On February 10, 2022 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, reported the company will host a conference call and live webcast on Thursday, Feb. 24, 2022, at 8:00 a.m. ET to report its fourth quarter and year end 2021 financial results and other business highlights (Press release, Agios Pharmaceuticals, FEB 10, 2022, https://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-fourth-quarter-and-year-end-2021 [SID1234607948]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 9873227. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.

On February 10, 2022 AstraZeneca reported on its strong growth trajectory in 2021, with industry-leading R&D productivity, five of our medicines crossing new blockbuster thresholds, and the acquisition and integration of Alexion (Press release, AstraZeneca, FEB 10, 2022, View Source [SID1234607947]). We also delivered on our promise of broad and equitable access to our COVID-19 vaccine with 2.5 billion doses released for supply around the world, and we made good progress on reducing our greenhouse gas emissions.

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Growth was well balanced across our strategic areas of focus, and we saw double-digit growth in all major regions, including Emerging Markets despite some headwinds in China. The positive news from our pipeline, including approvals for Evusheld and Tezspire, supports the outlook for 2022. This, along with the transformative acquisition of Alexion, means that we are confident in our long term growth and profitability. After a landmark year in 2021, we are increasing the dividend for our shareholders.

The differences between Reported and Core measures are primarily due to items related to the acquisition of Alexion, amortisation of intangibles, as well as impairments and restructuring charges, of which $1,030m in the year related to the Group Review detailed below. A full reconciliation between Reported EPS and Core EPS is provided in Tables 17 and 18 in the Financial performance section of this document. The differences between Actual Change and CER Change are due to foreign exchange movements between corresponding periods in 2021 vs 2020.

Key elements of Total Revenue performance in FY 2021
-An increase in Product Sales of 41% (38% at CER) to $36,541m-Among AstraZeneca’s thirteen7 blockbuster medicines in 2021, five medicines crossed new thresholds: Tagrisso ($5bn+), Farxiga ($3bn+), Lynparza ($2bn+), Calquence ($1bn+) and Fasenra ($1bn+)Following completion of the Alexion acquisition on 21 July 2021, Rare Disease medicines generated 8% of AstraZeneca’s FY 2021 Total Revenue, growing 8% (9% CER) on a pro-rata basis to $3,071m
-Growth of 19% (17% at CER) in Oncology to $13,663m, 13% (9% at CER) in CVRM8 to $8,034m, and 13% (9% at CER) in R&I9 to $6,049m-In the US, Total Revenue increased by 38% to $12,228m. In Europe, Total Revenue increased by 45% (40% at CER) to $8,050m including Vaxzevria10 revenue of $1,035m
-An increase in Emerging Markets revenue of 41% (36% at CER) to $12,281m, including Vaxzevria revenue of $2,304m.

In China, Total Revenue increased by 12% (4% CER) in the year to $6,011m. Pricing pressure associated with NRDL11 and VBP12 programmes led to a decline in growth in the second half of the year, and in Q4 2021 China Total Revenue was 4% lower (8% at CER) than in Q4 2020-Excluding vaccine revenue, Total Revenue in ex-China Emerging Markets increased by 19% in the year (21% at CER) to $3,977m and by 36% (38% at CER) in the quarter to $1,197m, driven by Oncology medicines and Farxiga Post Alexion Acquisition Group Review In conjunction with the acquisition of Alexion, the enlarged Group initiated a comprehensive review across the organisation, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments.

These activities are expected to be substantially complete by the end of 2025, with a number of planned activities having commenced in late 2021. The identified activities, including those previously announced regarding the integration of Alexion, are anticipated to incur one-time restructuring costs of approximately $2.1bn, of which approximately $1.4bn are cash costs and $0.7bn are non-cash costs, and capital investments of approximately $0.2bn. The activities are anticipated to realise run-rate pre-tax benefits, before reinvestment, of approximately $1.2bn, including previously-announced Alexion synergies, by the end of 2025.

In line with established practice, restructuring costs will be excluded from our Core (non-GAAP) financial measures. Guidance The Company provides FY 2022 guidance at CER. The CER growth rates include the full-year contribution of Vaxzevria in both FY 2021 and FY 2022-Total Revenue from COVID-19 medicines is anticipated to decline by a low-to-mid twenties percentage, with an expected decline in sales of Vaxzevria being partially offset by growth in Evusheld sales. The majority of vaccine revenue in 2022 is expected to come from initial contracts. The Gross Profit Margin from the COVID-19 medicines is expected to be lower than the Company average-Core Operating Expenses are expected to increase by a low-to-mid teens percentage, driven in substantial part by the full year integration of Alexion expenses-Emerging Markets Total Revenue, including China, is expected to grow mid-single-digits in FY 2022.

China Total Revenue is expected to decline by a mid-single-digit percentage in FY 2022, primarily due to continued NRDL and VBP programme impacting various medicines. The Company remains confident in the longer term outlook for Emerging Markets, driven by a large market opportunity, broader patient access and an increased mix of new medicines-A Core Tax Rate between 18-22% AstraZeneca continues to recognise the heightened risks and uncertainties from the effects of COVID-19. Variations in performance between quarters can be expected to continue.

The Company is unable to provide guidance on a Reported basis because AstraZeneca cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal-settlement provisions.

Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If average foreign-exchange rates for January 2022 were seen over the full year, it is anticipated that there would be a low single-digit adverse impact on actual Total Revenue and Core EPS versus the financials at CER.

The Company’s foreign-exchange rate sensitivity analysis is shown in the Operating and financial review.

On February 9, 2022 Bugworks Research reporteda $18 Mn Series B1 round, which was led by Lightrock India, with participation from existing investors, including 3one4 Capital.

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The startup’s other investors The University of Tokyo Edge Capital (UTEC) Japan, Global Brain Corporation, South Africa-based Acquipharma Holdings, I.M Holdings and Featherlite Group India, who had backed Bugworks in its Series B round in April 2020, also contributed to the current round. Kiran Mazumdar-Shaw, CMD, Biocon too participated in the round.

Founded in 2014 by Anand Anandkumar, Bala Subramanian, Santanu Datta, and Shahul Hameed, Bugworks was backed by the department of biotechnology and US-government backed CARB-X in its initial days. It was also associated with Bengaluru-based incubator Centre for Cellular and Molecular Platforms (CAMP).

Coming through these programs, it raised funds from the likes of 3one4 Capital to develop solutions for antimicrobial resistance. The startup will look to utilise the funds to support the clinical development of BWC0977, its novel broad spectrum antibacterial agent available in both IV and oral forms, as well as the pre-clinical development of its Adenosine immuno-oncology asset.

The company will look to accelerate clinical trials on AMR (antimicrobial resistance) and bolster its immuno-oncology program, which could be used to treat colon, colorectal, gastric, kidney, stomach, lung, and breast cancers. "We are very excited about our lead clinical asset BWC0977 that is potentially the first novel truly broad-spectrum anti-bacterial drug in nearly five decades," CEO Anandkumar said.

With its previous round of funding, the company had completed the first phase of the clinical research for GYROX series intravenous drug for AMR. It is also working on a DARE platform for immuno-oncology and other new drugs for diseases and indications that are not currently served by big pharma solutions. GYROX is said to be effective against bacterial superbugs, which are typically resistant to commonly-used antibiotics, and have led to widespread infections in many cases.

Speaking to Inc42 after the company’s last funding round, Anandkumar had said that it’s been decades since a new drug has been developed to target drug-resistant bacteria. Bugworks also has plans to enter the virology space soon, where too a lot of development has been seen in the past two years.

Biotech is a hot sector for startups in India, particularly as research into antivirals and antibacterials ramps up in light of various climate-change related diseases as well as the pandemic.

In January, Mumbai-based Epigeneres Biotech raised $6 Mn in a Series B funding round from Kotak Investment Advisors, Moez Daya (of Satya Capital), and LetsVenture Angel Fund. And in December, Bengaluru and Boston based biotech startup Zumutor Biologics has raised $6.2 Mn in its Series A4 funding round led by Siana Capital.

(Press release, Bugworks Research, FEB 9, 2022, View Source [SID1234661667])

On February 9, 2022 Hubro Therapeutics reported that an abstract has been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) World Congress 2022, 8-13 April (Press release, Hubro Therapeutics, FEB 9, 2022, View Source [SID1234609537]).

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The abstract will be released on the AACR (Free AACR Whitepaper) 2022 website March 8, 16:30 ET ( AACR (Free AACR Whitepaper) Annual Meeting 2022 | April 8-13, 2022 | New Orleans ).

The poster will be scheduled for presentation during the ACCR congress 8-13 April 2022.

Poster: Detection of TGFbR2 a10→a9 frameshift mutation in cell free DNA of liquid biopsies from MSI-colorectal cancer patients.

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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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.