Winter 2006

Alabama

BioCryst Ready to Test Avian Flu Vaccine on Humans

Birmingham-based BioCryst Pharmaceuticals Inc. has won approval to test its avian flu drug on people. The FDA said that BioCryst can begin the first of three testing stages required for full approval to sell a new drug. The company's shares have almost tripled in the past 12 months.

Florida

Scripps Partnering with IBM to Battle Pandemic Flu Viruses

The Scripps Research Institute and IBM will collaborate to combat the threat of pandemic flu viruses. IBM is the first major corporation to announce a direct research collaboration with Scripps Florida . The project called “Check Mate” will combine biological scientists at Scripps and a drug-screening machine at its Jupiter facility with IBM's data processing experts and its supercomputer Blue Gene - billed as the world's fastest. Scripps will use the computer power to interpret data and predict the behavior of flu viruses.

Palm Beach County Votes to Move Scripps to Jupiter

Although $116 million has already been spent on construction on the edge of the Everglades, Palm Beach County commissioners have voted to move the Scripps Research Institute farther north to Jupiter. Construction on the proposed 2,000-acre biotech park at the original Mecca Farms site was halted in 2005 after a federal judge ruled that key roads and support infrastructure couldn't be built until a broad environmental impact analysis was completed. Scripps and the county will now renegotiate a contract for the new site at Florida Atlantic University's John D. MacArthur campus in Jupiter's Abacoa community. More than 100 Scripps scientists, lab assistants, and other employees are already working in temporary labs there.

Georgia

Georgia Biotech Firm Enters Alliance with AstraZeneca

AstraZeneca has entered an alliance with Georgia biotech company AtheroGenics with up to $1 billion for the rights to AGI-1067. AGI-1067, a pill in Phase III trials, is designed to selectively block inflammation involved in hardening of the arteries. AtheroGenics is based in Alpharetta.

Kentucky

The University of Louisville Breaks Ground on Third Downtown Research Building

The University of Louisville has broken ground on a $70.2 million, 150,000 square-foot biomedical research building on its downtown Health Sciences Campus. The facility will be U of L's third biomedical research building. The facility will be used as laboratory space and offices for U of L's biomedical researchers. Fifty researchers working on cancer treatments will be its first tenants.

The site also has room for a five additional research buildings. Approximately $66 million in funding for a fourth research building was included in the budget bill submitted recently by Kentucky Gov. Ernie Fletcher.

Maryland

Maryland Groups Work Together on Biotech Education Program

The University of Maryland Biotechnology Institute and the Parenteral Drug Association will develop a training program to educate workers for biotech manufacturing. The University of Maryland Biotechnology Institute, which has offices in Baltimore and is expanding its facility in Montgomery County by 140,000 square feet, will host the new training program at its Rockville campus. That campus also features a biotech manufacturing plant. The Bethesda-based Parenteral Drug Association is a nonprofit group of more than 10,000 scientists involved in the development, manufacture, quality control and regulation of biotech and pharmaceutical products.

BioPort Weighs Maryland and Michigan for Expansion

BioPort and its parent company are weighing a potential expansion in either Maryland or Michigan that could give the winner several hundred biotech jobs. The vaccine maker needs more people because its clinical pipeline, which contains drugs targeting infectious diseases and bioterror agents, continues to grow. BioPort also is bidding for more lucrative contracts to supply its anthrax vaccine, the only one approved by the Food and Drug Administration, to the military and other federal customers.

The private company is considering a $75 million expansion of its facility in Lansing, Mich., adding several hundred workers to the city where BioPort was born in 1998. BioPort reportedly is also eyeing Maryland for that expansion. The company chose Frederick for a manufacturing plant in 2004; the same year that parent company Emergent BioSolutions established its headquarters in Gaithersburg.

MedImmune Posts $22 Million Loss

FluMist maker MedImmune posted a quarterly loss as it spent more on research and development and marketing for the new version of its flu vaccine. MedImmune's refrigerator-stable version of FluMist will replace the original frozen nasal spray vaccine. The company expects regulatory approval for use in young children and older adults for the new version of FluMist, which would greatly increase potential sales. The current version is approved only for healthy children and adults between 5 and 49 years old. On a more positive note, MedImmune forecasts 2006 sales to rise 10 percent to $1.4 billion.

PharmAthene Gets Fast Track Designation from FDA

Maryland-based PharmAthene, a privately held biotech company dedicated to the development of biodefense products, along with New Jersey-based Medarex announced that the FDA has granted Fast Track designation for Valortim ™ against anthrax infection. Preclinical studies suggest that Valorim has the potential to provide significant protection against anthrax infection when administered prior to the emergence of symptoms.

Maryland's Avalon Pharmaceuticals Initiates Clinical Trial

Avalon Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of small molecule therapeutics, has initiated a Phase I clinical trial of AVN944 in patients with advanced hematological malignancies. The first patient was treated recently at the University of Arkansas for Medical Sciences. Avalon is based in Germantown.

Missouri

Monsanto's Biotech Corns Cleared for Import by European Union

The European Commission has cleared three types of Monsanto's biotech corn for importing and use in the European Union. Two of the types of corn will be used for food and food ingredients. The other will be used primarily for animal feed. Monsanto is based in St. Louis.

North Carolina

Stiefel Laboratories Investing $50 Million at Research Triangle Park

Florida-based Stiefel Laboratories is relocating the R&D facilities of its August C. Stiefel Research Institute subsidiary to a 155,000-square-foot building formerly owned by Eli Lilly in Research Triangle Park. The deal is expected to create 200 jobs.

LabCorp Building Headquarters in Downtown Burlington

Laboratory Corp. of America Holdings has started demolition of a former Kayser-Roth Corp. warehouse in downtown Burlington to prepare the site for a $12 million headquarters building. The company, which is based in Burlington, plans to construct a 113,818 square-foot building, which is scheduled for completion in late 2007.

Durham Company Awarded Stem-cell Patent

Aldagen Inc. has received U.S. patent protection for technology involving the identification and harvesting of human stem cells to combat cardiovascular disease. The claims of the new patent relate to the Durham company's use of a particular enzyme - aldehyde dehydrogenase - to flag stem cells inside bone marrow. Aldagen's patented technology has been developed into a product called Aldesort, which is used by clinicians to isolate stem cells. It is currently undergoing clinical trials. Aldagen uses technology developed at Duke University and Johns Hopkins University to find treatments for cancers, heart disease and other degenerative diseases using stem cells.

Raleigh Company to Create 100 New Jobs with Moore County Plant

A Raleigh pharmaceutical company will build a 20,000 square-foot manufacturing facility in Moore County that is expected to create up to 100 new jobs in the area. Corneal Science Corp. said Wednesday that it plans to move its Vision Pharmaceuticals manufacturing facility from Mitchell, S.D., to Aberdeen, N.C. The move represents an effort to bring the company's manufacturing operations closer to its Raleigh headquarters.

Targacept Takes Another Shot at IPO

Ten months after calling off its first attempt, Winston-Salem-based drug discovery company Targacept has filed for an initial public offering that plans to raise as much as $59.8 million from investors, the company has announced. Already the most richly funded biotech startup in the state with more than $120 million in venture capital raised, the company plans to use the funds raised from public investors to fund clinical trials, preclinical testing and research, along with general corporate expenses. Targacept spun out of research conducted by R.J. Reynolds Tobacco Co. beginning in the early 1980s. That research focused on the therapeutic potential of nicotine. The company is working on treatments for cognitive impairments such as Alzheimer's disease, depression and anxiety, and post-operative pain.

Cornerstone BioPharma Lays Off 35 Percent of Work Force

Cornerstone BioPharma , a specialty drug company near Research Triangle Park that put itself on a fast growth track, has laid off 40 employees, or about 35 percent of its staff. The company's chief medical officer, says the cuts became necessary after the U.S. Food and Drug Administration required an additional clinical trial for an alternate form of a drug called Keflex that Cornerstone wanted to market. Cornerstone seeks new uses for existing drugs by changing their delivery method or creating additional uses for them.

Cornerstone BioPharma, Inc. and ASCEND Therapeutics Sign Co-Promotion Agreement

Cornerstone BioPharma, the Triangle-based specialty pharmaceutical company currently focused on the development and commercialization of niche prescription medications in the respiratory arena, today announced the company has signed a co-promotion agreement with ASCEND Therapeutics (ASCEND).  This agreement names ASCEND as a partner in the promotion of Balacet 325™, a mild-to-moderate pain medication. Balacet 325 was approved by the Food and Drug Administration in May 2005 and has since been promoted to pain specialists and primary care providers by Cornerstone's sales force.

RTP-based GlaxoSmithKline Looks to Build Momentum in 2006

GlaxoSmithKline, based in North Carolina's Research Triangle Park, says it beat forecasts for 2005 profits and will consider possible acquisitions as well as concentrate on its well-developed pipeline of new drugs. The company also says it plans to file in March for European regulatory approval for cervical cancer vaccine Cervarix and by the end of the year for approval in the U.S.

Two GlaxoSmithKline Drugs Get Regulatory Approval

Regulatory agencies on two continents approved a pair of GlaxoSmithKline products. The FDA approved Avandaryl, a combination of two drugs used against diabetes, and European regulators approved Hycamtin to treat lung cancer in addition to its already-approved use for treating ovarian tumors.

Tennessee

Smith & Nephew Dividing Orthopedics Business

Smith & Nephew , which employs about 1,900 in Memphis, is restructuring senior management and splitting up the orthopedics business into two separate business units. Orthopedics has been the shining star of Smith & Nephew for several years, and will now be organized into Memphis-based Orthopedic Reconstruction and Orthopedic Trauma divisions.

Texas

UTSA Opens $84 Million New Research Facility

The University of Texas at San Antonio (UTSA) has opened its new 227,000 square-foot Biotechnology Sciences and Engineering building. The five-story $84 million building is one of the largest research centers in Texas. The building includes 70 research and instructional laboratories that will facilitate interdisciplinary research and collaboration between scientists and engineers. The facility will accommodate graduate students studying biotechnology, biology, biomedical engineering, electrical and civil engineering and chemistry.

The University of Texas System Board of Regents allocated $54 million for the project and the Texas Legislature approved $23 million. The university raised the remaining $7 million through various gifts and grants, including $1.5 million from the U.S. Department of Commerce's Economic Development Administration, $1 million from the city of San Antonio and $500,000 from AT&T Inc.

Four-Year Medical School in Temple Approved by Texas A&M University Board of Regents

The Texas A&M Board of Regents approved an expansion of the A&M Health Science Center College of Medicine on Friday, a plan that will bring a full, four-year medical school to Temple and Scott & White Memorial Hospital. Under the expansion plan, Scott & White would become one of two complete branch campuses of the A&M medical school. The medical school expansion is predicted to have a huge impact on Temple's research and bioscience efforts.

Virginia

Richmond's Vital Sensors Completes $1 Million in Seed Financing

Vital Sensors, Inc., a medical device company and one of the newest tenants of the Virginia Biotechnology Research Park in Richmond, recently completed a $1 million seed financing round. Vital Sensors established its corporate headquarters at the Park in December 2005. The company will use the bridge money to continue development of its initial product, a sensor device that when implanted measures intra-cardiac pressure, information that can help physicians monitor and optimize treatment for patients with heart failure.

For more information on the South's biotechnology industry, visit SB&D's industry-specific Website: www.BioIndustrySouth.com.