Pharmaceutical Technology Editors

Specialist software provider, pharmasol, announced in a Feb 2, 2022 press release, that it has completed the strategic merger with PharmaLex—a provider of specialized services for the pharma, biotech, and medtech sectors.

Through the merger, PharmaLex will gain pharmasol’s SUSAR (Suspected Unexpected Serious Adverse Reactions) distribution platform. Additionally, pharmasol will provide key pharmacovigilance and end-to-end business support expertise to the newly expanded PharmaLex group.

“This strategic partnership with PharmaLex is a key milestone in our mission to create a dominant market position and enhance our total solution portfolio offering to our clients,” said pharmasol CEO Torsten Adam, in the press release. “This landmark alliance empowers both organizations to offer greater depth and breadth of service in the fast-growing and highly competitive area of pharmacovigilance—from best-in-class IT solutions, hosting and business process automation to strategic consultancy services.”

“We are delighted to have completed this strategic merger with pharmasol, and to be enhancing our solution set with pharmasol’s proven, specialist solutions that support companies to cost-effectively and efficiently meet their regulatory and operational responsibilities while increasing compliance,” added PharmaLex CEO Thomas Dobmeyer, in the press release. “With this consolidation of expertise from two industry leaders, we are excited to be further expanding our capabilities, and providing customers with access to pharmasol’s unparalleled technical expertise, highly talented team, and scalable, next-generation technology that will be instrumental in helping the industry to meet the complex data strategy and governance challenges, now and in the future.”

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pharmasol has completed the strategic merger with PharmaLex.

Pharmasol and PharmaLex Complete Strategic Merger

Commercial-stage biopharmaceutical company, Pharming Group, has announced positive results from the Phase II/III study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Currently, treatment of APDS is limited to supportive therapies, with no therapy approved for the treatment of the disease.

The study of leniolisib, which is a small-molecule PI3Kδ inhibitor, comprised two sequential parts and was sponsored by Novartis—the company that discovered and developed the drug before licensing it to Pharming in 2019. The primary efficacy results of the study have demonstrated that leniolisib is clinically effective when compared with placebo at reducing lymph node size and correcting immunodeficiency.

“These study results demonstrate the tremendous power of collaborative clinical research with scientists, clinicians, and patients working together with the pharmaceutical industry,” said Virgil Dalm, principal investigator, Erasmus University Medical Center Rotterdam, the Netherlands, in a Feb. 2, 2022 press release. “[APDS] patients have limited treatment options including symptomatic therapies, such as antibiotics, antivirals and immunoglobulin replacement therapy (IgRT) … I look forward to working with Pharming to bring leniolisib to APDS patients and studying it further in younger children, as well as other patient populations that may benefit from this precisely targeted therapy.”

Full study results will be presented at upcoming medical conferences and are also due to be published in a peer-review journal. Regulatory submissions for leniolisib as a treatment for APDS are expected to commence in the second quarter of 2022.

Pharming Group has announced positive results from the Phase II/III study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). 

Pharming Reveals Positive Trial Results for Leniolisib Study

AstraZeneca announced on Feb. 3, 2022 that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) for Forxiga (dapagliflozin) for the treatment of chronic kidney disease (CKD) in adults. The recommendation is based on results from the DAPA-CKD Phase III trial. According to the company, it will be the first treatment for CKD in nearly 20 years and addresses an unmet need.

Dapagliflozin is recommended for the treatment of CKD in adults if it is an add-on to optimized standard care and for people that have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 at the start of treatment and have type 2 diabetes or

a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, according to a company press release. NICE recommended removing the uACR testing restriction in people with type 2 diabetes (issued in November 2021) after a review of clinical data.

“This final recommendation from NICE is a watershed moment for people living with CKD, providing access to a new treatment option, which has the potential to change the way CKD is managed. We will work closely with NICE and the NHS to pull this through into clinical practice, supporting earlier identification of CKD to prevent disease progression and potentially defer the need for life-altering treatments like dialysis,” said Tom Keith-Roach, president, AstraZeneca UK, in a press release.

The UK’s NICE issued a Final Appraisal Document recommending marketing authorization for AstraZeneca’s chronic kidney disease treatment, Forxiga (dapagliflozin).

NICE Recommends Forxiga for Marketing Authorization

Eli Lilly and Company announced on Jan. 28, 2022 that it plans to invest more than $1 billion to create a new manufacturing site in Concord, N.C., which will use the latest technology to manufacture parenteral products and devices. The new facility will also increase the company's manufacturing capacity and create nearly 600 new jobs.

Lilly’s investment activity in North Carolina includes its previous investment of $470 million in 2020 to build up North Carolina's Research Triangle Park. In conjunction with the Research Triangle Park site, the new facility in Concord will allow the company to strengthen relationships with local governments and universities. The nearly 600 new jobs Lilly plans to create at the new facility in Concord will be for highly skilled workers such as scientists, engineers, and manufacturing personnel. In addition, an estimated 500 additional positions will be needed while the facility is under construction.

Over the past five years, Lilly has invested more than $4 billion in global manufacturing, including more than $2 billion in the United States. The company also announced plans on Jan. 28, 2022 to invest $500 million in a new biopharmaceutical manufacturing facility in Limerick, Ireland. Lilly also anticipates making additional future investments in manufacturing to meet growth in demand from potential new medicines to treat diabetes, Alzheimer's disease, cancer, and autoimmune conditions.

"Expanding our manufacturing footprint in North Carolina enables us to continue to produce today's medicines while providing additional capacity to manufacture the medicines of tomorrow. We are pleased to again partner with North Carolina to bring jobs to American workers and provide more medicines that patients need to address health challenges," said Edgardo Hernandez, senior vice-president and president, Lilly Manufacturing Operations, in a company press release.

Eli Lilly and Company is investing $1 billion to establish a new manufacturing site in Concord, NC, to manufacture parenteral products and devices.

Lilly to Invest $1 Billion to Build New Parenteral Manufacturing Facility in North Carolina

Eli Lilly and Company has entered into a research and collaboration agreement with Entos Pharmaceuticals under which Lilly acquired exclusive rights to Entos’ proprietary Fusogenix nucleic acid delivery technology. The technology will be used to research, develop, and commercialize nucleic acid products targeting the central and peripheral nervous system. Through this technology, Lilly will have access to a novel delivery platform with the potential to solve a key delivery challenge for many nucleic acid therapeutic modalities, according to a Jan. 6, 2022 press release.

Under the agreement, Lilly and Entos have agreed to multiple programs focused on the development of proteo-lipid vehicles (PLV) that deliver therapeutic cargo supplied by Lilly to targets in the central and peripheral nervous systems. Entos will be responsible for the generation, development, and optimization of PLVs using its Fusogenix platform technology, while Lilly will be responsible for selecting PLVs for clinical development and commercialization.

Entos will receive an initial payment of $50 million, including an equity investment by Lilly in Entos. For each program under the collaboration, Entos is also eligible to receive up to $400 million in potential developmental and commercial milestone payments as well as royalties based on the successful development and commercialization of products.

“Nucleic acid-based therapies hold great promise in addressing the biologic cause of many serious diseases that have significant unmet medical need,” said Andrew Adams, vice-president, Lilly Genetic Medicine, in the company press release. “Overcoming barriers to the safe and effective delivery of such therapies to specific target cells is essential to realizing their potential. We look forward to working with Entos as part of our efforts to overcome this challenge and develop potential new therapies that may improve patient outcomes.”

"We are excited for the opportunity to play a part in Lilly’s ongoing quest to develop high-quality medicines and believe our collaboration with Lilly is an important validation of the potential value of our expertise and technology platform,” said John Lewis, founder and CEO of Entos, in the press release.

Eli Lilly and Company has entered into a research and collaboration agreement with Entos Pharmaceuticals to develop new therapeutics for treating neurologic disorders.

Lilly and Entos Pharmaceuticals Partner in Research Collaboration to Develop Therapies for Multiple Neurologic Indications

ROSS VersaMix Triple Shaft Mixers with solids/liquid injection manifold (SLIM)- technology are the ideal choice for challenging mixing applications that require efficient powder dispersion and critical homogenization of medium to high viscosity slurries, pastes, gels, creams, and suspensions. 

The VersaMix models VMC-40 were designed for full vacuum operation and include a Three-Wing Anchor Agitator with Teflon blades scraping the sidewalls and bottom surfaces of the vessel, a High Shear Mixer with SLIM-style rotor/stator which draws solids sub-surface for virtually instantaneous wet-out, and a High-Speed Disperser that continues to apply shear as the batch increases in viscosity. 

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The ROSS VersaMix Triple Shaft Mixers offer fine dispersion, deagglomeration, emulsification, temperature control, and degassing.