insulin

Posted on Diabetes

Drug manufacturers use FDA, patent strategies to keep insulin prices high

Drug manufacturers use FDA, patent strategies to keep insulin prices high

Researchers highlight how manufacturers have listed an increasing number of patents on insulin products over the years. CREDIT Towfiqu barbhuiya, Unsplash (CC0, https://creativecommons.org/publicdomain/zero/1.0/)

Over the last four decades, insulin manufacturers have extended their periods of market exclusivity on brand-name insulin products by employing several strategies, including filing additional patents on their products after FDA approval and obtaining many patents on delivery devices for their insulin products. That is the conclusion of a new analysis of FDA and patent records carried out by William Feldman of Brigham and Women’s Hospital, USA, and colleagues, and published November 16th in the open access journal PLOS Medicine.

Insulin is the primary, life-saving treatment for type 1 and some type 2 diabetes but remains costly in the US even though it was discovered more than a century ago. A 2021 Congressional report found that for decades, the three major manufacturers of insulin continuously raised prices, often in tandem with one another. These high prices are additionally sustained by patents and regulatory exclusivity that limit competition on brand-name products. Patents are government-granted monopolies that last 20 years and the Food and Drug Administration (FDA) cannot approve generic versions of drugs for marketing until patents have expired.

In the new study, researchers used publicly available U.S. FDA and patent data to track all insulin products approved in the U.S. from 1986 to 2019. During the study period, the FDA approved 56 brand-name insulin products.

The researchers found that protection on insulin was enhanced by patents obtained after FDA approval, which lengthened expected market exclusivity by a median of 6 years. Moreover, many patents were on the insulin delivery devices rather than the drugs themselves. In two-thirds of drug-device combinations, the device patents were the last to expire; these last-to-expire device patents extended protection for a median of 5.2 years. Overall, manufacturers secured a median of 16 years of protection on their insulin products through patents and exclusivities, surpassing the median of 14 years observed in other studies of top-selling small-molecule drugs. The insulin lines with the longest periods of expected protection from the first product approved to last-to-expire patent was Lantus (32.9 years), followed by Novolog (32.3 years) and Novolog 70/30 (30.9 years).

“Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have timely access to drugs at fair prices,” the authors say.

Feldman adds, “Our study highlights how manufacturers have listed an increasing number of patents on insulin products over the years. These patents can delay competition and keep prices high for patients.”

Posted on Obesity

Obesity is linked to neurodegeneration through insulin resistance.

Obesity linked to neurodegeneration through insulin resistance

Sugar fly. Artistic rendering generated by DALL.E the prompt used is “The drawing of the fruit fly Drosophila in a dark background in the style of Seurat”. The researchers fed fruit flies high sugar diets and examined the effect on brain function. CREDIT Akhila Rajan created this image using DALL-E and owns it. They are making it available under CC-BY 4.0 (CC-BY 4.0, https://creativecommons.org/licenses/by/4.0/)

Researchers led by Mroj Alassaf at the Fred Hutchinson Cancer Research Center in the United States have discovered a link between obesity and neurodegenerative disorders like Alzheimer’s disease. Using the common fruit fly, the research shows that a high-sugar diet — a hallmark of obesity — causes insulin resistance in the brain, which in turn reduces the ability to remove neuronal debris, thus increasing the risk of neurodegeneration. Publishing November 7th in the open access journal PLOS Biology, the research will impact therapies designed to reduce the risk of developing neurodegenerative diseases.

Although obesity is known to be a risk factor for neurodegenerative disorders like Alzheimer’s disease and Parkinson’s disease, exactly how one leads to the other remains a mystery. The new study focused on answering this question by taking advantage of the similarity between humans and fruit flies. Having previously shown that a high-sugar diet leads to insulin resistance in the peripheral organs of flies, the researchers now turned to their brains. Specifically, they examined glial cells because microglial dysfunction is known to lead to neural degeneration.

Levels of the protein PI3k indicate how much a cell is able to respond to insulin. The researchers found that the high sugar diet led to reduced PI3k levels in glial cells, indicating insulin resistance. They also looked at the fly equivalent of microglia, called ensheathing glia, whose primary function is to remove neural debris, such as degenerating axons. They observed that these glia had low levels of the protein Draper, indicating impaired function. Further tests revealed that artificial reduction of PI3k levels led to both insulin resistance and low Draper levels in ensheathing glia. Finally, they showed that after actually damaging olfactory neurons, the ensheathing glia could not remove the degenerating axons in the flies on the high sugar diet because their Draper levels did not increase.

The authors add, “Using fruit flies, the authors establish that high-sugar diets trigger insulin resistance in glia, disrupting their ability to clear neuronal debris. This study provides insight into how obesity-inducing diets potentially contribute to the increased risk of neurodegenerative disorders.”

Posted on Diabetes, Patient Talk

A step closer to injection-free diabetes care: U of A’s innovation in insulin-producing cells

Using a patient’s own stem cells to replace insulin-producing cells “the horizon” for treating diabetes, says researcher
Using a patient’s own stem cells to replace insulin-producing cells “the horizon” for treating diabetes, says researcher

A University of Alberta team has developed a new step to improve the process for creating insulin-producing pancreatic cells from a patient’s own stem cells, bringing the prospect of injection-free treatment closer for people with diabetes.

The researchers take stem cells from a single patient’s blood and chemically wind them back in time, then forward again in a process called “directed differentiation,” to eventually become insulin-producing cells.

In research published this month, the team treated pancreatic progenitor cells with an anti-tumour drug known as AKT/P70 inhibitor AT7867. They report the method produced the desired cells at a rate of 90 per cent, compared with previous methods that produced just 60 per cent target cells. The new cells were less likely to produce unwanted cysts and led to insulin injection-free glucose control in half the time when transplanted into mice. The team believes its efforts will soon be able to eliminate the final five to 10 per cent of cells that do not result in pancreatic cells.

“We need a stem cell solution that provides a potentially limitless source of cells,” says James Shapiro, Canada Research Chair in Transplant Surgery and Regenerative Medicine and head of the Edmonton Protocol, which has allowed 750 transplantations of donated islet cells since it was first developed 21 years ago. “We need a way to make those cells so that they can’t be seen and recognized as foreign by the body’s immune system.”

The researchers suggest this safer and more reliable way to grow insulin-producing cells from a patient’s own blood could eventually allow transplants without the need for anti-rejection drugs. Recipients of donated cells must take anti-rejection drugs for life, and the therapy is limited by the small number of donated organs available. 

Shapiro says further safety and efficacy studies will need to be carried out before transplantation of stem-cell-derived islet cells is ready for human trials, but he is excited by the progress.

“What we’re trying to do here is peer over the horizon and try to imagine what diabetes care is going to look like 15, 20, 30 years from now,” he says. “I don’t think people will be injecting insulin anymore. I don’t think they’ll be wearing pumps and sensors.”

Posted on Diabetes

Nonprofit generic drug company co-founded by Gary and Mary West Foundation will manufacture and distribute low-cost insulin

Gary and Mary West Foundation Celebrates Decade of Grantmaking to Improve the Lives of Vulnerable Seniors

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.