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Also, Novozymes Biologicals settles pollution case with the US Department of Justice; EntreMed restructures management team; more...
London (Dec. 19)-AstraZeneca signed a deal with MAP Pharmaceuticals (Mountain View, CA) to develop and commercialize “Unit Dose Budesonide,” a nebulised formulation of budesonide developed for pediatric asthma. Under the terms of the agreement, AstraZeneca will pay MAP an upfront cash payment of $40 million and an additional $35 million upon the successful achievement of primary endpoint and safety results in the ongoing Phase III clinical study. In addition, MAP is eligible to receive up to $240 million in milestone payments. The agreement also provides for additional progressively demanding sales performance-related milestone payments of up to $585 million in the event the product is a considerable commercial success. This agreement is subject to customary regulatory approval.
Bend, OR (Dec. 23)-Blue Reference, a developer of process analytics software, formed the Quality by Design Product Development Consortium (QbD PDC). Blue Reference will work with participating global pharmaceutical companies to identify and develop methods for planning, execution, and management of Quality by Design principles in pharmaceutical research and development.
Illkirch, France (Jan. 5)-Chiral Technologies Europe, a subsidiary of Daicel Chemical Industries and the provider of Daicel chromatography products and services to pharmaceutical and biotechnology companies in Europe, acquired chromatography column manufacturer ChromTech (Congleton, UK).
Rockville, MD (Dec. 15)-EntreMed, a biopharmaceutical company, will focus the company’s resources on its most promising near-term product candidate, "ENMD-2076," an Aurora/angiogenesis kinase inhibitor. The company announced a restructuring plan that will transition the company to a clinically focused operation. Development of other product candidates will be on hold until financial resources are available. The company will reduce its workforce by approximately 60% across all areas of the business. The restructuring plan was implemented in late December 2008.
Essen, Germany (Dec. 17)-Evonik Industries began construction of a catalyst manufacturing plant in Shanghai, China, to produce precious metal powder catalysts used in pharmaceutical and fine-chemical production. The plant will start operation in the fourth quarter of 2009.
London (Dec. 23)-GlaxoSmithKline and Archemix formed an alliance to discover, develop and commercialize aptamer therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Aptamers are synthetized oligonucleotides, or short nucleic acid sequences, that bind to proteins with high affinity and specificity. Under the terms of the agreement, Archemix will receive $27.5 million in upfront payments from GSK, including a $6.5 million equity investment by GSK. Archemix could also be eligible to receive up to $200 million in development, regulatory, and sales milestone payments for each of seven potential aptamer therapeutics that may be discovered and developed as part of the alliance. Archemix would also receive tiered royalties up to lower double digits on worldwide sales of products that may result from the alliance.
Waltham, MA (Dec. 17)-InnoCentive, a global innovation marketplace, announced that the International AIDS Vaccine Initiative (IAVI), a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world, has posted a $150,000 challenge on InnoCentive's website. The challenge seeks proposals for and a sample of the protein that will provide researchers with new avenues for furthering HIV vaccine design and development.
Specifically, the challenge calls for the design of a protein-or trimer-that mimics the part of the HIV envelope that is first visible to the body's host defenses. The winner will have successfully designed and created a mimic of a stable functional HIV envelope trimer. IAVI will then test the trimer to see what kinds of immune responses it generates. If the trimer is sufficiently immunogenic, researchers will also be eligible for a bonus of up to $1 million and/or the opportunity to pursue their research further with support from IAVI.
Palo Alto, CA (Dec. 16)-The specialty pharmaceutical company Jazz Pharmaceuticals announced a reduction of 71 employees, or approximately 24% of its workforce, to lower operating expenses. The company expects to record a charge of approximately $1.9 million in the fourth quarter of 2008 related to this staff reduction. Also, the company announced that Chief Financial Officer Matt Fust left the company in December 2008 to pursue other interests. His responsibilities will be assumed by other members of the executive management team.
San Carlos, CA (Dec. 31)-Nektar Therapeutics closed the divestment of specific Nektar pulmonary delivery assets, technology, and intellectual property to Novartis for $115 million in cash. The transaction was completed on Dec. 31, 2008. With the closing, Novartis assumes ownership of certain dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment and manufacturing facility lease obligations. The sale also transferred to Novartis approximately 140 Nektar personnel, as well as certain intellectual property and manufacturing methods, including manufacturing and royalty rights to Novartis' "Tobramycin inhalation powder" (TIP) program.
Basel (Dec. 29)-Novartis formed an agreement to license AlphaVax's investigational cytomegalovirus (CMV) vaccine program. This CMV agreement adds to Novartis's early-stage pipeline of vaccines, which focuses on unmet needs for the prevention of fatal diseases such as meningococcal infections and other hospital- and community-acquired infections. AlphaVax is responsible for finalization of Phase I clinical trials, and will provide the clinical trial material for the Phase II trials. Novartis will be responsible for the development of the CMV program for Phase II clinical trials as well as for registration and worldwide commercialization. The AlphaVax vaccine candidate is based on an alphavirus replicon particle encoding CMV phosphoprotein 65, IE1 (immediate early protein 1) and soluble gB protein.
Bagsvaerd, Denmark (Dec. 18)-Novozymes Biologicals settled a pollution case with US Department of Justice (DOJ) regarding its Salem, Virginia, facility. The case stems from the discharge of products into a drain at the Salem facility in 2005, which resulted in a short-term environmental impact to nearby Mason’s Creek, a tributary of the Roanoke River, but resulted in no long-term harm either to Mason’s Creek or the Roanoke River, according to the company. Following the discharge, Novozymes said it took immediate action and implemented corrective measures. The company was subsequently investigated by the DOJ. The settlement involved a review by the US District court near Salem (Roanoke Federal Court) of the plea agreement entered by both parties, under which Novozymes agreed to plead guilty, pay a fine of $275,000, and make a payment of $250,000 for an environmental service project in the Roanoke area.
Castres, France (Dec. 22)-Pierre Fabre Médicament and Forest Laboratories signed an agreement for the development and marketing of “F2695” in the United States and Canada. F2695 is an active isomer of milnacipran and a mixed inhibitor of serotonin and noradrenaline recapture developed for use in the treatment of depression and other central nervous system disorders. Under the terms of the agreement, Forest will pay Pierre Fabre a first milestone payment of $75 million, followed by staggered payments. Pierre Fabre will also receive royalties based on sales. Forest will be responsible for the clinical development and marketing of F2695 in the United States and Canada, and Pierre Fabre will finance the preclinical development and production at an international level.
Wilmington, NC (Jan. 5)-PPD entered into a strategic collaboration with Merck & Co., Inc., involving vaccine testing and assay development. Under the agreement, PPD purchased Merck's 130,000-ft2 vaccine testing laboratory and related equipment in Wayne, Pennsylvania, and hired the nearly 80 Merck professionals who operate the facility. As part of this collaboration, PPD will provide Merck with assay development and immunogenicity testing services to support Merck's vaccine portfolio over a period of five years.
In December 2008, PPD announced plans to expand its global central lab services into Singapore. The lab is expected to begin operations in mid-2009. In a separate announcement, the company announced plans to expand its contract research operations into Athlone, Ireland, by initially establishing a CGMP analytical testing laboratory. PPD expects to create approximately 250 jobs and plans to invest up to $18 million to develop the facility, which is expected to begin operations by the second half of 2009.
Haninge, Sweden (Jan. 5)-Recipharm, a contract development and manufacturing organization, completed the transfer of a majority stake in the AstraZeneca Biotech Laboratory (ABL) to its new subsidiary, Recipharm Biologics, on Jan. 1, 2009. The facility adds mammalian recombinant protein and monoclonal antibody development and production capabilities to the group’s services. AstraZeneca retains a significant minority stake in the new company. Under the terms of the agreement, Recipharm will lease the ABL from AstraZeneca for an initial period of 12 years, purchasing all associated equipment and employing the existing staff.
Paris (Dec. 22)-Sanofi-Aventis (SA) and Novozymes (Bagsvaerd, Denmark), signed an agreement for the development and marketing of a new potential antibiotic. The drug candidate, developed by Novozymes, is an antimicrobial peptide named “Plectasin NZ2114” that targets the treatment of severe infections caused by bacteria like Staphylococcus and Streptococcus. Under the terms of the agreement, SA has been granted an exclusive worldwide license for the development, registration and commercialization of the drug. The two parties will jointly work to develop and implement commercial-scale manufacturing of the drug substance, with the goal of introducing a recombinant process building on Novozymes’ proprietary expression technology.
Ann Arbor, MI (Dec. 18)-The University of Michigan (UM) will purchase a former Pfizer site for $108 million. The nearly 174-acre site, which includes almost 2 million ft2 of laboratory and administrative space in 30 buildings, will be used for the university's research activities in health, biomedical sciences and other disciplines. UM expects to close on the property by June 2009, after successful due diligence and compliance with any state and regulatory requirements.
(Jan. 5)-Pharmalot blogger Ed Silverman announced he has resigned. Silverman accepted a buyout package from the New Jersey-based newspaper The Star-Ledger, and the blog will no longer continue. Silverman will contribute to various Elsevier Business Intelligence titles.
San Diego, CA (Jan. 7)-Accelrys, a company developing scientific business intelligence software for the life sciences, announced that Mark Emkjer, its president and CEO resigned as an officer and director of the company, effective Jan. 5, 2009. Emkjer will remain employed until Feb. 1, 2009 to transition his role and responsibilities. The company’s board of directors appointed Todd Johnson to serve as the company’s interim president and CEO.
Houston, TX (Jan. 5)-Ensysce Biosciences, a nanotechnology company, appointed Lynn Kirkpatrick president and CEO. Kirkpatrick is the cofounder of ProlX Pharmaceuticals, and was CEO from 1999 until its acquisition by Biomira in 2006. From 2006 through 2008 she was CSO of the merged company, which changed its name to Oncothyreon (Seattle, WA) in 2007.
Rockville, MD (Dec. 15)-As part of EntreMed’s restructuring and cost-reduction plans, President and CEO James S. Burns will leave the company and resign from the board of directors. Also leaving the company are CFO Dane Saglio; Senior Vice President of Research and Development Kenneth W. Bair; and Senior Vice President of Corporate and Business Development Thomas H. Bliss. The senior management team going forward will include: Carolyn F. Sidor, vice-president and chief medical officer; Mark R. Bray, vice-president of research; Cynthia W. Hu, vice-president of general counsel and secretary who has been appointed COO; and Kathy Wehmeir-Davis, controller who has been appointed principal accounting officer. This senior management team will report to a newly formed executive committee of the board comprising three independent directors: Michael M. Tarnow, Dwight L. Bush, and Jennie Hunter-Cevera.