Drugs in the Pipeline Analysis

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Generic Drug Name (Brand) Drug Company Route Indication(s) Regulatory Priority review * Status Therapeutic Considerations Affected Population Estimated Peak Sales Estimated Cost/day raltegravir (Isentress ) Merck Oral Priority review For the treatment of HIV-1 infections in treatmentexperienced patients NDA submitted: 4/2007 Estimated approval date: 10/2007 Isentress belongs to a new class of investigational antiretroviral therapy (ART) agents called integrase inhibitors that inhibit the insertion of the HIV viral DNA into human DNA. Integrase is one of three HIV enzymes - reverse transcriptase, protease and integrase - required by the virus to reproduce. The proposed use of Isentress is in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Results from two Phase III studies of Isentress demonstrated significantly greater antiretroviral activity when used in combination with optimized background therapy (OBT) versus placebo plus OBT in treatmentexperienced HIV-infected patients who had failed antiretroviral therapies and who had HIV virus resistant to at least one drug in each of the three available classes of oral ARTs. An estimated 40 million people are currently infected worldwide, and it is estimated that more than four million new infections occur worldwide annually. AIDS is one of the top causes of infectious diseaserelated mortality worldwide, responsible for approximately three million deaths each year. NA $20 - $30 per day Isentress is being studied in a twice daily Updated 8/2007 Copyright © 2007 Medco Health Solutions, Inc. 6
Generic Drug Name (Brand) Drug Company Route Indication(s) Regulatory Priority review * Status Therapeutic Considerations Affected Population Estimated Peak Sales Estimated Cost/day sevelamer carbonate (Renvela ) Genzyme Oral Control of serum phosphorus in patients with chronic kidney disease on hemodialysis NDA submitted: 12/2006 Estimated approval date: 10/2007 regimen as a single tablet administered without regard to food. Isentress does not require boosting with ritonavir. Isentress is also being investigated in treatment-naïve patients with HIV. Renvela is a follow-on product to Renagel with the hope of once-daily dosing. The proposed indication is the same as for Renagel, control of serum phosphorus in patients with chronic kidney disease on hemodialysis. Renvela would initially come in 800 mg tablets (which would not necessarily improve dosing), but the compound is also being studied in powder. Initial studies of the once daily powder showed that it was not as effective as Renagel. However, the powder will allow for sprinkling Renvela on food. According to prescribing information, Renagel patients must take one to four tablets three times daily with meals, depending on serum phosphorus levels. Renagel is dosed in 400 mg and 800 mg tablets. According to Genzyme, patient compliance has been an issue with Renagel. Genzyme is also seeking to expand the patient population for According to Genzyme, there are over 300,000 patients with stage 5 chronic kidney disease on dialysis in the United States. These patients have limited or no kidney function and depend on dialysis, along with dietary restrictions and phosphate binders to minimize serum phosphorus. Hyperphosphatemia and the secondary hyperparathyroidism that results have NA $10 - $12 per day Updated 8/2007 Copyright © 2007 Medco Health Solutions, Inc. 7
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Drugs in the Pipeline Analysis

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