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Friday, August 7, 2020

Biogen’s aducanumab-stoked rally lifts AC Immune

AC Immune SA (ACIU +2.4%) perks up, albeit on below-average volume, in apparent sympathy with the rally in Biogen on the news that the FDA has accepted the latter’s application for aducanumab for patients with early-stage Alzheimer’s disease (AD).
ACIU is also developing a treatment for early AD, anti-phospho-Tau vaccine ACI-35.030. A 24-subject Phase 1b/2a study is ongoing with an estimated primary completion date in October 2022. It is developing the asset, including ACI-35, with collaboration partner Janssen Pharmaceutical Company.

India’s Serum Institute to get $150 million from Gates Foundation for COVID-19 vax

Serum Institute of India said on Friday it would receive $150 million in funding from the Bill & Melinda Gates Foundation and the GAVI vaccines alliance to make 100 million COVID-19 vaccine doses for India and other emerging economies as early as 2021.

The candidate vaccines, including those from AstraZeneca and Novavax, will be priced at $3 per dose and will be made available in 92 countries in GAVI’s COVAX Advance Market Commitment (AMC), the company said in a statement.
The Gates Foundation will provide the funds to GAVI, which will be used to support Serum Institute.
GAVI, backed by the Gates Foundation, is a public-private global health partnership with the goal of increasing access to immunization in poor countries.
It co-leads COVAX – a scheme designed to guarantee fast and equitable access globally to COVID-19 vaccines – along with the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI).
COVAX aims to deliver 2 billion doses of approved and effective COVID-19 vaccines by the end of 2021.

Hikma making Gilead’s COVID-19 drug remdesivir to increase supply

Britain’s Hikma Pharmaceuticals said on Friday it has started manufacturing Gilead’s antiviral drug remdesivir under contract in Portugal, as the U.S. company outsources to increase availability of the COVID-19 treatment.

Remdesivir is one of only two medicines to have shown to help hospitalised COVID-19 patients in clinical trials, making it a front-runner treatment for the illness caused by the new coronavirus.
Hikma’s Chief Executive Siggi Olafsson said the company will start supplying batches of the drug “soon,” and Gilead is expected to distribute it.
“The terms of the deal are confidential, we are simply a contract manufacturer for Gilead – they order products from us as they expect the sales to be,” Olafsson told Reuters in a telephone interview.
Remdesivir, which is administered intravenously, has been conditionally approved or supported in many regions to treat COVID-19, which has killed more than 800,000 people globally.
A pledge by Gilead to send nearly all of its supplies to the United States between July and September stirred concerns about availability elsewhere.
This week, a bipartisan group of U.S. state attorney generals urged Washington to allow other companies to make the treatment to increase availability and lower the price.
On Friday, Pfizer said it had signed a multi-year deal with Gilead to manufacture and supply remdesivir.
Gilead said on Thursday that its manufacturing network for the drug had grown to more than 40 companies in North America, Europe and Asia.
The company had said in June that it was aiming to supply enough of the drug by the end of the year to treat more than 2 million COVID-19 patients, more than double its prior target of 1 million.
Gilead has signed several pacts with generic medicine makers in Egypt, India and Pakistan to distribute remdesivir in 127 countries. The deals include those with Cipla Jubilant and privately held Hetero.
Hikma’s announcement of the deal with Gilead helped its shares jump more than 10% on Friday as it also reported a jump in first-half operating profit and lifted its sales outlook.
Analysts said the deal highlights Hikma’s “growing importance as a trusted source of essential medicines.”

Trump signs executive action to boost U.S. production of ‘essential’ drugs

“We will bring our pharmaceutical and medical supply chains home – we’re going to bring them home where they belong – and we will end reliance on China,” President Trump said during a visit to the Whirlpool manufacturing plant in Ohio. “We’ll be making our product here – safely, beautifully and inexpensively. We’re reasserting American economic independence.”
The executive order will help increase production of essential medicines, medical equipment and protective gear in the U.S., according to trade adviser Peter Navarro. “If we’ve learned anything from the China virus pandemic… we are dangerously overdependent on foreign nations.”
The U.S. imported $3.B of pharmaceutical raw material from China in 2017, an increase of nearly one-quarter from the prior year, according to IHS Markit.
“If there’s preferential treatment given to products manufactured in the U.S., then of course we will move more of our manufacturing to the U.S.,” Teva Pharmaceutical CEO Kare Schultz said earlier this year. “If there’s no preferential treatment, then the basic economics will keep it the way it is right now.”
The plan comes as a proposal to lend $765M to Eastman Kodak (NYSE:KODK) draws scrutiny from the SEC. The loan, announced last week, would help the former photo giant produce drug ingredients from the U.S.
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Novavax inks deal with Takeda for COVID-19 vaccine in Japan

Takeda Pharmaceutical Company (NYSE:TAK) enters into an agreement with Novavax (NASDAQ:NVAX) to develop, manufacture and commercialize the latter’s COVID-19 vaccine candidate NVX-CoV2373, including its Matrix-M adjuvant, in Japan.
Japan’s Ministry of Health, Labor and Welfare will provide funding to Takeda to support technology transfer, establishment of infrastructure and manufacturing scale-up. The company plans to build capacity to make over 250M doses per year.
Takeda will be responsible for regulatory filings as well.
Novavax will receive undisclosed milestone payments and a portion of sales proceeds. Additional details remain confidential.

Heat Bio up on Q2 results; advances development plans for COVID-19 vaccine

Heat Biologics (HTBX) Q2 results:
Grant and licensing revenue: $0.6M (+100.0%).
Net loss: ($4.5M) (+6.3%); loss/share: ($0.05) (+64.3%).
The company has over $100M in cash and short-term investments as of August 6.
Heat Bio recently announced results from its COVID-19 vaccine candidate which showed encouraging action in pre-clinical study, validating that the selected vaccine antigen may be appropriate for human testing.
HTBX continue to accelerate PTX-35, a T-cell co-stimulatory antibody, through clinical development and announced patient enrollment in its first-in-human clinical trial in multiple solid tumors following FDA clearance of IND application.
“Additionally, we established a partnership with Waisman Biomanufacturing to manufacture our COVID-19 vaccine for anticipated Phase 1 trials in humans,” concluded Jeff Wolf, CEO.

Apollo Medical EPS beats by $0.12, beats on revenue

Apollo Medical (NASDAQ:AMEH): Q2 GAAP EPS of $0.19 beats by $0.12.
Revenue of $165.17M (+27.0% Y/Y) beats by $1.88M.