Approval for Merck’s Isentress

The European Union (EU) recently expanded the approval of Merck’s (MRK - Analyst Report) Isentress (raltegravir) for the first line treatment of HIV patients. Earlier, it was approved for patients who had not responded to other treatment options. In the US, following a recent Food and Drug Administration (FDA) approval, Isentress can be used in combination therapy for previously untreated patients as well.

Isentress recorded worldwide sales of $172 million for the second quarter of 2009, an increase of 123% compared with the year-ago period. We believe the recent FDA and EU approval (for previously untreated patients) could increase the number of targeted patients considerably, leading to a significant rise in sales. We expect the drug to record more than $1 billion in revenues by 2011.

Recently, at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held at San Francisco , Merck presented data from a study comparing Isentress with Bristol-Myers Squibb’s (BMY - Analyst Report) Sustiva (efavirenz) for 96 weeks in 563 previously untreated HIV patients. Patients who entered the study were required to have HIV viral loads greater than 5000 copies/mL.

The study found that treatment with Isentress resulted in similar virologic control as witnessed with patients treated with an efavirenz-based combination treatment. About 81% of the patients assigned to the raltegravir treatment arm had undetectable levels (below 50 copies/mL) of circulating HIV RNA compared to the 79% of patients treated with efavirenz.

According to the Centers for Disease Control and Prevention (CDC), in 2006 there were more than one million people in US living with HIV and AIDS. An estimated 33 million people are living with HIV and AIDS worldwide, and about 2.7 million new infections occurred worldwide in 2007. AIDS is one of the top causes of infectious disease-related mortality worldwide, responsible for approximately two million deaths in 2007 alone.

Gilead Sciences (GILD - Analyst Report), Bristol-Myers Squibb, GlaxoSmithKline (GSK - Analyst Report) and Abbott Labs (ABT - Analyst Report) are the major players in this segment.

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