PRESS RELEASES FROM GSK- LAST TWELVE MONTHS

TRELEGY ELLIPTA — JAPAN- MAY 29, 2018
An application has been submitted.
 Trelegy Ellipta is a"once-daily single inhaler triple therapy FF/UMEC/VI for patients with COPD"
 Japan currently has no triple therapy like this.

BEXSERO- EUROPE- JUNE 27, 2018
Infants can now be protected against meningitis in fewer doses with an alternative 2+1 dosing schedule instead of the 3+1 schedule.
 Bexsero is given in two doses, followed by a booster. Two months must pass between the first and second dose.
They hope the reduced doses will improve compliance.

KRINTAFEL- JULY 20, 2018
 Krintafel is a malaria cure that was approved by the FDA.
It is in collaboration with Medicines for Malaria (MMV).
It is indicated for patients age 16 and over.
"Krintafel is an 8-aminoquinoline derivative with activity against all stages of the P. vivax life cycle, including hypnozoites".
It is not approved anywhere else in the world, but submissions to Australia have been made.

PARTNERSHIP WITH ADAPTIMMUNE FOR T-CELL THERAPY (GSK-794)- JULY 24, 2018
This therapy is the first one to show a response with solid tumors.
"GSK ‘794 is an engineered T-cell therapy, for which a patient’s own cells have been genetically modified to express a T-cell receptor (TCR) recognising with high affinity the tumour-specific antigen, NY-ESO. When the modified cells are re-infused into the patient, they recognize and kill tumour cells that express the NY-ESO antigen".
"NY-ESO is expressed at various levels across different tumours, and appears to be expressed at high levels in defined sub-types of soft tissue sarcomas, melanoma, multiple myeloma, bladder cancer, non-small cell lung cancer, ovarian cancer and gastro-intestinal cancers".

GSK SIGNS AGREEMENT WITH 23ANDME- JULY 25, 2018
They will be working together to use genetic insights to develop new novel medicines.
The four-year agreement will focus on discovering new cures using genetics as the "basis of discovery".

KOZENIS- AUSTRALIA- SEPTEMBER 21, 2018
 Keozenis has been approved in Australia for malaria.
This is a single dose tafenoquine.
MEPOLIZUMAB FOR COPD- SEPTEMBER 7, 2018
GSK did not get approval for Mepolizumab for COPD, as the FDA needs more clinical data that it is an effective add-on treatment to "inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts."
 GSK will work with the FDA to determine next steps.

TRELEGY ELLIPTA - EUROPE- NOVEMBER9, 2018
The drug has gained expanded COPD indications.
It is a once-daily, single inhaler, triple therapy.

DAPRODUSTAT IN JAPAN- NOVEMBER 22, 2018
This is a potential new treatment for "anemia associate with chronic kidney disease".

GSK has partnered with Kyowa Hakko Kirin.
"We anticipate making a regulatory submission to the Japanese Ministry of Health, Labour and Welfare in 2019 and if approved, we believe daprodustat would be an important new oral treatment option for Japanese patients with anaemia associated with CK".
"Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the production of red blood cells and iron metabolism, similar to the physiological effects that occur in the body at high altitude".

GSK & MERK JOINTLY DEVELOP BINTRAFUSP ALFA- FEBRUARY 5, 2019
It is an immunotheraphy for difficult to treat cancers.
"M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers".
"This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC)."

DOVATO BY VIIV- APRIL 8, 2019
 Dovato has been approved as a "once daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults".
In Gemini trials the drug was studied for 48 weeks with no cases of resistance.
"Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC. Dovato, a two-drug regimen (2DR), reduces exposure to the number of ARVs from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional DTG-based three-drug regimen".
Several other submissions are planned for 2019. It is under review by the "European Medicines Agency (EMA) and regulatory authorities in Canada, Australia, Switzerland, and South Africa ".

BENLYSTA- APRIL 26, 2019
 Benlysta has received US approval for "intravenous use in children with lupus aged five years and above".
This is the first drug approved for children with "systemic lupus erythematosus (SLE)".
"The approval extends the current indication in the US for the IV formulation of Benlysta in adults, to patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy".
"The IV formulation of Benlysta is currently not approved for use in children anywhere else in the world although regulatory submissions are ongoing in other parts of the world."

CABOTEGRAVIR AND RILPIVIRINE COMBO DRUG- BY VIIV- APRIL 29, 2019
 ViiV submitted an application to the FDA for the "first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine for treatment of HIV. If approved, cabotegravir and rilpivirine would be the first-ever long-acting, injectable treatment regimen for adults living with HIV".
 ViiV submitted this drug with Pfizer and Shinogi Limited.
Injected monthly, it has been proven effective as a viral suppressor in a 48-week study.

SHINGRIX IN CHINA- MAY 23, 2019
 Shingrix has been approved in China for the "prevention of shingles in adults age 50 and over".
"Shingrix is a recombinant subunit adjuvanted vaccine given intramuscularly in two doses".
 China put Shingrix on the list of their urgently needed new medicines and expedited review.
The vaccine has 90% efficacy in all age groups.

NUCALA (MEPOLIZUMAB) — JUNE 6, 2019
The FDA has approved two new methods for administering "Nucala, and auto-injector and a pre-filled syringe, that is administered every four weeks".
It is the "first anti-IL5 biologic to be licensed in the US for home administration".
It is the first "respiratory biologic to be approved for administration by an auto-injector".

ZEJULA (NIRAPARIB)- JUNE 24, 2019
 Tesaro submitted a new drug application for the treatment of "advanced ovarian, fallopian, or primary peritoneal cancer for patients that have been treated with three or more prior chemotherapy regimens".
 Zejula is an active late line treatment.
It is an oral, once daily PARB inhibitor.
It is currently being evaluated in three different trials.

CURRENT GSK PRODUCT PIPELINE (06/26/2019)

DETAILED INFORMATION CAN BE ACCESSED HERE.
 ONCOLOGY 
Phase 3: Zejula, dostarlimab,
Phase 2: dostarlimab, 2857916- B-cell maturation antigen antibody drug conjugate, 3377794-NY-ESO-1 autologous engineered TCR-T cells (engineered TCR), 3359609- Induced T-cell co-stimulator (ICOS) agonist antibody, molibresib (525762), M7824- Transforming growth factor beta, TSR-022- Anti-T-cell immunoglobulin and mucin domain-3 (TIM-3) antibody
Phase 1/2: 3174998- OX40 agonist monoclonal antibody,
Phase 1: 3326595- Protein arginine methyltransferase 5 (PRMT5) inhibitor, 1795091- Toll-like receptor 4 (TLR4) agonist, 2636771- Phosphatidylinositol 3-kinase (PI3K) beta inhibitor, 3368715- Protein arginine methyltransferase 1 (PRMT1) inhibitor, 3145095- RIP1 kinase inhibitor, 35371422- NY-ESO-1-targeting bispecific, TSR-033- Anti-lymphocyte activation gene-3 (LAG-3) antibody
 HIV/INFECTIOUS DRUGS 

Submitted: Dectova, dolutegravir + lamivudine,
Phase 3: dolutegravir + lamivudine, fostemsavir, cabotegravir + rilpivirine,
Phase 2: cabotegravir, gepotidacin, 32288361- HBV antisense oligonucleotide, 33894041- HBV LICA antisense oligonucleotide, 3640254- HIV maturation inhibitor,
Phase 1: 3036656- Leucyl t-RNA synthetase inhibitor, 3810109- HIV broadly neutralizing antibody
 IMMUNO/INFLAMMATION 

Phase 3: Benlysta + Rituxan,
Phase 2: Benlysta + Rituxan, 3196165-Granulocyte macrophage colonystimulating factor monoclonal antibody, 2982772- Receptor-interacting protein 1 (RIP1) kinase inhibitor, 2330811- Oncostatin M (OSM) monoclonal antibody
Phase 1: 2831781- Lymphocyte activation gene 3 (LAG3) protein monoclonal antibody, 2983559- Receptor-interacting protein 2 (RIP2) kinase inhibitor, 3358699- BET targeted inhibitor, 3858279-CCL17 inhibitor,
 RESPIRATORY 

Complete Response Letter: mepolizumab
Phase 3: mepolizumab, fluticasone furoate + vilanterol + umeclidinium,
Phase 2: 2586881- Recombinant human angiotensin converting enzyme 2 (rhACE2), 2862277- Tumour necrosis factor receptor-1 (TNFR1) domain antibody, 3772847- Interleukin 33r (IL33r) monoclonal antibody, 2881078- Selective androgen receptor modulator
Phase 1: nemiralisib, 2292767- Phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor, 3511294- Interleukin 5 (IL5) long-acting monoclonal antibody,

VACCINES
Approved: Shingrix
Phase 3: Shingrix, Rotarix, Bexsero, MMR
Phase 2: COPD, Hepatitis C, Malaria next generation, Malaria prophylaxis (Plasmodium falciparum), Menveo Liquid, Shigella, Tuberculosis, RSV, HIV,
Phase 1/2: RSV, Flu universal,

 OTHER 
Approved: Krintafel
Phase 3: daprodustat
Phase 2: oxytocin (inhaled), linerixibat
Phase 1: 3439171- Hematopoietic prostaglandin D2 (hPGD2) synthase inhibitor

CURRENT LIST OF NEW PRODUCT DEVELOPMENTS (06/26/2019)
CURRENTLY, GSK IS SEEKING INPUT AND PRODUCTS IN THE FOLLOWING CATEGORIES. THEY REQUIRE PROOF OF CONCEPT AT THIS STAGE. THE COMPLETE LIST CAN BE VIEWED AT GSK.
Barrier Forming Products for upper respiratory tract
Antioxidant/Anti-inflammatory products that combat air pollution
Digital devices to manage respiratory health
Digital health platforms for respiratory conditions
Nasal spray deliveries for allergies
Next generation nicotine replacement- transdermal
Long lasting reflux management
Pain relief
Lower digestive health solutions
 

RESEARCH STRATEGY
Relevant information for GSK was taken directly from their press releases and website. Please note, there is a high occurrence of quotation marks due to the detailed medical jargon.