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Helsinn and Recordati Rare Diseases to announce satellite symposium on advances in Mycosis Fungoides-Cutaneous T cell Lymphoma (MF-CTCL) treatment at the 49th European Society for Dermatological Research Annual Meeting 2019

Lugano-Switzerland, Puteaux-France, September 19 2019 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and Recordati Rare Diseases, a worldwide leader in rare diseases and orphan drugs and part of Recordati Group, today announce that a co-sponsored Symposium, organized by the two companies at the European Society for Dermatological Research (ESDR) Annual Meeting, (Bordeaux, France 18-21 September 2019), will provide a better knowledge of Chlormethine Gel’s mode of action as well as guidance on the management of the Chlormethine gel induced dermatitis.

The satellite symposium entitled “A deep dive into chlormethine gel: “From bench to patientswill take place at 08:30-09:30 am CEST on 20 September 2019 in Amphitheatre B, Bordeaux Congress Centre.

The Symposium will be chaired by Emmanuella Guenova, MD, PhD (CH), and co-chaired by Brian Poligone (USA), MD, PhD. The event will provide the audience with an overview of Ledaga® (Chlormethine Gel) as a novel treatment option for Mycosis Fungoides-type Cutaneous T-cell Lymphoma (MF-CTCL), with a focus on the mechanism of action. Additionally, key learning points regarding the management of Ledaga® (Chlormethine Gel) induced dermatitis in MF-CTCL, will be widely discussed. Lastly, there will be an open discussion and the opportunity for experts to share their experiences with the attendees.

The full symposium agenda is available here: http://esdrmeeting.org/index.php/sessions/helsinnrecordati-symposium/

“We are very pleased to have the support of the Helsinn Group and Recordati Rare Diseases in bringing together an expert panel at the ESDR annual meeting, and to have built up a stimulating and educational symposium”, said Emmanuella Guenova, MD, PhD (CH). “Over half of CTCL patients are diagnosed with MF-CTCL, and there is yet no ultimate treatment for this rare indolent skin cancer. This symposium will be important for a better understanding of the research status on the mechanism of action of chlormethine as well as on the management of chlormethine induced dermatitis in MF-CTCL patients.”

Dr Silvia Sebastiani, Head of Medical Affairs at Helsinn, commented: “Our focus at Helsinn remains to improve the quality of life of those affected by cancer, so we are delighted be co-supporting a satellite symposium to explore the area of MF-CTCL alongside our partner, Recordati Rare Diseases. The symposium will allow the attendees to garner knowledge on the mechanism of action of chlormethine gel and its role in MF-CTCL therapeutic armamentarium.”

“As specialized in orphan diseases we are pleased, through this partnership with Helsinn, to have the opportunity to support a new patient community whose disease has still important unmet treatment needs”, said Dr Céline Plisson, Global Medical Director at RRD. “We hope Ledaga® will be a step ahead for MF-CTCL patients management and improvement of 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 with a median of 18years. 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 a total 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

Tel : (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 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