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HIV Protease inhibitors: let the battle commence!

Posted on: 07 Jun 04

Summary

The continued launch of new ‘boosted’ Protease Inhibitors (PIs) to treat HIV infection are expected to drive growth of today’s HIV drugs market, according to independent market analyst Datamonitor (DTM.L). In a new report*, Datamonitor expects that their launch will contribute to a global commercial market for HIV treatments worth almost $12bn by 2012. Current non-boosted PIs have achieved clinically significant reductions in viral replication prolonging patient life. However, side effects, pill burden and complex dosing constraints of the current generation of PIs, have proved a significant barrier to their continued success. According to the report, as rivals such as Boehringer-Ingleheim, Roche and new players such as Tibotec-Virco, all battle for a share of this burgeoning market, GSK’s dominant position is expected to take a significant hit with its overall market share expected to fall from 41% today to 20% in 2012. Increasing incidence of HIV and unmet need in HIV therapeutics fuels strong interest in continued new product development In 2003, HIV/AIDS is estimated to have killed 3m people worldwide with a further 5m new individuals adding to the existing 34-46m already living with the disease1. Within the Western World, AIDS-related mortality is decreasing thanks to the now widespread use of Highly Active Antiretroviral Therapy (HAART) combination therapy enabling individuals being treated to live decades after initial diagnosis. Despite this apparent success, HIV global incidence is still on the rise. Indeed agencies, such as the US CDC (Centers for Disease Control and Prevention), believe that between one-quarter and one-third of individuals are unaware of their infection, thus continually transmitting the virus. Currently there are 24-marketed antiretrovirals for the treatment of HIV. The majority having been launched between 1990-2000. Datamonitor estimates that the global** commercial market for HIV treatments is worth almost $6 billion2. GSK, responsible for the first product launch of Retrovir in 1987 and key combinations, Combivir (Retrovir/Epivir) and Trizivir (Retrovir/Epivir/Abacavir) has historically dominated, and accounts for just over 40% share of the global HIV treatments market. Bristol Myers Squibb (BMS) follows, with 21% share. Abbott comes third with 12%. Both companies have fast growing products such as Sustiva (efavirenz), Reyataz (atazanavir) and Kaletra (lopinavir/ritonavir). New generation protease inhibitors (PIs) set to boost market Datamonitor estimates that the current generation of PIs account for 25% ($1.5bn) of all HIV antiviral sales. Pill burden, however, has been an outstanding issue affecting the PI class. The frequency of dosage not only affects patient quality of life and ability to adhere to their recommended regimen, but it also continually reminds them about their condition. However, the new generation of ‘boosted’ PIs reduce pill burden and improve side effects such as lipid and metabolic disturbances, and according to Datamonitor will trigger growth in global HIV commercial market . Based on current analysis of the HIV drug pipeline, Datamonitor estimates that, in 2012, the PI market will be worth just over $3bn, double that of today. This represents a compound annual growth of almost 10%. The newly launched ‘boosted’ protease inhibitor Reyataz (atazanavir), a superior lipid profile coupled with ‘once daily’ dosing has already captured 14% of the US protease inhibitor market3. Compared to Abbott’s Kaletra (lopinavir/ritonavir) and GSK’s new Lexiva (fosamprenavir), Reyataz has recorded a faster uptake over an equivalent period after launch. In the three months ending April 2004, the product recorded sales of $75m compared to $88m from June 2003 (when it was launched), to December 2003. Datamonitor believes this is partly due to an effective, well-publicized expanded access program (EAP) and strong BMS pre-launch dissemination of Reyataz clinical benefits. Interestingly, an expanded access program was not conducted for Lexiva. Reyataz which has now been approved in EU market but has a more restrictive labelling. Let the battle commence! With a 9% share, US-based Gilead is currently, the fastest growing company within the HIV market reporting 2003 sales of $570m mainly driven by continued uptake of the NRTI Viread (tenofovir). Newly launched Emtreva (emtricitabine) has only recorded $4m of sales, but is expected to grow rapidly. Datamonitor forecasts sales to reach $436m in 2007. Gilead is also developing an Emtriva/Viread combination. Besides new product launches, a number of development candidates such as Boehringer Ingleheim’s Tipranavir and Tibotec-Virco’s TMC-114 are poised to reach the market in 2005 and 2008 respectively. Both are indicated for patients failing first-line PIs due to drug resistance or problems with regimen tolerability. Boehringer-Ingleheim is currently supplying Tipranavir as part of an Emergency Use Program (EUP) to gather more data, but also build more awareness of the compound prior to launch. Datamonitor forecasts peak sales of $464m in 2010, although TMC-114 is perceived to be a better compound requiring less ‘boosting’. “In the past year company tactical marketing and life cycle management (LCM) programs reveal much about the importance of the PI market. For example, in the US, Abbott raised the price of Norvir (ritonavir) which forms the boosting component of many rival firm’s products. This, in conjunction with the much-touted development of a ‘once-daily’ form of Kaletra, signals that the Chicago based firm are keen to defend their dominant position, comments John Savopoulos, Head of Infectious Diseases Business Unit at Datamonitor. As yet, Abbott does not have any pipeline HIV products. Roche, a long time player in the protease inhibitor market with Invirase, and Viracept (shared with Pfizer), has also recently announced the re-formulation of these products reducing the pill burden from 10 pills per day to 4. “This announcement suggests Roche is not willing to relinquish presence in the HIV field after the perceived first-year failure of Fuzeon and suspension of T-1249,” concludes Mr Savopoulos. Related Datamonitor Research:
  • Pipeline Insight HIV: Enter the new generation inhibitors
  • Datamonitor

    Last updated on: 27/08/2010 11:40:18

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