Summer 2006

ALABAMA

BioCryst Gets FDA Go-Ahead for Trial of Key Cancer Drug

Birmingham-based BioCryst Pharmaceuticals Inc. has received a Special Protocol Assessment, or SPA, letter from the U.S. Food and Drug Administration, a key step toward initiating a clinical trial for the company's lead anti-cancer compound Fodosine. The trial is slated to begin by the end of 2006 and is expected to enroll about 100 patients.

FLORIDA

The Burnham Institute Going to Orlando

The Burnham Institute, based in LaJolla, Calif., has chosen Orlando as the site for its East Coast branch. Burnham trustees approved the $310 million deal on August 23rd and formal contracts with the state, county and city government will be negotiated before the end of the year. Burnham becomes the second LaJolla-based biomedical lab--The Scripps Research Institute is the other--to announce plans for satellite labs in Florida. According to reports, several other companies in the San Diego area are eyeing Florida as well. The Burnham Institute will create 200 to 300 new jobs in Florida over the next 7 to 10 years.

Scripps Moving on Schedule

After nearly a year of legal delays, progress is being made on Scripps Research Institute's permanent facility in Jupiter. Work is progressing on schedule for the La Jolla, Calf.-based biotechnology giant as it builds its Florida home. Groundwork is set to start at Scripps' permanent facility in October.

GEORGIA

New 50-Million Gallon Cellulosic Ethanol Plant Expected Online by 2007 in Augusta

Xethanol Corporation, a New York-based biotechnology-driven ethanol company, has completed its due diligence process on its previously announced acquisition of a Pfizer pharmaceutical manufacturing complex in Augusta, which it plans to close. On the site, the company has announced plans to construct a 50-million gallon per year cellulosic ethanol plant, which would begin producing ethanol by mid-2007.

MARYLAND

Human Genome Sciences Ready to Move Drugs into Phase III Trials

Rockville-based Human Genome Sciences (HGS) will begin its Phase III clinical trials on its two leading drug candidates by the end of 2006, critically important steps to bring the products to commercialization. The company will begin Phase III trails on LymphoStat-B, a human monoclonal antibody that treats systemic lupus. To help develop and commercialize the lupus-treating drug, Human Genome Sciences has signed an agreement with current partner on the project GlaxoSmithKline. HGS also plans to begin trials for Albuferon, an interferon alpha for treating Hepatitis B and C, for which it has partnered with drug giant Novartis. Human Genome Sciences says it expects to end the year with $725 million to $755 million in cash and investments.

MedImmune Plans New Clinical Trials for Anti-flu Spray

Gaithersburg-based company MedImmune is in the planning stages for new clinical trials to test people over the age of 50 for its CAIV-T compound—a refrigerator-safe flu-fighting nasal spray. In addition, the company has recently filed an FDA request to offer CAIV-T to children as young as 12 months old based on clinical trials nearly two years ago.

FDA Approves MedImmune's Flu Technology

The FDA has approved MedImmune's reverse genetics technology so that it can begin producing flu vaccines.  This technology will be used in the product FluMist, the company's cutting-edge flu vaccine method.  The company's vice president of research stated that this should greatly expedite the process and increase the availability of vaccines to the public.

CoGenesys Cleared for Phase I Testing of Heart-Failure Drug

Rockville, Md.-based CoGenesys, a spin off from Human Genome Sciences, has received FDA clearance to test a drug for chronic heart failure. Only one month after CoGenesys became a separate company, it has received permission to begin Phase I testing of its Cardeva, a long-acting version of a typical treatment given for short periods to hospitalized heart-failure patients.

MedImmune's Bird Flu Vaccine Enters Phase I Trials

MedImmune, based in Gaithersburg, Md., said that National Institutes of Health researchers have begun testing its intranasal vaccine for the H5N1 strain of bird flu. A MedImmune executive said that the new vaccine technology "may provide several advantages over the flu shot that will be critically important in protecting people against a pandemic influenza virus."

In Vitro Technologies Being Acquired by Celsis

Cantonsville, Md.-based In Vitro Technologies is being acquired by London-based Celsis International for $30 million in cash plus an additional $5 million in potential milestone payments. In Vitro, which provides bioscience companies with test-tube products and services said it expects to be a "very significant component" of Celsis' business moving forward.

MISSOURI

Stem Cell Initiative Officially on Missouri Ballot

Missouri's secretary of state certified a stem-cell research initiative to appear on the November ballot. The nationally watched stem cell initiative will ask Missouri voters whether to amend the state constitution to guarantee that all federally allowed stem cell research and treatment can occur in the state.

NORTH CAROLINA

Expansion Plans Announced for North Carolina's Piedmont Biotech Park

North Carolina's Piedmont Triad Research Park has announced expansion plans that include relocating and expanding Wake Forest University's small-business incubator and adding short-term, affordable facilities for biotech companies. The plan's goal is to make the Park more attractive to outside firms and more accessible to startup companies.

Novartis Chooses North Carolina for New Plant

One of the largest vaccine companies in the world will invest $267 million in a new plant in Wake County, NC that will employ as many as 350 people. The plant, to be located in the Holly Springs community, is a division of Novartis Vaccines and Diagnostics and will be used to develop a new type of influenza vaccine that can be derived from cell cultures. Novartis also has sites in Greensboro and Wilson, NC that employ 680 people. According to company officials, Novartis had looked at three potential sites on the East Coast for the factory before selecting the Research Triangle Park area.

Biogen Idec Returns Product to Market

Biogen Idec, which manufactures in Research Triangle Park, has returned its multiple sclerosis treatment Tysabri to the commercial market after pulling the drug previously over safety concerns. After months of reviewing the drug's clinical data, the FDA has approved a new marketing application. Biogen Idec jointly developed and markets the drug with Irish company Elan Corp.

UNCC Offshoot Opens Near New Biotech Hub in Kannapolis

University of North Carolina Charlotte's Charlotte Research Institute has opened a satellite office in Kannapolis, staking its claim as part of the North Carolina Research Campus. The Research Campus, a 350-acre area located on the site of a former Pillowtex facility, will focus primarily on bioinformatics, nutrition and health behavior, and education.

More Ethanol Plants Coming in North Carolina

A Raleigh-based company that's planning to build a $150 million ethanol production plant in rural Eastern North Carolina announced that it wants to build as many as 20 more facilities on the East Coast. Agri-Ethanol has finalized "a financing agreement with a substantial international company of worldwide acclaim," chief executive Dave Brady said, though the company has declined to release financial details of the agreement or the name of the investor. According to company reports, two more of the plants will be in North Carolina in addition to the already announced plant in the Beaufort County community of Aurora. That plant is projected to employ about 74 workers.

TENNESSEE

Tennessee-based BioMimetic Gets Product OK in Canada

BioMimetic Therapeutics Inc. based in Franklin, Tenn., has been given permission to sell its system for treating dental-related bone defects in Canada. Health Canada, the country's equivalent to the U.S. Food and Drug Administration, has approved the company's first product, GEM 21S. The product, which speeds the growth of bone and tissue, was approved for sale in the U.S. in November 2005.

TEXAS

State Provides $3 Million to Enhance Biotech Training

A Texas state grant program will allocate $3 million to five workforce development programs that are designed to build a competitive workforce for the state's biotechnology and life sciences companies. The five programs receiving grants are the Greater Austin Area Workforce Board, which will promote science education among high school students and will develop associate degrees and training courses at the community college level; Numedeon Inc., which will work to expose Texas' youth to careers in biotech; Texas Business and Education Coalition, which will establish a Web-based portal of biotechnology career information from Texas employers; the University of Houston, which is developing an education and training program in biotechnology; and San Jacinto College District, which will train students for jobs in a variety of industry occupations.

Houston's Marathon Joins Ethanol Plant Venture

Houston's Marathon Oil Corp. is entering into a joint venture to build and operate ethanol plants. The announcement of the venture with an Ohio grain processing company makes Marathon the first major oil refiner to announce construction of an ethanol plant.

Texas A&M to Develop Biotech Mice for Research

Texas A&M University is working to develop as many as 22,000 kinds of biotech mice, the largest collection in the world, for use in genomic research. Working with Lexicon Genetics, which is based in The Woodlands, Tex., the university hopes to create a library of 350,000 “knockout mouse” embryonic stem cells, each with a single gene missing.

VIRGINIA

Biotech Company Attracts $8.3 Million Investment

Vienna-based biotech company Cel-Sci has earned $8.3 million in funds by selling convertible notes and warrants to independent investors, scoring the company's biggest single funding amount in recent years. The company is working on a treatment for head and neck cancer. Cel-Sci, which employs 19 now, says it plans to do more hiring as its drug Multikine moves into the third phase of clinical trials.

AROUND THE SOUTH

Ventria Bioscience Eyeing Southern Sites

Ventria Bioscience, a Calif.-based firm, expects to decide in the coming weeks whether it will relocate its processing plant and rice-growing acreage to the South, according to the company president. Ventria is involved in biopharming, the practice of growing food crops genetically engineered with human genes to produce drugs. The company's rice is used to make an experimental drug used to treat diarrhea. On the company's short list are potential sites in Kansas and North Carolina, according to officials.

Want more news about biotechnology and life sciences in the South? Visit www.BioIndustrySouth.com , Southern Business & Development's information-packed website about biotech sites and opportunities in the world's third-largest economy.