Pharmaceutical Technology Editors

SaNOtize and Glenmark Pharmaceuticals announced on August 2, 2021 an exclusive long-term strategic partnership to manufacture, market, and distribute SaNOtize’s nitric oxide nasal spray (NONS) for COVID-19 treatment to India and other Asian markets, including Singapore, Malaysia Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste, and Vietnam.

NONS were found to be a safe and effective antiviral treatment to prevent the transmission of COVID-19, shorten its course, and reduce the severity of symptoms in SaNOtize’s March 2021 clinical trials.

NONS is designed to kill the COVID-19 virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide, which has proven anti-microbial properties and a direct effect on SARS-CoV-2.

The Subject Expert Committee of India’s Central Drugs Standard Control Organisation recommended a Phase III clinical trial for NONS to be conducted in Indian patients in the coming weeks. The Phase III trial is expected to be completed by Q4 2021, followed by a commercial launch.

Articles

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

Nitric Oxide Nasal Spray for COVID-19 to Be Distributed to India and Other Asia Markets

BioMed X, an independent German research institute, announced on August 2, 2021 the start of two new research projects with Janssen Research & Development, which is one of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J). Both collaborations were facilitated by J&J Innovation.

The aim of the first research group, Protective Tissue Factors in Autoimmune Diseases (PTA), is to develop new approaches to combat chronic inflammatory diseases and identify protective factors in the tissue microenvironment of patients with auto-inflammatory diseases. The overall goal, therefore, would be discovering and validating novel drug targets in these diseases.

“We aim to develop a 3D human joint-in-a-dish platform that closely mimics the inflamed joints of patients with rheumatoid arthritis utilizing diverse methodologies including single-cell omics, gene-editing, bio-scaffold manufacturing, and stem to adult joint cell differentiation,” said Mojca Frank Bertoncelj, the new group leader of team PTA, in a press release. “This innovative platform will enable high-throughput testing and discovery of novel joint-protective therapeutics.”

The second research group, Translocation of Complex Macromolecules Across the Intestinal Epithelial Barrier (TMI), aims to discover novel transport mechanisms in the human intestinal tract that could be used for oral delivery of various macromolar therapeutic modalities.

“Our mission is to characterize the human intestinal epithelial barrier and thereby gain insights into how macromolecular therapeutics may be orally delivered,” said Dr. Kyungbo Kim, new group leader of team TMI, in the release. “The biology of the barrier will be explored at the cellular and molecular level.”

BioMed X Institute and Janssen Research & Development to start two new research programs in the field of autoimmune diseases and drug delivery.

Janssen Collaborates with BioMedX in Autoimmunity and Drug Delivery Research

On Aug. 2, 2021, AstraZeneca announced that FDA approved Saphnelo (anifrolumab-fnia), a type I interferon (type I IFN) receptor antagonist, for treating moderate to severe systemic lupus erythematosus (SLE) in adult patients who are receiving standard therapy. The approval was based on efficacy and safety data from Phase III and Phase II trials.

The clinical trials showed that patients treated with Saphnelo experienced a reduction in disease activity across organ systems, including skin and joints. The patients further achieved sustained reduction in oral corticosteroid use compared to placebo.

According to AstraZeneca, the approval of Saphnelo marks the first regulatory approval for a type I IFN receptor antagonist. The approval also marks the first new treatment for SLE in more than 10 years, the company stated in a press release. Saphnelo is also under regulatory review for SLE in the European Union and Japan. AstraZeneca has initiated testing the drug using subcutaneous delivery in a Phase III trial in SLE and plans to start additional Phase III trials in lupus nephritis, cutaneous lupus erythematosus, and myositis.

AstraZeneca acquired the global rights to Saphnelo via an exclusive license and collaboration agreement with Medarex in 2004, but an option for Medarex to co-promote the product expired when it was acquired by Bristol-Myers Squibb (BMS) in 2009. Instead, by agreement, AstraZeneca will pay BMS a royalty for sales dependent on geography.

“Our treatment goals in systemic lupus erythematosus are to reduce disease activity, prevent organ damage from either the illness itself or the medications, especially steroids, and improve one’s quality of life. Today’s approval of anifrolumab represents a big step forward for the entire lupus community. Physicians will now be able to offer an effective new treatment that has produced significant improvements in overall disease activity, while reducing corticosteroid use,” said Richard Furie, chief of the Division of Rheumatology at Northwell Health, New York, US, and a principal investigator in the Saphnelo clinical development program, in the press release.

“Today’s landmark approval of Saphnelo is the culmination of years of AstraZeneca’s pioneering research in the type I interferon pathway, a central driver in systemic lupus erythematosus pathophysiology. This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often debilitating disease,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca, in the press release.

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA Approves AstraZeneca’s Lupus mAb, Saphnelo

Genentech, a member of the Roche Group, announced that FDA has accepted its biologics license application (BLA) with priority review for faricimab, a bispecific antibody for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The company also said that FDA has accepted its submission of the drug for treating diabetic retinopathy, according to a July 28, 2021 press release.

Faricimab targets two pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). These two pathways drive a number of retinal conditions that can cause vision loss. Ang-2 and VEGF-A contribute to vision loss because they destabilize blood vessels, which causes the vessels to leak and causes inflammation. Faricimab simultaneously blocks both the Ang-2 and VEGF-A pathways, thus stabilizing blood vessels and potentially improving vision.

Genentech’s BLA submission is based on positive results from four Phase III studies in wet AMD and DME, which consistently showed that faricimab offered vision gains comparable to that of aflibercept; faricimab was given at intervals of up to four months and aflibercept was given every two months. The studies also showed that approximately three-quarters of people who were eligible to receive extended doses of faricimab were able to be treated every three months or longer within the first year. Genentech is additionally conducting long-term extension studies for faricimab in wet AMD and DME. Faricimab has been granted marketing authorization in Europe by the European Medicines Agency for treating wet AMD and DME.

“If approved [by FDA], faricimab would be the first in a new class of eye medicines targeting two key pathways that drive retinal disorders, with the potential to offer durable vision outcomes with fewer eye injections than the current standard of care,” said Levi Garraway, chief medical officer and head of Global Product Development, Genentech, in a company press release. “Therefore, we hope faricimab will become a new treatment option for millions of people living with wet AMD and DME.”

FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

FDA Accepts Genentech’s Application for Bispecific Antibody to Treat Eye Diseases 

GlaxoSmithKline and Vir Biotechnology announced on July 28, 2021 that they signed an agreement with the European Commission (EC) to jointly supply up to 220,000 doses of sotrovimab, an investigational single-dose monoclonal antibody (mAb) in development for treating SARS-CoV-2 infection. The joint agreement will allow participating European Union (EU) member states quick purchase access to the mAb, following emergency authorization at the local level or at the EU level. Early access will allow for the treatment of high-risk patients with COVID-19.

The EC’s move follows a positive opinion granted by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP). Sotrovimab is included in the EC’s portfolio of promising COVID-19 candidate therapies. Documentation to support a marketing authorization application for the mAb is currently in an ongoing regulatory review with the EMA. GSK and Vir announced results in June 2021 from a Phase III clinical study, which met its primary endpoint and demonstrated a 79% reduction in hospitalizations.

Sotrovimab was granted Emergency Use Authorization in the United States in May 2021 for treating mild-to moderate COVID-19 in high-risk patients. GSK and Vir plan to submit a biologics license application to FDA in the second half of 2021. Other countries in which sotrovimab has been authorized for emergency use include Bahrain, Kuwait, Qatar, Singapore, and United Arab Emirates.

“This agreement with the [EC] represents a crucial step forward for treating cases of COVID-19 in participating EU Member States, as it enables access to sotrovimab for high-risk patients who have contracted the virus. As the COVID-19 landscape continues to evolve and we meet new challenges—such as the Delta variant spreading across the globe—there remains an urgent need for treatment options to help those who do get sick to potentially avoid hospitalization or death,” said George Katzourakis, senior vice-president, Europe, GSK, in a company press release.

“It remains abundantly clear that additional treatment options are needed to fully address the toll of this pandemic. This agreement recognizes that monoclonal antibody treatments for those who become infected are essential, and we are pleased that European healthcare providers and their patients now have access to sotrovimab. Notably, the fact that sotrovimab was designed from the beginning to maintain activity against the evolution of this virus and has demonstrated, 

, its ability to maintain activity against the tested circulating variants of concern and interest, including Delta and Lambda, underscore its critical role in the fight against COVID-19,” said George Scangos, CEO of Vir, in the press release.

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

EC Makes Supply Agreement with GSK and Vir Biotechnology for mAb COVID-19 Treatment

On August 2, 2021, DisperSol Technologies and Catalent announced a strategic manufacturing collaboration aimed at accelerating the production of various DisperSol pharmaceutical products.

DisperSol’s KinetiSol technology manufacturing line will be installed at Catalent's oral solids development and manufacturing facility in Somerset, NJ. This technology is designed to turn molecules with great clinical promise but poor bioavailability into viable medicine.

Per the agreement, DisperSol will provide the KinetiSol technology while Catalent will provide staff for the development, scale-up, and commercial stages of KinetiSol product creation.

“This strategic collaboration with Catalent is integral to our company as we now move into late clinical-stage development and commercial-scale manufacturing of our products,” said DisperSol CEO Edward M. Rudnic in a press release. “The commercial amorphous solid dispersion manufacturing expertise of Catalent’s team and their globally accredited quality systems make them a perfect partner for DisperSol.”

DisperSol and Catalent announce manufacturing collaboration to accelerate DisperSol’s pharmaceutical production. 