Healthcare Industry News:  Atripla 

Biopharmaceuticals HIV/AIDS

 News Release - November 15, 2007

Significant Changes in Store for Growing HIV Market

London, Nov 15, 2007--(HSMN NewsFeed)--Worth $8 billion in 2006, the HIV market is expected to grow in value to an estimated $11.5 billion in 2016. The market is also expected to undergo significant changes during this time, with the patent expiries of several key products and the launch of several new drugs from both existing and new drug classes reshaping the entire HIV treatment paradigm. The biggest casualty in this evolution will be GlaxoSmithKline, which will see its long reign as the undisputed king of the HIV treatment market come to an end, as its aging portfolio of HIV drugs gradually lose their patent protection, according to new research* by independent market analyst Datamonitor.
Key patent expiries drastically reduce market share of leading HIV companies

The HIV market generated sales of about $8 billion in 2006 across the six major markets**. In the next 10 years patent expiries and new product launches are expected to bring significant changes to the HIV market. In fact, approximately 65% of the currently marketed drugs are expected to lose patent protection in the next five to 10 years. This will have a significant impact on the market share of several of the leading HIV companies – most dramatically for the long-standing HIV market leader, GlaxoSmithKline (GSK). However, the negative impact of these patent expiries on the HIV market as a whole will be counteracted by several newly introduced products and launches of developmental products from both existing and new drug classes. These drugs will ultimately change Highly Active Antiretroviral Therapy (HAART) regimens for both early and late stage therapy, and by 2016, Datamonitor expects the total value of the market to rise to approximately $11.5 bn.

Since the launch of the first antiretroviral, Retrovir in 1997, GSK has dominated the HIV market. In 2006, it accounted for 30% of total antiretroviral sales. However, this marked a notable decline from 2005 when it accounted for 33% of the overall market. Although GSK currently has eight marketed products, the majority are relatively old and at least five of them are expected to lose patent protection by 2014, according to Datamonitor infectious diseases analyst Mansi Shah. “As a result, GSK’s market share may be drastically reduced by 2016 if it does not find successful new products.”

Gilead and Bristol-Myers Squibb (BMS) are the second and third leading companies in HIV. The success of Viread and Truvada has led to Gilead rapidly gaining market share with the company’s HIV portfolio accounting for 23% of total antiretroviral sales in 2006. The collaboration between Gilead and BMS resulted in the first cross-class fixed dose combination (Atripla) consisting of Truvada and Sustiva. Atripla combines all three components of HAART – two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTIs) – into a single pill that can be taken once daily. It generated first year sales of $174million in the US alone owing to its simplicity and convenience. Atripla is expected to be launched in the EU in H2 2007 and Datamonitor believes it will dominate first-line therapy and generate substantial sales for Gilead and BMS.

A recent entrant into the HIV market is Tibotec/Johnson & Johnson (J&J), which currently only have one marketed product, Prezista. A future broader label for this protease inhibitor (PI) and the potential launches of the company’s developmental NNRTIs are likely to generate significant revenues for the company, making Tibotec/J&J one of the leading HIV companies by 2016.

New products will reshape established treatment paradigms

The reformulation of existing drugs into fixed dose combinations such as Gilead and BMS’ Atripla, and the increased availability of once-daily therapies such as Abbott’s Kaletra and BMS’ Reyataz have simplified early lines of treatment . Such therapies have more convenient dosing schedules and have a significantly reduced pill burden, thereby improving the quality of life for patients. Additionally, the launch of several new drug classes such as CCR5 inhibitors and integrase inhibitors from 2007 onwards will significantly change treatment paradigms for late stage therapy as they will give rise to countless new drug combinations for this patient population.

Atripla, a fixed dose combination of Truvada and Sustiva, has been the first drug to combine the components of HAART into a single pill that can be taken once-daily. It is already dominating first line regimens across the US due to the relative ease of the dosing regimen, Shah says. “The PI class has traditionally been associated with high pill burden and complicated dosing regimens. However, the availability of once daily Reyataz and reformulation of Kaletra into once daily tablets has resolved this issue for this particular class,” she says.

Tibotec/J&J’s PI Prezista is currently only approved for treatment-experienced patients. A once daily formulation of the drug was recently compared against the currently leading PI, Kaletra in a Phase III trial called ARTEMIS in treatment-naïve patients (those that have never received any form of HIV treatment). Data from this study supports the use of Prezista in early-stage therapy where it could become the preferred PI for first line patients. Datamonitor forecasts Prezista to become the leading PI by 2016, accounting for 27% of the HIV protease inhibitor market. Tibotec also has two NNRTIs in development, etravirine (TMC125) and rilpivirine (TMC278), Shah says. “The company has filed a new drug application for etravirine based on data in trials in treatment-experienced patients and has designed a phase III program for rilpivirine in treatment naïve patients.

“Datamonitor expects a US launch for etravirine early 2008,” she says.

By 2016 Datamonitor expects new drugs to account for almost half of total antiretroviral sales across the 6MM. New classes of drugs such as Pfizer’s recently approved Selzentry/Celsentri (CCR5 inhibitor) and Merck’s Isentress / raltegravir (integrase inhibitor) offer a novel mechanism of action and are therefore effective against strains of HIV that are resistant to currently available classes. Selzentry has been approved for treatment-experienced patients and it is likely Merck’s Isentress will be approved for the same patient population. Other developmental drugs from these classes include Schering Plough’s CCR5 inhibitor vicriviroc in Phase III development and Gilead’s integrase inhibitor elivitegravir (GS-9137) in Phase II development, Shah says. “Also in Phase II development are Panacos’ maturation inhibitor bevirimat and Tanox’s attachment inhibitor TNX-355.

“Bevirimat targets the viral maturation process while TNX-355 is a CD4 receptor inhibitor. So while the patent expiry of many of the currently efficacious and financially successful drugs is bad news for drugs developers, the good news for HIV patients is that there are a number of novel and very promising treatments in the development pipeline,” she says.

Notes for editors

*Commercial Insight: HIV - Reshaping Treatment Paradigms
**The six major markets are the UK, US, France, Germany, Italy and Spain.

Datamonitor’s report Commercial Insight: HIV - Reshaping Treatment Paradigms, explores key issues in the HIV market including an in-depth assessment of currently marketed HIV drugs as well as focusing retrospectively on their market dynamics in the last five years across the 6MM.

Source: Datamonitor

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