Ipsen and Spirogen Redesign Their Collaboration for the Development of SJG-136 (Now SG2000)
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PARIS & LONDON--(Business Wire)--
Regulatory News:
Ipsen (Euronext : FR0010259150; IPN) and Spirogen Ltd. announced today that the
parties have entered into a new agreement superseding their 2003 contractual
relationship regarding the DNA minor groove binder SJG-136 (now known as
SG2000). The new agreement between the parties will allow Spirogen to continue
and lead the clinical development of this first-in-class anticancer agent.
SJG-136 is planned to shortly continue clinical development in upcoming National
Cancer Institute-sponsored multi-centered Phase II clinical trials in ovarian
cancer and haematological malignancies.
Under the new agreement Spirogen is granted an exclusive worldwide license to
certain Ipsen intellectual property rights covering pyrrolobenzodiazepines in
combination with cytotoxic agents. Spirogen obtains full responsibility for the
design and execution of the global clinical development and commercialization of
SJG-136 as a single agent or in combination. In the event of commercialization
of SJG-136, Ipsen will be eligible to royalties and commercial milestones, in
addition to remaining a significant minority shareholder in Spirogen, including
membership on the board of directors of Spirogen.
Stéphane Thiroloix, Executive Vice President, Corporate Development of Ipsen
said: "We are pleased that the clinical development of an agent like SJG-136
will be furthered in the hands of Spirogen, a world leader in the field of DNA
minor groove binding agents and in particular pyrrolobenzodiazepine.This new
agreement stems from Ipsen`s strategic focus on molecular targeted agents for
hormone dependent cancers for our oncology portfolio. Spirogen has proposed a
clear path forward for SJG-136 to complement standard chemotherapy offerings in
ovarian and haematological cancers and we believe Spirogen`s commitment to the
product has the potential to benefit cancer patients in crucial need of better
therapies."
Chris Martin, Chief Executive Officer of Spirogen stated: "We are pleased that
Spirogen will assume leadership over the development of SJG136 as it continues
development in Phase II trials in ovarian and haematological cancers while also
maintaining Ipsen as an important shareholder and license partner. We are also
announcing today our partnership with Celtic Therapeutics, a specialised private
equity group which will provide both the capital for our upcoming planned
clinical trials and also the support and assistance of its world class drug
development team."
About the initial and new agreements
In May 2003, Ipsen signed a partnership agreement with Spirogen for a licensing
agreement covering the development and marketing (by Ipsen) of a patented
anti-cancer drug SJG-136 and a research agreement for other anti-cancer
compounds through implementation of a gene targeting technology patented by
Spirogen.
Pursuant to the development and licensing agreement, Ipsen held an exclusive
worldwide licence on Spirogen`s patents and expertise related to the
manufacture, use and sale of SJG-136 and its analogue or replacement compounds.
In May 2003, Ipsen acquired a shareholding in Spirogen`s capital by subscribing
for preference shares issued by the company.
Under the new agreement, and as noted above, Ipsen will remain a significant
shareholder with a right to 17% of Spirogen`s fully diluted equity, as well as
sharing in the economics stemming from commercialization of SJG-136 pursuant to
the new license agreement.
About SJG-136
SJG-136 (SG2000/BN2629/NSC 694501) is a small molecule which spans six base
pairs of DNA in the minor groove inducing DNA cross links and is currently
undergoing clinical development in refractory solid tumours and haematological
malignancies under a CRADA (Cooperative Research And Development Agreement) with
the Division of Cancer Treatment and Diagnosis as supported by NIH U01 CA099177
and M01 RR00095 grants. The agent belongs to an entirely new class of DNA minor
groove binding agents designed to minimize detection of the induced DNA lesions
by the DNA repair machinery and encouraging clinical results have been reported
in refractory solid tumors cancer at ASCO 2008.
About Ipsen
Ipsen (Paris:IPN) is an innovation-driven international specialty pharmaceutical
group with over 20 products on the market and a total worldwide staff of nearly
4,200. Its development strategy is based on a combination of specialty medicine,
which is Ipsen's growth driver, in targeted therapeutic areas (oncology,
endocrinology, neurology and haematology), and primary care products which
contribute significantly to its research financing. The location of its four
Research & Development centres (Paris, Boston, Barcelona, London) and its
peptide and protein engineering platform give the Group a competitive edge in
gaining access to leading university research teams and highly qualified
personnel. More than 800 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. This strategy is also
supported by an active policy of partnerships. In 2008, Research and Development
expenditure was about €183 million, close to 19% of consolidated sales, which
amounted to €971 million while total revenues exceeded €1 billion. Ipsen`s
shares are traded on Segment A of Euronext Paris (stock code: IPN, ISIN code:
FR0010259150). Ipsen`s shares are eligible to the "Service de Règlement Différé"
("SRD") and the Group is part of the SBF 120 index. For more information on
Ipsen, visit our website at www.ipsen.com.
Ipsen Forward-looking statements
The forward-looking statements, objectives and targets contained herein are
based on the Group`s management strategy, current views and assumptions. Such
statements involve known and unknown risks and uncertainties that may cause
actual results, performance or events to differ materially from those
anticipated herein. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and potential
future acquisitions, which may alter these parameters. These objectives are
based on data and assumptions regarded as reasonable by the Group. These targets
depend on conditions or facts likely to happen in the future, and not
exclusively on historical data. Notably, future currency fluctuations may
negatively impact the profitability of the Group and its ability to reach its
objectives. Actual results may depart significantly from these targets given the
occurrence of certain risks and uncertainties. The Group does not commit nor
gives any guarantee that it will meet the targets mentioned above. Furthermore,
the Research and Development process involves several stages each of which
involve the substantial risk that the Group may fail to achieve its objectives
and be forced to abandon its efforts with regards to a product in which it has
invested significant sums. Therefore, the Group cannot be certain that
favourable results obtained during pre-clinical trials will be confirmed
subsequently during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the product
concerned. The Group expressly disclaims any obligation or undertaking to update
or revise any forward looking statements, targets or estimates contained in this
press release to reflect any change in events, conditions, assumptions or
circumstances on which any such statements are based, unless so required by
applicable law. The Group`s business is subject to the risk factors outlined in
its registration documents filed with the French Autorité des Marchés
Financiers.
About Spirogen
The company is a clinical stage biotech company specializing in the development
of drugs that recognize genomic base pair sequences. These drugs have the unique
property of avoiding mechanisms that commonly lead to drug resistance with many
cancer therapies. SJG136 is the lead drug with another agent, SG2285, in late
pre-clinical development. A number of drugs and linker systems designed for
antibody drug conjugate therapy are in the discovery phase. Spirogen also has an
active research collaboration with the University of London School of Pharmacy
in the field of transcription factor inhibition based on this class of drugs.
Spirogen is a privately owned UK company, founded in 2001 by Professor David
Thurston and Dr Phillip Howard (now at the School of Pharmacy, University of
London), Professor John Hartley (University College London) and Dr Chris Martin.
Spirogen`s initial investors were: Cambridge Research Bioventures (lead
investor), Xenva Ltd, CRIL and Bloomsbury Bioseed Fund.
Spirogen`s website is www.spirogen.com
Ipsen
Media
Didier Véron
Director, Public Affairs and Corporate Communications
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail: didier.veron@ipsen.com
or
Financial Community
David Schilansky
Investor Relations and Financial Officer
Tel.: +33 (0)1 58 33 51 30
Fax: +33 (0)1 58 33 50 63
E-mail: david.schilansky@ipsen.com
or
Pierre Kemula
Investor Relations Manager
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
E-mail: pierre.kemula@ipsen.com
or
Spirogen
Chris Martin
CEO
Tel: +44 (0) 7788 720572
Fax: +44 (0) 1983 817001
E-mail: chris.martin@spirogen.com
Copyright Business Wire 2009
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