Helsinn and Advancell Sign a Partnering Agreement for ATH008, a New Compound for Chemotherapy-Induced Dermatological Injuries

LUGANO, Switzerland and BARCELONA, Spain, July 9, 2013 /PRNewswire/ --

The Swiss pharmaceutical group Helsinn  and the Spanish company, Advancell, Advanced In Vitro Cell Technologies, SA, today announced a partnering agreement for the development and worldwide commercialization of ATH008, a new topical product for the prevention and/or treatment of Palmoplantar Erythrodysesthesia Syndrome, PPES (caused for example by fluoropyrimidines-based chemotherapy) and of Hand-Foot Skin Reactions, HFSR (caused for example by multitargeted kinase inhibitors, MKIs). PPES and HFSR are seriously debilitating, painful conditions affecting patients undergoing cancer treatment with a range of chemotherapies; these side effects can be very severe and lead to chemotherapy dose reductions or even suspensions, potentially impacting on therapy outcome.

Under the terms of the agreement, Helsinn will receive a worldwide exclusive license to ATH008 and will be responsible for all further development, regulatory approval, manufacturing, marketing and sales either on its own or through its sub-licensees. In return the Swiss Group will pay Advancell development

milestones and sales royalties for an undisclosed amount.

Advancell has applied its knowledge in the development area and formulation optimization to develop ATH008. The pre-clinical and clinical studies conducted so far suggest that ATH008 may be a safe and effective agent for the prevention and/or treatment of dermatological injuries caused by chemotherapy treatment, resulting in a reduction in the incidence and severity of PPES / HFSR.

"We are excited about this promising development and cooperation with Advancell, which represents another important step in broadening and strengthening Helsinn Healthcare's pipeline of cancer supportive care products. We are confident that ATH008 will bring an important contribution to the treatment of chemotherapy-induced PPES / HFSR, currently an unmet medical need. We strongly believe that Helsinn's constant investment in R&D and in life-cycle activities of new and current products in this therapeutic area will allow us to fulfill our commitment to deliver benefits to the medical community and to improve patients' quality of life, commented Riccardo Braglia, Helsinn Group's Chief

Executive Officer.

"This drug has the potential to make a substantial contribution in cancer supportive care which is an area of increasing interest with a sizeable and underserved market potential" comments Clara Campas-Moya, Managing Director of Advancell. "We are delighted to have a partner like Helsinn which is fully committed to the quality of life of cancer patients. With this partnering agreement Advancell consolidates its business model consisting in the development of highly qualified scientific and clinical knowledge to real pharmaceutical products. The product serves a clear unmet need and has shown very promising results reported in preliminary studies where its effects were clearly visible.The aim of this new drug is that patients will be able to complete their chemotherapy according to schedule, as well as improve their quality of life during treatment. The syndrome affects a large proportion of people who suffer from breast cancer and colorectal cancer and are treated with certain chemotherapies. Among this group, more than 20% are forced to reduce or even interrupt their chemotherapy treatment, which considerably reduces their chances of survival".

About Palmoplantar Erythrodysesthesia Syndrome (PPES) / Hand-Foot Skin Reactions (HFSR)

PPES / HFSR are relatively frequent cutaneous reactions to certain types of chemotherapy. The onset of symptoms is variable and ranges from a few days up to several months after start of chemotherapy. The initial manifestations of the diseases involve painful erythema (redness), edema (swelling) and paresthesia (tingling and numbness) on palm and soles. Without appropriate interventions the lesions can blister, desquamate, form crusts, ulcerate, or in the most severe cases even progress to epidermal necrosis causing intense pain in the patients.  As a result, the diseases can interfere with basic functions such as walking or holding objects. In more severe cases, the patient becomes incapacitated and PPES / HFSR is the main cause of reduction or interruption of chemotherapeutic treatment. Generally the skin toxicity disappears once chemotherapy is suspended, but reappears, often more severely, once treatment is resumed.

About HELSINN GROUP

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland operating subsidiaries in Ireland, the United States and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices andnutritional supplement products in therapeutic niche areas. Helsinn is an important player incancer supportive care. Helsinn Group in-licenses early-to-late stage new chemical entities, completes their development through the performance of pre-clinical/clinical studies and Chemistry, Manufacturing, and Control (CMC) development, and files and attains their marketapprovals worldwide. Helsinn's products are out-licensed to its network of local marketing andcommercial partners, selected for their deep in-market knowledge and know-how whom Helsinnassists and supports by providing a full range of product and scientific management services,including commercial, regulatory, financial, legal, and medical marketing advice. The activepharmaceutical ingredients and the finished products are manufactured according to the highestquality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland andIreland and supplied worldwide to its customers.

For more information about Helsinn Healthcare, please visit http://www.helsinn.com

About ADVANCELL

Advancell is a privately held biotech company based in Barcelona, Spain, focused on the development of promising drug candidates in unmet needs with significant commercial potential.

The Company generates proprietary drug candidates by scouting the European academic environment and transforming basic research into drug development programs with a clinical proof of concept. Advancell develops the selected programs up to early clinical stage, with the goal to partner these products with strategic partners for worldwide commercialization. By doing this, Advancell puts in value highly qualified scientific and clinical knowledge, allowing these ideas to become real products in the market and return to society its investment in research, at the same time the company generates revenues for its shareholders.

Advancell focuses on indications with a clear unmet medical need in oncology, dermatology and CNS where its technologies and development capabilities can add distinctive value. The company has currently four programs in clinical development and pursues a series of preclinical opportunities.

For more information about ADVANCELL, please visit http://www.advancell.net

For further information, please contact:
HELSINN HEALTHCARE SA:
Roberto De Ponti, Senior Director,
Head of Corporate Business Development & Licensing In
Tel: +41-91-985-2121.
info-hhc@helsinn.com
http://www.helsinn.com

ADVANCELL Advanced in Vitro Cell Technologies SA:
Clara Campas-Moya, Managing Director,
Tel. +34-930-130-561
clara.c@advancell.net
http://www.advancell.net