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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On February 9, 2022 GSK reported that FY 2021 sales of £34 billion, stable at AER, +5% CER; Total EPS 87.6p -24% AER, -13% CER and Adjusted EPS of 113.2p -2% AER, +9% CER (Press release, GlaxoSmithKline, FEB 9, 2022, View Source [SID1234607874]).

Pharmaceuticals £17.7 billion +4% AER, +10% CER; New and Specialty medicines £10 billion +20% AER, +26% CER; Respiratory +21% AER, +28% CER; Immuno-inflammation +22% AER, +29% CER; Oncology +31% AER, +37% CER; total HIV -2% AER, +3% CER
Vaccines £6.8 billion -3% AER, +2% CER; Shingrix £1.7 billion -13% AER, -9% CER
COVID-19 solutions sales £1.4 billion; Xevudy £958 million; pandemic adjuvant £447 million
Consumer Healthcare £9.6 billion -4% AER, stable CER (+4% excluding brands divested/under review)
Continued momentum in R&D delivery and strengthening of pipeline
3 major product approvals during 2021; Apretude HIV long-acting medicine for prevention (Dec); Xevudy for COVID-19 (Dec); and Jemperli for endometrial cancer (April)
Strong pipeline of 21 vaccines and 43 medicines, many offering potential best or first-in-class opportunities for patients, and of which 22 are in pivotal trials
Positive Phase III data on daprodustat in anaemia due to chronic kidney disease presented at American Society of Nephrology. On track to file in EU and US in H1 2022
20+ deals executed securing access to 5 novel clinical assets, including with iTeos in immuno-oncology, Alector in immuno-neurology and Vir Biotechnology in flu, plus technologies that expand our capabilities in human genetics and AI
Expect to report milestones in 2022 on up to 7 of the 11 potential new vaccines and medicines identified as key future growth drivers including Older Adults RSV vaccine (H1 2022)
Cost discipline supports delivery of Adjusted EPS of 113.2p
Total Group operating margin 18.2%. Total EPS 87.6p -24% AER, -13% CER
Adjusted Group operating margin 25.8%. Adjusted EPS 113.2p -2% AER, +9% CER. This included a contribution to growth from COVID-19 solutions of approximately +8% AER, +9% CER (+17% AER, +20% CER for Q4 2021)
Full year 2021 net cash flow from operations £8.0 billion. Full year free cash flow £4.4 billion
On track to demerge a new world-leading Consumer Healthcare business mid-2022
Progress to create new Board with appointment of Chair Designate
Capital Markets Day on 28 February to highlight overall strategy, capabilities and operations, including detailed financial information and superior growth ambitions
2022 guidance for new GSK
New GSK, the biopharma business, expected to deliver growth in 2022 sales of between 5% to 7% at CER and growth in 2022 Adjusted operating profit of between 12% to 14% at CER including the anticipated benefit in royalty income from Gilead settlement
This 2022 guidance excludes any contribution from COVID-19 solutions
Dividend of 23p declared for Q4 2021; 80p FY 2021

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Emma Walmsley, Chief Executive Officer, GSK said:
"We have ended the year strongly, with another quarter of excellent performance driven by first-class commercial execution, and we enter 2022 with good momentum. This is going to be a landmark year for GSK, with a step-change in growth expected and multiple R&D catalysts, including milestones on up to 7 key late-stage pipeline assets. 2022 is also the year when we demerge our world-leading Consumer Healthcare business. At our capital markets event later this month, we will set out the future growth ambitions and highly attractive financial profile of this business, and the outstanding opportunity it provides for shareholders."

On February 9, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported that the Company will be presenting at the 2022 BIO CEO & Investor Conference being held February 14-17, 2022 (Press release, Synthetic Biologics, FEB 9, 2022, View Source [SID1234607911]). The conference will be conducted as a hybrid event at the New York Marriott Marquis and virtually.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Steven Shallcross, Chief Executive Officer and Chief Financial Officer of Synthetic Biologics is scheduled to present on Tuesday February 15, 2022 at 11:00 AM Eastern Time. Management will also be available to participate in 1×1 meetings with qualified investors throughout the conference. Synthetic’s presentation will be made available on their website at View Source

On February 9, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that it has initiated the Biologics License Application (BLA) rolling submission process with the U.S. Food and Drug Administration for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant (Press release, Gamida Cell, FEB 9, 2022, View Source [SID1234607926]). The company remains on track to complete the BLA submission in the second quarter of 2022.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are pleased to reach this important milestone for omidubicel and bring this potential therapy one step closer to reaching patients in need," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "In the Phase 3 study, omidubicel achieved a statistically significant reduction in time to neutrophil engraftment, reduced hospitalization time, decreased risk of infection and shorter time to platelet engraftment. Based on this positive data, we believe omidubicel has the potential to address the existing unmet needs in allogeneic transplant, offering a new standard of care and the opportunity to treat even more patients."

Omidubicel has the potential to be the first FDA approved advanced cell therapy product for allogeneic stem cell transplant. For patients with hematologic malignancies that are deemed eligible for an allogeneic stem cell transplant, the procedure is their best chance for a potential cure. In the U.S., there are approximately 8,000 patients above the age of 12 with hematologic malignancies who undergo an allogeneic stem cell transplant each year and we believe that number of patients may grow over time1. Unfortunately, there are approximately 1,000 patients each year, who are above the age of 12 and are deemed eligible for an allogeneic stem cell transplant but cannot find an appropriate donor2. Based on its encouraging clinical data and less stringent matching criteria, omidubicel has the potential to improve outcomes for allogeneic stem cell transplant patients compared to other donor sources and expand access for patients who cannot find a suitable donor.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a stem cell transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and shorter days of hospitalization. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On February, 9 2022 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the National Medical Products Administration (NMPA) of China has approved the new drug application (NDA) of TIBSOVO (ivosidenib tablets) for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (R/R AML) who have a susceptible IDH1 mutation, providing a new precision therapy for this patient population (Press release, CStone Pharmaceauticals, FEB 9, 2022, View Source [SID1234608048]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Acute myeloid leukemia (AML) is the most common type of leukemia in adults. The disease progresses rapidly, and the vast majority of patients are the elderly. In the US, there are about 20,000 new cases of AML each year, and the 5-year survival rate is about 29%. With the aging of the population, the incidence of AML in China has been rising, and particularly the elderly and relapsed/refractory patients have a poorer prognosis. In China, there are about 75.3 thousand new cases of Leukemia each year and approximately 59% are AML patients, among whom about 6-10% have IDH1 mutations.

Dr. Frank Jiang, Chairman and CEO of CStone, said, "This marks another milestone for CStone Pharmaceuticals. TIBSOVO is our fourth innovative drug successfully approved, and it only took 6 months from NDA acceptance to NDA approval, demonstrating once again the ‘CStone Speed’. Previously, CStone has successfully obtained regulatory approvals for the launch of two first-in-class precision medicines and a potential best-in-class immuno-oncology therapy. We will advance our broad and diversified pipeline of innovative products and aim to provide more high-quality innovative drugs for patients around the world."

Professor Wang Jianxiang from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, the Principal Investigator of registrational bridging study CS3010-101 in China, said, "For a long time, there have been limited treatment options for AML patients with IDH1 mutations, and patients had a low 5-year survival rate and poor quality of life. We are excited that TIBSOVO, as the first IDH1 inhibitor approved in China, demonstrated superior efficacy and safety in AML patients with IDH1 mutations. I believe that the approval of TIBSOVO will offer an innovative precision therapy to more AML patients, helping improve their quality of life and prolong their lives."

Dr. Jason Yang, Chief Medical Officer of CStone, said, "We are thrilled that TIBSOVO has been approved in Mainland China for the treatment of patients with R/R AML. As the first and only IDH1 inhibitor approved in China, TIBSOVO demonstrated proven efficacy and well-tolerated safety in Chinese patients with R/R AML who have a susceptible IDH1 mutation. At the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in 2021, the data were presented to show that TIBSOVO in combination with azacitidine significantly improved the event-free survival and overall survival in patients with treatment-naïve IDH1-mutated AML. We plan to hold regulatory discussions with the NMPA to bring this innovative therapy in combination with azacitidine to more Chinese patients as early as possible."

In China, TIBSOVO was selected in the list of the third batch of Overseas New Drugs Urgently Needed in Clinical Settings by the Center for Drug Evaluation, NMPA in China, and granted fast-track designation. As a potent and highly selective first-in-class oral IDH1 inhibitor, TIBSOVO was also recommended by the 2020 edition of the CSCO Guidelines for Diagnosis and Treatment of Hematological Malignancies due to its proven clinical advantages.

The approval of TIBSOVO was based on the China registrational bridging study CS3010-101, which aimed to evaluate the pharmacokinetic (PK), pharmacodynamics (PD), safety, and clinical efficacy of orally administered TIBSOVO in Chinese adult patients with R/R AML who have a susceptible IDH1 mutation. TIBSOVO demonstrated robust clinical efficacy and a well-tolerated, manageable safety profile in the treatment of Chinese adults with R/R AML with a susceptible IDH1 mutation. Among 30 evaluable patients, the primary efficacy endpoint of complete remission plus complete remission with partial hematologic recovery (CR+CRh) rate was 36.7% (11/30) with all 11 patients achieving CR. The median duration of CR+CRh is not reached, and the estimated 12-month CR+CRh duration rate is 90.9%. The data were presented in a proffered paper presentation at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

About TIBSOVO (ivosidenib tablets)

TIBSOVO is an oral targeted IDH1 inhibitor. The NMPA of China has approved the NDA of TIBSOVO for the treatment of adult patients with relapsed/refractory acute myeloid leukemia who have a susceptible IDH1 mutation.

TIBSOVO is currently approved in the U.S. as monotherapy for the treatment for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML), and for adults with newly-diagnosed AML with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. In 2021, TIBSOVO was the first and only targeted therapy approved for patients with previously treated locally advanced or metastatic cholangiocarcinoma with an IDH1-mutation as detected by an FDA-approved test.

In addition, data from the global phase 3 study AGILE demonstrated that TIBSOVO in combination with the chemotherapy azacitidine significantly improved event-free survival (HR=0.33) and overall survival (HR=0.44) compared to azacitidine plus placebo in patients with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy. The median overall survival (OS) of patients in the TIBSOVO plus azacitidine arm was 24.0 months, compared with 7.9 months in the placebo plus azacitidine arm. There are very limited safe and effective treatment options for these newly diagnosed AML patients. The treatment of TIBSOVO plus azacitidine has the potential to provide a new treatment option for treatment-naïve AML patients with IDH1 mutations who are not candidates for intensive chemotherapy.

The U.S. FDA has granted Breakthrough Therapy Designation for TIBSOVO in combination with azacitidine for this supplemental indication and Breakthrough Therapy Designation for TIBSOVO for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible IDH1 mutation.

Servier is the owner of TIBSOVO’s rights and has granted an exclusive license to CStone to develop and commercialize the product in Mainland China, Taiwan, Hong Kong, Macau and Singapore.