New Once Weekly Oral Interferon Belerofon in Phase 1

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New Once Weekly Oral Interferon Belerofon in Phase 1

According to the Datamonitor, the HCV market is expected to grow to

$4.4 billion in 2010 and $8.8 billion in 2015. Nautilus Biotech, a

private drug development company, based in France, has commenced a

clinical trial in the U.S., with its investigational subcutaneous

Belerofon, an Interferon-alpha drug in the treatment of Hepatitis C.

French Pride - Nautilus Biotech Begins Clinical Trial In U.S For

Hepatitis C Treatment, Belerofon

Nautilus Biotech, a private drug discovery and development company

based in France, initiated a Phase I clinical trial in the U.S. for

subcutaneous Belerofon, its long-lasting, Interferon-alpha drug, in

the treatment of Hepatitis C.

Belerofon has therapeutic potential for the treatment of a number of

conditions, including chronic Hepatitis C. Currently, there is no

vaccine to prevent Hepatitis C. The Phase I trial will compare four

doses of subcutaneous Belerofon, to subcutaneously administered

IntronA, a Schering-Plough product and Roche's Pegasys. The initial

results of the trial are expected to be released during the third

quarter of 2007. Nautilus Biotech filed an Independent New Drug

application for oral Belerofon in February 2007.

http://www.tradingmarkets.com

Press Release

27 February 2007 - Nautilus Biotech announces IND filing for

Belerofon®, its oral, long-lasting, Interferon-alpha drug.

Paris, France, 27 February 2007, Nautilus Biotech has announced that

it has submitted an Investigational New Drug (IND) filing to the US

Food and Drug Administration (FDA) for oral Belerofon®, its long-

lasting human Interferon (IFN) alpha. Belerofon has therapeutic

potential for the treatment of a number of conditions, including

chronic Hepatitis C. The new drug will be administered orally - all

currently marked interferon alpha drugs are administered by

injection - resulting in improved safety and patient compliance.

This IND filing for oral Belerofon follows Nautilus Biotech's recent

IND filing for injectable Belerofon in October 2006.

Belerofon is a designed variant of IFN-alpha. It has a single point

mutation for lower sensitivity to protease-mediated degradation,

unchanged molecular weight and specific antiviral activity compared

to non-pegylated IFNs. Following subcutaneous (SC) administration in

animals, SC Belerofon shows a longer half-life and subsequently

improved exposure profile compared to native IFN alpha and pegylated

derivatives. Nautilus Biotech has formulated lyophilized Belerofon

together with inactive ingredients to produce enteric coated tablets.

When administered orally, Belerofon shows blood levels comparable to

SC administered native IFN-alpha, which is not orally bioavailable.

Oral bioavailability of Belerofon is based on its low sensitivity to

protease degradation in the intestine which renders the molecule

available for absorption into the bloodstream.

Oral Belerofon is one of a number of proteins being developed by

Nautilus Biotech for oral administration and has been designed and

developed using the company's proprietary technology for protein

engineering.

“We are developing a pipeline of therapeutic proteins aimed at

improving the quality of life of patients through improved safety and

compliance. The IND for oral Belerofon is a major milestone in our

commitment to develop highly innovative, high value and orally

available protein drugsâ€, said Nautilus Biotech's CEO, Vega.

“The IND for oral Belerofon represents a significant advance in

protein therapeutics. The shift from subcutaneous injection to oral

administration marks an important step in the creation of next-

generation products and has wide applicability across many

therapeutic protein familiesâ€, said , Nautilus Biotech's

Vice President Strategy.

About Nautilus Biotech:

Nautilus Biotech is a drug discovery and development 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 $35bn,

and growing at a rate of 10-15% per annum. Nautilus Biotech has

created a portfolio of next-generation therapeutic proteins with

improved profiles, including long-lasting Interferon alpha

(Belerofon), hGH (Vitatropin®), Interferon beta, Erythropoietin,

Interferon gamma, Clotting Factor IX (in collaboration with Wyeth

Pharmaceuticals) and HMGB1 (in collaboration with Creabilis

Therapeutics). Nautilus Biotech has established a strong intellectual

property position covering enhanced versions of these multibillion

dollars molecules and is rapidly moving these products into clinical

development.