Emergent BioSolutions related Press Releases

Emergent BioSolutions Provides Preliminary 2011 Financial Results and Provides Guidance for 2012

Mon, 09 Jan 2012 07:20:44 -0500

ROCKVILLE, Md.--(BUSINESS WIRE)-- Emergent BioSolutions Inc. (NYSE: EBS) today announced preliminary 2011 financial results and provided guidance for 2012.

For 2011, the Company anticipates total revenues of $270 to $275 million. With respect to 2011 net income, and before taking into account all potential adjustments related to the termination by Abbott of the co-development agreement for TRU-016, the Company anticipates net income of $20 to $24 million. These potential adjustments could include, among others, an impairment to goodwill and intangible assets to be recorded in 2011.

In addition, the Company anticipates combined year end 2011 cash, cash equivalents and investments, plus accounts receivable to be approximately $200 million.

For 2012, the Company forecasts total revenue of $280 to $300 million, split between product sales of $220 to $230 million and contracts and grants revenue of $60 to $70 million. The Company also forecasts net income of $15 to $25 million.

2012 total revenue is expected to be driven by, among other things:

Increased BioThrax manufacturing yields as well as continued deliveries of BioThrax under the current multi-year procurement contract with CDC; and,
Level contracts and grants revenue based on continuing work under existing, multi-year development contracts associated primarily with the Company’s BioDefense Division programs.

Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions Inc., stated, “We are pleased with our preliminary 2011 financial performance and look forward to providing definitive results later this quarter. More importantly, we are enthusiastic about the prospects for continued growth in 2012. We are focused on increasing BioThrax output from our current facility, pursuing enhancements to BioThrax, furthering the development of the other candidates in our anthrax franchise and taking further steps toward licensure of our large-scale facility Building 55. We also are focused on continuing to invest in the development of our clinical-stage BioSciences programs targeting the high growth diseases of infectious diseases, oncology and autoimmune disorders. We anticipate publishing of data on certain key programs in 2012.”

The 2011 financial results will be finalized upon the completion of the Company’s external audit, anticipated in early March 2012.

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.

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 2011, and our expected revenue growth and net earnings for 2012, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. Such statements are based upon the current beliefs and expectations of management that are subject to risks, uncertainties and other 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 or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax^®; our ability to perform under our current development contracts with the U.S. government; our plans to expand our manufacturing facilities and capabilities, including our ability to develop and obtain regulatory approval for large-scale manufacturing of BioThrax^® in our large-scale vaccine manufacturing facility in Lansing, Michigan; 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; the extent to which our licensing and acquisition activities are complementary to the Company or whether anticipated synergies and benefits are realized within expected time periods; our ability to identify and acquire or in-license products and product candidates that satisfy our selection criteria; 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 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, 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.

CONTACT:

Emergent BioSolutions Inc.
Investors:
Robert G. Burrows, 301-795-1877
Vice President, Investor Relations
BurrowsR@ebsi.com
or
Media:
Tracey Schmitt, 301-795-1800
Vice President, Corporate Communications
SchmittT@ebsi.com

KEYWORDS: United States North America Maryland

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Oncology

MEDIA:

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Emergent Initiates Phase 2 Study of TRU-016 in Combination with Bendamustine in Patients with Relapsed Chronic Lymphocytic

Wed, 28 Dec 2011 07:20:30 -0500

ROCKVILLE, Md.--(BUSINESS WIRE)-- Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 2 study (protocol 16201) of TRU-016 in combination with bendamustine for patients with relapsed chronic lymphocytic leukemia (CLL). The initiation of this clinical trial triggers a $6 million milestone payment to Emergent. TRU-016 is a humanized anti-CD37 mono-specific protein therapeutic in development for the treatment of B-cell malignancies.

“Preclinical studies have demonstrated increased anti-tumor activity for the combination of bendamustine and TRU-016 beyond the results achieved when either drug was administered alone,” said Scott C. Stromatt, M.D., Senior Vice President and Chief Medical Officer, Emergent BioSolutions Inc. “The safety data from the Phase 1b portion of the combination trial of TRU-016 with bendamustine in relapsed CLL was recently reviewed by an independent Data Monitoring Committee, and they authorized advancement into Phase 2.”

The open-label, multi-center, active-controlled study is enrolling bendamustine-naïve patients with a confirmed diagnosis of relapsed CLL and who have failed up to three previous treatments. The Phase 1b portion of the study evaluated 12 patients with relapsed CLL to determine a safe and tolerable dose of TRU-016 in combination with bendamustine. The primary endpoint for the Phase 1b portion was the incidence of dose-limiting toxicities.

The Phase 2 portion of the study will evaluate the safety and efficacy of TRU-016 in combination with bendamustine compared with bendamustine alone in a total of approximately 100 randomized patients. TRU-016 will be dosed over six 28-day cycles. The primary endpoint for the Phase 2 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.

Pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study. Additional information about this Phase 1b/2 clinical study can be found on www.clinicaltrials.gov (protocol 16201).

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.

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 the success of our ongoing and planned preclinical studies and clinical trials; 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, 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.

CONTACT:

Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
SchmittT@ebsi.com

KEYWORDS: United States North America Maryland

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical Research Science

MEDIA:

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Results of Emergent BioSolutions Phase 1a Study on Adjuvanted BioThrax Anthrax Vaccine Published in the Journal Vaccine

Erica Teichert — Thu, 01 Sep 2011 07:59:11 -0400

Results of Emergent BioSolutions Phase 1a Study on Adjuvanted BioThrax Anthrax Vaccine Published in the Journal Vaccine

Subjects had a stronger, more rapid immune response when the adjuvant CPG 7909 is combined with BioThrax
Company also completes dosing of the last subject in ongoing NuThrax Phase 1b Clinical Trial

ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that results from a Phase 1a clinical trial evaluating an investigational anthrax vaccine, Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant mixed at bedside, have been published in Vaccine, a leading medical journal on vaccines and immunology.

In the study, which enrolled 69 subjects, the addition of the CPG 7909 adjuvant to BioThrax® (Anthrax Vaccine Adsorbed), the only FDA-licensed anthrax vaccine, accelerated and enhanced the immune response to the vaccine in healthy volunteers. Trial subjects received three doses of either: (1) BioThrax alone, (2) 1 mg of CPG 7909 alone or (3) BioThrax plus 1 mg of CPG 7909, all given intramuscularly on study days 0, 14, and 28. Data from the trial show that BioThrax plus CPG 7909 generated peak antibody responses that were 6-fold higher than those generated by BioThrax alone (232 μg/ml with BioThrax alone; 1465 μg/ml with BioThrax plus CPG 7909). BioThrax plus CPG 7909 also accelerated the time to reach the peak immune response seen following BioThrax vaccination by three weeks. Both of these findings were statistically significant (P<0.001). Early immune responses are important due to the rapid disease progression of anthrax.

The paper, "Marked enhancement of the immune response to BioThrax by the TLR9 agonist CPG 7909 in healthy volunteers," appears in the August 26 edition of Vaccine.

Emergent has also completed dosing of the last subject in its ongoing Phase 1b clinical trial to evaluate the safety, tolerability, and immunogenicity of different formulations of BioThrax pre-formulated with a novel immunostimulatory oligodeoxynucleotide compound, CPG 7909, also known as AV7909 or NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant). The study, which was initiated in December 2010, involves 105 healthy volunteers. The company anticipates preliminary data to be available as early as Q3 2011.

"Emergent is pleased to share this information related to our anthrax vaccine development program," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "The Phase 1a data on BioThrax plus CPG 7909 add support to our hypothesis that the combination could have enhanced characteristics over BioThrax alone. Such characteristics could increase the attractiveness of this product candidate to potentially support the U.S. government's multi-product strategy in stockpiling medical countermeasures."

The Phase 1a study was supported by Defense Advanced Research Projects Administration (DARPA) contract DAAD1903C0002. The ongoing Phase 1b trial for NuThrax 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 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.

Emergent BioSolutions (EBS)' Investigational Anthrax Vaccine, NuThrax, Granted Fast Track Designation

Erica Teichert — Thu, 16 Jun 2011 09:37:36 -0400

ROCKVILLE, Md.--(BUSINESS WIRE)-- Emergent BioSolutions Inc. (NYSE:EBS - News) announced today that its investigational anthrax vaccine, NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The vaccine candidate, also known as AV7909, consists of BioThrax® (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory oligodeoxynucleotide compound, CPG 7909, and is currently being evaluated in a Phase 1b clinical trial for safety, tolerability, and immunogenicity. The FDA's Fast Track Development Program provides for expedited regulatory review of drugs and biologics that treat serious or life threatening diseases and that demonstrate the potential to address unmet medical needs.

"Emergent is pleased to receive Fast Track Designation for NuThrax," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "Expedited regulatory review could mean more frequent communications with FDA, priority review of Biologics License Applications (BLA) for our vaccine, and a rolling BLA submission, which allows FDA to review sections of the BLA in advance of receiving the complete submission."

The Phase 1b trial for NuThrax 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 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.

Emergent BioSolutions Keynotes BARDA Industry Day

Mon, 06 Jun 2011 22:21:50 -0400

--(BUSINESS WIRE)-- The threat of biological agents such as anthrax is real. Contracting for countermeasures, the U.S. government works with industry in its preparedness efforts to protect the population. Following opening remarks by Dr. Robin Robinson, BARDA Director, learn about navigating the contracting process and working with the U.S. government in identifying and fulfilling medical countermeasure development and procurement requirements.


Who:				Barbara Solow, Ph.D.
				VP External Development
				Emergent BioSolutions

What:				Plenary Session: Working with the U.S. Government

When:				June 7, 2011, 8:30 – 10:00 am Pacific

Where:				Meeting Room 16 A & B
				San Diego Convention Center
				111 West Harbor Drive
				San Diego, CA 92101

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.

CONTACT:

Emergent BioSolutions
Tracey Schmitt, 301-795-1800
SchmittT@ebsi.com

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health Biotechnology Defense Other Defense

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Oxford-Emergent Tuberculosis Consortium Vaccinates Last Infant in Phase IIb Clinical Trial

Erica Teichert — Thu, 05 May 2011 08:06:57 -0400

Total of 2,784 infants vaccinated in TB efficacy trial evaluating MVA85A
Study results expected to be available as early as mid-2012

ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that its joint venture with the University of Oxford (Oxford), the Oxford-Emergent Tuberculosis Consortium (OETC), has vaccinated the last of the 2,784 infants in its Phase IIb efficacy trial evaluating MVA85A, the world's most clinically advanced tuberculosis (TB) vaccine in development. This clinical trial in Worcester, South Africa, is being conducted by the University of Cape Town's South African Tuberculosis Vaccine Initiative (SATVI), in partnership with Aeras, the clinical sponsor of the study, and the Wellcome Trust.

"Emergent BioSolutions joined the fight against TB when it formed OETC with Oxford to further develop MVA85A," said Daniel J. Abdun-Nabi, Chairman of the Board, OETC and President and Chief Operating Officer, Emergent BioSolutions. "We are pleased to complete the vaccination of our targeted 2,784 infants, which is the largest number of infants enrolled in any TB vaccine clinical trial. Our quest to fulfill Emergent's corporate mission - to protect life - will come to fruition when we can bring this vaccine candidate to market and ultimately make an impact in patients' lives."

"We are extremely proud of this achievement and are eager to see the study results, which are expected to be available as early as mid-2012," said Dr. Helen McShane, lead scientist and developer of MVA85A from the University of Oxford. "This milestone brings us a step closer to potentially having a new TB vaccine, from which millions of people around the world would benefit."

This Phase IIb clinical trial was initiated in July 2009 and involves a two-year follow up on the infants vaccinated as part of the trial to evaluate whether the vaccine candidate has conferred protection against TB.

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.

U.S. Government Expands BioThrax Procurement Contract to 17.92M Doses from 14.5M Increasing Contract Value by up to $101 Million

Erica Teichert — Wed, 04 May 2011 15:32:31 -0400

ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a modification to its current procurement contract (200-2009-30162) with the U.S. government to supply an additional 3.42 million doses of BioThrax® (Anthrax Vaccine Adsorbed). BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

This modification to the contract is valued at up to $101 million for the delivery and shipping of additional doses of BioThrax beginning 3Q 2011. Delivery of these doses will commence immediately following early completion of final delivery of the original 14.5 million doses of BioThrax under the contract prior to this modification. Emergent anticipates completing all deliveries of these additional 3.42 million doses of BioThrax during the remainder of 2011.

"Emergent proudly supports the U.S. government's efforts and unwavering commitment to meet its stated need of 75 million doses of anthrax vaccines," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "This contract is an indication that BioThrax remains a critical component of the government's arsenal of biodefense medical countermeasures. In addition to this contract modification, we are continuing discussions with the U.S. government regarding a follow-on procurement contract, which we anticipate will cover a multi-year period."

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 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.

Emergent BioSolutions Chairman and CEO Fuad El-Hibri Named Biotech CEO of the Year at the World Vaccine Congress

Erica Teichert — Thu, 14 Apr 2011 08:11:36 -0400

ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that Fuad El-Hibri, its chairman and chief executive officer, has been recognized as Biotech CEO of the Year during the Vaccine Industry Excellence (ViE) Awards at the World Vaccine Congress. The ViE awards showcase excellence and honor accomplishments of both individuals and companies in the global vaccine industry.

"This award is a testament to the collective efforts of the Emergent BioSolutions team, who on a daily basis and all over the world, lives out the corporate mission - to protect life," said Mr. El-Hibri. "Our team shares a passion and commitment to make vital contributions to address unmet and underserved medical needs. It is an honor to be recognized for the work that we do."

In selecting the winner for this category, the distinguished panel of judges evaluated the finalists based on their commitment to disease prevention and treatment, leadership, contribution to company performance, communication, and vision, industry influence, and achievements in company positioning and status.

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.

Life Science Innovation Northwest 2011 Features Prominent Life Science Executives and Thought Leaders in Conference Line U

Thu, 03 Feb 2011 16:20:39 -0500

- Unprecedented support received from regional conference underwriters -

SEATTLE--(BUSINESS WIRE)-- Life Science Innovation Northwest 2011, the Pacific Northwest’s premier investor and strategic partner conference, today announced that more than 70 organizations will present; and strategic discussions on critical local, national and global healthcare issues will be featured in six plenary sessions. The conference is scheduled for March 2 and 3 at the Washington State Convention Center Seattle.

Presentations by a wide mix of organizations provide an opportunity for executives from development- to commercial-stage public and private companies, research institutes and leading global health organizations to showcase their technologies, business strategies and innovations to leading investors and strategic partners. The select slate of life sciences organizations include Advanced Medical Isotope Corporation, Allon Therapeutics, Bill & Melinda Gates Foundation, Calistoga Pharmaceuticals, CMC Biologics, Emergent BioSolutions, Home Dialysis Plus, Insilicos, Oregon Health & Science University (OHSU), Omeros, Pacific Northwest Diabetes Research Institute (PNDRI), Seattle Genetics, SIGA Technologies, SonoSite, T-Ray Science, University of Washington Center for Commercialization (UWC4C), VLST, and Washington State University Research Foundation (WSURF) to name a few. For more information on Life Science Innovation Northwest 2011 (LSINW 2011) program please visit www.washbio.org.

“With presenting companies from British Columbia, California, Montana, Oregon and Washington, and delegations from more than ten countries, this regional conference has truly gone global,” noted Chris E. Rivera, President, Washington Biotechnology & Biomedical Association (WBBA). “The unprecedented level of support from our underwriters including, K&L Gates, University of Washington, Fenwick & West LLP, SightLife, Wells Fargo Insurance Services, Edelman Seattle, Perkins Coie, and Praxair, combined with the expert panelists at this year’s conference makes this a not-to-be-missed event.”

Featured Program Highlights

Keynote presentations by James C. Greenwood, President & CEO, Biotechnology Industry Organization (BIO) and G. Steven Burrill, CEO, Burrill & Company and co-host of LSINW.
Six strategic panel presentations, including:

Partnering to Drive Innovation. This discussion defines how partnering benefits product development and innovation and will be moderated by Doug Williams (Biogen Idec), joined by executives from Alder Biopharmaceuticals, Allen Institute for Brain Sciences, Bill and Melinda Gates Foundation, Bristol-Myers Squibb, Fred Hutchinson Cancer Research Center, and Merck Research Laboratories.
Life Sciences in the Pacific Northwest: Creating the Future. will be moderated by Stephen Graham (Fenwick and West) and includes executives from Amgen, CMC Biologics, NovoNordisk, Philips Healthcare, and Seattle Genetics.
Lessons Learned: How to Position your Company for Success. Seasoned industry executives share anecdotes, experiences and critical guidance to succeed in today’s environment. Michelle Burris (OncoGenex Pharmaceuticals) will moderate the panel, and includes panelists from Calistoga Pharmaceuticals, Cell Therapeutics, Immune Design, Integrated Diagnostics, and Mirador Biomedical.
Global Solutions, Local Benefit. Learn how innovation designed to meet the needs of developing nations, provides local benefits. Panel will be moderated by John Gardner (Washington State University) and includes panelists from Cascade Design and Swedish Hospital amongst other leading experts on the topic.
Social, Political and Legal Issues Relating to Intellectual Property Rights. This dynamic panel lends perspectives and counsel from Intellectual Ventures, K&L Gates, University of Illinois at Chicago College of Medicine and University of Alberta.
Early Stage Capital. Experts discuss views on the promise and impact of early stage funding to drive and fuel innovation from public institutions, angel and venture capital sources, as well as industry strategic investors. This panel is moderated by Franklin Berger (FMB Research), with panelists from Life Sciences Discovery Fund, NEA, PhaseRx, University of Washington’s Center for Commercialization, and WINGs.

Speed-Dating: This fast-paced, exciting session fosters introductions and conversations between emerging companies, innovators, entrepreneurs and investors to initiate and facilitate fund-raising activities.
Poster Alley: Poster sessions will be held throughout the conference, providing researchers and emerging organizations the opportunity to share cutting edge innovation with investors, CEOs, and entrepreneurs.

There is still time to apply for speed-dating and the poster session. The deadline is February 7.

Apply today for these popular events! | Poster Session | Speed Dating

Register

Register now to take advantage of advance registration rates available through February 25. Or take advantage of a 20% discount on registration if you plan to attend both the Life Science Innovation Northwest 2011 and BioPartnering North America™.

Sponsors/Partners

LSINW 2011 would not be possible without the support of our sponsors and partners Life Sciences British Columbia, Montana BioScience Alliance, and Oregon Bioscience Association. If you are interested in being a sponsor, please contact Stacie Byars at stacie@washbio.org or 206-732-6705.

About LSINW 2011

Life Science Innovation Northwest 2011 is presented by The Washington Biotechnology & Biomedical Association (WBBA) and Burrill & Company. For more information on the LSINW 2011 conference, please visit www.washbio.org.

About WBBA

The Washington Biotechnology & Biomedical Association (WBBA) is an independent, non-profit 501(c)(6) trade association serving the life sciences industry in the state of Washington. Our members include organizations engaged in, or supportive of, research, development and commercialization of life science technologies. Our mission is to translate innovation to realization: from breakthrough discoveries to better health solutions. Learn more about the WBBA at www.washbio.org.

About Burrill & Company

Burrill & Company has established unrivaled access and visibility in the life sciences industry. With more than $1 billion in assets under management, the firm’s businesses include venture capital, private equity, merchant banking and media. A unique combination of resources and capabilities enables the company to provide life sciences companies with capital, management expertise, insight, market intelligence and analysis through its investments, conferences, and publications. Headquartered in San Francisco, the company oversees a global network of offices throughout the United States, Latin America, Europe and Asia. (www.burrillandco.com).

CONTACT:

The Washington Biotechnology & Biomedical Association (WBBA)
Stacie Byars, 206-732-6705
Stacie@washbio.org

KEYWORDS: United States North America Washington

INDUSTRY KEYWORDS: Health Biotechnology Genetics

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Emergent BioSolutions (EBS) Receives Fast Track Designation for Its Investigational Monoclonal Antibody

Erica Teichert — Fri, 01 Oct 2010 10:27:15 -0400

Emergent BioSolutions (EBS) Receives Fast Track Designation for Its Investigational Monoclonal Antibody for the Treatment of Inhalational Anthrax

ROCKVILLE, Md.--(BUSINESS WIRE)-- Emergent BioSolutions Inc. (NYSE:EBS - News) announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Emergent recently commenced a Phase I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

"Emergent is pleased to receive FDA Fast Track Designation, which is designed to facilitate the development and review of new drugs and biologics, and could allow the shortest time to approval of our anthrax monoclonal antibody therapeutic," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "We look forward to continuing to work with the FDA to fill this significant unmet medical need and to address the acknowledged threat of inhalational anthrax as a biological weapon."

The FDA's Fast Track Development Program provides for expedited regulatory review of drugs and biologics that treat serious or life threatening diseases and demonstrate the potential to address unmet medical needs. Under the Fast Track Designation, Emergent is now eligible to receive expedited regulatory treatment, including frequent FDA meetings and written correspondence, receive priority review of its Biological License Applications (BLA) for the product, and submit its BLA on a rolling basis, which allows the FDA to review sections of the BLA in advance of receiving the complete submission.

Emergent's Phase I clinical trial, which involves 50 healthy volunteers, is a randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate the safety and pharmacokinetics of the monoclonal antibody candidate.

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.