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Pfizer/GSK HIV Spin-Off ViiV Healthcare Debuts With Personalized Drugs in Portfolio

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By Turna Ray

ViiV Healthcare, GlaxoSmithKline and Pfizer’s joint spin-off venture to market HIV treatments, will include in its pipeline at least two personalized drugs — Epizicom, which combines lamivudine and the genetically targeted abacavir, and the CCR5-antagonist Selzentry.

ViiV Healthcare, which GSK and Pfizer launched last week, is a new company combining the two firms’ HIV divisions and products. The companies first announced the decision to create the spin-off in April.

The transaction was completed Oct. 30. Eighty-five percent of ViiV Healthcare will be controlled by GSK and 15 percent by Pfizer. The company currently has 10 drugs in its portfolio, including Epizicom and Selzentry, and seven late-stage investigational drugs in its pipeline.

According to CEO Dominique Limet, ViiV Healthcare’s unique structure has the potential to “re-energize” the pharmaceutical industry’s involvement in driving HIV treatment innovation and improving access. However, it is currently unclear how prominent pharmacogenomically guided treatments will feature in ViiV’s R&D activities.

“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,” Limet said in a statement.

According to Limet, ViiV Healthcare launched in the face of growing innovation difficulties in the field of AIDS treatments. “In truth, we have to get closer to those people who live with the virus,” Limet said. “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.”

The two PGx-guided treatments already in ViiV’s portfolio could give the company a better strategic position in the personalized medicine arena than many other top drug firms.

For instance, one of the drugs, Selzentry, is indicated for CCR5-tropic HIV-1 patients and is marketed with Monogram’s companion diagnostic test Trofile, which is designed to establish a patient’s tropism status prior to administering the drug. Pfizer and Monogram this year extended its existing deal to globally market the assay to support Selzentry access. [see PGx Reporter 05-18-2009].

The other drug, Epizicom, combines abacavir and lamivudine. The US Food and Drug Administration last year updated the labeling for abacavir to include information about the increased risk of fatal hypersensitivity reaction in HIV patients who have the HLA-B*5701 allele [see PGx Reporter 07-30-2008].

It is unclear how the transferal of Selzentry and Epizicom to ViiV will impact the companion diagnostic developers for these drugs. LabCorp, which acquired Monogram over the summer and markets an HLA-B*5701 test, did not respond to questions prior to deadline.

Under the terms of the deal to create ViiV Healhcare, the new AIDS treatment-focused firm signed a Research Alliance Agreement with GSK and Pfizer to invest in the two companies’ R&D activities in HIV. In turn, GSK and Pfizer will grant ViiV Healthcare a right of first negotiation whenever either firm develops a new HIV-related medicine.

The 10 marketed drugs in ViiV’s portfolio generated around £1.6 billion ($2.65 billion) in sales in 2008, which “will provide ViiV Healthcare with financial stability and support sustained investment in its pipeline and programs,” GSK said in a statement announcing the company’s launch.

Since developing new treatments will be a major focus at ViiV, Limet noted that the company will employ “multiple” strategies, including geographic expansion, strategic partnerships, and licensing opportunities to advance HIV treatments for resistance and dosing.

Meantime, the seven investigational treatments in ViiV’s pipeline comprise five compounds in phase II development, including a late-stage integrase inhibitor development program. In total, the company is nursing 17 molecules in its portfolio to potentially develop into new HIV treatments.

“ViiV Healthcare’s R&D will not solely focus on creating ‘new’ medicines,” Limet added in the statement. “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.”

According to Limet, ViiV will seek strategic collaborations in developing countries, where AIDS and HIV are prevalent, and focus research activities in finding treatments for children with HIV.

“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,” Limet said.

One of the main reasons for the spin-out, according to GSK and Pfizer, is to improve access to HIV drugs.

“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,” Limet said. He added that GSK’s Positive Action community partnership program to improve HIV prevention and education will feature as a core component of ViiV.

Selzentry and Epizicom are both marketed globally.

ViiV Healthcare is headquartered in London, and is based in the US in Research Triangle Park, NC. The company’s executive management team includes John Pottage as chief medical officer, Subesh Williams as chief financial officer, and Manuel Goncalves as head of government affairs, patient advocacy, community partnership, and access.

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