22 July 2020

Gilead to acquire stake in Tizona Therapeutics for $300m

Gilead Sciences is set to acquire a 49.9% equity interest in cancer immunotherapies maker Tizona Therapeutics through an investment of $300m.

The investment will also provide Gilead with an exclusive option to buy the remaining stake in Tizona for up to an additional $1.25bn, including an option exercise fee and potential milestone payments.

Gilead can exercise the option to buy the remaining stake after the readout of a Phase Ib clinical trial of Tizona’s antibody candidate, TTX-080, or earlier.

Discovered by Tizona, the antibody candidate is designed to target HLA-G, a new immune checkpoint expressed in different tumour types.

The US Food and Drug Administration has cleared an investigational new drug application for TTX-080. Tizona intends to launch a Phase I trial of the candidate as monotherapy and combination therapy in patients with advanced cancers in the third quarter of this year.

Gilead Sciences chairman and CEO Daniel O’Day said: “Tizona is pursuing first-in-class cancer immunotherapies that could make an important difference in oncology by helping patients who don’t respond to current checkpoint inhibitors.

“This agreement with Tizona adds to the significant progress we’ve made in the first half of this year in building out a strong and diverse immuno-oncology pipeline.”

Gilead also agreed to provide funding support for Tizona’s ongoing research and development to advance its pipeline.

Tizona Therapeutics CEO Scott Clarke said: “Gilead’s support will enable Tizona to accelerate and broaden our TTX-080 clinical programme while also enabling us to rapidly advance our rich, first-in-class preclinical portfolio and target validation efforts.”

The acquisition is subject to customary closing conditions, expected for completion in the third quarter of this year. Gilead will have the right to appoint two individuals to Tizona’s board of directors after closing of the deal.

Tizona will spin off TTX-030, the company’s investigational antibody being developed in alliance with AbbVie, into a separate entity before the closing of this transaction. TX-030 is not covered under this agreement.

Last month, Gilead agreed to acquire a 49.9% equity interest in Pionyr Immunotherapeutics, along with an exclusive option to buy the remaining stake, for $275m.

22 July 2020

 Japan approves dexamethasone to treat Covid-19 patients

The Japanese health ministry has approved a low-cost and widely available steroid drug, dexamethasone, for the treatment of patients suffering from Covid-19.

This marks the second approval for a Covid-19 treatment in the country, following the authorisation of Gilead Sciences’ antiviral drug remdesivir in May.

The Health, Labour and Welfare Ministry included dexamethasone as a government-approved drug in a recent version of its handbook for novel coronavirus treatment, reported Japan Times.

According to the revised handbook, dexamethasone showed promise in a clinical study performed by the University of Oxford in the UK.

Last month, the UK Government authorised the drug for the treatment of Covid-19 on the National Health Service (NHS), after the report of positive data from the RECOVERY trial.

Preliminary results showed that the drug reduced death by up to one third in hospitalised patients with severe respiratory complications caused by the novel coronavirus disease.

During the trial, 2,104 patients received dexamethasone compared with 4,321 patients on usual standard of care alone.

Dexamethasone was able to mitigate the risk of death by 35% in patients on ventilation and 20% in patients on oxygen, leading to a 17% decrease in the total 28-day mortality rate.

The drug was said to be the world’s first to demonstrate a significant reduction in patient mortality, with RECOVERY trial demonstrating the impact.

Reuters added that the full results of the trial published in the New England Journal of Medicine confirmed the drug’s benefits for patients with advanced or moderate disease.

Based on trial results, the US National Institutes of Health revised its guidelines in June to recommend that dexamethasone can be given to patients needing ventilation and oxygen support.

21 July 2020

Merck, contract research firm IRBM partner on coronavirus therapies

Merck (MSD) has collaborated with contract research services company IRBM for the identification and development of new peptide therapeutics that can target various strains of coronavirus, including SARS-CoV-2.

The alliance will work on hit to lead optimisation and preclinical development to rapidly advance therapeutic candidates into the clinic.

IRBM is involved in peptide drug development, including target validation, initial hit identification and the development of a clinical candidate, established in 2010 as a spin-off from MSD.

IRBM CSO Carlo Toniatti said: “With this new outbreak of coronavirus, it makes sense for MSD and IRBM to join forces in this crucial area and work together on a treatment for this devastating pandemic as well as possible future pandemics.

“Our accomplished team here, led by Elisabetta Bianchi, and at MSD have a long heritage in the field of peptide development and have the expertise required to tackle this challenging project.”

As part of the collaboration with Merck, IRBM will leverage its previous SARS research to potentially identify and develop a treatment for SARS-CoV-2 and other future coronavirus strains.

MSD infectious diseases and vaccines discovery vice-president Daria Hazuda noted: “MSD and IRBM have a proud history of conducting breakthrough antiviral research. We look forward to advancing this important programme.”

Merck joined the Covid-19 research and development (R&D) race in May with separate agreements with Themis, IAVI and Ridgeback Biotherapeutics.

Later, in June, Merck collaborated with Japanese biopharmaceutical firm PeptiDream to discover and develop new peptide therapeutics against Covid-19.

Merck and PeptiDream intend to develop therapies with activity against SARS-CoV-2, as well as any future coronavirus outbreaks. The aim is to create drugs targeting several coronavirus strains.

21 July 2020

FDA accepts Acadia’s application for dementia drug Nuplazid

The US Food and Drug Administration (FDA) has accepted Acadia Pharmaceuticals’ supplemental new drug application (sNDA) for an antipsychotic drug, named Nuplazid (pimavanserin) to treat hallucinations and delusions in dementia patients.

The FDA had set 3 April 2021 as the action date to decide on the drug’s approval for this indication.

Pimavanserin is a selective serotonin inverse agonist and antagonist that targets 5-HT2A receptors, known to be involved in neuropsychiatric disorders.

Nuplazid was approved in 2016 to treat hallucinations and delusions associated with Parkinson’s disease psychosis in the US.

Later in October 2017, pimavanserin received breakthrough therapy designation from the FDA for hallucinations and delusions related to dementia-related psychosis (DRP).

Acadia Pharmaceuticals CEO Steve Davis said: “We are pleased that the FDA has accepted our sNDA for filing and we will be working closely with the FDA to facilitate completion of the review in a timely manner.

“If approved, Nuplazid would be the first therapy indicated for the treatment of hallucinations and delusions associated with dementia-related psychosis.”

The sNDA includes data from the pivotal Phase III HARMONY clinical trial, which met its primary endpoint with significantly reduced risk of relapse of psychosis in patients treated with pimavanserin compared to placebo.

Acadia said that its drug was able to mitigate the risk of relapse by 2.8 fold.

The sNDA also includes efficacy data from two other placebo-controlled studies, which also met their primary endpoints.

One of the studies was a Phase II trial in patients with Alzheimer’s disease psychosis and the second study was a Phase III trial in patients with Parkinson’s disease psychosis.

In addition, the application includes a safety database from completed and ongoing studies in a total of 1500 patients with neurodegenerative disease.

21 July 2020

Grifols to acquire GC Pharma’s plasma fractionation facility for $460m

Plasma-derived medicines company Grifols has executed purchase arrangements with South Korean-based GC Pharma to acquire a plasma fractionation facility in Montreal, Canada for $460m.

The deal also covers two purification facilities, as well as 11 US-based plasma collection centres.

Grifols said that the strategic acquisition is in line with its global growth strategy aimed at expanding plasma collection and fractionation capacity to enable access to plasma-derived medicines worldwide.

The deal will primarily boost the company’s footprint in Canada.

Grifols has been a plasma fractionator in Canada for more than 30 years under contract manufacturing services, offering plasma-derived medicines for patients and healthcare providers across the country.

This acquisition is intended to improve domestic self-sufficiency and security of plasma-protein-product supply.

Grifols co-CEO Víctor Grífols Deu said: “This deal builds on our long-term vision and strategy of sustainable growth, and wholly aligns with our commitment to helping countries reach self-sufficiency of life-sustaining plasma-derived medicines, which are critical for patients who need them.”

The company noted that no additional financing will be necessary for this transaction.

After the facilities are fully licensed and approved, Grifols will be a large-scale commercial manufacturer of plasma products in Canada. The company will have a fractionation capacity of 1.5 million litres a year.

The company will be ready to produce IVIG and Albumin in the facilities for supply to the Canadian market beginning in 2023.

Grifols has signed a plasma-supply agreement to provide a certain output of plasma from the Green Cross Collection Centers to GC Pharma for 24 months.

Last year, the centres recorded a collection volume of 350,000 litres of plasma.

Grifols Bioscience commercial division president Joel Abelson said: “This transaction represents a unique opportunity for Grifols to intensify our global expansion and presence in North America.

“Canada is a market with one of the highest rates of plasma consumption per capita in the world and one with significant growth potential.”

The acquisition is subject to regulatory approvals and is expected to close by the end of this year.

In March, Grifols collaborated with the US Government agencies, including the Biomedical Advanced Research Development Authority and Food and Drug Administration, to assess the use of plasma therapy for Covid-19.

20 July 2020

Gilead gets Hong Kong conditional approval for remdesivir for Covid-19

Gilead Sciences’ Hong Kong unit has received conditional approval from the country’s Pharmacy and Poisons Committee for the use of Veklury (remdesivir) to treat Covid-19.

The Committee held an ad-hoc meeting to review the company’s application and speed-up the registration approval of the drug.

Under the conditional approval, Gilead must submit additional data collected on the safety, efficacy and quality of remdesivir from ongoing clinical studies and post-marketing report to Hong Kong’s Drug Office of Department of Health.

In a statement, the Department of Health said: “The Committee considered that in view of the public health emergency under the Covid-19 pandemic, the local unmet medical need and there is no other registered pharmaceutical product indicated for use for the treatment Covid-19, the benefits of the use of remdesivir in the treatment of Covid-19 outweigh the risks even though the data on its efficacy and safety is very limited at the time being and hence conditionally approved the application for registration.”

Gilead’s drug secured authorisations for the treatment of Covid-19 patients in multiple countries, including conditional approvals in the US and European Union.

Earlier this month, the Therapeutic Goods Administration of Australia awarded provisional approval for Veklury, marking the first authorisation of treatment for Covid-19 in the country.

In Australia, remdesivir will be given to adults and adolescents who suffer from severe Covid-19 illness, need oxygen or high-level support for breathing and in-hospital care.

Recent data reported by Gilead showed that the drug demonstrated an improvement in clinical recovery and a 62% reduction in the risk of mortality compared to standard of care.

Also, analyses of the company’s compassionate use programme showed recovery by day 28 in 83% of paediatric patients and 92% of pregnant and postpartum women with a broad spectrum of disease severity.

17 July 2020

 J&J in talks with Japan and Gates Foundation for Covid-19 vaccine

US-based Johnson & Johnson (J&J) is in discussions with the Government of Japan, as well as the Bill and Melinda Gates Foundation, regarding allocations of its Covid-19 vaccine candidate.

In an interview with Reuters, J&J chief financial officer Joseph Wolk said that the company already agreed to an allocation deal with the US as part of its funding agreement with the US Biomedical Advanced Research and Development Authority.

The Bill and Melinda Gates Foundation intends to provide any vaccine it acquired to developing countries, noted Wolk. According to a previous report by Reuters, J&J is also in discussions with the European Union.

Wolk was quoted by the news agency as saying: “Nothing has been finalised yet. We continue to have those discussions. People from the countries and the organisations we mentioned want to lock in a certain minimum level of capacity that they would get.”

The ‘general construct’ of the talks is expected to be similar to AstraZeneca’s agreement with the US Government, which offered $1.2bn to support drug development in return for committing a delivery of around 300 million doses this year.

In addition, AstraZeneca received a contract from France, Germany, Italy and the Netherlands for up to 400 million doses of its Covid-19 vaccine candidate. The company also collaborated with non-profits for supply to developing countries.

Wolk added that these talks will help J&J fix a price for its vaccine, which the company plans to sell for no profit during the pandemic. The company intends to begin manufacturing later this year, based on its success in clinical trials.

In an earnings call on 16 July, J&J revealed plans to launch first human trials of its Covid-19 vaccine candidate on 22 July, with late-stage studies planned for September.

16 July 2020

Gavi announces 75 countries intend to join COVAX access facility

Gavi, The Vaccine Alliance, has said that 75 countries have expressed interest to join the COVAX access facility intended to ensure fast and equitable access to Covid-19 vaccines globally.

The 75 countries, which would fund the vaccines from their public budgets, will partner with up to 90 lower-income countries supported by voluntary donations to COVAX Advance Market Commitment.

Together, these countries are said to represent more than 60% of the global population.

Gavi CEO Dr Seth Berkley said: “COVAX is the only truly global solution to the Covid-19 pandemic. For the vast majority of countries, whether they can afford to pay for their own doses or require assistance, it means receiving a guaranteed share of doses and avoiding being pushed to the back of the queue, as we saw during the H1N1 pandemic a decade ago.

“Even for those countries that are able to secure their own agreements with vaccine manufacturers, this mechanism represents, through its world-leading portfolio of vaccine candidates, a means of reducing the risks associated with individual candidates failing to show efficacy or gain licensure.”

The COVAX Facility falls under the Access to Covid-19 Tools Accelerator, an alliance to speed-up the development, production and equitable access to Covid-19 tests, treatments and vaccines.

Gavi is co-leading COVAX with the Coalition for Epidemic Preparedness Innovations and the World Health Organization (WHO), in collaboration with vaccine manufacturers.

COVAX is meant to expedite the development and manufacture of Covid-19 vaccines, as well as guarantee equitable access for every country globally.

It plans to share the vaccine development risks, invest in manufacturing upfront in order to deploy vaccines at scale, and pool procurement and purchase power to obtain enough quantities to end the acute phase of the Covid-19 pandemic by next year.

The goal is to deliver two billion doses of safe and effective vaccines, which received regulatory approval and/or WHO prequalification, by the end of next year.

These vaccines will be distributed equally to all countries based on the proportion of their populations.

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