MannKind enrolls first patient in Afrezza study focusing on children

Rapid-acting insulin specialist MannKind Corp. (NSDQ:MNKD) has enrolled the first pediatric patient in its INHALE-1 study evaluating its Afrezza (Technosphere Insulin) with basal insulin versus multiple daily injections of insulin. The study will enroll participants aged four to 17 with type 1 or type 2 diabetes.

Afrezza first won FDA approval in 2014, and MannKind initially partnered with Sanofi (NSDQ:SNY) to market the drug. Sanofi pulled out of the partnership in 2016.

The INHALE-1 is a 26-week open-label, randomized study with a 26-week extension.

The primary endpoint of the study will be the average HbA1c level after 26 weeks. Secondary endpoints include changes in fasting plasma glucose and the rate of hypoglycemic events at the same interval.

Earlier this year, MannKind CEO Michael Castagna said that the company has focused on increasing the number of presentations and publications related to Afrezza to boost its sales.

MNKD shares, …

Read more
  • 0

Sanofi completes Translate Bio acquisition

Sanofi (NSDQ:SNY) announced today that it has completed the purchase of its mRNA partner Translate Bio.

The previously announced deal, according to Sanofi, accelerates the French pharma giant’s efforts to develop transformative vaccines and therapies using mRNA technology.

The deal comes during a year in which mRNA-based Moderna (NSDQ:MRNA) and Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccines are generating tens of billions of dollars.

Sanofi generated $41 billion in revenue last year.

As of today, Translate Bio is now an indirect, wholly-owned subsidiary of Sanofi. All Translate Bio shares not validly tendered in the tender offer have been converted into the right to receive the same $38 per share in cash.

 

Read more
  • 0

Sanofi to acquire Kadmon for $1.9B

Sanofi (NYSE:SNY) announced today that it entered into a definitive merger with therapeutic developer Kadmon (NSDQ:KDMN) for $1.9 billion.

The acquisition adds Rezurock (belumosudil), a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for patients over 12 years old who have failed at least two prior lines of systemic therapy, to Sanofi’s transplant portfolio.

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

Read more
  • 0

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…

Read more
  • 0

FDA approves Sanofi’s Nexviazyme for late-onset Pompe disease

With its recent approval of Nexviazyme (avalglucosidase alfa-ngpt), Sanofi (NSDQ:SNY) has asserted its control over the Pompe disease landscape.

In 2006, FDA approved Genzyme’s Myozyme (alglucosidase alfa) for Pompe disease. Sanofi acquired the company a decade ago. Additionally, FDA approved Lumizyme in 2010, which uses the same biologic, but is indicated for patients eight years of age or older. The company uses a larger bioreactor to make Lumizyme.

Nexviazyme is indicated for patients one year of age or older.

Pompe disease results from a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA), which triggers a surplus of glycogen in muscles.

Nexviazyme targets a pathway used to transport GAA to lysosomes in cells known as the mannose 6-phosphate receptor (M6P).

The drug resulted in a roughly 15-fold increase in M6P levels compared to alglucosidase alfa in the Phase 3 study. The double-blind COMET trial enr…

Read more
  • 0

Sanofi reshapes mRNA landscape with $3.2B Translate Bio buy

Sanofi (NSDQ:SNY) may be one of the biggest vaccine manufacturers in the world, but the quick rise of the mRNA vaccine platform during the pandemic caught the company by surprise. 

The company could be on the way to rectify that with its $3.2 billion acquisition of its mRNA partner Translate Bio. 

Sanofi began working with Lexington, Mass.–based Translate Bio in 2018 and expanded that partnership last June with a $2 billion collaboration. 

In the most recent deal, Sanofi will pay $38 per share for Translate Bio’s shares. 

Sanofi plans to use mRNA technology for various clinical uses beyond vaccines, including immunology, oncology and rare diseases.

The mRNA-based Moderna (NSDQ:MRNA) and Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) vaccines have generated tens of billions of dollars in sales in 2021. Pfizer anticipates the BNT162b2 vaccine could generate $33.5 billion in sales this year. Moderna’s market valuation hit $140 billion on Aug. 2, while B…

Read more
  • 0

Several companies could vy for next-gen COVID-19 vaccine market share

[Photo by Daniel Schludi on Unsplash]

A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market.

That could change in the long run, however, as a growing number of companies develop next generation mRNA COVID-19 vaccines, which promise to be more effective and less likely to cause side effects than their predecessors.

While mRNA COVID-19 vaccines are among the most effective vaccines against the novel coronavirus, researchers have linked their use to rare side effects such as myocarditis.

Future mRNA may be better tolerated. mRNA itself promotes an immune response future mRNA vaccines could optimize reactogenicity through refining the dose or structure of the single-stranded RNA molecule. 

Such next-gen vaccines will also likel…

Read more
  • 0

Sanofi to spend nearly half a billion dollars a year on mRNA vaccine research

Sanofi (NYSE:SNY) announced today that it plans to invest approximately $476.3 million (€400 million) per year on mRNA vaccine development.

Paris-based Sanofi’s intends for its annual investment to go toward a first-of-its-kind vaccine “mRNA Center of Excellence” to accelerate the development and delivery of next-generation vaccines.

Get the full story at our sister site, Drug Discovery & Development.

Read more
  • 0

Sanofi to spend nearly half a billion dollars a year on mRNA vaccine research

Sanofi (NYSE:SNY) announced today that it plans to invest approximately $476.3 million (€400 million) per year on mRNA vaccine development.

Paris-based Sanofi’s intends for its annual investment to go toward a first-of-its-kind vaccines “mRNA Center of Excellence,” where work will be conducted to accelerate the development and delivery of next-generation vaccines.

Approximately 400 employees will integrate end-to-end mRNA vaccine capabilities with dedicated R&D, digital and chemistry, manufacturing and controls (CMC) teams at sites in Cambridge, Mass., and Marcy l’Etoile, Lyon, France, according to a news release. The center will seek to accelerate the mRNA portfolio developed by Sanofi in collaboration with Translate Bio, the company said.

“During the COVID-19 pandemic, mRNA technologies demonstrated potential to deliver new vaccines faster than ever before,” Sanofi Pasteur global head of R&D Jean-Francois Toussaint…

Read more
  • 0

Sanofi and GSK start Phase 3 trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.

The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.

Get the full story at our sister site, Drug Discovery & Development.

Read more
  • 0

Sanofi and GSK start Phase 3 trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.

The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.

Prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults constitutes the primary endpoint, while the prevention of severe COVID-19 disease and prevention of asymptomatic infection makes up the secondary endpoints.

Stage one of the study will investigate the efficacy of the vaccine formulation targeting the original D.614 virus (Wuhan) while a second stage will evaluate a second formulation targeting the South African (B.1.351) variant. The global study offers a chance to evaluate the vaccine candidate against a number of circulatin…

Read more
  • 0

Pharma 50: Here’s how the world’s largest pharma companies are doing

The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead.

That’s one of the big takeaways from Drug Discovery & Development’s inaugural Pharma 50, a compilation of data on the largest pharma companies in the world. (Browse data on all 50 companies here.)

Overall, the 50 largest pharma companies brought in $851 billion in sales in 2020. Pharma companies also overcame COVID-19-related clinical trial disruption and staffing hurdles, driving unprecedented R&D advances to introduce novel vaccines and therapies to battle the pandemic. The resulting shift in public perception could benefit the industry for years to come.

One of the most notable achievements involved the mRNA vaccines from Pfizer/BioNTech and Moderna, according to analyst Mani Foroohar at SVB Leerink.

Other achievements, according to Foroohar, includ…

Read more
  • 0