New Vertex Type 1 Stem Cell Therapy Gets FDA Nod to Enter Clinical Trials by Andrew Briskin for diaTribe.org, 9 March 2023.
The FDA announced that a new type 1 diabetes stem cell therapy from Vertex has been cleared to enter clinical trials in the United States. The therapy, which hopes to avoid the need for immunosuppressive drugs when replacing damaged insulin-producing cells in someone with type 1 diabetes, is scheduled to enter clinical trials in the first half of 2023. Although there are several challenges that remain towards finding a safe and effective cure for type 1 diabetes, developments in stem cell therapy over the past year have offered much promise.
Biopharmaceutical company Vertex has been investigating its stem cell therapy, VX-880, as a way to replace the damaged insulin-producing beta cells in someone with type 1 diabetes with healthy beta cells created from stem cells.
Data released in June 2022 from the first person to receive VX-880, revealed that the participant increased his time in range to more than 99%, with glucose levels that nearly mirrored a person without diabetes. A major challenge, however, is that the participant required immunosuppressant medications to stop his own immune system from destroying the new beta cells.
To address this issue, Vertex is testing another new therapy, VX-264, that keeps the beta cells in an enclosed device, physically protecting them from the body’s immune cells while still allowing nutrients to reach the beta cells. This is a strategy known as encapsulation.
Nemaura Medical to offer CGM-guided insulin dose titration care model by Sean Whooley for DrugDeliveryBusiness.com, 15 March 2023.
Nemaura Medical announced that it now includes insulin under its DuoPack commercial license agreement. Loughborough, UK-based Nemaura Medical entered into a commercial agreement in September 2021 with MySugarWatch DuoPack Limited (MSWDL). Under the agreement, Nemaura’s non-invasive, wearable skin patch sensors are paired with prescription-only medicines for type 2 diabetes. This created the MySugarWatch-branded “DuoPack.”
Nemaura Medical develops and commercializes non-invasive, wearable diagnostic devices. Its sugarBEAT and proBEAT devices provide continuous glucose monitoring (CGM) plus additional capabilities.
The combination of sensors and medicine aimed to provide a “one-stop shop” supported by a holistic care approach. This offering used MSWDL nurses and nutritionists to create a long-term motivational relationship between patient and professional.
Nemaura Medical and MSWDL agreed to include injectable insulin for the European market as part of their agreement (as patent expiry allows). They believe as many as 4 million older patients between the UK and Europe with type 2 diabetes receive insulin.
Insulin deficiency leads to reduced pancreas size in type 1 diabetes by Emily Henderson for News-Medical.net, 10 March 2023.
Individuals with Type 1 diabetes have a smaller pancreas than people without diabetes. This is surprising because insulin-producing beta cells account for just a small fraction of the pancreas, so the loss of beta cells in Type 1 diabetes would not be expected to reduce pancreas size.
Now, a study of one family from Alabama has led Vanderbilt University Medical Center researchers to discover that insulin deficiency, independent of the autoimmunity associated with Type 1 diabetes, is the principal factor leading to a markedly smaller pancreas.
“We know the pancreas is much smaller in individuals with Type 1 diabetes, but there haven’t been good models to understand exactly what’s going on,” said Jordan Wright, MD, PhD, an instructor in the Division of Diabetes, Endocrinology and Metabolism and first author on the manuscript. “This is the first time we can actually demonstrate in humans that insulin is a major factor in determining pancreas size and the loss of it leads to a much smaller pancreas.”
Insulet to join S&P 500 after Silicon Valley Bank ousted by Elise Reuter for MedTechDive.com, 13 March 2023.
Insulet, a U.S.-based maker of tubeless insulin pumps, will join the S&P 500 starting on Wednesday, taking the place of SVB Financial Group. SVB is the parent of Silicon Valley Bank, which was closed by regulators and taken into receivership by the Federal Deposit Insurance Corporation.
Acton, Mass.-based Insulet has a market capitalization of $20.86 billion. The company’s shares rose 7%, or $19.67, to $300.03 in Monday morning trading. The shares are up more than 3% over the past five days.
Insulin Costs and Price Cuts
Why Does Insulin Cost So Much? Big Pharma Isn’t the Only Player Driving Prices by Arthur Allen for MedPageToday.com, 12 March 2023.
Eli Lilly & Co.’s announcement that is slashing prices for its major insulin products could make life easier for some diabetes patients while easing pressure on Big Pharma. It also casts light on the profiteering methods of the drug industry’s price mediators — the pharmacy benefit managers (PBMs) — at a time when Congress has shifted its focus to them.
Insulin has come to embody the perversity of the U.S. healthcare system as list prices for the century-old drug, which 8.4 million Americans depend on for survival, quintupled over two decades to more than $300 for a single vial. Just because Lilly — which sells about a third of the insulin in the U.S. — lowers its price doesn’t mean all patients will pay less, even in the long run.
Even as Lilly promotes its altruism, this move may actually save it money, said healthcare analyst Sean Dickson, JD, MPH. A federal rule taking effect next year penalizes companies that charge Medicaid high prices, especially for older, branded drugs. Lowering the list price of Humalog would allow Lilly to pay significantly less in rebates to government Medicaid programs that buy the drug.
Other parties at play include gigantic PBMs — owned by CVS Health and insurance giants UnitedHealthcare and Cigna — that have aggressively played the insulin makers off one another in a way that mainly fattened their own accounts, as was revealed in a scathing 2021 Senate Finance Committee report. In theory, when PBMs negotiate contracts with drug manufacturers on behalf of insurers, they pass along savings to patients. In practice, while hard-nosed bargaining may benefit the well-insured, it can hurt patients on fixed incomes and others less able to afford their insulin.
To compete for access to insured patients, according to the report, the three insulin makers in the 2010s steadily increased rebates and fees paid to the powerful PBMs, which are owned by or allied with major insurers. This spurred drugmakers to keep raising their list prices because the more they paid in rebates — calculated as a percentage of list price — the better their placement on insurance formularies, the more complex lists of drugs insurers cover for patients.
In other words, the more the insulin makers compete, the more consumers — the unlucky ones, anyway — may pay.
Novo Nordisk to slash US insulin prices, following move by Eli Lilly by Patrick Wingrove and Bhanvi Satija for Reuters.com, 14 March 2023.
Read more: Novo Nordisk to slash US insulin prices
Sanofi announces insulin price cuts, $35 monthly cap for people with commercial insurance by Jill Rollet for Healio.com/endocrinology, 17 March 2023.
Following on the heels of Eli Lilly and Novo Nordisk, Sanofi announced it will reduce the price of two of its branded insulins as well as cap out-of-pocket costs at $35 per month for people with commercial health insurance. Additionally, Sanofi announced patients with commercial insurance will pay no more than $35 out-of-pocket per month for insulin. Combined with the company’s Insulins Value Savings Program that caps out-of-pocket costs at $35 per month for those without insurance and the insulin cap instituted for Medicare beneficiaries in 2023, no patient will pay more than $35 for a monthly supply of insulin, the company stated.
“Sanofi believes that no one should struggle to pay for their insulin, and we are proud of our continued actions to improve access and affordability for millions of patients for many years,” Olivier Bogillot, head of U.S. general medicines for Sanofi, said in the release.
Speaking of Sanofi: Sanofi to pay $2.9B for Provention Bio and its diabetes-delaying drug Tzield by Drew Armstrong for Endpoints.com, 14 March 2023.
Sanofi and Provention Bio have made a $2.9 billion deal for the French drugmaker to acquire the biotech, which last year won approval for its drug to delay the onset of type 1 diabetes. Sanofi will pay $25 a share, the companies announced in a press release, a 273% premium over the New Jersey-based biotech’s closing price Friday. The companies already had a deal for Sanofi to co-promote the drug in the US, which they struck in October, that gave Sanofi first dibs on negotiating any licensing rights for the drug.
The news is likely to be well-received by the market, especially after the failure of Silicon Valley Bank last week sent worries rippling through public and private biotech companies about the industry’s stability.
Provention Bio’s treatment, sold as Tzield, was approved by the FDA in November after showing in trials that it could delay the onset of type 1 diabetes by about two years, the first treatment to show such an effect. It priced the drug at $193,000 for a course of treatment.