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Celgene Cancer Pill to Triple Sales on Data Threatening J&J

http://www.bloomberg.com/apps/news?pid=20601087&sid=aQWaVfVDmVN8&pos=7

By Elizabeth Lopatto

Nov. 30 (Bloomberg) -- Celgene Corp. can more than triple sales for its best-selling cancer pill Revlimid on new data that may convince doctors to choose the drug as a first option over Johnson & Johnson’s intravenous medicine, Velcade.

Revlimid generated $1.3 billion in sales last year as a back-up therapy for patients with the blood cancer multiple myeloma who don’t respond to other options. Findings from research to be reported next week will show how well the pill works as a first-choice treatment, in long-term use and against other tumors. A preliminary report on one study, released in July, suggested Revlimid helped patients live longer.

About 20,000 Americans are diagnosed yearly with multiple myeloma, which kills two-thirds of patients within five years, said Kenneth Anderson, a professor at Harvard Medical School in Boston. Broadened use of Revlimid may push annual sales to $4.4 billion by 2016, said Mike King, a Merriman Curhan Ford & Co. analyst in New York, in a telephone interview.

Positive results “change the standard of care,” said Anderson, who is an oncologist at Boston’s Dana-Farber Cancer Institute, in a telephone interview. “We treated the very first patients with Revlimid here many years ago. I have patients who have now spent 10 years on Revlimid therapy who are doing quite well. People will be very willing to go onto maintenance therapy” with this drug, he said.

Celgene, of Summit, New Jersey, fell 78 cents, or 1.4 percent, to $54.97 in Nasdaq Stock Market composite trading on Nov. 27. The stock had increased 5.5 percent in the 12 months before today. J&J, based in New Brunswick, New Jersey, declined 41 cents to $62.89 in New York Stock Exchange composite trading.

Bone Marrow Tumors

Multiple myeloma causes malignant plasma cells to form tumors, and hinders the body’s ability to fight infections. Revlimid, derived from the drug thalidomide, works by programming cancer cells to commit suicide, and by creating an environment that stalls tumor reproduction.

Celgene reported early results in July on the so-called MM- 015 study, designed to show whether using Revlimid and two older cancer therapies helped patients live longer than taking only the other drugs. That report suggested patients may benefit, and that the therapeutic effect was superior to Velcade’s in a similar trial, said Mark Schoenebaum, a Deutsche Bank analyst in New York, in a telephone interview.

The MM-015 trial is one of more than 200 involving Celgene to be reported at the American Society of Hematology meeting starting Dec. 5 in New Orleans. Given that Revlimid generated 59 percent of Celgene’s revenue last year, the MM-015 data will be “the first, second, and third act” of the meeting for Celgene, Schoenebaum said.

Market Share

“The better the data” on that study, Schoenebaum said, “the more market share Revlimid gains.”

Convenience will drive increased Revlimid use, because patients will prefer a once-a-day pill to infusions done in a medical office, said Ivan Borrello, an associate professor of oncology at Johns Hopkins University in Baltimore.

“Does someone who’s actively working want to go into a doctor’s office twice a week to get Velcade?” Borrello said in a telephone interview.

Revlimid was approved in the U.S. in December 2005 for patients with myelodysplastic syndromes, disorders of the blood cells that can lead to leukemia. It was cleared six months later for use as a secondary multiple myeloma therapy.

Celgene already has gained about 30 percent of the first- line multiple myeloma market, even though it doesn’t yet have U.S. approval for that use, said Yaron Werber, an analyst with Citigroup Global Markets, in a note to clients this month. Velcade’s share is about 40 percent, Werber said.

Velcade Sales

Velcade sales surged in 2008 after it won U.S. clearance as a primary treatment for multiple myeloma.

J&J, the world’s biggest maker of health products, markets Velcade outside the U.S. and last year reported a 47 percent increase in revenue to $787 million. Japanese drugmaker Takeda Pharmaceutical Co., of Osaka, sells the medicine in the U.S., where it generated $413.7 million last year, a 43 percent jump, said Lauren Musto, a spokeswoman.

The study that helped Velcade win clearance for first-line use in 2008 was a test similar to Celgene’s MM-015 research. Each trial examined whether patients lived longer without their tumors worsening after adding the new drug to a standard regimen of two older therapies, the steroid prednisone and Celgene’s Alkeran, sold generically as melphalan.

In the Velcade trial, patients kept cancer at bay an average of eight months longer when the drug was added to the regimen. For that trial, patients were treated for 39 weeks.

‘Big Win’

The Revlimid trial included 30 weeks of therapy or placebo, said King, of Merriman Curhan Ford.

“So you tie Velcade? That’s a big win,” King said. “You’re treating for a shorter duration, plus it’s a once-a-day pill rather than a twice-weekly infusion.”

J&J declined to comment, referring calls to Takeda.

Manisha Pai, a U.S. spokeswoman for Takeda, said in an e- mailed statement that she was “looking forward to interesting data at ASH that examine both the cost and convenience of Velcade compared with oral multiple myeloma therapy options, such as lenalidomide and thalidomide.”

Revlimid is designed to be a more potent derivative of thalidomide, first approved in the U.S. in 1998 for leprosy, a progressive skin disease. This family of medicines can also trigger the immune system to fight tumors and hinder growth of blood vessels that nourish them.

Thalidomide was linked to severe birth defects, including malformed limbs, in the 1960s and temporarily withdrawn from the market. The drug returned as a potent tumor-fighter, with a warning against use in women who are pregnant.

Thalidomide Risks

Because multiple myeloma is a difficult-to-diagnose form of cancer, it is often found late, when the benefits of treatment outweigh the risks associated with thalidomide, Harvard’s Anderson said.

“Revlimid has made a remarkable difference in terms of the response you can achieve,” Anderson said. “The characteristics that make it attractive are that it’s oral, low dosage, and has few side-effects.”

Celgene will also present preliminary results from its test of Revlimid as maintenance therapy at the hematology meeting, with more detailed results to follow in 2010 at the American Society of Clinical Oncology conference.

That trial, called IFM-05-02, “has the potential to establish Revlimid as long-term maintenance therapy,” said Geoffrey Porges, an analyst for Sanford C. Berstein & Co. in New York, in a Nov. 11 note to investors.

Other Cancers

Additional data at the hematology meeting will show how Revlimid works when combined with Velcade and Swiss drugmaker Roche Holding AG’s tumor-fighter Rituxan, approved in non- Hodgkin’s lymphoma and rheumatoid arthritis.

Revlimid is also being tested in chronic lymphocytic leukemia, a cancer of the white blood cells, and in so-called smoldering, or aysmptomatic, multiple myeloma.

Another study at the hematology meeting will offer the first large human study results for Celgene’s experimental drug pomalidomide, a next-generation product in the same family of medicines as Revlimid.

Pomalidomide “is expected to have significantly greater potency,” and “may genuinely have a role in late line multiple myeloma, even in patients who have progressed on prior Revlimid,” Porges said in his note.