October 28, 2022: Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the quarter and the half year ended September 30, 2022 (Press release, Dr Reddy’s, OCT 28, 2022, View Source [SID1234622567]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

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

                  Schedule Your 30 min Free Demo!

Revenue Analysis

Global Generics (GG)

Revenues from GG segment at Rs. 55.9 billion:

Ø Year-on-year growth of 18% and sequential quarter growth of 26% driven by launch of the Lenalidomide capsules in the US market (as part of the volume limited settlement with innovator) and sequential quarter improvement in Russia sales. However, the growth was partly offset by price erosion in our generic markets and higher base due to covid product sales in previous year.

North America

Revenues from North America at Rs. 28.0 billion:

Ø Year-on-year growth of 48% and sequential quarter growth of 57%, driven by launch and scale up of new products and favorable movement of forex rates, which was partly offset by price erosion in some of our key molecules.

Ø During this quarter, we launched 7 new products. These were Lenalidomide capsules (as part of the volume limited settlement with innovator), Fesoterodine Fumarate tablets, Bortezomib Inj 3.5 mg, Neostigmine PFS, Potassium Chloride UD, Fexofenadine HCl + Pseudoephedrine HCl ER tablets, and Oxaliplatin Inj in Canada.

Ø We filed one ANDA during the quarter. As of 30th September 2022, cumulatively 81 generic filings are pending for approval with the USFDA (78 ANDAs and 3 NDAs under 505(b)(2) route). Out of these 81 pending filings, 42 are Para IVs and we believe 22 have ‘First to File’ status.

Europe

Revenues from Europe at Rs. 4.2 billion, with year-on-year growth of 2% and sequential quarter growth of 1%. This was driven by volume traction in base business and new product launches across our markets, however, it was partially offset by price erosion in some molecules and the impact of adverse forex rates during the quarter. We launched ten new products across countries during this quarter.

India

Revenues from India at Rs. 11.5 billion:

Ø Year-on-year growth of 1% impacted due to higher base of Q1 FY22, which included contribution from covid product sales. Adjusted for this, we have grown in double digit.
Ø Sequential quarter declined by 14% primarily on account of high base impact, as we had recognized divestment income of a few non-core brands in Q1 FY23.
Ø We launched two new products during the quarter. These were Curaprox and Stig.

Emerging Markets

Revenues from Emerging Markets at Rs. 12.2 billion. Year-on-year decline of 6% and sequential quarter growth of 36%:

Ø Revenues for Russia at Rs. 5.9 billion. Year-on-year growth of 4% was on account of new product launches, increase in sales prices and favorable movement of forex rates, partly offset by reduction in base volumes. Sequential quarter growth of 85% was primarily due to lower sales base of Q1 FY23, which was impacted due to channel inventory normalization.

Ø Revenues from other CIS countries and Romania at Rs. 2.2 billion. Year-on-year decline of 1% due to reduction in base volumes and adverse movement of forex rates, partly offset by increase in sales prices and new product launches. Sequential quarter growth of 13% was driven by increase in base volumes and new product launches, partly offset by adverse movement of forex rates.

Ø Revenues from Rest of World (RoW) markets at Rs. 4.1 billion. Year-on-year decline of 18% was on account of reduction in the covid product sales in current quarter vs. last year, decrease in sales prices, which was partly offset by new product launches. Sequential growth of 6% was driven by new product launches, partly offset by a reduction in base volumes and sales price of some of our products.

Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 6.4 billion with a year-on-year decline of 23% and sequential decline of 9%.

Ø Year-on-year decline was primarily on account lower volumes due to higher base in Q2 FY22 which had covid product sales, partly offset by new product sales and favorable forex rates.
Ø sequential decline was majorly due to lower traction in the volumes for some of our products, partly offset by new product sales.
Ø During the quarter we filed three DMFs in the US.

Income Statement Highlights:

Ø Gross profit margin for the quarter at 59.1%:

– Increased by ~565 bps over previous year and ~920 bps sequentially, majorly driven due to product mix (including new products), accruals related to production linked incentive scheme, which was partly offset by price erosion and provision made on inventory for covid products.
– Gross profit margin for GG and PSAI business segments are at 65.4% and 3.6% respectively. Gross profit margin of PSAI have been impacted due to covid inventory provision and adverse impact of manufacturing overheads which are at similar levels over lower sales base.

Ø Selling, general & administrative (SG&A) expenses at Rs. 16.6 billion, increased by 4% on a year-on-year basis and by 7% sequentially, in line with the business growth.

Ø Research & development (R&D) expenses at Rs. 4.9 billion. As % to revenues – Q2 FY23: 7.7% | Q1 FY23: 8.3% | Q2 FY22: 7.7%. We continue to invest in R&D to build a healthy pipeline of products across our markets.

Ø Other operating income at Rs. 0.3 billion compared to Rs. 1.7 billion in Q2 FY22. Q2 FY22 was higher on account of recognition of income towards sale of rights relating to anti-cancer agent E7777 (denileukin diftitox).

Ø Net Finance expense at Rs. 156 million compared to net finance income of Rs. 319 million in Q2 FY22.

Ø Profit before Tax at Rs. 16.1 billion, increased by 27% year-on-year and by 10% sequentially.

Ø Profit after Tax at Rs. 11.1 billion. The effective tax rate is 30.9% for the quarter.

Ø Diluted earnings per share is at Rs. 66.89.

Other Highlights:

Ø EBITDA is at Rs. 19.3 billion and the EBITDA margin is 30.6%.

Ø Capital expenditure is at Rs. 2.5 billion.

Ø Free cash flow is at Rs. 5.8 billion.

ØNet cash surplus for the company is at Rs. 13.7 billion as on September 30, 2022. Consequently, net debt to equity ratio is (0.07).

No password/pin number is necessary to dial in to any of the above numbers. The operator will provide instructions on asking questions before and during the call.

Transcript: Transcript of the Earnings call will be available on the Company’s website: www.drreddys.com

On October 28, 2022 Mereo BioPharma Group plc (NASDAQ: MREO), ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, reported it has entered into a cooperation agreement (the "Agreement") with Rubric Capital Management LP ("Rubric"), its largest shareholder (Press release, Mereo BioPharma, OCT 28, 2022, View Source [SID1234622566]). Pursuant to the Agreement, four new directors – Dr. Annalisa Jenkins, Dr. Daniel Shames, Mr. Marc Yoskowitz and Mr. Justin Roberts – will be appointed to the Company’s Board of Directors as soon as practicable. Concurrent with these appointments taking effect, directors Dr. Peter Fellner, Dr. Brian Schwartz, Dr. Abdul Mullick and Ms. Anne Hyland will resign from the Board.

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

                  Schedule Your 30 min Free Demo!

Rubric has withdrawn its notice dated October 3, 2022 (the "Requisition Notice") which required Mereo to call a General Meeting of its shareholders (the "General Meeting").

"We have appreciated Rubric’s perspectives over the last several months and are pleased to have reached this Agreement," said Michael Wyzga, Chair of Mereo’s Board of Directors. "We look forward to working together constructively with our new colleagues to create value for all Mereo shareholders. I also want to thank our outgoing directors, each of whom has been instrumental in getting Mereo to where it is today, for their commitment and contributions to the Company."

"Rubric invested in Mereo because we believe in the Company’s mission and the inherent potential of its promising programs. Our Agreement reflects our confidence in that potential and our shared goal to maximize impact and value for all shareholders," said David Rosen, Founder and Partner of Rubric Capital Management. "We are pleased to have reached a constructive resolution and look forward to working diligently with management and the full Board as Mereo continues its important work."

"Now that we have reached this Agreement with Rubric, we will focus our attention executing on our revised operating plan and optimizing the value of the Company’s assets," said Denise Scots-Knight, Chief Executive Officer of Mereo. "We look forward to working with the Board as we guide our rare disease programs, setrusumab and alvelestat, through important milestones over the coming year."

In light of the Agreement with Rubric and the withdrawal of the Requisition Notice, the chair of the General Meeting, which is scheduled to be held on November 18, 2022, intends to present a motion withdrawing the Resolutions. It is not intended that the resolutions proposed by Rubric in the withdrawn Requisition Notice will be put to a vote. Shareholders are encouraged not to attend, submit voting instructions or proxies for, or take any other action in relation to the General Meeting.

On October 28, 2022 AbbVie (NYSE: ABBV) reported that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy (Press release, AbbVie, OCT 28, 2022, View Source [SID1234622565]). Additionally, Genmab has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for epcoritamab for the treatment of adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

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

                  Schedule Your 30 min Free Demo!

The regulatory submissions are supported by previously announced results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-center Phase 2 trial evaluating the safety and preliminary efficacy of investigational epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including DLBCL.

LBCL and its major subtype, DLBCL, are fast-growing types of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell.1 DLBCL is the most common type of NHL worldwide and accounts for approximately 30 percent of all NHL cases globally.1 Because NHL affects B-cell lymphocytes, the disease and its subtypes are classified as B-cell malignancies.

"The regulatory submissions for epcoritamab exemplify our pursuit to deliver innovative care for people living with large B-cell lymphoma and diffuse large B-cell lymphoma who have limited treatment options," said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. "This achievement represents an initial step in our commitment to scientific research and providing an important treatment option with the potential to become a core therapy for people living with B-cell malignancies such as LBCL and DLBCL."

Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. The companies are committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies, including an ongoing Phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494).

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL) that affects B-cell lymphocytes, a type of white blood cell.1 It is the most common type of NHL worldwide and accounts for approximately 30 percent of all NHL cases.1 DLBCL can arise in lymph nodes, as well as in organs outside of the lymphatic system.1 The disease occurs more commonly in the elderly and is slightly more prevalent in men.1

About Large B-cell Lymphoma (LBCL)
LBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes.1 There are an estimated 150,000 new LBCL cases globally each year.1

About the EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that includes a Phase 1 first-in-human, dose escalation part; a Phase 2 expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL, including LBCL and DLBCL. Data from the dose escalation part of the study, which determined the recommended Phase 2 dose, were published in The Lancet in 2021. In the Phase 2 expansion part, additional patients were treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-cell NHLs who had limited therapeutic options.

The primary endpoint of the Phase 2 expansion part was overall response rate (ORR) as assessed by an independent review committee (IRC). Secondary efficacy endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy, and rate of minimal residual disease negativity.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T-cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T-cells and CD20 on B-cells, and induces T-cell mediated killing of CD20+ cells.2 CD20 is expressed on B-cells and is a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.3,4 Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration.

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit View Source

On October 28, 2022 Peptomyc reported that Built on over 20 years’ research led by Laura Soucek, co-Director of the Vall d’Hebron Institute of Oncology’s (VHIO) Preclinical and Translational Research Program, and Principal Investigator of VHIO’s Models of Cancer Therapies Group, Omomyc (OMO-103) is a therapeutic mini-protein developed in-house by the VHIO and Catalan Institute of Research and Advanced Studies’ (ICREA) spin-off company Peptomyc SL, which was co-founded by Laura Soucek in 2014 (Press release, Peptomyc, OCT 28, 2022, View Source [SID1234622562]).

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

                  Schedule Your 30 min Free Demo!

Having previously shown the preclinical efficacy and safety of this novel cell-penetrating mini-protein in mouse models, Laura Soucek’s team successfully developed anti-MYC peptides for the treatment of several tumor types, the first of which, OMO-103, now shows promise in becoming the first ever clinically viable and direct inhibitor of MYC – a protein implicated in driving and maintaining cancer

Peptomyc’s Omomyc-based therapy put to the clinical test

Elena Garralda, Director of VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, enrolled 22 patients to a phase I clinical trial in April 2021 to determine the safety, tolerability, pharmacokinetics and pharmacodynamics, and proof-of-concept of OMO-103. These heavily pre-treated patients had a range of solid tumors including pancreatic, bowel, and non-small cell lung cancers, and had received at least three prior lines of therapy. Results of the CT scans of the 17 evaluable patients showed that 8 had stable disease, with the treatment having halted tumor growth.

"While it is still very early days to assess the activity of Omomyc, we are observing stabilization of disease in some patients. Notably, one patient with pancreatic cancer remained on the study for more than six months and his tumor shrank by eight per cent with an eighty-three per cent decrease in the quantity of circulating tumour DNA in the bloodstream," said Elena Garralda, Principal Investigator of VHIO’s Early Clinical Drug Development Group and first author of this present study that was carried out in collaboration with two other Spanish sites.

"Another patient with a salivary gland tumor, whose disease remains stable, is still on the study after 15 months, and a patient with sarcoma, who responded very poorly to other treatments previously, had stable disease for 8 months," added Garralda, who will present preliminary data from this study during a Plenary Session* at ENA 2022, that she will co-chair alongside Scientific Committee co-chair for the meeting, Ruth Plummer, Northern Centre for Cancer Care, Newcastle upon Tyne, UK.

The most common treatment-related adverse events included mild reactions to intravenous infusion, such as chills, fever, nausea, rash, and low blood pressure. Higher dose levels were associated with more reactions to the infusion but were easily treated.

"The biomarkers clearly show that we are successfully blocking MYC to treat cancer. In addition, the adverse side effects are mostly mild, which is important as we seek to assess the efficacy of OMO-103 in combination with chemotherapy or other therapies,"continued Elena Garralda, a member of the scientific committee of the meeting.

Another important aspect of the study focused on evaluating the pharmacokinetics of OMO-103 and establishing how the drug was absorbed and processed in the body, and how long it remained in the tumor. This analysis indicated that OMO-103 remained for at least 50 hours in blood, and possibly even longer in tumors.

"For many years this cancer-causing protein has been thought to be undruggable. OMO-103 is the first MYC inhibitor to successfully complete a phase I clinical trial and is ready to move to a phase II study over the coming weeks. This is a remarkable achievement considering that MYC is one of the most sought-after drug targets in cancer," added Laura Soucek, an ICREA Research Professor, co-founder and Chief Executive Director of Peptomyc SL.

She concluded, "Based on these preliminary data, we have reason to be optimistic that Omomyc-based therapy will continue to step up in more effectively treating several different tumor types and ultimately improve patient outcomes."

This study was funded by Peptomyc SL and by funding from the SME Instrument phase II within the EU’s Horizon 2020 programme.

The preclinical research on Omomyc, essential for understanding the mechanism of action of this molecule, was partially financed by the BBVA Foundation in the context of the CAIMI institutional program (Comprehensive Program of Cancer Immunotherapy & Immunology). Through this funding, Dra. Laura Soucek’s group was able to study, in humanized cancer models, the changes in the antitumor immune response upon Myc inhibition by Omomyc. We would like to thank Cellex for providing the necessary scientific infrastructure for the development of preclinical research associated with the clinical study.

Reference:

*34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, 26-28 October, Barcelona, Spain.

Plenary Session 6: New Drugs on the Horizon

Date: Friday 28 October

Abstract no: 7. Dose escalation study of OMO-103, a first in class Pan-MYC-Inhibitor in patients (pts) with advanced solid tumors E. Garralda, V. Moreno, G. Alonso, E. Corral, T. Hernandez-Guerrero, J. Ramon, B. Doger de Spéville, E. Martinez, L. Soucek, M. Niewel, E. Calvo (Spain).

On October 28, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the launch of "Extend", a translational BRIDGE partnership in cooperation with CDP Venture Capital Sgr, a strategic pillar to Italy’s economic growth and innovation, and Angelini Ventures, the Corporate Venture Capital arm of the multi-business industrial group Angelini Industries (Press release, Evotec, OCT 28 , 2022, View Source [SID1234622561]).

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

                  Schedule Your 30 min Free Demo!

Extend is a joint venture between Evotec, CDP Venture Capital and Angelini Ventures to develop translational drug discovery partnerships with highly renowned universities and research centres in Italy. Extend aims to use Evotec’s best-in-class technology platforms to accelerate the translation of academic innovation into robust and investable data points and Angelini Ventures’ network and knowledge of the life science sector to launch successful new companies.

The partnership brings together several academic institutions with strong track records in life science innovation from across Italy: Ospedale San Raffaele in Milan, the Universities of Milan, Florence, Modena and Reggio Emilia, Padua, Sapienza in Rome, the regional research district of Puglia through H-Bio and the Human Technopole. Extend will be located within Milan’s MIND district, the new centre of scientific excellence in Italy focused on life sciences.

Evotec’s BRIDGE (Biomedical Research, Innovation & Development Generation Efficiency) collaborations provide an integrated fund and award framework to validate exciting academic projects in collaborations with Pharma, biotech, and Venture Capital partners with the goal to form new companies.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "We are excited to launch Extend together with our partners at CDP Venture Capital and Angelini Ventures. The Academic sector in Italy has historically been a driving force behind innovation at a global scale. Extend provides researchers from the member institutions with a unique way to fast-track their projects, validate them on our industrial-grade platform and create partnering options that include the formation of new companies."

Enrico Resmini, CEO and General Manager of CDP Venture Capital, said: "The launch of the Extend National Technology Transfer Hub adds a key step to the path we are building to bridge the Italian tech transfer gap and open University laboratories to international markets. The pharmaceutical and drug discovery sectors represent one of the most striking examples of how research and deep tech technologies can shape people’s lives in a short time, as we have all experienced first-hand during the health emergency."

Prof. Sergio Marullo di Condojanni, CEO of Angelini Industries, added: "We are delighted to participate in the creation of Polo Extend together with high-level partners in the biotech and innovation sectors. Being involved in this project represents an important opportunity for Angelini Industries to contribute to the development of the Italian innovation ecosystem, of which Extend represents a virtuous example. The participation of Angelini Ventures, under the leadership of CEO and Managing Director Paolo Di Giorgio, underlines our desire to strengthen the bridge between the excellence of Italian academic research and the development of drug discovery programs in order to identify new treatment options"