, the U.K.'s NICE is again questioning its cost vs. benefit for certain patients.
New Jersey-based Celgene in 2011 tucked a notice into a financial report that a U.S. Attorney in California was investigating its marketing of its cancer meds Revlimid and Thalomid. Nothing more was said until Thursday when the company divulged that the probe was tied to lawsuits filed against it by whistleblowers.
Celgene CFO Jacqualyn Fouse recently noted the markets have been rewarding the biotech for plainly explaining how its pieces fit together to reward investors. That comfort with the company came into play again today when its shares were unfazed even though it reported lower net income on higher expenses. Investors were placated when the Summit, NJ-based company raised its earnings forecast for the year for the third time.
Celgene CEO Bob Hugin raised some eyebrows at the JP Morgan investor conference in January when he said the company would double sales to $12 billion by 2017. But his remarks look less like boosting with each passing earnings report as the company's small stable of drugs keeps churning out enough cash for the drugmaker to ratchet up projections.
For a long time, pharma companies have looked to large disease populations as the biggest potential revenue streams. But those days are long gone. That perception has shifted, especially with the prescription drug market stagnating in the U.S. and Europe. Orphan drugs--pharmaceutical treatments for rare diseases or disorders--have proven themselves as viable moneymakers, and the industry has taken note. Read the report >>
Today, Celgene said it halted a trial testing Revlimid as a first-line treatment for elderly patients with B-cell chronic lymphocytic leukemia, or CLL. The reason: almost twice as many deaths in Revlimid patients as in control patients.
Celgene's blood cancer drug Revlimid was cruising in the first half of 2013. Now, the U.K.'s cost-effectiveness watchdog has put up a roadblock, but some new positive trial data might keep the setback from taking too much wind out of Revlimid's sails.