U.K. may be near 60M dose deal with Sanofi, GSK for second COVID-19 vaccine partnership

Plus €75 million loan for CureVac, Indian approval for Mylan’s remdesivir generic

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The U.K. is reportedly in talks to secure access to a second COVID-19 vaccine, this time from GlaxoSmithKline and Sanofi, as concerns grow over vaccine nationalism.

The government has already partnered with AstraZeneca plc (LSE:AZN; NYSE:AZN) for 100 million doses of AZD1222, the COVID-19 vaccine it's developing with the University of Oxford. AZD1222 is in a Phase II/III trial in the U.K. (see “U.K. Expects First Access on Oxford Vaccine”).

The Sunday Times reported the U.K. government is closing in on a deal to pay GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Sanofi (Euronext:SAN; NASDAQ:SNY) £500 million ($624.4 million) for 60 million doses of their recombinant protein vaccine. The amount will be paid in stages as the vaccine progresses through clinical trials, with the final payment made on delivery.

The vaccine is slated to start a Phase I/II trial in September, with data expected late in 4Q20 and a potential emergency use authorization in January.

GSK declined to comment.

Sanofi told BioCentury, “Our discussions with various countries, including the U.K., are ongoing,” and declined to provide additional details. The French pharma also said it has “engaged in the construction of COVAX,” a global purchasing pool, and supports its mission “to make COVID-19 vaccines available and affordable around the world.”

The COVID-19 Vaccine Global Access Facility (COVAX) was established by the Access to COVID-19 Tools (ACT) Accelerator, a collaboration created in April by global health and private sector organizations (see “WHO Seeks $18 Billion for Vaccines Advanced Market Commitments”).

COVAX’s central idea is to negotiate advanced purchase commitments for vaccines -- guaranteeing manufacturers that they’ll be able to sell specific quantities at predetermined prices -- and couple these with agreements on principle for how countries of different income levels should pay in and receive back, when a vaccine becomes available.

In other vaccine news, German developer CureVac AG closed a €75 million ($84.8 million) loan agreement with the European Investment Bank on Monday. The European Commission had offered to provide up to €80 million in an EIB loan in March.

The funds will go toward the development and large-scale production of its SARS-CoV-2 vaccine and to complete its mRNA production facility in Tübingen, Germany.

CureVac started a Phase I trial of its vaccine in Germany and Belgium last month.

Mylan gets approval for India’s third remdesivir generic
Mylan N.V. (NASDAQ:MYL) said the Drug Controller General of India granted restricted emergency use to its generic injectable formulation of remdesivir as Desrem.

The drug will cost INR4,800 ($64.24) per vial and is approved to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

Last month, India approved injectable remdesivir formulations from Cipla Ltd. (NSE:CIPLA; BSE:CIPLA) and Hetero Drugs Ltd.

Two additional generic manufacturers have non-exclusive licensing agreements with Gilead Sciences Inc. (NASDAQ:GILD) to distribute remdesivir in 127 low- and lower-middle income countries: Pakistan-based Ferozsons Laboratories Ltd. (KSE:FEROZ) and India-based Jubilant Life Sciences Ltd. (NSE:JUBILANT; BSE:530019) (see “Gilead Secures Global Access to Remdesivir”).

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