Archive for the ‘Food and Drug Administration’ Category

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

Tuesday, June 7th, 2011

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.

Emergent BioSolutions Announces Initiation of Phase Ib/II Study of TRU-016 in Combination with Bendamustine for Chronic Lymphocytic Leukemia

Tuesday, February 1st, 2011

ROCKVILLE, Md., Jan 25, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a Phase Ib/II study (16201) of TRU-016 for chronic lymphocytic leukemia (CLL). TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.

The open-label, multi-center, active-controlled study is expected to enroll up to 114 bendamustine-naïve patients with a confirmed diagnosis of relapsed CLL and who have failed up to three previous treatments. The Phase Ib portion of the study will determine a safe and tolerable dose of TRU-016 in combination with bendamustine in up to 14 patients with relapsed CLL. The primary endpoint for the Phase Ib portion is the incidence of dose-limiting toxicities.

The Phase II portion of the study will evaluate the safety and efficacy of TRU-016 in combination with bendamustine compared with standalone bendamustine treatment in a total of 100 randomized patients. The primary endpoint for the Phase II portion of the study is an overall response rate as defined by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. Secondary endpoints include complete and partial response rates as defined by the 1996 National Cancer Institute (NCI) criteria, progression-free survival, duration of response, and improvement in quality of life and disease symptoms.

The pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study.

“Given the strong TRU-016 preclinical combination data, and the positive clinical results from the single agent dose escalation study, we believe human clinical evaluation of TRU-016 in combination with bendamustine could yield meaningful results,” said Dr. W. James Jackson, chief scientific officer at Emergent BioSolutions. “The dose escalation study in CLL continues to demonstrate that TRU-016 is well tolerated and clinically active and we look forward to Phase I combination data from this study, as well as the planned Phase I combination study for follicular Non-Hodgkin’s Lymphoma.”

Additional information about this Phase Ib/II clinical study can be found on www.clinicaltrials.gov (protocol 16201).

In December 2010, data were presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) from a Phase I TRU-016 monotherapy, dose escalation trial involving 57 patients who have had a median of four previous therapies and a median of two prior anti-CD20 therapies. Of the 57 patients, 46% received their last treatment for CLL less than 6 months before entering the study. Genomic data were available for 53 patients, the majority of which (n=35) had high-risk genomic features for CLL, including del(17p) and/or del(11q).

Pharmacokinetic data demonstrated rapid clearance of TRU-016 in the lower dose cohorts. Accumulation was seen in the 3mg/kg TIW and 6mg/kg weekly and higher cohorts. Patients in the 3 mg/kg TIW cohort (n=8) generally maintained serum concentrations of 10 g/ml during treatment. Partial response was observed in seven patients, including two patients with the del(17p) genomic risk factor. The median reduction in absolute lymphocyte count was 73% in those patients with lymphocytosis at baseline. The responses, all partial responses, were observed in patients who had received 1 – 2 prior therapies (n=16) for an overall response rate of 44% (n=7) with a median reduction in lymphocytes of 80% in this population. No responses were observed in patients who had received prior treatment with three or more therapies (n=41), although a median reduction in lymphocytes of 54% was observed in these patients. The median reduction in lymphocytes regardless of baseline lymphocyte count or the number of prior therapies was 60%.

The most commonly reported adverse events were nausea, fatigue, diarrhea, chills, pyrexia, and neutropenia. Serious adverse events occurring in more than one patient were pneumonia, febrile neutropenia, infusion reaction, pyrexia and dyspnea. A maximum tolerated dose has not yet been reached. Additional data from all TRU-016 ASH presentations can be found at: www.truemergent.com.

About CLL

According to the Leukemia & Lymphoma Society, there are approximately 85,710 people in the U.S. living with CLL, and more than 15,000 new cases are diagnosed each year. Existing treatments for CLL have shown significant efficacy in treating indolent B-cell cancers. However, research suggests that many patients do not achieve an initial response and most eventually relapse, which suggests an acute need for differentiated treatments.

About TRU-016

TRU-016 uses a different mechanism of action than currently marketed CD20-directed therapies. As a result, TRU-016 may provide patients with improved therapeutic options and enhance efficacy when used alone or in combination with chemotherapy and/or other CD20-directed therapeutics.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a global 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 and investigational products target infectious diseases, oncology, and autoimmune disorders. Additional information about the company 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, estimates of results for 2010, 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 our ability to obtain additional development funding for our product candidates; 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 other product candidates; our ability to obtain sales contracts for products; 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 September 30, 2010 and subsequent reports filed with the SEC.

SOURCE: Emergent BioSolutions Inc.

CEO took roundabout path to Emergent

Friday, January 7th, 2011

By Marjorie Censer

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

Emergent BioSolutions Starts Phase I Clinical Trial for Third Generation Anthrax Vaccine

Wednesday, January 5th, 2011

ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical trial for NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. The product candidate, a third generation vaccine 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.

“Emergent is pleased to commence this clinical trial in support of the U.S. government’s multiple product strategy to strengthen the nation’s biodefense capabilities,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe this third generation anthrax vaccine has the potential to exhibit advanced characteristics such as requiring fewer doses, generating an enhanced immune response, and having a favorable shelf life. If successful, this could be an attractive candidate for the government’s growing arsenal of medical countermeasures.”

The Phase I clinical trial, a parallel arm dose-ranging study, is designed to evaluate the safety, tolerability, and immunogenicity of the vaccine candidate. The study is being conducted in multiple sites within the U.S. and involves 105 healthy volunteers. Preliminary data from this study is expected to be available in the third quarter of 2011.

This Phase I trial is being conducted with support from a development contract that is jointly administered under contract number HHSN272200800051C by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a global 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 and investigational products target infectious diseases, oncology, and autoimmune disorders. Additional information about the company 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 September 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.

Fuad El-Hibri Recognized by Vilcek Foundation

Friday, December 10th, 2010

The Vilcek Foundation was established in 2000 by Jan and Marica Vilcek, immigrants from the former Czechoslovakia.  The Foundation was established with the aim of raising public awareness around immigrants’ contributions to the sciences, arts, and culture in the United States.  The Foundation’s mission was inspired by the couple’s careers in science and art, as well as their personal experiences and appreciation for the opportunities given to them as newcomers to the United States.  The Foundation showcases immigrant artists and performers in their New York gallery, awards the annual Vilcek Prizes, and sponsors numerous events such as the Santa Fe Opera and Hawaii International Film Festival.

In the 2010 Spring newsletter, the Vilcek Foundation recognized Fuad El-Hibri, Chairman and CEO of Emergent BioSolutions, Inc.  This is a summary of their report.  The original can be found here:

http://www.vilcek.org/news_articles/newsletters/2010/spring/newsletter_spring2010.html

In addition to his accomplishments in the business world, El-Hibri founded the El-Hibri Charitable Foundation in 2001 in honor of his father, Ibrahim El-Hibri.  The Foundation annually awards the El-Hibri Peace Education Prize to peace educators.  It also funds other programs aligned with its four part mission statement promoting Peace Education, Interfaith Dialogue, Humanitarian Aid, and Social Justice.

El-Hibri credits much of his success in the business and philanthropic world to his immigrant background. He was raised in Europe, North Africa, and the Middle East but always knew he wanted to attend college in the United States.  After being accepted to Stanford that dream became a reality.  After completing his undergraduate degree at Stanford he received his Master’s degree from Yale.  This international background instilled in El-Hibri the desire to encourage dialogue between different cultures which in 2007 lead to the annual El-Hibri Prize for Peace Education.

“We are trying to get to the crucial goal of establishing a more evident culture of peace,” said Zen Hunter-Ishikawa, Vice President of Operations at El-Hibri Charitable Foundation.  The Prize for Peace Educators awards individuals who have made major contributions to the field of peace education.  Past winners of the prize include Scott Kennedy, former Mayor of Santa Cruz, California, and Abdul Aziz Said, professor at American University in Washington D.C.

“It’s taken some time to get organized,” said El-Hibri, “So it’s only been the last few years we’ve been able to focus on our programs.  We hope to grow significantly over the years.”

Fuad El-Hibri and the International Biomedical Research Alliance

Saturday, November 13th, 2010

The International Biomedical Research Alliance (IBRA) is a philanthropic organization that is dedicated to the support of the NIH-Oxford-Cambridge Scholars Program, which strives to establish the highest standards of excellence in training biomedical researchers, advance groundbreaking biomedical research, enrich the pool of leaders in the field, and eliminate barriers which frustrate the transfer of a broad spectrum of knowledge to the next generation of researchers.

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.

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Emergent BioSolutions Awarded HHS Contract Valued at up to $186.6 Million to Develop rPA Anthrax Vaccine

Monday, September 20th, 2010

ROCKVILLE, MD, September 17, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract, valued at up to $186.6 million, with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the development of a recombinant protective antigen (rPA) anthrax vaccine.  This five year cost plus fixed fee development contract consists of a two-year base period of performance valued at approximately $51 million, three successive one-year option periods valued at approximately $126 million and funding for optional non-clinical studies valued at approximately $9 million.

“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.

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

Friday, September 10th, 2010

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.

Emergent BioSolutions to Acquire Trubion Pharmaceuticals

Thursday, August 19th, 2010
  • Trubion provides promising clinical-stage therapeutic candidates in the targeted disease areas of oncology and autoimmunity
  • Trubion offers novel, protein therapeutic platforms and scientific expertise for developing innovative therapeutic candidates
  • Transaction leverages large pharma partnerships to provide sales and marketing infrastructureidates
  • Emergent reaffirms 2010 guidance for revenues and net income

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:

Milestone Events Applicable Payments
Initiation of the first Phase 2 clinical study for TRU-016 $1.75 million
Release of TRU-016 manufactured for use in clinical studies $10.0 million
Initiation of dosing in the first Phase 2 clinical study for a non-CD20 target $0.75 million
Initiation of the first Phase 3 clinical study in oncology indication for TRU-016 $15.0 million
Initiation of dosing in the first Phase 3 clinical study for the first major indication for CD20 candidate $6.25 million
Initiation of dosing in the first Phase 3 clinical study for the second major indication for CD20 candidate $5.0 million

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.

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Emergent Revises Upward 2010 Financial Forecast

Tuesday, August 3rd, 2010

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.