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Vaccines: A Ton of Prevention

By Jim Shamp
Senior Editor

Though North Carolina's biotechnology profile continues to grow in a variety of sectors, few have given the state the economic "shot in the arm" that is coming from vaccine research, development and manufacturing.

One reason North Carolina may be so well positioned to take advantage of the dramatic upswing in vaccine demand is that the state already has a solid core of trained workers, researchers and companies engaged in finding and producing effective ways to prevent disease.

The roster of firms doing some level of vaccine work includes some relatively new companies helped through Biotechnology Center loan programs, as well as some mainstays with the biggest names in global pharmaceutical commerce:

Here are some specific vaccine-related highlights:

AlphaVax takes a shot at new viral vector system

In 1997, the North Carolina Biotechnology Center gave AlphaVax, of Research Triangle Park, a startup loan of almost $200,000. Since then the privately owned company raised more than $133 million, with some 70 percent of that coming from corporate partner and grant funding.

AlphaVax is developing a new vaccine technology with broad applications against infectious disease, cancer and biodefense threats. The company believes its technology has the potential to redefine vaccines and the role they play in medicine, using a specialized viral vector system to make alphavirus replicon vaccines called alphavaccines. They've shown excellent protection in multiple models for infectious disease and cancer.

So far the company has advanced the alphavaccine platform system from the academic laboratory to human clinical trials, establishing the technical, regulatory, and manufacturing foundation for commercializing alphavaccines.

The AlphaVax pipeline is targeting pandemic influenza and cytomegalovirus (CMV), as well as grant- and collaborator-supported programs in HIV, prostate and breast cancer, and several biodefense vaccines.

The firm employs more than 70 people in a state-of-the-art, 30,000-square-foot research facility that includes Bio-Safety Level 2 and 3 (BSL-2/3) laboratories, and a 10,000-square-foot development facility involved in vector design and development, new product research, product and process development, GMP manufacturing and technology transfer, quality assurance, and regulatory and clinical affairs.

The firm also manages a GMP clinical supply operation in a leased BSL-3 vaccine production facility in Lenoir.

Last July the firm won a three-year, $3.6 million contract from an agency of the Department of Health and Human Services to help boost vaccines.

The company said it will use the funds it received from the National Institute of Allergy and Infectious Diseases to advance its development of adjuvant technologies, which are agents used to enhance the effects of other agents used in vaccines.

In February 2007, the company raised $12.7 million in a preferred stock offering to begin clinical trials relating to herpes and influenza.

Novartis cell culture vaccine plant now open

In May 2006, the federal government awarded more than $1 billion to five companies to develop new flu technologies. The five companies were GlaxoSmithKline ($274.75 million), MedImmune ($169.46 million), Novartis Vaccines & Diagnostics ($220.51 million), DynPort Vaccine with Baxter Healthcare ($40.97 million), and Solvay Pharmaceuticals ($298.59 million).

This funding was part of the "National Strategy for Pandemic Influenza" plan that President Bush announced/released on November 1, 2005.

That helped Swiss drug maker Novartis AG decide to invest some $486 million in a new vaccine manufacturing plant in Holly Springs. The 430,000-square-foot facility was cited by Site Selection magazine as one of North America's top 20 economic development packages of the year.

When fully operating, the new Novartis Vaccines and Diagnostics facility will employ 350 people developing flu vaccines from cell cultures, a method believed to be faster than the current egg-derived flu vaccine manufacturing process, which can take up to nine months to complete.

Novartis also employs about 680 North Carolina workers at facilities in Greensboro and Wilson.

Novartis Vaccines and Diagnostics is a division of Novartis AG, based in Basel, Switzerland. The parent company employs more than 96,000 workers worldwide and had 2005 net sales of more than $32.2 billion.

Merck plant opens in Durham

In 2004 Merck & Co., Inc. started construction on a $300 million vaccine manufacturing facility in Durham County. It employs some 200 people and provides up to $300 million in additional investment to the area.

Merck received $39.4 million in state incentives in exchange for its commitment to employment at the 256-acre site in Durham County's Treyburn Corporate Park. Those included funds to help with buying and developing the property and with workforce training.

A cost-benefit analysis indicated the Merck plant will generate $118 million in gross state product annually and an additional 360 direct and indirect (multiplier) jobs.

The four primary buildings - the production facility, administration building, powerhouse and warehouse - include 272,000 square feet of office and manufacturing space. This is Merck's first vaccine manufacturing facility outside of its vaccine division headquarters in West Point, Pa.

Biotechnology Center helped hatch Embrex, now a Pfizer division

Poultry hatcheries around the world use an automated, in ovo (in the egg) vaccination system that was developed by Embrex.

Embrex has headquarters in Durham and a new vaccine production plant in Laurinburg.

The Biotechnology Center provided more than $260,000 in four separate rounds of funding to help bootstrap Embrex, starting in 1986. The company raised $16.7 million in 1991 through an initial public offering. On Jan. 19, 2007, Pfizer Animal Health, a division of Pfizer Inc., bought Embrex for $155 million.

By the time of the Pfizer buy-out, Embrex, now a wholly owned subsidiary of Pfizer, employed 169 people in North Carolina, 307 worldwide. Pfizer is keeping Embrex headquarters in Durham.

Murdocks to explore cancer vaccine at Kannapolis site

Dole Food owner David Murdock, who is bankrolling much of the initial construction at the $1.5 billion North Carolina Research Campus in Kannapolis, says one of the early tenants will be a vaccine company run by his son, Justin. The firm is working on a non-small-cell lung cancer vaccine.

Last March Murdock said he was committing $33 million to fund Phase III testing for his son's company, though he has declined to name the business or say what type of vaccine it was working on, citing competitive reasons.

You win some, you win some

These examples reflect the significant successes of the education, workforce training and loan programs established by the North Carolina Biotechnology Center, in partnership with other state and local incentives contributing to this vaccine base.

More than two decades of state commitment and $200 million in systematic funding, flowing from the General Assembly through the Biotechnology Center, have ensured that vaccines are firmly a part of the North Carolina's biotechnology landscape.

It's economic expansion at its best - contributing to worldwide disease prevention while protecting North Carolina's future with good jobs.