VIIV HEALTHCARE PTY LTD

GSK announced that ViiV Healthcare, with Pfizer and Shionogi as shareholders, received a positive CHMP opinion for Vocabria in combination with J&J's Rekambys for treating HIV-1 in adolescents.

The CHMP's positive opinion supports the first long-acting injectable regimen for adolescents with HIV, based on MOCHA study data showing 96.5% virologic suppression at week 24. 99% of participants preferred injectables over daily oral regimens for convenience and burden reduction. Marketing authorization in Europe is expected soon.

Science magazine names twice-yearly lenacapavir PrEP its 2024 Breakthrough of the Year, recognizing its potential to significantly reduce HIV acquisition risk. Lenacapavir, an HIV capsid inhibitor, is administered every six months and shows promise for broader viral disease applications. Gilead is developing longer-acting formulations, including a potential once-a-year injectable version. The breakthrough underscores ongoing efforts to combat HIV/AIDS, with lenacapavir offering a new, effective prevention option.

Lupin received FDA tentative approval for a generic version of ViiV Healthcare’s Triumeq PD, a once-daily HIV-1 treatment for pediatric patients. The product, manufactured in India, combines abacavir, dolutegravir, and lamivudine, with a market value of ~$1.3 million as of September 2024.

Lupin receives U.S. FDA tentative approval for its ANDA of Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, to be manufactured at its Nagpur facility. The product is a once-daily regimen for treating HIV-1 infection in pediatric patients.

The global HIV clinical trials market is projected to grow from USD 1.30 billion in 2024 to USD 2.42 billion by 2034, at a CAGR of 6.4%. Key factors driving growth include increasing HIV infections, R&D investments, drug approvals, and HIV vaccine trials. Phase I trials held the largest revenue share in 2024, while the Asia Pacific region is expected to register the fastest growth. Major companies like Gilead Sciences and Janssen Global Services are significant contributors to the market.

A twice-yearly HIV vaccine, lenacapavir, has shown 100% effectiveness in preventing HIV in women and nearly as well in men. Gilead plans to allow generic versions in 120 high-HIV countries but excludes Latin America, where rates are increasing. UNAIDS' Winnie Byanyima calls the vaccine 'unprecedented' and crucial for ending the epidemic. Gilead aims to expand access globally, but concerns remain over exclusion of Latin American countries, where stigma and rising HIV rates pose challenges.

CVS Caremark adjusts diabetes drug coverage for 2025, removing older therapies like V-go Infusion Pump and Merck's Janumet/Janumet XR, in favor of newer products and generics. Notable additions include Twiist infusion system, Zituvimet, and biosimilars to Lantus. CVS also adds HIV, cancer, and mental health treatments to its formulary.

Halozyme proposes to acquire Evotec for €11.00 per share, creating a leading global pharma services company with capabilities in drug discovery, biologic manufacturing, and drug delivery technologies, diversifying and scaling Halozyme's revenue and EBITDA into the next decade. The all-cash transaction would be funded by cash on hand and new debt, with expected net leverage less than 2x two years post-close.

ViiV Healthcare's DOLCE study showed Dovato, a two-drug regimen, had similar efficacy to a three-drug therapy in viral suppression for advanced HIV patients, with 82% achieving viral suppression at 48 weeks, compared to 80% in the three-drug arm. Safety profiles were also comparable.