Monday, October 30, 2006

Glass Half Empty in King County, WA

An article on the risk of investing in the life sciences...

It's risky to bank on biotech: Companies move, fail before communities see any benefits

By Clayton Park
Journal Business Editor
Article published Oct 29, 2006

In recent years, economic development boosters both in Seattle and on the Eastside have increasingly focused their efforts on attracting biotechnology companies, citing their potential for creating high-paying jobs.

But banking on biotechs can be as risky as betting on dot-coms, or, for that matter, betting on racehorses.

One local stock analyst told the Journal recently that he and his colleagues refer to early stage biotechs as "casinos" because of their 90 percent failure rate.

But conversely they are also referred to as "The Promised Land" by analysts like Paul Latta of McAdams Wright Ragen in Seattle. That's what he calls biotechs that can successfully bring multiple drug products to market because of the profits they generate.

Biotechs that fail to reach the "promised land," however, are bound to either eventually disappear, along with the jobs they provided, or get sold, which often also results in layoffs.

Job cuts likely on Eastside

An example of the latter is Bothell-based Icos Corp., which earlier this month agreed to be sold to Eli Lilly & Co., the Indianapolis-based pharmaceutical maker, for $2.1 billion.

Lilly's CEO has already said his company intends to eliminate a yet-to-be-determined number of the 700 positions at Icos once the sale closes either later this year or in early 2007.

Many of those job cuts will likely occur on the Eastside, where Icos employs 500 workers at facilities in Bothell, Redmond and Bellevue.

And Icos, which developed the blockbuster anti-impotence drug Cialis, is one of the region's more successful biotechs.

Despite the drug's growing popularity, Icos' board of directors earlier this month unanimously voted to accept Lilly's buyout offer of $32 a share — less than half of what the stock was worth at one point in 2001.

Latta said Icos' inability to get other new drug products through the development "pipeline" after 16 years of trying was the likely reason for the board's decision to sell.

1-drug companies at risk

"It was kind of a one-drug company," said Latta of Icos, noting that the same was true of the region's other big biotech, Seattle-based Immunex, which produced the popular arthritis drug Enbrel.

Immunex, despite being the Puget Sound region's biggest and arguably most successful biotech at the time, agreed to be sold to Thousand Oaks, Calif.-based Amgen for $16 billion in 2002.

The sale of Immunex left Icos as the region's largest Washington state-based biotech, a distinction that will most likely now go to Seattle-based ZymoGenetics.

Amgen, which laid off some workers here shortly after its acquisition of Immunex four years ago, announced earlier this year plans to expand its Seattle operations.

The sale of Icos will benefit some of the company's investors, including Microsoft Chairman Bill Gates, who, if he continues to hold on to his 5.36 million shares until the deal closes, would pocket more than $171.5 million.

Shaky future for startups

But backers of biotech startups don't always fare as well with their investments.

Of the region's 26 largest biotechs listed in the Puget Sound Business Journal's 2001 Book of Lists, 12 are missing from the publication's 2006 list. Some of the companies that failed to make the list this past year have gone out of business or have been acquired.

Several of those on the Business Journal's current list were locally based five years ago but now have out-of-state owners.

The number of impending job cuts by area biotech firms rose this past week when London-based GlaxoSimithKline announced that it will close its vaccine-research lab in Bothell by the end of the year, which will eliminate 70 positions, according to a Seattle Times report.

Benefits outweigh risks

Despite the long odds facing early stage biotech ventures, industry observers and local economic development boosters say the benefits to the area that those companies provide, even if they are sometimes short-lived, far outweigh any the risks.

"It is worth it," said Maura O'Neill, the former president of Explore Life, a regional economic development group that teamed up with the city of Renton a few years ago in an effort to establish a "Science City" hub for biotechs on land that Boeing was thinking of selling off.

That effort got put on hold indefinitely when Boeing decided to hang on to most of its potential surplus property as orders for its Renton-built 737 jetliners began picking up.

O'Neill said even though Icos, and many of its jobs, will soon become history, the company "provided a terrific set of high-paying jobs over the last decade for this region."

Research attracts biotechs

The good news, O'Neill said, is that many of those soon-to-be-former Icos employees will likely elect to remain in the area and either go to work for other biotech companies, which will strengthen them, or perhaps even start up new biotech ventures.

As long as the Puget Sound region is home to outstanding medical research institutions such as the University of Washington and the Fred Hutchinson Cancer Research Center, it will continue to attract biotech and lifesciences companies, and/or birth new ones, O'Neill said.

The presence of the Gates Foundation and other institutions such as the Benaroya Research Institute, which is a leading diabetes research center, among others, also are helping to make this region a magnet for biotech and lifesciences ventures, said O'Neill, who now works as the chairwoman of an e-text book company and a part-time instructor with the entrepreneurship program at the University of California Berkeley.

"What we're missing in this region is a broad and deep commercialization eco-system," that would allow biotechs, once they get to the size of Immunex or Icos, to continue to survive, and perhaps acquire other companies, as opposed to becoming acquired, O'Neill said.

State fund supports biotechs

Jack Faris, president of the Washington Biotechnology and Biomedical Association, said the Puget Sound region is making progress towards creating a better support system for biotechs, which could improve their chances for success in the coming years.

"We should NOT assume that we won't be able to improve the odds," Faris said.

One future "tool" to help biotechs in this region is the state's new Lifesciences Discovery Fund, which has already been approved by the Legislature, and is scheduled to receive funding beginning in 2008.

In addition, Faris said, his association is working with other economic development groups to create some "comprehensive strategies" on how to help more biotech and lifesciences ventures become commercialized.

The Puget Sound region already has a "great tradition of entrepreneurship," as evidenced by the success of homegrown global companies such as Starbucks and Amazon.com, Faris said.

"We certainly have enough (ingredients) that if we do the right things with them, we can be absolutely assured of success," Faris said.

27,000 jobs in Bothell

Terrie Battuello, manager of the city of Bothell's newly created economic development division, said the city is already home to 164 professional scientific and technical services companies, including a number of biotechs and medical device makers.

Bothell, which has a population of 32,000, has approximately 27,000 jobs, thanks in large part to the presence of those biotechs and other professional scientific firms, Battuello said.

Battuello said much of the credit for why the city is home to so many biotechs belongs to real estate developer Roger Belanich, who got the ball rolling when he built the Canyon Park Business Center in the 1980s, one of the first of many business parks now in the Bothell/Woodinville area.

The city also has been working closely with the Snohomish County Economic Development Council and other groups to continue to attract employers to the area.

Battuello expressed hope that Lilly will continue to operate Icos' facilities in Bothell and keep at least some employees. "I wouldn't say that it's a given that they'll leave," she said.

The city is currently working on a downtown revitalization project to create some new "opportunity sites for private investments in Bothell," Battuello said.

'Science City' on backburner

Alex Pietsch, who heads Renton's department of economic development, neighborhoods and strategic planning, said while efforts to create a "Science City" have been put on the backburner for now, "we continue to be interested in the industries of this community's future.

"Clearly, biotechs and lifesciences will be a part of that," Pietsch added.

For now, the city is focusing on making Renton "more attractive to companies like that by seeing that major retail projects," such as The Landing, a proposed mixed used complex by Harvest Partners next to Boeing's 737 plant, "are done right."

"We hope that The Landing will be that catalyst so that lifesciences, aerospace, information technology and clean technology companies will want to come here," Pietsch said.

As far as the risky nature of biotechs, Pietsch said, "the good thing" about creating facilities to house those kind of businesses is that "if one company fails, another company can come in and use it."

Sooner or later, because of the city's close proximity to the growing biotech hub in Seattle's Lake Union area, a "science city"-like development is "going to happen in Renton," just as it's "already happened in Bothell," Pietsch said.

Monday, October 23, 2006

Biotech Industry Closing Gap on Profitability

Analysts are saying that the Biotech industry will finally post a profitable year sometime in the next 5 years or so. This article is a re-hash of some of the arguments in the Brookings Institution Report from a few years ago. However, it does have some updated numbers from E&Y.

California pulls in most biotech money
Report lauds success of industry, but it has yet to turn a profit
JOURNAL STAFF AND WIRE REPORT
Saturday, October 21, 2006

SAN FRANCISCO

California remained biotechnology's favorite place of business last year as other states unsuccessfully tried to woo a disease-fighting industry that has yet to turn a profit, according to a report issued Thursday by an industry promoter.

The California Healthcare Institute found that biotech, broadly defined to include diagnostic companies and makers of medical equipment and devices, accounted for $62 billion in revenue in the state last year. The report didn't say how much the industry lost in that time.

Nearly half of the $5.9 billion in venture capital invested in the industry nationwide flowed to California companies. Many of the companies are developing so-called biological drugs to combat such diseases as cancer, diabetes and arthritis. These biological drugs are often derived from genetically engineered microbes, rather than chemicals used in traditional pharmaceuticals.

California scientists also landed $3.6 billion in National Institutes of Health grants in fiscal year 2004, the report found.

"California's biomedical industry is a vital and growing component of our state's high-tech economy," Gov. Arnold Schwarzenegger said in a foreword to the report.

With the average salary rising to $70,400 from $60,000 10 years ago, Florida, Arizona and other states have put biotechnology atop their economic-development lists.

In North Carolina, a major biotechnology research center being developed north of Charlotte will focus on food and the nutritional applications of biotechnology. The state's three major research universities - the University of North Carolina at Chapel Hill, North Carolina State University and Duke University - have said they plan to create research facilities at the campus.

Yet, for all its prestige, biotechnology remains an unprofitable, niche industry that analysts said can't single-handedly boost a sagging economy. Despite being home to 2,700 companies, most employ fewer than 100 workers.

With 260,000 of California's 15 million workers, it's a bigger employer than the aerospace, movie and computer industries individually but smaller than the labor force in government, manufacturing and services.

"It's an industry not growing very rapidly in terms of the number of jobs it's adding," said Joseph Cortright, a Portland, Ore., economist. "It's a relatively small component of the metropolitan economy."

Biotechnology companies are clustered around just a few cities, the three biggest being San Francisco, San Diego and Boston.

To a smaller extent, other companies have their homes in Austin, Texas, Seattle and North Carolina's Research Triangle Park.

Winston-Salem is also developing its downtown research park as a biotech hub.

In the California Healthcare Institute report, compiled by PriceWaterhouseCoopers, there was scant mention of profitability - something that has eluded a large majority of the state and country's biotechnology companies.

Since the industry's inception 30 years ago, U.S. biotechnology companies have lost a combined $52 billion.

The losses continued to mount last year when the sector finished another $2.1 billion in the red, according to a report issued earlier this year by Ernst & Young.

The report did note that the rate of loss was slowing compared with losses of $4.9 billion in 2004 and $6.4 billion in 2003. The Ernst report didn't break out losses by state.

"From a profit standpoint, these companies have very long gestation periods until they actually start selling products," said Tracy Lefteroff, a partner in Ernst & Young and the report's author.

He predicted that the industry as a whole will break even within five years and begin showing an overall profit within 10 years as smaller companies begin receiving regulatory approvals for their drugs.

A handful of biotechnology companies, such as Genentech Inc. of San Francisco and Amgen Inc. of Thousand Oaks, have hit it big after modest beginnings, making their initial investors wealthy.

But they remain an exception. What's more, the high prices of their drugs, especially to treat cancer, are coming under political pressure and several patents on pioneering drugs are set to expire.

"Though the biomedical industry is a solid, significant and growing component of the state's economy, California's life- science leadership is fragile," said David Gollaher, the institute's chief executive.

3rd Anniversary for Scripps Florida

This is the 3rd Anniversary of the Scripps Florida deal. Here is an update...

Science campus slowly takes root in Florida's soil
By Deana Poole and Stephen Pounds
Palm Beach Post Staff Writers
Monday, October 23, 2006

Gov. Jeb Bush called the vote a "defining moment in Florida's future." An opportunity unparalleled. A partnership unprecedented.
Three years ago today, the legislature approved a $310 million incentive package to bring the world-renowned Scripps Research Institute to Palm Beach County. And with the county's additional $200 million commitment, plans were laid to have the institute's Florida campus open this fall.
That was the plan, at least.
Instead of a ribbon-cutting to celebrate the opening of the institute's new home, a ribbon was cut last week to celebrate the opening of a second temporary building on Florida Atlantic University's Jupiter campus. The new 33,000-square-foot building will help ease space constraints and allow the institute to recruit more staff as the permanent facilities are built nearby.
Crews just started clearing the 30 acres of land late last week. The end of construction is expected in 2009.
The setbacks, prompted by a judge's order and subsequent debates over alternative sites, have changed the course of those plans. They originally called for Scripps' campus to be built on 100 acres at Mecca Farms with another contiguous 400 acres set aside for spinoff companies. Now Scripps' campus is divided between 30 acres at FAU and 70 on the Briger tract. Space for spinoff companies is spread through five north-county cities. Instead of a 30-acre contract between Scripps and Palm Beach County, it's now 15.
But Scripps President Richard Lerner said the changes have not hindered the scientists' endeavors.
"As painful it was, it was for the most part good," Lerner said.
Since Scripps Florida was born in late 2003, the institute has hired 191 employees, filed 29 patent applications and received $12 million in grants from the National Institutes of Health. It also has entered into five collaborative agreements with Florida universities and established more than 30 scientific collaborations with Florida scientists.
The notable accomplishments came during the same time period when the county and Scripps were engaged in a drawn-out saga over where the institute's Florida headquarters should end up, followed by contentious contract negotiations. The past 13 months alone create a dizzying timeline of ups and downs and one critical vote after another.
For many county commissioners, the problem started at the beginning with a hurried rush to approve a deal to build Scripps' biotech village at Mecca Farms. They say they had little choice; they might lose the coveted biotech venture to Orlando if they slowed the plan.
"Everybody wanted to listen to the governor," said Commissioner Addie Greene, who ultimately became the swing vote to build Scripps' labs in Jupiter. "We were really following the governor's lead rather than doing our job as the commission and looking out for the taxpayers."
Palm Beach County Administrator Bob Weisman said when the project was announced, it was "a moving target."
"What you learn from that is: When something of such impact is proposed, you really have to try to slow it down and have a very broad understanding of what all the impacts and repercussions might be," he said. "Having said that, when people are threatening you that they might leave and go someplace else, and you want them, it's tough to take that time."
Lerner said the secrecy in the beginning was critical.
"I actually think Jeb did it in the right way," he said. "I know you guys don't like secrecy. My guess is that if it wasn't a secret, we'd still be doing it right now."
Lerner admits the La Jolla, Calif.-based institute was naive about the political environment here.
"I'll use a stronger word: perhaps even foolish, in assuming that these kind of land wars wouldn't go on," he said.
The experience has left Palm Beach County more cautious in quickly approving hefty incentives for nonprofit institutes under time pressures and with many unknowns. Torrey Pines Institute for Molecular Studies is proof of that.
In two sometimes-hostile debates in August, county commissioners critically and harshly questioned Torrey Pines President Richard Houghten's $94 million proposal to build a biotech lab in Boca Raton. In the end, he chose Port St. Lucie because officials there treated him better.
Some wonder if the long debate over Scripps and the acrimonious exchange between Houghten and the commission could paint Palm Beach County as anti-business.
"It certainly was disconcerting for people like me who are thinking of making an investment," said Sheridan "Sherry" Snyder, president of Biocatalyst International, a Virginia-based firm involved in biotech ventures. "It went on for so long, and there was quite a bit of animosity between them and Scripps, that there was some bruises and bangs."



Read the full article here:
http://www.palmbeachpost.com

Friday, October 20, 2006

New VaBio Website is Launched

Check out the new VaBIO website-- we have added many new features including an RSS feed, podcasts and multiple viewing formats. The Virginia Biotechnology Association is trying to keep up with the latest technology, so the website was one of the first places we looked to update. Please send us your feedback.

www.vabio.org

Mid-Atlantic Bio in the News

Here is a great article about Mid-Atlantic Bio from the Montgomery County Gazette:

Bio talks
Mid-Atlantic BIO backs regional cooperation, funding strategies
Friday, Oct. 13, 2006
by Steve Berberich

Staff Writer
Can’t we all just get along? If we can, it will be better for all of us.

That was the major theme of the Mid-Atlantic Bio conference in Washington, D.C., this week, which highlighted efforts by bioscience leaders in Maryland, Virginia and the District to collaborate as a regional entity rather than push divisive provincial interests.

The second annual conference drew more than 800 investors, businesspeople and academic leaders in biotechnology industries to teach and learn how to better fund development of therapeutics, diagnostics, medical devices and health care services.

‘‘This conference is about regionalism,” said Aris Melissaratos, secretary of the Maryland Department of Business and Economic Development.

Melissaratos and Patrick Gottschalk, secretary of Virginia’s Department of Commerce and Trade, announced a joint plan to maintain regional investment conferences, in Bethesda in 2007 and in Chantilly, Va., in 2008.

‘‘And we are going to continue this regional push,” Melissaratos said. ‘‘This showcases individual companies to each other, smaller companies to the larger companies especially. And it showcases science to the investors and brings together the community. I think it works.”

Meanwhile, for venture capitalists, the main interest was in mid-stage bioscience companies, rather than biotech startups or latter-stage companies.

‘‘I think investors here are interested in finding companies that can be successful ... companies that legitimize their science,” Melissaratos said.

‘‘I have always had this response for the biotech community: They say there is not enough money. I say there is more money around than you can shake a stick at.”

Regional strengths

Conference co-organizer Julia Spicer, executive director of the Mid-Atlantic Venture Association, said she enjoyed the regional comradeship.

‘‘It was so refreshing to hear the business development leaders from both states talk about the strengths of each other,” Spicer said. The leaders are ‘‘getting it,” that venture capitalists look at the region as a whole for biotechnology infrastructure and educated workforces. Regional collaborations will mean better markets through entire investor cycles in the region, she said.

‘‘Yes, the states in the region should coalesce,” said David C. U’Prichard, a partner with Red Abbey Venture Partners of Lutherville.

‘‘Look, this region, or the southern Jersey-Philadelphia region, are competing with the top guns, Massachusetts and California” and North Carolina’s Research Triangle Park, ‘‘although I think to some extent [Research Triangle Park] is a little overblown,” he said.

U’Prichard, who is also former chairman of the trade association PennsylvaniaBio, lauded the two-day conference.

‘‘The quality of the turnout and the quality of the speakers from the companies here, they are excellent,” he said.

The conference’s focus on a regional approach was also a boon for scientific service firms in attendance.

‘‘It is hard to distinguish Maryland from the mid-Atlantic region of potential clients” who add value to exhibiting at the conference, said Greg Mingo, director of new business development and marketing for Chesapeake Biological Laboratories Inc. of Baltimore.

The regional approach also appealed to Robert J. McLinden Jr., business representative for the 100-employee Advanced BioScience Laboratories Inc. in Kensington. ‘‘We are finding vendors and new clients and get our name out in public across several states,” he said.

Kristin Olson of VWR BioSciences Inc. of West Chester, Pa., said she collected ‘‘great leads” for 10 new clients from Baltimore all the way to Richmond, Va., in the first two hours of the exhibit hall opening Tuesday.

Funding priorities

Venture capitalists in attendance frequently commented that biotech startups and late-stage, clinical drug development companies are less attractive than companies in mid-stage product development who have smart alliances with larger pharma or biotechs.

‘‘We actually feel a little cornered right now,” U’Prichard said. Many VCs have been focused on clinical stage drug development for the past five years, but the process is so expensive now that ‘‘you are lucky to get your money back.”

‘‘Things are changing because the returns are a lot more favorable for development stage companies,” he said.

The conference offered dozens of young, eager biotechnologists the opportunity to pitch for venture capital in workshops.

Miles Grody, senior vice president of operations and general counsel of ACell Inc. in Jessup, pitched his company’s extra-cellular matrix system of wound healing without scars.

‘‘The body heals almost as if it had never been injured,” Grody said of ACell’s technology. Then he asked for $7.5 million to help the company pursue its strategy.

‘‘We are not looking to becoming a large manufacturing company,” Grody said. ‘‘Instead our strategy is focused on partnering with large, established companies in the life sciences industries.”

Doug Doerfler, president and CEO of MaxCyte Inc. of Gaithersburg, asked investors for $10 million help advance its patented cell-based therapeutics with up to 20 new commercial and academic clients.

‘‘We are in a position now to take off,” Doerfler said. There are ‘‘several hundred companies” now involved in cell therapies that are potential clients, ‘‘so it is starting to look like we have the right technology.”

Doerfler said his company is typical of what VCs are seeking.

‘‘We are not a discovery company but strictly a development company, the development of clinical assets with our partners,” he said.

After only 15 months in operation and 20 employees, Boro Dropulic, founder and CEO of Lentigen Corp. of Baltimore, offered investors a unique, established technology of virus-transported gene therapy techniques called ‘‘lenti-viral vectoring.‘‘ He, too, pitched the mid-stage theme, touting Lentigen’s collaboration with Johns Hopkins Medical Center, the National Cancer Institute and the Army, as well as a bevy of patented technologies.

Larger players make their pitch

The mid-stage theme for investors is not just for smaller biotechs, said Steven Mayer, CEO of CoGenesys and a speaker on a panel, ‘‘Building a Sustainable Company: Practical Advice for Bioentrepreneurs.”

CoGenesys, a spin-off of Human Genome Sciences Inc. of Rockville, completed a $55 million financing round in June and has at least seven drug candidates in late preclinical stages.

‘‘Our objective is to move them into the clinic, have proof of principle, and then seek partners or out-licensing of these products. We really do not intend to commercialize. We want to find large pharmas or large bioechs who want to partner with us to commercialize our products,” Mayer said.

He said he and former HGS colleague Craig Rosen, also now with CoGenesys, ‘‘took a long time” to study the venture environment and come up with their current formula.

‘‘We feel that it is a better way to build value into a company that does not require as much funding. So we can do more things with less capital,” Mayer said. ‘‘That is our thesis.”

He added that many companies are abandoning using an initial public stock offering as their ‘‘exit strategy,” because of the rising costs of government regulations.

Conference speaker Todd Brady of Domain Associates LLC of Princeton, N.J., and San Diego also said investors are influenced by rising costs of government regulations on biotech startups.

‘‘Because biotech companies take a very long time and have high expenses to market a drug, I think that is why the whole field has changed,” Brady said. ‘‘The closer to revenues you are, the more like a real company you are to investors.”


Copyright © 2006 The Gazette -

Thursday, October 12, 2006

WBJ Article on NoVa Biotech

Cover story about Northern Virginia Biotech in the Washington Business Journal

Virginia's new biotech formula
As Northern Virginia rolls out the welcome mat for its new $500 million prize -- the Howard Hughes Medical Institute -- business leaders are thinking bigger than proteomics, and looking beyond their own county lines.

Washington Business Journal - October 6, 2006
by Joe Coombs and Vandana Sinha
Staff Reporters

A fort of trees veils it from the traffic-ridden reality of Route 7 on one side. On the other, the banks of the Potomac River quietly cushion it. Between the two lie 689 acres of green seclusion called Janelia Farm Research Campus.

The Loudoun County campus is sliced by meandering roadways that, when finished, will circle two man-made lakes, wild meadows and a veritable greenhouse for science: a glass-walled labyrinth of labs and meeting spaces in a wide staircase of a building burrowed into a hill that, at three football fields long, spans more square footage than Dulles International Airport's main terminal.

Inside that building, along curved hallways and past glass-enclosed office pods, roughly 50 scientists who chose Ashburn over Harvard or Oxford now unpack boxes of equipment and research materials that local economic development officials hope will herald a new era for biotech in Northern Virginia.

Janelia Farm, the Howard Hughes Medical Institute's $500 million retreat, celebrates a quiet public opening Oct. 7. But regional leaders are toasting a different occasion: the baby steps of a Northern Virginia biotech industry that's long been under construction compared with its counterpart across the river.

They hope that in the next generation these high-dollar life sciences projects will spawn the kind of roaring biotech sector Montgomery County has long enjoyed.

But before the celebrations begin, Northern Virginia must still round up some key ingredients -- wet lab space, incubators and gobs of venture capital -- to spur one of the world's costliest and most regulated industries.

"I think it's in its early stages. There's a good energy about it," says Cheryl Moore, chief operating officer for Janelia Farm Research Campus and a board member for VaBio, the state's biotech trade group, and the Virginia Biotechnology Research Park in Richmond. "I wouldn't say it's there yet, but there's a buzz."
'Friendly competitors'

Bound to cause the most buzz are the sudden sounds of regionalism, or at least, semiregionalism.

Cooperation among neighbors is often a foreign concept when it comes to economic development. But three Northern Virginia counties are doing the unthinkable: touting each other's strengths to create the region's -- and perhaps the country's -- next great cluster of bioscience activity.

Only a year old, the Northern Virginia Life Science Communities coalition will use a three-pronged sales pitch to reach its goal:

* The pending delivery of the Hughes campus in Loudoun County;
* A 1,500-acre, rapidly growing business park in Prince William County; and
* The powerful tech-based economy and international connections of Fairfax County.

The group consists of the three counties' economic development agencies, and while they'd all like a big piece of biotech for their own tax rolls, they're not averse to attracting business on a regional level.

"We are indeed competitors, make no bones about it," says Jerry Gordon, president and CEO of the Fairfax County Economic Development Authority. "But we're friendly competitors. This is one industry where we can't compete effectively on our own, or separately."

The wild card for Northern Virginia's biotech hopes is at George Mason University, which doesn't have a tradition rich with research but is increasing those efforts at campuses in Fairfax, Loudoun and Prince William.

Some of the university's current work is focused on two emerging bioscience sectors -- proteomics, the study of protein activity in cells, and theranostics, a combination of therapy and diagnostics that tailors treatments to specific individuals.

For now, the Northern Virginia coalition is just trying to let the industry know what the counties have to offer, says Dorri O'Brien Morin, manager of business investment for Loudoun County's economic development department. They're sending a team to the 2006 Mid-Atlantic Bio, an Oct. 10 trade conference in D.C. expected to attract heavyweights from the bioscience industry.

In November, Loudoun County for the first time will host a three-day international medical automation conference, which will be at the Lansdowne Resort Conference Center. The county ponied up $100,000 to bring the annual conference to Loudoun for the next five years, Morin says.

"That's just one example of the effort that's being made," Morin says. "If we can get the right people here on a regular basis, they're going to be in Loudoun and Northern Virginia and say, 'This place is on fire.'"

A work force study is also in the coalition's plans for early 2007. The goal, Morin says, is to find out "where we have gaps, and where we have strengths."
scientific shift

If there are budding strengths and a buzz in Northern Virginia, then Maryland has been comparatively drunk with biotech success. Virginia has 160 biotech and pharmaceutical players statewide, with a little less than half inhabiting the northern suburbs. In Maryland, more than 200 such companies reside in Montgomery County alone.

While Maryland began collecting biotech companies a quarter of a century ago, Northern Virginia scored what many consider its first biotech company in 1998 with American Type Culture Collection, a not-for-profit corporation that inventories microorganisms for research and christened now-growing Innovation @ Prince William Technology Business Park.

Northern Virginia, however, has lacked the research engines that drove most of Maryland's biotech development: large research universities, such as Johns Hopkins University and University of Maryland, and federal research agencies, such as the National Institutes of Health. The sizable budgets of those organizations fund scientific research, and then scores of their researchers graduate to entrepreneurialism.

Northern Virginia, meanwhile, has stuck with its strengths, banking more on information technology and telecommunications companies. Until now.

The region has captured attention with high-profile bioscience wins in recent years, including a $325 million Eli Lilly manufacturing plant, a $45 million George Mason University biocontainment lab and a $32 million FBI lab, all in Prince William County.

Three years ago, Northern Virginia opened its first biosciences incubator in Springfield, taking a step toward competing with Maryland, whose goal is to have seven incubators by the end of next year.

Earlier in the year, George Mason University hired a full-time licensing executive specifically for life sciences in the university's Office of Technology Transfer. That's already led to two new biotech licensing agreements and one new startup in Prince William County, with two more fledgling companies in the works.

"The goal is to keep these companies in Northern Virginia," says Matthew Kluger, vice president for research and economic development at George Mason. "We hope this will be the first of many."

But Janelia Farm is likely to remain the centerpiece of Northern Virginia's biotech strategy. Local leaders hope the campus will be the re search engine that pushes scientists into the business community.

In more than two decades, Hughes researchers around the country have won 11 Nobel Prizes and launched more than 100 companies, a few bulging to more than 500 employees. Last year, they licensed enough technology to earn $2 million in royalties.

"We improved the probability that some companies will want to locate here. There's no question about that, but we didn't make it 100 percent," says Janelia Farm Director Gerry Rubin. "But just having us is not going to do it."
Lab supplies

The Hughes institute surely can't do it alone. To lure startups, regional and state officials must have more potent biotech bait, including built-out lab space and pockets full of financing.

In Maryland, the state launched its own venture fund, 40 percent of which goes to biotech companies. The state also has subsidized incubators and this summer began offering generous tax breaks to those who invest in the earliest stages of biotech companies.

Northern Virginia companies, on the other hand, often end up paying their own way. In the past decade, that's amounted to $1.6 billion in private investments in the state's biotech communities.

"We are where we are today because we've done it on our own," says Eric Major, CEO of K2M who founded the spinal cord diagnostics company near his Leesburg home and next door to the regional airport. "I'm not saying Virginia is putting any roadblocks in our way. But they could spur this."

Virginia officials say that instead of pinpointing a specific sector to assist, they want to create a low-tax business-friendly climate that's appealing across industries.

Two years ago, however, Gov. Mark Warner commissioned a biotech committee to look at things the state could do to pump up its activity.

As a result, Virginia leaders say they are reviving a state technology research fund this year with $5 million in new funding for public-private academic partnerships and an additional $250,000 for research and development.

"Some of that is likely to be spent on biotech," says Aneesh Chopra, Virginia Secretary of Technology. "I'm not saying we've solved everything, but we've taken a step forward."

Where Northern Virginia continues to lag is in the amount of lab space. There is virtually none today.

The creation of wet lab space, whose price tag can be as much as five times the cost of office space and well beyond a startup's budget, was one of the recommendations of the governor's commission. For this budget cycle, however, it remains in discussion mode in Richmond.

"We have clients who need space now," says Dan Gonzalez, a VaBio board member and executive vice president of commercial real estate firm Scheer Partners. "So their only alternative is, they can go to Maryland. Or they can go down to Richmond."

Eli Lilly -- searching for temporary wet lab space while its 350,000-square-foot insulin manufacturing plant is being built -- has declared it will build its own 10,000-square-foot wet lab in Prince William County.
Within, without

It remains to be seen if the gentlemen's agreement among the members of the Northern Virginia Life Science Communities coalition yields the hoped-for big-time results.

Representatives of all three counties say this is the first time that they've been at the table together vying for the same business, and it's taking some adjustment.

However, there's never been such a confluence of events working in their favor:

* The region's economy is still booming.
* Fairfax County has a well-established, tech-based work force, and its economic development agency is building global contacts through several international offices.
* The Hughes campus in Loudoun will be fully operational in 2007.
* Prince William County's Innovation technology park is already creating a burgeoning bioscience sector, anchored by the Eli Lilly plant that will employ 350 people when it opens in 2009.

The Hughes complex could also have a good neighbor in the One Loudoun development, a proposed 360-acre project on Route 7 in Leesburg with 3.8 million square feet of office and commercial space, a 400-room hotel and 1,935 residences.

The project's partnership has teamed up with the International Association of Science Parks, and a significant portion of One Loudoun's commercial property will be devoted to bioscience companies expected to feed off research conducted at Hughes.

"We want a company to be in the best place possible," says Morin, the business investment manager for Loudoun's economic development department. "We may not have the work force available in Loudoun that Fairfax has, for example, but we've got Hughes and we've got some land. Prince William has the Innovation park and a lot of incentives already in place. We can find the right fit."

Prince William was already targeting life sciences before the coalition was formed, says Jason Grant, a spokesman for the county's Department of Economic Development.

As a targeted industry, bioscience companies are eligible for a fast-track permitting processes that lasts only 30 days and can get a reduction of up to 50 percent in county fees for site development. They also are eligible for assistance from a fund administered by the county's industrial development authority.

Although Prince William had begun taking steps on its own to become a biotech center, it jumped onboard when the idea for a regional coalition was proposed, Grant says.

"We asked the question, 'Are we helping ourselves by only marketing ourselves?,'" he says. "As it turns out, each of the three counties has assets that are substantial, and it's a stronger message for us to send out."

Even with a bioscience stronghold in Montgomery County, coalition members say there's plenty of room for the industry to grow elsewhere in Greater Washington.

"We all know that Virginia, Maryland and D.C. don't play together all that well," says Gordon of Fairfax County's economic development group. "So now we've got a Northern Virginia subset that has plenty to offer. There's a lot we can accomplish with simple marketing. We're still in the early stages, but this industry grows in short steps, too."

Even if Northern Virginia succeeds in expanding its biotech industry, the region still has several more years of baby steps before it nears the Maryland-level leagues.

"It's not a single company. It's not a single building. It's not a single facility," says Robert Skunda, president and CEO of the Virginia Biotechnology Research Park, a $585 million business park and incubator that's a partnership among the city of Richmond, the state and Virginia Commonwealth University. "It's really kind of creating a critical mass of all of those things."

Until then, from the terraced, plant-lined roof of the Janelia Farm Research Campus, Northern Virginia's proudest accomplishment in life sciences to date, the biotech community can get a front-row view of its competitor just miles across the Potomac River.
_________
Economic development = scientific developments

From unlocking the mysteries of the genetic code to following the brain's wiring, the Howard Hughes Medical Institute promises science in Ashburn that's never been explored.

The Chevy Chase-based nonprofit research organization -- whose roughly $16 billion endowment pays for long-term, society-altering science projects not profitable enough for most others to fund -- will focus on two areas at its new Janelia Farm Research Campus in Loudoun County.

In one area of emphasis, researchers will try to gain a better understanding of how the brain works. The second research field will focus on obtaining better images of biological pieces.

Its earliest efforts so far have been in imaging. Inventors Eric Betzig and Harald Hess, new employees at the Loudoun County lab, have created a microscope that uses light to differentiate proteins from one another at a resolution rate 10 to 100 times higher than its counterparts -- the equivalent of the difference between a soccer ball and marble.

The extra visibility from their technology, featured in a recent issue of the online Science Express magazine, could help biologists better determine where diseases formulate and grow.

"When you have that extra resolution, you can begin to ask, 'How do some of these organelles work?'" says Hess, Janelia Farm's director of the applied physics and instrumentation group. "How do proteins work together?"

Hughes constructed the lab in a way that makes it easier for researchers to work together. The lab's architects have carved out considerably wide hallways and open spaces that practically force scientists to bump into one another and share ideas.

Chemists, neurobiologists, geneticists, physicists, computer scientists, mathematicians, biologists and engineers will have access to a 500-square-foot cell culture lab, two equipment machine shops and a data center, among other resources.

Janelia Farm will be the only place where the Hughes Institute clusters its researchers, 300 of whom are now scattered across more than five-dozen universities around the world.

By the end of the decade, when Janelia Farm reaches capacity, more than 300 group leaders, researchers, fellows and visiting foreign scientists will be delving into everything from neurons to nanosensors in what Hughes calls its boldest work.

The Loudoun campus is seeking "people who are picked in the first round of the draft," says Gerry Rubin, director of Janelia Farm, which competes for scientists with the likes of the Massachusetts Institute of Technology and Harvard, Stanford and Oxford universities. "We are getting really ambitious, very talented people who set their sights very high and want to do important things. We want you to bet your career on your ideas."

* Vandana Sinha

______
Happenstance, not strategy, lured Hughes

Loudoun County can credit its top-billing biotech coup, the Howard Hughes Medical Institute's world-class $500 million Janelia Farm Research Campus, to one thing: near coincidence.

When searching for land six years ago, Hughes leaders knew they wanted at least 80 acres of relatively isolated, untouched expanse. They also wanted an airport nearby for visiting scientists, but no bustling office parks as neighbors. They envisioned a remote university-campus setting, with housing for the scientists and on-site eateries.

That largely left Northern Virginia, but finding the amount of space needed for research and development still proved more difficult than expected -- until the project's then-anonymous real estate adviser, The Mark Winkler Co., now Duke Realty, spotted the perfect proposition in the fields of Ashburn.

The lot's previous owner, Dutch software company Baan, had endured eight straight quarters of losses and was hemorrhaging $1 million a day. Days away from bankruptcy, it had no choice but to sell its land in 2000, only two years after announcing plans to construct 2.5 million square feet of office and training buildings to hold 1,000 people in a location already zoned for research.

At the time of the announcement, Gov. Jim Gilmore had called that $40 million project one of the largest development investments in the county's history.

Through Winkler, which had learned about the struggling software player, the Hughes institute approached Baan with an offer it wasn't able to refuse. For a relatively small $57 million, the institute became the proud owner of the 281-acre property.

Only after the negotiations ended and funds were transferred did Loudoun County officials learn of what would indeed become one of the largest development deals in its history.
The Loudoun County Board of Supervisors, in one of its last moves at the end of 2003, voted to award

$6 million in tax exemptions to the research campus. And they're watching closely for what the regional economic payback will be.

* Vandana Sinha

_______

Northern Virginia vs. Montgomery County: Competitors, or 'complements'?

Start with a handful of huge government research groups. Add a 288-acre piece of property for private-sector development and sprinkle in a couple of universities.

That's how Montgomery County crafted the recipe for its biotechnology industry, which today has about 12,000 workers, 200 companies and hundreds of millions of dollars in research and development activity.

Montgomery County is the place where giants such as MedImmune and Human Genome Sciences got their starts, and it's poised to make room for more: The county is in the preliminary stages of building out a 185-acre plot on its east side for life science companies.

As Northern Virginia tries to find its own identity in bioscience, it can turn to a pretty good blueprint on the other side of the Potomac.

Montgomery County, though, already was starting from a strong point when its effort began about 25 years ago: The National Institutes of Health, the U.S. Food and Drug Administration and the National Institute of Standards and Technology had homes in the county. But Montgomery officials knew they couldn't build a biotech industry on federal agencies alone.

"In the early 1980s, it was really the start of the biotech industry itself," says Joe Shapiro, a spokesman for Montgomery County's economic development department. "We had resources in place. The county leaders at the time realized that in order to attract the private sector, we needed to increase our higher education opportunities."

The county created the Shady Grove Life Sciences Center in 1983. The first two tenants at the 288-acre property in Rockville were Otsuka Pharmaceutical and Microbiological Associates, today known as BioReliance. The center then welcomed divisions of Johns Hopkins University and the University of Maryland. Montgomery County's biotech sector blossomed.

"Having Johns Hopkins and the University of Maryland here created the momentum the county was looking for," Shapiro says. After that, people like Wayne Hockmeyer came from Walter Reed and started MedImmune, and Craig Venter left NIH to create Celera Genomics.

Life science incubator complexes for startup companies have sprung up, and the next big thing is the East County Center for Science and Technology near the new headquarters of the FDA in White Oak, which, when finished in 2008, will house 8,000 employees.

Northern Virginia could be on the cusp of creating its own life sciences community, but "we're not trying to go head-to-head with Maryland," says Dorri O'Brien Morin, manager of business investment for Loudoun County's economic development department. "We know we're just getting started, but we think we'll see the metamorphosis of another industry cluster in our economy. We think we can be a complement to what Maryland already has.
"

Mid-Atlantic Bio Dates Set for 2007 & 2008

Save the dates: The 2007 Mid-Atlantic Bio conference will be held October 25-26 at the Bethesda North Marriott Hotel and Conference Center in North Bethesda, Maryland. The 2008 conference will be held on October 23-24, at the Westfields Marriott Conference Center in Chantilly, Virginia.

More than 800 Attended Mid-Atlantic Bio

MORE THAN 800 ATTENDEES PARTICIPATE IN 2ND ANNUAL MID-ATLANTIC BIO CONFERENCE

Science posters, research updates, commercialization guidance, international business perspective, federal policy trends and investor presentations part of regional conference

October 11, 2006 -- Washington, DC – More than 800 attendees from 18 states and countries, including representatives from 135 different life science companies and more than 60 venture investors, participated in the 2nd annual Mid Atlantic Bio Conference coordinated jointly by MdBio, the Virginia Biotechnology Association (VaBIO) and the Mid-Atlantic Venture Association (MAVA). The two-day program offered something for everyone, including 60 exhibits, 36 scientific posters, and plenary sessions by leaders of science and industry. Keynote speakers included Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease and David Holveck, President of Johnson & Johnson Development Corporation. A variety of scientific, business and investor workshops, panels, and focused roundtables rounded out a full programming agenda.

During the conference participants heard lessons learned from a panel of CEO’s; the current status of regenerative medicine, FDA policies and research funding from Washington policy makers and international companies; how to implement a corporate licensing program from representatives of GlaxoSmithKline, compugen USA, MedImmune and Pfizer; understanding and overcoming the unique challenges of running a company of ten or fewer employees; and how to master operating clinical trials on an international level.

Exhibitors interfaced with attendees and other exhibitors throughout the day, with both a luncheon and evening reception taking place in the exhibition hall on Tuesday. In the afternoon, companies from Maryland, Virginia, North Carolina, Delaware, and Pennsylvania who had survived a rigorous selection and preparation process made company presentations to industry colleagues and more than 60 investors from some of the leading life sciences private investment groups in the industry.

On day two, as part of the inaugural debut of the conference’s “Innovation Corridor,” thiry-six scientific posters were on display, featuring a variety of cutting edge academic, federal laboratory, and company research and development efforts providing commercial solutions to unmet needs and highlighting advances in biotechnology. During the morning plenary on October 11, 2006, Dr. Fauci provided insight into the “Matrix of Infectious Diseases.” He discussed both emerging infectious diseases such as AIDS and SARS, and re-emerging diseases such as West Nile Virus and Influenza. During his remarks he noted that a new case of West Nile Virus has just been reported this week in Maryland and that the disease, while prevalent in Africa and the Middle East for centuries, was not evident in the United States until 1999. “More than 26% of all deaths in the world are caused by infectious diseases,” Fauci said, adding that a new strain of drug resistant TB known as XDR-TB had recently lead to the deaths of several people overseas. Putting the common seasonal influenza in perspective, he said “Influenza is a very different, unique re-emerging disease for which the world’s population goes largely under vaccinated.”

The closing plenary luncheon took a look into what it takes to build a sustainable company, and included representatives from Aisling Capital, Morgan Stanley and UBS, who spoke candidly to the audience about their views of the market. They suggested that emerging companies need to understand the competitive landscape and provide a business plan that shows they have the in-house power to get things done from a financial, management and regulatory perspective. They noted the importance of the company having IP and a minimum of Phase II proof of concept data. Dennis Purcell from Aisling Capital noted that the new trend is for VCs to fund a company all the way through the process, so it is important to pick the right VCs from the beginning. He also noted that early stage companies today are further along in the development process than early stage companies of five to ten years ago. All panelists agreed that while now is a more difficult time to go public, it is a positive time for mergers and acquisitions and attractive ideas are getting funded.

The Mid-Atlantic Bio conference program is designed to offer business development and networking opportunities for academics, policy makers, federal labs, and industry leaders through exhibition, industry showcase, scientific poster sessions, and topical panel and plenary sessions. Unique to this event is the opportunity for companies at all stages of development to present to venture capital firms interested in the areas of therapeutics, diagnostics, medical devices, and healthcare services as well as network with potential pharmaceutical partners.

“This conference is growing in reputation and attendance,” said Julia Spicer, Executive Director of MAVA and a member of the Host Committee with partners MdBio and VaBIO. “2006 Mid-Atlantic Bio was an overwhelming success providing a platform where leaders of industry, science, academia, policy, and finance have all come together to collaborate and support the growth of the biotechnology and life sciences communities. We look forward to building on this success in 2007 and 2008, and hope even more members of the life science and investor community will participate in the upcoming regional conferences hosted jointly by MdBio, VaBIO and MAVA.”



During the event the Mid-Atlantic Bio host committee announced plans to rotate the conference around the region to further highlight area assets. The 2007 conference will be held October 25-26 at the Bethesda North Marriott Hotel and Conference Center in North Bethesda, Maryland, in the heart of “DNA Alley.” The 2008 conference will be held on October 23-24, at the Westfields Marriott Conference Center in Chantilly, Virginia, a commerce and technology hub. Aris Melissaratos, Secretary of Maryland’s Department of Business and Economic Development and Patrick Gottschalk, Secretary of Virginia’s Department of Commerce and Trade joined officials from Montgomery County, Maryland and Fairfax County, Virginia in applauding this regional commitment to promote the life science sector and public/private partnerships on a multi-state level.

“By rotating this conference from Washington, DC to other locations in the region, this will continue to be the ‘annual meeting’ for our region’s bioscience community, a place where industry leaders, academic entrepreneurs and researchers, investors, educators, policy makers, and economic development officials can meet, network, share ideas and foster the relationships and partnerships that strengthen the region’s bioscience sector,” said Bob Eaton, President of MdBio.

Lead and diamond sponsors for the 2006 conference included Alexandria Real Estate Equities, Cooley Godward Kronish, LLP, Quintiles Transnational and the states of Maryland and Virginia. For a complete list of sponsors visit www.midatlanticbio.org.
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About Mid-Atlantic Bio
Mid-Atlantic Bio is the only industry and investor conference and exhibition dedicated to promoting the growth of biotechnology in the region. The Conference is collectively sponsored by the mid-Atlantic's most influential bioscience and investor associations, MdBio, the Mid-Atlantic Venture Association (MAVA), and the Virginia Biotechnology Association (VaBIO). The initiative benefits from broad regional support, including the investor and greater business communities, academic institutions, government agencies, and partnered regional associations. The conference provides the platform for conducting business, and building broad alliances with key organizations and audiences sharing a common interest in the long-term growth and stability of biotechnology in the mid-Atlantic. For more information, please visit www.midatlanticbio.org.

Saturday, October 07, 2006

Mid-Atlantic Bio Pre-Registration Over 700

Great news about the upcoming 2006 Mid-Atlantic Bio event in Washington next week. According to the conference management team, pre-registration crossed the 700 threshold last night.

This is great news for the Maryland and Virginia biotech communities. The more attention this event gets the more interest we will have from investors, experienced managers and entrepreneurs from other major bioscience markets.

If you haven't signed up, do so before Tuesday to receive the pre-reg fee.

New River Pharma Drug Approved

More great news for Virginia biotech companies. This is from the Roanoke Times:

Will a new ADHD treatment make or break New River Pharmaceuticals?
A Radford company gets the go-ahead by the FDA to produce its first drug, NRP104
By Jeff Sturgeon | jeff.sturgeon@roanoke.com | 981-3251

A green light glowed Friday for a clutch of Radford drug executives who received tentative approval to sell a potentially lucrative treatment for attention deficit hyperactivity disorder.

New River Pharmaceuticals Inc. said the approval "is contingent upon final scheduling by the U.S. Drug Enforcement Administration."

The company predicted sales will begin during the April-June quarter of 2007. New River previously hired Organichem Corp. of Rensselaer, N.Y., to produce the pills. Officials don't envision filling any new manufacturing jobs.

But the Food and Drug Administration gave Western Virginia a regional business milestone: a homegrown biotechnology company taking a prescription medicine to market.

Success seems to be all the more remarkable because 10-year-old New River Pharmaceuticals employs only about 35 people (though it received help from a partner company that is larger).

The stock closed Friday before the news was released at $26.21, down $1.08, on a slightly higher-than-average trading volume of 567,949 shares.

ADHD is a psychiatric condition responsible for classroom fidgetiness and general unruliness seen in some children. Researchers have estimated that nearly 8 percent of school-age children had ADHD in 2003 based on information from parents, according to the Centers for Disease Control and Prevention. That adds up to millions of potential customers for New River, which sought approval to initially market its drug to children ages 6 through 12.

Drugs are already on the market for this condition and selling quite well. New River's treatment is designed to be as effective as these drugs but comes with a bonus. It's designed to produce little or no recreational high for those inclined to exceed the therapeutic dose or ingest it by unconventional means, such as snorting.

If regulators think the proof is adequate, they could grant doctors leeway to prescribe refills, saving patients the trouble of visiting the doctor monthly. That, in turn, could boost the drug's popularity beyond that of more tightly controlled ADHD stimulants, such as market leader Adderall XR. Friday's announcement left the classification question unresolved, however.

The most bullish backers say New River's drug could succeed Adderall XR as the market leader. This would be in keeping with New River's stated mission to create improved versions of widely prescribed drugs.

Earlier in the process, New River formed a strategic partnership with Adderall's manufacturer, English drugmaker Shire, in return for assistance. And Shire is planning to help market New River's drug as a next-generation improvement over its own in exchange for a share of the wealth it generates.

Andrew Forman, an analyst with W.R. Hambrecht+Co., whose firm helped take New River public two years ago, predicted before the announcement that sales could total $244 million in 2007 and rise to nearly $1.2 billion in 2010. By that time, New River would like to have approval to market to adults as well.

For perspective, the top-selling drug in the United States last year, cholesterol-lowering Lipitor, generated revenue of $8.4 billion for its owner, said data tracker IMS Health.

If Forman is correct, New River's drug would climb to the status of a blockbuster, an industry term for any preparation that brings in $1 billion or more for its owner.

That's not $1 billion in profit, mind you. Forman predicts New River's share of the profit will be closer to $200 million in 2010 and $5 million next year.

"This is the most important day in the company's history," Forman said Friday before the announcement. "You can't do anything in the pharmaceutical industry unless the FDA approves your product. This is the first time the FDA has responded to this company doing anything since they started."

A green light would "validate" the company's drugmaking technology and, by extension, drugs in its pipeline of future products, Forman said.

Less clear is what kind of impact a favorable announcement might have on the company's hometown of Radford. New River Pharmaceuticals is not a highly visible corporate citizen amid the city's small business community. Chief Executive Officer R.J. Kirk, who lives in rural Belspring, is perhaps better known in Radford than his business because of his vocal participation on the board of visitors of Radford University.

Michelle Linkous, executive director of the Radford Chamber of Commerce, was not aware that Friday was an important day for the company, nor was the chamber president Robert Roy.

But many local eyes are watching. Joe Meredith, president of the Virginia Tech Corporate Research Center in Blacksburg, where the company's main research and development laboratory is located, said by e-mail:

"I would suggest that FDA approval continues to reinforce the notion that great science and great businesses are continuing to grow at the CRC."

Still ahead would be such decisions as the drug's name and appearance. The compound still goes by its laboratory name of NRP104. Chemically, it's lisdexamfetamine dimesylate (pronounced liz-DEX-am-feta-meen die-MEZ-il-late).

Though a mouthful, it's a term that might be well worth learning to say.