El-Hibri Fuad Blog

Archive for August 2010

ROCKVILLE, Md., Aug 24, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today hosted “Looking Beyond the Bench,” a symposium organized for doctoral students enrolled in the NIH-Oxford-Cambridge Scholars Program. The symposium featured Emergent executives, who, based on their extensive experience in the biopharmaceutical industry, provided insight on potential career paths awaiting biomedical researchers. The speakers highlighted examples of how a scientific background would interrelate with such disciplines as Grants and Contracts, Clinical Development, Intellectual Property, and Product Development.

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

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

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

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

About Emergent BioSolutions Inc.

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

About the International Biomedical Research Alliance

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

August  17,  2010  — The El-Hibri Charitable Foundation announced today that prominent peace educator, nationally renowned columnist and accomplished author Colman McCarthy has been selected as the recipient of the  2010 El-Hibri Peace Education Prize. The Prize, which carries a monetary award of  $15,000, is given annually by the foundation to honor an individual or organization that has made a significant contribution to the field of peace education. McCarthy’s selection was made by a committee of peace education experts chaired by Dr. Mubarak Awad, President of Nonviolence International.

“Colman McCarthy has dedicated his life to teaching young people the principles of peaceful conflict resolution,” noted Robert Buchanan, president of the El-Hibri Charitable Foundation. “His personal commitment and example, combined with his access to national media, have inspired countless individuals to incorporate the values of peace and nonviolence in their personal and professional lives. The El-Hibri Charitable Foundation is pleased to recognize Colman McCarthy for his tireless efforts on behalf of peace education.”

McCarthy was a columnist with The Washington Post from  1969 to 1997. He also wrote for The New Yorker, The Nation, and The Atlantic, among other publications, and has been a frequent guest on C-SPAN. In addition to his career in journalism, McCarthy has been teaching courses on nonviolence and peace studies for nearly thirty years at Washington, D.C. area schools, universities, and student leadership programs. In 1985, he founded and continues to lead the Center for Teaching Peace, a non-profit organization that works with schools and individuals around the world to initiate and expand academic programs in peace education.

McCarthy’s publications include “I’d Rather Teach Peace”, “All of One Peace” and “At Rest with the Animals”.He is also the editor of two anthologies of peace essays that are used as course texts in high schools and colleges:  “Solutions to Violence” and  “Strength Through Peace”.

The  2010 El-Hibri Peace Education Prize will be awarded to Colman McCarthy at a ceremony to be held at 6:30 p.m. on September 25th at the El-Hibri Charitable Foundation’s Washington, D.C. headquarters.

The El-Hibri Charitable Foundation is a  501(c)(3) non-profit private foundation founded in 2001 and led by Fuad El-Hibri, Chairman of the Board of Trustees.. The foundation seeks to build a better world by encouraging peace education, interfaith dialogue, humanitarian aid and social justice.The El-Hibri Peace Education Prize was initiated in  2007. Past Laureates include Abdul Aziz Said, founder of the Center for Global Peace at American University; Scott Kennedy, peace activist and co-founder of the Resource Center for Nonviolence; and Mary E. King,international educator,author and policy advisor.

For further information, visit http://www.elhibriprize.org

  • 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.

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.