Fuad El-Hibri Wire » United States Department of Health and Human Services

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

admin — Wed, 05 Jan 2011 05:27:29 +0000

ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical trial for NuThrax^TM (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.

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Emergent BioSolutions Hosts Biopreparedness Roundtable for NATO Parliamentarians

admin — Tue, 13 Jul 2010 08:26:45 +0000

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

Emergent BioSolutions Inc. (NYSE:EBS) is hosting “Bioterrorism Prevention, Preparedness and Response,” a forum organized for members of the North Atlantic Treaty Organization (NATO) Parliamentary Assembly (PA) to raise global awareness of the importance of biopreparedness. The visiting delegation is composed of parliamentarians from Canada, Estonia, France, Finland, Germany, Greece, Italy, Hungary, Lithuania, the Netherlands, Norway, Romania, Poland, Portugal, Turkey, Sweden, Slovenia, Spain, and the United Kingdom.

“Emergent commends NATO parliamentarians for advancing the international dialogue on biopreparedness,” said Allen Shofe, senior vice president public affairs, Emergent BioSolutions. “We are pleased to share our knowledge based on Emergent’s extensive experience in the development, manufacture, and delivery of medical countermeasures that are critical to the U.S. government’s biodefense infrastructure.”

The forum features biodefense expert Dr. Robert Kadlec, Director of PRTM Biodefense and Public Health Practice, who will discuss the United States’ approach to bioterrorism prevention, including best practices and strategies such as funding, development, and manufacture of biodefense medical countermeasures, creation of strategic stockpiles, and cooperation within the international community.

Emergent BioSolutions’ senior management team, headed by Daniel J. Abdun-Nabi, President and Chief Operating Officer, Dr. Tevi Troy, Senior Visiting Fellow at the Hudson Institute and former Deputy Director of the U.S. Department of Health and Human Services, and Dr. Barry Kellman, President of the International Security and Biopolicy Institute (ISBI) are among the attendees. The forum is taking place in Washington, D.C.

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.

About the NATO Parliamentary Assembly

The NATO Parliamentary Assembly is the inter-parliamentary organization of legislators from the member countries of the North Atlantic Alliance as well as 14 associate members. The Assembly provides a critical forum for international parliamentary dialogue on an array of security, political and economic matters. For more information, visit www.nato-pa.int.

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Bad News Clouds Two Bio Defense Stocks

admin — Tue, 15 Dec 2009 13:13:33 +0000

Written by Staff and Wire Reports
Tuesday, 08 December 2009 01:28

Key news developments will affect shares of these two companies who help meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons.

The two companies which waited until late after hours on Monday to announce that the Biomedical Research and Development Authority had informed them of some negative news.

After hours on Monday, PharmAthene, Inc. (NYSE Amex: PIP) a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced that the Department of Health and Human Services Biomedical Research and Development Authority (BARDA) has canceled its request for proposal (RFP) for Recombinant Protective Antigen Anthrax Vaccine for the Strategic National Stockpile (RFP BARDA 08-15).

PharmAthene was informed of BARDA’s decision during a meeting late Monday afternoon with BARDA representatives. BARDA issued a press release after the close of the securities markets announcing that it will cancel RFP BARDA 08-15 because it did not believe vaccine developers submitting proposals in response to the request for proposal (RFP) could have product ready for FDA licensure within 8 years.

In similar news…

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been advised by the Office of the Biomedical Advanced Research and Development Authority (BARDA) that the Request for Proposal (RFP) for the procurement of rPA vaccines has been cancelled in favor of a Broad Agency Announcement (BAA) for rPA vaccine development. According to BARDA officials, BARDA took this action after a technical evaluation panel determined that none of the vaccine developers submitting proposals could meet the Project BioShield statutory requirement of having a product ready for licensure within 8 years.

Simultaneously, BARDA issued an amendment to BAA 09-34 to enable companies to submit proposals to obtain development funding for rPA vaccine candidates. The due date for all proposals is February 1, 2010. During a meeting with company officials today, BARDA strongly encouraged Emergent to submit a proposal to this BAA. Emergent intends to submit its proposal by the end of this year.

While the decision by BARDA has no impact on the company’s $400 million procurement contract with the Centers for Disease Control and Prevention (CDC) for the manufacture and delivery of 14.5 million doses of BioThrax® into the Strategic National Stockpile (SNS). Investors are still likely to react negatively to the news.

After selling dies down, there may be a bounce trade opportunity for EBS followers since the company feels that “BioThrax remains a critical and long-term countermeasure for the US government,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”

Source :: http://biomedreports.com/articles/most-popular/20870-bad-news-clouds-move-in-on-these-stocks.html

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Emergent Biosolutions on Answers.com

admin — Tue, 18 Aug 2009 12:15:45 +0000

Type: Public
On the web: http://www.emergentbiosolutions.com
Employees: 587
Employee growth: 4.8%

Emergent BioSolutions protects your thorax against anthrax. Emergent BioSolutions develops and produces, for government and commercial markets, drugs that treat or protect against infectious diseases and bio-agents. The company supplies BioThrax (the US’s only FDA-approved anthrax vaccine) primarily to the departments of Defense and Health and Human Services (HHS). Its biodefense unit is also developing a post-exposure treatment for anthrax and a preventive vaccine for botulinum toxin. For commercial markets, Emergent is working on therapies and vaccines for typhoid, Group B strep, and hepatitis B, among other things. Chairman and CEO Fuad El-Hibri controls more than half of the company.

Key numbers for fiscal year ending December, 2008:
Sales: $178.6M
One year growth: (2.4%)
Net income: $20.7M
Income growth: (9.8%)

Officers:
Chairman and CEO: Fuad El-Hibri
President, COO, and Director: Daniel J. Abdun-Nabi
SVP Finance and Administration, CFO, and Treasurer: R. Don Elsey

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Board expands with Election of Fuad El-Hibri

admin — Mon, 22 Jun 2009 01:16:06 +0000

NHM Chairman Louis Sullivan, MD, has announced the election of biotechnology executive Fuad El-Hibri, physician and public health expert Margaret A. Hamburg, MD, and technology entrepreneur James M. Philips to the NHM Board of Trustees for three-year terms of service. Fuad El-Hibri on National Health Museum, WASHINGTON— September 3, 2007.

Fuad
El-Hibri

Margaret Hamburg

James
Philips

“As we continue working toward our goal of an institution that will serve as a global information platform, we celebrate the election of three new board members who have each made key contributions to the creation of a healthier and safer world,” said Sullivan.

“Through his leadership in the field of biotechnology, Fuad El-Hibri is helping develop strategies to address serious threats to global health security. Throughout a distinguished career in public service, Peggy Hamburg has focused her considerable intellect and medical training on similar concerns as well as a range of other pressing health policy issues. And from his position at the vanguard of the information technology revolution, Jim Phillips has helped successfully launch companies and institutions that are improving our ability to connect, communicate and heal.

“We are proud to have earned the active interest and support of Fuad, Peggy and Jim and look forward to drawing extensively upon their experience and expertise as our efforts to develop NHM proceed,” said Sullivan.

Fuad El-Hibri, CEO and Chairman, Emergent Biosolutions

Fuad El-Hibri leads Emergent Biosolutions, a Maryland-based biotechnology company focused on the development, manufacture and commercialization of immunobiotics. The company operates in two business segments: biodefense and commercial. In its biodefense business, Emergent develops and commercializes immunobiotics for use against biological agents that are potential weapons of bioterrorism. In its commercial business, the company develops immunobiotics for use against infectious diseases with significant unmet or underserved medical needs.

El-Hibri served as chief executive officer and chairman of the board of directors of BioPort Corporation from 1998 until 2004, when BioPort became a subsidiary of Emergent. He also served as chairman of Digicel Holdings, Ltd., a privately held cellular telecommunications firm, from August 2000 to October 2006. Since 1990, he has also served as chairman of East West Resources Corporation, a venture capital and financial consulting firm.

He is a member of the board of trustees of American University and a member of the board of directors of the International Biomedical Research Alliance, an academic joint venture among NIH, Oxford University and Cambridge University. He also serves as chairman and treasurer of El-Hibri Charitable Foundation which has contributed to a variety of international development projects, including a children’s orphanage in Lebanon. He holds a master’s degree in public and private management from Yale University and a B.A. in economics from Stanford University.

Margaret A. Hamburg, MD, Senior Scientist, Global Health and Security Initiative, NTI

One of the youngest people ever elected to the Institute of Medicine of the National Academy of Sciences, Dr. Margaret “Peggy” Hamburg is a highly regarded expert in community health and bio-defense, including preparedness for nuclear, biological, and chemical threats. She currently serves as Senior Scientist for the Global Health and Security Initiative of the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. A graduate of Radcliffe College, she earned her M.D. from Harvard Medical School, and completed her training at the New York Hospital/Cornell University Medical Center.

From 1997 to 2001, Hamburg held the position of Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services (HHS), serving as principal policy advisor to Secretary of Health and Human Services Donna Shalala. From 1991 to 1997, she served as New York City Health Commissioner, a position in which she designed and implemented an internationally recognized tuberculosis control program that produced dramatic declines in tuberculosis cases, and created the first public health bio-terrorism preparedness program in the nation. Between 1986 and 1990, she held a variety of positions within HHS, including Special Assistant to the Director, Office of Disease Prevention and Health Promotion; and Special Assistant to the Director, and later Assistant Director, of the National Institute of Allergy & Infectious Diseases at the National Institutes of Health.

A member of the Harvard College Board of Overseers and the Boards of Trustees of Rockefeller University and the Rockefeller Foundation, Hamburg is also a distinguished senior fellow with the Center for Strategic and International Studies, and a fellow of the American Association of the Advancement of Science. She holds membership in the New York Academy of Medicine, and the Council on Foreign Relations and serves on the board of Henry Schein Company. She has served on the boards of other organizations, including the New York City Health and Hospitals Corporation, the Nathan Cummings Foundation, the Primary Care Development Corporation, and the Board of Scientific Counselors for the National Center for Infectious Diseases of the Centers for Disease Control and Prevention.

James M. Phillips, Vice Chairman, Luminetx

James “Jim” Phillips’s career has been marked by success at starting and guiding companies through successful initial public offerings and pioneering new technologies into major industry-leading positions – including the PDA, digital cell phone, fixed cellular and internet multimedia. A classic entrepreneur, Phillips’ began his career with Telecommunications System of America, which was sold to Northern Telecom (Nortel), where Phillips eventually became vice president. He held subsequent executive positions at SkyTel, which became the nation’s largest messaging company; Telular Corporation, the world’s largest fixed wireless cellular company; and Motorola, where he participated in launching digital cellular and multimedia, bringing cable modem to the market.

Phillips then became Chairman and CEO of IPIX, which produced digital photographs with 360° navigable images that are today widely used on major Web sites. After taking the company public, he was asked to become involved with the effort to build the FedEx Institute of Technology (FIT), a partnership between Federal Express Corp. and The University of Memphis. Phillips resigned from IPIX, moved to Memphis and raised $100 million to make FIT a reality. Information Week has called FIT the technology industry’s “newest center for innovation” and WIRED has compared it to the famous Media Lab at MIT.

After successfully launching FIT, Phillips served as CEO in residence at Morgan Keegan, a Memphis-based investment firm, before raising the capital to launch Luminetx Corporation. Luminetx produces the VeinViewer, which was named in 2004 by Time as “one of the coolest medical inventions of the year.” Phillips is Vice Chairman of Luminetx, having previously served as the company’s CEO, president and chairman. A holder of patents in cell phone, PDA and data modem design, he also serves on a number of boards including the American Museum of Science and Energy, Visio Technologies Corporation, EmergeMemphis, Memphis Biotech Foundation, University of Memphis Fogelman School of Business and Economics, and the Memphis Area Chamber of Commerce.

Posted in American University, El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri
Tags: United States, National Institutes of Health, United States Department of Health and Human Services, Centers for Disease Control and Prevention, Rockefeller Foundation, Harvard Medical School, Hamburg, United States Secretary of Health and Human Services

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Fuad El-Hibri EBS IPO and BioThrax

admin — Sun, 21 Jun 2009 23:10:05 +0000

“When you have two parties you can maybe exercise control over one party, which is ourselves. Our relationship with HHS continues to be strong, and we’re excited about this opportunity,” said Fuad El-Hibri, chief executive officer, in a conference call with analysts. “These are half-billion-dollar types of contracts. They just take time to negotiate.”

Delayed orders of its anthrax product drastically cut into Emergent BioSolutions Inc.’s fourth-quarter revenue and profits.

The Rockville biotech earned nearly $35.8 million in revenue in the fourth quarter last year, a 60 percent drop from the $89.6 million it pulled in during the same period of 2007. That also resulted in a nearly 95 percent plunge in fourth-quarter profits, from $27.7 million to nearly $1.5 million.

The company said it had expected to ship three additional lots of its BioThrax anthrax vaccine to the U.S. Department of Health and Human Services during the fourth quarter — representing $12 million worth of product sales — but that delivery was delayed.

“Such an event is further evidence that our revenues fluctuate quarter to quarter based on the timing of deliveries of BioThrax to HHS,” said Don Elsey, chief financial officer, in a statement.

Despite that drop, Emergent’s revenue for the full year in 2008 dipped only 2 percent, from $182.9 million to $178.5 million, and profit fell 10 percent, from $22.9 million to $20.7 million. Nearly all of the company’s product sales came from BioThrax, and Emergent said it saw a 16 percent drop in BioThrax doses delivered to HHS. That was offset, though, by an 18 percent rise in Emergent’s BioThrax dose price.

The company earns most of its money from HHS contracts. While Emergent still has two contracts outstanding, worth a total $853 million, to deliver more than 33 million doses to HHS, the larger of those two contracts, worth $448 million, will be completed in the third quarter of this year.

Emergent is awaiting an HHS decision on its bid last year to sell 25 million doses of a separate anthrax vaccine to the agency — a negotiation process that has been delayed by a protest from one of the other bidders on the HHS request for proposals, Emergent officials said.

Emergent thinks its revenue this year will grow by 25 to 35 percent and lie between $225 million and $240 million. It also expects profits to exceed $20 million this year.

Emergent had plans to expand its manufacturing space into Frederick, Md., but those plans have been put on hold as it concentrates its work at a current plant in Lansing, Mich. Emergent officials have been wary of giving any timelines for further manufacturing expansions but did say nothing would occur before the end of next year.

“We would be using existing manufacturing process, existing scale, existing equipment,” El-Hibri said. “We have plenty of space.”

By the end of last year, the company had $91.5 million in cash and equivalents.

Emergent’s share price (NYSE: EBS) dropped $1.08, or a little more than 6 percent, in trading after closing bell Thursday, when the company released its earnings.

Posted in El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri
Tags: Anthrax, Biological and Chemical, BioThrax, Chief executive officer, Chief financial officer, Emergent BioSolutions, Terrorism, United States Department of Health and Human Services

Fuad El-Hibri and EBS Initial Public Offering

A Gaithersburg drug company that makes most of its money selling the only federally approved vaccine against anthrax is in the final stages of preparing an initial public offering to raise up to $92 million.

Late last month, Emergent Biosolutions Inc. set the range of its offering at $14 to $16 a share. The company said it intends to use the money on its manufacturing facilities in Frederick and Michigan and to fund development of several products, according to documents filed with the Securities and Exchange Commission.

The company is tightly controlled by Fuad El-Hibri, its chairman and chief executive. El-Hibri, who lives in Potomac, has an extensive background in the telecommunications industry. He and his father have also had significant involvement with a British provider of anthrax vaccines. El-Hibri, who became a U.S. citizen in 1999, was born in Germany and grew up around Europe and the Middle East before attending Stanford and Yale universities.

El-Hibri controls 99.5 percent of the Emergent’s outstanding stock. After going public, he will control 81.4 percent. In SEC documents, the company said El-Hibri “will continue to have substantial control over us after this offering, including through his ability to control the election of the members of our board of directors, and could delay or prevent a change of control.”

Biotech analysts said Emergent could have a tough time with its initial public offering. Just two biotech companies — Osiris Therapeutics, a Baltimore biotechnology firm working on stem-cell therapies, is one — went public in the third quarter, and the market for IPOs in general has been spotty.

According to Thomson Financial, more companies have withdrawn IPOs this year than in any of the previous five years, indicating investors are skeptical of new company stock offerings despite the generally strong market for stocks. And venture capital-backed IPOs, traditionally the most prolific source of new company issues, fell significantly in the third quarter.

Companies that have managed to go public are in a broad range of industries, and those that have had the most success are in tried-and-true money-making or technologically hot industries. For example, locally, government contracting giant SAIC Inc. is up 33 percent since its Oct. 12 IPO. And Osiris Therapeutics is up 89 percent since its August IPO.

Emergent Biosolutions’ effort to finish its IPO comes as federal health officials deal with a troubled $877.5 million contract for another anthrax vaccine, made by VaxGen Inc. VaxGen is supposed to provide 75 million doses for the national stockpile, but the Food and Drug Administration recently halted human testing of the California company’s vaccine because of concerns about its potency, throwing the entire contract into doubt.

VaxGen’s contract was awarded under the Project Bioshield initiative, which seeks to develop modern vaccines and drugs for chemical, biological, radiological or nuclear attacks. VaxGen’s proposed anthrax vaccine, if successful, would require fewer doses over a shorter period of time to produce immunity than the older version made by Emergent.

Emergent has been urging Congress and federal health officials to buy more of its anthrax vaccine, called BioThrax, for the stockpile. The efforts are being aided by Louis W. Sullivan, who was health and human services secretary from 1989 to 1993, and Jerome M. Hauer, a former senior HHS official who oversaw public health emergency preparedness. Both men are on Emergent’s board.

So far, the government has purchased 10 million doses.

In its SEC filings, Emergent said the government’s efforts to stockpile a newer version “would limit, possibly significantly, the market for BioThrax.” The company said it is in the early stages of developing a next-generation anthrax vaccine and products for other diseases and bioterrorism agents.

Emergent officials could not comment because the company is in a quiet period before its offering.

While the $5.6 billion Project Bioshield program is potentially the most lucrative outlet for BioThrax, Emergent also sells the vaccine to the Defense Department. Since 1998, the Defense Department has vaccinated 1.5 million people with more than 5.7 million doses, according to SEC documents. It is providing 1.5 million doses to the military through September 2007.

BioThrax has been controversial in the military. Some soldiers have complained of significant side effects and have refused to use the vaccine, leading to a court battle that temporarily stopped mandatory vaccinations. The government recently resumed mandatory vaccinations with BioThrax after the FDA said the vaccine was safe and effective.

John T. McCamant, editor of the Medical Technology Stock Letter, said Emergent’s IPO could be particularly difficult because the only customer for bioterrorism products is the government.

“That’s a tall trick because the money will come in lumps at best,” he said.

Staff writer Terence O’Hara contributed to this report.

Posted in El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri, Initial Public Offering
Tags: Board of directors, United States, Emergent BioSolutions, U.S. Food and Drug Administration, Health, Vaccine, VaxGen, U.S. Securities and Exchange Commission

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Fuad El-Hibri Profits and Losses

admin — Sun, 21 Jun 2009 22:36:58 +0000

Fuad El-Hibri and Emergent BioSolutions Inc. Profits and Losses

Delayed orders of its anthrax product drastically cut into Emergent BioSolutions Inc.’s fourth-quarter revenue and profits.

The Rockville biotech earned nearly $35.8 million in revenue in the fourth quarter last year, a 60 percent drop from the $89.6 million it pulled in during the same period of 2007. That also resulted in a nearly 95 percent plunge in fourth-quarter profits, from $27.7 million to nearly $1.5 million.

The company said it had expected to ship three additional lots of its BioThrax anthrax vaccine to the U.S. Department of Health and Human Services during the fourth quarter — representing $12 million worth of product sales — but that delivery was delayed.

“Such an event is further evidence that our revenues fluctuate quarter to quarter based on the timing of deliveries of BioThrax to HHS,” said Don Elsey, chief financial officer, in a statement.

Despite that drop, Emergent’s revenue for the full year in 2008 dipped only 2 percent, from $182.9 million to $178.5 million, and profit fell 10 percent, from $22.9 million to $20.7 million. Nearly all of the company’s product sales came from BioThrax, and Emergent said it saw a 16 percent drop in BioThrax doses delivered to HHS. That was offset, though, by an 18 percent rise in Emergent’s BioThrax dose price.

The company earns most of its money from HHS contracts. While Emergent still has two contracts outstanding, worth a total $853 million, to deliver more than 33 million doses to HHS, the larger of those two contracts, worth $448 million, will be completed in the third quarter of this year.

Emergent is awaiting an HHS decision on its bid last year to sell 25 million doses of a separate anthrax vaccine to the agency — a negotiation process that has been delayed by a protest from one of the other bidders on the HHS request for proposals, Emergent officials said.

Emergent thinks its revenue this year will grow by 25 to 35 percent and lie between $225 million and $240 million. It also expects profits to exceed $20 million this year.

Emergent had plans to expand its manufacturing space into Frederick, Md., but those plans have been put on hold as it concentrates its work at a current plant in Lansing, Mich. Emergent officials have been wary of giving any timelines for further manufacturing expansions but did say nothing would occur before the end of next year.

“We would be using existing manufacturing process, existing scale, existing equipment,” El-Hibri said. “We have plenty of space.”

By the end of last year, the company had $91.5 million in cash and equivalents.

Emergent’s share price (NYSE: EBS) dropped $1.08, or a little more than 6 percent, in trading after closing bell Thursday, when the company released its earnings.

Posted in El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri, Profits and Losses
Tags: Anthrax, Biological and Chemical, BioThrax, Chief executive officer, Chief financial officer, Emergent BioSolutions, Terrorism, United States Department of Health and Human Services

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Fuad El-Hibri and Emergent gets boost from FDA

admin — Sun, 21 Jun 2009 22:21:11 +0000

: Image via Wikipedia

“We are pleased that the FDA has approved the 4-year expiry dating of BioThrax as this extends the ability of the U.S. government to store our product in the nation’s Strategic National Stockpile,” said Fuad El-Hibri, chairman and CEO.

Emergent BioSolutions hit a jackpot of sorts when the Food and Drug Administration approved extending the shelf life of its anthrax vaccine from three to four years.

The milestone approval means that the vaccines that the Rockville biotech has already sold to the Department of Health and Human Services‘ Strategic National Stockpile are worth $30 million more than the original price. In a statement, Emergent said it plans to record that extra income in the current quarter.

Furthermore, the extended shelf life means that the value of the company’s contract for 14.5 million additional doses has increased to $405 million.

“This is a critically important product feature that we believe will increase the attractiveness of BioThrax to the U.S. government as it increases BioThrax’s life cycle value. We are continuing our efforts to further enhance the attributes of BioThrax, including research toward a further reduction in the vaccination schedule and an expanded label indication for post-exposure prophylaxis. We believe these enhancements, if approved, will advance the U.S. government’s preparedness efforts in response to anthrax as a potential weapon of bioterrorism.”

Emergent has supplied more than 33 million doses of BioThrax, the only FDA-approved anthrax vaccine, to the federal government, with more deliveries scheduled through the third quarter of 2011.

Also this week, Emergent sued privately held Protein Sciences Corp. of Meriden, Conn., which it planned to acquire last year, according to a filing with the Securities and Exchange Commission. In connection with the planned acquisition, Emergent made a $10 million loan to Protein Sciences, which used its assets as collateral. A May 31 deadline for repayment passed, prompting the suit, Emergent said.

Emergent also plans to proceed with its pending lawsuits against Protein Sciences and its management, including claims for breach of contract, fraud and unfair business practices.

Posted in Anthrax Vaccine, El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Federal Drug Administration, Fuad El-Hibri
Tags: Federal government of the United States, Food and Drug Administration, Strategic National Stockpile, U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, United States, United States Department of Health and Human Services, US government

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