4SC AG / Key word(s): Agreement/Alliance
14.04.2015 14:24
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
4SC Signs Licensing and Development Agreement with Menarini for Resminostat
in Asia-Pacific Excluding Japan
Planegg-Martinsried, Germany and Singapore, 14 April 2015 - 4SC AG
(Frankfurt, Prime Standard: VSC), a discovery and development company of
targeted small molecule drugs for cancer and autoimmune diseases, and
Singapore based Menarini Asia-Pacific Holdings Pte. Ltd. ("Menarini AP")
announced today that they have entered into a licensing and development
partnership for 4SC's cancer compound resminostat for the Asia-Pacific
region excluding Japan ("APAC").
Menarini AP, a member of the world's largest Italian biopharmaceutical
group, the Menarini Group, will receive the exclusive licensing rights for
the development and marketing of resminostat in all APAC countries,
including among others China, South Korea, Australia, Thailand,
Philippines, Indonesia, and Vietnam. Menarini AP will be responsible for
the clinical development, regulatory approval and commercialization of
resminostat in China, and other territories included in the agreement, in
all oncological indications, and in particular liver cancer (HCC).
4SC will receive upfront and milestone payments totaling approximately up
to EURO 95 million from Menarini payable upon achieving specified
development, regulatory and commercialization milestones. In addition, 4SC
will be eligible to double-digit royalties linked to product sales of
resminostat.
---------------------------------------------------------------------------
Information and Explaination of the Issuer to this News:
The development of resminostat in APAC, and China in particular, is of key
strategic importance to 4SC. Liver cancer (hepatocellular carcinoma, HCC),
a large cancer indication with limited therapeutic options and one of the
lead indications of resminostat's clinical development programme, has an
extremely high incidence in this region. More than 75% of all HCC cases
occur in the APAC region, largely in association with chronic hepatitis B
virus (HBV) infection. Approximately 50% of HCC cases globally occur in
China alone. HCC is currently the fifth most common cancer worldwide and
the third most common cause for cancer-related mortality. The incidence of
HCC cases globally is expected to grow strongly from about 700,000 per year
in 2014 to over 1 million in 2030 (source: Globocan).
Enno Spillner, Chief Executive Officer of 4SC, said: 'We are delighted to
be entering into this partnership with Menarini. This is a further step in
the clinical development of our lead compound resminostat for Asia, which
is an important market with significant and growing medical need - in
particular in the indication of liver cancer. Menarini, a multinational
pharma player of European origin, has a strong footprint in the APAC
region. We are convinced that Menarini AP, with its vast commercial
experience in Asia and broad capabilities in clinical development and
regulatory processes, is a perfect partner for us - and an ideal complement
to our existing resminostat partner Yakult Honsha in Japan.'
John Graham, Chief Executive of Menarini AP commented, 'Oncology represents
a strategic area of focus for the Menarini Group. We are delighted to be
embarking on a partnership with 4SC in Asia on resminostat that offers
promise as a therapeutic option in liver cancer, among others, one of the
most prevalent forms of cancer in Asia and one with the highest unmet
need.'
About Resminostat
Resminostat (4SC-201), 4SC's lead oncology compound, is an oral
histone-deacetylase (HDAC) inhibitor with an innovative epigenetic
mechanism of action that potentially enables the compound to be deployed as
a novel, targeted tumour therapy for a broad spectrum of oncological
indications, in particular in combination with other cancer drugs.
Like other epigenetic therapies, resminostat has been shown to modify
transcription of genes in cancer cells and, thereby, to reprogram the
phenotypes of such cancer cells. Resminostat is therefore assumed to be
able to halt tumour progression and induce tumour regression. Furthermore,
due to its epigenetic mode of action resminostat is supposed to develop
additional synergetic effects when combined with classical cancer therapies
and thus also fight the development of tumour cell resistance. For example,
in preclinical trials, resminostat has shown that it effectively inhibits
epithelial-mesenchymal transition (EMT). EMT, which may be promoted through
the administration of certain conventional cancer therapies, leads to the
formation of particularly aggressive tumour cells, which ultimately may
result in greater proliferation of cancer cells in patients and the
patients' death. On the whole, a reinforcing positive therapeutic effect is
expected to be achieved through well-tolerated parallel administration of a
traditional cancer therapy and an epigenetic compound such as resminostat.
Resminostat - by 4SC and its Japanese partner Yakult - has been
investigated in a broad clinical campaign comprising liver cancer
(hepatocellular carcinoma, HCC), Hodgkin's Lymphoma (HL), colorectal cancer
(CRC), and non-small-cell lung cancer (NSCLC). In the Phase II SAPHIRE
trial in patients with advanced Hodgkin's Lymphoma (HL), resminostat
monotherapy has demonstrated anti-tumour activity, with an overall response
rate of 34% and a clinical benefit in 54% of the patients in a heavily
pre-treated patient population together with very good safety and
tolerability. In the Phase IIa SHELTER study resminostat has been evaluated
as monotherapy and in combination with sorafenib as a second-line treatment
in advanced HCC after proven radiological disease progression under
first-line sorafenib therapy. Patients receiving the resminostat/sorafenib
combination therapy showed a median overall survival of 8.1 months. The
resminostat/sorafenib combination therapy had shown a progression-free
survival rate (PFSR) after 12 weeks of 70.0% and a median PFS of 5.4
months. Notably, in both tumour indications, HCC and HL, gene expression
levels of the new biomarker ZFP64 measured prior to study treatment start
in blood cells of patients, were identified to be potentially indicative of
survival outcome upon treatment with resminostat. Hereby, the set of
patients with a high level of ZFP64 gene expression at baseline showed a
statistically significant increase of median overall survival compared with
patients with low ZFP64 expression levels. Resminostat was further studied
in a Phase I dose escalation approach in advanced colorectal cancer (CRC)
patients evaluating resminostat in combination with the standard
chemotherapeutic FOLFIRI regimen. Positive results for safety and
tolerability as well as promising signs of clinical activity of this
combination were published at the 2013 ASCO conference. Yakult Honsha is
currently developing resminiostat in two randomised clinical Phase II
trials in Japanese and Korean patients in the indications of HCC and NSCLC.
Resminostat is partnered with Yakult Honsha for Japan and with Menarini in
China and the Asia Pacific (APAC) region excluding Japan.
About Menarini Asia-Pacific
Menarini Asia-Pacific is part of the world's largest Italian
biopharmaceutical company with a heritage of over 129 years and over 16,000
employees in more than 100 countries. Menarini Asia-Pacific's vision is to
be a leading provider of important healthcare brands to improve the lives
of people in the region. Menarini Asia-Pacific operates across the entire
commercial value chain, from clinical development, regulatory approval and
product launch to lifecycle management with a diverse portfolio of
proprietary and partnered brands in key therapeutic fields, including
Consumer Health, Dermatology, Primary Care, Allergy/Respiratory,
Cardiovascular, Oncology/Specialty Care and Men's Health.
About 4SC
The Group managed by 4SC AG (ISIN DE0005753818) discovers and develops
targeted, small-molecule drugs for treating diseases with high unmet
medical needs in various cancer and autoimmune indications. These drugs are
intended to provide innovative treatment options that are more tolerable
and efficacious than existing therapies, and provide a better quality of
life. The Company's pipeline comprises promising products that are in
various stages of clinical development. 4SC's aim is to generate future
growth and enhance its enterprise value by entering into partnerships with
leading pharmaceutical and biotech companies. Founded in 1997, 4SC had a
headcount of 66 employees (57 FTEs) at 31 December 2014. 4SC AG has been
listed on the Prime Standard of the Frankfurt Stock Exchange since December
2005.
Cautionary statement regarding forward-looking statements
This press release contains certain forward-looking statements. Any
forward-looking statement applies only on the date of this press release.
By their nature, forward-looking statements are subject to a number of
known and unknown risks and uncertainties that may or may not occur in the
future and as a result of which the actual results and performance may
differ substantially from the expected future results or performance
expressed or implied in the forward looking statements. No warranties or
representations are made as to the accuracy, achievement or reasonableness
of such statements, estimates or projections, and 4SC AG has no obligation
to update any such information or to correct any inaccuracies herein or
omission herefrom which may become apparent.
For more information about 4SC please visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Corporate Communications & Investor Relations
jochen.orlowski(at)4sc.com, Tel.: +49-89-7007-6366
MC Services
Katja Arnold, Michelle Kremer
katja.arnold(at)mc-services.eu, Tel.: +49-89-2102-2840
The Trout Group
Chad Rubin
crubin(at)troutgroup.com, Tel.: +1-646-378-2947
For more information about Menarini please visit www.menarini.com or
contact:
Jennifer Lin, Corporate Branding and Communications Asia-Pacific
JenniferCW.Lin(at)menariniapac.com, Tel: +65 6494 3427
14.04.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Germany
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
E-mail: public@4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
DGAP-Adhoc: 4SC Signs Licensing and Development Agreement with Menarini for Resminostat in Asia-Pacific Excluding Japan
| Source: EQS Group AG