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Gilead secures global access to remdesivir via generic manufacturing deals

IMI unveils grant recipients; plus Glenmark starts India Phase III and updates from CanSino, Moderna

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The first manufacturing deals for Gilead’s remdesivir, plus a series of grants for institutions across Europe to develop COVID-19 diagnostics and therapeutics, highlight the importance of global collaboration to tackle the pandemic.

Gilead Sciences Inc. (NASDAQ:GILD) on Tuesday signed non-exclusive voluntary licensing agreements with five companies in India and Pakistan to manufacture remdesivir for distribution in 127 countries, nearly all low- and lower-middle income.

The generic manufacturers are Cipla Ltd. (NSE:CIPLA; BSE:CIPLA), Ferozsons Laboratories Ltd. (KSE:FEROZ), Hetero Labs Ltd., Jubilant Life Sciences Ltd. (NSE:JUBILANT; BSE:530019) and Mylan N.V. (NASDAQ:MYL).

The companies will set their own prices for the generic product.

The remdesivir licenses will be royalty-free until the WHO declares an end to the public health emergency or another therapeutic or vaccine is approved.

Gilead is also working with the UN-backed Medicines Patent Pool (MPP) and UNICEF to license and distribute the antiviral in developing countries (see “Gilead Building Coalition Spanning South Asia, Europe and the UN”).

Remdesivir received Emergency Use Authorization (EUA) from FDA on May 1 to treat certain COVID-19 patients with severe disease. The company has said it could invest up to $1 billion in manufacturing remdesivir and has a goal of producing at least 1 million treatment courses by December (see “Remdesivir’s Challenge”).

The Japanese Ministry of Health, Labour and Welfare approved the therapy last week as Veklury through an exceptional approval pathway, and separately, EMA’s CHMP on Monday recommended expanding the compassionate use of remdesivir to hospitalized patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or extracorporeal membrane oxygenation. The program had been limited to patients undergoing invasive mechanical ventilation.

IMI picks first recipients

The Innovative Medicines Initiative has selected eight programs to receive funding from its COVID-19 call for proposals, and increased the total funding available to €72 million ($77.9 million) from €45 million.

EFPIA companies, IMI Associated Partners and other organizations will contribute an additional €45 million.

IMI received over 144 proposals since opening the program in March (see “Europe at Heart of Global Response”).

Of the eight recipients, five focus on diagnostics, including the Universitair Medisch Centrum Utrecht in The Netherlands, which will use wearable technologies and mobile apps to prioritize individuals for testing; and GNA Biosolutions GmbH in Germany, which is developing a disposable molecular diagnostic system that can perform a test anywhere and produce results within 15 minutes.

The three other projects focus on COVID-19 treatments.

Institut National de la Santé et de la Recherche Médicale (INSERM) will receive a grant to test repurposed and novel agents in the clinic.

Exvastat Ltd. in Ireland will test Gleevec imatinib in a randomized, double-blind clinical trial. The BCR-ABL and c-Kit inhibitor from Novartis AG (NYSE:NVS; SIX:NOVN) is approved to treat multiple cancers.

The Swedish National Veterinary Institute will study how to exploit the SARS-CoV-2 ACE2 receptor, and will map out factors that are critical for virus replication.

Glenmark starts Indian trial

Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) started a Phase III trial of a generic version of Avigan favipiravir to treat COVID-19, becoming the first pharmaceutical company in India cleared to start a study for the disease.

Avigan, a viral RNA polymerase inhibitor from Fujifilm Holdings Corp. (Tokyo:4901), is approved in Japan to treat influenza.

The trial will enroll 150 patients with mild to moderate COVID-19 across 10 government or private hospitals in India; it is expected to conclude in July or August.

Moderna, CanSino vaccine updates

Moderna Inc. (NASDAQ:MRNA) received Fast Track designation for its COVID-19 vaccine mRNA-1273 on Tuesday.

The company was cleared by FDA last week to start a Phase II trial, and a Phase III study is expected to start early this sumer (see “Moderna’s Bancel Highlights Speed, Flexibility of mRNA Platform”).

Separately Tuesday, CanSino Biologics Inc. (HKEX:6185) partnered with the National Research Council of Canada (NRC) Tuesday to start clinical testing of the biotech’s COVID-19 vaccine, Ad5-nCoV in Canada. CanSino is in the process of filing a CTA.

CanSino was the first vaccine company to reach Phase II; it started a Chinese trial in April. Four of the nine clinical vaccines for COVID-19 are being developed in China (see “China Emerging as a Leader in Vaccines”).

The collaboration builds on a 2013 licensing deal for a HEK cell line designed at the NRC, which CanSino used to develop its Ebola vaccine. Ad5-nCoV was also developed with the same HEK cell line.

The Canadian government will also build out its vaccine bioprocessing capabilities and has allotted $44 million to upgrade the NRC’s Montreal facility to comply with GMP standards.

Targets

BCR-ABL - BCR-ABL tyrosine kinase

c-Kit (KIT; CD117) - Stem cell factor receptor tyrosine kinase

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