Nutri Pharma ASA to launch a voluntary offer for vaccine developer Bionor Immuno AS

Dienstag, 12.01.2010 09:00 von Hugin - Aufrufe: 178

This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
(Oslo, January 12, 2010) Nutri Pharma ASA ("Nutri Pharma") to submit a voluntary
exchange offer ("Offer") for all outstanding shares in Bionor Immuno AS
("Bionor"). The shareholders of Bionor will be offered 1 Nutri Pharma share per
2 shares in Bionor.
 
The proposed acquisition will combine two strong R&D traditions into one
integrated bio-technology company, leveraging Nutri Pharma's network and
commercialization experience with Bionor's unique platform technology and R&D
pipeline. The transaction will provide the shareholders of Nutri Pharma with
access to an exciting research portfolio, proven proprietary technology, and
candidates with blockbuster sales potential (revenue > USD 1bn p.a.) and the
ability to positively impact the lives of millions affected by chronic viral
infections.
 
- The offer represents a unique opportunity for the shareholders of Nutri Pharma
to take part in a potential breakthrough development within the field of
vaccines. We are very excited about the prospects and results of the trials and
research undertaken and we look forward to taking part in the upcoming
commercialization process and in bringing these very important products to the
market, says Trond Syvertsen, CEO of Nutri Pharma ASA.
 
About Bionor Immuno AS:
Bionor Immuno AS was spun out as a separate entity from Bionor AS in 2000 based
on the diagnostic research carried out on the HIV-virus since 1985. The
proprietary patent protected peptide-based technology resulted in the first HIV
vaccine candidate (Vacc-4x) entering Phase I clinical trials in 1999.
 
Bionor Immuno AS has developed a novel vaccine platform technology that has been
tested positively in Phase I and II clinical studies. The unique vaccine
candidates under development can be used both for preventative and therapeutic
purposes.
 
The results obtained and the technology developed are regarded as very promising
according to statements from leading members of the medical community. The 88
approved patents, assembled in three patent families, protect the Intellectual
Property in addition to one patent family application, and further patent
applications that will be submitted once Phase I clinical study data are
completed for new therapeutic indications. Furthermore, the company also
controls undisclosed proprietary technology.
 
·         In 2001-03 Vacc-4x was tested in a Phase IIa clinical trial with very
encouraging results, providing patients with prolonged periods off traditional
anti-viral treatment without displaying concerning side-effects. Vacc-4x allowed
patients to interrupt anti-viral therapy for a median time of 31 months as
compared to the expected 3-5 months.
·         In 2003-04 Vacc-5q, with similarities to and providing a back up to
Vacc-4x, entered into a Phase I/II clinical trial showing similar strong immune
responses to that induced by Vacc-4x,.
·         In 2008 Vacc-4x entered into a Phase IIb placebo controlled clinical
study that investigates the effect of Vacc-4x in a larger group of patients,
providing safety and efficacy data and with the objective of confirming the
previous Phase IIa study. The Phase IIb study will be completed in July 2010 and
results are expected in the 4th Quarter of 2010. Based on the results of the
clinical trial the company will evaluate strategic options, including entering
into a potential partnership with a large pharmaceutical company.
·         A re-vaccination study, with patients from the 2001 Phase IIa trial,
is ongoing with results expected in June 2010.
 
The technology represents a completely new and unique approach to vaccination.
The modified vaccine effectively targets the core of the virus, i.e. the
structure containing the genetic information, and is capable of triggering a
cell-mediated immune response effective against rapidly mutating and tolerance
inducing viruses, two properties that help the virus to escape vaccines of
traditional technology. There are no known competing products using a similar
approach to that of Bionor Immuno´s..
 
The technology is applicable to a wide variety of virus species, and the company
has a well developed preclinical pipeline consisting of candidate vaccines for
Hepatitis C virus (HCV), Influenza virus and therapeutic Human Papillomavirus
(HPV) - all products with blockbuster potential. Open label Phase I/II clinical
data on Bionor`s vaccine for HCV are expected in 2011 and the vaccine candidate
for Influenza will be selected 2010.
 
Offer terms, details and timetable
Shareholders in Bionor will be offered 1 Nutri Pharma share per 2 shares in
Bionor. A maximum of 44,649,266 new Nutri Pharma shares will be issued as
remuneration for the shares in Bionor. The shares in Nutri Pharma will be issued
following approval by the extraordinary general meeting of Nutri Pharma, to be
held on or about 4 February 2010. The new shares will be listed when the
prospectus regarding issuance of the shares has been approved by the Oslo Stock
Exchange.
 
The complete details of the Offer, including all terms and conditions, will be
contained in an offer document (the "Offer Document") to be sent to eligible
Bionor shareholders. The Offer shall be outstanding, and any accepting
shareholders shall be bound by their acceptance until the earlier of (i) the
date at which Nutri Pharma announces that it will not complete the Offer, and
(ii) March 31, 2010 (the "Cut-Off Date").
 
Conditions:
 
Completion of the offer will be subject to satisfaction of customary conditions
which include inter alia:
 
·         The successful completion of a share offering in Nutri Pharma raising
a minimum of NOK 50 million, to fund completion of Phase IIb clinical trial,
initiation of Phase IIa trial and ongoing pre-clinical activity
·         Acceptance by a minimum of 95 % of Bionor shareholders. Shareholders
representing 63 % of Bionor's share capital have pre-committed to accept the
indicated Offer, including the Board of Directors.
·         Agreement with Bionor's creditor to write-down the company's debts
from NOK 43.6 million to NOK 20 million.
·         Satisfactory due diligence investigation of Bionor.
·         Approval by the shareholders of Nutri Pharma.
 
Timeline:
 
·         The Voluntary Offer will commence on January 13, 2010 and the Offer
Period is expected to last until January 20, 2010.
·         Settlement will take place when the conditions under the offer are
fulfilled or waived, at the latest by 31 March 2010.
 
Exclusivity agreement and Board support
Bionor have entered into an agreement giving Nutri Pharma exclusivity in
relation to transactions involving an offer for the shares of Bionor, or any
other type of transaction reasonably determined to be a competing offer until
March 31, 2010.
 
The Board of Directors of Bionor has issued a strong written recommendation to
the offer put forth by Nutri Pharma and remains supportive of the ongoing
process.
 
- I continue to be very enthusiastic about the portfolio of therapeutic vaccine
candidates based on Bionor Immuno's platform technology, especially given their
potential to meet significant unmet medical needs. The proposed transaction with
Nutri Pharma will significantly strengthen our ability to fund their
development, and equally importantly create a company with both commercial and
product development capabilities, as well as a better balanced and diversified
R&D portfolio, says Douglas Watson, Chairman of the Board of Bionor.
 
Analyst, press, and investor presentation
A presentation of the transaction will be held today, January 12, at Hotel
Continental at 11:00 CET (see enclosed presentation). Light refreshments will be
served. The taped presentation will be made available to investors at
www.nutripharma.com <http://www.nutripharma.com/> and at www.hegnar.no
<http://www.hegnar.no/>
 
Advisors and legal counsel
Pareto Securities is acting as financial advisor and Wikborg Rein & Co is acting
as legal counsel to Nutri Pharma ASA. Bugge, Arentz-Hansen & Rasmussen (BAHR) is
acting as legal counsel to Bionor Immuno AS.
 
Contact information
 
Trond Syvertsen
CEO, Nutri Pharma ASA
Tel: +47 23 01 09 60
Email: syvertsen@nutripharma.com
 
Nutri Pharma ASA
Nutri Pharma ASA (ticker: NUT) is a public limited company under Norwegian law.
Incorporated in January 1993, it was listed on the Oslo Stock Exchange in May
2000. Since its establishment in 1993, Nutri Pharma has become one of the
leaders in soy technology for treatment and prevention of life-style related
diseases. It has developed a number of unique patented products in the following
fast growing areas:
  •           Weight management & meal replacement products
  •           Dietary supplements for heart health, female health and sports
    nutrition
  •           Functional foods for cholesterol reduction
    In 2005, Nutri Pharma began realigning its operations in accordance with a new
    business model. This involves changing its main distribution focus from
    international cooperative relationships to direct sales. In 2008, Nutri Pharma
    entered into a Distribution, Product Supply and Marketing support agreement with
    Nikken UK Ltd. for the European launch of it Nutri5® female health product
    through Nikken's direct marketing network. Nutri5® was subsequently launched
    into 17 European markets in May 2009.
     
    Bionor Immuno AS
    Bionor Immuno AS was established on July 14, 2000 and is a Norwegian based
    biomedical company focused on discovery and development of novel vaccines
    through an innovative platform technology for immune modulating therapeutic
    agents. The Company has developed a unique proprietary platform for peptide
    derived vaccines. By improving the immune response through peptide modifications
    the Company can target diseases associated rapidly mutating viruses and thereby
    satisfy documented unmet medical needs. Bionor Immuno. The Company is the
    successor to Bionor AS, founded in 1985 to create low-cost tests for HIV and
    other infectious diseases for emerging markets.The Company's proprietary
    technology involves innovative design of patented modified peptides as the basis
    for therapeutics that target viral-based diseases. The technology is
    particularly suitable for viruses that exhibit extreme antigenic variation such
    as human immunodeficiency virus (HIV), hepatitis C virus (HCV), and influenza
    virus. In 2008 the company had an operating income of NOK 192 000, a net loss of
    NOK 21. 4 million and NOK 132 million in assets and 69.5 million in total
    liabilities.
     
    [HUG#1372456]
     
    Presentation: http://hugin.info/131219/R/1372456/336152.pdf
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