Tag Archives: information

Diurnal: The Market Authorization Application for Alkindi® is submitted to Swissmedic | Instant News


Posted on Wednesday, 21 / Oct / 2020 Posted by michelle

Swiss partner EffRx Pharmaceuticals expects a market launch in 2022

Diurnal Group plc (AIM: DNL), a specialized pharmaceutical company targeting the needs of patients in chronic endocrine (hormonal) diseases, announced that the Company’s marketing and distribution partner in Switzerland, EffRx Pharmaceuticals (EffRx), has submitted a Market Authorization Application (MAA) to Swissmedic for Alkindi registration® (hydrocortisone granules in capsules for opening) in Switzerland.

MAA submission to Swissmedic for Alkindi® based on European regulatory files and published clinical trial data, with EffRx expecting a potential market launch in Switzerland by 2022.There are about 200 patients in Switzerland with pediatric AI, providing an estimate of the total market opportunity for Alkindi® about $ 1 million per year. As previously announced under the terms of the agreement, EffRx will receive the exclusive rights to market and sell Alkindi® in Switzerland once registered.

Alkindi® approved and marketed in Europe and is the first hydrocortisone preparation (synthetic version of cortisol) specifically designed for use in children with AI, including CAH-related conditions.

Diurnal will provide EffRx with products for sale from an established European supply chain and are part of the Company’s ongoing strategy for commercialization of its main products by optimizing market access outside of Europe’s main markets through marketing and distribution agreements with niche-focused and orphaned companies. condition.

Martin Whitaker, CEO of Diurnal, comments:

‘We are very pleased to see the MAA submission for Alkindi® in Switzerland by EffRx. Today’s announcement is a further validation of the quality of our products and extends Alkindi’s future availability® outside our core markets in line with our global strategy. We look forward to working with EffRx to create Alkindi® available to patients suffering from pediatric AI in Switzerland. ‘

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

For more information, please visit www.diurnal.co.ukor contact:

Diurnal group plc +44 (0) 20 3727 1000
Martin Whitaker, Executive Director
Richard Bungay, Director of Finance

Panmure Gordon (UK) Limited (Nomination Advisor and Joint Brokerage) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Broking Company: Rupert Dearden

Consultation FTI +44 (0) 20 3727 1000
Simon Conway
Victoria Foster Mitchell

Notes to Editors

About Alkindi® (hydrocortisone granules in capsules for opening)
Alkindi® is the first hydrocortisone preparation specifically designed for use in children with pediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediately released hydrocortisone formulation for children in a capsule for the opening that allows age-appropriate dosing in children. This therapeutic approach has the potential to help young patients aged less than eighteen who suffer from cortisol deficiency diseases including AI in children and congenital adrenal hyperplasia (CAH). AI requires lifelong treatment and Diurnal’s new approach to product development has the potential to significantly improve the lives of young patients. The European Commission has granted a pediatric use marketing authorization (PUMA) for Alkindi® as replacement therapy for AI in infants, children and adolescents (from birth to

Alkindi® also approved in Israel and Australia.

Alkindi® known as Alkindi® Sprinkle in the US and approved by the US Food and Drug Administration (FDA) on September 29, 2020.

About Pediatric Adrenal Insufficiency
AI in children, including the genetic condition CAH is a condition characterized by a deficiency of cortisol, an essential hormone in the regulation of metabolism and response to stress. The main symptom of AI is chronic fatigue and patients are at risk for adrenal crisis and death if they are not given adequate cortisol replacement. AI is primary or secondary, with primary AI due to disease intrinsic to the adrenal glands and AI secondary to pituitary disease where there is failure of adrenal stimulation by the pituitary of the signaling hormone ACTH (adrenocorticotropic hormone).

About Diurnal Group plc
Founded in 2004, Diurnal is a European specialty pharmaceutical company headquartered in the UK that develops high quality products for the global market for the lifelong treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, and hypogonadism. Her expertise and innovative research activities focus on circadian-based endocrinology to produce new product candidates in the arena of rare and chronic endocrine diseases.

For more information about Diurnal, please visit www.diurnal.co.uk

About EffRx Pharmaceuticals
EffRx Pharmaceuticals is a commercial-stage pharmaceutical company focused on the late-stage development and commercialization of prescription drugs for special indications and orphanages. The business model is centered on providing superior clinical and commercial value propositions for clinicians, payers and patients. EffRx is pro-actively exploring licensing opportunities for Europe in the specialty therapy field, with particular interest for rare diseases, for which EffRx has received the FDA’s orphaned drug (ODD) designation for pipeline assets.

For more information on EffRx Pharmaceuticals, please visit www.effrx.com

Preparation date: October 2020 Code: CORP-GB-0087

See the pdf document: The Market Authorization application for Alkindi® was submitted to Swissmedic

Rejection

Diurnal group plc publish this content on 21 October 2020 and take full responsibility for the information contained therein. Distributed by the Public, unedited and unaltered, at October 21 2020 06:09:05 UTC

.



image source

BRAZIL WANTS CHINESE SYNOVAC VACCINE IN NATIONAL IMMUNIZATION PROGRAM, WITH ASTRAZENECA, Says GOVERNOR MARANHAO DINO | Instant News


20/10/2020 | 15.07 EDT

BRAZIL WANTS CHINESE SYNOVAC VACCINE IN NATIONAL IMMUNIZATION PROGRAM, WITH ASTRAZENECA, Says GOVERNOR MARANHAO DINO

All news about EURO / BRAZILIAN REAL (EUR / BRL)

EURO / BRAZILIAN REAL (EUR / BRL) chart
Duration:

Point:

Euro / Brazilian Real (EUR / BRL) Technical Analysis Chart |  MarketScreener

EURO / BRAZILIAN REAL (EUR / BRL) technical analysis trends

Short-term Medium-term Long-term
Trends Bullish Bullish Bullish

.



image source

BRAZIL WANTS CHINESE SYNOVAC VACCINE IN NATIONAL IMMUNIZATION PROGRAM, WITH ASTRAZENECA, Says GOVERNOR MARANHAO DINO | Instant News


20/10/2020 | 15.07 EDT

BRAZIL WANTS CHINESE SYNOVAC VACCINE IN NATIONAL IMMUNIZATION PROGRAM, WITH ASTRAZENECA, Says GOVERNOR MARANHAO DINO

All news about EURO / BRAZILIAN REAL (EUR / BRL)

EURO / BRAZILIAN REAL (EUR / BRL) chart
Duration:

Point:

Euro / Brazilian Real (EUR / BRL) Technical Analysis Chart |  MarketScreener

EURO / BRAZILIAN REAL (EUR / BRL) technical analysis trends

Short-term Medium-term Long-term
Trends Bullish Bullish Bullish

.



image source

STATE GOVERNMENT SAO PAULO SAYS BRAZIL’S HOPE TO START NATIONWIDE IMMUNIZATION WITH SINOVAC Vaccine IN JANUARY 2021 | Instant News


20/10/2020 | 15.20 EDT

STATE GOVERNMENT SAO PAULO SAYS BRAZIL’S HOPE TO START NATIONWIDE IMMUNIZATION WITH SINOVAC Vaccine IN JANUARY 2021

All news about EURO / BRAZILIAN REAL (EUR / BRL)

EURO / BRAZILIAN REAL (EUR / BRL) chart
Duration:

Point:

Euro / Brazilian Real (EUR / BRL) Technical Analysis Chart |  MarketScreener

EURO / BRAZILIAN REAL (EUR / BRL) technical analysis trends

Short-term Medium-term Long-term
Trends Bullish Bullish Bullish

.



image source

Ultima Capital: intends to acquire new extraordinary properties in Gstaad, Switzerland | Instant News


PERS CONFERENCE

Ultima Capital SA intends to acquire a fabulous new property in Gstaad, Switzerland

Switzerland, 15 October 2020 – Ultima Capital SA (BX: ULTIMA; “Ultima”), an owner and developer of luxury Swiss real estate, has signed an exclusive purchase agreement for the acquisition of “The Chesery”, an iconic chalet in the pedestrian area of ​​Gstaad, Switzerland.

Once acquired, “The Chesery” will benefit from a major renovation program and will further be entrusted to ULT Management Holding SA, which has managed Ultima Gstaad Hotel & Residences.

About Ultima Capital SA

Ultima Capital SA owns and develops a portfolio of 42 hotels, residences, chalets, villas and plots across 15 properties. Ultima Group’s business activities include long-term direct or indirect ownership of luxury properties, located in well-known ski resorts in Switzerland (Gstaad, Schönried, Crans-Montana), in France (Cannes, Courchevel, Megève) while other properties are located in the City area Geneva and in Greece (Corfu).

The Company’s shares are traded on the Swiss BX exchange in Switzerland under the ticker symbol ‘ULTIMA’ (Swiss Security number 49106400, ISIN: CH0491064009).

Media:

Investors:

Private Consulting Firm (CPC), Geneva

Ultima Capital SA

Toomas Kull: +41 76748 01 74

Margaux Hirzel, Investor Relations

Nick Miles: +41 79 678 76 26

[email protected]

CPC: +41 22 552 46 46

[email protected]

Rejection

This communication express or implies certain forward-looking statements about ULTIMA CAPITAL SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievement of ULTIMA CAPITAL SA to be materially different from the stated future results, performance or achievements or implied by the forward-looking statement. ULTIMA CAPITAL SA provides this communication from this date and does not update the forward-looking statements contained herein as a result of new information, future events or otherwise.

Page 1 / 1

This is an excerpt from the original content. To continue reading, access the original document here.

Rejection

Ultima Capital SA publish this content on 15 October 2020 and take full responsibility for the information contained therein. Distributed by the Public, unedited and unaltered, at October 15 2020 05:29:08 UTC

.



image source