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Newly formed company to focus on creating critical R&D and manufacturing infrastructure and supplying biodefense countermeasures within Asia and other territories.

ROCKVILLE, Md. & PUTRAJAYA, Malaysia — Emergent BioSolutions (NYSE: EBS) and Ninebio Sdn. Bhd. (”9Bio”)

today announced the formation of a joint venture in Malaysia that will focus on creating critical biologics infrastructure and supplying biodefense countermeasures, including BioThrax[R] (Anthrax Vaccine Adsorbed), and other medical and complementary products and services to the Government of Malaysia. It is anticipated that the joint venture will also supply such products and services to certain member countries of the Organisation of the Islamic Conference (”OIC”) and other countries within Asia. 9Bio is a Malaysian Government owned company and one of the National Institutes of Health under the Ministry of Health. 9Bio is fully funded by the Government of Malaysia. The Government of Malaysia, through 9Bio, has selected Emergent BioSolutions as one of its principal partners to assist, as a contract service provider, in building vaccine development and manufacturing infrastructure. The joint venture will be majority owned by Emergent BioSolutions.

“This joint venture is a step towards our objective to obtain vaccine development and manufacturing capabilities as well as bio-terrorism preparedness. I am very proud that 9Bio has been entrusted to serve as an extension of the Malaysian Government’s implementation of these critical objectives. Emergent BioSolutions is the most appropriate partner for 9Bio for this venture and I am confident that the new company will exemplify both expertise and experience in this area,” said chief executive officer of 9Bio, Datuk Dr. Nor Shahidah Khairullah. “We are looking forward to working very closely with the Ministry of Health and other agencies in Malaysia in developing and implementing this plan.”

“We are honored to partner with 9Bio for this important joint venture and to have been selected by the Government of Malaysia to provide these important services. It is our belief that this joint venture will not only expand the use of our anthrax vaccine in this market, but will also serve as a platform for joint product development and manufacturing activities,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Emergent BioSolutions applauds the Malaysian Government’s support of a public-private partnership approach to growing the Malaysia biotechnology sector and we welcome the opportunity to play a pivotal role in the implementation of its plan.”

Witnessing the signing ceremony, Director General of the Malaysian Ministry of Health, Tan Sri Datuk Dr Haji Ismail Merican affirmed that through 9Bio, one of the National Institutes of Health in Malaysia, the Ministry of Health would be able to focus on developing and manufacturing biologics, biosecurity and bioterrorism countermeasures for Malaysia.

About Ninebio

Ninebio Sdn. Bhd. is a Malaysian Government owned company, and as one of the National Institutes of Health, under the Ministry of Health, is focused on the research and development of vaccines, natural products and biologics. Its vision is to “drive innovation solutions for a healthier world.” One of the focus areas of development is in biosecurity and bioterrorism counter-measures. 9Bio is currently cementing strategic alliances with companies that meet its needs. 9Bio is constructing its research and development and secondary manufacturing facility in Bandar Enstek, Negeri Sembilan, Malaysia. It is expected to be completed by 2010. Pending the completion of its facilities, 9Bio intends to procure and distribute vaccines, natural products and biologicals to customers in the ASEAN region thereby building its brand name. 9Bio is primarily funded by the Government of Malaysia.

About Emergent BioSolutions Inc

Emergent BioSolutions Inc is a profitable, multinational biopharmaceutical company dedicated to one simple mission – to protect life. We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease and other medical conditions that have resulted in significant unmet or under deserved public health needs. Our marketed product, BioThrax[R] (Anthrax Vaccine Absorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. More information on the company is available at www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, prospects, plans and objectives of management, including development plans, and any other statements containing the words “believes,” “expects,” “anticipates,” “plans,” “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including the rate and degree of market acceptance and clinical utility of products; ability to identify and acquire or in license products and product candidates that satisfy selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in Emergent’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and subsequent reports filed with the SEC. Emergent disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Source :http://www.allbusiness.com/company-activities-management/company-strategy/6597937-1.html

Emergent BioSolutions Inc. (NYSE:EBS) and Protein Sciences Corporation (PSC), based in Meriden, Connecticut, announced that the two companies have entered into an asset purchase agreement under which Emergent will acquire PSC’s ongoing operations, including FluBlok, a Phase III recombinant influenza vaccine candidate, and certain other assets. This agreement achieves a key component of Emergent’s stated strategy for growth through acquisition of late-stage product candidates.

Under the terms of the agreement, Emergent will acquire substantially all assets of PSC, including:

- FluBlok® (trivalent recombinant hemagglutinin vaccine). FluBlok is a Phase III influenza vaccine candidate that, if approved, would be the first recombinant cell culture influenza vaccine. FluBlok has potential for use in both seasonal and pandemic settings. The clinical program for FluBlok, which includes four trials and more than 6,000 participants, has demonstrated promising immunogenicity, including in the elderly. FluBlok has been granted both fast track status and priority review by FDA.

- Baculovirus Expression Vector System (BEVS) technology. BEVS is a cell culture-based manufacturing platform used to manufacture FluBlok. The BEVS technology can be applied to develop vaccines and therapeutic candidates to prevent or treat a wide range of diseases.

- Other product candidates. PSC’s other product candidates are based on the BEVS platform and include a SARS vaccine in preclinical development.

- A vaccine manufacturing facility. This facility is located in Meriden, Connecticut and includes a 600-liter bioreactor and related upstream and downstream capabilities.

Emergent intends to retain all of the approximately 50 PSC employees and anticipates continuing production of FluBlok in the Meriden, Connecticut facility. Emergent expects to launch out of this location. In parallel, Emergent is evaluating plans for future large-scale manufacturing of FluBlok and is considering Meriden as a site for the facility.

In April 2008, PSC submitted to FDA a Biologics License Application (BLA) for FluBlok, including data from the Phase III clinical program. The next steps in the BLA process include readiness preparations for the upcoming FDA pre-approval inspection. In addition, late last year, PSC applied for a research and development grant in response to a  (BARDA) RFP, “Advanced Development of Recombinant Influenza Virus Vaccines.” BARDA has indicated its intention to issue one or more awards under this RFP in late 2008.

“We are delighted about the opportunity to commercialize the first recombinant cell culture influenza vaccine. We believe that FluBlok will become a strong competitive product in the sizeable and growing seasonal influenza market and that BEVS will provide a unique platform for the development of a novel pandemic influenza candidate. We congratulate the management of PSC in building a manufacturing operation and for bringing FluBlok through a Phase III clinical trial to the point of a BLA submission. Emergent, with the combined resources of PSC, is well positioned to bring this exciting product to the market successfully, based on our product development, regulatory and manufacturing experience,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “The acquisition of FluBlok is consistent with Emergent’s strategy of expanding its product portfolio with a vaccine candidate focused on a major infectious disease.”

Daniel D. Adams, president and chief executive officer of Protein Sciences Corporation, said, “We are grateful that Emergent recognized the value of our lead product, FluBlok, and our proprietary BEVS technology and is providing financial and operational assistance to assist us in bringing FluBlok through regulatory approval. Combining our expertises should help to ensure the continued success of FluBlok and our other strategic assets.”

William H. Narwold, chairman of the board of directors of Protein Sciences Corporation, commented, “Emergent enhances our regulatory, manufacturing and process development capabilities and brings a proven track record of working with the United States Government to deliver critical infectious disease products. It is for these reasons that the Board of Directors of Protein Sciences has approved this transaction and believes that our shareholders will have the opportunity to benefit from the continued growth and success of Emergent BioSolutions.”

Terms of Acquisition

Under the terms of the asset purchase agreement, the consideration paid by Emergent will include:

- Up to $28 million in cash and the assumption of PSC liabilities, including trade payables associated with the Phase III clinical trials of FluBlok;

- A $20 million, 4.75%, 5-year note, convertible into Emergent common stock at a conversion price of $12.50 per share;

- Up to $30 million in future payments based on the achievement of FluBlok commercialization milestones and net sales of FluBlok;

- A percentage of net sales of FluBlok.

The closing of this transaction, anticipated by the end of the second quarter of this year, is subject to the approval of the stockholders of PSC, the receipt of regulatory approvals and the satisfaction of certain conditions of closing. Emergent BioSolutions’ financial advisor on this transaction was Jefferies & Company, with Thelen Reid Brown Raysman & Steiner LLP as primary legal counsel. PSC’s financial advisor on this transaction was BMO Capital Markets, with Brenner, Saltzman & Wallman, LLP as legal counsel.

Update on Emergent BioSolutions 2008 Financial Guidance

As Emergent evaluates the impact of this acquisition on current year financial guidance, management expects revenue for 2008 to remain unchanged, between $180 and $195 million. With respect to net income, management is still evaluating current forecasts related to PSC’s anticipated operating costs as well as the appropriate accounting treatment for the acquisition. Management expects to be in a position to update guidance for 2008 net income when the company reports financial results for the second quarter of 2008, anticipated during early August.

About the Influenza Market

According to industry reports, there are 1 billion cases of influenza each year, resulting in 250,000 to 500,000 deaths, world-wide. In the US alone, there are an estimated 15 million to 60 million cases and 30,000 to 40,000 deaths annually, making influenza a major public health concern. Young children and the elderly are at a particularly high risk of infection and complications.

About FluBlok®

FluBlok is a novel recombinant subunit influenza vaccine manufactured in a cell culture medium, which represents the next-generation in flu vaccine technology. The currently licensed flu vaccines are manufactured through egg-based technology, which presents numerous operational and market challenges. FluBlok consists of three recombinant hemagglutinin (rHA) proteins derived from the flu strains selected by the World Health Organization and the U.S. Centers for Disease Control and Prevention for each year’s seasonal flu vaccine. These proteins are produced in a proprietary cell culture and formulated without preservatives, adjuvants, or antibiotics. FluBlok has been developed as a single-dose vaccine to be administered intramuscularly. In clinical trials, FluBlok has demonstrated promising immunogenicity in both healthy adults and the elderly, with a positive safety profile. Preliminary evidence of protection against influenza disease has been observed in adults, as published in the April 2007 issue of JAMA® (The Journal of the American Medical Association).

About BEVS

The Baculovirus Expression Vector System (BEVS) is recognized as a robust and versatile tool for producing a variety of functional recombinant proteins. The BEVS manufacturing process begins by cloning the gene for the desired target protein into a virus capable of infecting insect cells (baculovirus). When these genetically engineered baculoviruses are used to infect insect cell cultures, these cells are “programmed” to manufacture the desired proteins.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a profitable biopharmaceutical company dedicated to one simple mission-to protect life. We develop, manufacture and commercialize vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Our products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.