ViiV HEALTHCARE LAUNCHES
Today, ViiV Healthcare, a new specialist HIV company established by GlaxoSmithKline (GSK) and Pfizer, was officially launched. Dr Dominique Limet, the Chief Executive Officer of ViiV Healthcare, outlined the company’s ethos and priorities to tackle the increasingly diverse and complex needs of people living with HIV/AIDS worldwide.
Reflecting on the current challenges in HIV and the opportunity for ViiV Healthcare, Dr Limet said, “Rising infection rates and increasingly complex treatment issues have created a challenging landscape in the treatment of HIV and the need for innovative research and better patient resources.”
The discovery of anti-retroviral treatments for HIV was, said Dr Limet ‘a momentous achievement’, turning a life threatening illness into a chronic disease. However, he also noted that at present even those people who have access to proper care and treatment live, on average, ten years less than people without the virus. “This is unacceptable and we must stay relentless in the pursuit of new medicines” maintained Dr Limet.
He acknowledged that research and development into HIV had become more difficult and that to deliver effective medicines a new approach is needed. “In truth, we have to get closer to those people who live with the virus,” said Dr Limet. “Much of our historic effort has been led by the virus – a chase of science. This must continue, but we must also listen and better understand the needs of people living with HIV. If we get this balance right, I believe ViiV Healthcare can really make a difference.”
Strong focus on stimulating research and development
ViiV Healthcare has 10 medicines currently available including therapies such as Epzicom/Kivexa (abacavir sulfate+lamivudine) and Selzentry/Celsentri (maraviroc). Revenues from these available treatments, which generated sales of approximately £1.6 billion in 2008, will provide ViiV Healthcare with financial stability and support sustained investment in its pipeline and programmes.
Dr Limet stated that ViiV would be pursuing ‘multiple’ strategies to develop this existing business and to deliver new growth opportunities, including geographic expansion, new collaborations and business development activities.
The company also has a pipeline of seven innovative and targeted medicines, including five compounds in phase II development. Altogether, ViiV Healthcare has 17 molecules in its portfolio to develop as potential new HIV treatments.
Dr Limet commented, “Our ambition is to conduct research and development both inside and outside ViiV Healthcare. Our R&D efforts, strategic partnerships and licensing opportunities will be focused on delivering medications that help address resistance issues and dosing complexity. Within our own pipeline we have some very exciting molecules, including our late stage integrase inhibitor development programme.”
“ViiV Healthcare’s R&D will not solely focus on creating ‘new’ medicines. We will explore the potential of all our molecules for broader utility, for example to create new formulations and combinations that can help improve adherence or overcome resistance to the virus.”
“We are also actively seeking new collaborative opportunities to address the diverse needs of patients in the developing and developed world,” said Dr Limet. “Our ambition is to leverage the best science, from multiple external partners, to create better treatment.”
ViiV Healthcare has signed a Research Alliance Agreement with GSK and Pfizer under which it will invest in research and development into HIV medicines being conducted by both companies. GSK and Pfizer have also agreed to grant ViiV Healthcare a right of first negotiation in relation to any new HIV-related medicine developed by either GSK or Pfizer.
Dr Limet specifically highlighted the need to drive advances in research for children living with HIV, “A core objective of ViiV Healthcare will be to address the current treatment and formulation gaps faced in responding to paediatric needs. One of our first tasks will be to identify partners to help develop fixed-dosed combinations and we are providing £10 million of seed funding to support a Public Private Partnership approach to the discovery of much needed clinical evidence into new HIV/AIDS medicines for children.”
Access to Medicines
Dr Limet affirmed that improving access to HIV treatments will be a critical priority for ViiV Healthcare. He made it clear that ViiV Healthcare is committed to broadening access to its current medicines for all those people requiring life-saving treatment regardless of income and geography.
“It is essential that ViiV Healthcare continues and builds upon GSK and Pfizer’s commitments to improve access to HIV medicines” said Dr Limet. “We will work to identify ways to best support access, whether it is in developing country settings through not-for-profit, preferential pricing and voluntary licences or by providing assistance for people in need in developed nations”.
The long-standing Positive Action programme, established by GSK in 1992, will be at the core of ViiV Healthcare’s partnership programmes, supporting local communities impacted by HIV/AIDS globally. With an emphasis on community engagement, ViiV Healthcare will support efforts to address the challenges of HIV prevention, tackling stigma and discrimination, building capacity and treatment literacy.
As part of the Positive Action programme, ViiV Healthcare is committed to a recently announced series of initiatives under the new Positive Action for Children Fund, a £50 million programme over 10 years focused on the prevention of HIV transmission from Mother-to Child, and the health and well being of women, orphans and vulnerable children around the globe.
In conclusion, Dr Limet stated that ViiV Healthcare had the potential to “re-energise” the pharmaceutical industry’s participation in HIV.
He emphasised the strong commitment of ViiV Healthcare’s shareholders, GlaxoSmithKline and Pfizer, to the new company and said that he wanted to build upon their heritage and success in developing and providing access to HIV treatments.
“ViiV Healthcare has a sustained commitment to delivering advances in HIV care and treatment. By focusing solely on HIV, we will have the ability to explore a broad and diverse range of opportunities within this specialist area of medicine”, he said. “This is ViiV Healthcare’s potential and our aim is to deliver for all people living with HIV.”
About ViiV Healthcare:
ViiV Healthcare will have worldwide headquarters in London, and US headquarters based in Research Triangle Park, North Carolina. Dr Limet will be a member of the ViiV Healthcare Board and will lead the company’s executive management team with Dr John Pottage, Chief Medical Officer, Subesh Williams, Chief Financial Officer, and Dr Manuel Goncalves, Head of Government Affairs, Patient Advocacy, Community Partnership and Access.
GSK holds an 85% interest in ViiV Healthcare and Pfizer holds 15%. GSK and Pfizer announced that they had agreed to form a new specialist HIV company on 16th April 2009. The transaction was completed on October 30th 2009.
For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.
ViiV Healthcare – A global specialist HIV company established by GlaxoSmithKline and Pfizer to deliver advances in treatment and care for people living with HIV
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Cautionary statement regarding forward-looking statements
GlaxoSmithKline disclosure notice: Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.
Pfizer disclosure notice: Pfizer assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events or developments.
This release contains forward-looking information about Pfizer, GlaxoSmithKline and ViiV Healthcare and about the prospects of the companies, including revenues from in-line products and the potential benefits of product candidates that will be contributed to that company, as well as the potential financial impact of the transaction. Such information involves substantial risks and uncertainties including, among other things, decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates; and competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer’s Annual Report of Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.12
Brand names throughout this document are trademarks of the ViiV Healthcare group of companies.