BMS’ dasatinib expected to rival Gleevec
Posted by rob on November 22, 2005 under Uncategorized | 
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By STEVE MITCHELL
WASHINGTON, Nov. 21 (UPI) — An analyst firm predicts Bristol Myers Squibb’s chronic myelogenous leukemia drug dasatinib, which is currently in phase 2 trials, could be as clinically and commercially successful as Novartis’ Gleevec.
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Novartis may still be in the running, however, because their AMN-107, which also is in phase 2, appears to have the potential to tackle Gleevec-resistant CML cases.
Dasatinib and AMN-107 are second-generation protein tyrosine kinase inhibitors, and both stand to gain accelerated approval by the Food and Drug Administration if they pan out in clinical trials, said Nish Saini a senior oncology analyst with Datamonitor who authored a new report on the future of CML therapies.
“Should the ongoing Phase II studies confirm dasatinib’s clinical benefit in Gleevec-resistant or -intolerant patients, Datamonitor believes it is likely to garner accelerated approval from the FDA,” Saini said. “Similarly, should Phase II data consolidate the demonstrable Phase I activity of AMN-107, Novartis has the opportunity to drive accelerated approval.”
Novartis might have a competitive advantage because of its experience marketing Gleevec. If Novartis can capitalize on this background and establish AMN-107 as a standard for Gleevec-resistant CML, the company could gain a secure foothold in the CML market, Saini said.
Gleevec, a protein tyrosine kinase inhibitor launched in 2002, proved enormously successful due to its ability to provide effective treatment with little toxicity. The drug had sales of nearly $1 billion in 2004. However, many CML cases are resistant to Gleevec and there is a need for new medications to fill that gap.
“Resistance, along with Gleevec’s relatively modest response rate amongst patients with advanced disease indicate the need for novel, efficacious second line treatment strategies to counter these challenges,” Saini said.
Decision Resources, an analyst firm in Waltham, Mass., said in a May report that it expected the anticipated launches of dasatinib and AMN-107 to “increase patient drug consumption by offering a viable, and likely durable, second-line pharmacological approach to the treatment of chronic CML.”
Decision Resources differs from Datamonitor, however, and expects BMS’ dasatinib to have the biggest influence on the market.
The drug “is active against a wider range of resistance-conferring mutations compared with AMN-107 and is widely hailed as the more promising agent,” the Decision Resources report said. The approval of the drug for first-line treatment in combination with Gleevec “would have enormous impact on the CML market,” the report stated.
Decision Resources predicted the market for CML therapies will grow by nearly 12 percent per year from 2004 to 2009 due to the launch of new medications for the disease, but then it is expected to drop to less than 1 percent per year until 2014.
Other protein tyrosine kinase inhibitors in development that could have an impact, include Aria Pharmaceuticals’ AP-23464 and Wyeth’s SKI-606, Decision Resources said. Both are in preclinical development.
Another medication that could factor into the CML market in 2006 is Supergen/MGI Pharma’s decitabine. Decision Resources said this drug is pre-registered in the United States and Europe for myelodysplastic syndrome, although it is not yet approved by any regulatory agency. Decitabine is expected to be used off-label beginning in 2006 in patients with accelerated- and blastic-phase CML. These forms of CML can be difficult to treat but they have responded well to decitabine.
If new protein tyrosine kinsase inhibitors are launched, Decision Resources said, they will likely have a negative impact on the development of other CML medications, such as ChemGenex’s Ceflatonin and Cell Therapeutics’ Trisenox.
The report stated that doctors said they would be reluctant to enroll patients in trials for these drugs if they are eligible for studies involving protein tyrosine kinase inhibitors.
Copyright 2005 by United Press International. All Rights Reserved.