PHARMA MARKET:Millennium Looks To Expand Velcade Label,Sales
Dow Jones
October 09, 2007: 03:18 PM EST
Millennium Pharmaceuticals Inc.'s (MLNM) sole product on the market is an injectible blood-cancer treatment called Velcade. The drug is approved as a secondary treatment for multiple myeloma, but the Cambridge, Mass., drug developer is trying to expand Velcade's use to the front line - where further marketing challenges are likely to exist.
THE DRUG: Velcade was co-developed with Johnson & Johnson (JNJ) and launched in May 2003. The drug inhibits proteasomes, which are present in all cells and function to help regulate cell growth. According to the Multiple Myeloma Research Foundation, normal cells appear to be able to recover from intermittent proteasome inhibition in non-clinical studies, but many types of cancer cells die when proteasomes are inhibited, even for a short time.
The most common side effects of Velcade are asthenic conditions, nausea, diarrhea, constipation and peripheral neuropathy.
APPLICATION: Velcade is given in 21-day cycles, according to Millennium, with a vile given on days one, four, eight, and 11. At $1,161 a vile, the cycle costs $4,644. The company recommends patients take Velcade for eight cycles, but the average use is about 5.5 cycles.
In the U.S., the drug is approved to treat patients with multiple myeloma or mantle cell lymphoma who have received at least one prior therapy. Velcade is already approved in the European Union for patients with multiple myeloma after first relapse.
THE COMPETITION: Recurrent myeloma is treated according to prior therapies administered because those are unlikely to be effective if given again. Treatments are frequently given along with high dose of dexamethasone, a steroid, though Velcade is the most useful new drug for treating recurrent myeloma, according to the American Cancer Society.
For newly diagnosed patients, regimens including Thalomid and Revlimid, both made by Celgene Corp. (CELG) are widely used.
THE OPPORTUNITY AND CHALLENGE: The American Cancer Society estimates that about 19,900 new cases of multiple myeloma will be diagnosed in 2007, characterizing the disease as a "relatively uncommon cancer." The five-year relative survival rate for multiple myeloma is around 33%, according to the organization.
In September, Millennium halted a late-stage trial because of Velcade's success in treating newly diagnosed multiple myeloma in conjunction with chemotherapy. The hope is that this data will succeed in the getting approval as a front-line treatment.
Some are skeptical that Velcade sales will benefit from front-line approval, as Revlimid and Thalomid are seen as equally or more effective and are more convenient because of their oral administration.
PERFORMANCE: Velcade is Millennium's only product on the market and had second-quarter sales of $62.6 million, up 6% from a year earlier. The company projects 2007 sales of $250 million to $260 million, a gain of 13% to 18% from $ 220.5 million in 2006.
WHAT WALL STREET SAYS: "We think Velcade is close to full market share in myeloma, the only variable being whether it is used in front line or later; the only upside to Velcade is retreatment use, which is still being investigated. We continue to forecast peak Velcade sales in the U.S. of $400 million by 2010." - Friedman Billings Ramsey analyst Jim Reddoch on Sept. 18.
WHAT MILLENNIUM SAYS: "We are looking at Velcade in various settings, and we have over 300 trials running in exploring different combinations in myeloma, lymphoma, other hematologic malignancies like Waldenstom's Macroglobulemia and Acute Myelogenous Leukemia, but also exploring solid tumors in various different combinations." - Deborah Dunsire, Millennium's president and chief executive, on Sept. 27.
WHAT'S NEXT: Millennium plans to file a supplemental new drug application with the FDA in the first quarter to enable use of Velcade as a front-line treatment for multiple myeloma. Millennium expects the application to get priority review and noted that an approval would double the number of patients eligible to receive Velcade.
Johnson & Johnson, which will handle the filing for the added indication in the European Union, is about to launch what amounts to a "money-back guarantee" for Velcade in the U.K. In order for Velcade be covered by the National Health Service, J&J promised to rebate the cost of the drug for patients who don't meet a pre-specified response target after four cycles of treatment. The average cost for a cycle of treatment is $6,000, according to the U.K. National Institute for Health and Clinical Excellence. NICE had previously determined that Velcade's benefit wasn't worth the cost, but it has been won over by J&J's innovative pricing scheme. A final decision from NICE is expected in late October.
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