BIOTECHNOLOGY/PHARMACEUTICAL
UPDATE
January 2007
McIlvaine Company
CEL-SCI Gets $15 Million for Cancer Therapy Manufacturing Facility
BioProperties, a real estate firm specialized in the biomedical sector, committed $15 million to CEL-SCI to acquire and build out a manufacturing facility for the company’s cancer product, according to a letter of intent. Multikine® was recently approved to enter Phase III studies for the treatment of head and neck cancer.
The facility is expected to cost about $12–$14 million, to be paid through a long-term lease agreement. "We will be able to produce our drug Multikine in our own CGMP facility for Phase III trials as well as for sale once marketing approval is granted,” states Geert Kersten, CEO of CEL-SCI.
“An additional benefit of having this facility,” Kersten adds, “is that during the Phase III study, it may also be used for contract manufacturing work with other biotech companies and/or the U.S. government since it will contain a clean cold-fill suite."
AstraZeneca Invests $100 Million in Boston R&D Center
AstraZeneca made a $100-million investment to expand its R&D facility in Boston, which is focused on infectious diseases and cancer. AstraZeneca believes that Boston gives the company access to the leading scientific talent, potential partners and collaborators, and emerging science in a worldwide biotechnology hub.
The company predicts that construction of the 132,000-sq-ft facility will begin at the Waltham, MA, site during the first quarter of 2007 and will be complete by mid 2009. The total size of the research facility will then be 382,000 sq. ft. The expanded facility will thus be able to accommodate up to 100 additional researchers.
€100 Million for R&D Centre at Warsaw Medical Academy
The Cabinet has earmarked €100 million for the construction of a Pre-Clinical Research and Technology Centre (CEPT), coordinated by the Medical Academy (AM) in Warsaw. The Centre is to be completed in six years’ time.
The construction will cost PLN 180m (€47m) and equipment of the laboratories a further PLN 680m (€178m), so in order to finance the total amount, the AM will also seek institutional and commercial partners interested in investing in the Centre to conduct their own research there later. The aim is to create one of the most technologically advanced research centers in Europe.
The Centre is to comprise 10 state-of-the-art laboratories, where research will be conducted on the structure and functioning of proteins in the human body, biotechnology, nanotechnology, and new medicines. Scientists will work there on new technologies to combat lifestyle and age-related diseases, e.g. Parkinson’s and Alzheimer’s. Four labs will be created on the AM campus, and the other six on sites belonging to the Polish Academy of Science and Warsaw University, which, with the Warsaw University of Technology, are partners in the project.
In addition to the labs, the Centre will also have a high-powered computing unit and accommodation for firms engaged in implementing the results of research.
Artielle, QSV Sign cGMP Contract for MS Drug
QSV Biologics, Ltd. and Artielle ImmunoTherapeutics, Inc. have signed a contract for the process development and cGMP manufacturing of RTL 1000 for multiple sclerosis. QSV will be responsible for technology transfer, process development and cGMP manufacture of Phase II/III trial material. RTL 1000, licensed by Artielle from Oregon Health & Science University, is a Recombinant T cell receptor Ligand (RTL) that can treat a wide range of autoimmune diseases.
Kendle Opens of New Ann Arbor Office
Kendle has opened a new office in Ann Arbor, MI, expanding its Phase II-IV clinical development services for its biopharmaceutical customers. The new office also creates opportunities for the region.
“With the University of Michigan nearby, Ann Arbor as a region is increasing its commitment to become a hub of biotech activity,” said Kendle’s senior vice president, global clinical development, North America, Martha Feller, Ph.D. “Building on a year in which we experienced significant growth, this new office will allow us to hire extremely qualified employees who are able to serve our customers immediately. In fact, our ability to attract and retain clinical research professionals is part of what separates Kendle from other CROs.”
UT Announced Plans to Set Up International-Caliber Research Center
The University of Tartu, the Estonian University of Life Sciences and the Estonian Biocentre have signed a cooperation agreement to establish a research-intensive drug development centre of European scale and importance.
The Drug Development Centre will be a place for internationally competitive research into the molecular and physiological factors causing human and animal diseases, the identification and validation of drug targets, the design and construction of new compounds having drug potential, the elaboration of production technology for these compounds and their testing in preclinical and clinical trials. R&D work in drug development will initially take place under various drug development programs, with a view to subsequently attracting the interest of the pharmaceutical industry for continuing development and commercial use projects.
Dr. Ustav estimates that in six to seven years the Centre will reach a turnover of at least €100m and employ 400 research staff. The Centre should develop into a sustainable organization that wields considerable intellectual capital and participates in internationally significant projects as part of a wide cooperation network including the world’s leading pharmaceuticals and biotechnology companies as well as research institutions and universities.
QuantRx® Biomedical Receives Grant and Incentives for New R&D Facility
QuantRx® Biomedical Corporation, an emerging leader in the research and development of medical diagnostic platforms and products, announced that, as part of its plan for expansion of its research and development capabilities, the Company was selected to receive a grant and other incentives from the Portland Development Commission (PDC) to open the Company's new research center in Portland, Oregon.
The PDC funds are allocated to a new 7,000-square-foot state-of-the-art Portland R&D facility, scheduled to open mid-February, which is to be registered with the United States Food and Drug Administration for development and manufacturing of QuantRx lateral flow devices, PAD kit technology and other biotechnology and biomedical projects.
QuantRx Biomedical is one of the first companies to benefit from joint PDC and Oregon Bioscience Association efforts to attract firms within the biotechnology and biomedical industries to the Pacific Northwest and, particularly, to the Portland metropolitan area.
The Portland infrastructure is conducive to growth across the Company's range of technology platforms — rapid point-of-care testing products, PAD technology that provides the basis of a variety of diagnostic and treatment products, diagnostic molecular imaging products for use in the PET — positron emission tomography — market and clinically optimized genome-based diagnostic microarray chips with an initial focus on detecting immune system-related disorders.
About QuantRx Biomedical
QuantRx Biomedical Corporation is an emerging leader in the research and development of medical diagnostics, specializing in creating, acquiring and commercializing diagnostic platforms and developing products, based on its core intellectual property, for both professional and consumer use. The Company's technology portfolio includes rapid point-of-care testing products that bring medical information directly to the healthcare provider or the patient; genome-based diagnostics chips for medical professionals and institutions; PAD technology for diagnosis and treatment of women's health concerns and other medical needs; and diagnostic imaging products for the positron emission tomography (PET) market.
QuantRx has corporate offices in Doylestown, Pennsylvania, and its research and development Center in Portland, Oregon. Additionally, the Company holds significant positions in FluoroPharma, Inc., a Boston-based molecular imaging company, and Genomics USA, a Chicago-based developer of microarray technology for DNA testing.
New $114 Million Center for Regenerative Medicine to be Established in Scotland
A $114-million Scottish Center for Regenerative Medicine (SCRM) will be developed by the University of Edinburgh in collaboration with Scottish Enterprise. The SCRM will provide research facilities, manufacturing capacity, and commercialization facilities.
The Scottish Executive will provide support for the SCRM with more than $46M in funding. “This backing will allow Scotland to build on its international lead,” says University of Edinburgh principal, Timothy O'Shea.
The SCRM, which will be part of the new Center for Biomedical Research at Edinburgh’s Little France, will be unique in Europe and is thought to be equaled only by Kobe in Japan. It will have three main elements: high-quality accommodation to support 220 academic researchers, a center for scale-up development and manufacturing of cells, and multi-occupancy space to house commercial regenerative medicine research organizations and spin-outs.
FAU Cuts Deal with Torrey Pines
The Torrey Pines Institute for Molecular Studies has struck a deal with Florida Atlantic University to create a formal scientific link between the two institutions.
The deal calls for scientists from each to collaborate, and describes how to accomplish it. But it also spells out in detail what FAU had promised months ago as its part in the financial package to lure La Jolla, Calif.-based Torrey Pines to Port St. Lucie.
Under the contract, FAU will provide temporary space to Torrey Pines at the Harbor Branch Oceanographic Institution north of Fort Pierce for 212 years, while the institute builds its $40 million laboratory in the Tradition development west of Interstate 95.
Torrey Pines plans to move into the 100,000-square-foot permanent facility by late 2008, giving it more than enough time under the agreement's provision for temporary space. Even if construction drags on, the deal has a contingency for Torrey Pines to pay rent to FAU until it can move out.
Ultimately, FAU could establish a presence at Tradition near the Torrey Pines lab.
The agreement calls for FAU to budget $3 million to create post-doctoral positions for research scientists at Torrey Pines who also would teach at the graduate level at FAU. In addition, the school is required to budget $1.9 million for graduate-student researchers. FAU would fulfill those financial obligations over five years.
Although the deal makes only brief reference to who would have rights to inventions and how patents would be sought for inventions in a joint project, this partnership could be a source of income for FAU in the form of royalties and a boost to its image as a research institution.
Houghten could not be reached Tuesday for comment, but Brogan said the arrangement with Torrey Pines is similar to the deal FAU and other universities struck with Scripps Florida, which is building permanent quarters at the university's Jupiter campus.
Under those arrangements, scientists can work together without Scripps or the school's lawyers becoming involved. So far, there are about 50 such collaborations going on, with five to 10 involving FAU scientists, said Harry Orf, Scripps vice president of operations.
Lilly Manufacturing Changes / Insulin Facility Cancelled, Bio-Plans Unveiled
After taking stock of its drug pipeline, Indianapolis, IN-based Eli Lilly and Co. has announced plans to streamline its global manufacturing operations.
The company halted construction of its planned insulin manufacturing plant in Prince William County, VA, after deciding that expected growth demands would be better met by existing sites and by the company’s new insulin capacity currently under construction in Sesto, Italy. In addition, the assembly operation for Lilly's new Humalog MirioPen pre-filled insulin pen will take place at the company’s delivery device assembly operations in Indianapolis.
Lilly’s second strategic change will pare down some 250 of the 1,000 employees working at the company’s Tippecanoe manufacturing site in Lafayette, IN.
“Both of these decisions, along with the previously announced decision to close our manufacturing site in Basingstoke in the United Kingdom, are based on current capacity needs and an assessment of the future mix of products in our portfolio,” said Scott Canute, Lilly's president of manufacturing operations.
The company’s estimated restructuring and asset impairment charges will be approximately $155 to $185 million. These charges will be split between the fourth quarter of 2006 and the first quarter of 2007, and will result in a fourth quarter 2006 earnings per share charge of 5 cents.
And finally, the company announced that “significant new investments” would be made to expand its Kinsale, Ireland operation. The Indianapolis parent operation will also be expanded to convert the biotech active ingredients made in Kinsale into their final dosage form. Both expansions are part of a $1.5 billion investment in the company's biotechnology capabilities announced over the past five years. These investments include a newly completed biotech pilot manufacturing plant and a soon-to-be-completed biotech research laboratory, both located in Indianapolis.
Lilly has big plans on the upgraded facilities, since it expects to launch one biotech product per year, on average, beginning in 2010. Biotechnology-based programs and drug candidates now make up more than 30% of the company’s drug portfolio and pipeline.
Mr. Canute noted that these expansions come on the heels of the recently completed $1 billion expansion of its Puerto Rico manufacturing operations (August 2006), which includes new bulk capacity for Humalog insulin analog.
Province Invests $1.7 Million in U of G Research
(University of Guelph) The Ontario Ministry of Research and Innovation is investing more than $1.7 million in ongoing research projects at the University of Guelph. It's part of a $11-million investment to support 68 innovative projects at Ontario research institutions through the created Ontario Research Fund.
The funding was announced by Premier Dalton McGuinty, minister of research and innovation. The provincial investment matches funding commitments made earlier this year by the Canada Foundation for Innovation (CFI) and the national Canada Research Chairs program. Support is also provided by the research institutions and private-sector partners.
Among other things, the provincial investment will support the construction of Canada's first one-micron nuclear microprobe; Ontario's first single-unit microneurography facility; and new laboratories for studying nutraceutical encapsulation and tissue, cell and protein dynamics.
It is also supporting U of G projects that will advance knowledge in pest management, mathematics, cardiovascular health and disease, physics, food science, and food packaging and design.
Funding recipients are:
Oak Ridge ‘Best Fit’ for Expanding Company
Daxor Corp., a medical instrumentation and biotechnology company, has announced the purchase of two 10,000-square foot facilities for Daxor Oak Ridge Operations.
DORO, which conducts Daxor's equipment manufacturing, testing and development for the Blood Volume Analyzer BVA-100, will move into its new facilities to accommodate its existing operations and planned future research projects. A portion of that move could happen within the next 120 days.
Daxor Corp. manufactures and markets the Blood Volume Analyzer-100 and is also engaged in the development and marketing of cryopreservation (freezing) technology for human semen and blood.
The BVA-100 is a semi-automated blood volume analyzer that can rapidly and accurately measure human blood volume. It is used in conjunction with a single-use diagnostic injection and collection kit and can calculate blood volume measurement to within an accuracy of approximately 98 percent.
The company maintains a frozen blood bank in New York that allows people to store their own blood for up to 10 years and also provides frozen semen services to physicians worldwide.
UF Center Replacing Agriculture Lab Destroyed by 2004 Hurricanes
As plans to build a campus for the Torrey Pines Institute for Molecular Studies take shape in Port St. Lucie, construction of an 8,000-square-foot agricultural research facility is under way at the University of Florida's Indian River Research and Education Center in Fort Pierce.
The new building will replace a 5,000-square-foot lab destroyed by hurricanes Frances and Jeanne in 2004. The Legislature denied the $4.8 million project before the storms rendered the buildings unusable, said Brian Scully, director of the local campus.
By the time it opens in November, the new lab will house plant and soil research and also allow the campus' burgeoning aquaculture program to expand.
Although biotechnology has taken center stage in recent efforts to lure research outfits to the Treasure Coast, agricultural science will continue to be a staple in the region.
The new laboratory also means the campus will be eligible for more state and federal grants, which call for advanced technology and the latest equipment.
Highest Priced Deals of Q4 ‘06
The last quarter of 2006 gave rise to over 50 mergers and acquisitions of all sizes. The five largest reported deals are as follows:
Merck-Serono Biopharmaceuticals was born at an almost $13.58-billion price paid by Merck KGaA. Upon the Bertarelli Family giving up their majority stake in Serono, a company with a $13.66-billion market cap as of December 28, 2006, Merck transformed itself from one of the oldest pure pharmaceutical and chemical companies into a formidable biopharmaceutical firm.
Abbott shelled out $3.7 billion in cash to expand its lipid management portfolio. The acquisition of Kos Pharmaceuticals and its on-market products is set to give Abbott a bigger slice of the $20-billion cholesterol market.
Gilead Sciences took over Myogen in a deal worth $2.5 billion. The transaction was part of a diversification strategy for Gilead’s portfolio of mainly HIV drugs.
Eli Lilly plans to take control over Icos’ erectile dysfunction drug, Cialis, by buying the company for $2.3 billion. Lilly originally offered $2.1 billion. The companies have a joint venture related to the drug that enjoyed $456 million in sales for the first quarter of 2006.
To strengthen its foothold in the RNAi field, Merck & Co. proffered $1.1 billion to Sirna Therapeutics. The price was more than double Sirna’s closing price of $6.45 per share the day before the announcement.
South Africa Wins International Centre for Genetic Engineering and Biotech
The announcement was made that South Africa had won the bid to host a laboratory of the International Centre for Genetic Engineering and Biotechnology (ICGEB). This means that South Africa will be the first country in Africa to host this laboratory and only the third in the world.
One report noted that the "ICGEB is an international organisation dedicated to advanced research and training in molecular biology and biotechnology, with special regard to the needs of the developing world”. The ICGEB laboratory has been described as one of the most important in the world and will be housed at the University of Cape Town's Institute for Infectious Diseases and Molecular Medicine.
"The laboratory will be dealing with many scientific issues such as better disease control and the management of crops. Hosting this laboratory in South Africa is expected to strengthen our scientific community and attract many scientists from all over the world to Cape Town. There are only two other ICGEB laboratories in the world, situated in New Delhi, India and Trieste, Italy."
Mold Designer Moves into More Cleanroom Space
A global leader in mold design and manufacture for the biotech industry has moved into expanded quarters at Westover Air Park North.
Development Associates of Agawam has completed construction of a new 23,700-square-foot design and manufacturing facility for Seahorse Labware, formerly known as Seahorse Bioscience and Innovative Microplate.
The firm moved after growing the business for five years in a nearby 14,000-square-foot facility at 1998 Westover Road in Airpark East, another project developed and managed by Development Associates. The firm has 40 employees but more employees are expected to be hired. The firm has international distribution in Europe, Japan, throughout the United States and Canada for its custom designed products.
Since 1984, Seahorse Labware has designed and produced more molds for microplates than any other company in the world.
By integrating design, mold making, molding and assembly steps within a single facility, Seahorse is able to complete designs quickly and at low cost.
The firm's expansion to 300 Griffith Road will provide additional offices, engineering, and assembly space and will triple the company's clean room manufacturing, assembly and test space. Interior finishes include a 1500-square-foot class 100,000 cleanroom for injection molding and a 2,700-square-foot class 10,000 cleanroom for assembly and packing. Instrument suppliers and end users of custom parts as well as other firms rely on Seahorse to design and manufacture sophisticated module consumables.
The new facility is part of a newly developed 42,500-square-foot multi-tenant industrial building already home to Hudson Home Health Care which moved in earlier this year.
This project was financed by Peoples Bank of Holyoke and construction executed by The O'Leary Company of Southampton.
McIlvaine Company,
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061;
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