Pharmaceutical Technology Editors

The European Medicines Agency (EMA) has announced, in an Oct. 12, 2021 press release, that the rolling review of CVnCoV—CureVac’s COVID-19 vaccine candidate—has been brought to an end as a result of the company withdrawing from the process.

EMA’s review of CVnCoV had started in February 2021, which involved the agency’s Committee for Medicinal Products for Human Use reviewing submitted data on a rolling basis in an accelerated review pathway. Data from non-clinical and ongoing clinical studies had been received and were under review, in addition to data on the quality and manufacturing process of the vaccine. Furthermore, a risk management plan had been submitted to the agency by the company.

However, questions around the quality of the vaccine were being raised that could impact the benefit-risk balance of the vaccine, and results from the main studies under consideration only provided modest vaccine efficacy in adults. Therefore, CureVac withdrew from the process and stated, in a letter to EMA, that it has taken the decision to focus on another COVID-19 vaccine development program.

As a result of the withdrawal, EMA will no longer continue reviewing data on CVnCoV and will not provide conclusions on the review. The company does still have the option of requesting another rolling review or can submit a marketing authorization application in the future.

EMA specified in its press release that any participants of the clinical trials for CVnCoV who have questions about their vaccination status should contact the relevant authority in their country of residence.

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EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

EMA Ends Rolling Review of CureVac’s COVID-19 Vaccine Candidate

The Medicines and Healthcare products Regulatory Agency (MHRA)—regulatory body of the United Kingdom—has awarded an ‘Innovation Passport’ to CellResearch, a Singaporean biotech, for CorLiCyte—an umbilical cord lining stem cell therapy.

CorLiCyte has been awarded the Innovation Passport through MHRA’s Innovation Licensing and Access Pathway (ILAP) for the treatment of chronic diabetic foot ulcers (DFUs), which affects more than 30 million people worldwide. The award is expected to facilitate accelerated access to the stem cell therapy for patients suffering from DFUs in the UK.

“We are delighted with this development—it is an important step closer to treating patients with this serious and debilitating disease,” said Gavin Tan, CEO of CellResearch, in an Oct. 13, 2021 press release. “This is, I believe, the first Innovation Passport granted to an asset born in Singapore and helps strengthen our country’s position as a leader in biotechnology on the global stage.”

“Umbilical cord lining technology is exciting because its applications range from chronic DFUs to other difficult-to-heal wounds such as venous ulcers and burns,” added Phan Toan, chief scientific officer, CellResearch, in the press release. “There is also the promise of future treatments for further diseases such as lupus, age related macular degeneration, and other auto-immune conditions.”

ILAP was introduced by MHRA in January 2021 and is aimed at the acceleration of time-to-market of therapeutics, hence improving UK patients’ access to medicines. The regulatory pathway involves close engagement with other industry stakeholders, such as the National Institute for Health and Care Excellence and the Scottish Medicines Consortium.

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

MHRA Awards ‘Innovation Passport’ to CellResearch for Stem Cell Therapy

Smiths Detection, a company specializing in threat detection and security screening technologies, announced on Oct. 13th, 2021, that its air sampler, BioFlash, can detect multiple SARS-CoV-2 variants. In addition to the Alpha variant, it can detect the Beta, Gamma, Kappa, Delta, and Delta plus variants. Confirmation of additional emerging variants, including the Lambda variant, is currently ongoing.

The BioFlash Biological Identifier is a bioaerosol collection and identification system. In addition to COVID-19, it can also identify threats such as anthrax, ricin, botulinum toxin, black plague, tularemia, and smallpox.

Last January, Smiths Detection announced that the BioFlash was capable of detecting airborne SARS-CoV-2  following tests done by the United States Army Medical Research Institute of Infectious Diseases. According to a company press release, it has been used by several universities to stop the spread of COVID-19 following detection of the virus.

“It has been a great asset to have this equipment at UMBC,” said Mike Pound, director of environmental health and safety for University of Maryland, Baltimore Country (UMBC), in the press release. “As everyone knows, you need a layered protection strategy to combat COVID. BioFlash is easy and fast to use which makes it a critical part of our mitigation strategy to help prevent transmission.”

“Emerging variants are a threat to pandemic recovery; however, mitigation strategies that utilize BioFlash will have an advantage,” said Warren Mino, managing director at Smiths Detection, in the press release. “BioFlash works by collecting aerosols and identifies the presence of dangerous pathogens using sensitive, specific and rapid detection in near-real time without laboratory analysis. Not only can BioFlash detect COVID-19 and its variants, it can be used by anyone, giving them immediate results, in minutes not days, which helps stop the spread of COVID-19 and other airborne pathogens.”

Smiths Detection has confirmed that the Bioflash air sampler can detect Beta, Gamma, Kappa, Delta, and Delta plus variants.

Smiths Detection Confirms BioFlash Detects Multiple Airborne SARS-CoV-2 Variants

Pacira BioSciences, a biopharmaceutical company focused on non-opioid pain management, announced that it had acquired Flexion Therapeutics, a company specializing in treatments for musculoskeletal conditions, on Oct. 11th, 2021. Pacira purchased Flexion for $8.50 a share, placing an approximate equity of $450 million on the company, or $630 million including debt.

Paxira’s acquisition of Flexion gives them access to the latter’s lead product, Zilretta (triamcinolone acetonide extended-release injectable suspension), a non-opioid injection intended for pain relief. According to a company press release, Zilretta is the first and only FDA approved extended-release intra-articular therapy for patients confronting osteoarthritisv (OA)-related knee pain.

The acquisition also gives Pacira access to two of Flexion’s drug candidates, FX201 and FX301. FX201 is a novel, intra-articular gene therapy product candidate designed to produce an anti-inflammatory protein, interleukin-1 receptor antagonist. FX301 is designed as a peripheral nerve block for control of postoperative pain. Both candidates are currently in Phase IB trials that the company expects to have results from by the end of the year.

“This acquisition is a major milestone in our strategy to build a robust offering of novel, non-opioid treatments to improve patient care along the neural pain pathway while simultaneously providing us with a complementary commercial asset in ZILRETTA for the treatment of OA knee pain,” said Dave Stack, chairman and CEO of Pacira, in the press release. “We believe the Flexion portfolio further solidifies Pacira as a leader in opioid-sparing pain management as we continue to redefine the role of opioids as a last resort rescue medication.”

“Pacira shares our commitment to advancing non-opioid pain control and we believe it is ideally positioned to drive continued clinical and commercial success of ZILRETTA, FX201, and FX301,” said Michael Clayman, CEO and co-founder of Flexion, in the press release.

Pacira’s acquisition grants them access to Flexion’s pain management portfolio.

Pacira BioSciences Acquires Flexion Therapeutics for $630 Million

Astrazeneca announced on Oct. 11, 2021, that a Phase III clinical trial (TACKLE) investigating the long-acting antibody (LAAB) combination, AZD7442, had met its primary endpoint. According to a company press release, AZD7442 is the only LAAB that has demonstrated effectiveness in both treating and preventing COVID-19.

In the Phase III trial, AZD7442, a combination of tixagevimab (AZD8895) and cilgavimab (AZD1061), was studied for the ability to block the binding of SARS-CoV-2 virus to host cells to protect against infection. The trial included 903 participants with a confirmed SARS-CoV-2 infection in a 1:1 randomization of AZD7442 to placebo, 822 of which were used in the primary analysis. Ninety percent of the patient pool came from populations with a high risk of progression to severe COVID-19, including those with comorbidities.

In the trial, patients were dosed with 600 mg of AZD7442 (n=452) or saline placebo (n=451) through intramuscular injection. There were 18 events (severe COVID-19 or death) among patients given AZD7442 (18/407) and 37 among patients given the placebo (37/415), demonstrating a 50% reduction in risk among the AZD7442 population. The LAAB was generally well tolerated.

An analysis of participants who received treatment within five days of symptom onset found that AZD7442 reduced the risk of severe COVID-19 or death by 67% compared to placebo. There were nine events among participants given AZD7442 (9/253) and 27 among participants given the placebo (27/251).

“These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for use of this therapy in both prevention and treatment of COVID-19,” said Mene Pangalos, executive vice-president of BioPharmaceuticals R&D at AstraZeneca, in the press release. “An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months.”

The company announced that they had requested an emergency use authorization of AZD7442 from FDA for prophylaxis of COVID-19 on Oct. 5th, 2021. Full results from TACKLE will be published in as of yet unnamed peer-reviewed medical journal.

AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.

AstraZeneca’s AZD7442 Clinical Trial Meets Primary Endpoint

Supernus Pharmaceuticals, a biopharmaceutical company focused on conditions targeting the central nervous system (CNS), announced on Oct. 11, 2021, that it would acquire Adamas Pharmaceuticals, a pharmaceutical company focusing on neurological therapies, for approximately $400 million dollars. The acquisition is expected to close late in the 2021 fourth quarter or early in the 2022 first quarter.

Under the agreement, Supernus will purchase shares of Adamas at $8.10 per share. An additional $1.00 per share, equivalent to approximately $50 million, will be paid contingent on Gocovri hitting particular sales milestones. Through this acquisition, Supernus will gain the rights to Adamas’ Gocovri (amantadine) and Osmolex (amantadine) extended-release capsules.

According to a Supernus press release, Gocovri is the first and only FDA-approved medicine for the treatment of both dyskinesia and “off periods” in patients with Parkin’s disease receiving levodopa-based therapy. Osmolex is approved for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients.

“This acquisition represents a significant step to further build a strong and diverse Parkinson’s disease portfolio and aligns with our focus of acquiring value-enhancing, clinically-differentiated medicines to treat CNS diseases,” said Jack Khattar, president and CEO of Supernus Pharmaceuticals, in the press release. “We have a proven track record of strong commercial execution and look forward to building on [Gocovri’s] growth momentum so that more patients can benefit from access to Adamas’ innovative neurological therapies."

Supernus will acquire Adamas’ Parkinson's disease treatment portfolio through a $400 million acquisition.