Helsinn Group and Chugai Pharma Marketing Enter Into Agreement for Marketing Rights of Netupitant-Palonosetron Fixed-Dose Combination (NEPA) in the UK and Ireland and for Palonosetron Monotherapy in the UK

July 17, 2014

LUGANO, Switzerland and TOKYO, July 17, 2014 /PRNewswire/ –

Under the exclusive agreement, Chugai Pharma Marketing gains rights for the marketing
of palonosetron in the UK and NEPA in the UK and in Ireland from Helsinn Group,
strengthening the existing alliance between the companies in therapeutic area of
supportive cancer care.

Helsinn, the Swiss Group focused on building quality cancer care, and Chugai
Pharmaceutical Co., Ltd. today announced that exclusive rights to NEPA, an investigational
oral fixed-dose combination of netupitant and palonosetron being evaluated for the
prevention of chemotherapy-induced nausea and vomiting (CINV), have been granted to Chugai
Pharma Marketing Ltd., a wholly owned subsidiary of Chugai, in the UK and Ireland. Chugai
has also been granted the exclusive right to market the palonosetron monotherapy, Aloxi,
in the UK as from January 1st, 2015.

NEPA is a fixed-dose combination of a novel NK1receptor antagonist (Netupitant) and
the best-in-class 5-HT3receptor antagonist palonosetron. It is currently in the
registration phase in both the USA and Europe for the prevention of Chemotherapy Induced
Nausea and Vomiting (CINV) in humans in the oncology field.

One of the components of NEPA is palonosetron, the market-leading treatment for CINV
in patients with cancer. Palonosetron worldwide sales in 2013 were around USD 625 million
(IMS data). The product is marketed and available in over 65 countries worldwide under the
brand names of Aloxi(R), Onicit(R)and Paloxi(R).

In the phase 2 and phase 3 clinical trials NEPA demonstrated that it provides a
significant improvement in the prevention of acute and delayed CINV when compared to oral
palonosetron. Clinical data have been published in peer reviewed medical journals and
presented in several international congresses such as the American Society of Clinical
Oncology (ASCO) and the Multinational Association of Supportive Care in Cancer (MASCC).

Chugai is already one of Helsinn’s partners for anamorelin, a new first-in-class, once
daily ghrelin receptor agonist, currently in phase 3 trials for the treatment of Cancer
Anorexia Cachexia Syndrome (CACS) in non-small cell lung cancer, in seven EU countries
including Germany, France, Belgium, Netherlands, Luxemburg, the UK and Ireland.

Under the terms of the new agreement, Helsinn retains all development activities and
the supply of both NEPA and palonosetron for commercial use, as well as regulatory and
clinical development. Chugai will be responsible for all marketing activities in the
designated territories.

Riccardo Braglia, CEO of Helsinn Group, said: “Helsinn is delighted to sign this
additional agreement with Chugai, extending our scope of work to the area of CINV on top
of our agreement in CACS. To be able to work with the same partner in the UK and Ireland
helps us to create significant synergies across these regions when marketing the products.
This agreement will allow Helsinn’s products to reach more cancer patients and help to
deliver a better quality of life*. It is rare that patients only suffer a single side
effect from chemotherapy and this alliance means that we can offer physicians a wider
choice of products, to treat patients and help them achieve a better quality of life and
potentially better outcomes.”

Chugai’s continuing partnership with Helsinn has led to further collaborations in the
European market and we are pleased with the announcement that Chugai will introduce
Helsinn’s novel new treatment for the treatment of CINV, NEPA in the UK and Ireland. In
addition to NEPA, Aloxi, an important drug for the prevention of CINV, will now be
distributed in the UK by Chugai from 2015. Chugai has a strong presence in the oncology
supportive care market in the UK and Ireland, and the future addition for Helsinn’s novel
medicines with strong supporting data will enhance our presence in this field giving
physician and patients more treatment choices’ said John Halls, Managing Director of
Chugai Pharma Marketing.

* Lorusso V et al. Support care Cancer 2009; 17(12): 1469-73

Notes to editors

About Netupitant 300 mg + Oral Palonosetron 0.50 mg (NEPA)

NEPA is currently under review by the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA). NEPA is an investigational single-day, oral, fixed-dose
combination of a selective NK1 receptor antagonist, netupitant, and a 5-HT3receptor
antagonist, oral palonosetron, believed to target two critical signaling pathways
associated with CINV.

About the Helsinn Group

Helsinn is a family run, privately owned pharmaceutical group focused on building
quality cancer care with a large portfolio of products. Founded in 1976 with headquarters
in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the USA and a
representative office in China. Helsinn’s business model is focused on the licensing of
pharmaceuticals, medical devices and nutritional supplement products in the therapeutic
area of cancer care.

Helsinn Group in-licenses early-to-late stage new chemical entities, completing their
development by performing pre-clinical/clinical studies as well as associated
manufacturing activities. Helsinn then prepares necessary regulatory filings in order to
achieve marketing approvals worldwide. Helsinn’s products are out-licensed to its global
network of marketing and commercial partners that have been selected for their local
market knowledge. Helsinn supports these partners by providing a full range of product and
scientific management services, including commercial, regulatory, and medical marketing
advice. Helsinn has built a large product portfolio of cancer care products with the
alliance of over 65 global partners. In March 2013, Helsinn established a new commercial
organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct
direct sales and marketing activities within the U.S. market. Helsinn’s products are
manufactured according to the highest quality, safety, and environmental standards at
Helsinn’s GMP facilities in Switzerland and Ireland from where they are then supplied
worldwide to customers. Further information on Helsinn Group is available at
http://www.helsinn.com [http://www.helsinn.com/%20/t%20_blank ]

About Chugai Pharma Marketing

Chugai Pharma Marketing Ltd. is the headquarters of all Chugai’s commercial activities
throughout Europe and coordinates the European marketing operations through subsidiaries
located in the UK, France, and Germany. Products which are currently marketed in those
countries include “RoActemra(R) (tocilizumab)”, a humanized anti-human IL-6 receptor
monoclonal antibody, “Granocyte(R)(lenograstim)”, a G-CSF preparation, and “Antepsin(R)(
sucralfate)”, an antiulcer agent (marketed in the UK and Ireland).


About Chugai

Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical
companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in
prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange.
As an important member of the Roche Group, Chugai is actively involved in R&D activities
in Japan and abroad. Specifically, Chugai is working to develop innovative products which
may satisfy the unmet medical needs, mainly focusing on the oncology area.

In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to
develop new pharmaceuticals and Ukima is conducting research for technology development
for industrial production. Overseas, Chugai Pharmabody Research was established in
Singapore in January 2012 for conducting research focusing on the generation of new
antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering
technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical
development activities in the United States and Europe.

The consolidated revenue in 2013 of Chugai totaled 423.7 billion yen and the operating
income was 79.9 billion yen. We are aiming at the consolidated revenue of 451.0 billion
yen and operating profit of 71.0 billion yen in IFRS core basis, in 2014.

Additional information is available on the Internet at


        For more information, please contact:
        Helsinn Group
        Paola Bonvicini
        Head of Communication & Press Office
        Tel: +41-91-985-21-21
        For media/ external inquiries
        Consilium Strategic Communications
        Mary-Jane Elliott / Jessica Hodgson / Matthew Neal / Laura Thornton

        Chugai pharmaceutical Co., Ltd.
        Corporate Communications Dept.
        Media Relations Group
        Tel: +81(0)3-3273-0881

SOURCE Helsinn Group

Source: PR Newswire

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