Nutri Pharma ASA to launch a voluntary offer for vaccine developer Bionor Immuno AS
Oslo, 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 more than 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
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”).
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.
* 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 and at 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.
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.
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)
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