Fuad El-Hibri Blog

October 14, 2011

Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government

Filed under: BioDefense, BioThrax, Chief executive officer, Emergent BioSolutions Inc, Food and Drug Administration, Fuad El-Hibri, US Food and Drug Administration — Tags: , , , , — fuadelhibri @ 11:39 am

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.,(NYSE: EBS) announced that, in response to solicitation RFP-2011-N-13414, it has received an award to supply the U.S. government with 44.75 million doses of BioThrax(R) (Anthrax Vaccine Adsorbed) over a period of five years for a total value of up to $1.25 billion. BioThrax is the only vaccine licensed by the  U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

Initial deliveries under this award are expected to begin in 2011 with 8.5 million doses scheduled to be delivered during the first year of a five-year contract. The company may modify the timing of deliveries depending on manufacturing yields and other factors.

“Emergent is proud to be able to contribute to the U.S. government’s program of protecting the nation from the threat of anthrax,” said  Fuad El-Hibri. “This 5-year award provides for uninterrupted supply of this critical biodefense countermeasure while addressing the government’s mandate to reduce spending across all programs. In coming to agreement, Emergent and the  Centers for Disease Control and Prevention worked diligently to establish business terms that incorporate substantial price concessions.”

About Emergent BioSolutions Inc.

Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company 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. To date, Emergent has delivered over 55 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.6 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 2011, 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 or modifications to existing 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 of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 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.

July 7, 2011

Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax

Filed under: BioThrax, Chief executive officer, Emergent BioSolutions Inc, Fuad El-Hibri, Healthcare, US Food and Drug Administration — Tags: , , , , , — fuadelhibri @ 4:08 pm

ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June 23rdthat the Singapore Health Sciences Authority (HSA) has approved Emergent’s product license application for the marketing and sale of BioThrax(R) (Anthrax Vaccine Adsorbed) in Singapore. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

“Emergent is pleased with this development as it continues to grow its presence in the Pacific Rim,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “With HSA approval of BioThrax, we look forward to initiating discussions with the government of Singapore, as well as other allied governments that recognize HSA registered products such as Brunei, to help protect their constituents against the threat of anthrax as a biological weapon.”

HSA is the statutory board of the Singapore Ministry of Health that administers the country’s regulatory framework for pharmaceuticals, complementary medicines, medical devices and other health products. Its vision is to be the leading innovative authority that protects and advances national health and safety in Singapore.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO Fuad El-Hibri protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at http://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. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel. For full prescribing information, please visit http://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 2011, 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 or modifications to existing 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 of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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.

June 7, 2011

Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule

Filed under: BioThrax, Chief executive officer, Emergent BioSolutions Inc, Food and Drug Administration, Fuad El-Hibri, US Food and Drug Administration — Tags: , , , , , — fuadelhibri @ 4:14 pm

ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that eight lots of BioThrax(R) (Anthrax Vaccine Adsorbed) have received regulatory release for delivery to the U.S. government under the company’s contract (200-2009-30162) originally written to supply 14.5 million doses of BioThrax to the Strategic National Stockpile. This marks the largest single-week regulatory release of product for delivery in the company’s history. The company expects to complete delivery of the 14.5 million doses as early as June, approximately three months ahead of the schedule originally set forth in the contract. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

“Emergent is pleased with its progress towards early completion of its original procurement contract to supply 14.5 million doses of BioThrax,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “Upon completion of this delivery, anticipated to occur as early as June, the company will focus on delivering the additional 3.42 million doses under the modified procurement contract. With the recent request for proposal issued by the U.S. government, Emergent is also advancing discussions to supply 44.75 million doses of BioThrax over the next five years.”

About Emergent BioSolutions Inc.

Emergent BioSolutions.led by Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company 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. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 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 2011, 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 or modifications to existing 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 of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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.

May 12, 2011

Emergent BioSolutions Reports Financial Results for First Quarter 2011

Filed under: BioDefense, BioThrax, Business, Chief executive officer, Chief financial officer, Revenue — Tags: , , , , , — fuadelhibri @ 1:28 pm

ROCKVILLE, Md., May 05, 2011 (BUSINESS WIRE) — Emergent BioSolutionsInc. (NYSE: EBS) announced  its financial results for the first quarter ended March 31, 2011.

For 1Q 2011, total revenues were $18.5 million as compared to $46.8 million in 2010. In addition, for 1Q 2011 the company recorded a net loss of $21.4 million, or $0.61 per basic share, as compared to net income of $2.5 million, or $0.08 per basic share, in 2010.

R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, “While our first quarter revenues were slightly lower than expected, we remain on track to achieve our full year guidance of total revenues of $320 to $340 million and net income of $35 to $45 million.”

1Q 2011 Key Financial Results

Product Sales

For 1Q 2011, product sales were $5.6 million, a decrease of $33.3 million, or 86 percent, from $38.9 million for 1Q 2010. This decrease was primarily due to an 88 percent decrease in the number of doses of BioThrax delivered. During the first quarter, the company redeployed its potency testing capacity from BioThrax release testing to qualification of replacement reference standards and other development testing. This process, which is required to enable continued future release of BioThrax doses, has now been substantially completed. Product sales revenues for 1Q 2011 consisted of BioThrax sales to CDC of $5.0 million and aggregate international and other sales of $0.6 million.

Contracts and Grants Revenues

For 1Q 2011, contracts and grants revenues were $12.9 million, an increase of $5.0 million, or 63 percent, from $7.9 million for 1Q 2010. The increase was primarily due to revenues from the recently awarded contract from BARDA for large-scale manufacturing for BioThrax, collaborations with Abbott and Pfizer, along with increased activity and associated revenue from development contracts with BARDA and NIAID.

Cost of Product Sales

For 1Q 2011, cost of product sales was $1.1 million, a decrease of $6.4 million, or 86 percent, from $7.5 million for 1Q 2010. This decrease was primarily attributable to the 88 percent decrease in the number of BioThrax doses sold.

Research and Development

For 1Q 2011, research and development expenses were $34.8 million, an increase of $14.8 million, or 74 percent, from $19.9 million for 1Q 2010. This increase primarily reflects higher contract service and personnel costs, and includes increased expenses of $13.9 million on product candidates and technology platform development activities associated with the BioSciences segment and increased expenses of $0.9 million on product candidates associated with the BioDefense segment. Net of development contracts and grants reimbursement revenue along with the net loss attributable to noncontrolling interests, research and development expenses were $20.0 million for 1Q 2011.

Selling, General and Administrative

For 1Q 2011, selling, general and administrative expenses were $18.2 million, an increase of $2.0 million, or 12 percent, from $16.2 million for 1Q 2010. This increase is primarily due to increased personnel-related expenses and professional services to support the business. Selling, general and administrative expenses for 1Q 2011 consisted of $14.0 million associated with the BioDefense segment and $4.2 million associated with the BioSciences segment.

Financial Condition and Liquidity

Cash and cash equivalents combined with investments at March 31, 2011 was $143.3 million compared to $171.0 million at December 31, 2010. Additionally, at March 31, 2011, the accounts receivable balance was $12.0 million, which is comprised primarily of unpaid amounts under our NIAID and BARDA development contracts.

2Q 2011 Revenue Forecast

For the second quarter of 2011, the company anticipates total revenues of $80 to $90 million.

2011 Forecast

For full year 2011, the company is reaffirming its financial forecast of total revenues of $320 to $340 million and net income of $35 to $45 million.

2011 total revenue is expected to be driven by, among other things:

  • the continuation of deliveries of BioThrax under the current multi-year procurement contract with CDC, which was recently modified to increase the total contracted doses to 17.9 million;
  • additional deliveries of BioThrax under a follow-on, multi-year procurement contract with CDC, anticipated to begin in 4Q 2011;
  • a significant increase in contracts and grants revenue based primarily on development contracts related to product development programs in the company’s BioDefense segment; and
  • collaboration and milestone revenues associated with achievement of clinical development milestones related to the company’s oncology product candidate, which is under an existing co-development agreement with Abbott, and the company’s autoimmune product candidate, which is being developed by Pfizer under a license agreement from the company.

Conference Call and Webcast

Company management hosted a conference call at 5:00 pm Eastern on May 5, 2011 to discuss the financial results for the first quarter of 2011, recent business developments, revenue guidance for the second quarter of 2011 and revenue and net income guidance for the full year 2011.

A replay of the conference call will be accessible by dialing 888/286-8010 or 617/801-6888 and using the passcode 12159691. The replay will be available through May 19, 2011. The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO, Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. 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 estimates of preliminary results for 2010, and our expected revenue growth and net earnings for 2011, 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 or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax(R); our ability to perform under our current development contracts with the U.S. government; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products and product candidates; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the potential benefits of our existing collaborations and our ability to selectively enter into additional collaborative arrangements; ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company’s Annual Report on Form 10-K for the year ended December 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.

October 23, 2010

Emergent BioSolutions to Release Third Quarter 2010 Financial Results and Conduct a Conference Call on November 4, 2010

Filed under: Anthrax Vaccine, BioThrax, Chief executive officer, El-Hibri Fuad, Emergent BioSolutions Inc, Fuad El-Hibri — Tags: , , , , , , — fuadelhibri @ 4:31 pm

ROCKVILLE, Md., Oct 13, 2010 — Emergent BioSolutions Inc. (NYSE: EBS) announced today it will report financial results for third quarter 2010 on Thursday November 4, 2010, after market close.  Company management will host a conference call at 5:00 pm Eastern on November 4, 2010 to discuss the financial results for the third quarter and first nine months of 2010, recent business developments and the forecast for 2010. The conference call will be accessible by dialing 888/713-4211 or 617/213-4864 (international) and providing passcode 50859780. A webcast of the conference call will be accessible from the Company’s website at www.emergentbiosolutions.com, under “Investors”.

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.

September 10, 2010

Emergent BioSolutions Awarded NIAID Contract That Increases Potential Funding to Over $58 Million for Advanced Development of Third Generation Anthrax Vaccine

Filed under: Anthrax Vaccine, BioThrax, Chief executive officer, Emergent BioSolutions Inc, Food and Drug Administration, Fuad El-Hibri — Tags: , , , , , — fuadelhibri @ 3:13 pm

New Contract Valued at up to $28.7 Million for Phase II Clinical Trial

ROCKVILLE, Md., Sep 01, 2010 –Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), for advanced development of the company’s third generation anthrax vaccine candidate. The award of this contract increases to over $58 million the total potential development funding from NIAID for this product. This product candidate, one of two third generation vaccines being developed as part of Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909 (VaxImmuneTM).

“Emergent applauds the U.S. government’s commitment to protecting the nation against biological threats by supporting critical development of advanced vaccine and therapeutic candidates,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe our vaccine candidate addresses key criteria established by the government for a third generation anthrax vaccine. If successfully developed, we believe this product would strengthen the government’s portfolio of biodefense medical countermeasures.”

This four-year development contract consists of a two-year base, valued at $9.1 million, and milestone-based options that if exercised, would increase the total contract value to up to $28.7 million. The base contract will fund activities related to manufacturing and stability studies of Phase II clinical trial lots, process characterization and assay validation, and clinical trial preparation. The milestone-based options include continued stability testing of Phase II clinical trial lots and a clinical study to evaluate safety and immunogenicity of the product candidate. The Phase II clinical trial is anticipated to begin in the first quarter of 2012, with preliminary data expected to be available in the second half of 2012.

This new contract was awarded to expand the development efforts being conducted under a Biomedical Advanced Research and Development Authority (BARDA)/NIAID contract awarded in September 2008, which provides for funding of up to $29.7 million. Thus, with this new contract, the potential funding from the U.S. government for this third generation anthrax vaccine candidate increases to over $58 million.

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 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 the success of our ongoing and planned preclinical studies and clinical trials; our plans to pursue label expansions and improvements for BioThrax(R); the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; 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 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.

August 3, 2010

Emergent Revises Upward 2010 Financial Forecast

Filed under: BioThrax, Chief executive officer, Emergent BioSolutions Inc, Food and Drug Administration, Fuad El-Hibri — Tags: , , , , , , , — fuadelhibri @ 11:24 am

Company anticipates total revenues of $275 to $300 million and net income of $40 to $50 million

ROCKVILLE, MD, July 20, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it is revising upwards its 2010 annual guidance to now reflect anticipated total revenues of $275 to $300 million and net income of $40 to $50 million.  Of the anticipated total revenues of $275 to $300 million, $165 to $190 million is expected to be recognized in the second half of 2010.  This revised forecast does not reflect or incorporate any revenue impact from a possible development contract for the company’s rPA vaccine candidate.

The revision to the 2010 financial forecast is supported primarily by the recent modification to the company’s current BioThrax® procurement contract with the US Centers for Disease Control and Prevention (CDC).  This contract modification increased the number of doses of BioThrax that the company can deliver into the Strategic National Stockpile (SNS) during calendar 2010.  This increased volume of available doses of BioThrax is due to consistently high production yields throughout 2010.

“This modification by the CDC to our existing BioThrax procurement contract reinforces, yet again, the US government’s commitment to BioThrax as a critical component of the Strategic National Stockpile and to our nation’s defense against bioterrorism,” said Fuad El-Hibri, chairman and chief executive officer of Emergent.  “This is another example of how we continue to work with our US government partners in establishing BioThrax as the backbone of our readiness against the threat of anthrax and to building a stockpile as rapidly as possible.”

Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, also commented, “The production yields we have been experiencing are a direct result of our commitment to driving innovation in our manufacturing process and to a multi-year initiative focused on process optimization of the existing Building 12 production facility.  We are extremely pleased with the results of our continuous process improvement program for BioThrax and expect this program to drive the maintenance of positive production metrics going forward.”

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.

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 45 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® procurement; our ability to obtain new BioThrax® sales contracts; our plans to pursue label expansions and improvements for BioThrax®; 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 manufacturing success rates; 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.

July 15, 2010

Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax

Filed under: BioThrax, Chief executive officer, Emergent BioSolutions Inc, Food and Drug Administration, Fuad El-Hibri, Healthcare Conference, United States — Tags: , , , , , — fuadelhibri @ 4:39 pm

ROCKVILLE, Md., Jul 14, 2010

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.

July 7, 2010

Emergent BioSolutions Completes Deliveries of BioThrax to Allied Foreign Governments

Filed under: BioThrax, Chief executive officer, Emergent BioSolutions Inc, Fuad El-Hibri, Infectious disease — Tags: , , , , — fuadelhibri @ 12:50 pm

ROCKVILLE, MD, June 24, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) led by CEO Fuad El-Hibri,announced today that it has completed separate international sales and deliveries of BioThrax® (Anthrax Vaccine Adsorbed) to governments of several allied nations.  The company’s international sales efforts have resulted in these sales of an undisclosed number of BioThrax doses for aggregate revenue of approximately $2.3 million in the second quarter.

“Emergent recognizes that governments play a key role in protecting citizens against the growing threat of bioterrorism,” said Allen Shofe, senior vice president public affairs of Emergent BioSolutions.  “As the maker of the only U.S. FDA-licensed anthrax vaccine, and in line with our corporate mission to protect life, we are honored to support such biopreparedness efforts of allied international governments.”

About BioThrax

BioThrax is the only U.S. 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 9.5 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.

Important Safety Information for BioThrax®

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.

Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. This product should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.

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 appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts; our plans to pursue label expansions and improvements for BioThrax®; 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; 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.

December 16, 2009

Fuad el-Hibri, king of anthrax, wins an award from Ernst & Young

Filed under: BioThrax, El-Hibri Fuad, Emergent, Ernst & Young, Fuad El-Hibri — Tags: , , , — fuadelhibri @ 6:32 pm

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

Older Posts »

Theme: Shocking Blue Green. Blog at WordPress.com.

Follow

Get every new post delivered to your Inbox.