On July 28, 2023 Sanofi reported Solid Q2 performance and strong pipeline momentum, Full-year 2023 business EPS guidance raised (Press release, Sanofi, JUL 28, 2023, View Source [SID1234633484]).

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Q2 2023 sales growth of 3.3% at CER and business EPS(1) growth of 8.1% at CER

Specialty Care grew 11.8% driven by Dupixent (€2,562 million, +34.2%) and Nexviazyme (€103 million, +146.5%) more than offsetting anticipated impact of Aubagio generic competition in the U.S.
Vaccines up 9.1% due to strong PPH vaccines sales in Rest of World region and COVID vaccine supply in Europe
General Medicines core assets grew 2.4%, non-core assets lower mainly due to Lantus (€353 million, -36.5%)
CHC sales growth continued (+0.7%) despite unfavorable effect from inventory build in the prior quarter
Business EPS(1) of €1.74 up 0.6% on a reported basis and 8.1% at CER
IFRS EPS of €1.15 (up 22.3%)
Key R&D milestones and regulatory achievements in Q2

Nirsevimab unanimous FDA AdCom vote for prevention of RSV lower respiratory tract disease in infants
Dupixent BOREAS Phase 3 COPD results presented at ATS and published in the New England Journal of Medicine
Itepekimab in COPD passed a recent interim futility analysis of the Phase 3 AERIFY studies
Amlitelimab positive Phase 2b data support potential for transformational target profile in Atopic Dermatitis
Frexalimab Phase 2b primary endpoint met demonstrating significantly reduced disease activity in MS
Vaccines pipeline moving at pace with 12 innovative assets with new data highlighted at a recent investor event
Progress on Corporate Social Responsibility strategy in Q2

Inclusivity targets implemented across clinical trial; 45% of U.S. trials achieved at least 1 target
B Corp Certification granted to CHC North America in recognition of environmental and social achievements
Full-year 2023 business EPS guidance revised upward

Sanofi now expects 2023 business EPS(1) to grow mid single-digit(2) at CER, barring unforeseen major adverse events. Applying average July 2023 exchange rates, the currency impact on 2023 business EPS is estimated between -6.5% to -7.5%. This upgrade includes approximately €400 million of expected one-off COVID vaccine revenues in the second half of the year.

Paul Hudson, Sanofi Chief Executive Officer, commented:

"We have delivered yet another quarter of growth, with Specialty Care and Vaccines as the main drivers. As we move into the second half our Play to Win strategy, we are particularly enthusiastic about the strong flow of positive R&D data readouts and regulatory achievements of this second quarter, highlighting the significant growth potential of our innovative pipeline assets. With the FDA approval of Beyfortus for the prevention of RSV in all infants in July, the landmark Phase 3 data in COPD with Dupixent, and the important clinical milestones with amlitelimab and frexalimab which support our decision to initiate pivotal trials, we expect to add multiple innovative medicines to our existing growth drivers over the coming years. As we enter the second half of 2023, we are executing on our new launches and we are encouraged by the early launch indicators of ALTUVIIIOTM and TZIELDTM, while navigating the anticipated impact from generic competition on Aubagio. Our strong results in the first six months make us confident in our outlook for the remainder of the year and as a consequence we are raising our full-year 2023 EPS guidance to mid single-digit growth."

Q2 2023 Change Change
at CER H1 2023 Change Change
at CER
IFRS net sales reported €9,965m -1.5% +3.3% €20,187m +2.0% +4.4%
IFRS net income reported €1,435m +22.1% _ €3,430m +7.7% —
IFRS EPS reported €1.15 +22.3% _ €2.74 +7.5% —
Free cash flow(3) €1,592m +3.7% _ €3,129m -3.5% —
Business operating income €2,726m -1.0% +6.6% €6,059m +4.1% +8.0%
Business net income(1) €2,177m +0.3% +8.0% €4,876m +6.1% +10.0%
Business EPS(1) €1.74 +0.6% +8.1% €3.90 +6.0% +9.8%

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q2 2023 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2022 business EPS was €8.26; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 9).

On July 28, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the pivotal Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of pathological complete response (pCR) rate following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer (Press release, Merck & Co, JUL 28, 2023, View Source;Breast-Cancer/?feedref=JjAwJuNHiystnCoBq_hl-SZsvSFSeS2k6e-jDETKtk7rEQumBjqILHhqiwHg7GoJnkvYMqDDYxFrLs-oQ2BHQ-mJCMFkCosC_NGzuJ8TW18j0KvNpL5ik-rnXyj1_o5vU-QF2vCj0ELWlPt_oGwViA== [SID1234633482]). At a prespecified interim analysis conducted by an independent Data Monitoring Committee (DMC), the KEYTRUDA-based regimen demonstrated a statistically significant improvement in pCR rate compared to neoadjuvant placebo plus chemotherapy. A pCR is defined as a lack of all signs of cancer in tissue samples analyzed following completion of neoadjuvant therapy and definitive surgery.

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Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual primary endpoint of event-free survival (EFS), per the trial design. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting.

"This is the first positive Phase 3 study evaluating an immunotherapy-based regimen for patients with high-risk, early-stage ER-positive, HER2-negative breast cancer, and an important milestone in our efforts to advance research in early-stage breast cancer," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "We look forward to sharing the detailed results with the medical community and thank the patients and investigators for their important contributions to this study."

"While significant advancements have been made in the treatment of ER-positive, HER2-negative breast cancer, people diagnosed with high-risk disease as assessed by clinical and pathologic criteria typically have a worse prognosis and limited options before surgery," said Dr. Fatima Cardoso, director of the Breast Unit of the Champalimaud Clinical Centre, Lisbon, Portugal and co-principal investigator. "Data from KEYNOTE-756 suggest that adding pembrolizumab to neoadjuvant chemotherapy before surgery can significantly improve the pCR rate compared to neoadjuvant chemotherapy alone for people with high-risk, early-stage ER-positive, HER2-negative breast cancer."

"Worldwide, more than two million people are diagnosed with breast cancer each year, and it is critically important that breast cancer is found and treated early, especially for patients with high-risk disease," said Dr. Aditya Bardia, attending physician, medical oncology, Massachusetts General Hospital, director, breast cancer research, Massachusetts General Cancer Center, Associate professor, Harvard Medical School and co-principal investigator. "While we wait for event-free survival data, these initial pCR results provide a potentially encouraging signal and may have important therapeutic implications for patients with high-risk, early-stage ER-positive, HER2-negative breast cancer."

In the U.S., KEYTRUDA is approved for two indications for the treatment of patients with triple-negative breast cancer (TNBC). Based on results from KEYNOTE-522, KEYTRUDA is approved in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery for patients with high-risk, early-stage TNBC. Based on results from KEYNOTE-355, KEYTRUDA is approved in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (combined positive score [CPS ≥10]) as determined by an FDA-approved test. In addition to the U.S., KEYNOTE-522 and KEYNOTE-355 supported the approvals of KEYTRUDA-based regimens for certain patients with high-risk early-stage TNBC and locally recurrent unresectable metastatic TNBC, respectively, in more than 90 countries around the world.

About KEYNOTE-756

KEYNOTE-756 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03725059) evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment, followed by adjuvant treatment with KEYTRUDA plus endocrine therapy for the treatment of high-risk, early-stage ER+/HER2- breast cancer. The dual primary endpoints are pCR rate and EFS, and secondary endpoints include overall survival and safety. The trial enrolled 1,240 patients who were randomized 1:1 to receive:

KEYTRUDA (200 mg every three weeks [Q3W]) plus chemotherapy (paclitaxel weekly) for four cycles, followed by four additional cycles of KEYTRUDA in combination with chemotherapy (doxorubicin or epirubicin plus cyclophosphamide) as neoadjuvant therapy prior to surgery, followed by nine cycles of KEYTRUDA (Q3W) plus endocrine therapy (for up to 10 years) as adjuvant therapy post-surgery; or,
Placebo (Q3W) plus chemotherapy (paclitaxel weekly) for four cycles, followed by four additional cycles of placebo in combination with chemotherapy (doxorubicin or epirubicin plus cyclophosphamide) as neoadjuvant therapy prior to surgery, followed by nine cycles of placebo (Q3W) plus endocrine therapy (for up to 10 years) as adjuvant therapy post-surgery.
About breast cancer

Breast cancer is one of the leading causes of cancer-related death in women worldwide, with more than two million patients diagnosed and approximately 685,000 deaths from the disease globally in 2020. In the U.S., it is estimated there will be approximately 298,000 patients diagnosed with breast cancer and 43,700 deaths from the disease in 2023. The are many different types of breast cancer and various subtypes. Of all breast cancer patients, about 70% will be diagnosed with hormone receptor-positive, HER2-negative disease. Cancer recurrence following surgery for this type of cancer is most common within five years, and patients with high-risk features have a greater chance of recurrence.

On July 28, 2023 EpiAxis Therapeutics reported its participation in the Venture & Capital Sydney investor conference, scheduled for Thursday, 3 August 2023 (Press release, EpiAxis Therapeutics, JUL 28, 2023, View Source;utm_medium=rss&utm_campaign=epiaxis-heads-to-venture-and-capital-sydney-investor-conference [SID1234633481]).

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The event will be held at Hilton Sydney, located at 488 George St, Sydney NSW, from 9am to 6pm. This conference provides a fantastic opportunity to connect with investors and our CEO Dr Jeremy Chrisp would be delighted to speak with attendees at the event.

Venture and Capital 2023 is an exclusive conference designed to empower high-net-worth VCs, Family Offices and professional investors lwith unparalleled access to investment opportunities and exclusive networking.

EpiAxis will be highlighting its disruptive epigenetic approach to overcome treatment resistance and prevent cancer recurrence at the conference.

On July 28, 2023 CYTEA BIO reported that it has taken a significant step towards addressing the urgent medical need for effective glioblastoma multiforme (GBM) treatments (Press release, CYTEA BIO, JUL 28, 2023, View Source [SID1234633480]). The company has submitted Briefing Documents to both European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) regulatory bodies seeking advice for the completion of pre-clinical and manufacturing development of the company’s first oncology treatment for glioblastoma multiforme, based on the proprietary PinTM platform, utilizing monoclonal antibody-armed Natural Killer (NK) effector cells.

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This advice will enable completion of pre-clinical studies and chemistry, manufacturing and control (CMC) development to position CYTEA|BIO to enroll first patients in a clinical study in 2025.

GBM, the most aggressive form of brain cancer, remains a devastating pathology with alarmingly poor patient prognosis. With the average age at diagnosis being less than 60 years and average survival rates extending for barely one year from diagnosis, there is an urgent and pressing need for novel and innovative therapies to help manage this life-threatening disease.

On July 28, 2023 Curium, a world leader in nuclear medicine, reported that the European Commission has granted marketing authorization for PYLCLARI (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings (Press release, Curium, JUL 28, 2023, View Source [SID1234633479]):

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Primary staging of patients with high-risk PCa prior to initial curative therapy
To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Today’s decision follows the positive recommendation for marketing authorization approval by The Committee for Medicinal Products for Human Use of the European Medicines Agency in May 2023.

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, "We are very pleased to receive marketing authorization in the EU for PYLCLARI. The successful clinical development and granted marketing authorization of PYLCLARI in the EU confirms our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine. We are looking forward to bringing PYLCLARI to prostate cancer patients as well as to working together with health care professionals across the EU."

Benoit Woessmer, PET Europe CEO at Curium added, "The decision by the European Commission means that PYLCLARI will soon be available across Europe for the benefit of prostate cancer patients. With the leading PET radiopharmaceutical network in Europe, we are pleased to be improving the set of diagnostic tools available to better diagnose and monitor prostate cancer – ultimately for the benefit of prostate cancer patients."

Curium currently has the widest European network of PET products production sites – 32 sites with the capability to supply in 18 countries. When in full production, PYLCLARI will be the most widely available 18F-PSMA tracer in Europe.

Prostate cancer is one of the most frequently diagnosed cancers in men in Europe, accounting for around 23 percent of all new cancer cases in 2020 and nearly 10 percent of all deaths due to cancer in men.

In the U.S., Lantheus received approval for [18F]-DCFPyL, now PYLARIFY (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 PSMA PET Imaging Agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018.