Pharmaceutical Technology Editors

Otsuka Pharmaceutical Europe (Otsuka) announced on Sept. 20, 2022 that the European Commission (EC) has approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV, or V lupus nephritis (LN).

The EC decision applies to all 27 European Union member states, as well as Iceland, Norway, Liechtenstein, and Northern Ireland. According to a company press release, voclosporin is the only oral treatment approved in Europe for the treatment of active LN in adult patients.

LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease, and is suggested to cause irreversible nephron loss. According to the press release, up to 210 in 100,000 people in Europe live with SLE, and between 40 and 60 percent of those with SLE are at risk of developing LN during their lifetime.

"Today's EC approval of voclosporin represents a significant development for lupus nephritis patients in Europe, offering the appropriate patients a new treatment option," said Andy Hodge, CEO, Otsuka Pharmaceutical Europe, in the release.

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Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis. 

EC Approves Lupkynis for Treatment of Active Lupus Nephritis

Glenn Youngkin, governor of Virginia, announced on Sept. 8, 2022 that Civica, a non-profit generic drug company, will invest $27.8 million to establish a new laboratory testing facility at Meadowville Technology Park in Chesterfield County, VA.

 facility will support Civica’s Petersburg pharmaceutical manufacturing operation through quality testing and development of new products. According to a press release, the project will create 51 jobs, as well as additional employment through the hosting of a scale-up manufacturing facility operated by Virginia Commonwealth University’s Medicines for All Institute.

“Civica’s investment is another transformational step forward in strengthening the advanced pharmaceutical manufacturing hub in the Richmond-Petersburg region and positioning Virginia as a key player in domestic drug manufacturing in America,” said Youngkin in the release. “Civica is a critical partner in the Commonwealth’s emerging pharmaceutical ecosystem that will ensure access to affordable, lifesaving medications while providing high-quality jobs and an incredible boost to our economy.”

“Civica’s new laboratory testing facility in Chesterfield County extends the footprint of the rapidly growing pharmaceutical manufacturing cluster in the region and will support the coalition’s long-term vision to serve as the world’s central access point for advanced pharmaceutical manufacturing and R&D,” said Caren Merrick, Viriginia Secretary of Commerce and Trade, in the release. “Today we celebrate Virginia’s vital role in addressing the shortage of affordable essential medicines in our nation and the investment in a new facility that will create high-paying jobs and accelerate research and innovation in the industry.”

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Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility. 

Civica to Invest $27.8 Million in New Testing Facility

Novo Nordisk announced on Sept. 12, 2022 that it has entered a strategic collaboration with Microsoft to accelerate drug discovery and development. The collaboration will combine Microsoft’s computational services, cloud, and artificial intelligence (AI) with Novo Nordisk’s drug discovery, development, and data science capabilities.

According to a company press release, AI models arising from the collaboration will be applied to a range of use cases, two of which are currently in execution. One of the uses will be automated summarization and analysis of information from sources such as literature, patents, scientific reports, and discussion forums. The AI will be used to gain novel scientific insight. The second use aims to develop models that predict a person’s risk of developing atherosclerosis, a cardiovascular disease caused by fat build-up, cholesterol, and other substances on the artery walls. The AI will also be used to establish biomarkers of the disease.

“We are very excited about this new partnership that allows us to work closely together with key experts from Microsoft as we look to expand our digital science and AI capabilities,” said Lars Fogh Iversen, senior vice-president, digital science & innovation at Novo Nordisk, in the release. “Together, we are on a path to enable faster and scaled use of AI in drug discovery, ultimately leading to more breakthrough innovations and efficiency gain to better serve the needs of patients.”

Novo Nordisk and Microsoft are collaborating to accelerate drug discovery and development using big data and artificial intelligence. 

Novo Nordisk and Microsoft Collaborate to Accelerate Drug Discovery and Development

Ensysce Biosciences, a clinical-stage biotech company focused on improving prescription drug safety, and Quotient Sciences, a drug development and manufacturing accelerator, announced a partnership to support the development and clinical testing of PF614-MPAR.

According to a press release from August 31, 2022, PF614-MPAR is Ensysce’s novel opioid combination product for the potential treatment of chronic pain that is designed to prevent both abuse and overdose. Quotient Sciences will use its integrated Translational Pharmaceutics platform to identify a PF614-MPAR formulation that allows conversion into oxycodone within the prescribed dose range, but reduces conversion to oxycodone at higher than prescribed dose levels in an overdose scenario. The formulation will balance dose and release rate and will be tested in the clinic on humans rather than preclinical species.

“The PF614-MPAR program is designed to fill a great unmet need for effective pain medications that reduce the risk of abuse and specifically prescription drug overdose,” said Lynn Kirkpatrick, CEO of Ensysce Biosciences, in the release. “This partnership serves as validation of our mission and ultimately our platforms. We continue to make strong progress towards our clinical development of PF614 and are excited to partner with Quotient Sciences to develop PF614-MPAR, as we believe we will be bringing to market important therapeutic options for those in severe pain.”

Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.

Ensysce Biosciences and Quotient Sciences Announce Partnership 

Sanofi announced on Sept. 16, 2022 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Enjaymo (sutimlimab) for the treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD).

CAD is a serious, rare, and chronic autoimmune hemolytic anemia, where the part of the body’s immune system mistakenly destroys healthy red blood cells (hemolysis). According to a company press release, CAD impacts the lives of an estimated 12,000 people in the United States, Europe, and Japan, and is associated with profound fatigue and increased risk of thromboembolic events and mortality.

Enjaymo was approved by FDA in February 2022 and is the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. The European Commission will review the CHMP recommendation, with an anticipated decision by the end of 2022.

EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.

EMA Recommends Approval of Enjaymo

Leistritz recently announced the date and location for its Twin Extrusion Workshop, which will be held from Nov. 29 to Dec. 1 at the Hilton Somerset Hill Hotel in Warren, NJ. Classroom training will be dovetailed with twin screw demonstrations at the Leistritz Process Laboratory in Branchburg, NJ.

The first day of the workshop will focus on classroom theory and will feature live twin screw extrusion system demonstrations. The second will touch on concepts like rheology and die design basics, featuring interactive screw programming demonstrations. The last day is optional and dedicated to various pharmaceutical and life science applications such as granulation, nano-scale sampling, and downstream technologies.

Leistritz’s Twin Extrusion Workshop, hosted from Nov. 29 to Dec. 1 in Warren, NJ, will dovetail classroom training and twin screw demonstrations.