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Helsinn to co-host alongside Recordati Rare Diseases satellite symposium on MF-CTCL diagnosis optimization at European Academy of Dermatology and Venereology Congress 2019

Lugano, Switzerland, Puteaux, France, October 9, 2019 Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces it will be co-hosting alongside Recordati Rare Diseases, a worldwide leader in rare diseases and orphan drugs, part of Recordati Group, a satellite symposium at the 28th European Academy of Dermatology and Venereology (EADV) Congress, held this year in Madrid from 9 – 13 October 2019.

The symposium will be co-hosted alongside Recordati Rare Diseases and will be entitled: An MF-CTCL path free of potholes: avoiding misdiagnosis and optimizing the patient journey. The event will take place at 17:00–18:30 on 10 October 2019 in Room N115–116, North Convention Centre, IFEMA – Feria de Madrid.

This symposium will bring together three experts (Emmilia Hodak, Pablo Ortiz-Romero, Pietro Quaglino) involved in the treatment of Cutaneous Lymphoma who will give an overview on Mycosis Fungoides-type Cutaneous T-cell Lymphoma (MF-CTCL). Additionally, they will discuss on the patient journey, particularly focusing on diagnosis and occurrences of misdiagnosis. There will also be a discussion around the real-world experience with chlormethine gel (Ledaga®) and how it can be used in the treatment of MF-CTCL.

The full agenda is available at the following link:


Dr Silvia Sebastiani, Helsinn Head of Medical Affairs, commented: “We are pleased to be hosting a symposium alongside our partner Recordati Rare Diseases in order to raise awareness and stimulate debate on how to optimize the diagnosis of MF-CTCL, whose delay has a devastating impact on patient’s quality of life.

“As specialist in rare disease, at RRD we know how important it is, even with an efficient drug such as Ledaga® to support more than only the treatment of the disease. This is part of our responsibility as leading company in Orphan diseases” said Dr Céline PLISSON Global Medical Director from RRD “and we are pleased to have the opportunity to help patients and physicians to better manage this rare and psychologically heavy pathology”.

Pablo Ortiz-Romero, MD, PhD, Hospital Universitario 12 de Octubre, Madrid, Spain and Chair of the Symposium said: “One of the issues with MF-CTCL is that it can be very hard to diagnose as each patient often presents different symptoms and MF-CTCL frequently mimics other skin conditions. Helsinn and Recordati Rare Diseases have come together to co-host this symposium today so together we can highlight this disease and help educate patients and clinicians about the signs, symptoms and treatment options that will, ultimately, help patients get better treatment and give them a better quality of life.”

About Ledaga®

Ledaga® gel is an alkylating drug indicated for the topical treatment of MF-CTCL in adult patients. Ledaga® is a gel which is applied topically once a day. The drug has been approved by the European Commission (for the treatment of MF-CTCL in adult patients). Since June 2019, Ledaga® is commercialized in Germany, The Netherlands, France and Italy.

For additional information please see the EU Summary of Product Characteristics.

About Mycosis Fungoides

Mycosis fungoides (MF) accounts for almost 60% of all primary cutaneous T-cell lymphomas, a form of non-Hodgkin’s lymphoma. The cause of MF remains unknown and there are no curative treatments. MF has an indolent clinical course, slowly progressing from patches to thicker plaques and eventually to tumours over years or decades. Signs include rash, patch and plaques with severe itch. MF typically affects older adults (median age at diagnosis: 55-60 years) with male predominance. However, people of all ages can be affected. Depending on the stage and diagnosis at presentation, life expectancy can vary from less than five years after diagnosis to full life expectancy. Evidence from seven global studies (US, n = 4; Europe, n = 3) indicated that the incidence of CTCL has increased over time, reaching 10 cases per million individuals per year.

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco and China, as well as a product presence in approximately 190 countries globally.

To learn more about Helsinn Group please visit www.helsinn.com

About Recordati

Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with atotal staff of more than 4,100, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations throughout the whole of Europe, including Russia, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases. Consolidated revenue for 2018 was € 1,352.2 million, operating income was € 442.2 million and net income was € 312.4 million

Recordati Rare Diseases, a part of the Recordati Group, is a pharmaceutical company that provides treatment for patients with rare diseases. Created in 1990, Recordati Rare Diseases is one of the most active companies in the field of rare diseases. At Recordati Rare Diseases, we focus on the few – those affected by rare diseases. We believe that every single patient has the right to the best possible treatment. Patients with rare diseases are our top priority. They are at the core of our planning, our thinking and our actions.

Our specialty rare disease products are marketed directly by Recordati Rare Diseases in Europe, the Middle East, the U.S.A., Canada, Russia, Japan and Australia, in some Latin American countries, and through selected partners in other parts of the world.

For more information:

Helsinn Group Media Contact

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

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For more information, please visit www.helsinn.com and follow us on Twitter, LinkedIn and Vimeo

Recordati Rare Disease contact

Global Medical Director

Dr Céline Plisson

(33) 1 47 73 64 58

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For further information visit :

Recordati website at www.recordati.com

Recordati Rare Diseases website at www.recordatirarediseases.com

Statements contained in this release, other than historical facts, are “forward-looking statements” (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company’s control. Hence, actual results may differ materially from 5

those expressed or implied by such forward-looking statements. All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company’s activities and are not intended to indicate the advisability of administering any product in any particular instance