Viatris

Seven leading pharma companies released first-quarter 2021 financial results in May, while one Japanese firm reported full-year 2020 results for the fiscal year ending in March. (Figures exclude exchange rate and portfolio changes where applicable.)
 
Leading the pack, first-quarter sales for South Korea’s newly public SK Bioscience soared 397% year-over-year to $101.1 million, as its Covid-19 vaccine CMO business started “making numbers in earnest” in supplying the AstraZeneca/…

ViiV Healthcare has started a rolling submission for U.S. FDA approval of long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP), the GSK subsidiary announced Tuesday. The U.S. regulator awarded Breakthrough Therapy Designation to the PrEP formulation in November 2020, after Phase 3 data showed that an injection every two months was 89% more effective than Gilead’s daily Truvada (emtricitabine/tenofovir disoproxil fumarate) in preventing HIV acquisition in women.

Viatris detailed last week previously announced plans to close, downsize or divest up to 15 manufacturing sites deemed “no longer viable”—a multiyear initiative that could affect up to 20% of its global workforce.

The Pennsylvania-based generics company (formed last month through Mylan’s merger with Pfizer’s Upjohn) had promised investors that restructuring would help reduce costs by $1 billion by the end of 2024.

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Newly formed generics giant Viatris announced Monday that the U.S. FDA has tentatively approved its 10mg pediatric dolutegravir antiviral tablets for oral suspension for treatment of HIV-1.

According to the press release, the tentative approval—granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)—permits the distribution in certain PEPFAR countries of generic products still under U.S. patent or exclusivity protection.

Pfizer’s Upjohn generics subsidiary…

Pfizer’s Upjohn generics subsidiary and Mylan formally launched Viatris—the new company resulting from their merger—on Monday. With operations in Hyderabad, Pittsburgh and Shanghai, Viatris has projected 2020 revenue of about $19.4 billion, according to FiercePharma.

In the press release announcing its launch, the new company also revealed “a significant global restructuring program” seeking $1 billion in savings.

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U.S. regulators have cleared Mylan’s merger with Pfizer’s Upjohn generics subsidiary (pending the divestiture of several drugs), the companies announced last week. Noting that they’ve now secured all necessary antitrust clearances, their joint press release said the newly merged entity—Viatris—will formally launch on November 16.

In other deal news, Gilead in late October announced the completion of its $21 billion acquisition of New Jersey-based oncology specialist Immunomedics.

Mylan and Pfizer announced yesterday that they’ve added a nod from the European Union to their tally of approvals for Mylan’s merger with Pfizer’s Upjohn generics subsidiary, subject to Mylan divesting certain products in Europe.

Mylan’s executive chairman said the companies remain on track to close the deal—creating a new combined entity, Viatris, projected to be 57% owned by Pfizer’s shareholders—before year-end.

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