PHARMACEUTICAL & BIOTECHNOLOGY

UPDATE
 

August 2006 

McIlvaine Company

UF to Build Next to Biotech Firm's New Florida Branch

According to Jack Stripling, wherever the California-based Burnham Institute plans to build its new site, the University of Florida is sure to follow.

The Burnham Center for Medical Research, a nonprofit biotechnology firm, is expected to announce today whether it will set up an East Coast branch in Orlando or Port St. Lucie. Either way, UF will build a facility alongside the institute, ensuring a collaborative relationship in the study of cancer, aging and genetics, UF President Bernie Machen confirmed.

Officials from both cities, which have been in heated competition to land Burnham, have agreed to provide UF with adjacent land to build a facility alongside Burnham, Machen said. UF will then pay for the construction costs of what Machen envisions as a 50,000-square-foot building.

Getting land in close proximity to the Burnham site was essential for the level of collaboration that UF and Burnham intend, Machen said.

UF could begin planning its facility immediately, Machen said, and then push for legislative dollars to fund it.

The state will give Burnham $155.3 million to set up a 175,000-square-foot facility in Florida, and both potential sites are expected to at least match that amount in order to hook the institute. Over the next seven to 10 years, Burnham plans to hire as many as 300 people.

Researchers at Burnham study cell behavior, which has potential applications in the study of infectious diseases, aging and cancer. UF, which boasts a $250 million annual budget for biological science research, already conducts research into many of the areas that are of interest to the institute.

Winn Phillips, UF's vice president of research, said the university will offer its facilities to the institute while Burnham's fledgling Florida enterprise takes shape. In time, Burnham researchers will be paid on joint-faculty appointments at UF, and existing UF faculty will collaborate with Burnham as well, Phillips said.

Eventually, however, Burnham stands to help boost UF's research reputation, drawing more dollars from agencies interested in funding the institute's projects, Phillips said.

The university has just come off a banner year of its own in the research arena, receiving a record $518.8 million in research funding in 2006. The partnership with Burnham, along with collaboration with the Jupiter-based Scripps Institute, can only help those research dollars to grow, Phillips said.

"We are poised right now to seize the new biological revolution," Phillips said. ". . . I think the sky's the limit now. It's a whole new era for UF and the state of Florida."

Biotech Free Zone to Create 20,000 Jobs

Dubai: Dubiotech, a free trade zone being developed to attract biotechnology companies and researchers to Dubai, will create 20,000 jobs when completed, said Dubiotech executive director Abdul Qader Al Khayat.

These will be high-tech positions, which will employ people with specialised skills in both Dubiotech projects and companies operating within the zone, he said.

Set up under the Dubai Technology and Media Free Zone Authority, Dubiotech facilities will be built in phases on a 300-hectare area close to the Dubailand project. Work on laying the infrastructure has begun and is scheduled for completion by July 2007.

Construction of the four-storey lab building will start in two months and will take about two years to finish.

The headquarters building, which will mainly house offices, is in the final design stage and construction work will start in four months.

Al Khayat said infrastructure development cost is about Dh130 million, while the lab and headquarters buildings will require an investment of Dh600 million.

Dubiotech is also busy developing a regulatory framework to tackle copyright issues and intellectual property rights.

"We will have most of the basic regulations completed by the end of the year. These regulations will be available in both English and Arabic. US-based institute RTI (Research Triangle Institute) is our consultant and advisor on regulation," Al Khayat said.

Dubiotech has already licensed 16 companies and is in the process of welcoming 10 more companies.

The licenced companies are currently operating from temporary locations and will move into the biotech park when it is ready in early 2008. Among Dubiotech's biggest clients is American biotechnology firm Amgen. It will set up its regional office in Dubai to sell cancer and arthritis drugs to patients throughout the Middle East and Africa.

Dubiotech has also signed an agreement with Frankfurt Biotechnology Innovation Centre to jointly conduct life sciences research and collaborate in developing healthcare products.

Leaders are optimistic that the project will be successful despite the UAE's own lack of academic work in the biotechnology field.

"These days transfer of knowledge is not a big issue, especially since Dubai is already a business hub. There are already big companies from different sectors present in Dubai and I don't think biotechnology will be different in that sense."

Biotech Center Nears Completion

Acccording to Rasmi Hunt, Marshall University is finally ready to plunge into one of the most research-intensive industries in the world following the completion of the Robert C. Byrd Biotechnology Science Center.

Construction of the 144,000 square-foot, five-story building began early March 2004 and will be open for classes by the beginning of the 2007 spring semester. Byrd himself is expected to help dedicate the building this Friday.

Classes at Marshall, like other colleges around the state, were starting today. Many students were coming back to campus to see the state-of the-art building well under way.

Plans to build a biotech center were hatched in 1999 when Marshall administrators decided it was time for the university to enhance its biotechnology education and research. The hope was to attract more scientists to the area and improve the science and technology programs in the university. Mascaro Construction of Pittsburgh was signed on to build the facility.

The center is equipped with high-tech classrooms and state-of-the-art research laboratories. It boasts several specialty units that include mass spectrometer and chromatography suites, tissue culture rooms and a DNA microarray laboratory. The first floor has been specifically designed to house rodents and small animals for research and testing purposes.

Howard Aulick, vice president for research at Marshall University said one main aspect of having the biotech center so close to campus is to allow undergraduate students to determine which scientific field most interests them.

"Of the science buildings on campus, this is definitely the cornerstone," he said. "By using the facility, our students will be able to make better informed decisions about what field they want to pursue in the future."

Apart from benefiting students and faculty, the building is expected to double as an economic generator. The building has enabled Marshall University to become part of a billion dollar scientific research industry.

Biotechnology, in a nutshell, is where biological processes are harnessed using technological applications to benefit humankind. Two familiar products of biotechnology are insulin and antibiotics.

"Today the nature of research is interdisciplinary," Aulick said. "There is far more exchanging of ideas, more grant work. There are vast benefits that can be achieved through our research here at Marshall."

If an idea developed through the biotech center has potential for commercial value, it can be patented. Then the intellectual property can either be licensed to another company or be the foundation of a new research company.

Marshall University President Stephen Kopp said having the biotech center on campus was imperative for students to have a hands-on, out-of-the-classroom learning experience.

"I look at it as a learning incubator, a research incubator," he said. "We want students to have hands-on experience, applied learning experiences and take the study of any aspect of science and engineering out of the classroom."

Kopp took Vandalia Research Inc. as an example of what could be achieved through university-based research. The biotechnology corporation was conceived in a lab at Marshall University in 2004. Kopp said he expects to see the development of more ideas and patents coming out of the new biotech center.

"To have this kind of economic generator, to have that potential in Huntington, West Virginia, is revolutionary," he said. "This building and its capabilities are truly transformative to Marshall University and its future."

It's taking $48 million to complete the facility, $8 million more than the original price tag. The price increase was mainly due to climbing fuel and steel costs.

U.S. Senator Robert C. Byrd managed to secure $35.6 million of federal funding for the project. Byrd is to be present at the building's dedication ceremony recently.

The center is one of six main construction and renovation projects intended for medical and scientific research facilities. The other buildings are the Edwards Cancer Center, School of Medicine Outreach Center, Biotechnology Science Development Center, Forensic Science Center and Morrow Building Science Center.

Sigma Acquires Pharmorphix to Expand R&D Capabilities

Sigma-Aldrichh (SAFC) has acquired Pharmorphixx, a privately held firm, based in Cambridge, U.K., that offers solid-form research services to the global pharmaceutical and biotech markets, in an all cash deal. The addition will broaden SAFC Pharma’s manufacturing services customer base and enhance its technology services offering for existing customers, say company officials.

The addition of Pharmorphix, which had sales of roughly $5 million over the last 12 months, will not materially impact Sigma’s sales. All current employees are expected to remain with the company.

Pharmorphix is the second company this year to be integrated within SAFC, following the May acquisition of Iropharm, a cGMP compliant commercial-scale chemical synthesis manufacturing site in Arklow, Ireland.

Precision Medical Products Has Class 10,000 Cleanroom

Precision Medical Products, Denver, PA, has designated 72,000 sq. ft. of its new building to manufacturing and 24,000 sq. ft. of that for Class 10,000 (ISO class 7) cleanroom.

BioVex Receives Funds From MassDevelopment to Expands in Woburn, MA

MassDevelopment announced a $2,500,000 Emerging Technology Fund (ETF) loan for BioVex, Inc.  The loan will support BioVex’s plans to capitalize on the Bay State’s world-class life sciences cluster and highly-skilled workforce.  In December 2005, the company signed a lease agreement with Cummings Properties to expand into 30,000 square feet of space at 34 Commerce Way in Woburn, MA. The facility will house the Company’s global headquarters, lab space and pilot manufacturing facility.  BioVex estimates its facility will be fully operational in 2007. 

Rentschler Expands Bio-CMO Facilities

Rentschler Biotechnologie GmbH is expanding its facilities, buildings and laboratory units at the company’s site in Laupheim, Germany. This will increase production capacities for antibodies and mammalian cell culture-derived proteins.

The Rentschler Group will invest $64 million in its biotechnology segment to build two fermentation suites with a total volume of 5,000 liters (2,500 L each) for market production and several smaller suites ranging from 250 to 500 liters for clinical supplies, creating more than 100 jobs. The first new production line will be operational early in 2008. In the future, 10 independent GMP facilities will be available for the production of biopharmaceuticals.

At its 37,660 sq. ft. facilities in Laupheim, the company currently has the capacity for manufacturing clinical supplies and market supply of low-dosed drugs. According to the company, by setting up additional fermenter suites, the Rentschler Group will strengthen its biotechnology business of custom manufacturing services from cell line development to large-scale cGMP production, registration of drugs and fill and finish.

Alexion to Buy Bio-Manufacturing Site

Alexion Pharmaceuticals is buying a new facility in Rhode Island to make its experimental drug, Soliris, for a rare blood disorder.  The 55,000 sq. ft. plant in Smithfield, RI, was previously used by Dow Chemical as a biopharmaceutical facility.  Alexion will retrofit the plant to include two 10,000-liter bioreactors and associated purification suites with a pilot plant.  The company hopes to begin manufacturing at the site in 2008.

The drug will be filed in the second half of 2006 with the FDA and EMEA. The drug Soliris is presently manufactured by Lonza Biologics of Switzerland at a plant in Portsmouth, New Hampshire.

Novartis To Build Vax Plant in NC

Novartis plans to build the first cell culture-derived influenza vaccines manufacturing plant in the U.S. in Holly Springs, NC.  Construction of the $600-million facility is expected to begin in 2007.  $200-million was awarded from the Department of Health and Human Services to Novartis. Once completed and approved for commercial production, the NC site is expected to annually produce up to 50-million doses of seasonal flu vaccines for use in the U.S.  They also will be able to produce monovalent doses in the event of a pandemic.

At the same time, Novartis announced the first EU submission of a cell culture-derived influenza vaccine. The submission was made in June. U.S. clinical trials started in 2005 and are ongoing

 Novartis is also making additional investments in its site in Marburg, Germany to expand capacity for flu cell culture vaccines production in Europe. The vaccines for the EU and U.S. clinical trials were produced at the Marburg site, where the product was developed.

Once completed and approved for commercial production, the planned NC site is expected to annually produce up to 50 million doses of seasonal trivalent flu vaccines, which will be for use in the U.S., according to Novartis. In the event of a flu pandemic, the site is planned to have a capacity of up to 150 million monovalent doses annually within six months of a pandemic declaration.

Top 20 Pharma Companies Report

According to Gil Y. Roth, last year Pfizer was 47 percent ahead of its closest competitor in drug revenues ($46 billion to $31 billion), but that margin was shaved to 30 percent in 2005 as Pfizer sales dropped 4 percent. The company remains at #1 in our Top 20 Pharmaceutical rankings, with a $10 billion buffer between it and neck-and-neck competitors Sanofi-Aventis and GlaxoSmithKline.

Roche posted the biggest dollar gains in 2005 revenues, up $2.8 billion (20 percent), thanks to a major contribution from Tamiflu (up $987 million in 2005).

At the lower end of our ranks, recent mergers in Japan have brought Astellas and Daiichi-Sankyo into the Top 20. Bayer’s acquisition of Schering AG will lead to another major jump next year, and more pressure placed on mid-tier firms.
 

Jaskson Secures Chesterford Project

Jackson Construction has secured a £2 million project with Morley Fund Management & The Churchmanor Estates Co plc at Chesterford Research Park, near Cambridge.

The project will see Jackson build a new research & development (R&D) office unit at the 250-acre low-density research park, which aims to attract a wide range of biotechnology and R&D companies into the area.  The two-storey steel frame R&D office building will feature a predominantly open plan layout, with brickwork and cladding to the facade.

Jackson will install solar shading panels to the front elevation and externally, the contractor will create a new car park and carry out a range soft landscaping finishes around the building, with the project due for completion early 2007.
 

Amgen to Relocate Headquarters

At the end of June 2006, the world's largest biotechnology company said it planned to relocate part of its corporate administration to its 232- acre Longmont campus. Thousand Oaks, Calif.-based Amgen told employees the company had outgrown its West Coast headquarters.