Helsinn and Kyowa Kirin Asia Pacific sign exclusive license and 
distribution agreement to strengthen their presence in Asia Pacific's 
rare disease therapy area 
 
   Lugano, Switzerland, and Singapore, December 1, 2020 - Helsinn Group 
("Helsinn"), a Swiss pharmaceutical group focused on building quality 
cancer care and rare diseases products, and Kyowa Kirin Asia Pacific 
("Kyowa Kirin"), part of Japan-based global specialty pharmaceutical 
company, Kyowa Kirin Co Ltd, announced today the signing of an exclusive 
license and distribution agreement in China for VALCHLOR(R) 
(chlormethine, also known as mechlorethamine) gel 0.016%, a topical 
treatment of mycosis fungoides-type cutaneous T-cell lymphoma 
("MF-CTCL"), which is currently under review by the China National 
Medical Products Administration ("NMPA"). 
 
   Under the terms of the licensing and distribution agreement, Helsinn 
will grant Kyowa Kirin an exclusive license to distribute, promote, 
market, and sell VALCHLOR(R) in China. Helsinn will be responsible for 
clinical development, regulatory activities, and the supply of 
VALCHLOR(R) for commercial use in China. 
 
   About the Disease MF-CTCL 
 
   Mycosis fungoides is the most common form of cutaneous T-cell lymphoma. 
It is a rare disease with about 30,000 diagnosed patients in the world 
and accounts for approximately 45% of primary cutaneous lymphomas(1) . 
According to a large population-based cohort study and a retrospective 
5-year review(2,3) the MF-CTCL annual incidence rate in Asia Pacific 
ranges between 0.62-0.65/100,000 suggesting that MF-CTCL is generally a 
rare disease among Asians and Caucasians alike. 
 
   Dr. Riccardo Braglia, Helsinn Group CEO and Vice President, commented, 
"We are very pleased to have signed this license agreement with Kyowa 
Kirin for the distribution of VALCHLOR(R) in China, which is an 
important milestone for us and for MF-CTCL patients globally. Kyowa 
Kirin has a strong and established presence in this important market, 
which coupled with our shared vision and commitment to improving the 
lives of cancer patients, makes it the ideal partnership for Helsinn. We 
are looking forward to working closely in partnership with Kyowa Kirin 
in order to make VALCHLOR(R) available to patients in China as soon as 
possible." 
 
   Dr. Tan Boon Heon, Kyowa Kirin's President in the Asia Pacific, 
commented: "Kyowa Kirin is committed to delivering life-changing value 
to people living with severe diseases. VALCHLOR(R) joins a growing 
portfolio of innovative products that we are introducing in the rare 
disease, nephrology and hemato-oncology space in Asia. In this respect, 
we are proud to partner with Helsinn, a leader in the development of 
innovative cancer and rare disease therapies, in our very first 
partnership specific to the Asia Pacific region, to bring an important 
treatment to MF-CTCL patients in China." 
 
   Enrico Magnani, Local General Manager, Helsinn Pharmaceuticals (Beijing) 
Co., Ltd., P.R.C., commented: "We are pleased to have secured this 
important partnership with Kyowa Kirin, a strategic player in the 
pharmaceutical space in Asia. With this licensing deal, VALCHLOR(R) is 
expanding our cancer care product portfolio in China, strengthening our 
position in the region and allowing us to deliver treatments to an even 
greater number of patients." 
 
   "By having the commercial rights of VALCHLOR(R) (mechlorethamine) in 
China, Kyowa Kirin has shown that it is serious about meeting patients' 
unmet needs in the rare disease therapeutic areas" added Kazunobu Mikawa, 
General Manager in China (KKCN), "VALCHLOR(R) will be one of our 
strategic products for our dermatology and hemato-oncology franchise. We 
are delighted to promote VALCHLOR(R) as an additional therapeutic option 
for MF-CTCL patients in China." 
 
   Global Overview 
 
   Chlormethine gel 0.016, also known as mechlorethamine gel, is approved 
for use in multiple countries including the US and EU and is marketed 
under the trade names LEDAGA(R) and VALCHLOR(R) . The authorized use for 
each country varies based on design of the registrational trials and the 
individual health authority requirements. For more details, please refer 
to the package insert for the respective country. 
 
   In the US 
 
   About VALCHLOR(R) 
 
   INDICATION 
 
   VALCHLOR(R)  (mechlorethamine) gel is indicated for the topical 
treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell 
lymphoma (MF--CTCL) in patients who have received prior skin-directed 
therapy. 
 
   IMPORTANT SAFETY INFORMATION 
 
   CONTRAINDICATIONS 
 
   VALCHLOR(R) is contraindicated in patients with known severe 
hypersensitivity to mechlorethamine. Hypersensitivity reactions, 
including anaphylaxis, have occurred with topical formulations of 
mechlorethamine. 
 
   WARNINGS AND PRECAUTIONS 
 
 
   -- Mucosal or eye injury: Exposure of mucous membranes to mechlorethamine 
      such as the oral mucosa or nasal mucosa causes pain, redness, and 
      ulceration, which may be severe. Exposure of the eyes causes pain, burns, 
      inflammation, photophobia, and blurred vision. Blindness and severe 
      irreversible anterior eye injury may occur. Should eye exposure or 
      mucosal contact occur, immediately irrigate for at least 15 minutes with 
      copious amounts of water, followed by immediate medical consultation 
 
   -- Secondary exposure: Avoid direct skin contact with VALCHLOR(R) in 
      individuals other than the patients due to risk of dermatitis, mucosal 
      injury, and secondary cancers 
 
   -- Dermatitis: Dermatitis may be moderately severe or severe. Monitor 
      patients for redness, swelling, inflammation, itchiness, blisters, 
      ulceration, and secondary skin infections. Stop treatment with 
      VALCHLOR(R) or reduce dose frequency 
 
 
   -- Non--melanoma skin cancer: Monitor patients during and after treatment 
      with VALCHLOR(R) 
 
 
   --Embryo--fetal toxicity: May cause fetal harm. Women should avoid 
becoming pregnant while using VALCHLOR(R) due to the potential hazard to 
the fetus. For nursing mothers, do not breastfeed during treatment with 
VALCHLOR(R) 
 
 
   -- Flammable gel: VALCHLOR(R) is an alcohol--based gel. Avoid fire, flame, 
      and smoking until the gel has dried 
 
 
   ADVERSE REACTIONS 
 
   The most common adverse reactions (>=5%) were dermatitis (56%), pruritus 
(20%), bacterial skin infection (11%), skin ulceration or blistering 
(6%), and hyperpigmentation (5%). These reactions may be moderately 
severe or severe. Elderly patients aged 65 and older may be more 
susceptible. Depending on severity, treatment reduction, suspension, or 
discontinuation may be required. 
 
   USE IN SPECIFIC POPULATIONS 
 
 
   -- Contraception: Females who are able to become pregnant, and males with 
      female partners who are able to become pregnant, should use a barrier 
      method of contraception to avoid direct exposure of reproductive organs 
      to VALCHLOR(R) 
 
   -- Infertility: The reproductive effects of VALCHLOR(R) have not been 
      studied: however systemically administered mechlorethamine may impair 
      fertility. The reversibility of the effect on fertility is unknown. 
 
 
   DOSING AND APPLICATION 
 
   VALCHLOR is for topical dermatologic use only. Apply a thin film of gel 
once daily to affected areas of the skin. VALCHLOR(R) is a cytotoxic 
drug and special handling and disposal procedures should be followed 
during use. Caregivers must wear disposable nitrile gloves when applying 
VALCHLOR(R) . Patients and caregivers must thoroughly wash hands after 
handling or applying VALCHLOR. (R) 
 
   To report SUSPECTED ADVERSE REACTIONS, contact Helsinn Therapeutics 
(U.S.), Inc. at  1-855-482-5245 or FDA at 1--800--FDA--1088 or visit 
www.fda.gov/medwatch. 
 
   Please see the VALCHLOR full Prescribing Information and Medication 
Guide 
https://www.globenewswire.com/Tracker?data=DGkV1oeYQ3e4AZvVrJp4sVQZtnWmZhI4j5YBetI9p5OWprb_iUniwtuRfGyOFq7gzi7btZoc0ut71VR44exo1I0XN3XoyEY8PNIHLgYpyQ4TSNTw048gKmDRexm2wd0yCJn0noFdqalz81fRYKF5obARqI9ufR_vyc5zpDMDaziW_OiuSx6Ydb0QpvjnyRY-lj8-sDVoNbCUyfh83gZbgA== 
. 
 
   In the EU 
 
   About Ledaga(R) 
 
   Ledaga(R) gel is an alkylating drug indicated for the topical treatment 
of MF-CTCL in adult patients. Ledaga(R)  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). Ledaga(R) 
gel is commercialized in the EU since June 2019. 
 
   For additional information please see the 
https://www.globenewswire.com/Tracker?data=bzpNIYEigFoq_W4C-F0gbNs6b8rt5_Q7K9vLxLyz3NQ_U2xXQ33KDIqmHnK5uup79nqtOLAPWZAqQ4_ltl5Ax9jI9Vn41aM3EwhnN8m0dJ483kDBT-t8oSC8XApqWnI_P3zqFKDMpYE1FHYBH5jrCfQCXbzofZygouLSIboyX373LNrrYex5VMQ9f0u74NnsGMhJWJqP1kwKIbBQd8gvJi6eHksD2tXCCC9huwdto2Y= 
EU Summary of Product Characteristics. 
 
   About the Helsinn Group 
 
   Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has 
been improving the lives of patients, guided by core family values of 
respect, integrity and quality. The Group has an extensive portfolio of 
marketed innovative cancer and rare disease therapies, a robust drug 
development pipeline and ambitions to further accelerate its growth 
through in-licensing and acquisition to address unmet medical needs. 
Helsinn operates a unique integrated licensing business model, achieving 
success with over 80 long-standing partners in 190 countries, who share 
our values. The Group's pharmaceutical business (Helsinn Healthcare) is 
headquartered in Lugano, Switzerland with operating subsidiaries in the 
U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) 
which market the Group's products directly in these countries. The Group 
has additional operating subsidiaries in Switzerland (Helsinn Advanced 
Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland 
(Helsinn Birex Pharmaceuticals, a drug product manufacturer). Helsinn 
Investment Fund was created to enhance the future of healthcare by

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