Pharmaceutical Technology Editors

According to an August 16, 2021 press release, FDA approved an expanded label for Eli Lilly's rapid-acting insulin, Lyumjev (insulin lispro-aabc injection) 100 units/mL to include administration through continuous subcutaneous insulin infusion (CSII) with an insulin pump. Lyumjev is a formulation of insulin lispro—developed to speed the absorption of insulin into the bloodstream and reduce A1C levels—and is indicated to improve glycemic control in adults with type 1 and type 2 diabetes. It was approved by FDA in June 2020.

Results from PRONTO-PUMP-2, a phase III study, was what FDA approval was based on. The study confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with type 1 diabetes. Lyumjev is available in the United States and select global markets, including Japan and the European Union.

"Insulin pumps are an important delivery option for people with diabetes—many of whom struggle with high postmeal blood sugar levels," said Leonard Glass, vice president of medical affairs, Lilly. "The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes. It is an exciting development for pump users seeking to manage their blood sugar levels and reduce postmeal spikes."

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Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

FDA Approves Expanded Label for Lilly’s Lyumjev

Cipla—a global pharmaceutical company that specializes in complex generics—announced in an August 12, 2021 press release that it received final approval for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05% from FDA. Difluprednate ophthalmic emulsion 0.05% is the generic version of Novartis’s Durezol and is used for the treatment of inflammation and pain associated with ocular surgery as well as for the treatment of endogenous anterior uveitis.

Novartis’s Durezol had US sales of approximately $106 million for the 12-month period (ending June 2021), according to IQVIA (IMS Health). Cipla’s press release states difluprednate ophthalmic emulsion 0.05% will be available for shipping soon.

Cipla receives final approval from FDA for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%.

FDA Approves Cipla’s ANDA Application for Generic of Novartis’s Durezol

TriRx Pharmaceutical Services hosted various state and community leaders at the ribbon-cutting ceremony celebrating the acquisition of their Shawnee, Kan. facility. In attendance were state and local government officials.

was acquired from Elanco Animal Health Incorporated

 on August 1, 2021. They also entered into a long-term supply agreement which will assure a reliable supply of Elanco products.

Dave Urbanek, executive vice president of manufacturing and quality for Elanco, attended the ceremony to officially grant ownership to Timothy C. Tyson, chairman and CEO of TriRx. He also thanked Elanco employees for their continuous contributions and support.

The facility, which employs approximately 300 individuals, can make parenterals, topicals, non-sterile liquids, solid oral dose, and soft chews. It features a pilot plant, quality control laboratories, veterinary technical services, and a large warehousing and distribution facility.

"We are looking forward to increasing the capabilities and efficiencies of this site’s operations,” said Tyson in a company press release. “The journey ahead will bring prosperity to TriRx, TriRx team members and stakeholders, and the broader Shawnee community. This site will represent a highly valued addition to the TriRx capabilities to continue to serve the rapidly expanding global biopharmaceutical market.”

TriRx hosts various leaders at a ribbon-cutting ceremony for their new facility.


TriRx Hosts State and Community Leaders to Celebrate Acquisition of Shawnee, Kansas Facility

On Aug. 17, 2021, BlueAllele, a US-based biotechnology company specializing in transformational gene correction technologies, announced that is has been granted US Patent No. 11,091,756 (the ‘756 Patent) by the United States Patent and Trademark Office (USPTO) for its PALIDON gene-editing technology platform.

The ‘756 Patent covers claims on methods using PALIDON to edit genes in any cell type and system (e.g., animal cells for 

 applications) as well as its use for correcting any gene in the genome. The patent therefore provides broad coverage for the technology’s use in the development and advancement of human gene correction technologies.

PALIDON’s repair templates are built with a palindromic, bi-directional structure designed to leverage the high rate of non-homologous end joining (NHEJ) repair that is observed in cells, while at the same time preserving the ability of cells to precisely correct damaged messenger RNA (mRNA) and protein. The repair templates are designed to be compatible with existing gene editing nucleases and delivery systems, thus PALIDON is suitable for targeting many loss-of-function and gain-of-function monogenic diseases, the company stated in a press release.

With its palindromic design, PALIDON can convert byproduct (reverse integration) into a functional event, which contributes to enhanced efficacy. When PALIDON is integrated within introns, any potential error introduced by the NHEJ pathway can be tolerated, which in turn can minimize unwanted byproducts. PALIDON can also capture natural expressions from endogenous genes, which gives it precise control of protein levels with stable and durable edits.

“We are pleased that the USPTO has recognized the significance of our PALIDON technology and granted this patent. Protecting intellectual property is a critical part of our business model, particularly as we continue to develop novel and innovative methods for achieving precise gene correction,” said Nicholas J. Baltes, BlueAllele’s chief scientific officer, in the press release. “Further, the grant of this new patent highlights the unmet need for improving the precision, efficacy, and versatility of insertion-based gene editing techniques. As the examiner of the ‘756 Patent noted, PALIDON ‘expands the field of CRISPR technology in a novel way that was not recognized by prior researchers in this area.’”

“This patent demonstrates our expertise and commitment to unlocking the full potential of gene editing for treating genetic diseases,” said Joseph B. Saluri, BlueAllele’s CEO in the press release. “We are excited to continue advancing our PALIDON platform, along with the other innovative gene correction technologies in our R&D pipeline.”

BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.

Patent Office Grants BlueAllele Patent for Advanced Gene Editing Technology

Xellia Pharmaceuticals, a pharmaceutical manufacturer specializing in anti-infective treatments, announced that its manufacturing site in Cleveland, Ohio is now commercially operational. The company has released the first anti-infectives manufactured at the site for distribution to US hospitals.

As part of their vertical integration strategy, Xellia plans to continuously expand the capabilities of this site. For example, in addition to commencing commercial supply, the facility is also preparing ramp-up of its newly installed aseptic bag manufacturing line.

Xellia bought the Cleveland site in 2015 and has significantly renovated it since then. It passed a comprehensive Current Good Manufacturing Practices (CGMP) test by FDA in 2020. The facility currently employs over 300 individuals.

“The release of the first commercial product manufactured at our Cleveland facility is a significant milestone for Xellia,” said Carl-Ake Carlsson, CEO and president of Xellia Pharmaceuticals, in a company press release. “We acquired the site to fulfil an ambition to provide US hospitals and patients with critical care products made locally. We are proud to be producing high quality, key anti-infectives and we look forward to working with more partners who are aligned with Xellia’s purpose to save patient lives.”

The Cleveland, Ohio facility will produce critical anti-infective drug products for US hospitals.

Xellia Pharmaceuticals Officially Opens New Anti-Infective Drug Products Manufacturing Site

Artiva Biotherapeutics, an oncology company specializing in primary allogeneic natural killer (NK) cell therapies to treat cancer, announced on Aug. 12, 2021 an expansion of its US presence with a new R&D and good manufacturing practice (GMP) manufacturing facility in San Diego, Calif., for cell therapies. The new 52,000-ft

 facility will include research and process development laboratories as well as a multi-suite custom-built GMP manufacturing center that will support NK and chimeric antigen receptor (CAR)-NK cell production for the company’s pipeline development and clinical trial supply. The facility is expected to be completed in 2022.

The new facility and capabilities build on Artiva’s continued research and GMP manufacturing operations at the Korea-based cell center of its partner, GC LabCell. GC LabCell’s cell center consists of research labs, process development labs, and a 50,000-ft

 GMP cell therapy manufacturing facility.

Artiva’s cell therapies leverage the anti-tumor activity and safety features of NK cells, which are further optimized using the company’s AlloNK platform. The platform supports targeted anti-cancer activity by either genetically expressing CARs to drive tumor cell engagement or combining with therapeutic antibodies or innate-cell engagers to enhance antibody-dependent cellular cytotoxicity. In addition, Artiva’s manufacturing platform supports large-scale production and cryopreservation of off-the-shelf allogeneic NK cell therapies as well as proprietary CAR-NK and NK-specific gene-editing technologies that augment therapeutic activity.

“Artiva’s new San Diego R&D and manufacturing facility is an important element of the [c]ompany’s expansion and will support research and development for our evolving pipeline of optimized NK and CAR-NK cell therapies for the treatment of cancer,” said Peter Flynn, COO of Artiva, in a company press release. “The custom-built manufacturing center will produce clinical product and position Artiva for pivotal studies and potential commercial supply.”

“Artiva’s manufacturing-first approach, leveraging more than 10 years of pioneering NK cell therapy R&D by GC LabCell, has enabled us to successfully initiate clinical trials of our first allogeneic, cryopreserved, off-the-shelf NK cell therapy and positions us to file INDs [investigational new drug applications] on two novel and distinct CAR-NK cell therapy programs in 2022,” added Fred Aslan, CEO of Artiva, in the press release.

Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.