Kaine blocks funding for embryonic stem cell research

From CNN

Virginia Gov. Tim Kaine, the chairman of the Democratic National Committee, has signed a bill into law banning the use of state funds for embryonic stem cell research.

The move puts the DNC chairman at odds with President Obama, who signed an executive order earlier this month reversing the Bush administration's ban on federal funding for research on embryonic stem cells.
Kaine approved the Virginia bill on Monday, according to the governor's office, the same day he enacted legislation that would permit "Choose Life" license plates in the commonwealth — an act that angered state and national abortion rights advocates.

The governor signed another piece of legislation Monday aimed at promoting "science and technology-based" research and development in Virginia. It contains language inserted by the General Assembly that would prevent a state fund from providing dollars to organizations or businesses that undertake "research in Virginia on human cells or tissue derived from induced abortions or from stem cells obtained from human embryos."

Kaine's support for the legislation is not surprising: He is a staunch Catholic who has long opposed using taxpayer money for embryonic stem cell research. But the platform of the Democratic Party, now headed by Kaine at Obama's behest, describes embryonic stem cell research as "research that could save lives."

Both the stem cell bill and the license plate uproar highlight the balancing act Kaine faces in his dual roles of the moment: one as policy-minded governor of a moderate state, and another as a the national face for a partisan organization seeking to promote President Obama agenda. Kaine will assume the DNC position full time when his term expires in January.

Asked for comment about Kaine's departure from the national party line, the DNC referred questions to the governor's office in Richmond.

Lynda Tran, the governor's communications director, said that Kaine's decision is "in keeping with his faith and his personal beliefs."

"The governor is opposed to the use of state funds to fund embryonic stem cell research, but he generally agrees with the national platform broadly, that there are scientific values to stem cell research," Tran said. "In Virginia, where there has been strong opposition to embryonic research, he has made it a choice to focus on other forms of research like adult and placental stem cell research."

The bill signed Monday allows funding for non-embryonic types of research.
All three of the Democrats vying to replace Kaine as governor this fall — Terry McAuliffe, Brian Moran and Creigh Deeds — support using state money for embryonic research.

WSJ: Congressional IRB Sting Used Fake VA Medical Device Firm

The fake company was called, "Device Med Systems" of Clifton, Virginia. It was part of a Congressional "sting" operation that targeted for-profit IRBs. The probe also tested whether or not HHS was vetting IRB registrations. Apparently, HHS had no issue registering and IRB called, "Truper Dawg," after a staffer's three-legged dog.

Sting Operation Exposes Gaps in Oversight of Human Experiments

By ALICIA MUNDY

WASHINGTON -- Thousands of medical research groups that monitor clinical trials on behalf of the drug industry may face tougher regulations in the wake of a congressional sting operation that found gaps in the nation's oversight of experiments on humans.

The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.

Drug and device makers along with hospitals and university research facilities must retain an independent IRB to oversee the methodology and safety issues for human studies. Corporations cannot get Food and Drug Administration approval for their products without an IRB certifying their clinical trials. About 6,350 IRBs are registered with the Department of Health and Human Services.

Lawmakers have raised concerns over whether IRBs routinely approve medical studies for paying clients. The committee leaders are considering whether to introduce a bill to strengthen IRB regulations.

Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

"We realized it was a terrible risk for the patient … It is the worst thing I have ever seen," an Argus IRB reviewer said, according to a slide shown at the hearing.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.

Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes -- congratulations." Because the product was fake, it was never used.

As part of the sting, the committee also created a sham IRB to see whether the Department of Health and Human Services, which registers IRBs, would certify their fictitious group.

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.

At Thursday's hearing, the toughest complaints were reserved for HHS. Rep. Joe Barton of Texas, the committee's ranking Republican, asked one HHS official: "Do you have any sense of outrage?" Referring to Coast, he continued, "What steps are being taken right now to decertify these charlatans?"

The director of HHS's office that registers review boards, Jerry Menikoff, said at the hearing that his bureau had only recently received the committee information about Coast, and would look into the matter.

CBS's "Eleventh Hour" Popular with Conservatives

In this article, BIO's website, "Eleventh Hour Facts" is mentioned.

The Nation's Pulse Down to a Science
Mar 30, 2009, The American Spectator
By Nicole Russell on 3.30.09 @ 6:04AM

There's not a lot out there that specifically appeals to conservatives when it comes to television drama. Sure, there are whispers of ancient politicos on Lost and terrorists get what they have coming to them on 24. But for conservatives who want a break from watching Kiefer Sutherland shoot someone in the thigh every thirty seconds, there is Eleventh Hour. The new CBS series earned some of the highest ratings in its time slot and is both provocative and prudent in its approach to the ethical dilemmas confronting science.

Based on the British miniseries by the same name, Eleventh Hour follows Dr. Jacob Hood -- a biophysicist and "special science advisor to the government" -- as he and a pretty blonde sidekick swoop into thwart scientists pushing the bioethical envelope so before the clock strikes midnight. The show stars Rufus Sewell as Hood, that bronze-skinned British hunk with a mass of black curly hair, laser-sharp cheekbones, and a raspy voice sure to make any woman devour even the most boring, science-laden jargon he lays on his viewers with ease.

A common theme is that science can do great harm when it isn't restrained by morality. Even the show's website proclaims: "Hood is dogged in his pursuit of those who would abuse and misuse scientific discoveries and breakthroughs for their own gain. His passion and crusade is to protect the substance of science from those with nefarious motives."

The show is not always politically correct in its choice of villains. Several weeks ago, an episode aired on mercury poisoning. After looking into a few milk companies, Hood found the source was a contaminated lake -- intentionally poisoned by an environmental extremist to bring attention to the dangers of mercury. Another episode explored genetic engineering -- a scientist was doing experimental testing on a group of military soldiers which would make them kill on command, with no moral conscience to give them pause. Still another highlighted biological terrorism, this time by a group of European teenagers. who try to kill their victims in the name of Allah with biological weapons.

The most intriguing episodes have been about reproductive cloning, in which a scientist named "Geppetto" conducts cloning operations and is finally caught towards the end of the season. In every episode, Hood shows both a healthy respect for science and the ethical boundaries that must constrain scientists. Hood warns against "playing God" at a time when scientists are pushing for greater freedom to clone.

That hasn't stopped people from citing the show while cheering the Brave New World. The website "Eleventh Hour Facts" -- a project of BIO, the Biotechnology Industry organization -- is solely dedicated to discussing the "facts, the science and the real-life people portrayed on Eleventh Hour." The site declares: "The reality of biotechnology is dramatic and intense, and the discoveries that result are revolutionary. These discoveries are curing debilitating diseases, extending the lives of patients and improving quality of life." Eleventh Hour doesn't exactly contradict this, but such statements fail to capture the program's biotech caution.

Eleventh Hour's high ratings are no doubt in part at least because of Jerry Bruckheimer's magic touch. The man helped make hits out of CSI and Without Trace. The star producer's involvement could also explain Eleventh Hour's conservative tilt: Bruckheimer is a conservative who supported President George W. Bush, donated to John McCain's campaign, and has regularly given money to other GOP candidates. The subtle conservatism of his new project may be his latest contribution.

iPS Cell Breakthrough? No cancer in induced stem cell

Bloomberg has the story here.

From USA Today:

Stem-cell lookalikes may end controversy

Stem cell researchers have created embryonic-cell lookalikes that don't have the cancer-causing genes found in earlier experiments.

The team led by University of Wisconsin researcher James Thomson Thursday released a study showing how it changed skin cells into "induced pluripotent" cells by adding growth genes that disappear after the new cells reproduce. Induced pluripotent cells can turn into all types of tissue, raising hopes that they can one day be used to create organ replacements, but they lack the controversy surrounding similarly-capable human embryonic stem cells. Embryos are destroyed in harvesting those cells.

Stem cell researcher George Daley of Children's Hospital in Boston called the new study "a beautiful and important contribution." The study will be published in today's Science journal.

NCBC taps Brooks Adams to lead Center of Innovation in Nanobiotechnology

From Biotech Transfer Week

The North Carolina Biotechnology Center said recently that Brooks Adams will be the executive director of the Center of Innovation in Nanobiotechnology when it is formally launched later this year.

Adams, who has worked for 14 years in innovation management in the life sciences, will be charged with creating a business plan for COIN, the formation of which was announced by NCBC earlier this year to coordinate North Carolina research leading to commercial opportunities in nanobiotechnology.

NCBC said that Adams has worked in global business development and marketing with several undisclosed multinational and startup companies, and has worked on commercialization of products in the areas of nano-aerosols for drug delivery, gene arrays, and DNA diagnostics.

VA Ranks 28th in Percentage of Federal $ in State Research Funding

According to SSTI, NSF reports that Virginia ranks 28th in the percentage of state research dollars derived from Federal funds. Virginia's total academic research expenditures in 2007 were $972 million, nearly 60% of which came from Federal sources.

From SSTI: Total R&D Expenditures at Universities and Colleges
The National Science Foundation has made available the FY 2007 version of its Academic Research and Development Expenditures statistical tables. The release contains detailed information on research expenditures at individual academic institutions.

SSTI has prepared a table that shows for each state the amount of R&D expenditures from 2003 to 2007, the percent change and relative rank over this period, the percentage of each state's expenditures that originate from the federal government, and the relative rank of this percentage.

California led the nation with $6.7 billion in expenditures at its universities and colleges, followed by New York and Texas with $3.9 billion and $3.4 billion respectively. Maryland, Massachusetts, and Pennsylvania were in the $2 billion to $3 billion range in FY07, while six states - Illinois, Ohio, Michigan, Florida, Georgia, Wisconsin - had amounts larger than $1 billion. Fifteen states had amounts lower than $300 million.

From 2003-2007, the U.S. saw a 23.3 percent increase. Maine experienced the largest five-year jump greatly exceeding the national average, rising by 63.7 percent to $137 million in FY07. Four other states - South Dakota, Hawaii, Ohio, North Carolina - increased by more than 35 percent from 2003 to 2007. No states witnessed a decrease in expenditures over that time.

Vermont, Colorado, Hawaii, Massachusetts, as well as the District of Columbia received more than 75 percent of their academic R&D funding from the federal government in FY07. On the other end of the spectrum, Wyoming had only 32 percent come from federal funds. Nevada, South Carolina, Arkansas, and Oklahoma round out the five states with the lowest percentages of their academic R&D expenditures from the federal government.

Other sources of academic R&D expenditures in the tables come from state and local governments, industry, and the institutions themselves.

The chart is available at: http://www.ssti.org/Digest/Tables/032509at.htm

Academic Research and Development Expenditures: Fiscal Year 2007 is available at: http://www.nsf.gov/statistics/nsf09303/?govDel=USNSF_178

$6M Maryland Biotech Tax Credit Faces the Ax, as State Lawmakers Plug Budget Shortfalls

From BioRegion News

The state's $6 million biotechnology tax credit may be cut or eliminated entirely by legislators seeking ways to further trim the budget, a Tech Council of Maryland official told Maryland Community Newspapers
.
Richard Zakour, executive director of the TCM's MdBio division, has circulated a letter to biotech executives and others urging them to contact legislators to request that the program not be cut: "This is an invaluable incentive for Maryland's biotech business community and provides access to capital at a time when Maryland needs to be encouraging our most innovative companies," Zakour wrote.

Zakour and other biotech executives sought earlier this year to double the tax credit to $12 million, as Gov. Martin O'Malley originally said he would do, before the economic upheaval that has reduced state revenues.

Concern over a cut to the biotech tax credit was heightened earlier this month when the state Board of Revenue Estimates adopted revised estimates projecting that state revenues will fall $445.5 million short of forecasts this fiscal year, and $716.5 million short in fiscal 2010, which begins July 1.

The first-come, first-served program allows investors in Maryland biotechnology companies to take a 50 percent credit against state income taxes. The company must be headquartered in Maryland, have fewer than 50 employees, and have been in business less than 12 years.

On the first day applications were taken last July, some biotech executives camped out in front of the doors to the Maryland Department of Business and Economic Development, to make sure they would obtain their share of the credits — which ran out on that first day, with $8.5 million worth requested by local biotechs in applications, officials said.

Burrill Report: VA "Road Map" for Biotech Econ Dev Policy in Downturn

Great article from Burrill on the VaBIO bills passing the VA Legislature.

A Boost for Biotech


March 20, 2009

Legislative approach by Virginia Biotechnology Association may offer roadmap for others.

The Virginia General Assembly has given a boost to the state’s life sciences industry by passing a bioscience bill that provides tax credits, grants, and loans that could help expand the industry there. The bill, which now goes to Governor Tim Kaine for his signature, will initially offer modest funding—a potential $4 million in the current fiscal year—but could be worth several times that once the economy improves.

Despite the modest investment the legislation represents, industry representatives view its passage as a significant victory given the current recession. The legislature passed the bill in the face of a $4-billion deficit. It also comes as several other states, such as Maryland and Massachusetts, are seeing recent economic development initiatives aimed at stimulating growth of the life sciences sector being threatened as they scramble to find ways to close budget gaps during the economic downturn.

“While Virginia in the grand scheme of things was not a giant sum of money, it was a clear indication from a legislature in a very challenging fiscal situation that the biotech and bioscience community is a key growth industry for that state,” says Patrick Kelly, vice president of state government relations for the Biotechnology Industry Organization. “That being said, obviously Virginia like many other states is facing significant fiscal challenges. Some states are actually looking at rescinding previously enacted legislation to try to close budget gaps. That’s something that obviously we are very concerned about.”

The Virginia Biotechnology Association, which pushed for the legislation, followed a strategy that emerged at a meeting in the Fall of the Council of State Biosciences Associations, an organization of state-level biotechnology trade groups. The group sought to determine how best to work with state legislatures in the down economy and struck upon the idea of focusing on existing programs already on the books and refining them to better promote the life sciences.

“The key is we were not asking for any new, additional state resources,” says Mark Herzog, executive director of the Virginia Biotechnology Association. “What we did was we took existing programs and made the case that in this difficult economy it is important to truly hone those resources so that they produce the best results for twenty first century economic development.”

In reality, Virginia is not allocating new funds to the bioscience industry, but instead taking existing programs and given them a greater focus for the benefit of the biotechnology industry. The legislation calls for a bioscience investment tax credit, which limits the state’s existing angel investor tax credit to bioscience and other advanced technology start-ups. It also reserves up to half of the available credit to start-ups created with technology spun out of the state’s universities.

In addition, the legislation provides matching funds for Small Business Innovation Research grants and Small Business Technology Transfer awards. To be eligible, companies must employ fewer than 12 full-time employees (more than half must be in Virginia) and more than half of the applicant’s property must also be located in the Commonwealth. Last, provides a construction loan program for facilities used in commercializing qualified research, such as wet labs in research parks or at universities. Both of those programs will be funded out of the state’s existing Commonwealth Technology Research Fund.

Mitch Horowitz, vice president and managing director of Battelle Technology Partnership Practice, a non profit R&D organization that in conjunction with the trade group BIO produces a regular report on state bioscience initiatives, says states are slowing down their investments. “Commitments are still there,” he says, “I just think it takes a longer time for these commitments to play out.”

But others are concerned that the downturn will do more than just slow or undo state commitments to spur growth of the industry. They fear officials will take more draconian steps to close state budget gaps that hurt the broader business environment and harm the growth of the industry. Matt Gardner, president and CEO of the Northern California biotechnology association BayBio, says with more than a $40-billion budget gap in the Golden State, across-the-board cuts are likely to spread the pain. But he’s worried about “knee-jerk reactions” to impose fees and taxes that hurt the industry, particularly at a time where many companies are at a point of commercializing their pipelines and making decision about long-term investment in facilities.

“When a state goes through something like this and changes its business taxation or increases fees, it is a turn for the worse,” says Gardner. “Some of those opportunities to capture downstream investment for some companies that have been here for three decades are only going to come once. If we miss them now, we may not get them back.”

For the most part, the trade group BIO sees the current year as one which the industry will be playing defense. Rather than worry about winning new economic incentives for the industry, the organization says it expects to spend much of its time protecting what has been won in recent years.

“What Virginia did may well be a model, but I think from BIO’s perspective, we don’t expect to go into many of state legislatures and expect a whole lot of help on the economic development front,” says BIO’s Kelly. “We’re trying to make sure we preserve the commitments that have been made in the last several years.”

NC Biotech to Launch Medical Device Center

N.C. Biotechnology Center issues $2.5M grant to launch medical device program
Triangle Business Journal

The North Carolina Biotechnology Center will pay out $2.5 million over four years to establish a new program to grow the state’s medical devices sector.

The Biotech Center, a nonprofit, state-supported institution, says the grant will establish what’s known as a Center of Innovation for advanced medical technologies in North Carolina.

The proposed center isn’t a physical site. Rather, it will include a team that focuses specifically on growing the advanced medical technologies sector.

Activities will include outreach to hospitals, work on improving inventors’ access to possible sources of funding and business advice, and collaboration with economic development groups.

“North Carolina is already home to a promising and robust cluster of advanced medical technologies companies,” says J. Greg Davis, president and CEO of Tryton Medical in Durham, who led the planning for the new center. “Our state’s strengths in biotechnology, information technology, regenerative medicine, medical devices and other technological disciplines provide us with an ideal opportunity to promote future economic growth based on the convergence of existing medical technologies with these complementary innovation assets.”

The Biotechnology Center is looking for a founding president for the new center.

When the program launched in May, the Biotech Center says, it plans on receiving matching grants. Private donations, conference sponsorships and other revenue streams eventually will replace the Biotechnology Center grant.

Novozymes Predicts $0.50 Per Gallon Biofuel in 2010

Novozymes, a leading industrial biotechnology company with a major facility in Salem, Virginia, projects cellulosic ethanol enzyme costs as low as $0.50 per gallon by 2010.

At World Biofuels Markets, Novozymes global marketing manager Cindy Bryant credited the company?s Cellic enzyme product family for ?achieving the best cost/performance ratio seen so far? and helping to enable cellulosic ethanol pioneers to make CE a reality. Bryant said that Cellic had a wide versatility proven on different feedstocks and processes, and that the company expects enzyme costs for cellulosic ethanol to come down to the $0.50-$1.50 per gallon range by 2010, down from $2.00-$4.75 per gallon in 2007.

Jim Lane

Mar. 17, 2009 (Biofuels Digest delivered by Newstex) --

BIO Applauds Bipartisan FOBs Bill

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding H.R. 1548, the Pathway to Biosimilars Act, introduced today by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton (R-TX) that would develop a regulatory pathway for approving biosimilars, medicines which are similar to pioneering biomedical therapies and treatments:

“The legislation introduced today by Representatives Eshoo, Inslee and Barton bill lays out an effective, reasonable and safe pathway to biosimilars. It is the right medicine for lowering costs, ensuring patient safety and providing fair, responsible incentives for continued biotech research into cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS. In short, the bill provides patients with the right balance between innovation and competition.

“This bill will lead to real solutions for our nation’s health care challenges and provide real hope for patients. It will help reduce costs by enabling additional competition among biologics but at the same time help safeguard patient safety by requiring demonstration of the purity, safety and effectiveness of biosimilars. More, the bill includes the incentives necessary for biotechnology researchers to develop new breakthrough therapies and potential cures.

“The Eshoo-Inslee-Barton bill establishes parity with the outcomes of the Hatch-Waxman regime developed for traditional pharmaceuticals, balancing the need to increase access, lower costs, ensure drug safety and promote continued biomedical breakthroughs. At the same time, the bill recognizes the fundamental differences between biologics and traditional pharmaceuticals. Traditional pharmaceuticals are produced by machines and are relatively simple for generics makers to copy. Innovative biologics, on the other hand, are grown from living cells and are so molecularly complex that current science does not allow for an exact copy to be made, as the Food and Drug Administration (FDA) has recognized. The fact that the medications are different calls for a slightly different set of rules around safety and competition incentives to achieve the same goals.

“BIO commends Reps. Eshoo, Inslee and Barton for their continued efforts to establish a pathway for the development and approval of biosimilars. We are pleased to join them, their 35 additional Congressional co-sponsors, and a diverse array of patient, physician and other organizations in announcing our support for this legislation. We look forward to working with the Congress as they consider this balanced, landmark bill.”

VBRP Named Example Of "Major Biotech Superstar"

3/14/2009
By Matthew Stolle
Post-Bulletin, Rochester MN

So you want to start your own biotechnology park?

The group of investors and entrepreneurs behind efforts to build the Elk Run biotech project have yet to reveal all of what is on their drawing board, but the announcement of a venture capitalist company, Burrill & Co., now in the mix, it appears that the biotechnology park 15 miles north of Rochester will be moving ahead.

Not a lot is known about what will happen next. But we do know one thing: The landscape is littered with start-up causalities and biotech wannabes.

Biotech experts point to at least three main ingredients needed to create a major biotech superstar, say, like Virginia's Biotechnology Research Park, which has 2,000 scientists, researchers, engineers and technicians housed on a 32-acre downtown campus.

"The thing about biotech parks is that there is a long time to market. It's not like they form and next day they're kicking out product. But what they do is they form and begin to create jobs," said Dale Wahlstrom, CEO of the BioBusiness Alliance of Minnesota, an organization that promotes bioscience-based businesses in the state.

One key component is access to collaborative, leading-edge academic institutions. Research Triangle Park in North Carolina, for example, is located within a half-hour's drive of three major academic institutions -- the University of North Carolina, Duke University and North Carolina State University. The University of Minnesota and Mayo Clinic would both fit the bill in Elk Run's case.

"You need to have access to academia, because there are certain fundamental skills and infrastructure that typically you can only get from an academic sector," Wahlstrom said.

The second ingredient is what Wahlstrom calls "domain knowledge." These are people, primarily in the private sector and academia, who have extensive know-how and understanding of the industries that the park is focused on.

Two areas in which Minnesota has an "unbelievable amount of domain knowledge" are medical devices and renewable energy.

And last but not least is an acceptable business environment, a term which covers a full range of financial issues ranging from tax policy to loan programs and venture capital.

Investment element

A critical piece of the biotech park puzzle appears to have fallen into place when San Francisco investor Steve Burrill agreed to put as much as $900 million toward funding firms for the planned development in Pine Island. Combined with the money developer Tower Investments says it is investing into the project, that brings to $1 billion the amount people say is being committed to the project.

Burrill is no stranger to Minnesota. The venture capitalist was the commencement speaker for the University of Minnesota's College of Biological Sciences last spring. Robert Elde, dean of the U's biological sciences college, calls Burrill, a "person of substance" and a "very big player," who has been involved since the dawn of the biotech industry.

"He's from Wisconsin originally, and he's been dying to get something going in the Upper Midwest, and he really believes this is the next place for things to happen," Elde said.

Elde said the biotech revolution in many ways resembles the technology revolution in which search engine and social networking companies were engaged in a mad scramble for commercial supremacy.

Like the tech shakeout, the biotech industry has had its fair share of start-up companies fall by the way side. Oftentimes, they fail because they run out of cash.

The significance of Burrill's involvement is that it "dramatically increases the number of times that the roulette wheel can be spun," Elde said. "There are going to be a lot of them, and that kind of money will really galvanize the competition to get that money."

Mayo's proximity

Biotech experts say that proximity to Mayo Clinic was no doubt a factor in the location of the proposed Elk Run. Mayo has indicated it could participate in the venture, but has not signed any deal with Tower.

Mayo Clinic declined to make Eric Wieben, the program director for the Minnesota Partnership for Biotechnology and Medical Genomics, the partnership forged between Mayo and the University of Minnesota, available for comment.

Biotech experts at the U said they were intrigued with the site near Pine Island, noting that the location was closer to Mayo than the Twin Cities.

"In a certain sense, it's an open field down there, literally and figuratively," Elde said.

One expert wondered whether it might be too far off the beaten track.

"It's like trying to strike a compromise, making it halfway," said Marc von Keitz, director of the Biotechnology Institute in the Twin Cities. "It might be too far away. Again, I'm not familiar enough with the geography, but it would definitely be a concern that I have."

Experts say Minnesota has been in "catch-up" mode in the biotech race, but they said the Elk Run project has the potential to be a game-changer.

"We're not a very big player yet, yet something like this ... It's hard to imagine how we would get to be a big player without something big happening. And this, in my judgment, is something big that could help us move in that direction," Elde said.

http://news.postbulletin.com/newsmanager/templates/localnews_story.asp?z=7&a=389893

US Lawmakers Propose Generic Biotech Drug Plan

* Would pave way for cheaper copies of biotech drugs

* Generic biotech drugs could save govt, patients money

* Brand-name makers say measure jeopardizes new treatments (Adds industry, lawmaker, analyst comments)

By Lisa Richwine

WASHINGTON, March 11 (Reuters) - U.S. lawmakers unveiled a bipartisan proposal on Wednesday to allow government approval for cheaper copies of biotechnology medicines that cost as much as tens of thousands of dollars per year.

Representative Henry Waxman, joined by a Democratic colleague and two Republicans, said biotech drugs were the fastest-growing and most expensive part of the nation's prescription drug bill. Generic versions could provide safe alternatives while saving money for patients, employers, insurers and the federal government, the lawmakers said.

If the measure becomes law, it would open a vast new market for generic drugmakers such as Teva Pharmaceutical Industries Ltd (TEVA.TA) and Mylan Inc (MYL.O) and lead to competition for brand-name biotechnology companies.

Biotech drugs, or biologics, are man-made forms of human proteins and tougher to produce than traditional medicines.

They are typically injected and treat conditions ranging from anemia and rheumatoid arthritis to cancer. Examples include Genentech Inc's (DNA.N) Herceptin and Avastin cancer treatments, and Amgen Inc's (AMGN.O) Epogen and Aranesp anemia therapies.

The legislation would give the Food and Drug Administration authority to approve "biosimilar" drugs that are "highly similar in molecular structure" and provide no meaningful difference to patients.

Companies also could try to prove their copies were "biogeneric," or interchangeable. The first maker to show interchangeability would win six months of market exclusivity.

Similar bills died in the previous Congress, but prospects may be better now with support from President Obama and a desire to cut soaring health costs. Waxman has called the effort one of his highest priorities this year.

Brand-name biotech companies back the idea if it includes an adequate period of market exclusivity for the original products and safety protections for patients.

Waxman's measure would give original products five years of market exclusivity, and three years for modifications of existing drugs in some cases. The exclusivity prevents patent challenges during that period, and the length of time is consistent with the approach in place for chemical-based drugs.

The exclusivity could be extended by up to one year for pediatric studies or new uses, according to a summary of the legislation.

"This bill will lead to healthy competition and long-term savings for patients and payers, and will preserve innovation in the biotech marketplace," said Waxman, chairman of the House of Representatives Energy and Commerce Committee and co-author of a 1984 law that opened the door to generic competition for traditional, chemical-based drugs.

Brand-name companies, however, are pushing for 14 years of exclusivity for biotech drugs. That time is needed to entice manufacturers to develop new treatments, the companies say.

"The legislation introduced today would take patients and our industry down the wrong path - a path that jeopardizes the continued development of new breakthrough therapies and potential cures for debilitating diseases," said Jim Greenwood, president of the Biotechnology Industry Organization.

Obama called for access to generic biologics in a budget outline last month, and the authors of the new bill said their approach was consistent with the president's proposal.

The Generic Pharmaceutical Association (GPhA), an industry group for generic drugmakers, welcomed the bill. GPhA President Kathleen Jaeger said it would "save our health care system billions of dollars."

A broad range of groups and employers support the measure including seniors lobby AARP, General Motors (GM.N), the AFL-CIO labor group and others, Waxman said.

Sanford Bernstein analyst Ronny Gal said the bill was more pro-generic than an earlier version but he thought the final law would be "a lot more balanced" after lawmakers debate the exclusivity period, approval standards and other issues. (Reporting by Lisa Richwine and Susan Heavey; editing by Matthew Lewis and Tim Dobbyn)

http://www.reuters.com/article/latestCrisis/idUSN11301138

FierceBiotech: Peggy Hamburg to be FDA Commissioner

From FierceBiotech:

White House looks to foil FDA-chief debate
By Tracy Staton

The word on leadership at FDA is solidifying: The Wall Street Journal confirms with its own sources that former New York health commissioner Margaret "Peggy" Hamburg will be tapped to top the agency, while Baltimore's point man on health, Joshua Sharfstein, will be named deputy. The two-pronged appointment is designed to paint the Obama FDA as a public health agency, the sources said.

By depicting Hamburg and Sharfstein as leaders who can direct the agency back to its original public-health mission, the administration may be able to sidestep a pro-industry/anti-industry debate over the appointments. As you know, advocates for the pharma industry have been lobbying Congress for their FDA picks, while consumer groups have been lobbying for theirs. Without a strategy to forestall the pro/anti debate, an FDA pick could get caught in the crossfire.

The Journal's unnamed sources are verifying what RPM Report unearthed Monday. But there's still no official word--or named person "familiar with the matter"--on Hamburg or Sharfstein. Here's hoping we get an announcement soon.

VaBIO Joins Coalition Opposed to "Card Check"

Virginia Businesses and Industry Call on Congressional Delegation to Reject Employee Free Choice Act
“Card Check” bill would radically alter labor laws and strain employer, employee relations

Virginia’s business community is calling on the Commonwealth’s congressional delegation to oppose the Employee Free Choice Act (“EFCA”), expected to be introduced today in both the United States House of Representatives and the United States Senate.

EFCA, or “card check”, would radically alter labor laws and fuel antagonism between employers and employees. EFCA would eliminate an employee's right to a secret ballot in union elections. Just as problematic is the mandated use of federal arbitrators who can unilaterally impose the terms of a contract between a business and a newly formed union, without the approval of the employer or a vote by the employees.

Comments from Virginia Business Leaders:
Hugh Keogh, President and CEO of the Virginia Chamber of Commerce
“EFCA is a brazen attempt by organized labor to tilt the playing field in organizing efforts to favor the unions in a clear and unmistakable way. Our labor-management atmosphere in Virginia for many years has been conducive to rising productivity and largely free of work stoppages. The current economic uncertainty is hardly the time to upset that fragile apple cart.

“Where is the freedom in a piece of legislation that denies workers one of the most basic liberties, the right to a secret ballot? The secret ballot gives workers the ability to state their choice, for or against the union, without fear of intimidation or reprisal from union organizers, management, or fellow employees. By stripping away the secret ballot and replacing it with the simple checking of a card, quite likely in a public setting, EFCA eliminates the most important and cherished safeguard available to the American workers.”

Brett Vassey, President and CEO of the Virginia Manufacturers Association
"The main thrust of EFCA is fundamentally anti-democratic and will only serve to erode Virginia's right-to-work statute, productive work environment and competitiveness."

Julia Hammond, Virginia Director of the National Federation of Independent Business
“In a time of economic uncertainty for small businesses around the state, the last thing Virginia's family-owned businesses need is a federal arbitrator who knows nothing about their business, dictating the wages and benefits they must pay their employees.
“EFCA’s binding arbitration provision takes critical operational decisions away from the small business owner and places them in the hands of a federal arbitrator who is accountable to no one. A dictate from an uninformed bureaucrat cannot and should not replace the judgment of the employer and the employees who have collectively labored to ensure that the small business prospers and grows.”

Laurens Sartoris, President of the Virginia Hospital and Healthcare Association
“Hospitals throughout the Commonwealth strongly oppose EFCA. We believe that employees have the right to unionize, but we also believe employees have an equal right to reject union membership. Regardless of their individual choice, an employee must be allowed to express their preference in an environment that is free of manipulation and potential coercion. The only method that truly protects employees is the secret ballot, yet EFCA forcefully denies employees this time honored protection.”

Bobbie Kilberg, President and CEO of the Northern Virginia Technology Council
“Technology companies, perhaps more than most business ventures, rely on close collaboration between management and their employees in an innovative workplace environment. In this rapidly changing global market place, survival for technology companies depends on employees and management sitting on the same side of the table.

“From top to bottom, EFCA is designed to sow the seeds of discord within the workplace. From possible union intimidation as a result of the elimination of the secret ballot, to the loss of a company’s sovereignty as a result of mandatory binding arbitration, EFCA systematically places employees and employers in an adversarial position that can only serve to stymie innovation and limit the fortunes of employer and employee alike. In an economy as difficult as the one we currently face, our collective focus must be on building bridges between labor and management, not creating more profound divides.”

More than 20 Virginia business organizations oppose EFCA. They include:
National Federation of Independent Business
Virginia Hospital and Healthcare Association
Northern Virginia Technology Council
Virginia Ready-Mixed Concrete Association
Virginia Association of Broadcasters
Virginia Hospitality and Travel Association
Virginia Retail Federation
Virginia Chamber of Commerce
Hampton Roads Chamber of Commerce
Fairfax Chamber of Commerce
Roanoke Regional Chamber of Commerce
Harrisonburg-Rockingham Chamber of Commerce
Virginia Poultry Federation
Virginia Retail Merchants Association
Virginia Healthcare Association
Virginia Trucking Association
Virginia Manufacturers Association
Home Builders Association of Virginia
Virginia Petroleum, Convenience and Grocery Association
Virginia Biotechnology Association
Associated General Contractors

Gwathmey CEO Works to Preserve Community Culture

Judith K. Gwathmey VMD, Ph.D., FACC, FAHA has served as Chief Executive and Chief Scientific Officer of Gwathmey, Inc. for twelve years. Gwathmey, Inc. is an internationally recognized leader in providing pre-clinical testing services for evaluation of lead compounds prior to their conversion into marketable products.

Dr. Gwathmey recently embarked on a campaign with other members of the quiet rural community in Aylett, Virginia to preserve the town's rural character and natural resources (wetlands, wildlife, and water).

"Morrison LLC wants to place a motocross raceway in the middle of an agricultural and residential area. Many working folks and retired seniors who live in King William County are deeply disturbed about the environmental and community degradation the motorcycle raceway will cause. The relentless noise, the added air, water and soil pollution, and increased traffic of outsiders makes many residents very concerned about their community and their property values," says Gwathmey.

Dr. Gwathmey is working with others to raise awareness about the adverse effects the motocross raceway will cause. Dr. Gwathmey, who is on faculty at Harvard University and Boston University Medical School, is a celebrated cardiac scientist. Along with her numerous publications, she received the 2001 Presidential Mentoring Award and was recognized recently as a Hero for 2008 in Boston for providing coats and uniforms to needy students in elementary schools."

3/10/2009 from Bio-Medicine

Two Leading DC Bioscience Lawyers Leave Firms

Two especially well-known DC bioscience lawyers have left their firms in the last month.

Henry N. Wixon, formerly of WilmerHale, is now the chief counsel at the National Institute of Standards and Technology (NIST), an agency of the US Department of Commerce.

Former Foley & Lardner partner Sandy Sterrett is now at Blank Rome's office at the Watergate in DC.

Both gentlemen are long-time supporters of VaBIO, MdBio and MAVA. Best wishes to them both!

HGS Shares Crash on New Trials Data

From BusinessWeek: "Shares of drug developer Human Genome Sciences Inc. were nearly cut in half Monday as Wall Street expressed disappointment over the company's latest study results for the developing hepatitis C drug Albuferon.

Shares plunged 76 cents, or 45 percent, to 94 cents in midday trading, after earlier slumping to 80 cents, its lowest point in at least 10 years.

On Monday, the Rockville, Md.-based company said Albuferon met its treatment goal of working as well as a current drug in a late-stage study. In the study, 900-micrograms of Albuferon given every two weeks prompted a sustained response rate in 48.2 percent of patients. Meanwhile, Switzerland-based Roche's Pegasys prompted a response in 51 percent of the patients."

http://www.businessweek.com/ap/financialnews/D96QJV380.htm

NYT: VC's Attempting to Shutter Vanda Pharma?

NYT: Drug Investors Lose Patience

Mar 10, 2009
New York Times


By ANDREW POLLACK

As merger mania plays out among the pharmaceutical giants, a different sort of financial frenzy has seized some small, struggling drug makers. Investors are demanding that stragglers close up shop and hand over any remaining cash.

That is what happened to one company, Avigen, after its most promising drug failed in a clinical trial last October. Avigen said it would do what countless other biotechnology companies had done in similar circumstances: move on to the next product in its pipeline.

Not so fast, said its biggest shareholder, the Biotechnology Value Fund. The fund demanded that Avigen, after 16 years of trial and error, immediately liquidate itself and return its remaining cash to shareholders.

So much for the traditional model of patience in biotechnology investing, in which companies may burn through more than a decade and hundreds of millions of venture capital or shareholder dollars before reaching profitability — if they ever get there. Now, with cash scarce, credit tight and big drug companies like Merck intent on branching into biotechnology themselves, struggling start-ups may no longer get second and third chances to succeed.

In at least eight cases in the last year, anxious investors have tried to block an unsuccessful biotech company’s quest for the next blockbuster, and have fought with management for control of the corporate carcass. The investors argue that the remaining cash belongs to them and that they — not a losing company’s executives — should decide how to invest it.

Some companies, including Avigen, are fighting back. “I hear that argument” about shareholder rights, said Kenneth G. Chahine, Avigen’s chief. “But it’s really ‘I want to raid the cash.’ We’re back to 1987 and ‘Barbarians at the Gate.’ ”

Such battles have become much more common in recent months, as the stock market crash has pounded the value of many biotech companies to less than the cash on hand. When that happens, investors can realize an immediate return if the company dissolves itself — even if some of the cash will be consumed in closing the company.

In some cases, investors are succeeding. Under pressure from the hedge fund RA Capital Management, for example, Northstar Neuroscience, a medical device company in Seattle whose stroke treatment failed, is proposing to liquidate, with shareholders receiving an estimated $1.90 to $2.10 a share in cash. The company’s stock, which had been as low as 90 cents in November, closed at $1.90 on Monday.

Another company, Trimeris, whose only product, the AIDS drug Fuzeon, has lost sales to newer competitors, halted research and development last year and repaid $55 million — or $2.50 a share — to stockholders. The company continues in business, but with few employees.

And two companies, VaxGen and NitroMed, have canceled planned reverse mergers because of shareholder opposition. In a reverse merger, a publicly traded company essentially cedes its cash and stock listing to a private company with presumably better prospects.

For every Gilead Sciences, which spent $450 million over 15 years and abandoned its original technology before becoming profitable, there have been countless “zombies” — companies that lurch from product to product, surviving years or even decades without ever achieving success.

One company so tarred, by one of its biggest investors, is Penwest Pharmaceuticals.

“The company’s history is an unfortunate progression of failed development programs,” Perceptive Advisors, an investor in the company, wrote in November to Penwest’s board. Perceptive demanded that Penwest cease all research and development and become a virtual company that would just collect royalties on its one successful drug. Penwest defended its track record and said it was sticking to its course.

Some investors say that with capital markets now so tight, the walking dead should be buried to free up financing for more viable companies. “It’s in a time like this that the good companies are being dragged down by the bad ones,” said Oleg Nodelman, a portfolio manager at the Biotechnology Value Fund.

In some cases, however, the investors asking for their money back are not long-suffering shareholders. They are speculators who bought in only after the stock price collapsed, hoping to make a quick killing.

Tang Capital Partners, for instance, began accumulating its 14.9 percent stake in Vanda Pharmaceuticals only after the Food and Drug Administration rejected Vanda’s schizophrenia drug in July. Tang is now pressing for the company to cease all operations and return cash to shareholders. Vanda’s stock is trading at 80 cents, well below the $1.74 a share in cash it had as of Dec. 31.

Vanda says that it is still hopeful that it can get its drug approved and that liquidation is not in the interest of all shareholders.

The Biotechnology Value Fund, often called BVF, was a longtime shareholder in Avigen. But it sold 640,000 shares, nearly all its holdings, for about $3.95 to $4.60 a share. The sale was near the stock’s highs for the year — in the two months before Avigen was scheduled to announce, in October, the clinical trial results of its drug to treat a symptom of multiple sclerosis.

After the drug failed, BVF swooped in and bought more than eight million shares, nearly a 30 percent stake, at about 58 cents a share. That was well below Avigen’s cash total of about $1.90 a share at the time.

BVF has made a $1-a-share tender offer for Avigen and is trying to replace the directors. If it gains control, it could liquidate Avigen or sell it to MediciNova, which has said it wants to buy it. Mr. Chahine, the chief of Avigen, which is based in Alameda, Calif., said its assets might be parlayed into a deal that would be worth more than BVF or MediciNova would pay and more than the liquidation value. “All we’re saying is, give us an opportunity to canvass the field, see what’s out there and bring something to the shareholders,” he said.

But Mr. Nodelman said such a process might eat up the company’s remaining cash. “Someone’s got to police the space,” he said. “We’re making sure that the last $50 million in the company don’t go to the bankers and the consultants and the golden parachutes.”

BVF, which specializes in smaller biotech companies, has become the most outspoken investor pressing for its money back. The fund, based in San Francisco, gets about half of its capital from the Ziff family, which made its fortune in magazine publishing.

Mr. Nodelman makes no apologies for BVF’s having bought Avigen stock again after the collapse. The fund is also pressing for a cash-out to shareholders from CombinatoRx. BVF has been a continuous shareholder in the company, although it added to its stake after some CombinatoRx clinical trials failed.

CombinatoRx, whose strategy is to combine two old drugs to make one new one, has lost $236 million since its inception in 2000. The company has about $1.45 a share in cash, but its stock is trading for only 66 cents.

Alexis Borisy, the chief executive, said the company, based in Cambridge, Mass., was not ready for the grave. “We obviously think there’s a lot of upside value in the CombinatoRx technology,” he said.

BVF and CombinatoRx are now in confidential discussions about the company’s future.

BVF is also one of four investors, which collectively own about two-thirds of the shares, demanding money back from Neurobiological Technologies of Emeryville, Calif.

The company’s stroke drug is derived from the venom of the Malayan pit viper. Three of the investors, including BVF, were shareholders when that drug failed in a clinical trial in December. The fourth bought in after the failure. The stock now trades at 58 cents, but its liquidation value would be as high as $1 a share.

Matthew Loar, the chief financial officer, said the company was sympathetic to the requests but had not yet decided what to do. In any case, he said, it could not act as fast as the investors want.

“You can’t just turn off the lights in a company in a day,” he said. Among other things, the company must figure out what to do with 1,000 poisonous snakes, he said. “We’re going to get rid of them in the most expeditious, reasonable way possible.”

WSJ: Drug-Industry Shakeout Hits Small Firms Hard

Mar 10, 2009
Wall Street Journal


By AVERY JOHNSON and RON WINSLOW

Drug makers have begun a frenzied consolidation drive that is redrawing the industry landscape.

Merck & Co.'s $41.1 billion agreement to acquire Schering-Plough Corp., announced Monday, follows Pfizer Inc.'s $68 billion January takeover deal for Wyeth. Roche Holding AG's seven-month pursuit of Genentech Inc. was also nearing an agreement Monday, according to people familiar with the situation.

The push to consolidate is being driven by the knowledge that the big companies' pipelines aren't producing enough new moneymakers to keep growth going when major products lose patent protection over the next couple of years. As a result, the drug giants are looking to consolidations that will cut costs by combining research and sales efforts and eliminating other overlaps.

What will be left is an industry dominated by behemoths, raising questions about the fates of smaller drug companies, as well as the countless small biotechs hungry for suitors. Even though their labs aren't what they used to be, the major pharmaceutical companies have product lineups that still command fat margins, giving most of them the cash to pursue deals.

"There are too many companies chasing smaller revenue opportunities, so there's got to be a shakeout," says analyst Tim Anderson at Sanford C. Bernstein & Co. "If you've got cash and the value of the companies you want to buy is lower, it's the perfect setup."

There could also be pressure tied to moves in Washington, where health-care reform could eat into margins. Bigger drug companies might be in a better position to bundle their products and negotiate with the government, analysts say.

The wreckage on Wall Street is also a factor: The health-care sector is traditionally viewed as a relatively safe bet, making it easier for drug companies to get financing than other industries.

But megadeals haven't cured industry problems in the past. Pfizer paid $116 billion for Warner-Lambert in 2000 and an additional $54 billion for Pharmacia in 2003, yet still needed to acquire Wyeth this year to help replenish an anemic pipeline.

As the dust settles, Eli Lilly & Co., Bristol-Myers Squibb Co., AstraZeneca PLC, Sanofi-Aventis SA and Johnson & Johnson seem most likely to be involved in the next wave of consolidation, analysts say. Factors including existing partnerships, the timing of patent expirations and how well drug makers can absorb multiple acquisitions could affect who will be a buyer and who will be a seller.

"Bristol and Lilly stand out in terms of size versus the rest of the industry," says Les Funtleyder, an industry analyst at Miller Tabak. "They'll have to do something, because it's a consolidating industry."

Lilly, based in Indianapolis with a market capitalization of $32 billion, will lose patent protection on its bestselling antipsychotic Zyprexa in 2011. It just bought ImClone for $6.5 billion. Mr. Anderson suggests it could merge with Bristol-Myers, whose chief executive, James Cornelius, came from Lilly.

Lilly, which has strong ties to Indiana and an undesirable series of patent losses coming up, would be more likely to buy than sell. "There's no way Lilly's a takeout," says Mr. Anderson.

Mark Taylor, a Lilly spokesman, says, "We're not interested in large-scale M&A activity in pharma and believe small and medium scale acquisitions, licensing and internal development" are the best way forward for Lilly.

Bristol-Myers faces a similar dilemma, because Plavix, the bloodthinner it sells with Sanofi-Aventis, faces generic competition in 2011. A merger with Lilly could face antitrust hurdles because both companies have clotting drugs and antipsychotics. A tie-up with Sanofi-Aventis is frequently rumored because of Plavix.

Bristol-Myers sold its ConvaTec wound-care business last May for $4.1 billion and offered a $720 million partial initial public offering for its nutritional business last month -- divestitures that could either add to its war chest for deals or make it a more attractive takeover target. Bristol-Myers declined to comment.

Sanofi-Aventis's new chief executive, Christopher Viehbacher, said in an interview last week that he isn't seeking a megamerger but would consider deals of under $19 billion. Some analysts say that could leave Sanofi-Aventis open to buying the U.S. biotech company Biogen Idec Inc., which has a market value of $13.3 billion. Both companies have declined to comment.

Another possibility for Bristol-Myers could be a deal with Britain's AstraZeneca because the companies are co-developing a drug for diabetes called saxagliptin. One rationale for the combination of Merck and Schering-Plough is to run the companies' joint venture selling the cholesterol medicines Vytorin and Zetia under one roof. AstraZeneca declined to comment, but has said in the past it's not interested in big deals.

Catherine Arnold, a drug-industry analyst at Credit Suisse, says that hasn't stopped companies in the past. "Sanofi, Glaxo and Novartis have said they're not interested in big deals, but Jeff Kindler said that nine months ago," she said, referring to a statement in March 2008 by Pfizer's chief executive that he did not see a megamerger on the horizon.

Meantime, 180, or 45%, of publicly traded biotech companies have less than a year of cash on hand, and about half are trading below $1 a share, according to BIO, the trade group for the biotechnology industry based in Washington.

But biotech acquisitions aren't a panacea. One reason is that small companies offer little opportunity for cost savings. Another is the worry that founders and scientists will leave if their companies are taken over.

In the interview last week, Mr. Viehbacher indicated his preferred strategy would be to enter partnerships with biotech companies rather than acquire them. "You don't want to bring them in to the mother ship because then you ruin it," he said.

The severe funding crunch facing small biotech companies is prompting worries that important new drugs won't make it to market, impeding the progress of medicine. "Innovation has been on the biotech side, but now the money is gone," says Edward Saltzman, president of industry consultant DefinedHealth. "We're in a pickle."

Meanwhile, the next target could actually be Schering-Plough. Johnson & Johnson, an historically acquisitive company, could throw a wrench in Merck's plan by making a more attractive offer for Schering. J&J sells Remicade, an anti-inflammatory drug, with Schering-Plough, and a deal for the company could give it full rights to the drug.

--Jeanne Whalen contributed to this article.

BIO Statement Connects IP Law and FDA Staffing to Stem Cell Change

BIO President Jim Greenwood notes that there is so much more to the bioscience industry than just hESC research. IP protection, commercialization and FDA staffing are key factors that Congress must not overlook. Here is his key quote:

"And for biotechnology companies to succeed, we need to ensure that we have public policies in place which encourage innovation by protecting intellectual property, fully funding and appropriately staffing the Food and Drug Administration, and providing adequate reimbursement.”


WASHINGTON, D.C. (March 9, 2009) – The Biotechnology Industry Organization (BIO) lauded President Barack Obama’s Executive Order to allow the National Institutes of Health (NIH) to fund research using embryonic stem cells. The NIH was previously able to fund research only on a very limited number of stem cell lines.

“We fully support and are enthusiastic about President Obama’s decision to allow the NIH to fund embryonic stem cell research,” said Jim Greenwood, president and CEO of BIO. “BIO believes that research on both adult and embryonic stem cells holds great promise to produce new therapies and possibly cures for the millions of patients in the U.S. and around the world suffering from cancer, diabetes, Alzheimer’s, Parkinson’s, spinal cord injuries and other life-threatening diseases and conditions.”

Embryonic stem cell research will also further the development of cell-based therapies by leading to greater scientific understanding of cell differentiation (the process by which cells become specialized to perform certain functions) and proliferation (the process by which cells expand or multiply for controlled use as a potential therapeutic).

“Today’s action to expand NIH funding of stem cell research is a welcome and critical step. But it is only the first step in a very long and complex process to move from the promise of research to the reality of new therapies and cures for patients,” continued Greenwood. “To fulfill this promise, we need the advanced research capabilities and product development expertise of biotechnology companies. And for biotechnology companies to succeed, we need to ensure that we have public policies in place which encourage innovation by protecting intellectual property, fully funding and appropriately staffing the Food and Drug Administration, and providing adequate reimbursement.”

“We look forward to working with Congress and the Administration to develop public policies that enable our industry to turn the hope of basic research to the reality of cures and advanced therapies,” Greenwood concluded.

Hi-Tech Pharmacal Acquires ECR Pharma

Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today the signing of a definitive agreement under which Hi-Tech acquired the assets of ECR Pharmaceuticals, a privately held branded specialty pharmaceutical company for $5.1 million in an all-cash transaction, which will be paid over an eight month period. Additionally, Hi-Tech may pay up to $4.0 million in performance incentives tied to future ECR product sales and profits. Under the terms of the acquisition Hi-Tech receives rights to ECR’s product line, including branded prescription products for the treatment of allergy, headache and dermatitis/poison ivy. ECR Pharmaceuticals has 45 sales representatives promoting products to physicians and pharmacists in 12 mid-Atlantic and southern states. ECR had net sales of $13.2 million and operating income of $2.0 million in calendar 2008. The company will continue to operate under the name ECR Pharmaceuticals.
“This acquisition allows Hi-Tech to capitalize on ECR’s growing sales, and brings experienced management with a successful track-record developing new products,“ said David Seltzer, President and CEO of Hi-Tech Pharmacal. “The addition of ECR makes Hi-Tech a more diverse and flexible company, as we have an additional outlet to market differentiated products currently in development. We believe that the ECR acquisition will be earnings accretive and cash flow positive in the near term, and contribute to the Company’s long term growth.”
Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded products. The Company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products. The Company's Health Care Products Division is a leading developer and marketer of branded prescription and OTC products for the diabetes marketplace.