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- November 15 2004
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Geneva, Switzerland and Paris, France - November 15, 2004 - Serono (virt-x: SEO and NYSE: SRA) and protein evolution company
Nautilus Biotech (Private) announced today that they have signed an agreement under which Serono and Nautilus will work together
to develop the next-generation of human growth hormone, with improved biological, pharmacological and clinical profiles. This
improved version of human growth hormone would allow less frequent injections of this therapeutic protein which is currently
administered daily.
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Under the terms of the agreement, Serono will receive an exclusive license to develop the next-generation human growth
hormone and an exclusive option to license exclusive worldwide rights to develop, manufacture, and commercialize
improved variants of the protein generated by Nautilus's rational evolution technology, a process mimicking natural
evolution. In return, Nautilus will receive an initial fee and potential milestone payments related to development progress,
regulatory submissions and approvals. If a new version of growth hormone is successfully developed and registered worldwide,
and Serono exercises its option right, the aggregate amount of these payments could reach Euro 19 million. Nautilus will also
receive undisclosed royalties on sales of the improved protein.
“Serono has a long-term commitment to people with endocrine and metabolic disorders requiring growth hormone treatment”,
said Tim Wells, Senior Executive VP Research of Serono. “We believe that the rational evolution technology of Nautilus
represents a promising approach to generate growth hormone variants with great potential to deliver improved patient
care.”
“Serono has an impressive track record in the development and marketing of protein therapeutics”, said Manuel Vega CEO
of Nautilus Biotech. “We are confident that in Serono we have found a strong and committed partner to fully exploit
the power of our protein improvement technology and to develop this new product as a competitive improvement to currently
marketed alternatives. This agreement with Serono, a world leader in protein pharmaceuticals, validates our strategy and
business model in the area of biopharmaceuticals”.
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Serono forward-looking statements
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and
unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A.
and affiliates to be materially different from those expected or anticipated in the forward-looking statements.
Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number
of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form
20-F filed with the U.S. Securities and Exchange Commission on March 25, 2004. These factors include any failure or
delay in Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems
in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement
coverage for our products, and government regulations limiting our ability to sell our products. Serono has no responsibility
to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after
the date of this press release.
#####
About Serono
Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif®, Gonal-F®, Luveris®, Ovidrel®/Ovitrelle®,
Serostim®, Saizen®, Zorbtive™ and Raptiva®. In addition to being the world leader in reproductive health, Serono has strong market
positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company's research programs are focused
on growing these businesses and on establishing new therapeutic areas. Currently, there are approximately 30 ongoing development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a net income of US$390.0 million, making it the third largest
biotech company in the world. Its products are sold in over 90 countries. Bearer shares of Serono S.A., the holding company, are traded
on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
About Nautilus Biotech
Nautilus is focused on improving and developing next generation protein pharmaceuticals. Using its proprietary and unique
technologies, Nautilus has generated a pipeline of improved therapeutic protein molecules with single amino acid substitutions;
and has IP claims on 20 improved cytokines. Long lasting interferon alpha and interferon beta, presently in preclinical development,
are Nautilus' lead molecules. Nautilus Biotech is a privately owned, VC backed company, founded in late 1999.
More about Nautilus: www.nautilusbiotech.com
For more information, please contact:
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Serono in Geneva, Switzerland:
Corporate Media Relations:
Tel:
Fax:
www.serono.com
Corporate Investor Relations:
Tel:
Fax:
Reuters: SEO.VX / SRA.N
Bloomberg: SEO VX / SRA US
Serono, Inc., Rockland, MA:
Media Relations, USA:
Tel:
Fax:
www.seronousa.com
Investor Relations, USA:
Tel:
Fax:
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Nautilus Biotech:
Jon Watts
VP Business Development
jwatts
tel : +
Manuel Vega, CEO
jwatts
tel :
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- September 16 2004
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Paris, September 16th 2004: Drs. Silvano Fumero and William Larry Respess have been appointed
to the Board of Directors for Nautilus Biotech. At the same time, Silvano Fumero has been appointed Chairman
of the Nautilus' Board of Directors.
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Silvano Fumero, PhD, has 35 years of experience in the Pharma sector where he has covered different positions
in research and development. Silvano has been the Senior Executive VP, Head of Research and Pharmaceutical
Development, of Serono International S.A. in Généva, until May 2003. He is currently CEO of Creabilis Therapeutics,
a drug discovery and development Company located in the Bioindustry Park of Canavese (Ivrea, Italy).
Larry Respess, PhD, JD, is an intellectual property lawyer with nearly 30 years experience in the biotechnology
industry. Larry has been the Chief Legal Officer and General Counsel of Applied Molecular Evolution, Inc.
until 2004, and, previously, of Hybritech, Inc., Genprobe, Inc. and Ligand Pharmaceuticals, Inc. He is currently
Senior Vice President, General Counsel of Nanogen Inc. of San Diego, California (USA), a leading developer of
DNA probe diagnostic products.
“We are most proud to welcome Silvano and Larry on Board” said Nautilus CEO M.Vega. “I am confident that
their contribution will be key for the further development of Nautilus as a well established player in the
industry of protein pharmaceuticals. They bring to Nautilus their strong personal leadership and vision and
their first-hand experience in biotechnology, which has been built over years of active involvement in remarkably
successful companies, top leaders in the field where Nautilus operates, such as Serono in protein pharmaceuticals
and Applied Molecular Evolution in protein improvement.”
About Nautilus Biotech
Nautilus Biotech is focused to improving therapeutic protein pharmaceuticals and next generation products.
Nautilus is a privately owned company that has generated a pipeline of improved therapeutic protein molecules
with single point amino-acid substitutions using its proprietary protein evolution technologies. Improved
IFNa (Belerofon™) and IFNb presently in pre-clinical stage are Nautilus' lead molecules.
Additional information on Nautilus Biotech can be obtained from either
www.nautilusbiotech.com
or by e-mail:
contact
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Manuel Vega
CEO
Nautilus Biotech
mvega
tel :
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Jon Watts
VP Business Development
Nautilus Biotech
jwatts
tel : +
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- September 3 2004
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Ivrea, Italy and Paris, France - September 3rd, 2004 : Nautilus Biotech SA and Creabilis
Therapeutics SRL today signed a collaboration agreement for the identification and development of
an improved variant of CT500, a non-antibody protein selected by Creabilis Therapeutics, with antagonist
activity against HMGB1.
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HMGB1 is a DNA binding chemo-cytokine that has become in the last years a relevant drug target, due to
its key and in some cases causative role in several pathological conditions. The new anti-HMGB1 variant
protein, object of the agreement, is expected to have potential applications in various acute and chronic
clinical indications such as autoimmune diseases, infective diseases, sepsis, tumours, cardiovascular and
also neurologic and amyloid pathologies.
Nautilus' proprietary technology for protein evolution, based on systematic mutagenesis and already
successfully applied to a number of well known therapeutic proteins, will be used to improve the pharmacodynamic
profile of CT500.
M.Vega, CEO of Nautilus Biotech comments: “So far our technology has been applied to marketed proteins,
such as IFNa and IFNb, to
improve them by single point amino-acid substitution to create new products with highly competitive PK/PD
characteristics compared to the marketed counterparts. This agreement allows us to apply the same methodology
to a novel protein at a very early stage of development. It is a good demonstration on the flexibility of our
approach that can be used to improve lead proteins right after the discovery phase.”
“We are most confident - said Creabilis Therapeutics CEO Silvano Fumero - that Nautilus technology will
allow to obtain an improved candidate drug with higher and competitive pharmacological and clinical
potential. This collaborative project perfectly complement the most promising line of research of our
Company aimed to identify and develop new antagonists of relevant DNA-binding proteins, such as HMGB1.
Our proprietary technology platform has already allowed to obtain a series of bent DNA/PNA chimeras and
hybrids, now in phase of lead optimisation. The improved variant of CT500 is expected to enter into
pre-clinical phase, together with the DNA/PNA lead in the second half of next year.”
Using its proprietary technologies, Nautilus is strongly focused to improving human protein pharmaceuticals. Nautilus' pipeline is
strategically focused on FDA-approved, marketed proteins, for which an improvement of their pharmacological profile would increase
their already demonstrated clinical efficacy and market potential.
The terms of the agreement have not been disclosed.
About Creabilis Therapeutics
Creabilis Therapeutics is a privately owned drug-discovery and development company, founded in 2003 and
located inside the Bioindustry Park of Canavese, Ivrea, near Turin. The company activity is mainly
focused on DNA-binding proteins, such as HMGB1 and tat, as pharmacological targets for novel classes of
inhibitors/antagonists to be developed as therapeutics in relevant clinical indications. The portfolio
is complemented with selected projects in related biochemical or clinical areas.
Additional information on Creabilis Therapeutics can be obtained from either
www.creabilistherapeutics.com
or by e-mail:
info
About Nautilus Biotech
Nautilus Biotech is focused to improving therapeutic protein pharmaceuticals and next generation products.
Nautilus is a privately owned company founded in 2000 and which has since generated a pipeline of improved
therapeutic protein molecules with single point amino acid substitutions using its proprietary protein
evolution technologies. Improved IFNa (Belerofon™) and IFNb
presently in pre-clinical stage are Nautilus' lead molecules. Nautilus has IP claims on 20 other improved therapeutic proteins.
Additional information on Nautilus Biotech can be obtained from either
www.nautilusbiotech.com
or by e-mail:
contact
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Jon Watts
VP Business Development
Nautilus Biotech
jwatts
tel : +
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Silvano Fumero
CEO
Creabilis Therapeutics
sfumero
tel: +
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- June 18 2004
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Paris, June 18th 2004: The Ministerial Conference of EUREKA, composed by a minister from each member country and a Commissioner
from the European Commission announced today the endorsement of the NGB project (S ! 3351) jointly presented by Nautilus Biotech
(France) and Serono SA (Switzerland).
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The NGB project associates Serono SA and Nautilus Biotech who will work together to develop next generation therapeutic proteins
with improved biological, pharmacological and clinical profiles.
The partnership brings together a strong synergy between the two companies. Nautilus, which has proven proprietary technology for
the improvement of bio-therapeutics, would design the new protein variants and validate them in vitro and in vivo. Serono would
select protein variants created and validated by Nautilus and bring them through pre-clinical and clinical development to market.
“NGB is a strategic project for the two partners involved. It is expected to allow next generation therapeutic proteins, with
improved profiles, to reach market and thus to improve patience compliance and quality of life”, said Nautilus CEO Manuel Vega.
EUREKA is a pan-European network for market-oriented, industrial R&D. EUREKA supports the competitiveness of European companies
through international collaboration, in creating links and networks of innovation. The objective is to bring high quality research
and development efforts to the market and to use the multiplying effects of co-operation. For more information on EUREKA can be
obtained at www.eureka.be.
Using its proprietary technologies, Nautilus is strongly focused to improving human protein pharmaceuticals. Nautilus' pipeline is
strategically focused on FDA-approved, marketed proteins, for which an improvement of their pharmacological profile would increase
their already demonstrated clinical efficacy and market potential.
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Manuel Vega
CEO
Nautilus Biotech
mvega
tel :
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Jon Watts
VP Business Development
Nautilus Biotech
jwatts
tel : +
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- March 23 2004
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Paris, March 23rd 2004: Nautilus Biotech today announced the successful completion of
comparative monkeys studies between Nautilus proprietary IFNa
(Belerofon™) and two leading commercial IFNa drugs:
native IFNa and pegylated IFNa.
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Belerofon™ is a single amino acid variant of natural IFNa engineered using Nautilus'
proprietary protein evolution technology to create an improved, non-pegylated, non-chemically
modified IFNa, with longer half-life in serum.
The market(1) for IFNa in the treatment of chronic hepatitis C infection only, reached
$2.7 bn in 2003 and is projected to grow to $8.7 bn by 2013 and $12.6 bn by 2018.
Pegylated IFNa dominates the market based on its improved pharmacokinetics (PK) profile,
which translates into lower dosing frequency and higher patient compliance, compared
to native IFNa.
(1) includes US, UK, France, Germany, Italy and Spain
Initial pre-clinical studies of Belerofon™ in cynomolgus monkeys have recently been completed
and show the following positive results:
Low toxicity - Preliminary dose escalation and repeat dosing studies of Belerofon™ in monkeys
have shown an absence of adverse clinical or hematological events associated with treatment.
Good biological response - Pharmacodynamic studies using surrogate markers, such as neopterin,
MxA and 2'5'AOS, indicate that Belerofon™ is active in vivo and that it triggers the appropriate
biological response.
Improved pharmacokinetics - The PK profile observed for Belerofon™ in primates outperformed those
obtained for non-pegylated commercial IFNa and compared
favourably with those obtained for commercial pegylated-IFNa,
in all parameters measured.
Lower dosing - Belerofon™ showed comparable performance in terms of PK and pharmacodynamics
despite 1/10 (w/w) dosage levels being administered compared to pegylated IFNa.
This is in line with the higher specific activity of Belerofon™ measured in vitro, probably due to
the absence of pegylation. As a result of its improved PK profile and lower dosing, Belerofon™
holds great potential to improve on the current IFNa-based
therapies for hepatitis C chronic infection, melanoma and kidney cancer.
“The profile shown by Belerofon™ in monkeys fully confirm earlier in vitro and in mice studies,
and demonstrate our capacity to effectively design improved proteins. This constitutes a strong
validation for our protein evolution approach and its potential to generate significant improvements
in therapeutic proteins. We are currently applying this powerful technology to a number of other
commercially attractive protein-based pharmaceuticals, including IFN-b
(PR Feb 27, 2004, 'Nautilus Biotech announces progress on improved Interferon beta for Multiple
Sclerosis)”, said Nautilus CSO, Dr Lila Drittanti.
“This milestone reached with Belerofon™ is a key step in our strategy of developing high value,
next generation therapeutic protein products. Given its highly competitive profile, as demonstrated
in monkeys, Belerofon™ is positioned to move into clinical development. Nautilus becomes one of the
very few directed evolution companies that has demonstrated clear success in the evolution of
biopharmaceuticals”, said Nautilus CEO, M Vega.
About Nautilus Biotech
Using its proprietary technologies, Nautilus is strongly focused to improving human protein
pharmaceuticals and next generation products. Nautilus' corporate headquarters and R&D
facilities are in France, while clinical development is driven from its subsidiary in the US.
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Manuel Vega
CEO
Nautilus Biotech
mvega
tel :
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Jon Watts
VP Business Development
Nautilus Biotech
jwatts
tel : +
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- February 27 2004
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Paris, February 27th 2004: Nautilus Biotech today announced that it has developed enhanced
IFNb molecules, engineered to have a substantially increased half-life.
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The novel molecules, developed using Nautilus' proprietary technology for protein
evolution, show significantly higher level of stability in vitro, compared to natural
IFNb including higher thermal stability as well
as higher resistance to biological clearance. At the same time they elicit the specific
activity levels of native IFNb.
“Greater stability is a key objective for the improvement of IFNb,
as it will increase the half-life of the molecule in the body and decrease the frequency of
repeat treatments. This is one of the most important clinical criteria for any next generation
product for the treatment of MS. Nautilus' improved IFNb
offers a significantly longer half-life which can be expected to translate into an improved
PK profile. This enhancement has been achieved using Nautilus mutagenesis approach, without
the need of PEGylation, coating or any other chemical modification of the IFNb
molecule”, said Nautilus CSO Lila Drittanti.
Nautilus has created a portfolio of next generation therapeutic proteins with improved
profiles. It is aggressively establishing a strong intellectual property position
covering enhanced versions of these multibillion dollars molecules and is rapidly
moving these products towards initial clinical phases.
“The achievement of this key milestone is an important step in our strategy of becoming an
early stage drug discovery and development company. Nautilus' next generation IFNb
has been designed to satisfy a major unmet clinical need in this $2 billion market and demonstrates
our ability to rapidly discover proprietary novel proteins with the potential to become the
next generation of blockbusters”, said Nautilus VP of Strategy, Paul Martin.
About Nautilus Biotech
Using its proprietary technologies, Nautilus is strongly focused to improving human protein
pharmaceuticals and next generation products. Nautilus most advanced product is a long-lasting
in serum, non-pegylated, high specific activity IFNa for the treatment of HepC infection.
Nautilus' corporate headquarters and R&D facilities are in France, while clinical development
is driven from its subsidiary in the US.
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