GSK will hold an 85% interest, but ownership will shift according to milestones achieved by parent firms’ pipeline drugs.

GlaxoSmithKline (GSK) and Pfizer are creating a joint venture focused on HIV drug discovery, development, and commercialization. The new company will start off with 11 marketed products, six pipeline candidates, and will be fueled through the founder firms’ R&D activities.

The transaction expands GSK’s marketed portfolio, helping to reduce the impact of future patent expiries of several HIV products. It also provides the company with access to a broad range of new pipeline assets. For Pfizer, the collaboration will provide Selzentry/Celsentri and its pipeline assets with access to GSK’s global HIV commercial organisation and HIV distribution network.

Under the agreement, GSK will hold 85% of equity interest in the new company. This structure will be adjusted with the achievement of specific sales and regulatory milestones.

GSK and Pfizer estimate that with 11 approved products, the new entity could hold nearly a fifth of the market share. Sales of these therapies including Combivir, Kivexa, and Selzentry/Celsentri together reached £1.6 billion, or $2.38 billion, in 2008, says GSK.

A further six medicines are in the new firm’s pipeline, four of which are in Phase II development. The new business will focus on innovative HIV treatments as well as formulations that improve adherence and overcome resistance to the virus. Altogether, the new company will have 17 molecules at its disposal to develop in fixed-dose combinations as possible new HIV treatments.

The new company will contract R&D services directly from GSK and Pfizer to develop these medicines. Additionally, it will invest in HIV-related R&D activities at GSK and Pfizer, which will be conducted under the newly inked research alliance agreement. This agreement gives the new firm exclusive rights of first negotiation on all products.

Depending on certain milestones or regulatory events, the equity holdings could shift, according to the agreement. If all products achieve their goals, Pfizer’s stake will increase to 24.5%, and GSK would hold the remaining 75.5%. If Pfizer’s contributions are successful but not those of GSK’s, Pfizer’s stake would increase to 30.5%. If only GSK’s milestones are achieved, GSK will own 91%.

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