Civica Rx, the nation’s first not-for-profit generic pharmaceutical company co-founded by the Gary and Mary West Foundation in 2018, announced plans today to manufacture and distribute insulins at significantly lower prices than those currently on the market. The availability of affordable insulins will benefit people with diabetes, particularly the uninsured or underinsured, who often pay the most out of pocket costs for their medications and are constantly forced to choose between life-sustaining medicines and essential living expenses. An estimated one in every four Americans with diabetes are now rationing or skipping lifesaving doses due to cost.
“For decades, patients living with diabetes have been victim to drug company price gouging. Today’s announcement turns that narrative on its head, shifts power back into the hands of patients, and demonstrates the disruptive force of Civica in the pharmaceutical industry,” said Shelley Lyford, CEO and Chair of the Gary and Mary West Foundation and Vice Chair of the Board of Civica Rx. “The Gary and Mary West Foundation is committed to developing and supporting innovative solutions to combat the high cost of prescription drugs in America that harm seniors and patients of all ages, and we are proud to have Civica as a strong partner in these efforts.”
Civica will produce three generic insulins at a recommended price of no more than $30 per vial and no more than $55 for a box of five pre-filled pens. The Civica-produced insulins – glargine, lispro, and aspart – are biologics interchangeable with Lantus, Humalog, and Novolog, brand-name insulins with current list prices of nearly $300 or approximately 10 times the amount of Civica’s prices. Contingent on FDA approval, the company anticipates that its first insulin (glargine) will be available for purchase as early as 2024.
“More than 8 million Americans rely on insulin to live, but many can’t afford to take the amount they need because of the historically high and prohibitive cost of insulin,” said Martin VanTrieste, President and CEO of Civica. “We know that to really solve for the insulin cost and access challenges so many Americans face, we need a process – from manufacturing to setting a transparent price – that ultimately lowers the cost of the drug for those living with diabetes. In that spirit, we will ensure patients know where Civica’s low-cost insulin is available.”
The initiative is the product of a collaboration with partners that represent nearly every corner of the diabetes ecosystem, including foundations, payers, providers, patient advocates, and nonprofit organizations. The collaborating partners are Arnold Ventures, Beyond Type 1, Blue Cross Blue Shield Association and 12 independent BCBS companies (Arkansas Blue Cross and Blue Shield, Blue Cross and Blue Shield of Alabama, Blue Cross and Blue Shield of Hawaii, Blue Cross and Blue Shield of Vermont, Blue Cross of Idaho, Blue Shield of California, CareFirst BlueCross BlueShield, Florida Blue, Highmark Blue Cross Blue Shield, Horizon Blue Cross Blue Shield of New Jersey, Independence Blue Cross), Gary and Mary West Foundation, Glen E. Tullman Fund, Intermountain Healthcare, JDRF, Kaiser Permanente, Peterson Center on Healthcare, Providence, The Leona M. and Harry B. Helmsley Charitable Trust, Transcarent and Trinity Health.
Civica will sell its insulins at one low, transparent price for all based on the cost of development, production, and distribution. Manufacturing will occur at Civica’s state-of-the-art 140,000 square-foot manufacturing plant, currently being constructed in Petersburg, Virginia. The facility, which will be operational in the first quarter of 2024, will have the capacity to produce a substantial amount of the insulin needed in the United States, with additional space to increase production if necessary.
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Researchers led by a team from The University of Texas Medical Branch at Galveston were able to dramatically reduce the pain of fibromyalgia patients with medication that targeted insulin resistance.
This discovery could dramatically alter the way that chronic pain can be identified and managed. Dr. Miguel Pappolla, UTMB professor of neurology, said that although the discovery is very preliminary, it may lead to a revolutionary shift on how fibromyalgia and related forms of chronic pain are treated. The new approach has the potential to save billions of dollars to the health care system and decrease many peoples’ dependence on opiates for pain management.
The UTMB team of researchers, along with collaborators from across the U.S., including the National Institutes of Health, were able for the first time, to separate patients with fibromyalgia from normal individuals using a common blood test for insulin resistance, or pre-diabetes. They then treated the fibromyalgia patients with a medication targeting insulin resistance, which dramatically reduced their pain levels. The study was recently published in PlosOne.
Fibromyalgia is one of the most common conditions causing chronic pain and disability. The global economic impact of fibromyalgia is enormous – in the U.S. alone and related health care costs are about $100 billion each year. Despite extensive research the cause of fibromyalgia is unknown, so there’s no specific diagnostics or therapies for this condition other than pain-reducing drugs.
“Earlier studies discovered that insulin resistance causes dysfunction within the brain’s small blood vessels. Since this issue is also present in fibromyalgia, we investigated whether insulin resistance is the missing link in this disorder,” Pappolla said. “We showed that most – if not all – patients with fibromyalgia can be identified by their A1c levels, which reflects average blood sugar levels over the past two to three months.”
Pre-diabetics with slightly elevated A1c values carry a higher risk of developing central (brain) pain, a hallmark of fibromyalgia and other chronic pain disorders.”
The researchers identified patients who were referred to a subspecialty pain medicine clinic to be treated for widespread muscular/connective tissue pain. All patients who met the criteria for fibromyalgia were separated into smaller groups by age. When compared with age-matched controls, the A1c levels of the fibromyalgia patients were significantly higher.
“Considering the extensive research on fibromyalgia, we were puzzled that prior studies had overlooked this simple connection,” said Pappolla. “The main reason for this oversight is that about half of fibromyalgia patients have A1c values currently considered within the normal range. However, this is the first study to analyze these levels normalized for the person’s age, as optimal A1c levels do vary throughout life. Adjustment for the patients’ age was critical in highlighting the differences between patients and control subjects.”
For the fibromyalgia patients, metformin, a drug developed to combat insulin resistance was added to their current medications. They showed dramatic reductions in their pain levels.
Interim results from a multicenter clinical trial demonstrate insulin secretion from engrafted cells in patients with type 1 diabetes. The safety, tolerability, and efficacy of the implants, which consisted of pancreatic endoderm cells derived from human pluripotent stem cells (PSCs), were tested in 26 patients. While the insulin secreted by the implants did not have clinical effects in the patients, the data are the first reported evidence of meal-regulated insulin secretion by differentiated stem cells in human patients. The results appear December 2 in the journals Cell Stem Cell and Cell Reports Medicine.
“A landmark has been set. The possibility of an unlimited supply of insulin-producing cells gives hope to people living with type 1 diabetes,” says Eelco de Koning of Leiden University Medical Center, a co-author of an accompanying commentary published in Cell Stem Cell. “Despite the absence of relevant clinical effects, this study will remain an important milestone for the field of human PSC-derived cell replacement therapies as it is one of the first to report cell survival and functionality one year after transplantation.”
Approximately 100 years following the discovery of the hormone insulin, type 1 diabetes remains a life-altering and sometimes life-threatening diagnosis. The disease is characterized by the destruction of insulin-producing β-cells in the Islets of Langerhans of the pancreas, leading to high levels of the blood sugar glucose.
Insulin treatment lowers glucose concentrations but does not completely normalize them. Moreover, modern insulin delivery systems can be burdensome to wear for long periods, sometimes malfunction, and often lead to long-term complications. While islet replacement therapy could offer a cure because it restores insulin secretion in the body, this procedure has not been widely adopted because donor organs are scarce. These challenges underscore the need for an abundant alternate supply of insulin-producing cells.
The use of human PSCs has made significant progress toward becoming a viable clinical option for the mass production of insulin-producing cells. In 2006, scientists at Novocell (now ViaCyte) reported a multi-stage protocol directing the differentiation of human embryonic stem cells into immature pancreatic endoderm cells. This stepwise protocol manipulating key signaling pathways was based on embryonic development of the pancreas. Follow-up studies showed that these pancreatic endoderm cells were able to mature further and become fully functional when implanted in animal models. Based on these results, clinical trials were started using these pancreatic endoderm cells.
Now two groups report on a phase I/II clinical trial in which pancreatic endoderm cells were placed in non-immunoprotective (“open”) macroencapsulation devices, which allowed for direct vascularization of the cells, and implanted under the skin in patients with type 1 diabetes. The use of third-party off-the-shelf cells in this stem cell-based islet replacement strategy required immunosuppressive agents, which protect against graft rejection but can cause major side effects, such as cancer and infections. The participants underwent an immunosuppressive treatment regimen that is commonly used in donor islet transplantation procedures.
In Cell Stem Cell, Timothy Kieffer of the University of British Columbia and his collaborators provided compelling evidence of functional insulin-secreting cells after implantation. PEC-01s — the drug candidate pancreatic endoderm cells produced by ViaCyte — survived and matured into glucose-responsive, insulin-secreting cells within 26 weeks after implantation. Over the up to one year of follow-up, patients had 20% reduced insulin requirements, and spent 13% more time in target blood glucose range. Overall, the implants were well tolerated with no severe graft-related adverse events.
“For the first time, we provide evidence that stem cell-derived PEC-01s can mature into glucose-responsive, insulin-producing mature β-cells in vivo in patients with type 1 diabetes,” Kieffer says. “These early findings support future investment and investigation into optimizing cell therapies for diabetes.”
However, two patients experienced serious adverse events associated with the immunosuppression protocol. Moreover, there was no control group and the interventions were not blinded, limiting causal conclusions, and outcomes were highly variable among the small number of participants. In addition, further studies need to determine the dose of pancreatic endoderm cells necessary to achieve clinically relevant benefits for patients.
In Cell Reports Medicine, Howard Foyt of ViaCyte and his collaborators reported engraftment and insulin expression in 63% of devices explanted from trial subjects at time periods ranging from 3 to 12 months after implantation. The progressive accumulation of functional, insulin-secreting cells occurred over a period of approximately 6-9 months from the time of implant.
The majority of reported adverse events were related to surgical implant or explant procedures or to immunosuppressive side effects. Despite potent systemic immune suppression, multiple surgical implantation sites, and the presence of foreign materials, the risk of local infection was exceedingly low, suggesting that this approach is well tolerated in subjects who are at risk for a poor healing response. The researchers are currently working on ways to promote graft vascularization and survival.
“The present study demonstrates definitively for the first time to our knowledge, in a small number of human subjects with type 1 diabetes, that PSC-derived pancreatic progenitor cells have the capacity to survive, engraft, differentiate, and mature into human islet-like cells when implanted subcutaneously,” Foyt says.
Both reports showed that the grafts were vascularized and that cells in the device can survive up to 59 weeks after implantation. Analyses of the grafts revealed that the main islet cell types, including β-cells, are present. Moreover, there was no formation of tumors called teratomas. However, the ratio of different endocrine cell types was atypical compared to mature pancreatic islets, and the total percentage of insulin-positive cells in the device was relatively low.
Regarding safety, most severe adverse events were associated with the use of immunosuppressive agents, emphasizing the life-long use of these drugs as a major hurdle for wider implementation of these types of cell replacement therapies. “An ideal and sunny possible future scenario would be the wide availability of a safe and efficacious stem cell-based islet replacement therapy without the need for these immunosuppressive agents or invasive, high-risk transplantation procedures,” says Françoise Carlotti of Leiden University Medical Center, a co-author of the related commentary.
According to de Koning and Carlotti, many questions remain to be answered. For example, researchers need to determine the differentiation stage at which the cells are most optimal for transplantation, and the best transplantation site. It is also not clear whether the effectiveness and safety of the cells can be maintained over time, and whether it is possible to eliminate the need for immunosuppressive therapy.
“The clinical road to wide implementation of stem cell-derived islet replacement therapy for type 1 diabetes is likely to be long and winding. Until that time, donor pancreas and islet transplantation will remain important therapeutic options for a small group of patients,” de Koning says. “But an era of clinical application of innovative stem-cell based islet replacement therapy for the treatment of diabetes has finally begun.”
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