FDA authorizes new antibody from Lilly that holds up to omicron

FDA has authorized bebtelovimab, a monoclonal antibody from Eli Lilly and Company (NYSE:LLY), for certain high-risk patients with COVID-19.

The emergency use authorization (EUA) for the antibody covers the treatment of mild-to-moderate COVID-19 in individuals at least 12 years of age who weigh at least 40 kg (about 88 pounds). The EUA is constrained to individuals who are not good candidates for existing approved or authorized alternative COVID-19 therapies.

The authorization covers a single 175-mg intravenous dose of bebtelovimab is 175 mg administered over at least 30 seconds.

Lilly began developing bebtelovimab early in 2021 and confirmed its potency against omicron in pseudovirus and authentic virus testing.

Dr. Daniel Skovronsky

The broadly neutralizing antibody “could be used to fight a highly mutated variant, should one emerge,” said Dr. Daniel Skovronsky, Lill…

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Lilly to supply up to 600,000 doses of investigational COVID antibody to U.S. government

Monoclonal antibodies were one of the first weapons to emerge in the battle against COVID-19, but only a single antibody therapy, sotrovimab from Vir Biotechnology and GSK, retains potency against the omicron variant. Two weeks ago, FDA recommended limited use of Eli Lilly’s (NYSE:LLY) bamlanivimab and etesevimab and Regeneron’s (NSDQ:REGN) REGEN-COV (casirivimab and imdevimab), given their diminished protection against omicron.

Eli Lilly, however, said it has found its investigational antibody bebtelovimab retains full neutralizing activity against the variant based on pseudovirus and authentic virus testing.

Lilly also noted that the antibody retains neutralization against the BA.2 subvariant.

Now, the company has reached an agreement with the U.S. government to supply up to 600,000 doses for a price tag of at least $720 million. The supply agreement asks for delivery of that number of doses by March 31. The U.S. has the option of purchasing an additio…

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Lily delays timeline for Alzheimer’s candidate donanemab amidst aducanumab chaos 

Eli Lilly (NYSE:LLY) announced it planned to complete the application for donanemab, which received FDA’s Breakthrough Therapy designation as a potential Alzheimer’s treatment last summer.

Lilly had initially planned on filing the application for donanemab in the first quarter of the year.

LLY shares fell 2.40% to $244.81 after announcing the news.

Medicare had announced a proposal to limit coverage for monoclonal antibodies targeting amyloid to treat Alzheimer’s disease.

Lilly anticipates data from a confirmatory donanemab in 2023.

According to recent research from Spherix Global Insights, about half of neurologists are skeptical about prescribing monoclonal antibodies targeting amyloid, given the controversy related to Biogen’s aducanumab.

A study published in NEJM in 2021 found that patients with early Alzheimer’s disease who received donanemab had an improved composite score for cognition at 76 weeks compared to placebo.

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Lilly to invest $1B in new plant in North Carolina

Eli Lilly and Co. (NYSE:LLY) said it would invest more than $1 billion to build a new manufacturing facility in Concord, North Carolina.

The company says it would hire almost 600 new employees to staff the new site, which will include a campus of five buildings focused on manufacturing parenteral (injectable) products and devices.

The average salary for the new employees will be approximately $70,000.

The location of the proposed 800,000-ft2 site was formerly occupied by a Philip Morris plant.

“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,” said Edgardo Hernandez, senior vice president and president, Lilly Manufacturing Operations, in a statement. “We are pleased to again partner with North Carolina to bring jobs to American workers and provide more medicines that patients need to addre…

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Eli Lilly to build $1B manufacturing facility for injectable products, devices in North Carolina

Eli Lilly (NYSE:LLY) announced today that it plans to invest more than $1 billion to create a new manufacturing site in North Carolina.

Indianapolis-based Eli Lilly’s new facility, which it expects to bring with it nearly 600 jobs in Concord, North Carolina, will manufacture parenteral (injectable) products and devices while increasing the company’s manufacturing capacity.

Get the full story at our sister site, Drug Delivery Business News.

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Eli Lilly to build $1B manufacturing facility for injectable products, devices in North Carolina

Eli Lilly (NYSE:LLY) announced today that it plans to invest more than $1 billion to create a new manufacturing site in North Carolina.

Indianapolis-based Eli Lilly’s new facility, which it expects to bring with it nearly 600 jobs in Concord, North Carolina, will manufacture parenteral (injectable) products and devices while increasing the company’s manufacturing capacity.

Get the full story at our sister site, Drug Delivery Business News.

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Lilly could pay up to $450M to use Entos Pharmaceuticals’ Fusogenix nucleic acid delivery technology

Eli Lilly (NYSE:LLY) has acquired exclusive rights to Entos Pharmaceuticals’ Fusogenix proteolipid vehicle (PLV) drug-delivery technology.

Indianapolis-based Lilly plans on using the platform to discover and develop nucleic acid products intended for the nervous system.

Lilly is optimistic that Fusogenix could help it address hurdles tied to nucleic acid therapeutic modalities.

In the collaboration, Edmonton, Canada–based Entos will focus on creating and optimizing PLVs, while Lilly will select PLVs it intends to use for clinical development and commercialization.

The Fusogenix platform delivers a proteo-lipid vehicle (PLV) payloadinto the cytoplasm. Fusogenix image courtesy of Entos Pharmaceuticals

Lilly will pay Entos $50 million upfront and could pay up to $400 million in additional milestone payments. Entos also could receive royalties from commercialized products stemming from…

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FDA authorizes COVID-19 antibody cocktail for younger children

The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns.

The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression.

The EUA previously covered children at least 12 years of age who weigh at least 40 kilograms.

The FDA will now allow the use of the antibody cocktail as post-exposure prophylaxis (PEP) to prevent COVID-19 in all pediatric patients with a high risk of progressing to severe COVID-19.

Bamlanivimab and etesevimab image courtesy of Lilly.

The expanded authorization is not intended to provide an alternative to vaccination, said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “Vaccines remain our best tool in the fight against the virus, an…

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Early data suggest COVID-19 monoclonal antibodies offer less protection against Omicron variant

SARS-CoV-2 image courtesy of Wikimedia Commons

The antibody cocktails from Regeneron (NSDQ:REGN) and Eli Lilly (NYSE:LLY) may provide less protection against the Omicron COVID-19 variant than earlier circulating variants.

Independent researchers at the Fred Hutchinson Cancer Research Center (Seattle) concluded that bamlanivimab and etesevimab had a decrease in protection against Omicron, according to The Wall Street Journal.

Omicron could be more resistant to SARS-CoV-2 antibodies than “all the other major variants,” surmised Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center, in an interview with Science.

Regeneron released a statement with similar conclusions about its REGEN-COV treatment. While noting that there are “no direct data” pertaining to Omicron’s resistance to monoclonal antibodies or vaccine-induced antibodies, Regeneron stated that earlier in vitro studies an…

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Fountain Therapeutics closes $15 million in Series A-2 financing

South San Francisco–based biopharma Fountain Therapeutics has pulled in $15 million in Series A-2 financing, bringing its total Series A funding to $26 million. The company focuses on drug development for chronic degenerative diseases.

Eli Lilly and Company (NYSE:LLY), Alexandria Venture Investments and R42 Group joined as new investors in the funding round. Prior investors Khosla Ventures and Nan Fung Life Sciences also contributed to the Series A-2 financing.

Like many other biopharma startups, Fountain Therapeutics aims to use computer vision, artificial intelligence and machine learning to enhance its drug discovery efforts.

The company’s specific focus is on treating age-related diseases by reversing cellular age.

“We have already identified novel biology around known targets and potential new insights into chronic disease states that may lead to new therapies,” said Dr. William Greene, CEO of Fountain Therapeutics, in a press release. “We lo…

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7 diabetes treatment innovations to look out for on World Diabetes Day

World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes.

This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease.

Some of those treatments involve insulin, which was discovered as a treatment for diabetes in 1922 and remains a vital part of the standard of care. World Diabetes Day falls on Nov. 14 because it is the birthday of Frederick Banting, one of the scientists involved in discovering insulin as a treatment for diabetes.

However, while many medtech companies look for ways to make insulin accessible and efficient in treating diabetes, others are innovating treatment avenues outside of insulin. Regardless of the path chosen, all have created intriguing options for managing and treating diabetes. Here are seven innovations in diabetes treatment that are worth keeping an eye on:

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Lilly beats Street in Q3, raises guidance on COVID-19 antibody revenues

Eli Lilly (NYSE:LLY) shares slightly dipped today on third-quarter results that topped the consensus forecast.

The Indianapolis-based company posted profits of $1.1 billion, or $1.22 per share, on sales of $6.8 billion for the three months ended Sept. 30, 2021, for a -8.1% bottom-line slide on sales growth of 18%.

Adjusted to exclude one-time items, earnings per share were $1.94, 26¢ ahead of Wall Street, where analysts were looking for sales of $5.7 billion.

“Lilly demonstrated strong performance again this quarter. Revenue attributable to our newer medicines grew more than 35 percent and represented nearly 60 percent of our core business, an important indicator of our long-term growth potential,” Lilly Chairman & CEO David A. Ricks said in a news release. “With numerous positive pipeline events this quarter, we have the potential to continue to expand the number of patients we serve through new indications for both Verzenio and Ja…

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