07.17.23
Headquarters: London, UK
twitter.com/GSK
www.gsk.com
Headcount: 69,400
Year Established: 2000
Revenues: $35,360 (+19%)
Net Income: $18,836 (>100%)
R&D: $6,618 (+9%)
It was an eventful year for GlaxoSmithKline, with high growth top sellers, key approvals, acquisitions, and alliances. Fiscal growth for year was largely attributed to record Shingrix sales of nearly $3.6 billion, and COVID-19 treatment, Xevudy, with sales topping $2.8 billion. Meanwhile, within the company’s three segments, Specialty Medicines sales were up 37% to $13.6 billion, Vaccines sales were $9.5 billion, up 17% thanks to Shingrix, and General Medicines accounted for $12.2 billion, up 5%. Earnings for the year primarily reflect the gain from discontinued operations arising from the demerger of the Consumer Healthcare business, which took place in July.
In a big win for GSK, Arexvy the company’s respiratory syncytial virus vaccine, was recently approved in by the FDA in May and the European Commission in June, becoming the world’s first RSV vaccine for older adults. Regulatory reviews in Japan and other counties underway. At press time, phase III trial results showed vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons. U.S. launch is planned before the 2023/24 RSV season.
In corporate news, GSK announced that its new global headquarters will be in central London. The company will move to the new headquarters in 2024 from its current location in Brentford, West London. The site, known as the Earnshaw, is under construction and offers close proximity to the fast-growing global Life Sciences hub, London’s Knowledge Quarter, and GSK’s existing collaboration partners including the Francis Crick Institute and King’s College London.
For approximately $1.9 billion, GSK acquired Sierra Oncology, a CA-based biopharmaceutical company focused on targeted therapies for rare forms of cancer, adding Momelotinib, a treatment for Myelofibrosis, and building on its commercial and medical expertise in hematology. Momelotinib has a differentiated mode of action that may lead to beneficial treatment effects on anemia and reduce the need for transfusions while also treating symptoms. The MOMENTUM phase III trial met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anemia.
Additionally, GSK acquired Affinivax, Inc., a clinical-stage biopharmaceutical company based in Cambridge, MA, for $2.1 billion upfront and as much as $1.2 billion in potential development milestones. Affinivax is developing a new class of vaccines, the most advanced of which are next-generation pneumococcal vaccines, and its Multiple Antigen Presenting System (MAPS) technology supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent strains and potentially creating higher immunogenicity than current vaccines.
Its most advanced candidate, AFX3772, includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins (compared to up to 20 serotypes in currently approved vaccines). A 30-plus valent pneumococcal candidate vaccine is also in preclinical development.
In the phase I/II clinical trials, AFX3772 was well tolerated and demonstrated good immune responses compared to the current standard of care. In July 2021, the U.S. FDA granted Breakthrough Therapy designation for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia in adults 50 years and above.
Ibrexafungerp first received FDA approval in September 2021 to treat vaginal yeast infections, and in December 2022, it was approved for vulvovaginal candidiasis and the reduction in recurrence. Ibrexafungerp is currently in Phase III trials for the treatment of invasive candidiasis. Successful development of the therapy for this indication will trigger up to $245.5 million in payments from GSK. Scynexis recently achieved a $25 million performance milestone following a development goal for the Phase 3 MARIO study for ibrexafungerp in invasive candidiasis.
Meanwhile, a strategic alliance with Wave Life Sciences aims to advance oligonucleotide therapeutics, including Wave’s preclinical RNA editing program targeting alpha-1 antitrypsin deficiency (AATD), WVE-006. AATD is an inherited genetic disease that affects both the lungs and liver with limited treatment options. WVE-006 is a first-in-class RNA editing therapeutic that is designed to address both liver and lung manifestations of the disease.
The four-year collaboration combines GSK’s insights from human genetics with Wave’s discovery and drug development platform, PRISM. Wave received $170 million upfront and is eligible to receive as much as $225 million and $300 million in development and launch milestones, as well royalties. Wave anticipates submitting clinical trial applications for WVE-006 this year. Once a phase 1 trial is complete, GSK will take over development.
Oligonucleotides are short strands of DNA or RNA that can reduce, restore, or modulate RNA through several different mechanisms with the capability to address a wide range of genomic targets in multiple therapeutic areas. Wave’s PRISM platform offers three RNA-targeting modalities (editing, splicing, and silencing, including siRNA and antisense). Importantly, these modalities incorporate novel chemistry to optimize the pharmacological properties of oligonucleotides. The discovery collaboration enables GSK to advance up to eight programs and Wave to advance up to three programs.
Among several key late-stage assets that are advancing are gepotidacin, bepirovirsen, tebipenem, and depemokimab. Pivotal phase III trials for gepotidacin, an antibiotic for uncomplicated urinary tract infections (UTIs), were stopped early for efficacy. The company also achieved positive phase IIb data for bepirovirsen, a potential functional cure for chronic hepatitis B. GSK entered an exclusive license agreement with Spero Therapeutics for tebipenem Hbr, a late-stage antibiotic for complicated UTIs. Also, GSK expanded the depemokimab phase III program with trials for long-acting IL-5 inhibitor in three additional eosinophil-driven diseases.
Lastly, the FDA granted Orphan Drug Designation for Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis. Plans to initiate a phase II/III trial in systemic sclerosis associated interstitial lung disease is on track for the first half of 2023.
twitter.com/GSK
www.gsk.com
Headcount: 69,400
Year Established: 2000
Revenues: $35,360 (+19%)
Net Income: $18,836 (>100%)
R&D: $6,618 (+9%)
It was an eventful year for GlaxoSmithKline, with high growth top sellers, key approvals, acquisitions, and alliances. Fiscal growth for year was largely attributed to record Shingrix sales of nearly $3.6 billion, and COVID-19 treatment, Xevudy, with sales topping $2.8 billion. Meanwhile, within the company’s three segments, Specialty Medicines sales were up 37% to $13.6 billion, Vaccines sales were $9.5 billion, up 17% thanks to Shingrix, and General Medicines accounted for $12.2 billion, up 5%. Earnings for the year primarily reflect the gain from discontinued operations arising from the demerger of the Consumer Healthcare business, which took place in July.
In a big win for GSK, Arexvy the company’s respiratory syncytial virus vaccine, was recently approved in by the FDA in May and the European Commission in June, becoming the world’s first RSV vaccine for older adults. Regulatory reviews in Japan and other counties underway. At press time, phase III trial results showed vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons. U.S. launch is planned before the 2023/24 RSV season.
In corporate news, GSK announced that its new global headquarters will be in central London. The company will move to the new headquarters in 2024 from its current location in Brentford, West London. The site, known as the Earnshaw, is under construction and offers close proximity to the fast-growing global Life Sciences hub, London’s Knowledge Quarter, and GSK’s existing collaboration partners including the Francis Crick Institute and King’s College London.
Acquisitions
GSK spent more than $6 billion on several acquisitions over the course of the year, adding late-stage assets to its vaccines, oncology, and general medicines portfolio. Complementing its respiratory medicines, GSK recently acquired Bellus Health, a Canada-based biopharmaceutical company focused on treating refractory chronic cough (RCC), for approximately $2 billion, gaining camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the treatment of adults with RCC. Current clinical data show that by selectively inhibiting P2X3 receptors, camlipixant may reduce cough frequency. Regulatory approval and launch of camlipixant is anticipated in 2026.For approximately $1.9 billion, GSK acquired Sierra Oncology, a CA-based biopharmaceutical company focused on targeted therapies for rare forms of cancer, adding Momelotinib, a treatment for Myelofibrosis, and building on its commercial and medical expertise in hematology. Momelotinib has a differentiated mode of action that may lead to beneficial treatment effects on anemia and reduce the need for transfusions while also treating symptoms. The MOMENTUM phase III trial met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anemia.
Additionally, GSK acquired Affinivax, Inc., a clinical-stage biopharmaceutical company based in Cambridge, MA, for $2.1 billion upfront and as much as $1.2 billion in potential development milestones. Affinivax is developing a new class of vaccines, the most advanced of which are next-generation pneumococcal vaccines, and its Multiple Antigen Presenting System (MAPS) technology supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent strains and potentially creating higher immunogenicity than current vaccines.
Its most advanced candidate, AFX3772, includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins (compared to up to 20 serotypes in currently approved vaccines). A 30-plus valent pneumococcal candidate vaccine is also in preclinical development.
In the phase I/II clinical trials, AFX3772 was well tolerated and demonstrated good immune responses compared to the current standard of care. In July 2021, the U.S. FDA granted Breakthrough Therapy designation for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia in adults 50 years and above.
Alliances
GSK partnered with Scynexis to develop Brexafemme (ibrexafungerp) in drug-resistant fungal infections, for which the CDC recently issued a warning citing an increase of drug-resistant Candida auris infections. GSK paid $90 million upfront and Scynexis is eligible for additional milestone-based payments totaling a potential $593 million plus royalties.Ibrexafungerp first received FDA approval in September 2021 to treat vaginal yeast infections, and in December 2022, it was approved for vulvovaginal candidiasis and the reduction in recurrence. Ibrexafungerp is currently in Phase III trials for the treatment of invasive candidiasis. Successful development of the therapy for this indication will trigger up to $245.5 million in payments from GSK. Scynexis recently achieved a $25 million performance milestone following a development goal for the Phase 3 MARIO study for ibrexafungerp in invasive candidiasis.
Meanwhile, a strategic alliance with Wave Life Sciences aims to advance oligonucleotide therapeutics, including Wave’s preclinical RNA editing program targeting alpha-1 antitrypsin deficiency (AATD), WVE-006. AATD is an inherited genetic disease that affects both the lungs and liver with limited treatment options. WVE-006 is a first-in-class RNA editing therapeutic that is designed to address both liver and lung manifestations of the disease.
The four-year collaboration combines GSK’s insights from human genetics with Wave’s discovery and drug development platform, PRISM. Wave received $170 million upfront and is eligible to receive as much as $225 million and $300 million in development and launch milestones, as well royalties. Wave anticipates submitting clinical trial applications for WVE-006 this year. Once a phase 1 trial is complete, GSK will take over development.
Oligonucleotides are short strands of DNA or RNA that can reduce, restore, or modulate RNA through several different mechanisms with the capability to address a wide range of genomic targets in multiple therapeutic areas. Wave’s PRISM platform offers three RNA-targeting modalities (editing, splicing, and silencing, including siRNA and antisense). Importantly, these modalities incorporate novel chemistry to optimize the pharmacological properties of oligonucleotides. The discovery collaboration enables GSK to advance up to eight programs and Wave to advance up to three programs.
Advancing assets
GSK’s pipeline is comprised of 69 vaccines and specialty medicines based on science of the immune system, with 18 in phase III/registration. This year, the FDA granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a FDA-approved test, that has progressed on or following a prior platinum-containing regimen and are not candidates for surgery or radiation. Additional approvals by the FDA for Jemperli in first line endometrial cancer, and momelotinib, in myelofibrosis, are anticipated in 2023.Among several key late-stage assets that are advancing are gepotidacin, bepirovirsen, tebipenem, and depemokimab. Pivotal phase III trials for gepotidacin, an antibiotic for uncomplicated urinary tract infections (UTIs), were stopped early for efficacy. The company also achieved positive phase IIb data for bepirovirsen, a potential functional cure for chronic hepatitis B. GSK entered an exclusive license agreement with Spero Therapeutics for tebipenem Hbr, a late-stage antibiotic for complicated UTIs. Also, GSK expanded the depemokimab phase III program with trials for long-acting IL-5 inhibitor in three additional eosinophil-driven diseases.
Lastly, the FDA granted Orphan Drug Designation for Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis. Plans to initiate a phase II/III trial in systemic sclerosis associated interstitial lung disease is on track for the first half of 2023.