From 27 to 29 July, the ‘IHF Beach Handball Showcase’ will take place on the fringes of the Paris 2024 Olympic Games
IHF.info: Tell us a little about yourself and your Beach Handball background…
but currently live in Brest where I finished my professional (indoor) handball playing career – I played internationally for France between 2008 and 2012
winning two silver medals at the 2009 and 2011 IHF Women’s World Championships in China and Brazil
I discovered Beach Handball back in 2017 at the first-ever European Beach Handball Championships for the French women’s team
I captained the side and it was an incredible experience as we reached the quarter-finals
eventually finishing seventh to qualify for the 2018 IHF Women’s Beach Handball World Championship in Russia
but I could not go there because it was my last season as a professional player in Brest
I did return for the 2019 European Beach Handball Championship in Poland and finished my career as a player there
I was asked by the French Handball Federation if I could join their staff to share my experience for the new challenge and in 2021
I joined the women’s national team as assistant coach
where I worked at the 2021 European Beach Handball Championship and EHF Championship in 2022 before taking time out for the birth of my second child
In late 2023 I became head coach of the women’s national team and recently
we won our first-ever senior Beach Handball medal
with silver at the EHF Beach Handball Championship in Varna
I am also coach at club side Brest Bretagne Handball
who participated twice in the EHF Champions Cup and have coached the regional team who became French champion in both 2022 and 2023
IHF.info: You will coach games on home sand at the ‘IHF Beach Handball Showcase’ on the sidelines of the Paris 2024 Olympic Games
Marion Limal: I am honoured to welcome all these great players to France
in what is sure to be an incredible tournament which will show the best of Beach Handball
I’m so excited to feel the atmosphere around and on the court
For my players and myself it will also be a rich experience to meet all the players and exchange information about our sport
IHF.info: Why is the IHF Beach Handball Showcase important for Beach Handball
Marion Limal: It’s an amazing way to promote Beach Handball
To be in Paris during the Olympic Games is a great opportunity to show how this sport can be spectacular
I hope it can help us to be as fast as possible into the Olympic sports programme
IHF.info: What has been your biggest success in Beach Handball as a coach
Marion Limal: My biggest achievement is for sure the silver medal we earned two weeks ago in Varna
We have a really young and talented team and worked hard all year to make the gap between us and the top eight European nations smaller at each competition
In Varna we played with a lot of serenity and it was great to be their coach
IHF.info: What do you love about Beach Handball
how we play and the atmosphere between the teams and delegations
This game offers us a lot of technical and tactical possibilities
I fell in love with this sport at first sight and I would love to have discovered Beach Handball earlier so I could have had the opportunity to play much longer
IHF.info: What are your hopes for the future of Beach Handball and the Olympic Games
Marion Limal: I would like to see it in the Olympic Games soon
Everyone is working hard to show how great is this sport to make this dream for all of us come true
IHF.info: What would you say to anyone who has never played or watched Beach Handball and is thinking of getting involved with the sport
Paul Mourioux: I was born in Angoulême but now live in Bordeaux
I have never played for any national teams
but as a coach I have been assistant and coach of the men’s youth national team for three years
I am coach of the men’s senior team as well as being responsible for training and technical projects at the French Handball Federation
I have also been the coach of the Lacanau club side for three years too
we participated in our first EHF European Beach Handball Tour (ebt) Finals this season because we were the organisers and hosts
I am also very proud to be the director of the Handball Xperience Tournament in Lacanau as we were the first major Beach Handball tournament in France
Paul Mourioux: It’s an honour for France and for Beach Handball to be present during the Olympic Games and
it’s the first time for all participants to be in Paris
it’s the first big step – we must be visible and accessible
Paul Mourioux: Beach Handball is a spectacular sport
you have to show the best and the IHF Beach Handball Showcase brings together the best athletes and coaches
Paul Mourioux: In my young coaching career so far
there have been two events which changed my perspective
during the 2022 IHF Men’s Youth Beach Handball World Championship in Heraklion
this past week when we won bronze in the HF Beach Handball Championships 2024 in Varna
Paul Mourioux: We need to accept that Beach Handball is different to the traditional
‘Indoor’ Handball and should not try to copy the model of current
We must innovate with events but also reflect the universality of sport
I find that today the sport spectacle does not create resources for amateur sport so we must think about generating international events in the service of local sport
The Olympic Games are a stage to validate our sport
we must develop Beach Handball among young people
there is a competition for the young people after the U17/U18 – the countries
continents and IHF must lead this generation to carry Beach Handball to reach a maturity by the next or
Paul Mourioux: Come and sit down for a few minutes and watch it
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2025Idorsia Ltd (SIX: IDIA) today announced its financial results for 2024
Guidance for 2025 unforeseen events excluded
commented:“We were not able to close the envisaged out-licensing agreement for aprocitentan
but we will now pivot to potential alternative partners
we were able to agree a holistic restructuring of our convertible bond debt and secure additional funding for future operations
With so much attention going to the financial situation of the company during the past six months
it’s easy to lose sight of how well the company was performing in other areas
with a particularly strong performance in France and Germany
was made available for prescription in the US
and submitted for review in Switzerland and Canada
We closed a great deal with Viatris for our Phase 3 assets
and we have advanced our early-stage pipeline of potentially first- or best-in-class discoveries
With commercial profitability forecast in 2026
and overall profitability forecast for 2027
we have a lot to be excited about.”Financial results
Net revenue of CHF 113 million in 2024 is the result of QUVIVIQ product sales (CHF 61 million)
product sales to partners (CHF 47 million)
This compares to net revenue of CHF 152 million in 2023
which included CHF 107 million one-off incomes (mainly PIVLAZ sales in Japan and the APAC (ex-China) Nxera deal)
Other revenues in 2023 consisted of QUVIVIQ product sales (CHF 31 million)
and other contract revenue of CHF 15 million
US GAAP operating expenses in 2024 (CHF 351 million) and 2023 (CHF 409 million) were impacted by one-off incomes of CHF 125 million (Viatris deal) and CHF 298 million (Nxera deal) respectively
US GAAP operating expenses in 2024 amounted to CHF 476 million
decreasing by CHF 231 million compared to 2023 (CHF 707 million)
mainly driven by R&D expenses of CHF 144 million decreasing by CHF 150 million compared to 2023 (CHF 294 million)
and SG&A expenses of CHF 273 million decreasing by CHF 120 million compared to 2023 (CHF 392 million)
US GAAP net loss in 2024 amounted to CHF 264 million (CHF 298 million in 2023)
The net loss was favorably impacted by the one-off income related to the Viatris deal (Nxera deal in 2023) and lower operating expenses throughout all functions
The reduction in operating expenses is mainly a result of the restructuring initiative from 2023 which became fully cost effective in 2024 and the Viatris Deal
which relieved the group from Phase 3 development costs related to selatogrel and cenerimod
The US GAAP net loss resulted in a basic net loss per share of CHF 1.45 (basic and diluted) in 2024
compared to a net loss per share of CHF 1.67 (basic and diluted) in 2023
and issues guidance on non-GAAP operating performance
Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors
These non-GAAP measures are reported in addition to
Non-GAAP net loss in 2024 amounted to CHF 330 million; the difference versus US GAAP net loss was mainly driven by a net gain from the Viatris Deal (CHF 125 million)
The non-GAAP net loss resulted in a net loss per share of CHF 1.81 (basic and diluted) in 2024
compared to a net loss per share of CHF 3.04 (basic and diluted) in 2023
Idorsia entered into a global research and development collaboration with Viatris
for the global development and commercialization rights to selatogrel and cenerimod
Idorsia received an upfront payment of USD 350 million (CHF 308 million) with Idorsia obligated to contribute USD 200 million for the development of selatogrel and cenerimod
Idorsia is entitled to potential development and regulatory milestone payments
and certain contingent payments of additional sales milestone payments and tiered royalties in the mid-single to low-double digit percentages on annual net sales
Idorsia reached an agreement with Viatris to update the terms of the collaboration
In exchange for a USD 100 million reduction to Idorsia’s contribution to the development costs due in 2025
Idorsia has agreed to a USD 250 million reduction in future potential regulatory and sales milestone payments
and an expansion of territorial rights to Viatris for cenerimod
The agreed royalties on future sales remain unchanged
Idorsia's contribution for the development of selatogrel and cenerimod is reduced to USD 100 million with no commitment in 2025
Idorsia has contributed USD 73 million in 2024 for the performance of development services
and the remaining USD 27 million will be paid in 2026
Capital increaseIn connection with the holistic restructuring of the convertible bond debt and raising of additional funds
35 million registered shares with a nominal value of CHF 0.05 each have been created out of capital band and will be listed today
Financial guidance for 2025As previously announced
the company expects a continued acceleration of QUVIVIQ with net sales of around CHF 110 million
SG&A expenses of around CHF 210 million
and R&D expense of around CHF 100 million
leading to non-GAAP operating expenses of around CHF 325 million
This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 215 million and US-GAAP operating loss of around CHF 260 million
The company expects US-GAAP EBIT for the partnered business of around CHF 105 million
mainly driven by the amended deal with Viatris
This would result in a US-GAAP loss for the global business of around CHF 155 million
All amounts exclude unforeseen events and potential revenue related to additional business development activities
commented:“I’m pleased that our performance in 2024 exceeded our expectations
The series of initiatives that we announced last week totally changes the financial situation of Idorsia
By relieving the significant debt overhang
removing significant and immediate cash requirements
Idorsia is able to continue to operate into 2026
We will continue our efforts to maximize QUVIVIQ sales and reduce costs moving forward in order to make the money last.”
Liquidity and indebtednessAt the end of 2024
Idorsia’s liquidity amounted to CHF 106 million
and Sweden generated total product sales of CHF 61 million
QUVIVIQ (daridorexant) net sales in 2024 reached CHF 32 million in the EUCAN region
a significant increase from CHF 6.5 million in 2023
QUVIVIQ is reimbursed for moderate and severe chronic insomnia patients after
cognitive behavioral therapy for insomnia (CBT-I) since January 2024
and was launched in March 2024 as the first and only pharmacotherapy recommended for the treatment of chronic insomnia
Through a commercial partnership with Menarini in France
Idorsia expanded its commercial reach from specialist prescribers to general practitioners (GPs) in October 2024
which has substantially increased sales quarter on quarter with France being one of the main drivers of sales growth in the EUCAN region
QUVIVIQ was launched in November 2022 and is the only sleep medication in Germany that can be prescribed for long-term treatment of chronic insomnia
The progress made in Germany is reflected by the performance of QUVIVIQ on the market
with net sales increasing by 279% in 2024 compared to 2023
Idorsia successfully concluded negotiations for the reimbursement price in Germany
Idorsia is expanding its commercial reach from specialist prescribers to general practitioners (GPs) through a commercial partnership with Berlin-Chemie (a wholly owned subsidiary of the Menarini Group) beginning in early April 2025
QUVIVIQ is recommended as first-line pharmaceutical treatment for patients with chronic insomnia
cognitive behavioral therapy for insomnia (CBT-I)
QUVIVIQ was launched in October 2023 at NICE approval
The priority in the UK in 2024 was to secure regional access
and the team has achieved reimbursement throughout 85% of the UK
as well as raising awareness of QUVIVIQ among general practitioners
Increased access and awareness have started to translate into strong demand in the UK
QUVIVIQ was launched in November 2023 to the private market
representing 55% of the Canadian insomnia market
The focus is now on public payers; the company submitted public reimbursement dossiers and expects decisions by the end of 2025
where we are still negotiating for reimbursement
launches have been very successful despite the out-of-pocket costs for patients
particularly in Switzerland where we see a strong demand
we have achieved an expansion of the prescriber base from specialists to now include general practitioners who represent nearly 80% of the total insomnia market
commented:“Commercial efforts with QUVIVIQ in the EUCAN region are beginning to translate into promising success
Sales have shown a steady increase since the first launch in November 2022
with a recent acceleration – particularly driven by an outstanding launch in France and a great performance in Germany
This dynamic is expected to continue in the coming months as access expands in key European markets
We are also expanding our commercial reach from specialist prescribers to general practitioners through commercial partnerships such as Menarini in France and Berlin-Chemie in Germany.”
QUVIVIQ® (daridorexant) net sales in 2024 reached CHF 28.6 million in the US
almost 175,000 patients have been treated with QUVIVIQ since launch in the US
over 550,000 prescriptions have been dispensed
and the product has been prescribed by more than 51,000 healthcare professionals
President and General Manager of Idorsia US
we have implemented a change to the commercialization approach for QUVIVIQ with the objective to reduce operating costs while maintaining the sales
We are still hopeful that descheduling of the dual orexin receptor antagonist (DORA) class can be achieved and the real value of QUVIVIQ in the US market can be unlocked
instead of the around 100 field force sales reps we had before
data analytics and market access activities in support of the virtual representatives.”
For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide)
the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs
to lower blood pressure in adult patients who are not adequately controlled on other drugs
Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events
primarily strokes and myocardial infarctions
The recommended dosage of TRYVIO is 12.5 mg orally once daily
the US team rapidly established both the REMS program and specialty distribution channel
begun engaging with hypertension experts at major cardiovascular and nephrology congresses
and initiated encouraging discussions with payors
resulting in TRYVIO being made available for prescription in October 2024
Michael concluded:“TRYVIO has been available to prescribe to the millions of patients in the US whose high blood pressure is not adequately controlled by other drugs since October 2024
campaign and educational approach is now complete
although funding for a field sales force and promotional activities continues to be dependent on a partnership deal
we have started to execute a limited launch of TRYVIO in the US in order to maintain and increase the value of a potential out-licensing deal for aprocitentan.”
For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide)
Research & DevelopmentOur drug discovery engine has produced innovative drugs with the potential to transform the treatment paradigm in multiple therapeutic areas
The company also has a vaccine platform for the discovery and development of glycoconjugate vaccines to prevent infection
The company has focused its drug discovery efforts
reducing the number of active projects in research and development and preparing some for out-licensing
The prioritization has resulted in a portfolio of assets where Idorsia intends to develop to the next inflection point before partnering
The company expects new lucerastat data from a kidney biopsy sub-study (to the ongoing Phase 3 open-label extension study) in the second quarter of 2025
with further discussions on the regulatory pathway to follow
The results from a Phase 1 study of our Clostridium difficile infection vaccine are also expected in the coming months
The company will need to further prioritize activities in order to reduce costs and the decisions on which assets to advance will be taken based on the data when available and the results of ongoing out-licensing discussions for early-stage assets
Idorsia-led portfolioThe company will develop each asset to the next inflection point or seek a partner
Further details including the current status of each project in our portfolio can be found in our innovation fact sheet.Idorsia partner-led portfolioFor Idorsia
sophisticated partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline
We seek suitable external project partners to maximize the value of internal innovation
Aprocitentan is an innovative and highly differentiated drug
commercially available in the US and approved in Europe and UK for the millions of patients who are unable to bring their hypertension under control with existing medications
As the first drug to target the endothelin pathway in systemic hypertension
aprocitentan has blockbuster potential in uncontrolled hypertension
particularly for difficult to treat patients with chronic kidney disease and hypertension
The priority remains to partner aprocitentan
having been released from the exclusivity constraint with the undisclosed party
the company will resume discussions with alternative potential partners that recognize the value of aprocitentan
See the commercial operations section above
the European Commission (EC) approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products
The recommended dose is 12.5 mg orally once daily
The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control
For more information about JERAYGO in the EU, see the Summary of Product Characteristics
Further details including the current status of each project in our partner-led portfolio can be found in our innovation fact sheet
Human ResourcesIdorsia reduced 249 positions worldwide in 2024
bringing the total number of permanent employees to 689 (2023: 938)
Following a consultation process with employee representatives at headquarters in December 2024
a further reduction of approximately 250 positions globally was anticipated
The company has already begun the implementation of the restructuring and expects the cost reduction to be largely effective by Q2 2025
The total number of permanent employees who are not on notice at the end of February 2025 is 552
Financial ReportThe Financial Report 2024 is available at www.idorsia.com/annual-report
Annual ReportIdorsia's Annual Report 2024 – consisting of the Business Report
and Financial Report (already published today) – will be published on March 27
Note to ShareholdersThe Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31
Registered shareholders with voting rights individually or jointly representing at least 0.5% of the share capital of the company
being entitled to add items to the agenda of the general meeting of shareholders
Any proposal received after the deadline will be disregarded
In order to vote at the Annual General Meeting
shareholders must be registered in the company's shareholder register by May 19
Results Day CenterInvestor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: www.idorsia.com/results-day-center
About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science
The purpose of Idorsia is to challenge accepted medical paradigms
and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company
Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals
covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant)
a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients
Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA)
For further information, please contactInvestor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com
The above information contains certain "forward-looking statements"
which can be identified by the use of forward-looking terminology such as "estimates"
"pending" or "anticipates" or similar expressions
Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith
descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio
Such statements reflect the current views of the company with respect to future events and are subject to certain risks
Many factors could cause the actual results
performance or achievements of the company to be materially different from any future results
performances or achievements that may be expressed or implied by such forward-looking statements
Should one or more of these risks or uncertainties materialize
or should underlying assumptions prove incorrect
actual results may vary materially from those described herein as anticipated
After the three men’s and three women’s All-star Teams for the ‘IHF Beach Handball Showcase’ in Paris were announced last month we can now reveal the France men’s and women’s national team squads which will make up the eight teams and 64 players for the event that will highlight the spectacular sport and its culture
The two national teams will join the three men’s and three women’s All-star Teams playing games across three days – Saturday 27
Sunday 28 and Monday 29 July 2024 – at the headquarters of the FFHB
Joining All-star Teams coaches Leticia BRUNATI (Argentina)
Tamas NEUKUM (Hungary) and Alexander NOVAKOVIC (Germany) will be men’s coach Paul MOURIOUX and women’s coach Marion LIMAL
who won silver with the France women’s national (indoor) team at both the 2009 and 2011 IHF Women’s World Championships has named eight players
while Matilde AMELOT is at the other end of the scale and is set to make her debut at the showcase
“It’s an amazing way to promote Beach Handball,” said LIMAL to ihf.info about the event
“To be in Paris during the Olympic Games is a great opportunity to show how this sport can be spectacular
has named eight players from eight different clubs across France
AS Monaco goalkeeper Maxence GALAS is the oldest
while winger Aurélien AMBROGINI has just turned 18
“It’s an honour for France and for Beach Handball to be present during the Olympic Games and
it’s the first time for all participants to be in Paris,” explained MOURIOUX
it’s the first big step – we must be visible and accessible.”
IHF Beach Handball Showcase – France Teams
The ‘IHF Beach Handball Showcase’ is part of a wider series of celebrations in Créteil
based in the Val-de-Marne region of France
which will receive the Olympic Flame on its global tour
For the duration of the Olympic Games – July 26 to August 11 – a variety of free events will take place
including a fan zone for up to 2,000 people featuring live broadcasts
The IHF Beach Handball Showcase is a collaborative effort between the International Handball Federation (IHF)
Paris 2024 Organising Committee for the Olympic and Paralympic Games (COJOP2024)
French Handball Federation (FFHB) and International Olympic Committee (IOC)
had spent 20 years living in Copenhagen and looking for love in the hope of raising children
He recently took his quest online but was dismayed by the results
"I got frustrated with everyone trying to sell themselves as really active
always travelling or with a long list of hobbies but no mention of children," Limal said
there was an option to click saying: 'I'd like kids someday,' but you would read the person's profile and think: 'You will never have time!' If someone's going to the gym eight times a week and travelling every month
they are not putting a family first."
Limal has a six-year-old daughter from a previous relationship but coming from a big family – his father is one of 11 – he has always wanted more children
"I couldn't seem to meet anyone willing to prioritise starting a family and struggled with when to mention wanting kids any time I met someone new
It's the ultimate dating taboo," he said
"Then one day I read a profile from a 38-year-old who said she knew it was 'really bad to admit' but she wanted children
And I just thought: 'You shouldn't be ashamed of this.'"
Limal remortgaged his apartment to fund the setting up of Babyklar.nu – or Baby-ready now in English
It functions like a normal dating site but every potential dater is asked to be honest about their wish to start a family soon
"We ask people if they are OK with someone who already has children as well as wanting another baby," Limal said
"But we don't make them specify how many children they'd like
That would be a bit too much like grocery shopping online."
The response to the site has been overwhelming
"We had 50 sign-ups an hour when we launched in June and we are already hearing from couples who have met through the site and are now together
I'm fully expecting the first Babyklar.nu baby by next summer."
More men have signed up than women (53% to 47%)
with testimonials such as "It's so lovely to be able to say this out loud …" and "I finally dare to be honest about what I want."
The site has come at an opportune time for the country of 5 million people. Danes are not having enough babies, according to a report from the Copenhagen hospital Rigshospitalet, and the current rate of 1.7 children per family is not enough to maintain Denmark's population
The usual suspects are being blamed for the new low – women leaving it "too late" and couples cohabiting and waiting to start families
men and women who want to start a family but haven't met the right person yet will have another option," says Limal
He's keen to point out that this isn't just about baby farming: "I want this to be about children and love
My goal is to pair up people who really want a family and a partner – and who'll stay together
There are plans to roll out the site in France and the UK later this year
but for now it is the Danes who are reaping the benefits
"Danes have no problem having children before marriage so things can move fast
a Jutlander can date a Copenhagener without too much travel," Limal said
"I've met a nice woman and she wants a baby too – so we shall see."
2020Save this storySaveSave this storySaveFor this San Francisco–based couple
It all began with a year the wife spent abroad during college
With stunning views of both the Invalides and the Eiffel Tower
this gracious space immediately brings to mind the refrain “location
(The clients met Teze-Limal while they were in graduate school.) It didn't take them long
The couple knew they had found their perfect getaway after opening the door to this fifth-floor space in the middle of the elegant 7th arrondissement
It had great bones in a historic building that had been owned by the same person for the past 50 years
the couple called on designer Benjamin Wood to help them with the interiors
The clients had met him over 20 years ago in Sun Valley
But the team had their work cut out for them
“The place was entirely gutted and it took a few years
but it now has heating and air-conditioning,” Wood says
"They wanted to keep the Parisian 18th-century spirit but with all the modern aspects they were used to.” Fortuitously
who is based in Austin and has a pied-à-terre in the City of Light
was working on another project nearby when the couple contacted him
active professionals with other residences
the key was to make it feel like home but retain its sense of place
“They are curious people and collect photography,” Wood remarks
pointing to a painting of Versailles by Robert Polidori
one of several works he helped acquire for the two-bedroom
When an additional service room on the floor above became available
they combined floors and added a charming library upstairs
“I wanted to help them create some memories," says the English-American creative
noting special touches like a Christofle tea set found at the Paris flea market and a guest room appointed with paperback books about the metropolis
Two smaller rooms above the apartment's main floor allowed for additional space to create this library with amazing views over the Invalides esplanade
1 / 8ChevronChevronThis article first appeared in AD US
The material on this site may not be reproduced
except with the prior written permission of Condé Nast
Metrics details
The aim of this study was to describe serum GH
and IGF binding protein (BP) 3 levels at birth and during the first 2 y of life in intrauterine growth-retarded (IUGR) children and to correlate these hormonal values with auxologic parameters noted during this period to investigate their predictive value on the postnatal growth pattern
Three hundred and seventeen children were included at birth and studied for auxologic and biologic parameters at birth
when analyzed according to gestational age
serum GH levels were increased(p = 0.0001) and serum IGF-I and IGFBP3 levels were decreased(p = 0.0001) in IUGR as compared with normal neonates
When two cohorts were established at birth as a function of the ponderal index (PI)(≤ or >3rd percentile)
serum IGF-I and IGFBP3 levels were found to be significantly reduced in the case of low PI
All parameters were within normal limits at 1 mo of age and remained normal thereafter
a positive correlation was found between IGF-I increment and weight gain(r = 0.28
None of the biologic parameters at birth were predictive either of later growth or of short stature at 2 y of age
low serum IGF-I and IGFBP3 levels at birth were related to fetal malnutrition and were not predictive parameters for later growth
Although a decrease in the amount of IGFBP3 was found in cord sera from human neonates with IUGR
the serum concentration of GH-dependent IGFBP3 at birth and during the catch-up growth period has never been described in cases of IUGR
To elucidate any hormonal abnormalities at birth due to IUGR and to identify any parameters which could be useful in predicting later growth
and IGFBP3 levels in the cord blood of both preterm and full-term newborn infants showing IUGR
and IGFBP3 levels as well as their auxologic status during the first 24 mo of life
They were subjected to blood sampling for routine examinations at 3 d
false positive cases in our screening program
who undergo blood sampling for free health examination
served as the control group for the 12- and 24-mo-old children
Supine length (height) measurements required two observers and were made twice at each time of recording with the infants
with the head on the midline and the knees extended
on a neonatometer (Harpenden produced by Holtain Ltd.)
The asymmetric IUGR group was defined as having a birth weight of <-2SDS but height > -2 SDS and the symmetric IUGR group as being < -2 SDS for both body weight and height according to the gestational age at birth
Two groups were constituted according to a PI ≤ or >3rd percentile at birth
Historic high risk factors and high risk factors that developed during gestation were recorded at birth during the recruitment
Blood samples were collected during the study at any time of the day
and the sera were stored at -20 °C until assayed
The serum GH concentration (ng/mL) was measured on a single sample by RIA using a solid phase two-site immunoradiometric assay (Elsa-hGH
Standards were calibrated against as international standard(1st IRP 66/217)
The polyclonal IGF-I antiserum used in the RIA was kindly provided by P
The within-run coefficients of variation were 5.5 and 8.8%
respectively for the middle (137 ng/mL) and low values (85 ng/mL)
and the between-run coefficients of variation were
and low values (from 62.5 ng/mL) (concentration values after dilution)
The mean within and between run coefficients of variation were 3.5 and 6.5%
All results were expressed as the mean± SD
Statistical analysis was performed using paired and unpairedt tests and the Mann-Whitney U test
Correlations between variables were assessed using linear regression analyses
Comparisons of group mean parameter estimates were made using analysis of variance
Multivariate linear regression analysis was used to study differences in hormonal levels and child growth status (IUGR or appropriate for gestational age) adjusted for gestational age
NJ) software running under OS2 on a compaq Deskpro 486/33 M microcomputer was used
The study was reviewed and approved by the faculty ethical committee
It was explained to each parent who signed a written consent
Description of the cohort. Characteristics of the IUGR and control newborn infants are indicated in Table 1
Among the 317 IUGR newborns included in the study
105) were studied for hormonal evaluation at birth
The mean gestational age was 37.6 ± 2.5 wk
and 32% were preterm newborn (<37 wk gestational age)
Factors associated with IUGR included pregnancy-induced hypertension (n = 67)
congenital anomalies or chromosomal abnormalities (n= 26)
and maternal short stature (<152 cm)(n = 13)
Medical indications of risk associated with growth status at birth such as low Apgar score (≤ 7 at 1 min of life) (n = 60) were assessed
53% were symmetrically IUGR for height and weight
The PI was normal (>3rd percentile) for 62% and low (≤3rd percentile) for 38% of the infants
An auxologic description of the entire cohort and part of that cohort only in those cases submitted to hormonal evaluations is reported inTable 2
and the number of cases of each group are indicated
Not all biologic parameters and growth measurements were available on every child at each time because of noncompliance of the families either in the blood sample collection and/or in the long-term follow up
No significant differences among these groups were found for gestational age
and the auxologic data either at birth or during follow-up
Short stature (height ≤ -2 SDS) was observed in 8% of the subjects of the entire cohort studied at 2 y of age
IGF-I and IGFBP3 levels at birth according to the gestational age and growth status in IUGR (•) compared with normal neonates (○) [linear regression lines were shown with 95% CL for mean (- - - - - -); — for intrauterine growth-retarded neonates
Multivariate linear regression analysis was made on log values
Log GH = 4.37 - 0.037 gestational age + 0.63 growth status
Log IGF-I = 1.86 + 0.06 gestational age - 0.996 growth status.F = 63.86
Multivariate model on log binding protein 3 values was not significant as no relation with gestational age was found
Serum IGFBP3 were significantly reduced in case of IUGR (F = 14.51
demonstrated significantly higher serum GH levels (r = 0.37
p = 0.0001) and lower serum IGF-I levels (r = 0.53
p = 0.0001) in IUGR neonates compared with controls according to gestational age
Serum IGFBP3 levels were significantly lower in IUGR as compared with controls(r = 0.32
p = 0.0001) with no relation to gestational age
Wide individual variations were observed for all hormonal parameters in IUGR and control groups
In IUGR infants a significant correlation was found between serum IGF-I levels and birth weight (r = 0.20
Separate analysis of the hormonal data from neonates for each of the known causes of IUGR
and for the asymmetricversus the symmetric for height group
revealed no differences for the hormonal parameters at birth
When considered as a function of gestational age
serum IGF-I and IGFBP3 levels were significantly lower in cases where the PI was below the 3rd percentile than in those in which the PI was ≥3rd percentile (IGF-I,p = 0.004; IGFBP3
For all the subjects(premature and term infants)
26± 18 ng/mL versus 35 ± 23 ng/mL and the mean serum IGFBP3 level was 1.0 ± 0.6 μg/mL versus 1.3 ± 1.0μg/mL for neonates with PI < 3rd percentile compared with neonates with PI ≥ 3rd percentile
Serum IGF-I levels were also significantly lower in cases showing a low Apgar score at 1 min of life (≤7) than in those showing an Apgar score >7 (p = 0.0001) with
a mean serum IGF-I level at 23 ± 17 versus 34 ± 22 ng/mL
all biologic parameters had attained normal levels up to 24 mo of life
As shown in Table 4
when data are analyzed in IUGR children whose height was ≤ -2 SDS compared with IUGR children whose height was > -2 SDS at 2 y of age
the mean serum IGF-I level was found to be significantly reduced only in children with short stature at 2 y of life (50± 18 versus 101 ± 43 ng/mL; p = 0.03)
no significant difference in hormonal parameters was observed as a function of low (≤ -2 SDS) or normal (> -2 SDS) body mass index
which represents an index of nutritional state in postnatal life
A correlation was found between serum IGF-I and IGFBP3 levels at each studied period (at birth: r = 0.52
p = 0.0001) and between serum GH and IGFBP3 levels at birth (r = 0.41
No statistically significant correlation was found between GH and IGF-I levels at any age
Correlation between the increase in the serum IGF-I levels and weight gain during the first 3 mo of life in IUGR children (linear regression line with 95% confidence level for the mean; gain IGF-I = 18.26 + 12.78 weight gain SDS
Our study is in accordance with these results and documents a decrease of cord serum IGFBP3 levels measured by RIA in IUGR compared with normal neonates
This demonstrates that the IGF-binding protein which modulates IGF activity
may play a major role in the regulation of fetal growth in relation with the growth and the metabolic status of the fetus
which in part reflects the efficacy of transplacental nutrient transfer and placental perfusion
These findings are in marked contrast with those of the majority of other investigators and concern very small groups of infants observed at birth or during the first days of life
The reason for this discrepancy is not obvious
More precise measurement of serum GH-binding protein levels is needed to study their respective values in IUGR compared with appropriate weight for age neonates
Lowered serum IGF-I and IGFBP3 levels were found in IUGR infants showing a low PI
suggesting that intrauterine nutrition influences the levels of these parameters
We can speculate that deficient substrate transfer to the fetus for any given reason might be responsible for both depressed IGF-I synthesis and subsequent growth retardation
The results of such studies strongly suggest that nutritional intake is of great importance in the regulation of IGF-I synthesis
This study allows a better description of the endocrine status in neonates and during the first 2 y of life in IUGR and appropriate weight for age children
Abnormal levels of serum IGF-I and IGFBP3 were related to nutritional factors control ling growth
Study Group of IUGR includes pediatric clinics: Y
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JULIANE LEGER, MICHÈLE NOEL, JEAN MARIE LIMAL, PAUL CZERNICHOW, on behalf of the Study Group of IUGRFootnote 1
This work was presented in part at the Fourth Joint Meeting of the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology
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DOI: https://doi.org/10.1203/00006450-199607000-00018
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Reproductive Biology and Endocrinology (2014)