Monday, January 3, 2011

Fuad El-Hibri has lived in all sorts of exotic locales, working for Citicorp in Saudi Arabia, consulting for Booz Allen Hamilton in Indonesia and establishing mobile telecommunications businesses in Russia, Venezuela and El Salvador.

But getting started in his current position as chief executive of Rockville-based pharmaceutical company Emergent BioSolutions took him to a far more mundane location. It was at a public auction in Lansing, Mich., in 1998 that El-Hibri offered a $25 million package of cash and commitments to privatize a government facility that was producing an anthrax vaccine.

Since then, he’s built what is now known as Emergent into a local pharmaceutical company that posted earnings of $31.1 million last year.

El-Hibri took an unusual path into the industry, spending much of his career in telecommunications. Born to a Lebanese father and German mother, he split his childhood between Lebanon and Germany before attending Stanford University. El-Hibri quickly moved on to a graduate degree, heading to Yale’s business school.

Though he wanted to start his own business, El-Hibri wanted to gain experience first. After marrying, he and his wife moved to Saudi Arabia so El-Hibri could work for Citicorp. After several years, he moved to consulting giant Booz Allen Hamilton and spent about three years in Jakarta, Indonesia. In one instance, he helped a state-owned petroleum company in Malaysia open up mini-convenience stores alongside its gas stations.

By the late 1980s, El-Hibri was ready to return to the United States, where he opened his own Potomac-based consulting firm. He quickly began working with the Moscow City Telephone Network and helped the company build and implement a mobile telecommunications network that’s still in use today. Partnering with his father — who had worked in telecommunications — El-Hibri eventually sold his interest in the firm and reinvested in a Venezuelan mobile network. He repeated the work in El Salvador.

What made El-Hibri different from other entrepreneurs was his interest in not just making money but also integrating the business into the local economy, said Brian Kim, whose company invested with El-Hibri in both his Venezuelan and El Salvadoran enterprises.

“He had a real sense that the company had [to do] something else — other than creating value for its shareholders,” Kim said. “He took a very local approach.”

Not long after, El-Hibri got involved with a business venture to sell $50 million worth of anthrax vaccine to the Saudi Arabian government, which was worried about its troops. He immediately took an interest in the field, and, after leading a management buyout of a biotechnology firm in Britain, El-Hibri set out to purchase the only facility producing a Food and Drug Administration-licensed anthrax vaccine in the United States.

He headed to Lansing, where the governor had announced the state would privatize its facility, which also had a licensed rabies vaccine, among others. El-Hibri and his partners submitted the winning bid and began renovating the facility, which was relicensed in 2001.

Emergent, which has its corporate headquarters in Rockville, soon added locations, which now extend from Seattle to Munich to Singapore. Best known for its anthrax vaccine, for which it received in July a contract worth up to $107 million, Emergent is also working on a pandemic flu vaccine and a tuberculosis vaccine.

The most recent contract, from the Department of Health and Human Services Office of the Biomedical Advanced Research and Development Authority, is meant to ready the vaccine for large-scale manufacture.

But El-Hibri doesn’t plan to end his career with pharmaceuticals and said he’d next like to work in the environmental field. (In 2001, El-Hibri launched the El-Hibri Charitable Foundation, which focuses on interfaith dialogue and peace education.)

Roberto Smith-Perera, a former minister of transport and communications in Venezuela who partnered with El-Hibri on both the Venezuelan and El Salvadoran cellular businesses, credited El-Hibri’s geographically and culturally diverse background with teaching him how to handle virtually any kind of business.

He’s the kind of person “that specializes in not . . . being a specialist,” said Smith-Perera. “He’s the ultimate project developer.”

Reprinted from the January 3, 2011 edition of  The Washington Post

Related posts:

1. Emergent BioSolutions Chairman and CEO Fuad El-Hibri Appointed to U.S. Chamber of Commerce Board of Directors ROCKVILLE, Md., Jun 13, 2011 (BUSINESS WIRE) — Emergent BioSolutions...
2. Emergent BioSolutions to Release Fourth Quarter and Full Year 2010 Financial Results and Conduct a Conference Call on March 10, 2011 ROCKVILLE, Md., Feb 24, 2011 (BUSINESS WIRE) — Emergent BioSolutions...
3. Emergent BioSolutions to Present Today at Needham & Company Healthcare Conference Emergent BioSolutions Inc. (NYSE: EBS) will be webcasting its presentation...

Related posts brought to you by Yet Another Related Posts Plugin.

Along with colleagues from industry, education, and government, Fuad El-Hibri is a member of the IBRA Board of Directors. The Alliance helps provide opportunities for students to build and develop important elements of scientific leadership, giving students the opportunity to grow into exceptional biomedical research leaders. IBRA firmly believes in the ability of outstanding researchers to transform today’s promise of cures and treatments into available therapies, drugs and prevention measures that enhance the world’s health.

Since its inception in 2000, the Scholars program has recruited gifted, inquiring, creative and dedicated minds for a uniquely designed doctoral program of training and investigative, exploration to challenges some of the worlds greatest minds to achieve IBRA’s main goal to create the premier PhD and MD/PhD program.

Related posts:

1. Fuad El-Hibri and the Heifetz International Music Institute The Heifetz International Music Institute was established by Daniel Heifetz and...
2. Emergent BioSolutions Chairman and CEO Fuad El-Hibri Appointed to U.S. Chamber of Commerce Board of Directors ROCKVILLE, Md., Jun 13, 2011 (BUSINESS WIRE) — Emergent BioSolutions...
3. Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions...

Related posts brought to you by Yet Another Related Posts Plugin.

Emergent BioSolutions is offering call participants a pre-registration option that expedites access to the call and minimizes hold times. Pre-registrants will be issued a pin number to be used when dialing into the live call which will provide quick access to the conference call by bypassing the operator upon connection. Pre-registration, while not mandatory, can be accessed using the following website: https://www.theconferencingservice.com/prereg/key.process?key=PNP49E4W7.

A replay of the conference call will be accessible, approximately one hour following the conclusion of the call, by dialing 888/286-8010 or 617/801-6888 and using the passcode 97521313. The replay will be available through November 18. The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO, Fuad El-Hibri, is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax^(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

Related posts:

1. Emergent BioSolutions to Release Fourth Quarter and Full Year 2010 Financial Results and Conduct a Conference Call on March 10, 2011 ROCKVILLE, Md., Feb 24, 2011 (BUSINESS WIRE) — Emergent BioSolutions...
2. Emergent BioSolutions to Release Fourth Quarter and Full Year 2011 Financial Results and Conduct a Conference Call on March 8, 2012 ROCKVILLE, Md.–(BUSINESS WIRE)–Jan. 30, 2012– Emergent BioSolutions Inc. (NYSE: EBS)...
3. Emergent BioSolutions Reports Financial Results for First Quarter 2011 ROCKVILLE, Md., May 05, 2011 (BUSINESS WIRE) — Emergent BioSolutionsInc....

Related posts brought to you by Yet Another Related Posts Plugin.

“We applaud the U.S. Government’s commitment to the biodefense industry and to the development of additional medical countermeasures using multiple technologies and additional sites to address the acknowledged anthrax threat,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.  “This award solidifies Emergent’s anthrax franchise and reaffirms our position as a leading supplier to, and developer for, the U.S. government of anthrax biomedical countermeasures. We are enthusiastic about the role we serve in addressing this need and in creating jobs and expanding economies within the local communities where we operate.”

Under the contract, the base value will fund activities related to process characterization and assay validation, as well as formulation and stability studies.  Milestone-based options include completion of a Phase II clinical study and non-clinical efficacy studies, process validation, as well as consistency lot manufacture. Emergent has developed this comprehensive plan as a foundation to advance its rPA anthrax vaccine candidate in preparation for pivotal studies that would potentially lead to licensure application with the U.S. Food and Drug Administration.

The company anticipates recognizing revenues from this award in the fourth quarter of 2010 of approximately $2 million with no major impact on pretax earnings.

Emergent’s rPA anthrax vaccine candidate is a purified recombinant protective antigen protein formulated with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins.  It is based on the pioneering work of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and has been the subject of two research and development grants totaling approximately $100 million by the National Institute of Allergy and Infectious Diseases (NIAID).

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease.  Emergent’s 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.  Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia.  Additional information may be found 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, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, 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 the company’s actual results to differ materially from those indicated by such forward-looking statements, including our ability to win a procurement contract with the U.S. government for our recombinant protective antigen anthrax vaccine candidate; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Related posts:

1. Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June...
2. Emergent BioSolutions’ Investigational Anthrax Vaccine, NuThrax, Granted Fast Track Designation ROCKVILLE, Md., Jun 09, 2011 — Emergent BioSolutions Inc. (NYSE:EBS)...
3. Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions...

Related posts brought to you by Yet Another Related Posts Plugin.

The NIH-Oxford-Cambridge Scholars Program (Scholars Program) was created in 2001 to revolutionize the way in which the most talented biomedical PhD and MD/PhD students are trained. Every pedagogical and logistical element of the Scholars Program was designed to produce scientists who will generate high-impact, breakthrough results at the speed at which science, government and industry must move to meet the demanding healthcare needs of a global population. The Scholars Program trains more “prestige” scholars (Rhodes, Marshall, Churchill, Gates, Howard Hughes Medical, Fulbright, and Goldwater) than any other program in the world. To date, the Scholars Program has produced 45 doctoral graduates and currently has 113 scholars enrolled.

“Emergent is pleased to welcome the future leaders in scientific research and discovery, who are already engaged in and contributing to public health improvement by exhibiting academic excellence,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions and member of the Alliance Board of Trustees. “We congratulate them for their exceptional talent, which brought them to the scholars program and which will guide them to its completion.”

“The Alliance is most grateful for Mr. El-Hibri’s private sector perspectives which have helped to shape the values, culture, goals and metrics of success of the Scholars Program,” said Ann Marie Drucker, Alliance President.

Over 35 scholars participated in the symposium and laboratory tour that was held at Emergent’s product development facility in Gaithersburg, Maryland.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

About the International Biomedical Research Alliance

The International Biomedical Research Alliance (Alliance) was created in 2005 as a private, not-for-profit (501(c)(3) providing expertise and resources to assure the NIH-Oxford-Cambridge Scholars Program’s financial viability and unwavering adherence to absolute standards of excellence, continuous innovation and dedication to accelerated discovery for generations to come. In pursuit of its mission, the Alliance provides philanthropic, scientific and industry resources dedicated to developing the NIH-Oxford-Cambridge Scholars Program into the pre-eminent biomedical training pathway for leaders in the life sciences.

Related posts:

1. Emergent BioSolutions Chairman and CEO Fuad El-Hibri Appointed to U.S. Chamber of Commerce Board of Directors ROCKVILLE, Md., Jun 13, 2011 (BUSINESS WIRE) — Emergent BioSolutions...
2. Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June...
3. Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) — Emergent BioSolutions...

Related posts brought to you by Yet Another Related Posts Plugin.

ROCKVILLE, Md., Aug 12, 2010 (BUSINESS WIRE) –

Emergent BioSolutions Inc. (NYSE: EBS) announced today it has entered into a definitive agreement to acquire Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) for upfront consideration of $96.8 million of value and up to $38.7 million of success-based milestones, resulting in a total consideration of up to $135.5 million. The acquisition will diversify Emergent’s product development pipeline with the addition of Trubion’s two clinical-stage product candidates focused on the targeted disease areas of oncology and autoimmunity. The acquisition also offers novel platforms, consisting of proprietary Small Modular Immunopharmaceutic (SMIPTM) and SCORPIONTM technologies, for developing additional innovative therapeutic candidates.
The acquisition of Trubion is expected to further Emergent’s position as a leading, fully integrated biopharmaceutical company focused on the manufacture, development and commercialization of vaccines and antibody therapeutics. Trubion’s clinical and preclinical stage programs, as well as its leading edge science, will expand Emergent’s product development pipeline and significantly broaden its antibody-based capabilities. Upon closing, the transaction is expected to provide approximately $20 million in cash, net of customary closing costs, and $70 million of net operating losses (NOLs) that are expected to be used over the next ten years.
Trubion’s development pipeline is comprised of two clinical-stage therapeutic candidates and multiple preclinical programs, including:

• a clinical-stage CD20 directed SMIP candidate (SBI-087) for the treatment of Rheumatoid Arthritis (Phase 2) and Systemic Lupus Erythematosus (Phase 1/2) in partnership with Pfizer;
• a clinical-stage CD37 targeted SMIP candidate (TRU-016) for the treatment of Chronic Lymphocytic Leukemia (Phase 1/2), Non-Hodgkin’s Lymphoma (Preclinical/Phase 1) in partnership with Abbott; and
• promising preclinical candidates based on the novel, proprietary SMIP and SCORPION platforms for the treatment of selected oncology and autoimmune diseases.

Fuad El-Hibri, chairman of the board of directors and chief executive officer of Emergent BioSolutions, stated, “This acquisition strengthens Emergent’s biologics capabilities in two key aspects. First, it diversifies our product pipeline beyond infectious diseases into the two high growth areas of oncology and autoimmunity. And, second, it broadens our monoclonal antibody therapeutic capabilities. Emergent’s stable vaccine franchise, substantial capital resources, and expertise in manufacturing and product development combined with Trubion’s world-class therapeutic platform technologies and clinical-stage development programs should translate into significant value over the near and long term.”
Steven Gillis, Ph.D., executive chairman of the board of directors and acting president of Trubion, stated, “The acquisition of Trubion by Emergent should accelerate the continued development of our leading products and technologies. We believe the combination of Emergent’s strong financial position and expertise in development of biologics with Trubion’s innovative SMIP and SCORPION protein therapeutic product candidates and technologies will provide an efficient and effective development path for these promising products and technologies.”
Emergent will maintain research facilities in Seattle, Washington upon completion of the acquisition, and the location will become a therapeutics-focused product development site for the combined company. Taking this transaction into account, Emergent is reaffirming its annual 2010 forecast of $275 to $300 million in total revenues and $40 to $50 million in net income.

Terms of the Agreement

The transaction has been approved by the Boards of Directors of both companies and is subject to customary closing conditions, including the approval of the acquisition by stockholders of Trubion Pharmaceuticals and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Under the terms of the agreement, each share of Trubion Pharmaceuticals common stock will be converted into the right to receive an upfront payment of $1.365 per share in cash and 0.1641 shares of Emergent BioSolutions common stock. The upfront payment represents a value of $4.55 per share, or approximately $96.8 million, based on Trubion’s total common shares outstanding, the net value of dilutive stock options, and the trading average of Emergent BioSolutions common stock for the five days prior to the signing of the definitive agreement. In the aggregate, Emergent will issue approximately 3,350,000 shares of its common stock as part of the upfront consideration, which after the closing of the merger will represent approximately 9.2% of Emergent’s total shares outstanding. Certain of these shares will be subject to lockup provisions. Trubion Pharmaceuticals stockholders will also receive one Contingent Value Right (CVR) per share, which will entitle the holders to receive cash payments based upon achievement of five predefined Phase 2 and Phase 3 clinical study initiation milestones and one manufacturing-related milestone. The total potential aggregate value of the CVRs is $38.7 million over a 36-month period following the closing of the merger.

Details regarding the predefined milestones are as follows:

The acquisition of Trubion is expected to close in the fourth quarter of 2010.

Conference Call and Webcast

Emergent hosted a conference call to discuss the acquisition of Trubion Pharmaceuticals on August 12, 2010 at 5:00 pm Eastern.  A replay of the conference call is accessible by dialing 888/286-8010 or 617/801-6888 and using the passcode 48453582. The replay will be archived for an indefinite period on the company’s website, www.emergentbiosolutions.com, under “Investors”.

Advisors

Wedbush PacGrow Life Sciences is acting as financial advisor and Bingham McCutchen LLP is acting as legal advisor to Emergent BioSolutions for this transaction. MTS Health Partners, L.P. is acting as financial advisor and Fenwick & West LLP is acting as legal advisor to Trubion Pharmaceuticals.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax^(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

Additional Information and Where to Find It

This communication is being made in connection with the proposed merger (the “Merger”) among Emergent BioSolutions Inc. (”Emergent”), Trubion Pharmaceuticals, Inc. (”Trubion”) and certain of Emergent’s direct and indirect wholly-owned subsidiaries. Emergent intends to file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, which will contain a prospectus relating to the securities Emergent intends to issue in the proposed Merger. Trubion intends to file a preliminary proxy statement in connection with the proposed Merger and to mail a definitive proxy statement and other relevant documents to Trubion’s stockholders. Stockholders of Emergent and Trubion and other interested persons are advised to read, when available, the registration statement and Trubion’s preliminary proxy statement, and amendments thereto, and definitive proxy statement in connection with Trubion’s solicitation of proxies for the special meeting to be held to approve the Merger because these documents will contain important information about Trubion, Emergent and the proposed Merger. The definitive proxy statement will be mailed to stockholders as of a record date to be established for voting on the Merger. Stockholders will also be able to obtain a copy of the documents filed with the SEC, without charge, once available, at the SEC’s website at http://www.sec.gov or by directing a request to: Emergent BioSolutions Inc., Attn: Investor Relations, 2273 Research Boulevard, Suite 400, Rockville, Maryland 20850, or Trubion Pharmaceuticals, Inc., Attention: Investor Relations, 2401 4th Avenue, Suite 1050, Seattle, Washington, 98121.

Participants in Solicitation

Emergent, Trubion and their respective directors and officers may be deemed participants in the solicitation of proxies from Trubion’s stockholders. Information regarding Emergent’s directors and officers is available in Emergent’s proxy statement for its 2010 annual meeting of stockholders and its 2009 annual report on Form 10-K, which were filed with the SEC and are available at the SEC’s website at http://www.sec.gov. Information regarding Trubion’s directors and officers is available in Trubion’s proxy statement for its 2010 annual meeting of stockholders and its 2009 annual report on Form 10-K, which were filed with the SEC and are available at the SEC’s website at http://www.sec.gov. Information regarding Trubion’s directors and officers will also be contained in Trubion’s proxy statement in connection with the Merger when it becomes available. Emergent’s and Trubion’s stockholders may obtain additional information about the interests of Trubion’s directors and officers in the Merger by reading Trubion’s proxy statement when it becomes available.

Emergent BioSolutions Forward-Looking 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 and how the acquisition of Trubion will impact that strategy, the financial impact of the merger on Emergent’s 2010 forecast, the provision of expected cash and NOLs, the anticipated timing for the transaction and anticipated future operations, 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 the company’s actual results to differ materially from those indicated by such forward-looking statements, including the parties’ ability to consummate the transaction; the conditions to the completion of the transaction, including the effectiveness of Emergent’s registration statement on Form S-4 or the regulatory approvals required for the transaction may not be obtained on the terms expected or on the anticipated schedule; and the parties’ ability to meet expectations regarding the timing, completion and financial and tax treatments of the merger; the possibility that the parties may be unable to achieve expected synergies and operating efficiencies in the merger within the expected time-frames or at all and to successfully integrate Trubion’s operations into those of Emergent; such integration may be more difficult, time-consuming or costly than expected; operating costs, partner loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, partners, licensors and others) may be greater than expected following the transaction; the retention of certain key employees of Trubion may be difficult; the parties are subject to intense competition and increased competition is expected in the future; the failure to protect either party’s intellectual property rights may weaken its competitive position; third parties may claim that either party’s products infringe their intellectual property rights; the rate and degree of market acceptance and clinical utility of the parties’ products; the success of ongoing and planned development programs, preclinical studies and clinical trials; the ability to identify and acquire or in license products and product candidates that satisfy Emergent’s selection criteria; the potential benefits of the parties existing collaboration agreements and the ability to enter into selective additional collaboration arrangements; the timing of and ability to obtain and maintain regulatory approvals for other product candidates; commercialization, marketing and manufacturing capabilities and strategy; and other factors identified in Emergent’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 and subsequent reports filed with the SEC. The company 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: Emergent BioSolutions Inc.

Related posts:

1. Emergent BioSolutions Reports Financial Results for Full Year 2010 2010 revenues of $286.2 million 2010 net income of...

Related posts brought to you by Yet Another Related Posts Plugin.

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax^(R) (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company’s large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.

“In line with Emergent’s mission of protecting life, we are proud to be working with HHS to scale-up manufacturing of BioThrax, the only vaccine licensed by the Food and Drug Administration (FDA) for the prevention of anthrax infection,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We applaud HHS for its unwavering commitment to strengthen the country’s biodefense infrastructure and to protect our military and civilian populations.”

This cost plus fixed fee development contract has a total value of $107 million and consists of a two-year base period of performance valued at $54.6 million and three option years that, if exercised by BARDA, would increase the contract value to up to $107 million. Under the contract, the company anticipates recognizing revenues of up to $10 million and pretax earnings of up to $5 million during the second half of 2010. A substantial majority of the value of the $107 million contract will be realized in the first three years of performance (July 2010 to July 2013), assuming exercise of the first option year.

The contract award is based on a technical proposal provided to BARDA that projects an annual large-scale manufacturing capacity of 26 million doses in Building 55. This is a significant increase from the company’s current capacity of approximately 7-8 million doses per annum.

The company has developed a comprehensive plan to demonstrate comparability between the current manufacturing process and the large-scale manufacturing process for BioThrax. The contract will fund activities related to process validation, assay validation, fill/finish, and if required, non-clinical and clinical studies. The plan also includes regulatory activities in support of the submission to FDA of a supplemental Biologics License Application (sBLA) for BioThrax at the expanded scale. The company expects to begin manufacturing consistency lots as early as the fourth quarter of 2011.

Emergent has invested significant resources in Building 55, which has been designed to manufacture up to 25 to 30 million doses of BioThrax as currently configured, and is expandable by adding a second manufacturing train that would double annual capacity, based on demand. This is aligned with the company’s core strategy to enhance its manufacturing capabilities to meet the increasing government demand for anthrax vaccines for inclusion in the SNS.

The company also continues to enhance the attractiveness of BioThrax as a significant component of the SNS, most recently through FDA approval of extended shelf life to four years. In addition, based on data from a seven-year study by the Centers for Disease Control and Prevention, the company has submitted to FDA an sBLA to further reduce the BioThrax vaccination schedule to three doses within six months with triennial booster vaccinations. To date, Emergent has supplied over 42 million doses of BioThrax to the U.S. government with additional deliveries scheduled through the third quarter of 2011 pursuant to the current procurement contract with HHS.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax^(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured over 42 million doses of BioThrax. During that time period, more than 9.6 million doses have been administered to nearly 2.4 million military personnel. For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, 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 the company’s actual results to differ materially from those indicated by such forward-looking statements, including appropriations for BioThrax^(R) procurement; our ability to obtain new BioThrax^(R) sales contracts; our plans to pursue label expansions and improvements for BioThrax^(R); our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our 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 other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Related posts:

1. Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June...
2. Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) — Emergent BioSolutions...
3. Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions...

Related posts brought to you by Yet Another Related Posts Plugin.

Mr Fuad El-Hibri and to his right Rep. Chris Van Hollen (D-MD)

ROCKVILLE, Md., Mar 11, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (EBS 15.96, -0.03, -0.19%) announced today that Fuad El-Hibri, its chairman and chief executive officer, has been named by the World Trade Center Institute (WTCI) as one of Maryland’s outstanding international business leaders. Celebrating the spirit of global ambition and excellence in international leadership, WTCI presents the Maryland International Leadership Awards annually to leaders within the state who exemplify entrepreneurial spirit, innovation, and global reach.

Mr. El-Hibri stated, “Across the globe and on a daily basis, the Emergent team lives out the company mission of protecting life – a commitment to make meaningful contributions to address unmet medical needs especially in underserved markets. It is an honor to be recognized for the work that we do and to receive this award on behalf of the team.”

“Mr. El-Hibri recognizes the importance of global markets as key to future growth. WTCI is pleased to showcase Mr. El-Hibri and Emergent BioSolutions’ many achievements and is honored to name him as one of Maryland’s 2010 International Business Leadership Award winners,” said Deborah M. Kielty, president and executive director of the World Trade Center Institute.

WTCI was established in Baltimore in 1989 as a non-profit membership organization to help connect Maryland to the globe. It is the region’s premier private sector international business partner and a member of the World Trade Center Association, a family of 300 centers located in vibrant business communities around the world.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

SOURCE: Emergent BioSolutions Inc.

Related posts:

1. Fuad El-Hibri and the Heifetz International Music Institute The Heifetz International Music Institute was established by Daniel Heifetz and...
2. Emergent BioSolutions Chairman and CEO Fuad El-Hibri Appointed to U.S. Chamber of Commerce Board of Directors ROCKVILLE, Md., Jun 13, 2011 (BUSINESS WIRE) — Emergent BioSolutions...
3. Fuad El-Hibri on Arabian Business Power 500 ArabianBusiness.com focuses on the business of Arabs around the...

Related posts brought to you by Yet Another Related Posts Plugin.

Mohamad Chakaki is a founding member of Green Muslims, a Washington, D.C. group that seeks to relate sustainable environmental policy to faith. He works on projects in the US and the Middle East.

Fuad El Hibri is the CEO of Emergent BioSolutions, Inc. BioSolutions is a multinational bio-pharmaceutical company that is the sole-holder of the FDA-approved anthrax vaccine. He is also Chairman of the East West Resources Corporation and Chairman and Treasurer of the El Hibri Charitable Foundation.

Dr. Mehmet Oz is a cardiothoracic surgeon recently named one of the sexiest men alive for 2009. A frequent visitor of the Oprah Winfrey show and now host of his own show, he is a professor at Columbia University and leads numerous charities and organizations. He has authored several books on personal health.

Ahmed Zewail is the recipient of the 1999 Nobel Prize in Chemistry for his research on femotochemistry. He is the Linus Pauling Professor at the California Institute for Technology and was recently asked to serve at President Obama’s invitation as an adviser to the Presidential Council of Advisors on Science and Technology.

For more info: IBSN: 2009-9-4078

Source :
http://www.examiner.com/x-26018-SE-Michigan-Islamic-Examiner~y2009m12d27-500-Most-Influential-Muslims-Science-and-Technology?cid=edition-rss-Detroit

Related posts:

1. Fuad El-Hibri on Arabian Business Power 500 ArabianBusiness.com focuses on the business of Arabs around the...
2. Fuad El-Hibri and the TAKREEM Achievement Awards TAKREEM was created as a venue in which to recognize...
3. Fuad El-Hibri Interviewed by Ricardo Karam Fuad El-Hibri was interviewed a few months ago by...

Related posts brought to you by Yet Another Related Posts Plugin.

Marie-José Daoud

Awarded the Ernst and Young prize for Entrepreneur of the year 2009 in the Technology category for the Greater Washington region last June, Fuad El-Hibri is the CEO of Emergent Biosolutions, an American company that supplies the anthrax vaccine to the American government. He is in line for the national E&Y 2009 prize, which will be awarded on November 14 in California
He is a tall, imposing and smiling man. He has the assurance of those who are proud of their career and the modesty of those who attribute their success to the staff around them. He has just won the Ernst and Young prize for Entrepreneur of the year 2009 in the Technology category for the Greater Washington region. This prize rewards over 15 years in the biopharmaceutical industry, ten of which have been dedicated to Emergent Biosolutions, the company that supplies the only anthrax vaccine approved by the American government’s powerful Food and Drug Administration (FDA). Fuad El-Hibri landed in biopharmaceuticals somewhat by chance and somewhat by interest. He defines himself as “an entrepreneur in spirit” and, before dedicating himself to biopharmaceuticals, he had already created and sold various telecommunications companies in Russia, Venezuela and El Salvador. In the early 90s, this German native, born to a Lebanese father and a German mother, and who had spent time in the banking industry (Citibank) and consultant (BoozAllen & Hamilton), joins Porton Product, a biotechnology company located in the United Kingdom. There he plays a predominant role in marketing and sales of biodefense vaccines to foreign governments. Hibri is, in particular, a key man behind the purchase by Saudi Arabia of anthrax vaccines during the first Gulf war. This is where he maintains he gained his insight into the magnitude of the need for medical solutions to combat bioterrorism. In 1994, he organized the buy-back of Porton Products by its managers, before reselling his shares in 1996 (the price is not known).

In 1998, an opportunity opened up for him to buy BioThrax in competitive bidding, the only anti-anthrax vaccine approved by the Food and Drug Administration, until then owned by the State of Michigan. So he creates BioPort, obtains American nationality . in 1999, wins the bidding (approximately 24 million dollars) and finds himself at the head of a company with 170 employees, and develops a product: BioThrax.

Hibri has in fact the advantage of a monopoly situation since he is the only supplier of the American government who buys millions of doses of BioThrax per year from him to vaccinate its servicemen and to maintain a stock in case of bioterrorist attack. A situation which fuels all the controversies, as proved by the frenzied comments posted on the Internet.

Once BioPort is consolidated, and to diversify his portfolio, Hibri buys several biotechnology companies. In 2003, BioPort buys Antex, an American company working on the development of a vaccine against chlamydia. In 2005, the company, which in the meantime has become Emergent Biosolutions, acquired Microscience, an English company which had invested in research on hepatitis B and typhoid. In 2006, it purchased VIVACS, a German company specialized in research on the influenza vaccine. In 2008, it does a joint venture with Oxford University (among others) to develop a vaccine against tuberculosis.

Today, Emergent is at the head of a developing portfolio of vaccines and treatments against seven diseases which could bring in “hundreds of millions of dollars per year” when the products are on the market, according to Hibri. Four of these should be on the market within four to seven years. Most of these products have the specific feature of only requiring two technologies that the company has: a technology for vaccines given orally and another for vaccines administered by injection. “Which leads to major synergies enabling substantial cost savings to be made,” explains Hibri. But Emergent is in direct competition with large pharmaceutical laboratories such as Sanofi, Novartis and Roche on the development of these treatments and vaccines, of more commercial use than BioThrax. Furthermore, even with anthrax, Emergent will probably have to face competition from other biotechnology laboratories, like PharmAthene and Cangene, who are currently in the development phase of vaccines and treatment against the bacterium. In the meantime, to meet increasing demand from the American government, and that of other foreign governments who fill out its client portfolio, Emergent has recently invested in its BioThrax production capacity: it has gone from a capacity of three million doses per year to eight million and is currently validating a new factory in Michigan which can produce up to 40 million doses per year.

Today, eleven years after acquiring BioThrax, the latter, still provides the bulk of the company’s turnover (178.6 million dollars in 2008), the other part coming from development contracts with the government and revenue granted by public or private funds.

Anthrax

Anthrax is an infectious disease caused by the spore-forming bacterium Bacillus anthracis.

Anthrax most commonly occurs in wild and domestic animals but it can also occur in humans when they are exposed to infected animals or tissue from infected animals.

The disease is transmitted by spores, or contaminated hide, but not from human to human. Cultivation of the bacterium and spores are relatively easy in a laboratory, which makes it an ideal biological weapon.

The company has 600 employees and has been quoted on the New York stock exchange since 2006, with a capitalization of 500 million dollars. Hibri, his family and his management staff keep control of the company with over half of the capital. Emergent has a presence in the United States, United Kingdom, Singapore, China and Germany. And for seven years, between 2000 and 2007, it has experienced uninterrupted growth.

This is partially why the E&Y prize was awarded to Hibri. Other criteria were also taken into account: his ability to inspire his staff, who, he himself acknowledges are “dedicated and motivated”; and his philanthropic involvement in numerous charity organizations, among which the El-Hibri Charitable Foundation, created by his father, that among other things finances the Dar Al-Aytam orphanage in Lebanon.
—

www.emergentbiosolutions.com

Related posts:

1. FUAD EL-HIBRI TO AWARD 2011 EL-HIBRI PEACE EDUCATION PRIZE TO GENE SHARP The El-Hibri Charitable Foundation has announced that internationally acclaimed author...
2. Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions...
3. Fuad El-Hibri Interviewed by Ricardo Karam Fuad El-Hibri was interviewed a few months ago by...

Related posts brought to you by Yet Another Related Posts Plugin.