A Proof-of-concept Study to Assess the Effect of Recombinant Human Growth Hormone on the Size of the Replication-competent Viral Reservoir in HIV-infected Individuals on Suppressive Antiretroviral Therapy

Antiretroviral therapy (ART) has improved the health of more than 18 million people infected with HIV by controlling viral replication, AIDS and non-AIDS events, and by reducing the risk of transmission. However, the existence of latent viral reservoirs in long-lived memory CD4 T cells remains a hurdle to curing HIV infection; consequently patients must remain on ART for the rest of their lives. Recently, a more realistic approach under limelight is to identify strategies leading to a functional cure, which is defined as the natural control of viral reservoir by the host. Use of recombinant human growth hormone has been shown to improve immune function by several mechanisms. This study hypothesizes that treatment with recombinant human growth hormone will decrease the size of the replication competent HIV reservoir in HIV-infected immune-reconstituted individuals.
The specific study objectives include:
To evaluate the effect of recombinant human growth hormone administration for 48 weeks on the size of the replication competent HIV reservoir
To evaluate the safety and tolerability of recombinant human growth hormone administration for 48 weeks in HIV-infected individuals on suppressive ART.
For this purpose, the investigators will add recombinant human growth hormone treatment for the patients receiving stable ART. Approximately 22 participants will be enrolled in this study at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada), which will last about 52 weeks. Participants will be treated with recombinant human growth hormone for a total of 48 weeks. The initial recombinant human growth hormone dose will be 3 mg/day (30-40 µg/kg/d) for 24 weeks administered by subcutaneous injection on an outpatient basis, followed by dose reduction to 1.5 mg/day for the final 24 weeks of the treatment period, also conducted on an outpatient basis. The study inclusion criteria include male and female participants, ≥18 and <40 years of age, with an undetectable viral load (the quantity of the HIV virus in the blood must be less than 50 copies/ml) during last 24 months and with a CD4 T-cell count ≥350 cells/mm3 obtained within 30 days prior to study entry. The findings from this study will contribute to the development of novel strategies to eradicate HIV.

Start Date01 Dec 2016

Sponsor / Collaborator

Centre universitaire de santé McGill

[+1]

NCT01746862

/ CompletedPhase 3

A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen® 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature

This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose, for 12 months (12 months of treatment in the test group, and 6 months of no treatment and then 6 months of treatment in the control group).

Start Date01 Dec 2012

Sponsor / Collaborator

Merck KGaA

NCT01616225

/ TerminatedPhase 2/3IIT

Adjuvant Growth Hormone in Infertile Women With Prior Poor IVF Response: a Randomized, Controlled, Open-label Study

This study (the "Adjuvant Growth Hormone Study") is being done to see the effects of adding Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF). Growth Hormone is a protein that your body normally produces. Growth Hormone can act on several different organs, including the ovaries, where eggs are made. From evidence gathered from studies done by fertility doctors over the years, researchers believe that women who have not become pregnant through IVF in the past might have better results if they go on a course of Growth Hormone during the IVF treatment. However, more research needs to be done to confirm whether adding Growth Hormone is beneficial and also to find out the best time to start Growth Hormone treatment during IVF.
We hope that our Adjuvant Growth Hormone study will help answer these questions.

Start Date01 Jun 2012

Sponsor / Collaborator

Pacific Center For Reproductive Medicine

[+1]

100 Clinical Results associated with Somatropin (Merck Serono SA)

100 Translational Medicine associated with Somatropin (Merck Serono SA)

100 Patents (Medical) associated with Somatropin (Merck Serono SA)

172

Literatures (Medical) associated with Somatropin (Merck Serono SA)

01 Jan 2025·HUMAN REPRODUCTION

Empirical use of growth hormone in IVF is useless: the largest randomized controlled trial

Article

Author: Tadevosyan, Artak ; Phillips, Simon ; Mourad, Ali ; Jamal, Wael ; Hemmings, Robert ; Kadoch, Isaac-Jacques

Abstract:

STUDY QUESTION:

Does adjuvant growth hormone (GH) therapy in GnRH antagonist cycles improve reproductive outcomes in the general IVF population?

SUMMARY ANSWER:

Empiric adjuvant GH therapy in GnRH antagonist cycles does not improve IVF stimulation results or reproductive outcomes, including implantation, miscarriage, and clinical pregnancy rates.

WHAT IS KNOWN ALREADY:

Previous evidence regarding the benefits of GH therapy in IVF cycles has been inconclusive due to the lack of well-designed, large-scale randomized controlled trials (RCTs) in the general IVF population.

STUDY DESIGN, SIZE, DURATION:

This is a phase III open-label RCT involving 288 patients undergoing antagonist IVF cycles at the Ovo clinic in Montreal, Canada, between June 2014 and January 2020. Patients were randomly assigned at a 1:1 ratio to either the GH or control group. The intervention group received daily 2.5 mg subcutaneous injections of GH from Day 1 of ovarian stimulation until the day of oocyte retrieval, while the control group received standard ovarian stimulation without any adjuvant therapy.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Patients were expected normal responders. All embryo transfers, both fresh and frozen, resulting from the studied IVF cycle were included in an intention-to-treat and per-protocol analyses. The primary outcome was the clinical pregnancy rate, while secondary outcomes included the number of retrieved oocytes, good-quality embryos, maturation, fertilization, implantation, and miscarriage rates.

MAIN RESULTS AND THE ROLE OF CHANCE:

A total of 288 patients were recruited and randomly assigned at a 1:1 ratio to either the GH or the control group. After excluding cycle cancellations and patients who did not undergo transfer, 105 patients remained in each group. The overall mean age was 38.0 years, the mean BMI was 25.11 kg/m2 and the mean anti-Müllerian hormone was 2.51 ng/ml. The cycle characteristics were similar between both groups. No differences were observed regarding the total dose of gonadotropins (4600 versus 4660 IU for the GH and control groups, respectively, P = 0.752), days of stimulation (11.4 versus 11.7 days, P = 0.118), and endometrial thickness (10.63 versus 10.94 mm, P = 0.372). Both the intention to treat (ITT) and per protocol analyses yielded similar results for stimulation outcomes. In the ITT analysis, no differences were found in the number of follicles ≥15 mm (7.8 versus 7.1, P = 0.212), retrieved oocytes (11.7 versus 11.2, P = 0.613), mature oocytes (8.5 versus 8.6, P = 0.851), maturation rate (73.8 versus 78.4%, P = 0.060), fertilization rate (64.3 versus 67.2%, P = 0.388), and good quality embryos (2.5 versus 2.6, P = 0.767). Reproductive outcomes in fresh embryo transfer showed no difference for implantation rate (38.2 versus 39.5%, P = 0.829), miscarriage rate (26.5 versus 31.1%, P = 0.653), clinical pregnancy rate (43.6 versus 50.0%, P = 0.406, rate difference, 95% CI: −0.06 [−0.22, 0.09]), and live birth rate (32.1 versus 33.3%, P = 0.860). The number of embryos needed to achieve a clinical pregnancy was 3.0 versus 2.5 in the GH and control groups, respectively. Similarly, reproductive outcomes in first frozen embryo transfer showed no difference for implantation rate (31.6 versus 45.3%, P = 0.178), miscarriage rate (28.6 versus 26.3%, P = 0.873), clinical pregnancy rate (35.1 versus 44.2%, P = 0.406, P = 0.356, rate difference, 95% CI: −0.09 [−0.28, 0.10]), and live birth rate (22.8 versus 32.6%, P = 0.277). The number of embryos needed to achieve a clinical pregnancy was 3.1 versus 2.4 in the GH and control groups, respectively.

LIMITATIONS, REASONS FOR CAUTION:

The study focused on expected normal responders, limiting its applicability to other patient populations such as poor responders.

WIDER IMPLICATIONS OF THE FINDINGS:

These findings suggest that adding GH therapy to ovarian stimulation in GnRH antagonist cycles may not benefit the general IVF population. Additional high-quality RCTs are warranted to identify subgroups of patients who might benefit from this treatment.

STUDY FUNDING/COMPETING INTEREST(S):

EMD Serono Inc., Mississauga, Canada, supplied Saizen® for the study, free of charge. In addition, they provided funding for the statistical analysis. I-J.K. declares grants or contracts from Ferring Pharmaceuticals, consulting fees from Ferring Pharmaceuticals, honoraria from Ferring Pharmaceuticals and EMD Serono, support for attending meetings or travel from Ferring Pharmaceuticals and EMD Serono, participation on a Data Safety Monitoring Board or Advisory Board for Ferring Pharmaceuticals, and stock or stock options from The Fertility Partners; W.J. declares support for attending meetings or travel from EMD Serono; and S.P. declares stock or stock options from The Fertility Partners. All other authors have no conflicts of interest to disclose.

TRIAL REGISTRATION NUMBER:

NCT01715324.

TRIAL REGISTRATION DATE:

25 October 2012.

DATE OF FIRST PATIENT’S ENROLMENT:

25 June 2014.

15 Nov 2024·MEDICINE

A retrospective study of recombinant human growth hormone in the treatment of school-aged pediatric patients with idiopathic short stature

Article

Author: Li, Yun-Hai ; Zhang, Xue-Rong ; Chen, Yao

The present study aims to investigate the clinical efficacy of recombinant human growth hormone (r-hGH) in the treatment of school-age pediatric patients with idiopathic short stature (ISS). Pediatric patients who were diagnosed with ISS and treated with r-hGH at our hospital were enrolled as research subjects. The main outcome indicators included the serum level of insulin-like growth factor-1, insulin-like growth factor binding protein-3, baseline height standard deviation scores, and posttreatment height standard deviation scores and retrospective analysis was performed. This study complies with the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. A total of 42 pediatric patients with a diagnosis of ISS were enrolled in the present study (24 males and 18 females). Following treatment, the levels of insulin-like growth factor-1 and insulin-like growth factor binding protein-3 were significantly higher than the baseline level and the difference was statistically significant. The posttreatment height standard deviation scores was significantly higher than the baseline height standard deviation scores and the difference was statistically significant. There were no significant differences between male and female participants in height standard deviation scores, either before or following treatment. This study found that r-hGH therapy may increase height in school-age pediatric patients with ISS and is therefore worthy of clinical application.

01 Nov 2024·ACTA BIOCHIMICA ET BIOPHYSICA SINICA

Significant biomarkers for predicting 1-month changes in IGF-1 in growth hormone-deficient children following r-hGH therapy

Article

Author: Lu, Wenli ; Huang, Yu S ; Hu, Liangjian ; Lei, NokI ; Hu, Ronggui ; Li, Wunying ; Liu, Fei ; Zheng, Yiwen

Growth hormone deficiency (GHD) is the most common pituitary hormone deficiency and is clin. characterized by short stature, delayed bone age and central distribution of body fat, and it has also been proven to be mildly heritable.Treatment with recombinant human growth hormone (r-hGH) is primary and safe for GHD children, and a dose of 0.15-0.20 mg/kg each week results in a considerable increase in height velocity, with noteworthy growth during the first year of therapy.An open-label, prospective, multicentric, noncomparative, nonrandomized phase IV interventional study was conducted to investigate the relationship between the prospective biomarkers of GHD patients and the individual variation in the primary therapeutic response following 4 wk of r-hGH therapy.The expression quant. trait locus (eQTL) anal. and differentially expressed gene (DEG) anal. were conducted to identify significant biomarkers for GHD treatment.The most significant eQTL association was between SNP rs12882504 in the intronic region of SOS2 and the expression probe 237640_at of VCPKMT, which are relatively close in position on the chromosome, indicating that VCPKMT is a possible gene that affects the GHD response and that SOS2 may have a regulatory function.Interestingly, the SOS2-VCPKMT pathway was found to have a significant cis-eQTL association, and a set of differentially expressed probes with greater absolute fold changes were found to be strongly correlated with the GH-IGF-1 axis, which provides potential targets for further research on GHD treatment response.

News (Medical) associated with Somatropin (Merck Serono SA)

16 Dec 2024

·www.globenewswire.com

New InsiGHTS Trial of TransCon™ hGH (Lonapegsomatropin) in Turner Syndrome Achieved Primary Objective at Week 26

- Results for all three TransCon hGH starting dose cohorts, in first clinical trial of an indication outside of growth hormone deficiency, showed a safety and tolerability profile comparable to daily somatropin - Annualized height velocity was similar at Week 26 in once-weekly TransCon hGH-treated and daily somatropin-treated children COPENHAGEN, Denmark, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced positive Week 26 topline results from New InsiGHTS, its Phase 2 randomized, open-label, active-controlled trial in the U.S. to investigate the safety, tolerability, and efficacy of once-weekly TransCon hGH (lonapegsomatropin; approved for pediatric growth hormone deficiency) compared to daily somatropin in prepubertal children with Turner syndrome. New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old into one of four treatment groups 1:1:1:1 – one of three starting doses of TransCon hGH (0.24, 0.30, or 0.36 mg/kg/week) or an active comparator of daily somatropin with a starting dose of 0.35 mg/kg/week. Doses were individualized based on IGF-1. On the primary endpoint of annualized height velocity and secondary endpoint of change from baseline in height SDS, children treated with TransCon hGH demonstrated improved growth similar to daily somatropin at Week 26, independent of starting dose.In the trial, TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with comparable safety and tolerability to daily somatropin. “Week 26 topline data from the New InsiGHTS Trial showed that once-weekly TransCon hGH provided comparable safety and endocrine benefits to those seen with the established use of daily somatropin in Turner syndrome,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “These positive results lay the foundation for our planned basket trial in 2025 to support label expansion.” Ascendis expects Week 52 results for lonapegsomatropin-treated children compared to daily somatropin-treated children in 2025. About Turner SyndromeTurner syndrome is the most common congenital sex chromosomal condition in females, with an estimated prevalence of 1 out of every 2,000 to 2,500 live female births. Short stature, associated with short stature homeobox-containing gene (SHOX) haploinsufficiency, is the most common clinical feature of Turner syndrome. Clinical manifestations of Turner syndrome affect multiple organ systems and are associated with significant and potentially life-threatening complications including cardiovascular disease, ovarian dysfunction, endocrine disease, renal malformation, liver disease, sensorineural hearing loss, and varied neuropsychological manifestations. About Ascendis Pharma A/SAscendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the timing of Week 52 results for lonapegsomatropin-treated patients compared to daily somatropin-treated patients, (ii) Ascendis’ plans for a basket trial in 2025 and SKYTROFA’s potential label expansion, (iii) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (iv) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ prospectus supplement filed on September 20, 2024 and Ascendis’ current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 20-F filed with the SEC on February 7, 2024. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © December 2024 Ascendis Pharma A/S. Investor Contacts:Media Contact:Scott SmithMelinda BakerAscendis PharmaAscendis Pharmair@ascendispharma.com+1 (650) 709-8875 media@ascendispharma.comPatti Bank ICR Healthcare +1 (415) 513-1284 patti.bank@icrhealthcare.com

Clinical ResultDrug ApprovalPhase 2

30 Oct 2024

·www.globenewswire.com

Sandoz reports third-quarter and nine-month 2024 sales

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong third-quarter biosimilars growth of 37% in constant currencies from existing portfolio and recent launchesGenerics growth acceleration driven by EuropeThird-quarter net sales¹ of USD 2.6 billion, up 12% in constant currencies (up 11% in USD)Nine-month net sales of USD 7.6 billion, up 9% in constant currencies (up 8% in USD)Net sales growth guidance increased to high-single digit in constant currencies (from mid- to high-single digit) and core EBITDA margin² guidance of around 20% confirmed Basel, October 30, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year. Richard Saynor, Chief Executive Officer of Sandoz, said: “We remain focused on execution, meeting key milestones in our biosimilars business and progressing on our journey as a standalone company. In recent months, we received approval for Pyzchiva® and Enzeevu™ in the US, launched Pyzchiva® in Europe and see continued strong uptake of Hyrimoz® in the US. “Net sales growth was achieved across generics and biosimilars, with generics accelerating in the third quarter and strong double-digit biosimilars growth in both the third quarter and first nine months. Additionally, all three regions contributed to this strong performance. We expect momentum in our business to continue, driving margin expansion through favorable product mix and leveraging our cost base. We have further advanced on our path to simplifying our business, including progression on the transformation program we launched earlier this year.” THIRD-QUARTER AND NINE-MONTH SALES Net sales for the third quarter were USD 2.6 billion, up 12% in constant currencies, compared to the third quarter of 2023. Volume contributed 13 percentage points of growth. This was partially offset by price erosion of 1 percentage point. Biosimilars were the key driver of growth in the quarter, while generics experienced solid demand. Growth accelerated in both businesses. Net sales for the first nine months of 2024 were USD 7.6 billion, up 9% in constant currencies compared to prior year. Volume contributed 11 percentage points of growth. This was partially offset by price erosion of 2 percentage points. The growth was primarily driven by biosimilars, with strong demand for both the base business and new in-market organic and acquired products in the US. Net sales by business Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc* USDcc*Generics 1 8541 794 34 5 5585 512 12Biosimilars 741 543 3637 2 0841 592 3132Net sales to third parties 2 5952 337 1112 7 6427 104 89 *constant currencies Generics overviewNet sales for the third quarter were USD 1.9 billion, up 4% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 5.6 billion, up 2% in constant currencies versus prior year. Growth in the Europe region accelerated in the third quarter, mainly driven by recent launches. The momentum continued in the International region, aided by demand for the antifungal agent Mycamine® and favorable pricing dynamics, partly offset by the divestment of the Chinese business. North America declined due to timing of new launches in the US. Biosimilars overviewNet sales for the third quarter were USD 741 million, up 37% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 2.1 billion, up 32% in constant currencies versus prior year. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz® (adalimumab) in the US, the acquisition of Cimerli® (ranibizumab), the continued strong demand for our first-ever biosimilar, Omnitrope® (somatropin), and the launches of Tyruko® (natalizumab) and Pyzchiva® (ustekinumab) in Europe. Net sales by region Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc USDccEurope 1 3621 204 1312 3 9963 751 76North America 598 510 1718 1 7421 514 1515International 635 623 28 1 9041 839 49Net sales to third parties 2 5952 337 1112 7 6427 104 89 Europe overviewNet sales for the third quarter were USD 1.4 billion, up 12% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 4.0 billion, up 6% in constant currencies versus prior year. Strong growth in biosimilars continues, led by demand for Omnitrope® and the contribution from the recent launches of Tyruko® and Pyzchiva®. Generics momentum accelerated in the third quarter, driven by recent launches and the lapping of the strong prior-year comparison in the first half. North America overviewNet sales for the third quarter were USD 598 million, up 18% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.7 billion, up 15% in constant currencies versus prior year. Growth was driven by the ongoing uptake of Hyrimoz® in the US, the acquisition of Cimerli®, share gain of Omnitrope® in the US and the launch of Wyost®/Jubbonti® in Canada. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the third quarter were USD 635 million, up 8% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.9 billion, up 9% in constant currencies versus prior year. This was primarily a result of strong volume growth across both generics and biosimilars, contribution from the acquisition of Mycamine® in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter. GUIDANCE 2024 On the back of strong momentum in its biosimilars business and solid generics demand, the company is increasing its full-year 2024 net sales guidance to high-single digit growth in constant currencies versus prior year (from mid- to high-single digit) and is confirming its core EBITDA margin guidance of around 20%. THIRD-QUARTER STRATEGIC MILESTONES Sandoz continued to execute on its strategy and passed additional milestones in its biosimilars portfolio. On July 1, the company announced the US FDA approval of biosimilar Pyzchiva® for all indications of the reference medicine. The company intends to launch Pyzchiva® in the US among the first wave of ustekinumab biosimilars in February 2025. On July 25, Sandoz announced the launch of biosimilar Pyzchiva® across Europe to treat chronic inflammatory diseases. Pyzchiva® was the first biosimilar to launch in Europe with all reference medicine strengths, including an initiation dose for Crohn’s disease. On August 12, Sandoz received FDA approval for Enzeevu™ to treat neovascular age-related macular degeneration. This approval further enhances the company’s leading US ophthalmology portfolio and increases access for patients. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential litigation or any potential settlements. KEY LINKS Webcast – Live at 9am CET Analyst call presentationAnalyst consensus DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contacts Investor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comSteffen Kurzawa+41 79 800 8501Laurent de Weck+41 79 795 7364Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 5217 SUPPORTING FINANCIAL INFORMATION Quarterly net sales 2024 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDccGenerics 1 86901 1 835-11 1 85434Biosimilars 6232121 7203537 7413637Net sales to third parties 2 49256 2 55579 2 5951112 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDcc Europe 1 32642 1 30823 1 3621312North America 52466 6202223 5981718International 642412 62759 63528Net sales to third parties 2 49256 2 55579 2 5951112 2023 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Generics 1 86826 1 85046 1 79454 1 92066Biosimilars 5161117 5331314 54374 6232926Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Europe 1 2701016 1 2771412 1 204113 1 272104North America 496-5-3 508-4-2 510-4-3 6152020International 618-14 598-38 623312 656414Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 ¹ Net sales in this document refer systematically to net sales to third parties. In the first nine months of 2023, third-party sales excluded sales to our former parent. Post spin-off, sales to our former parent are reported as third-party sales.² An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024 Attachment 241030_Q3 and 9M Sales 2024_ Media Release.pdf

Drug ApprovalBiosimilarAcquisition

14 May 2024

·www.merckgroup.com

Off to a Good Start in Fiscal 2024

Financial results of Q1 2024 Healthcare with strong performance Electronics increases sales and earnings organically, driven by higher demand for semiconductor materials Inventory destocking in Life Science continues; sales recovery expected in the second half of the year Net sales down organically by 1.2% to € 5.1 billion EBITDA pre decreases organically by 5.2% to € 1.5 billion Forecast for fiscal 2024 Qualitative guidance confirmed with Group returning to organic growth Net sales: in a range of € 20.6 billion to € 22.1 billion, organically +1% to +5% EBITDA pre: in a range of € 5.7 billion to € 6.3 billion, organically +1% to +7% Merck KGaA, Darmstadt, Germany, a leading science and technology company, has had a good start to fiscal 2024. The Healthcare business sector performed strongly. Electronics also delivered solid organic sales growth, mainly driven by Semiconductor Solutions. Life Science recorded sales and earnings declines compared with the particularly high base of the year-earlier quarter. In the first quarter of 2024, thanks to the sound business performance and compared with the high base of the first quarter of 2023, Group sales decreased by only 3.3% (organically: ‑1.2%) to € 5,120 million. Foreign exchange effects, mainly from the Chinese renminbi, had a negative impact of 2.0% on the sales development. EBITDA pre fell by 8.4% (organically: ‑5.2%) to € 1,454 million. Negative foreign exchange effects impacted EBITDA pre by 3.2%. The EBITDA pre margin was 28.4% in the first quarter of 2024 and earnings per share pre were € 2.06. “We had a good start to the year and gained initial momentum in the first quarter of 2024, once again benefiting from our diversified business model,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “We expect acceleration in the second half of the year, especially in Life Science, and thus a gradual return to organic growth for the Group in fiscal 2024.” Life Science: Decline in first quarter against high comparables, in line with expectation of a softer first half of the year Net sales of the Life Science business sector declined organically by 12.6% against the particularly high base of the first quarter of 2023. Foreign exchange had a negative impact of 1.2% on the sales development. Overall, sales of the business sector decreased by 13.8% to € 2,144 million in the first quarter of 2024. The main reason for this was the continued inventory destocking by customers of Process Solutions. Net sales of this business unit declined organically by 19.0%. As a positive signal, order income in Process Solutions increased sequentially as well as year-on-year. The company expects customers to reach their target inventory levels by the end of the second quarter of 2024. However, due to the manufacturing and delivery times for products ordered by customers, this will significantly increase sales only in the second half of the year. In addition to inventory destocking, the phase-out of Covid-19-related demand was also a headwind for the business development of Life Science in the first quarter of 2024. Compared with the high year-earlier figure, EBITDA pre of Life Science decreased organically by 30.3% and amounted to € 611 million. This was due, among other things, to the lower sales volume and the lower share of higher-margin products sold. The EBITDA pre margin of the business sector was 28.5%, a sequential increase against the 26.3% EBITDA pre margin in the fourth quarter of 2023. Healthcare: Double-digit organic sales growth of “Wave 1” products, further supported by strong performance of established product portfolio The Healthcare business sector performed strongly across all franchises in the first quarter of 2024 amid the market recovery in mainland China, where the year-earlier quarter had been adversely affected by the high rate of Covid‑19 infections. Sales of Healthcare rose organically by 10.1%. Including negative foreign exchange effects of 2.6%, sales increased overall by 7.5% to € 2,048 million. The “Wave 1” products Bavencio (+14.2%) and Mavenclad (+12.2%) achieved double-digit organic sales increases. The oncology drug Erbitux delivered very strong organic sales growth of 19.3%, boosted by the softer year-earlier comparables in mainland China. Net sales of the Fertility (+7.7%) and Cardiovascular, Metabolism & Endocrinology (+4.2%) franchises also rose organically. EBITDA pre of Healthcare went up organically by 28.3% to € 708 million, supported by the regaining of the exclusive worldwide rights to Bavencio and strong sales momentum. The EBITDA pre margin was 34.6%. Electronics: Positive start to the year, full market inflection still expected in the second half of the year Electronics delivered solid organic sales growth of 6.3%. This was particularly driven by Semiconductor Solutions, the sector’s largest business unit, which grew organically by 7.8%. The main reason for this was increased demand for certain semiconductor materials, for example materials used for leading-edge logic chips. However, the Group does not yet view this as a general inflection point, since demand in other end markets remained soft. The other two business units, Display Solutions (+4.2%) and Surface Solutions (+1.8%), also recorded organic sales increases. Amid negative foreign exchange effects of 3.2%, sales of the Electronics business sector rose overall by 3.1% to € 928 million. EBITDA pre increased organically by 3.9% compared with the year-earlier quarter. Due to negative foreign exchange effects of 4.2%, the earnings development saw a slight decline by 0.3% to € 237 million overall. The EBITDA pre margin of Electronics was 25.5%. Forecast for fiscal 2024: Qualitative guidance confirmed with Group returning to organic growth In fiscal 2024, Merck KGaA, Darmstadt, Germany, expects to return to organic sales and earnings growth for the Group. In particular, the company assumes the following development, in line with its qualitative guidance provided in March 2024: Net sales: in a range of € 20.6 billion to € 22.1 billion with organic growth of +1% to +5% and foreign exchange effects of ‑3% to 0%. EBITDA pre: in a range of € 5.7 billion to € 6.3 billion with organic growth of +1% to +7% and negative foreign exchange effects of ‑4% to ‑1%. EPS pre: € 8.05 to € 9.10. Overview of the key figures for Q1 2024 Group Key figures € million Q1 2024 Q1 2023 Change Net sales 5,120 5,293 -3.3% Operating result (EBIT) 1 931 1,035 -10.0% Margin (% of net sales) 1 18.2% 19.6% EBITDA 2 1,385 1,491 -7.1% Margin (% of net sales) 1 27.0% 28.2% EBITDA pre 1 1,454 1,587 -8.4% Margin (% of net sales) 1 28.4% 30.0% Profit after income tax 699 800 -12.5% Earnings per share (€) 1.60 1.83 -12.6% Earnings per share pre (€) 1 2.06 2.36 -12.7% Operating cash flow 1,035 853 21.4% Net financial debt 3 7,498 7,500 – Number of employees 4 62,345 64,011 -2.6% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 Figures for the reporting period ending on March 31, 2024, prior-year figures as of December 31, 2023. 4 Figures for the reporting period ending on March 31, 2024, prior-year figures as of March 31, 2023. This figure refers to all employees at sites of fully consolidated entities. Life Science Net sales by business unit € million Q1 2024 Share Organic growth 1 Exchange rate effects Acquisitions/ divestments Total change Q1 2023 Share Science & Lab Solutions 1,169 55% -6.9% -1.5% – -8.4% 1,276 51% Process Solutions 817 38% -19.0% -1.1% – -20.0% 1,022 41% Life Science Services 157 7% -16.6% – – -16.7% 188 8% Life Science 2,144 100% -12.6% -1.2% – -13.8% 2,487 100% 1 Not defined by International Financial Reporting Standards (IFRS). Healthcare Net sales by major product lines/products € million Q1 2024 Share Organic growth1 Exchange rate effects Total change Q1 2023 Share Oncology 500 24% 19.3% -3.8% 15.5% 433 23% thereof: Erbitux ® 287 14% 19.3% -4.3% 15.0% 250 13% thereof: Bavencio ® 186 9% 14.2% -2.8% 11.4% 167 9% Neurology & Immunology 419 20% 8.8% -1.5% 7.3% 390 20% thereof: Mavenclad ® 261 13% 12.2% -2.0% 10.2% 237 12% thereof: Rebif ® 158 8% 3.7% -0.9% 2.8% 154 8% Fertility 383 19% 7.7% -3.3% 4.4% 366 19% thereof: Gonal-f ® 204 10% 6.8% -3.5% 3.3% 197 10% Cardiovascular, Metabolism and Endocrinology 689 34% 4.2% -2.4% 1.7% 677 36% thereof: Glucophage ® 221 11% 5.1% -3.7% 1.4% 218 11% thereof: Concor ® 140 7% 1.6% -3.6% -1.9% 142 7% thereof: Euthyrox ® 139 7% 8.9% -1.7% 7.2% 130 7% thereof: Saizen ® 89 4% 17.0% -0.2% 16.7% 76 4% Other 57 3% 38 2% Healthcare 2,048 100% 10.1% -2.6% 7.5% 1,905 100% 1 Not defined by International Financial Reporting Standards (IFRS). Electronics Net sales by business unit € million Q1 2024 Share Organic growth 1 Exchange rate effects Acquisitions/ divestments Total change Q1 2023 Share Semiconductor Solutions 633 68% 7.8% -3.0% -0.1% 4.7% 604 67% Display Solutions 187 20% 4.2% -4.3% – -0.1% 187 21% Surface Solutions 109 12% 1.8% -2.2% – -0.4% 109 12% Electronics 928 100% 6.3% -3.2% -0.1% 3.1% 901 100% 1 Not defined by International Financial Reporting Standards (IFRS). Notes to editors: The press conference for media representatives will take place at 9:30 a.m. (CEST). The respective presentation and further information for journalists, including a digital press kit , can be found here The quarterly statement can be found here Merck KGaA, Darmstadt, Germany, on LinkedIn Photos and videos can be found here Stock symbols Reuters: MRCG, Bloomberg : MRK GY, Dow Jones : MRK.DE Frankfurt Stock Exchange : ISIN : DE 000 659 9905 – WKN : 659 990 All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.emdgroup.com/subscribe to register for your online, change your selection or discontinue this service. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2023, Merck KGaA, Darmstadt, Germany, generated sales of € 21 billion in 65 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Financial Statement

100 Deals associated with Somatropin (Merck Serono SA)

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KEGG	Wiki	ATC	Drug Bank
-	-	H01AC01	DB00052

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Failure to Thrive	Australia	Merck Healthcare Pty Ltd.	22 Aug 2011
Gonadal Dysgenesis	Australia	Merck Healthcare Pty Ltd.	22 Aug 2011
Growth retardation	Australia	Merck Healthcare Pty Ltd.	22 Aug 2011
Turner Syndrome	Australia	Merck Healthcare Pty Ltd.	22 Aug 2011
Short Bowel Syndrome	United States	EMD Serono, Inc.	19 Nov 2001
Growth hormone deficiency	United States	EMD Serono, Inc.	08 Oct 1996
HIV Infections	United States	EMD Serono, Inc.	23 Aug 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic short stature	Phase 3	South Korea	Merck KGaA	01 Dec 2012
Infertility	Phase 3	Canada	EMD Serono, Inc.	01 Jun 2012
Fibromyalgia	Phase 3	Spain	Merck KGaA	01 Dec 2007
Dwarfism, Pituitary	Phase 3	United States	EMD Serono, Inc.	01 Jan 2005
HIV-Associated Lipodystrophy Syndrome	Phase 3	United States	EMD Serono, Inc.	28 May 2004
HIV-Associated Lipodystrophy Syndrome	Phase 3	Canada	EMD Serono, Inc.	28 May 2004
Small-for-dates baby	Phase 3	Italy	Merck KGaA	01 Feb 2004
Fetal Growth Retardation	Phase 3	-	Merck KGaA	01 Nov 1998
HIV Wasting Syndrome	Phase 3	-	EMD Serono, Inc.	01 Jul 1997
Hypochondroplasia	Phase 2	France	Merck KGaA	21 Mar 2006

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Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESPE2022	Not Applicable	Growth hormone deficiency	-	Somatropin	aiknxibelp(vgmidgvgrn) = zaolzuhonv rklyqozmcr (vlfyqsdkdp ) View more	Negative	15 Sep 2022
ESPE2019	Not Applicable	Hypochondroplasia FGFR3 mutation	-	Saizen (r-hGH, Merck France)	ulrszoddmb(dzumrcimlq) = xbdnfcrrss gihvhfcqkv (hapmpiyjsn )	-	19 Sep 2019
				Growth Hormone (GH)	ulrszoddmb(dzumrcimlq) = amqoptcctw gihvhfcqkv (hapmpiyjsn )
NCT01111019 (CTgov)	Phase 2	Hypochondroplasia	19	Recombinant human growth hormone (r-hGH)	kfkmbnoyrm(npmvqxdahu) = cabckcjqpo hzokjqqrra (yldktwklmw, 0.9) View more	-	15 Feb 2019
NCT00082628 (CTgov)	Phase 3	HIV-Associated Lipodystrophy Syndrome	326	Placebo (Period I: Placebo)	uwootqsved(vylzbrzecw) = pctnvsivfh cbgedunupt (hmeuiwxpmd, 34.5) View more	-	20 Jul 2018
				Serostim® 4 mg (Period I: Serostim® 4 mg)	uwootqsved(vylzbrzecw) = okqihcznat cbgedunupt (hmeuiwxpmd, 37.9) View more
NCT00256126 (CTgov)	Phase 4	Turner Syndrome \| Growth hormone deficiency	318	Saizen (Turner Syndrome (TS))	fermzykkwv(cdqohhjlup) = lbhuoczyio flusqrfiwo (ahdeirzrht, 1.1889) View more	-	20 Mar 2018
				Saizen (Growth Hormone Deficiency (GHD))	fermzykkwv(cdqohhjlup) = bpdbilwlox flusqrfiwo (ahdeirzrht, 0.9811) View more
NCT01746862 (SYNERGY, CTgov)	Phase 3	Idiopathic short stature	90	Saizen® (Saizen Test Group)	ibzayxrzul(mrjcmrwohr) = fgnyridwpd jhvaywqnnw (anbsqhtmse, 1.62) View more	-	18 Oct 2016
				Saizen® (Saizen Control Group)	ibzayxrzul(mrjcmrwohr) = zuqqpzqhno jhvaywqnnw (anbsqhtmse, 1.91) View more
NCT00933686 (CTgov)	Phase 3	Fibromyalgia	113	Saizen® (Saizen®)	ngjksewhbe = eyhflldvbs tuntlmhaoz (xeoatoslpx, geztpkvjdu - pfcvlrqfkp) View more	-	02 Aug 2013
				Placebo+Saizen® (Placebo + Saizen®)	ngjksewhbe = qzclcndrmx tuntlmhaoz (xeoatoslpx, pjidheluwp - cmfttbxpqm) View more
NCT01237340 (CTgov)	Phase 3	Growth hormone deficiency	59	Saizen®	cipltoiemj = utizbgpkpr bdugvofblc (amhyrdnvnx, iunvmugzcc - bfxfaiiubt) View more	-	11 Oct 2012
NCT00249821 (SGA OPTIMIS, CTgov)	Phase 3	Small-for-dates baby	22	Saizen® (Saizen® 0.057 mg/kg/Day)	echgkynfig(uharnmpbxs) = zesocxmtds hqxfasltdk (cursjypnhi, 1.35) View more	-	10 Oct 2012
				Saizen® (Saizen® 0.035 mg/kg/Day)	echgkynfig(uharnmpbxs) = jyvftbfofh hqxfasltdk (cursjypnhi, 1.15) View more
NCT00100698 (CTgov)	Not Applicable	Lipodystrophy \| Acquired Immunodeficiency Syndrome	56	Growth Hormone (Recombinant Human Growth Hormone)	fznjqcfswg(wjewjeiiao) = ixyakwlxrn bcpwyreklb (doqojiyjii, 6) View more	-	22 Jul 2010
				placebo (Placebo)	fznjqcfswg(wjewjeiiao) = oanqbfgbfg bcpwyreklb (doqojiyjii, 4) View more

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