December 1, 2009 / 4:35 PM / 10 years ago

PREVIEW-Eyes on Celgene's Revlimid data at ASH meeting

What: Annual meeting of the American Society of Hematology

When: Dec. 5-8 in New Orleans

Key data: Revlimid in newly diagnosed multiple myeloma

By Toni Clarke

BOSTON, Dec 1 (Reuters) - Sales of Celgene Corp’s (CELG.O) cancer drug Revlimid could rise by more than a third if data due to be presented next Monday at the annual meeting of the American Society of Hematology shows the drug works better when given early and for extended periods of time.

Revlimid is approved, in combination with dexamethasone, to treat patients with multiple myeloma, a blood cancer, who have failed at least one other therapy.

Now the company wants to show that the drug, which is expected to generate sales of $1.7 billion this year, works in patients who have not received prior therapy.

Preliminary data from the trial, known as MM-015, was released in July. It showed that newly diagnosed patients who were given Revlimid plus the standard treatments melphalan and prednisone, followed by Revlimid alone, lived longer without the disease progressing than those who received melphalan and prednisone followed by placebo.

If detailed results confirm the preliminary data, Celgene could apply for the right to market the drug for newly diagnosed patients. An approval could add $500 million to $700 million to the drug’s annual sales, according to Christopher Raymond, an analyst at Robert W. Baird.

Physicians in the United States are allowed to prescribe drugs however they wish, and some already prescribe Revlimid for newly diagnosed patients. But companies are not allowed to promote drugs for “off-label” uses. In Europe, doctors are not allowed to prescribe off label at all.

Detailed results of the trial, which tested patients over the age of 65 who are not eligible for a stem cell transplant, may also show whether it is beneficial to take Revlimid as a maintenance therapy, to keep the disease in check.

While not the main goal of the trial, investors will be looking closely at the data to see if treating patients with Revlimid, melphalan and prednisone, followed by Revlimid alone (RMP-R), is more effective than treating patients with Revlimid, melphalan and prednisone followed by a placebo (RMP-P).

If so, it could substantially extend the time that patients are on Revlimid.

“That’s where the commercial opportunity is,” said Raymond. “Maintenance use in the U.S. alone would add, conservatively, another $500 to $700 million in annual sales.”

Chances are, the data will be too preliminary to show a clear benefit in the RMP-R arm compared with the RMP-P arm. That information will most likely be available next year. But any hint of an improvement, even if not significant, could add $3.OO or $4.00 to the company’s shares, Raymond said.

Celgene shares have risen nearly 19 percent since late July, when the company said the MM-015 trial was successful. The shares were up 90 cents to $56.35 in morning Nasdaq trade on Tuesday. Future gains will most likely be driven by Revlimid’s effectiveness as a maintenance therapy.

Dr. Antonio Palumbo, lead investigator on the trial and head of the myeloma unit at the University of Torino, said it remains an open question how well patients do on RMP alone, without follow-up with Revlimid. If it turns out that RMP produces a result that is closer to the RMP-R arm than to the MP arm, physicians would likely not use RMP-R as it would not be cost-effective.

“If RMP alone is significantly superior to MP but very close to RMP-R, at that point you drop RMP-R,” he said.

VELCADE

If approved in newly diagnosed patients, Revlimid would compete with Velcade, a drug made by Millennium Pharmaceuticals — now owned by Takeda Pharmaceutical (4502.T) — which was approved for newly diagnosed myeloma patients in June 2008. Celgene’s drug Thalomid has also been approved for newly diagnosed patients.

At the time of Velcade’s approval, a trial known as VISTA showed that after 16 months, patients who took Velcade in combination with melphalan and prednisone (VMP) lived 20.7 months without the disease progressing, compared with 15 months in those taking melphalan and prednisone alone.

The risk of death was reduced by 39 percent.

Millennium plans to release new data on Monday from the same trial. According to a preliminary summary known as an abstract, the data will show that after three years, patients who took Velcade in combination with melphalan and prednisone had a reduction in a risk of death of about 35 percent.

The data also showed that 68.5 percent of patients who took VMP were still alive after three years, compared with 54 percent of MP patients.

Palumbo said it is difficult to draw comparisons between trials. However, he said that with the data currently available, he would most likely treat relatively young patients with aggressive disease with Velcade — given by infusion in a doctor’s office — in combination with melphalan and prednisone.

For patients who are older, perhaps less able to get to a doctor’s office and whose disease is not as aggressive, he would most likely use melphalan and prednisone with either Thalomid or Revlimid. Both are oral drugs in the same class.

“The real truth is that today, whether we give Thalomid, Revlimid or Velcade, we significantly improve outcomes when compared to MP alone,” he said. “From here, to say one drug is better than the other is something people will probably discuss for the next 10 years because the differences are only subtle.” (Reporting by Toni Clarke; editing by John Wallace) ((toni.clarke@thomsonreuters.com; 617-856-4340; reuters messaging: toni.clarke.reuters.com@reuters.net))

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