Regeneron Archives - Medical Design Sourcing

HHS awards more than $1 billion to advance next-gen COVID-19 vaccines and therapeutics

The U.S. Department of Health and Human Services (HHS) has awarded $1.4 billion to support vaccine clinical trials to test new, more effective and longer-lasting COVID-19 vaccines. In all, Project NextGen is a $5 billion initiative from Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the program is to identify and address strengths and weaknesses of current COVID-19 therapies and vaccines, as well as the back the development of next-gen COVID-19 vaccines and therapies

The latest funding announcement announced allots $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody and another $100 million to spark innovation of novel vaccine and therapeutic technologies.

Towards next-gen COVID-19 vaccines and therapies

Regeneron alone received $326 million under the program, dubbed Project NextGen. The funding for the Tarrytown, New York–bas…

Regeneron agrees to spend up to $213M to acquire Decibel Therapeutics

To date, 2023 is shaping up to be a relatively brisk year for M&A deals. A recent case in point is Regeneron’s acquisition of Decibel Therapeutics. The centerpiece of the deal is DB-OTO, a gene therapy intended for patients with otoferlin-related hearing loss. The drug is in its first clinical trial. Regeneron agreed to pay $4.00 per share for Decibel stock with the potential to pay up to $3.50 per share in cash if Decibel hits agreed-upon regulatory milestones for DB-OTO in a specified time frame, bringing the total value of the deal to roughly $213 million.

Last year, Decibel touted DB-OTO’s ability to support otoferlin expression for several weeks before it plateaued. The company said the data for the drug were in line with earlier preclinical research in which mice achieved a functional recovery.

Involved in transmission of sound signals in the inner ear, the protein otoferlin is essential for hearing. Deficiency or mutations in the gene that produces o…

4 top drug discovery innovations of 2022

Prix Galien

Late last year, the Galien Foundation highlighted several drug discovery innovations in its annual Prix Galien USA Award Winners, which specifically highlighted drugs from Regeneron and Amgen as well as a platform from Exscientia and the incubators BioLabs and LabCentral.

The foundation recently hosted a webinar featuring several executives from the respective winning companies discussing their view on their respective drug discovery innovations.

1. Inmazeb: The first FDA-approved Ebola drug

The Galien Foundation chose Regeneron’s (Nasdaq:REGN) Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the best biotechnology product of 2022. The antibody cocktail became the first FDA-approved treatment for Ebola (Zaire Ebolavirus) for pediatric and adult patients in 2020.

There were several hurdles involved in developing Inmazeb, said Neil Stahl, EVP of R&D at Regeneron Phar…

And the most innovative biotechnology and pharma products are…

The Galien Foundation has selected Regeneron’s (Nasdaq:REGN) Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the best biotechnology product of 2022 and Amgen’s (Nasdaq:AMGN) Lumakras as the best pharmaceutical agent.

The organization announced the news last week as part of the Prix Galien USA 2022 awards series.

The antibody cocktail Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) became the first FDA-approved treatment for Ebola (Zaire Ebolavirus) for pediatric and adult patients in 2020.

The Tarrytown, New York–based biotechnology company Regeneron developed Inmazeb with its proprietary VelocImmune mouse technology to facilitate the immediate generation of genetically altered mice from modified embryonic stem cells. In addition, the technique enabled the company to study the drug preclinically without breeding multiple generations of mice.

“Our groundbreaking ‘rapid response’ application of our Veloci…

FDA grants priority review of aflibercept in retinopathy of prematurity

[Image courtesy of Regeneron/Bayer]

Regeneron Pharmaceuticals (Nasdaq:REGN) has announced that the FDA has granted Priority Review of the supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection to treat retinopathy of prematurity (ROP) in preterm infants.

First approved in 2011 to treat wet age-related macular degeneration, aflibercept is a blockbuster drug. Last year, it generated $9.2 billion for Regeneron and aflibercept co-developer Bayer. The drug is also indicated for diabetic retinopathy, diabetic macular edema and macular edema following retinal vein occlusion.

The Tarrytown, New York–based company has conducted two randomized Phase 3 studies testing aflibercept against laser in infants with retinopathy of prematurity. Both the FIREFLEYE and BUTTERFLEYE studies tested a 0.4 mg dose of aflibercept. Both studies found that roughly 80% of aflibercept recipients had an abs…

Regeneron purchases exclusive rights to Libtayo from Sanofi for $900M

Sanofi (Nasdaq:SNY) has agreed to sell Regeneron (Nasdaq:REGN) exclusive international rights of Libtayo (cemiplimab) for $900 million. Sanofi will also receive an 11% royalty on global sales of the drug.

Libtayo is a monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.

Sanofi could also receive $100 million if the drug hits regulatory milestones in the next two years. The Paris-headquartered company could get an additional $100 million for meeting sales-related milestones in the same time window.

FDA approved the drug for advanced cutaneous squamous cell carcinoma in 2018. In 2021, Libtayo picked up indications for advanced basal cell carcinoma and first-line advanced non-small cell lung cancer with PD-L1 expression of at least 50%.

Sanofi and Regeneron entered into an international immuno-oncology alliance in 2015, agreeing then to split operating profits for Libtayo in the U.S. Sanofi agreed then to commercialize the dr…

Gilead Sciences, Merck near the top of Newsweek’s most responsible companies list

A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined assessments on environmental, social and corporate governance performance.

Gilead Sciences (NSDQ:GILD), Merck (NYSE:MRK) and Pfizer (NYSE:PFE) were among the pharmaceutical companies to land a spot in the top-500, with a number of other drug development, pharmaceutical processing and manufacturing companies included.

The highest-ranking company was Gilead in sixth, landing an overall score of 89.9 points (90.6 environmental, 81.1 social and 98.2 corporate governance).

Merck was next-best in ninth at 89.3 points (94.6, 81.4, 92.…

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…

REGEN-COV cuts viral load within 7 days in COVID-19 patients

Regeneron Pharmaceuticals (NSDQ:REGN) and Roche (OTCQX: RHHBY) are touting positive results from a Phase 2/3 study investigating the potential of REGEN-COV (casirivimab and imdevimab) antibody cocktail in hospitalized COVID-19 patients. The study met its primary endpoint of reducing viral load within one week in seronegative patients needing low-flow or no supplemental oxygen.

REGEN-COV, known as Ronapreve outside of the U.S., led to a 36% reduced risk of death by day 29 in the overall treatment population.

“These new results, combined with the nearly 10,000-patient RECOVERY trial, further validate how REGEN-COV can change the course of illness for patients even after they are hospitalized with COVID-19,” said Dr. George D. Yancopoulos, president and chief scientific officer at Regeneron, in a statement.

Roche has partnered with Regeneron (NSDQ: REGN) to help manufacture and distribute REGN-COV2, which Regeneron first developed.

Roche’s chief medi…

Pfizer’s abrocitinib goes head-to-head with Sanofi’s Dupixent

Abrocitinib chemical structure. Image courtesy of Wikipedia.

Pfizer (NYSE: PFE) recently announced that its once-daily oral Janus kinase 1 (JAK1) inhibitor abrocitinib bested Sanofi’s Dupixent (dupilumab) in a Phase 3 study focused on moderate to severe atopic dermatitis (AD).

Meanwhile, Sanofi (EPA:SAN) announced that a Dupixent pivotal trial met its primary and secondary endpoints, making it the first biologic to demonstrate significant reductions in moderate-to-severe atopic dermatitis symptoms in children down to six months of age.

Regeneron Pharmaceuticals (NSDQ: REGN) partnered with Sanofi in developing Dupixent. In July, both companies announced that Dupixent met all primary and second endpoints in a Phase 3 trial focused on moderate-to-severe chronic spontaneous urticaria (hives).

Last year, Dupixent generated more than $8 billion in total revenue.

The Pfizer study compared a 200…

DeSantis sets plan for Regeneron monoclonal antibodies to fight COVID-19

Battling its worst surge in COVID-19 cases, Florida has announced it will use Regeneron’s (NSDQ:REGN) REGEN-COV to protect its population.

Florida Governor Ron DeSantis announced that the state would dispense the monoclonal antibody cocktail through mobile clinics and a rapid response unit in Jacksonville. DeSantis stressed that high-risk individuals, including the elderly, along with people with chronic illness and weak immune systems, should obtain the treatment as soon as they develop symptoms.

DeSantis also said the state would use “strike teams” to deploy the monoclonal antibody in nursing homes.

“We are going to bring a lot more Regeneron into Florida, which I think is important,” DeSantis said in an announcement. “This is the most effective treatment that we’ve yet encountered for people who are infected with COVID-19.”

Clinical trials have demonstrated that the drug is effective at reducing hospitalizations and severe illness stemming from…

CMS retreats from ‘most favored nation’ drug pricing scheme

Former President Trump’s plan to peg the price of some drugs to those paid in other developed nations was always controversial. Not long after Trump unveiled an executive order supporting the idea on Sept. 13, 2020, organizations, including PhRMA and Regeneron, filed lawsuits to block the rule.

Several courts agreed that the policy, which CMS codified in November 2020, had procedural issues. Namely, the agency provided less time for involved parties to comment on the rule than the Administrative Procedures Act prescribes.

HHS predicted the rule would save the federal government $85 billion over the next seven years.

Now, the Biden administration is moving to revoke the interim final rule that would have enacted the rule.

It remains unclear, however, what scheme to reduce drug pricing might follow. The Biden administration has stated that it is eyeing ways to reduce spending on Medicare Part B drugs.

The ‘most favored nation’ rule was not ju…