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2023-10-03| Manufacturing

GSK Boosts HIV Drug Business Forecasts as Apretude Sales Surge

by Sinead Huang
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British pharmaceutical giant GlaxoSmithKline (GSK) has announced an upward revision of its medium-term growth forecast for its HIV drug business, ViiV Healthcare. This development follows robust sales performance, particularly in long-acting injectable drugs designed to replace daily pills for both the prevention and treatment of HIV.

Related article: ViiV Healthcare to Present First Head-to-head Data for New HIV Treatment Regimen Cabenuva Against Biktarvy

The Significance of ViiV Business

The ViiV business, with investments from Pfizer and Shionogi, has become a pivotal component of GSK’s strategy to bolster investor confidence in the company’s drug development pipeline. This move aims to address the gap between GSK and its competitors in this area. Strong sales of HIV medications have contributed significantly to the company’s improved earnings guidance for 2023, announced in July, along with the sustained growth in demand for GSK’s shingles vaccine.

During a recent capital markets day focused on GSK’s HIV business, the company set its sights on annual sales growth rates ranging from 6% to 8%. These projections aim to reach between £6 billion and £7 billion by 2026, a notable increase from the previously expected “mid-single-digit” percentage growth.

Apretude’s Impact and Future Plans

Apretude, a long-acting anti-HIV drug administered every eight weeks, has played a pivotal role in GSK’s recent success. The drug, designed to replace daily pills for preventing HIV infection, has gained acceptance among individuals at high risk of contracting the virus. GSK’s subsidiary, ViiV Healthcare, also offers Cabenuva, a similar long-acting injectable drug for HIV treatment.

In the realm of HIV prevention, where it is known as pre-exposure prophylaxis (PrEP), Apretude faces competition from Gilead Sciences’ daily pill Truvada and a more affordable generic version marketed by Teva as Atripla.

Expansion and Future Developments

Deborah Waterhouse, CEO of ViiV Healthcare, expressed optimism about Apretude’s performance, noting broad reimbursement in the United States and strong adoption. The drug received U.S. approval in late 2021 and gained European approval recently in 2023. The company is now actively exploring reimbursement options in various European countries.

Building upon Apretude’s success, GSK aims to introduce a preventive drug regimen in 2026 that requires administration once every four months, with plans for an even longer interval of once every six months by the end of the decade.

Patent Expiry and Future Prospects

Dolutegravir, ViiV’s top-selling anti-HIV drug, achieved substantial sales of £1.3 billion in the second quarter of 2023. The drug’s core patent is set to expire gradually, commencing in 2028. While the core patent will expire in the United States in April 2028 and in Europe in mid-2029, Waterhouse indicated that the U.S. patents for two dolutegravir-containing branded drugs would remain valid until 2029 and 2030.

In conclusion, GSK’s strong performance in the HIV drug business, driven by the success of Apretude and a promising future outlook, underscores the company’s commitment to combating HIV/AIDS and providing innovative solutions to patients worldwide.

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