GSK’s Covifenz, A Plant-Based COVID Vaccine, Receives First Approval

The recombinant COVID-19 vaccine developed by Medicago, now known as Covifenz, has received approval in Canada, the company’s home country. Covifenz employs Coronavirus-Like Particle (CoVLP) technology, with the vaccine consisting of recombinant spike (S) glycoprotein expressed as virus-like particles co-administered with GSK’s pandemic adjuvant. It can be kept refrigerated at room temperature ranging from 2 degrees Celsius (35.6 degrees Fahrenheit) to 8 degrees Celsius (46.4 degrees Fahrenheit). The vaccine is given intramuscularly in two doses, 21 days apart. Covifenz is Medicago’s first approved vaccine and the first nod for a COVID shot using GSK’s pandemic adjuvant.

Covifenz demonstrated a solid 71% efficacy against COVID-19 by various SARS-CoV-2 variants in a Phase 3 trial conducted in over 24,000 adults across six countries, though not omicron because it was not present at the time of the study.

Medicago supplies the COVID-19 vaccine under a Marketing Authorization Holder contract with the Canadian government. This order will be filled as soon as feasible by Medicago. Health Canada approved the vaccine based on scientific data provided by Medicago as part of a rolling submission that began in April 2021 under an Interim Order and finished with the filing of a New Drug Submission-CV.

Before the approval of Covifenz, the Canadian government reserved mRNA COVID-19 vaccine doses from Pfizer/BioNTech and Moderna for 2022 and 2023. It also has supply agreements with companies including Medicago, Novavax, Sanofi-GSK, and others.

Idorsia’s Quviviq Receives EU Approval for People with Insomnia

The Committee for Medicinal Products for Human Use (CHMP) has given Idorsia’s Quviviq (daridorexant) a positive opinion, which means it will likely be approved for use within two months.

The drug is the first dual orexin receptor antagonist (DORA) approved in the EU to treat adults with insomnia who have had symptoms for at least three months and have significantly impacted their daytime functioning.

In a Phase 3 study involving over 800 patients, Idorsia discovered that daridorexant 50mg significantly improved sleep onset, sleep maintenance, and self-reported total sleep time at one and three months when compared to placebo.

The most significant effect was seen in those who took the highest dose (50 mg), followed by 25 mg, and the 10 mg dose had no effect. In contrast to findings reported with benzodiazepine receptor agonists, the proportions of sleep stages were preserved in all treatment groups.

While all DORA manufacturers warn against next-day residual somnolence, Idorsia claims that daridorexant will be less likely due to its shorter half-life. DORAs are thought to reduce overactive wakefulness by blocking the binding of the wake-promoting neuropeptides orexins, which differs from treatments that generally sedate the brain.

Furthermore, a separate application for the use of daridorexant for the same indication in the United Kingdom will be submitted immediately to the Medicines and Healthcare products Regulatory Agency (MHRA) under the European Commission Decision Reliance Procedure, a post-Brexit, temporary administrative process in which the MHRA will rely on the EC’s decision on product approval.

GSK’s ZEJULA Approves for NHS Use

The UK’s National Institute for Health and Care Excellence (NICE) has announced that GlaxoSmithKline’s (GSK) ZEJULA (niraparib) can be used for some forms of the ovarian, fallopian tube, and peritoneal cancer treatment. The once-daily capsule is recommended for routine use in the NHS. ZEJULA (niraparib) is a Poly ADP-ribose polymerase (PARP) inhibitor for patients to treat relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers. 

The drug is also recommended for cancer patients, especially those who don’t have a germline BRCA mutation and in past have had two or more courses of platinum-based chemotherapy. Initially, NICE cleared the drug niraparib through availability from Cancer Drugs Fund (CDF). It’s a program for increasing the speed of drugs to market within spending margins. After this recommendation is processed from NICE, ZEJULA marks as the 20th treatment to complete the CDF process. This is the first time the drug regulator recommended a PARP inhibitor to be made available apart from the CDF for patients with ovarian cancer. Approximate 41k women in the UK are supposed to be experiencing ovarian cancer. For women who are diagnosed with the advanced form of ovarian cancer, almost 22% of them will proceed with the requirement of second-line therapy. 

EMA Adds New Indications for Several Drugs in Boons to Novartis, BMS, and Eli Lilly

The European Medicines Agency (EMA) is backing up for first-time approvals for products from pharma companies such as Biohaven, Myovant Sciences, and VBI Vaccines. In addition to that, the drug regulator giant is adding new indications for a few of the already approved drugs (in the US) that will be beneficial for large pharma such as Novartis, Eli Lilly and Bristol Myers Squibb.

A highly critical update for Eli Lilly with this news, as the EMA drug reviewers have considered recommending CDK4/6 inhibitor – Verzenio usage in combination with endocrine therapy for post-surgery adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer that is at high risk of recurrence. Verzenio grabbed the first-in-class approval in the U.S. last October, gaining a little edge over Pfizer’s Ibrance. Many physicians have been prescribing Ibrance in the past years and are less familiar with adding a CDK4/6 drug in the adjuvant setting. 

In addition to that, EMA’s Committee for Medicinal Products for Human Use (CHMP) is observed to support the addition of three new indications to Bristol Myers Squibb’s blockbuster drug – PD-1 inhibitor Opdivo. It constituted Opdivo’s use alongside either chemotherapy or Yervoy for esophageal squamous cell carcinoma with tumor cell PD-L1 expression of at least 1%, then Opdivo monotherapy for the adjuvant treatment of PD-L1-positive muscle-invasive bladder cancer that is at high risk of recurrence after surgery

Lastly, Novartis’ Beovu is also on track to expand into the landscape of diabetic macular edema in the EU, even though safety concerns will be continued to haunt the anti-VEGF drug.

Cantex Obtains a License to Develop a Small Molecule Drug for Inflammatory Lung Diseases

Cantex Pharmaceuticals, a clinical-stage pharmaceutical business, has received a global license from Harvard University’s Office of Technology Development to develop the small-molecule medication Azeliragon to treat inflammatory lung illnesses such as COVID-19.

Lung cells can be damaged by viral or bacterial infections and airway irritants, causing them to generate damage-associated molecular pattern (DAMP) molecules, which bind to and activate the RAGE protein on the cell membrane.

Azeliragon suppresses activation through average binding partners by attaching to RAGE proteins, lowering inflammation. It is currently the only RAGE inhibitor in human clinical studies, a minor oral molecule.

Cantex now wants to start phase 2 clinical studies of azeliragon in hospitalized patients with severe COVID-19 and phase 2 trials in other pulmonary inflammatory disorders, such as chronic obstructive pulmonary disease steroid-refractory asthma, based on the positive study results.

The company also plans to investigate azeliragon’s therapeutic potential in pancreatic malignancies and breast malignancies, where RAGE has been linked to disease progression and treatment problems.

Azeliragon has already been evaluated for Alzheimer’s disease and diabetic nephropathy, with the medicine demonstrating good levels of safety in phase 3 clinical studies involving over 2,000 patients, according to Cantex.

“Monoclonal antibodies have made a significant contribution to COVID-19 treatment.” “However, their efficacy is limited, and manufacturing, storing, distributing, and administering them can be difficult,” stated Cantex CEO Stephen Marcus. “Thanks to the Wyss Institute’s hard work, we now have compelling evidence that azeliragon, in the form of a once-daily medication, has the potential to prevent severe COVID-19 sickness.”

Viatris Sells its Biosimilar Business to Biocon for USD 3.3 billion.

Biocon Biologics Ltd., a Biocon Ltd. subsidiary, announced today that it had reached a definitive agreement with Viatris Inc. To develop a unique, fully integrated worldwide biosimilars firm, Biocon Biologics Ltd. will purchase Viatris’ biosimilars business. Viatris will receive up to USD 3.335 billion in compensation, including USD 2.335 billion in cash and USD 1 billion in Compulsorily Convertible Preference Shares (CCPS) in Biocon Biologics Limited (BBL).

The Board of Directors of both companies have approved the deal. BBL will have a diverse portfolio that includes its current commercialized insulins, cancer, and immunology biosimilars, and several other biosimilar assets in development. Through its previously announced cooperation with Serum Institute Life Sciences (SILS), BBL has access to the vaccine portfolio.

After the post-closure of the deal, BBL will realize the total revenue and associated profits from its partnered products, a step-up from its existing arrangement with Viatris. The sale will expand BBL’s EBITDA base and strengthen overall financials, enabling investments for sustained long-term growth.

The agreement will result in operational efficiencies throughout the whole value chain and the creation of agile capabilities in development, production, regulatory, supply chain, and commercialization in both developed and emerging countries. The merger of Viatris’ biosimilars company with BBL accelerates BBL’s commercial capability in developed regions, allowing it to become a solid worldwide brand with a direct presence in the United States, Europe, Canada, Japan, Australia, and New Zealand.

BBL presently has 20 biosimilars in its portfolio. Biocon Biologics Limited’s position in delivering affordable access to patients through its portfolio in diabetes, oncology, immunology, and other non-communicable illnesses has been dramatically strengthened by the acquisition of Viatris’ biosimilars assets. It also positions BBL for colossal success in commercializing its future pipeline.