Nautilus Biotech announces IND filing for Belerofon, its oral, long-lasting, Interferon-alpha drug

Announced that it has submitted an Investigational New Drug (IND) filing to the US Food and Drug Administration (FDA) for oral Belerofon(r), its long-lasting human Interferon (IFN) alpha.

PARIS, France | Feb 27, 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(r), 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 drugs", said Nautilus Biotech's CEO, Manuel 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 families", said Paul Martin, Nautilus Biotech's Vice President Strategy.

About Hepatitis C

Hepatitis C (HCV) is the most prevalent liver disease in the world. HCV infection causes chronic inflammation in the liver that can lead to cirrhosis, liver failure, liver cancer or death. HCV infection represents a significant medical challenge worldwide. Currently, there is no vaccine that can prevent hepatitis C. According to the World Health Organization, more than 170 million people worldwide suffer from chronic HVC. With only half of all HCV patients benefiting from current therapy, there is considerable market potential for new medical solutions. The HCV market is expected to grow from $2.2 billion in 2005 to $4.4 billion in 2010 and $8.8 billion in 2015 due to improved market penetration and improved diagnosis rates (source: Datamonitor).

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(r)), 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 dollar molecules and is rapidly moving these products into clinical development.

Nautilus Biotech is a private company with headquarters in Genopole(r) biopark, (Evry, France). For more information about Nautilus Biotech visit <>

SOURCE: Nautilus Biotech

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