RxCell

Jørgensen stated that Novo Nordisk does not control the price that patients pay for the medications as these are determined by the insurance companies. Image credit: Andrea Izzotti / Shutterstock. A high-profile US Senate committee hearing on the drug prices of Novo Nordisk ’s marketed versions of semaglutide, Ozempic and Wegovy, started with Senator Bernie Sanders claiming that the Danish company is treating the US as its “cash cow”. Soon after, the discussion devolved into an exercise of assigning blame for high list prices, to different parties including pharmacy benefit managers (PBMs). On 24 September, Novo Nordisk’s CEO, Lars Fruergaard Jørgensen, appeared before the Senate Committee on Health, Education, Labor, and Pensions (HELP) to discuss the US prices for the company’s blockbuster glucagon-like peptide-1 (GLP-1) receptor agonists that are approved in type 2 diabetes and obesity. Jørgensen was quick to point out that Novo Nordisk does not expect anyone to pay list prices for their medications, and those are “just a starting point of the negotiations” with the PBMs. He added that PBMs favour drugs with higher list prices on formularies and that dropping the list prices often leads to narrower insurer coverage. For every dollar the company makes, 74 cents are passed onto the PBMs, he added. Jørgensen also noted that list prices are based on rebates that Novo Nordisk has to pay in the US to PBMs and federal programmes like Medicare. Consequently, he emphasised that Novo Nordisk does not control the price that patients pay for the medications as these are determined by the insurance companies. The role and impact of PBMs became the contentious centre of the Senate hearing, which pulled up Novo Nordisk and its GLP-1 drugs in particular, having called Jørgensen as the only witness. In the last few years, GLP-1 receptor agonists have come into the mainstream earning several billion dollars in revenues for leading companies like Novo Nordisk and Eli Lilly, and continue to be on a growth trajectory. PBM executives have also been called to the fore in recent Senate hearings to explain their role in rising drug prices . Jørgensen said if the US could delink the PBM income to list prices it would create an incentive for lower drug costs. See Also: Telix acquires RLS Radiopharmacies to expand US manufacturing presence RxCell’s iPSC-based cell therapy approach secures US patent However, Senator Sanders hit back saying “I have received commitments in writing from all of the major PBMs that if Novo Nordisk substantially reduced the list price for Ozempic and Wegovy, they would not limit coverage. In fact, all of them told me they would be able to expand coverage for these drugs if the list price was reduced.” Jørgensen remained sceptical as he said that immediately after Novo Nordisk dropped the US list price for Levamir (insulin detemir), a long-acting insulin, by 65% last year, insurer coverage for it dropped from 90% to about 35%. Novo Nordisk discontinued Levamir in January. When questioned about the discontinuation, Jørgensen cited the coverage and the subsequent decrease in the demand for Levamir as the primary reasons. When pressed by Senator Maggie Hassan if the company will transfer the Levamir formulation to a manufacturer interested in making the product, Jørgensen noted that the company has not found anyone interested in manufacturing Levamir. Adding that Novo Nordisk would be happy to collaborate with the government or any company interested in such an endeavour, he, however, cautioned that the market for Levamir is disappearing.

Olanzapine is an atypical antipsychotic and was first approved by the US Food and Drug Administration in 2009 by Eli Lilly. Image credit: Jonathan Weiss / Shutterstock. Teva Pharmaceuticals has shared new safety data from the Phase III SOLARIS trial and a Phase I study of extended-release subcutaneous olanzapine, TEV-‘749, showing that none of the patients in the two studies experienced post-injection delirium/sedation syndrome (PDSS). Olanzapine is an atypical antipsychotic and was first approved by the US Food and Drug Administration (FDA) in 2009. Eli Lilly markets it as Zyprexa and a longer-acting version as Zyprexa Relprevv. Generics of the therapy are also available, however, its use as a long-acting treatment has been limited as it is linked with a risk of developing PDSS. The condition causes the sudden onset of delirium or sedation within hours of receiving treatment. Zyprexa was a breakthrough product for Lilly, generating peak sales of over $3bn in 2001. Pharmaceutical Technology ‘s parent company GlobalData expects Teva’s olanzapine extended-release product to reach annual sales of $145m by 2034 in the US. The SOLARIS study (NCT05693935) met its primary endpoint by showing improvement in symptom severity of schizophrenia, measured using Positive and Negative Syndrome Scale (PANSS). The results from the two trials were presented at the Annual European College of Neuropsychopharmacology (ECNP) Congress taking place from 21 to 24 September in Milan, Italy. “Developing a long-acting olanzapine formulation that poses potentially no risk of PDSS is crucial in preventing these dangerous episodes that otherwise limit the use of olanzapine to daily oral options,” said Dr Christoph Correll, professor of psychiatry at the Zucker School of Medicine. The placebo-controlled SOLARIS trial enrolled 675 patients with schizophrenia. The study was divided into two sections, a double-blinded eight-week period one followed by a 48-week open-label extension. At eight weeks, participants who received three different doses of TEV-‘749 , corresponding to 20mg/day, 15mg/day and 10mg/day, showed a difference of -9.71 points, -11.25 points, and -9.69 points, respectively, versus placebo compared to baseline. See Also: Telix acquires RLS Radiopharmacies to expand US manufacturing presence RxCell’s iPSC-based cell therapy approach secures US patent The participants also met the trial’s secondary endpoint by improving the clinical global impression severity (CGI-S) scale. The patients saw a reduction of 0.47 points, -0.61 points, and -0.53 points versus placebo on high, medium and low doses of TEV-‘749, at eight weeks compared to baseline. Whilst there were no reported cases of PDSS, other treatment-emergent side effects included weight gain along with injection site induration, pain, and erythema. Serious adverse events were seen in 1% of the patients in TEV-‘749 compared to 2% in the placebo group, with 3% of the participants discontinuing treatment in both groups. Topline safety data from the open-label period is expected in the first half of next year. The safety and tolerability results from the Phase I trial (NCT06319170) evaluating TEV-‘749 in patients with schizophrenia were also presented at the conference. Teva emphasised there was no incidence of PDSS in the study.

The patent provides RxCell with exclusive rights to use iPSC-derived cells for treating a wide array of diseases. Credit: Pickadook/Shutterstock. RxCell has announced a US patent for its induced pluripotent stem cells (iPSCs)-based cell therapy approach, a method of generating multiple cellular therapy products from a single source of iPSCs. Patent 11,946,069 provides RxCell with exclusive rights to use iPSC-derived cells for treating a wide array of diseases. It details a method for differentiating cells from a clinically compliant iPSC source of a minimum of passage 20 or greater, produced under good manufacturing practice (GMP) compliance. The process can produce cellular products including astrocytes, dopaminergic neurons, endothelial cells, hepatocytes, mesenchymal cells, retinal epithelium and retinal progenitors. With this patent, RxCell will strengthen its portfolio of new therapies targeting retinal degenerative diseases such as age-related macular degeneration, and neurodegenerative disorders such as Parkinson’s disease. See Also: Commercial drug manufacturing companies for the pharmaceutical industry Clinical development services for clinical trials The company is also developing liver cell therapies for hepatic diseases and vascular and connective tissue cells for a range of therapeutic applications. The methodology covered by the patent will enhance RxCell’s capabilities in developing effective treatments. By harnessing the potential of advanced iPSC technology, RxCell plans to deliver safe and effective therapeutic solutions for patients globally. The company aims to support other entities seeking to tackle various health conditions, leveraging the patented technology to achieve these goals. RxCell said in a statement: “The potential of cell replacement therapy has been evident for many years, yet its feasibility has been constrained by ethical concerns associated with embryonic cells, technological limitations affecting clinical efficacy, and safety concerns. “The maturation of iPSC technology has now addressed these challenges, enabling the development of novel therapeutic approaches for degenerative conditions.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy