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Nautilus Biotech Announces IND Filing for its Injectable Long-Lasting

Interferon-alpha, Belerofon

PR Newswire Europe (inc. UK Disclose) - Oct. 10, 2006

PARIS, Oct. 10, 2006 /PRNewswire/ -- Nautilus Biotech has announced that it

has submitted an Investigational New Drug (IND) filing to the U.S. Food and

Drug Administration (FDA) for injectable BELEROFON®, its

protease-resistant, long-lasting Interferon (IFN) alpha. The drug candidate

BELEROFON® has therapeutic potential for the treatment of a number of

clinical diseases, including Chronic Hepatitis C. It is expected that it

will be possible to administer the new drug at a significantly lower dose

while maintaining the weekly frequency of the established pegylated IFN

alpha products, resulting in improved safety and patient compliance.

Nautilus expects to commence a Phase 1 study in the US in Q12007, with the

aim of confirming the enhanced pharmacological profile of subcutaneous

BELEROFON®.

BELEROFON® has been designed and developed using Nautilus Biotech's

proprietary technology for protein engineering. It carries a single

amino-acid substitution that renders the molecule highly resistant to

proteases in blood and tissues, whilst its activity level and profile remain

equivalent to native IFN alpha. Animal studies have shown that the

particular mutation carried by BELEROFON® confers longer half-life and an

improved pharmacokinetic profile after subcutaneous administration compared

to established pegylated and non-pegylated IFN alpha products. At the same

time, the level of biological activity of the native IFN alpha, which is

significantly lower in pegylated products, is fully maintained in

BELEROFON®.

The improved pharmacokinetic profile of BELEROFON® is designed for

once-a-week subcutaneous administration, which is the same as pegylated

products currently available. However, because BELEROFON® has been shown

to maintain a high level of activity, it is expected that it will be

possible to administer the new drug at lower doses compared to established

pegylated IFN alpha products. These factors should result in better safety

and tolerability and greater patient compliance.

" This milestone reached with BELEROFON® is a key step in our commitment to

develop innovative, high value and best-in-class therapeutic proteins. This

is just the beginning of a sustained effort to aggressively move our

pipeline of proprietary products into the clinic. " Said Nautilus Biotech

CEO, Vega.

" We believe BELEROFON® can be given at a significantly lower dose compared

to the current gold standard of care and this will give it an important

competitive advantage over established pegylated IFN alpha products.

Nautilus Biotech's technology has wide applicability across many therapeutic

protein families. Increasing resistance to proteolysis offers important

improvements in drug profiles and has the potential to create highly

differentiated therapeutic products with better patient compliance. " Said

VP Strategy.

Notes to Editors:

About BELEROFON®

BELEROFON® is Nautilus Biotech's proprietary variant of human IFN alpha

that involves a single amino-acid change compared to native IFN alpha. The

single point mutation introduced to create BELEROFON® has been

specifically designed to increase the resistance of the entire molecule to

proteolysis in blood, tissues and in the intestine. The increased resistance

to proteolysis leads to a significantly improved pharmacokinetic and

pharmacodynamic profile.

BELEROFON® shows the high biological activity associated with native IFN

alpha, which is significantly greater than for pegylated derivatives.

BELEROFON® is a non-pegylated, non-chemically modified, highly active,

long-lasting in serum human interferon alpha.

About Nautilus Biotech

Nautilus Biotech is a drug discovery company with a pipeline of

next-generation therapeutic proteins with superior pharmacological profiles

that address unmet clinical needs. The Company's protein engineering

technology can significantly improve the pharmacological characteristics of

important blockbuster protein drugs, offering improvements in drug stability

and administration. The Company is also creating proprietary 'third

generation' therapeutic proteins which are, per se, suitable for oral

administration.

The therapeutic proteins market is currently valued at over US$30bn, and

growing at a rate of 10-15% per annum. Nautilus has created a portfolio of

next-generation therapeutic proteins with improved profiles, including long

lasting Interferon alpha (Belerofon®), hGH (Vitatropin), Interferon

beta, Clotting Factor IX, Erythropoietin, Interferon gamma and HMG-B1; it

has established a strong intellectual property position covering enhanced

versions of these multibillion dollars molecules and is rapidly moving these

products towards clinical phases.

Nautilus Biotech is a private company with headquarters in Genopole®

biopark, (Evry, France). For more information about Nautilus Biotech visit

www.nautilusbiotech.com

For more information please contact:

At Nautilus Biotech:

Dr Vega, CEO

Nautilus Biotech SA

1 rue Pierre Fontaine

91000 Evry, France

Tel: +33-(0)1-60-87-54-60

Fax: +33-(0)1-60-87-54-61

Email: mvega@...

Media relations:

At Northbank Communications

Lorna , Account Director

Northbank Communications Ltd

The Media Village, 131-151 Great

Titchfield Street,

London, W1W 5BB, UK

Tel: +44-(0)20-3008-7559

Fax: +44-(0)20-3008-7551

Email: l.watson@...

Nautilus Biotech

For more information please contact: At Nautilus Biotech: Dr Vega,

CEO, Nautilus Biotech SA, 1 rue Pierre Fontaine, 91000 Evry, France, Tel:

+33-(0)1-60-87-54-60, Fax: +33-(0)1-60-87-54-61, Email:

mvega@.... Media relations: At Northbank Communications,

Lorna , Account Director, Northbank Communications Ltd, The Media

Village, 131-151 Great, Titchfield Street, London, W1W 5BB, UK, Tel:

+44-(0)20-3008-7559,.Fax: +44-(0)20-3008-7551, Email:

l.watson@...

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1107277 & contentty\

pe=sentryarticle & channelID=31

_________________________________________________________________

Find a local pizza place, music store, museum and more…then map the best

route! http://local.live.com

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Nautilus Biotech Announces IND Filing for its Injectable Long-Lasting

Interferon-alpha, Belerofon

PR Newswire Europe (inc. UK Disclose) - Oct. 10, 2006

PARIS, Oct. 10, 2006 /PRNewswire/ -- Nautilus Biotech has announced that it

has submitted an Investigational New Drug (IND) filing to the U.S. Food and

Drug Administration (FDA) for injectable BELEROFON®, its

protease-resistant, long-lasting Interferon (IFN) alpha. The drug candidate

BELEROFON® has therapeutic potential for the treatment of a number of

clinical diseases, including Chronic Hepatitis C. It is expected that it

will be possible to administer the new drug at a significantly lower dose

while maintaining the weekly frequency of the established pegylated IFN

alpha products, resulting in improved safety and patient compliance.

Nautilus expects to commence a Phase 1 study in the US in Q12007, with the

aim of confirming the enhanced pharmacological profile of subcutaneous

BELEROFON®.

BELEROFON® has been designed and developed using Nautilus Biotech's

proprietary technology for protein engineering. It carries a single

amino-acid substitution that renders the molecule highly resistant to

proteases in blood and tissues, whilst its activity level and profile remain

equivalent to native IFN alpha. Animal studies have shown that the

particular mutation carried by BELEROFON® confers longer half-life and an

improved pharmacokinetic profile after subcutaneous administration compared

to established pegylated and non-pegylated IFN alpha products. At the same

time, the level of biological activity of the native IFN alpha, which is

significantly lower in pegylated products, is fully maintained in

BELEROFON®.

The improved pharmacokinetic profile of BELEROFON® is designed for

once-a-week subcutaneous administration, which is the same as pegylated

products currently available. However, because BELEROFON® has been shown

to maintain a high level of activity, it is expected that it will be

possible to administer the new drug at lower doses compared to established

pegylated IFN alpha products. These factors should result in better safety

and tolerability and greater patient compliance.

" This milestone reached with BELEROFON® is a key step in our commitment to

develop innovative, high value and best-in-class therapeutic proteins. This

is just the beginning of a sustained effort to aggressively move our

pipeline of proprietary products into the clinic. " Said Nautilus Biotech

CEO, Vega.

" We believe BELEROFON® can be given at a significantly lower dose compared

to the current gold standard of care and this will give it an important

competitive advantage over established pegylated IFN alpha products.

Nautilus Biotech's technology has wide applicability across many therapeutic

protein families. Increasing resistance to proteolysis offers important

improvements in drug profiles and has the potential to create highly

differentiated therapeutic products with better patient compliance. " Said

VP Strategy.

Notes to Editors:

About BELEROFON®

BELEROFON® is Nautilus Biotech's proprietary variant of human IFN alpha

that involves a single amino-acid change compared to native IFN alpha. The

single point mutation introduced to create BELEROFON® has been

specifically designed to increase the resistance of the entire molecule to

proteolysis in blood, tissues and in the intestine. The increased resistance

to proteolysis leads to a significantly improved pharmacokinetic and

pharmacodynamic profile.

BELEROFON® shows the high biological activity associated with native IFN

alpha, which is significantly greater than for pegylated derivatives.

BELEROFON® is a non-pegylated, non-chemically modified, highly active,

long-lasting in serum human interferon alpha.

About Nautilus Biotech

Nautilus Biotech is a drug discovery company with a pipeline of

next-generation therapeutic proteins with superior pharmacological profiles

that address unmet clinical needs. The Company's protein engineering

technology can significantly improve the pharmacological characteristics of

important blockbuster protein drugs, offering improvements in drug stability

and administration. The Company is also creating proprietary 'third

generation' therapeutic proteins which are, per se, suitable for oral

administration.

The therapeutic proteins market is currently valued at over US$30bn, and

growing at a rate of 10-15% per annum. Nautilus has created a portfolio of

next-generation therapeutic proteins with improved profiles, including long

lasting Interferon alpha (Belerofon®), hGH (Vitatropin), Interferon

beta, Clotting Factor IX, Erythropoietin, Interferon gamma and HMG-B1; it

has established a strong intellectual property position covering enhanced

versions of these multibillion dollars molecules and is rapidly moving these

products towards clinical phases.

Nautilus Biotech is a private company with headquarters in Genopole®

biopark, (Evry, France). For more information about Nautilus Biotech visit

www.nautilusbiotech.com

For more information please contact:

At Nautilus Biotech:

Dr Vega, CEO

Nautilus Biotech SA

1 rue Pierre Fontaine

91000 Evry, France

Tel: +33-(0)1-60-87-54-60

Fax: +33-(0)1-60-87-54-61

Email: mvega@...

Media relations:

At Northbank Communications

Lorna , Account Director

Northbank Communications Ltd

The Media Village, 131-151 Great

Titchfield Street,

London, W1W 5BB, UK

Tel: +44-(0)20-3008-7559

Fax: +44-(0)20-3008-7551

Email: l.watson@...

Nautilus Biotech

For more information please contact: At Nautilus Biotech: Dr Vega,

CEO, Nautilus Biotech SA, 1 rue Pierre Fontaine, 91000 Evry, France, Tel:

+33-(0)1-60-87-54-60, Fax: +33-(0)1-60-87-54-61, Email:

mvega@.... Media relations: At Northbank Communications,

Lorna , Account Director, Northbank Communications Ltd, The Media

Village, 131-151 Great, Titchfield Street, London, W1W 5BB, UK, Tel:

+44-(0)20-3008-7559,.Fax: +44-(0)20-3008-7551, Email:

l.watson@...

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1107277 & contentty\

pe=sentryarticle & channelID=31

_________________________________________________________________

Find a local pizza place, music store, museum and more…then map the best

route! http://local.live.com

Link to comment
Share on other sites

Nautilus Biotech Announces IND Filing for its Injectable Long-Lasting

Interferon-alpha, Belerofon

PR Newswire Europe (inc. UK Disclose) - Oct. 10, 2006

PARIS, Oct. 10, 2006 /PRNewswire/ -- Nautilus Biotech has announced that it

has submitted an Investigational New Drug (IND) filing to the U.S. Food and

Drug Administration (FDA) for injectable BELEROFON®, its

protease-resistant, long-lasting Interferon (IFN) alpha. The drug candidate

BELEROFON® has therapeutic potential for the treatment of a number of

clinical diseases, including Chronic Hepatitis C. It is expected that it

will be possible to administer the new drug at a significantly lower dose

while maintaining the weekly frequency of the established pegylated IFN

alpha products, resulting in improved safety and patient compliance.

Nautilus expects to commence a Phase 1 study in the US in Q12007, with the

aim of confirming the enhanced pharmacological profile of subcutaneous

BELEROFON®.

BELEROFON® has been designed and developed using Nautilus Biotech's

proprietary technology for protein engineering. It carries a single

amino-acid substitution that renders the molecule highly resistant to

proteases in blood and tissues, whilst its activity level and profile remain

equivalent to native IFN alpha. Animal studies have shown that the

particular mutation carried by BELEROFON® confers longer half-life and an

improved pharmacokinetic profile after subcutaneous administration compared

to established pegylated and non-pegylated IFN alpha products. At the same

time, the level of biological activity of the native IFN alpha, which is

significantly lower in pegylated products, is fully maintained in

BELEROFON®.

The improved pharmacokinetic profile of BELEROFON® is designed for

once-a-week subcutaneous administration, which is the same as pegylated

products currently available. However, because BELEROFON® has been shown

to maintain a high level of activity, it is expected that it will be

possible to administer the new drug at lower doses compared to established

pegylated IFN alpha products. These factors should result in better safety

and tolerability and greater patient compliance.

" This milestone reached with BELEROFON® is a key step in our commitment to

develop innovative, high value and best-in-class therapeutic proteins. This

is just the beginning of a sustained effort to aggressively move our

pipeline of proprietary products into the clinic. " Said Nautilus Biotech

CEO, Vega.

" We believe BELEROFON® can be given at a significantly lower dose compared

to the current gold standard of care and this will give it an important

competitive advantage over established pegylated IFN alpha products.

Nautilus Biotech's technology has wide applicability across many therapeutic

protein families. Increasing resistance to proteolysis offers important

improvements in drug profiles and has the potential to create highly

differentiated therapeutic products with better patient compliance. " Said

VP Strategy.

Notes to Editors:

About BELEROFON®

BELEROFON® is Nautilus Biotech's proprietary variant of human IFN alpha

that involves a single amino-acid change compared to native IFN alpha. The

single point mutation introduced to create BELEROFON® has been

specifically designed to increase the resistance of the entire molecule to

proteolysis in blood, tissues and in the intestine. The increased resistance

to proteolysis leads to a significantly improved pharmacokinetic and

pharmacodynamic profile.

BELEROFON® shows the high biological activity associated with native IFN

alpha, which is significantly greater than for pegylated derivatives.

BELEROFON® is a non-pegylated, non-chemically modified, highly active,

long-lasting in serum human interferon alpha.

About Nautilus Biotech

Nautilus Biotech is a drug discovery company with a pipeline of

next-generation therapeutic proteins with superior pharmacological profiles

that address unmet clinical needs. The Company's protein engineering

technology can significantly improve the pharmacological characteristics of

important blockbuster protein drugs, offering improvements in drug stability

and administration. The Company is also creating proprietary 'third

generation' therapeutic proteins which are, per se, suitable for oral

administration.

The therapeutic proteins market is currently valued at over US$30bn, and

growing at a rate of 10-15% per annum. Nautilus has created a portfolio of

next-generation therapeutic proteins with improved profiles, including long

lasting Interferon alpha (Belerofon®), hGH (Vitatropin), Interferon

beta, Clotting Factor IX, Erythropoietin, Interferon gamma and HMG-B1; it

has established a strong intellectual property position covering enhanced

versions of these multibillion dollars molecules and is rapidly moving these

products towards clinical phases.

Nautilus Biotech is a private company with headquarters in Genopole®

biopark, (Evry, France). For more information about Nautilus Biotech visit

www.nautilusbiotech.com

For more information please contact:

At Nautilus Biotech:

Dr Vega, CEO

Nautilus Biotech SA

1 rue Pierre Fontaine

91000 Evry, France

Tel: +33-(0)1-60-87-54-60

Fax: +33-(0)1-60-87-54-61

Email: mvega@...

Media relations:

At Northbank Communications

Lorna , Account Director

Northbank Communications Ltd

The Media Village, 131-151 Great

Titchfield Street,

London, W1W 5BB, UK

Tel: +44-(0)20-3008-7559

Fax: +44-(0)20-3008-7551

Email: l.watson@...

Nautilus Biotech

For more information please contact: At Nautilus Biotech: Dr Vega,

CEO, Nautilus Biotech SA, 1 rue Pierre Fontaine, 91000 Evry, France, Tel:

+33-(0)1-60-87-54-60, Fax: +33-(0)1-60-87-54-61, Email:

mvega@.... Media relations: At Northbank Communications,

Lorna , Account Director, Northbank Communications Ltd, The Media

Village, 131-151 Great, Titchfield Street, London, W1W 5BB, UK, Tel:

+44-(0)20-3008-7559,.Fax: +44-(0)20-3008-7551, Email:

l.watson@...

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1107277 & contentty\

pe=sentryarticle & channelID=31

_________________________________________________________________

Find a local pizza place, music store, museum and more…then map the best

route! http://local.live.com

Link to comment
Share on other sites

Nautilus Biotech Announces IND Filing for its Injectable Long-Lasting

Interferon-alpha, Belerofon

PR Newswire Europe (inc. UK Disclose) - Oct. 10, 2006

PARIS, Oct. 10, 2006 /PRNewswire/ -- Nautilus Biotech has announced that it

has submitted an Investigational New Drug (IND) filing to the U.S. Food and

Drug Administration (FDA) for injectable BELEROFON®, its

protease-resistant, long-lasting Interferon (IFN) alpha. The drug candidate

BELEROFON® has therapeutic potential for the treatment of a number of

clinical diseases, including Chronic Hepatitis C. It is expected that it

will be possible to administer the new drug at a significantly lower dose

while maintaining the weekly frequency of the established pegylated IFN

alpha products, resulting in improved safety and patient compliance.

Nautilus expects to commence a Phase 1 study in the US in Q12007, with the

aim of confirming the enhanced pharmacological profile of subcutaneous

BELEROFON®.

BELEROFON® has been designed and developed using Nautilus Biotech's

proprietary technology for protein engineering. It carries a single

amino-acid substitution that renders the molecule highly resistant to

proteases in blood and tissues, whilst its activity level and profile remain

equivalent to native IFN alpha. Animal studies have shown that the

particular mutation carried by BELEROFON® confers longer half-life and an

improved pharmacokinetic profile after subcutaneous administration compared

to established pegylated and non-pegylated IFN alpha products. At the same

time, the level of biological activity of the native IFN alpha, which is

significantly lower in pegylated products, is fully maintained in

BELEROFON®.

The improved pharmacokinetic profile of BELEROFON® is designed for

once-a-week subcutaneous administration, which is the same as pegylated

products currently available. However, because BELEROFON® has been shown

to maintain a high level of activity, it is expected that it will be

possible to administer the new drug at lower doses compared to established

pegylated IFN alpha products. These factors should result in better safety

and tolerability and greater patient compliance.

" This milestone reached with BELEROFON® is a key step in our commitment to

develop innovative, high value and best-in-class therapeutic proteins. This

is just the beginning of a sustained effort to aggressively move our

pipeline of proprietary products into the clinic. " Said Nautilus Biotech

CEO, Vega.

" We believe BELEROFON® can be given at a significantly lower dose compared

to the current gold standard of care and this will give it an important

competitive advantage over established pegylated IFN alpha products.

Nautilus Biotech's technology has wide applicability across many therapeutic

protein families. Increasing resistance to proteolysis offers important

improvements in drug profiles and has the potential to create highly

differentiated therapeutic products with better patient compliance. " Said

VP Strategy.

Notes to Editors:

About BELEROFON®

BELEROFON® is Nautilus Biotech's proprietary variant of human IFN alpha

that involves a single amino-acid change compared to native IFN alpha. The

single point mutation introduced to create BELEROFON® has been

specifically designed to increase the resistance of the entire molecule to

proteolysis in blood, tissues and in the intestine. The increased resistance

to proteolysis leads to a significantly improved pharmacokinetic and

pharmacodynamic profile.

BELEROFON® shows the high biological activity associated with native IFN

alpha, which is significantly greater than for pegylated derivatives.

BELEROFON® is a non-pegylated, non-chemically modified, highly active,

long-lasting in serum human interferon alpha.

About Nautilus Biotech

Nautilus Biotech is a drug discovery company with a pipeline of

next-generation therapeutic proteins with superior pharmacological profiles

that address unmet clinical needs. The Company's protein engineering

technology can significantly improve the pharmacological characteristics of

important blockbuster protein drugs, offering improvements in drug stability

and administration. The Company is also creating proprietary 'third

generation' therapeutic proteins which are, per se, suitable for oral

administration.

The therapeutic proteins market is currently valued at over US$30bn, and

growing at a rate of 10-15% per annum. Nautilus has created a portfolio of

next-generation therapeutic proteins with improved profiles, including long

lasting Interferon alpha (Belerofon®), hGH (Vitatropin), Interferon

beta, Clotting Factor IX, Erythropoietin, Interferon gamma and HMG-B1; it

has established a strong intellectual property position covering enhanced

versions of these multibillion dollars molecules and is rapidly moving these

products towards clinical phases.

Nautilus Biotech is a private company with headquarters in Genopole®

biopark, (Evry, France). For more information about Nautilus Biotech visit

www.nautilusbiotech.com

For more information please contact:

At Nautilus Biotech:

Dr Vega, CEO

Nautilus Biotech SA

1 rue Pierre Fontaine

91000 Evry, France

Tel: +33-(0)1-60-87-54-60

Fax: +33-(0)1-60-87-54-61

Email: mvega@...

Media relations:

At Northbank Communications

Lorna , Account Director

Northbank Communications Ltd

The Media Village, 131-151 Great

Titchfield Street,

London, W1W 5BB, UK

Tel: +44-(0)20-3008-7559

Fax: +44-(0)20-3008-7551

Email: l.watson@...

Nautilus Biotech

For more information please contact: At Nautilus Biotech: Dr Vega,

CEO, Nautilus Biotech SA, 1 rue Pierre Fontaine, 91000 Evry, France, Tel:

+33-(0)1-60-87-54-60, Fax: +33-(0)1-60-87-54-61, Email:

mvega@.... Media relations: At Northbank Communications,

Lorna , Account Director, Northbank Communications Ltd, The Media

Village, 131-151 Great, Titchfield Street, London, W1W 5BB, UK, Tel:

+44-(0)20-3008-7559,.Fax: +44-(0)20-3008-7551, Email:

l.watson@...

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1107277 & contentty\

pe=sentryarticle & channelID=31

_________________________________________________________________

Find a local pizza place, music store, museum and more…then map the best

route! http://local.live.com

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