Everest Medicines, Providence Therapeutics to bring cheaper mRNA COVID-19 vaccines to Asia

22, Sep. 2021

Providence Therapeutics' PTX-COVID19-B is currently in Phase 2 human clinical trial which began in August 2021. (Photo: Providence)
Providence Therapeutics' PTX-COVID19-B is currently in Phase 2 human clinical trial which began in August 2021. (Photo: Providence)

By Celine Chen

CHINA, NNA - China-based biopharmaceutical company Everest Medicines Ltd. has signed a package of deals worth hundreds of millions with Providence Therapeutics Holdings Inc. of Canada to produce and distribute messenger RNA (mRNA) vaccines and therapies to fight the deadly COVID-19 virus and other infectious diseases throughout emerging markets in Asia including China.

Hong Kong-listed Everest Medicines will pay licensing rights for Providence Therapeutics' mRNA COVID-19 vaccine candidates and share profits for ventures under their agreements.

The rapid development and commercialization of PTX-COVID19-B and PTX-COVID19-Variant, two potentially best-in-class vaccines by Providence Therapeutics (Providence), will provide significant opportunities to the partners, as well as to patients in Asia, said Kerry Blanchard, MD and CEO of Everest Medicines (Everest) in a press release on September 13.

Targeting a market of 2.4 billion people or 30 percent of the global population stretching from Greater China and Pakistan to Southeast Asia, the partners aim to bring affordably priced vaccines to regions that may be underserved by large pharmaceutical programs.

With very low rates of vaccination being carried out in Myanmar, Thailand, Vietnam, Philippines, Pakistan and Indonesia, it is unlikely the market territories will be fully vaccinated by the end of 2022, Everest said in reply to NNA questions.

Besides, it is likely that booster shots will be needed to maintain protection against COVID-19 and its more dangerous variants, the company added.

The two companies are also forging a strategic partnership to develop mRNA products globally leveraging Providence's cutting-edge mRNA technology.

Apart from Greater China and Pakistan, Everest's rights will specifically cover Singapore, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand, Timor-Leste and Vietnam.

Providence's first-generation COVID-19 vaccine candidate, PTX-COVID19-B, currently in Phase 2 clinical trials, has so far shown to be very effective against the original strain of SARS-CoV-2 (G614), and also, generally safe and well tolerated. Its efficacy increased more than 10-fold after the second dose, said Everest.

Its high defence against current variants of concern (VOC) Alpha, Beta and Delta compares "favorably to currently approved mRNA vaccines", Everest added.

A spokesman for Everest told NNA that the PTX-COVID19-B "has very good coverage of VOCs, especially the Delta variant" with no serious adverse events reported. It can also be used as a booster shot on top of other widely approved vaccines, he said.

Blanchard said, "We believe that mRNA vaccines for COVID19 can provide another option in the armamentarium for fighting this pandemic. Gaining exclusive access to a unique and clinically-validated mRNA technology platform through this strategic collaboration redoubles our commitment to accelerate global pharmaceutical innovation and deliver best-in-class medicines to people in China and other parts of Asia."

Headquartered in Shanghai, the company will also gain rights for Providence's next-generation mRNA COVID-19 vaccine candidates such as the PTX-COVID19-Variant targeted at specific variants of concern and now in pre-clinical development.

Everest plans to produce the COVID-19 vaccines at its manufacturing facility in Jiashan in Zhejiang province, which is near Shanghai.

Although production figures and sale prices are not available at this stage, the company said it will boost capacity to meet Chinese demand at a new location yet to be picked in China. The company will also find production sites in Asia to serve other countries.

It appears Everest can only begin production next year at the earliest.

Its spokesman told NNA, "We will commence the technology transfer process immediately. However, the timeline for production depends on a number of factors, including timeline and data for the ongoing Phase II trial, the timing of obtaining emergency use authorization in a major market, and discussions with each local regulatory agency. Since there are many factors at play, at this point we cannot give a definitive timeline."

Everest and Providence will also enter into a 50/50 global collaboration with a "most likely" focus on infectious diseases as well as to explore technologies for other prophylactic and therapeutic uses.

The Everest spokesman said, "We intend to initially focus on projects in our current core therapeutic areas, but we will not be limited to these if there are compelling opportunities to deploy the technology in other therapeutic areas."

Apart from both companies sharing a core interest in oncology currently, Everest's key areas include autoimmune disorders and cardio-renal diseases.

In addition, their partnership will enable Everest to create products using Providence's mRNA technology for product discovery across a broad range of other prophylactic and therapeutic areas. It covers the full technology transfer of Providence's current and future manufacturing processes to Everest.

"This transfer will allow the company to, pending regional product approval, produce and distribute these important medicines locally, enabling people in Greater China and other Asia territories access to differentiated and clinically validated mRNA vaccines for COVID-19, mRNA vaccines for other infectious diseases, as well as mRNA therapies for a range of devastating diseases," said Everest.

Brad Sorenson, CEO of Providence Therapeutics, said, "We're thrilled to enter into this agreement with a strong partner such as Everest as we work together to bring novel mRNA vaccines, like PTX-COVID19-B, to patients in need around the world and help combat COVID-19 as well as other diseases."

Incorporating equity consideration and profit-sharing, the partnership helps to align ongoing corporate interests between Everest and Providence and fosters future collaboration for innovative mRNA vaccine development across a range of disease areas, Sorenson added.

Blanchard of Everest said both companies share the same vision to make "affordable, innovative, high quality medicines available to patients in need".

Meanwhile, they seem confident of clinching huge sales and have agreed on terms in their deal package, such as Everest paying Providence $50 million initially for rights to COVID-19 vaccines. For the Greater China and Singapore markets, both would get up to $100 million in profit-sharing.

Once their profit share has hit an aggregate of $100 million, they will get mid-to-high single-digit royalties. Royalties on COVID-19 vaccine sales in markets outside of Greater China and Singapore will be double-digits in mid-teens.

As for other collaboration products, any additional products and transfer of mRNA technology, Everest will make $50 million in initial upfront payment.

Providence will also get $300 million in future payments in the form of newly-issued Everest stock, following achievement of certain technology transfer, manufacturing, preclinical, development and commercial milestones.

Everest said it has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. Its areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.

Providence, which has operations in Calgary, Alberta and Toronto, said it went beyond its focus on oncology therapies to develop a world-class mRNA vaccine for COVID-19 in response to the global call for help to tackle the virus which has killed more than 4.67 million worldwide so far.

According to Arizton Advisory & Intelligence, the global COVID-19 vaccine market is expected to be worth $35 billion by the end of this year and grow 6 percent in 2022.

In another study by Allied Analytics LLP, the global vaccine market accounted for $32.462 billion in 2019. It is expected to reach $54.150 billion by 2027, registering a CAGR (compound annual growth rate) of 6.6 percent from 2020 to 2027.

The Asia Pacific, with two of the most populous nations of China and India, will account for the major share.

Allied Analytics said the surge in investments by governments on immunization programs and rising awareness for vaccination in developing countries will drive further growth of the market.

Indonesia, the most populous nation in Southeast Asia, said last week that it is in talks with the World Health Organization (WHO) as well as six drug companies to develop the country as a global hub for manufacturing vaccines.

Two top European producers have already announced plans to build regional plants in Singapore to make vaccines in preparation for future pandemic risks. Germany's BioNTech will start production in 2023, while Sanofi of France expects its facility to be fully operational by 2026.

Across the causeway link, Malaysia will produce its own COVID-19 vaccines, starting in 2024. Anglo-Swedish AstraZeneca is already producing its vaccine in neighboring Thailand though manufacturing hiccups had slowed down its inoculation campaign and delayed exports to a few countries like Malaysia and Taiwan.

Vietnam, which is producing four local vaccines, will manufacture Cuba's Abdala vaccine following a recent agreement.

Across the South China Sea, the Philippines is still in talks with foreign manufacturers to set up its first vaccine plant in 2022.

While the region is beset with worries over the rise of the Delta mutant, increasing vaccine roll-outs have given confidence to countries to ease lockdowns.

Thailand's popular islands like Phuket and Singapore have started reopening their doors to fully vaccinated foreign tourists slowly and cautiously. Indonesia's Bali island is eyeing the same move.