Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

A collaboration between global contract development and manufacturing organization (CDMO), Rentschler Biopharma, and pre-clinical-phase gene therapy company, Ikarovec, has been unveiled in a June 1, 2023 press release. The partnership aims to accelerate the development of novel gene therapies for the treatment of ophthalmic disease.

Under the agreement, Rentschler Biopharma will support the bioprocess development of adeno-associated virus (AAV) material in its advanced therapy medicinal product (ATMP) site in Stevenage, UK. This AAV material will then be used for pre-clinical testing of Ikarovec’s novel gene therapy, developed for the treatment of geographic atrophy—an advanced form of age-related macular degeneration.

“We are delighted to collaborate with Rentschler Biopharma on our lead program. As we look to find new and better ways to treat ophthalmic diseases, we want to get it right and ensure that our product candidates can be scaled up appropriately for each development stage and, ultimately, for commercialization,” said Katie Binley, chief scientific officer of Ikarovec, in the press release. “Thus, it is critical to work with a team that has strong AAV experience in our field and that will be a true partner every step of the way.”

“We are excited to have the opportunity to collaborate with Ikarovec, which is developing truly innovative treatments for major ophthalmic indications. With our client-focused, highly tailored approach, our seasoned team will work closely with Ikarovec scientists to enable them to move forward into pre-clinical testing as rapidly as possible,” added Robert Panting, general manager of Rentschler’s ATMP business, in the press release. “By laying the foundation with process development and scale-up work, we aim to ultimately improve development timelines and increase the chances of success for our clients, who are working tirelessly to advance potentially groundbreaking treatments.”

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A partnership between Rentschler Biopharma and Ikarovec will support the accelerated development of novel gene therapies for the treatment of eye diseases.

Rentschler Biopharma, Ikarovec Collaboration Set to Speed Up Ophthalmic Therapy Development 

Global biotech, Alvotech, and UK pharma company, Advanz Pharma, have signed a strategic partnership agreement for the supply and commercialization of five biosimilar candidates in Europe, it was announced in a May 24, 2023 press release.

Under the terms of the agreement, Advanz Pharma will gain the exclusive rights for commercialization of five biosimilars, including a biosimilar to Simponi (golimumab) and Entyvio (vedolizumab), from Alvotech. Advanz Pharma will be responsible for the registration and commercialization of the biosimilars within the European market and Alvotech will be responsible for the development and commercial supply of the biosimilars.

“We are very excited to extend our existing partnership with Advanz Pharma into additional therapeutic areas,” said Robert Wessman, chairman and CEO of Alvotech, in the press release. “The growth of our collaboration is based on a common vision and commitment to provide better patient access to more affordable biologics.”

“This partnership positions Advanz Pharma as a key future player in European biosimilars,” added Steffen Wagner, CEO of Advanz Pharma, in the press release. “It is also an important next step in Advanz’s ambition to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe.”

Alvotech and Advanz Pharma have signed a strategic partnership agreement for the supply and commercialization of five biosimilar candidates in Europe.

Partnership Forms to Commercialize Five Biosimilars in Europe

The United Kingdom’s government has announced a significant cash injection, worth £39 million (US$48 million), will be made to support antimicrobial resistance (AMR) research through the Global AMR Innovation Fund (GAMRIF).

Part of the funding, worth up to £24 million (US$30 million), will be awarded over the course of a four-year period to support the continuation of early development of novel antibiotics, vaccines, rapid diagnostics, and other products to treat drug-resistant infections. This investment will reinforce the UK’s relationship with the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) partnership.

Additionally, GAMRIF will invest a total of £5 million (US$6 million) into the Global Antibiotic R&D Partnership over a period of two years. This money will be used for the development of novel antibiotic treatments against major global health priorities as well as assuring global access to these treatments.

This financial announcement has been made as the UK’s health minister, Will Quince, alongside the development minister, Andrew Mitchell, launched the country’s Global Health Framework for 2023 to 2025 during the World Health Assembly (WHA) in Geneva, Switzerland.

“Antimicrobial resistance is a major threat to global health and has led to millions of tragic deaths per year, but the Global AMR Innovation Fund is supporting cutting-edge research and developing vital new treatments to prevent death and disease across the world,” said Quince at WHA. “This funding will provide a much-needed boost to protect people from diseases such as drug-resistant gonorrhoea, life-threatening sepsis in newborn babies, and serious bacterial infections.”

In response to the announcement of the cash injection, the Association of the British Pharmaceutical Industry (ABPI) issued a statement in support of the action.

“This is a positive step for research into finding long-term solutions for AMR. Beyond research there is an essential need for collaboration, on a global scale, that allows research efforts to be developed into effective antibiotics available for all,” said Claire Machin, ABPI executive director of International Policy and UK Competitiveness, in a May 22, 2023 press release. “Alongside [this] announcement, England has also been leading the way as the first country to implement a pilot scheme for incentivising the development of new treatments using an innovative payment arrangement, but the UK acting on its own cannot combat AMR. Multiple global solutions which bring together governments, healthcare systems, and the pharmaceutical industry are needed at scale if we are to stand a chance against AMR. We look forward to [National Health Service] plans for taking forward the learnings from the pilot, and the development of a more permanent solution for the development of new treatments against AMR.”

UK government supports AMR research with significant cash injection, provided through the Global AMR Innovation Fund (GAMRIF).

UK Government Boosts AMR Research with Cash Injection

ILC Therapeutics, a UK-based biotech that is focused on the discovery and development of hybrid interferon drugs, has signed a R&D partnership agreement with Dechra Pharmaceuticals, which specializes in veterinary pharmaceuticals and related products.According to a May 23, 2023 press release, the aim of the partnership will be the development of ILC’s Caniferon product as a treatment for atopic dermatitis in dogs.

“While ILC’s main focus to date has been around human health, the partnership with Dechra is a validation of our technology and the potential to develop products in the animal health market,” said Alan Walker, CEO of ILC Therapeutics, in the press release. “The industry as a whole has experienced a pandemic-driven increase in pet ownership and pet care, and we see considerable growth prospects for the product.”

“We are pleased to enter into this research agreement in a therapeutic sector of the market which is a key area of focus for Dechra,” added Ian Page, Dechra’s CEO, in the press release. “Although at a relatively early stage of research, we see real possibilities for the technology to lead to a full development program to add to our exciting pipeline.”

ILC Therapeutics has entered into a strategic partnership with Dechra Pharmaceuticals to develop an atopic dermatitis treatment for dogs.

Scottish Biotech Forms R&D Partnership with Veterinary Medicine Group

In this brief podcast interview, Felicity Thomas, European/Senior editor for the Pharmaceutical Technology Group, sits down with Andy Dumelow, Head of Technical Sales at I Holland, to find out more about the importance of tablet tooling maintenance in ensuring tableting productivity is maintained.

An article based on this podcast can also be viewed in the latest 

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Felicity Thomas, European/Senior Editor, Pharm Tech Group, and Andy Dumelow, Head of Technical Sales, I Holland, chat about tablet tooling maintenance in this brief podcast.

Maximizing Productivity by Maintaining Tablet Tooling Correctly

The National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its final draft guidance, recommending dapagliflozin (Forxiga) from AstraZeneca as a treatment option for adults with symptomatic chronic heart failure (HF) with preserved or mildly reduced ejection fraction.

According to a May 18, 2023 company press release, this recommendation expands the current National Health Service use of dapagliflozin, which had previously been recommended by NICE for use in HF patients with reduced ejection fraction only. NICE’s decision to recommend dapagliflozin for HF regardless of ejection fraction was based on results from a Phase III clinical trial that demonstrated the ability of the drug, when combined with diuretics, to reduce the risk of patients dying from cardiovascular death or potential hospitalization with HF when compared with placebo.

“We are pleased that NICE has recommended dapagliflozin for routine use within NHS England for patients with chronic heart failure with preserved or mildly reduced ejection fraction,” said Tom Keith-Roach, president, AstraZeneca UK, in the press release. “Dapagliflozin now has NICE recommendations for patients with chronic heart failure regardless of ejection fraction. This represents an important step forward in this setting and reflects our ongoing commitment to eradicate unplanned hospital admissions across the full spectrum of heart failure (inclusive of reduced and preserved ejection fraction), in turn reducing potential health service burden at a time when it is needed most.”

“Until now there have been no treatments available to delay or slow the progression of this type of heart failure. The committee heard from patient and clinical experts who described how the lack of research and available treatments in this area led to a lack of hope and support that impacts the quality of life and mental health of people with the condition. And we know that chronic heart failure also places a significant burden on the NHS through hospitalisations,” said Helen Knight, director of medicines evaluation at NICE, said in a May 18, 2023 press release issued by NICE. “[This] draft guidance means that for the first time there is an effective treatment available on the NHS for people with this type of heart failure. Not only does dapagliflozin have the potential to help them live well for longer, but it could also save the NHS money and free up space by reducing their risk of having to go to hospital for unplanned emergency treatment.”

The UK’s National Institute for Health and Care Excellence has recommended dapagliflozin (Forxiga) from AstraZeneca as a treatment option for adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.