MD To Open Two Biotech Centers and Increase Venture Funding

Thursday, May 21, 2009, 9:30am
O’Malley: Maryland’s biotech strategy to get funding boost
Baltimore Business Journal - by Julekha Dash Staff

Maryland plans to increase funding for the Maryland Venture Fund and a biotechnology tax credit to boost the state’s $29 billion life sciences industry.

Gov. Martin O’Malley unveiled a more detailed version of the state’s 10-year, $1.3 billion strategy Wednesday afternoon at the BIO 2009 Convention in Atlanta. The convention attracted more than 400 attendees from Maryland, including a delegation of 30 Maryland bioscience companies. State officials and biotech executives made the trip with the hopes of landing new biotech companies for Baltimore and getting investors that have been scarce since the downturn.

Offering access to capital is a key piece of the state’s Bio 2020 plan.

The roadmap includes increasing the Maryland Venture Fund from $2 million to $24 million by 2020 and raising the biotech tax credit from $6 million to $24 million by 2020.

On Monday, O’Malley said the state will open two biotechnology centers in Rockville and Baltimore in the next 30 days. Other features of the Bio 2020 plan include:

• Establishing a bioscience commercialization institute that can help speed up drug discoveries;

• Creating a venture capital trust with $10 million in seed capital;

• Branding Maryland as a leader in the biotech industry;

• Providing loans of up to $5 million to bioscience companies that are in the later stages of product development;

• Increasing funding for technology transfer initiatives at research universities.

The proposals were made at the recommendation of a 15-member life sciences advisory board, which solicited input from more than 100 industry experts to devise the plan.

Insmed's Drug Focus of Moving ALS Story in NYT

Very moving story about a mother's fight to get the right to use Iplex in the care of her son suffering from Lou Gehrig's disease.

May 17, 2009
Months to Live
Fighting for a Last Chance at Life
By AMY HARMON

VIRGINIA BEACH — As Lou Gehrig’s disease sapped Joshua Thompson of his ability to move and speak last fall, he consistently summoned one question from within the prison of his own body. “Iplex,” he asked, in a whisper that pierced his mother’s heart. “When?”

Iplex had never been tested in people with amyotrophic lateral sclerosis, the formal name for the fatal disease that had struck Joshua, 34, in late 2006. Developed for a different condition and banished from the market by a patent dispute, it was not for sale to the public anywhere in the world.

But Kathy Thompson had vowed to get it for her son. On the Internet, she had found enthusiastic reviews from A.L.S. patients who had finagled a prescription for Iplex when it was available, along with speculation by leading researchers as to why it might slow the progressive paralysis that marks the disease. And for months, as she begged and bullied biotechnology companies, members of Congress, Italian doctors and federal drug regulators, she answered Joshua the same way:

“Soon,” she said. “Soon.”

At a time when terminally ill patients have more access to medical research than ever before, and perhaps a deeper conviction in its ability to cure them, many are campaigning for the chance to be treated with drugs whose safety and effectiveness is not yet known.

But even as advances in areas like stem cells and genetics generate greater hope for experimental therapies, there is little consensus on how and when to provide them to dying patients whose lives could be prolonged, or shortened, by trying them.

Insurance companies typically do not pay for drugs that are part of a not-quite-finished scientific process. But even affluent families like the Thompsons find themselves pleading simply for the right to buy a drug, with institutions and individuals that often seem to them to have no logic — and sometimes no heart.

Doctors worry about instilling false hope and doing unnecessary harm. Companies fear damaging a drug’s chance of winning approval from the Food and Drug Administration if a patient suffers a bad reaction. The F.D.A. itself does not want patients to bypass clinical trials, which require that some participants receive a placebo to determine reliably whether a drug works.

Some patient advocates are lobbying for laws and policies that would sanction what has become known as the “compassionate use” of experimental drugs by seriously ill patients who have run out of other options. But for now, each appeal to the guardians of untested drugs is an improvisation, in which success relies on connections, determination, mercy and luck, and the hope of prevailing can sometimes eclipse the hope held out for the drug itself.

The Search for a Treatment

Kathy discovered Iplex deep in the pages of her first Google search for “A.L.S. and treatment” late one night in spring 2007, shortly after Joshua’s diagnosis.

In the daylight, she still had trouble believing that her athletic, magnetic son had the devastating disease with an unknown cause, named for the 1930s New York Yankees star whose career was cut short by it. When Joshua’s racquetball racket flew out of his hand because he could not grip it, his mother’s diagnosis was tennis elbow. When the first neurologist mentioned A.L.S., she scheduled more tests, rooting for Lyme’s disease, multiple sclerosis or even cancer.

But an A.L.S. specialist at Johns Hopkins University, Dr. Jeffrey D. Rothstein, had confirmed it. Like the 5,600 other people given the diagnosis each year in the United States, Dr. Rothstein said, Joshua would almost certainly die of the disease in two to five years.

The doctor prescribed the only drug approved for A.L.S., Rilutek, which typically prolongs life by a few months. Joshua, he said, would be eligible to participate in a clinical trial for another drug, Arimoclomol, that would start as soon as the F.D.A. gave the go-ahead. There was nothing else.

Except, maybe, Iplex.

To read the rest of the story, please visit the New York Times.

Nanotechnology for PED/HGH Detection

From Steroid Nation posted by GRG51

Interesting concept: use of nanotechnology to monitor doping, even those compounds difficult to assay.

A Virginia-based biotechnology company, Ceres uses its patented Nanotrap™ -- a spherical, carbon-based nanoparticle designed to collect, concentrate, isolate and preserve the smallest and scarcest of molecules found in body fluids -- to pursue a range of applications in the diagnosis and treatment of diseases, as well as uses in sports doping screening, homeland security and environmental remediation.

Ceres and the U.S. Anti-Doping Agency have partnered to study the potential for a viable urine-based test for the detection of human growth hormone (HGH). Laboratory findings recently published in NanoLetters and Nano Research strongly suggest that development of this screening tool is highly probable, a move that would revolutionize the way college and professional sports organizations monitor potential drug use by athletes.

The Nanotrap technology also is being reviewed by SAIC-Frederick Inc., a wholly owned subsidiary of Science Applications International Corp., to determine the feasibility of developing diagnostic tools that detect cancer at the earliest possible stage when treatment is most effective.

Lab testing for a peptide (protein) hormone like HGH is always vexing. Whereas the anabolic steroids either show a long half-life, or slowly seep out of muscle, HGH exits the body relatively quickly. A sensitive way of trapping the molecule would be a boon for dope testing.

Former Qimonda workers line up at VCU/VCATS job fair

EMILY C. DOOLEY TIMES-DISPATCH STAFF WRITERPublished: May 20, 2009

Randall "Randy" Pak stood in a long line yesterday waiting for those precious moments when he could sell himself.

Out of work since February, Pak and more than 500 other former Qimonda employees gathered at a career fair at Virginia Commonwealth University yesterday to network and talk with prospective employers about their job offerings.

"I'm looking at all opportunities right now," said Pak, who moved here from Texas two years ago to work at the now-closed memory-chip plant in eastern Henrico County.

"I think the semiconductor industry in the U.S. is really dying," Pak said. "You go through a roller coaster ride emotionally, but you just have to be optimistic."

His goal: getting some face time with the Naval Surface Warfare Center, which recently has been hiring a number of former Qimonda employees.

The lines were long to speak with one of the 18 employers attending the fair. The lines to see representatives from the Naval Surface Warfare Center ran nearly out a door.

"It was very well-attended," said Nan Stewart, district manager for Virginia for the staffing firm Kelly Scientific Resources. "The caliber of candidate was very professional among all of the levels."

Seminars on a variety of subjects were offered, including on managing finances while in career transition, crafting a résumé and applying for federal jobs.

The five-hour fair, held at VCU's School of Business and School of Engineering, was open only to former Qimonda employees.

"What I'm really after is to find someone in the logistics industry who will sit down and talk to me," said Kristian Cauffman, an engineer with a degree in geology, as he sat in the school's atrium named after Qimonda.

"I want to get away from manufacturing," he said.

The event was sponsored by VCU, the Greater Richmond Partnership and the Virginia Council on Advanced Technology Skills.

The semiconductor company had a close relationship with VCU's engineering school. The company has an endowed chair and professorship there and had been the single largest employer of engineering school graduates.

Qimonda has "done a lot for VCU," said Mike Eisenman, director of the career center for the business and engineering schools. "It's done a lot for central Virginia. We thought it was the right thing to do."

In addition to the 18 employers, 10 others that work with entrepreneurs or offer educational training attended the fair.

"There's going to be a lot of competition," said Melba Rainey-Sayed, who left Qimonda in March after nine years there. "It's like 500 people for one job. A lot of us are thinking it's time to go back to school."

Qimonda idled its two production lines at its plant in eastern Henrico this year, putting about 2,500 people out of work. The company filed for bankruptcy in February.

"To see the birth of a company and then to see it go away . . . it was important to me to help put something together," said Don Owen, the former human resources director at the Sandston plant who helped organize the fair.

"We committed to the employees that we would do something for them, and this is kind of the fulfillment of that promise."

Report Finds States Lagging in Science Education

Virginia ranks in second tier.

Link to the Virginia Data: http://www.bio.org/local/battelle2009/VA_bio_09.pdf

States across America are failing to prepare students for pursuing biosciences in higher education—a key pipeline for developing the bioscience workforce of the future. A new report funded and researched by BIO, Battelle, and the Biotechnology Institute provides the first ever comprehensive study of middle and high school bioscience education in the 50 states, Puerto Rico, and the District of Columbia. The report also finds a wide disparity across measures of student achievement in overall science and biosciences, an uneven record across states in incorporating the biosciences in state science standards, supporting focused bioscience education programs and higher level bioscience courses, and ensuring science and bioscience teachers are well qualified.

The findings, which came to light at BIO’s annual convention, indicate a clear need for improved science education that incorporates the biosciences at the middle and high school levels if the United States bioscience industry sector is to remain globally competitive.

“The biosciences are a dynamic economic driver with a sizable footprint in nearly every state,” explains James Greenwood, President of BIO and member of the Board of the Biotechnology Institute. “The bioscience industry is a knowledge-based sector dependent upon the skills of its workers. Bioscience workers are needed to conduct research, translate innovation into product development and improved health care techniques, and ultimately to manufacture biomedical and other bioscience-related products. The prospect of the United States losing its competitive edge in student achievement and the subsequent skills of our future workforce is a matter of significant concern.”

This is not to say that bioscience education is non-existent in the United States because there are many examples of programs that work. However, the report does say that these programs should be replicated across the country and that states need to commit resources to them.

“The biosciences are the great adventure of our time, and states that aspire to play a part, either as supporters or leaders, must nurture their life science education programs," says Paul A. Hanle, president of the Biotechnology Institute. "This report rates the states' performance in life science education according to certain indicators of achievement. It also identifies best practices and programs throughout the nation. Both will be vital tools to help states wanting to strengthen their life-science education efforts."

This review of state activities in bioscience education suggests a number of actions that should be taken. For example, individual states:

Should incorporate biotechnology as they revise their science standards and should involve research scientists with expertise in the biosciences in their development.
Must commit to improving student achievement in biology and the life sciences and ensuring that their high school graduates are ready to pursue college-level bioscience courses.
Should improve the collection and dissemination of data, tracking student participation and performance in the biosciences and the broader sciences and if they do not participate in the National Assessment of Educational Progress (NAEP) science exam should be encouraged to do so.
Should take a more systematic approach to teacher professional development, experiential learning, and career awareness.
“The study recognizes the important link that high schools and middle schools have as the primary feeders to post-secondary institutions and in shaping career preparation,” explains Mitch Horowitz, Vice President and Managing Director of the Battelle Technology Partnership Practice. “The vast majority of bioscience jobs require some level of post-secondary education to ensure quality control and good manufacturing practices, conduct clinical research, design and engineer new products, or conduct research and development.”

The report provides the following evidence that states are not measuring up:

On average, only 28% of the high school students taking the ACT , which is a national standardized test for college admission, reached a score indicating college readiness for biology and no state reached even 50%.
Only 52% of 12th graders are at or above a basic level of achievement in the sciences, and for 8th graders only 57% are at a basic level of achievement.
Average scores for 12th graders in the sciences have actually declined from 1996 to 2005 and shown no improvement for 8th graders both overall and on the life science component.
A significant gap exists in science achievement for low-income middle-school students, although the gap is slowly narrowing.
Some states fared much better than others with respect to student achievement in the biosciences. While it is difficult to give a single grade across states because of the limited quality and comparability of the student achievement data, the patterns of student performance suggest the states fall into several broad categories.

Leaders of the Pack: Connecticut, Massachusetts, Minnesota, New Hampshire, New Jersey, Ohio, Vermont, Wisconsin

Second Tier: Colorado, Delaware, Illinois, Maryland, Missouri, North Carolina, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Utah, Virginia, Washington

Middling Performance: Alabama, Arizona, California, Hawaii, Indiana, Kentucky, Maine, Michigan, Montana, South Carolina, Wyoming

Lagging Performance: Arkansas, Florida, Georgia, Louisiana, Mississippi, Nevada, New Mexico, Oklahoma, Texas, West Virginia

Not Rated: States that do not participate in the NAEP science assessment were not rated.

The report also finds an uneven record across states in incorporating the biosciences in state science standards, supporting focused bioscience education programs and advanced bioscience courses, and ensuring well-qualified science and bioscience teachers.

Only thirty-one states reported that their science standards explicitly mention or define standards or applied laboratory or other instruction tools specifically for biotechnology or the biosciences.

At least half the states have at least one school with a bioscience focus, and all of the states have schools with a focus on broader STEM education. But states do not seem to be succeeding in encouraging high school students to take upper-level science courses. Although data on this subject are very limited, the share of students taking the AP biology exam averages 4.6% of high school graduates.

The report also notes that nearly one in eight U.S. high-school biology teachers was not certified to teach biology. The average share of biology teachers who are certified in a given state ranged from 50% to 100% in data collected by the Council of Chief State School Officers (CCSSO), although 88% of biology teachers are certified nationally on average.

The study and individual state profiles are available at: http://bio.org/battelle2009

Persistence pays off for biotech firm Insmed

JOHN REID BLACKWELL TIMES-DISPATCH STAFF WRITER
Published: May 15, 2009

At a time when many small biotechnology firms are struggling to stay afloat, Richmond-based Insmed Inc. is in the enviable position of being a newly cash-rich company.

Thanks to the sale of some of its biotech drug candidates in March, the biopharmaceutical company has received a cash infusion of $125 million. That's a huge turnaround from the $2.4 million in cash the company had on hand in late December, when it was burning through about $1.2 million per month.

Insmed executives say the deal, which came after two years of work and struggles for the company, gives it a war chest to hunt for new growth opportunities, possibly by acquiring drug candidates from other biotech companies that are facing financial distress in the economic downturn.

"It's a tribute to the tenaciousness with which we've run our business over the years," said Geoffrey Allan, the company's president and chief executive officer. "Two years ago, we could have folded the tent. We didn't do that."

The money also gives Insmed a cash buffer while it continues to test one of its key drugs, Iplex, for treatment of myotonic muscular dystrophy, a genetic, muscle-wasting disease that affects about 30,000 Americans.

The timing of the deal also was important, coming just as the financial crisis has made it more difficult for biotechnology firms to raise money. About 30 percent of publicly traded biotech companies have less than six months' worth of cash on hand, while 45 percent have less than one year, according to a recent report by the Biotechnology Industry Organization, a national trade group.

"I would definitely say that Insmed is in a unique position of having significant resources on hand," said Mark Herzog, executive director of the Virginia Biotechnology Association.

"The vast majority of companies I speak to are really struggling with only having enough cash on hand to last three to six months," Herzog said. "Insmed is very well-placed to be able to continue their research and development efforts."

The deal is the latest in a series of twists and turns for Insmed, which was founded in Charlottesville in 1988 to develop diabetes drugs.

In 1995, the company became one of the first tenants of the Virginia BioTechnology Research Park in downtown Richmond. It has since moved its corporate office to Stony Point Parkway in South Richmond.

The company has taken its share of lumps in recent years, most notably in 2007, when Insmed settled a patent-infringement lawsuit filed by a competitor, which forced it to remove Iplex from the market for treatment of a rare growth disorder in children.

The settlement allowed Insmed to continue developing and marketing Iplex for other illnesses such as muscular dystrophy and Lou Gehrig's disease, but the lawsuit "had a fairly devastating effect on our business," Allan said.

In the past couple of years, the company suffered from cash-flow issues and fought to keep its shares listed on the Nasdaq stock exchange.

Setbacks come with the territory in biotech, where the outcome of product research is uncertain and financial backing is often difficult to obtain.

"I think we are pretty battle-hardened here in terms of what we have gone through," said Kevin Tully, the company's executive vice president and chief financial officer. "You are always in the situation where you are having to finish a clinical trial, manufacture a drug, and look for cash to support it. You are constantly having to adjust. As a small company, we have been able to do that. We don't have a lot of bureaucracy."

After the lawsuit settlement, Allan said, "we essentially circled the wagons and figured out what we were good at, and how to deploy the resources we had available to survive that particular blow."

Insmed's strategic solution in 2007 was to move into follow-on biologics, an area of research in developing and making generic versions of drugs produced through biological processes. The company was successful at developing several experimental versions of drugs used in therapies for cancer patients.

The strategy paid off in February when pharmaceutical company Merck & Co Inc. agreed to buy Insmed's follow-on biologics platform for $130 million. Insmed said it will have about $125 million from the deal after fees and taxes.

On Wednesday, Insmed reported a first-quarter profit of $117.8 million, compared with a loss of $4.9 million in the same period of 2008. The turnaround was largely because of the sale of its follow-on biologics business to Merck.

The deal also makes Insmed a much leaner company, with just 20 employees at its Richmond office. Its Boulder, Colo., facility, which employs 70 people, was sold as part of the Merck deal.

The company's next step is to complete testing on its Iplex drug for muscular dystrophy, which has no other drug treatment.

"We are, in many ways, pioneering development in that area," said Glen L. Kelley, the company's vice president for regulatory affairs. Though the outcome is still uncertain, "it is a great place for a company like Insmed to spend time developing drugs, because it is a niche opportunity."

Insmed executives said they are also going to carefully evaluate other opportunities such as acquisitions of potential drugs that are in the late stage of development that would help the company become profitable for the long term.

"Can we repeat the exercise and in two years have a very positive outcome?" Allan said. "I can't guarantee it, but we will all work towards it."

Biotech Jobs And Training In Virginia

WhatCanBiotechDoForYou Question of the Day on May 13

I am a Chemical Engineer with 30+ yrs. experience in a variety of materials processing industries. Now I’m preparing to go to school to gain stronger technical background for a position in biotech. Can you refer me to any contacts for advice on specific school programs that would be most useful?May 13th, 2009

Hi Terry. Given the state of the economy, it probably shouldn’t be too surprising that our sister site http://www.iambiotech.org/ receives a lot of similar requests every week. It turns out that a good number of folks are now looking to the biotech industry when exploring their career options.
The Virginia Biotechnology Association for example has received so many queries that they’ve launched a career center website for local biotech jobs in Virginia. Now while that’s all good and interesting, it doesn’t really address your question. What does is another project that the Virginia Biotechnology Association has established called VCATS.

VCATS is co-led by the Virginia Biotechnology Association, Virginia Manufacturers Association, and Training & Development Corporation. What these co-sponsors (and other states!) have realized is that there must be a program that solves the critical and growing skill shortage locally. With more than 100,000 retirements among manufacturing workers anticipated over the next ten years, including 45,000 technically skilled workers, Virginia is currently failing to qualify their replacements.

What VCATS does is provide an easily accessible solution to this problem. They are developing a three-tier certification system for work in biotechnology laboratories. This system will be recognized (at the very least) statewide, and may provide an innovative model for those regions not already considering programs like this. By setting basic standards, employers can hire with greater confidence, and more biotech businesses will know that Virginia is an attractive destination for them.

And speaking of employers… in Virginia alone, the local employers partnering and co-investing in VCATS include: Alcoa, Boehringer Ingelheim Chemicals, Merck, Micron Technologies, Novozymes Biologicals, Philip Morris, and Wyeth Pharmaceuticals. Other principal partners include the Maryland Biotechnology Association, Virginia Community College System, Virginia Career Education Foundation, Virginia Department of Business Assistance, and the Capital Area, Northern Virginia, and Richmond Workforce Investment Boards.

So I would encourage you to look up your local state or regional biotech organization (assuming you don’t live in Virginia) and ask if they too are starting a biotech certification program. It sounds like a perfect match for what you’re looking for.

Scientist arrested for smuggling Ebola research into US

Scientist arrested for smuggling vials used in Ebola research into US
A Canadian scientist has been arrested for smuggling 22 vials stolen from Canada's National Microbiology Lab, used in Ebola and HIV research, into the United States, Canadian and US officials said Wednesday.

Konan Michel Yao, 42, "was taken into custody" while crossing the border from Manitoba province into the western US state of North Dakota on May 5, said a spokeswoman for the Public Health Agency of Canada, which operates the lab.

According to US prosecutor Lynn Jordheim, Yao was detained for carrying unidentified biological materials in vials wrapped in aluminium foil inside a glove and packaged in a plastic bag, along with electrical wires, in the trunk of his car.

Yao said in an affidavit he stole the vials, described as research vectors, from the Winnipeg lab on his last day of work there on January 21.

He told US border guards he was taking them to his new job with the National Institutes of Health at the Biodefense Research Laboratory in Bethesda, Maryland.

US authorities feared their contents could pose a terrorist threat. But tests later showed "they are not hazardous," said Jordheim.

"This turned out not to be a terrorism-related case," he said by telephone from North Dakota. "It appears to be exactly as he (Yao) said. However, he still faces possible charges for smuggling the vials into the United States."

Yao, meanwhile, remains in US custody after waiving his right to bail and preliminary hearings, as he awaits a possible grand jury indictment for smuggling, he said.

A Public Health Agency of Canada spokeswoman told AFP Yao "was working on vaccines for the Ebola virus and HIV, among other things."

"But he only had access to harmless and non-infectious materials, similar to what you'd find in a hospital or university lab. He did not have access to dangerous materials."

The Ivory Coast-born scientist is said to have studied at Laval University in Quebec and briefly worked at the University of Manitoba's plant sciences department.

Charlottesville Biotech Ships "SpermCheck" Product

This is great news for Ed Leary's company, ContraVac. Several new products on the way.


Charlottesville company sends out its home male sterility tests

A Charlottesville biotech company has begun shipping out samples of its cutting-edge home tests for male sterility. ContraVac, located off Preston Avenue, is dispatching its SpermCheck Vasectomy test to urologists across the country.

The test, which is based on a protein discovered at the University of Virginia, aims to measure a man’s sperm count following a vasectomy.

According to the World Health Organization, a fertile male has a sperm count of 20 million sperm per milliliter. The SpermCheck Vasectomy tests if a vasectomy recipient has a sperm count of above or below 250,000 sperm per milliliter, essentially a trace level of sperm. ContraVac President and CEO Ed Leary said the home test can replace a follow-up appointment after a vasectomy operation. Often, he said, patients skip the follow-up appointment, during which they must provide a sperm sample.

“For the patient, it’s inconvenient and embarrassing,” he said.

A study that appeared recently in the British Journal of Medicine found that 35 percent of vasectomy patients do not return for their first sperm-level test following a vasectomy. More than 70 percent do not return for their second.
While the success rate of vasectomy operations is fairly high, one of every 238 vasectomies results in at least a partial failure, Leary said. The SpermCheck Vasectomy test ensures the procedure worked.

“There is an overall cost saving,” Leary said. “It saves the patient time and it saves the physician time.”

The test kit, which will soon be available at many urology practices and vasectomy clinics, carries a price tag of $39.99. Some 1.5 million men have vasectomies each year worldwide. In the United States, there are an estimated 500,000 such procedures each year. The Charlottesville company’s technology is based on inventions by the firm’s founder, John C. Herr, a UVa professor of cell biology and director of UVa’s Center for Research in Contraceptive and Reproductive Health.

ContraVac has another product, called Sperm-Check Fertility, which is targeted at couples trying to conceive. SpermCheck Fertility measures if a male’s sperm count is above or below 20 million sperm per milliliter, essentially showing if he is fertile or subfertile. ContraVac has filed for Food and Drug Administration approval of SpermCheck Fertility. The company expects the product will be approved by the end of July. SpermCheck Fertility will be sold at pharmacies across the country, Leary said, ideally alongside home pregnancy tests. The company is also working on a third product, a new contraceptive drug for men. The drug, called SpermCheck Contraception, is being tested in a multi-center National Institutes of Health-funded study.

“The SpermCheck family of products is intended for use by men on both sides of the fertility equation — those who don’t want to father children and those who do,” Herr said in a statement.

In an interview, Herr said it is exciting to see products finally come to market that are based on his scientific breakthroughs.
“It’s all coming together,” he said.

AP: Insmed swings to 1Q profit on Merck deal

AP story on Insmed's financial success since selling the FOB business to Merck...

Insmed swings to 1Q profit on Merck deal
RICHMOND, Va. (AP) - Insmed Inc. reported a first-quarter profit Wednesday, bolstered by Merck & Co. buying several of the biopharmaceutical company's drug candidates.

In February, Merck said it would pay $130 million to buy a slate of biotech drug candidates and a manufacturing facility from Insmed.

The company earned $117.8 million, or 96 cents per share, compared with a loss of $4.9 million, or 4 cents per share, during the period a year prior. Revenue remained flat at $2.4 million.

The swing to a profit came from the Merck deal, which included Insmed's biosimilar assets. Biosimilars are copies of biotech-based drugs. There is currently no approval process in place in the U.S., though Congress is debating several bills on the issue.

Insmed recorded a pretax gain of $127.8 million in the quarter from sale of assets.

The company, meanwhile, continues developing the muscular dystrophy treatment candidate Iplex.

Shares of Insmed fell 10 cents, or 7.3 percent, to $1.28 in afternoon trading. The stock has traded between 32 cents and $1.52 over the past 52 weeks.

Big Turnout for BIO Town Hall in Virginia

 
More than 80 bioscience industry guests attended a special "Biotech town hall" meeting organized by the Virginia Biotechnology Association (VaBIO) and the Biotechnology Industry Organization (BIO). Speakers included BIO CEO Jim Greenwood, Joe Trippi, Howard Dean's 2004 campaign manager and Ray Cypess, CEO of ATCC, the host venue for the event.

The event promoted social media avenues for advocates of the bioscience industry:

What Can Biotech Do for You? http://whatcanbiotechdoforyou.com/

I am Biotech: http://iambiotech.org/

VaBIO on Twitter: http://twitter.com/vabio

VaBIO on Facebook.

Biotech Leaders Raise Funds for Science Education Foundation

  More than eighty people turned out April 29th to support the Chesapeake Bioscience Education Foundation (C-BEF) at a special fundraiser at Indoor Biotechnologies in Charlottesville, Virginia. The event, “Biotech and Art After Hours,” was organized by the Virginia Biotechnology Association, and featured more than twenty works of art, Moroccan food, lab tours and networking with the crowd heavy with bioscience leaders from across the Piedmont region of the state.

“We couldn’t have been more pleased with the strong support we received for the Foundation,” said Mark A. Herzog, executive director of the Virginia Biotechnology Association (VaBIO). “The event was like nothing we had ever done before in terms of mixing works of art in a wet-lab environment. The patrons who attended really enjoyed the experience.”

Chesapeake Bioscience Education Foundation is a non-profit charitable organization that develops and promotes programs designed to encourage young students before they choose specific careers, to appreciate and participate in the challenging work of math and science so that they do not preclude subsequent career choices in the biosciences. Among other initiatives, C-BEF funds internships at eligible biotech companies through matching grants.

Photos of the event are available here:

In addition to VaBIO, the event was sponsored by the Charlottesville Business Innovation Council, the University of Virginia, Indoor Biotechnologies, Woods Rogers PLC, Birch Studio Graphics, Diffusion Pharmaceuticals, Afton Scientific, Garris and Company, PGxHealth and Klann Plastics.

OSTP Launches New Blog on Science Policy

President Obama's Office of Science & Technology Policy (OSTP) launched a blog to serve as a place where the public can have input into the policy-making process as it relates to science and technology. http://blog.ostp.gov/

NAS Posts Video of Obama Speech on US Research Funding

From the National Academy of Sciences: President Obama addressed members of the National Academy of Sciences on April 27, announcing a renewed commitment to science, technology, engineering, and medicine. Topics included America's energy future, revitalizing our health care system, science and math education, and allocating funding and implementing policies to ensure that America reclaims a position of world leadership in scientific innovation.

Click here for the video: http://www.nap.edu/obama/obama_nasvideo.html

Senator Specter Calls for New Federal Biotech Agency

From Reuters and the Boston Globe:

Republican senator pushes biotech funding
Apr 25, 2009, Boston Globe

WASHINGTON (Reuters) - A Senate Republican who could prove a swing vote in the U.S. healthcare debate said on Saturday he wanted a new agency to help struggling biotech companies as part of a future healthcare system.

Senator Arlen Specter said the new agency could be important as Democrats push a health plan that aims to rein in soaring costs and to provide health coverage for an estimated 46 million uninsured Americans.

"I believe that we can live not only longer lives, but healthier lives, by harnessing and applying the genius of our biomedical research community and getting about the task of accelerating cures," Specter said in remarks prepared for a Chicago speech to physicians and researchers.

Specter, who has survived two bouts of cancer, proposed a new agency known as the Cures Acceleration Network that would award grants to cash-strapped biotech companies to help them develop new treatments.

He said these companies are having difficulty tapping into private capital and a number have cut or put on hold important drug development programs that could provide new treatments for cancer, multiple sclerosis, diabetes and other diseases.

"Without adequate funding, these companies will be unable to take these products to the development state, the basic research done by the NIH (National Institutes of Health) will be lost, and many patients will die waiting for drugs and devices to give them a better quality of life," Specter said.

A copy of his speech was made available in Washington.

Specter was able to secure additional funds for NIH as part of the $787 billion economic stimulus package signed into law by President Barack Obama.

Specter's vote for that package got him into trouble with some of his fellow Republicans and he is facing a primary challenge for re-election in Pennsylvania next year from conservative Pat Toomey.

Specter said he would make creation of the new agency and increased funding for NIH a major focus of his re-election bid next year. He also said he would push to include the measure in the sweeping healthcare overhaul that Obama wants.

Democrats control 58 votes in the 100-member Senate and could need the support of at least two Republican votes to overcome any procedural roadblocks.

Coast IRB Closes Doors After Federal Investigation

From FierceBiotech:

At the beginning of this month, Coast IRB was a flourishing independent-review firm overseeing some 300 clinical trials. Today, it's dead.

The company has sent out an e-mail saying that the company's owners have decided to cease doing business. Oversight of the clinical trials it has been working with is being transferred to other independent review board companies.

Coast IRB's trouble hit hard and fast after the company approved a clinical trial for a product that never existed. Federal investigators wanted to see how much due diligence the review boards were bringing to the table. And in Coast IRB's case, that wasn't a lot--at least not in this instance.

The company CEO tried to fight back, saying that the federal sting operation amounted to nothing more than entrapment. But lawmakers were a little less than happy to hear that.

Virginia's Previous Attempts at a UK-style Investment Fund

Virginia legislators have debated policies similar to what was just announced by Alistair Darling, the Chancellor of the Exchequer in Britain. Two examples are posted below. It would be great if all of the candidates for Governor would look at innovative programs like these. This was one of the key recommendations from the Virginia Biotechnology Initiative back during Mark Warner's term as Governor.

So far this year, Terry McAuliffe does include the state-supported VC concept in his plan. Maybe we can get Brian Moran, Creigh Deeds and Bob McDonnell to weigh in as well.

HB 1572 Venture capital funds; creation of an investment program.
http://leg1.state.va.us/cgi-bin/legp504.exe?051+sum+HB1572


HB 75 Venture capital investments; creates program which makes investment return guarantees for certain.
http://leg1.state.va.us/cgi-bin/legp504.exe?071+sum+HB75

UK Govt Announces $1B Advanced Tech Investment Fund

LONDON, April 22 (Reuters) - The UK's high-tech industrial sector will get an investment of 750 million pounds ($1.09 billion) through a fund focusing on advanced technology, the government said on Wednesday.

The Strategic Investment Fund -- announced by Chancellor Alistair Darling in his annual Budget speech to parliament -- will provide financial support, focusing on emerging technologies and regionally important sectors in, for example, advanced manufacturing, digital and biotechnology.

As part of the fund, 250 million pounds will be earmarked for low-carbon investments, a further 50 million pounds for the Technology Strategy Board and 10 million pounds for UK Trade and Investment.

The Technology Strategy Board cash will be used to increase its capacity to support innovation in areas that have high potential to drive future growth, such as low-carbon technologies, advanced manufacturing and the life sciences, the budget report said.

National Endowment for Science, Technology and the Arts Chief Executive Jonathan Kestenbaum welcomed the new fund, saying it would help to regenerate the UK economy.

"The fund will give a new vibrancy to the UK's technology market and will bring about deep and lasting change to our economy," he said.

However, it falls well short of the 1 billion pounds that was hoped for by the biotechnology industry.

In the budget report, Darling also said the government would be looking at whether to change the tax system to encourage global firms to locate their R&D activities in the UK.

Richard Barker, Director General of UK trade body Association of the British Pharmaceutical Industry, said: "It could have significant impact on how companies make their investment decisions."

Terry McAuliffe Touts Plan for Biotech in VA

VaBIO staff met Terry McAuliffe, one of the candidates for the Democratic nomination for Governor of Virginia, yesterday at a "meet & greet" event in Richmond. Mr. McAuliffe said that if he were to be elected, Virginia would have plenty of wet lab space for commercialization. He asked us to read his plan which is posted on his website.

Here are some quotes that relate directly to the Life Sciences...

"Reward in-state investment in research
and development: Virginia is one of a rapidly shrinking number of states not offering a research and development (R&D) tax credit. Recent enhancements of the federal R&D tax credit have made this a more attractive incentive than ever before, particularly when states closely link their offerings to the federal credit. According to the Kauffman Foundation’s 2008 State New Economy Index, Virginia
ranks below the national average in industrial R&D investment.

To improve its standing, we should consider initiatives such as New York’s Research and Development tax credit that offers businesses who invest in research and development facilities a 9 percent corporate tax credit. In June 2008, Governor Deval Patrick put into place the new Massachusetts Life Sciences law. This legislation, designed to make the state the national leader in the life sciences field, provided $500 million in capital funding for infrastructure projects related to life sciences and $250 million for the Massachusetts Life Sciences Investment Fund for loans, grants, and investments to stimulate increased research and development in the life sciences sector."

McAuliffe also discussed venture capital:

"Investing in venture capital firms with a commitment to pursue investments in Virginia: A Virginia Capital Investment
Corporation could be created to conduct a national solicitation for investment plan
proposals from qualified venture capital investment fund allocation managers,
focusing on businesses within Virginia committed to maintaining a physical presence
in Virginia. For instance, the Iowa Fund of Funds (IFOF) is a $100 million venture capital development program influenced by similar initiatives in Oklahoma and Arkansas. Monies are invested in venture capital projects agreeing to establish
a presence in Iowa and actively seek Iowa investments. A contingent tax credit is also available through the State. Cimarron Capital Partners LLC manages the fund. The first investment by an IFOF-supported venture fund in an Iowa company was made in 2007. The IFOF’s $28 million in commitments has attracted six venture funds with over $570 million in venture investing capacity to the state."

On NOL's:

"Match federal net operating loss “carry
back” for small businesses: The American Recovery and Reinvestment Act will provide some help for small businesses, including additional funding for the federal Small Business Administration and its loan programs. The federal stimulus will also provide some new tax breaks for small businesses, notably extending a net operating loss “carry back” provision from two years to five years, a change that will provide immediate cash infusion for many small businesses. In basic terms, lengthening the “carry back” provision will enable business owners to balance out their net losses over years when the business had a net operating gain. The ability to “spread out” its tax liability will help a business to decrease the impact of recent bad
years. We should enhance the impact of the federal “carry back” provisions here in
Virginia by making parallel changes to our own tax policies."

Mr. McAuliffe spoke to about 30 lawyers and industry representatives.

UK: Second hESC Trial Announced

Blind to be Cured with Stem Cells
Apr 19, 2009 The Times UK
Sarah-Kate Templeton, Health Editor

BRITISH scientists have developed the world’s first stem cell therapy to cure the most common cause of blindness. Surgeons predict it will become a routine, one-hour procedure that will be generally available in six or seven years’ time.

The treatment involves replacing a layer of degenerated cells with new ones created from embryonic stem cells. It was pioneered by scientists and surgeons from the Institute of Ophthalmology at University College London and Moorfields eye hospital.

This week Pfizer, the world’s largest pharmaceutical research company, will announce its financial backing to bring the therapy to patients.

The treatment will tackle age-related macular degeneration (AMD), the most common cause of blindness. It affects more than 500,000 Britons and the number is forecast to increase significantly as people live longer. The disease involves the loss of eye cells.

Under the new treatment, embryonic stem cells are transformed into replicas of the missing cells. They are then placed on an artificial membrane which is inserted in the back of the retina.

Tom Bremridge, chief executive of the Macular Disease Society, said: “This is a huge step forward for patients. We are extremely pleased that the big guns have become involved, because, once this treatment is validated, it will be made available to a huge volume of patients.”

Embryonic stem cells have the ability to develop into all types of body tissue. Their use is controversial, however, because it involves the destruction of human embryos.

Laboratory trials completed by the British team have demonstrated that stem cells can prevent blindness in rats with a similar disease to AMD. They have also successfully tested elements of the technology in pigs.

The team is led by Professor Pete Coffey, director of the London Project to Cure Blindness, working alongside Lyndon da Cruz, a surgeon at Moorfields.

Coffey said the treatment would take “less than an hour, so it really could be considered as an outpatient procedure. We are trying to get it out as a common therapy”.

He welcomed Pfizer’s agreement to manufacture the membranes, saying: “This is a major development because of the size of the partner. We need a big pharmaceutical company to scale it up.

“We have nearly 14m people within Europe with AMD. This will ensure that the therapy gets through to clinical trials in a safe and effective manner.”

Professor Peng Khaw, director of the Biomedical Research Centre at Moorfields and the UCL Institute of Ophthalmology, added: “This shows that stem cell therapy is coming of age. It offers great hope for many sufferers around the world who cannot be treated with conventional treatment.” He added: “All my patients say to me is, ‘When will this stem cell treatment be ready? I want it now’.”

Pfizer’s role would be crucial in bringing production of the membranes to an industrial level.

The team is applying for regulatory approval for trials from the Medicines and Healthcare products Regulatory Agency, the Human Tissue Authority and the gene therapy advisory committee.

The clinical trial, due within two years, is expected to be the second in the world to use embryonic stem cells on humans. The first, on patients with spinal cord injuries, will start this year in America.

Device Industry: Stop Bill to Overturn Riegel v Medtronic

Device Industry Says Anti-Preemption Bill Would Hurt Innovation
Apr 16, 2009 Inside Health Policy

As the debate over FDA preemption for medical devices shifts from the courts to Congress, the device industry is arguing that revoking preemption would undermine innovation and have a disproportionate effect on small businesses. Manufacturers are also casting the U.S. Supreme Court's pro-preemption decision on devices as an affirmation of long-standing policy that they say Congress should leave alone.

The Advanced Medical Technology Association is hoping to defeat a bill that would overturn the Supreme Court's 8-1 decision in Riegel v. Medtronic, in which the court held that federal law blocks state tort suits involving devices with premarket approval from FDA. AdvaMed officials said this week that lobbying on the bill has fallen along the traditional battle lines for tort issues -- a framework that would appear to work in the Riegel bill's favor but has historically failed to produce results even when one party controls the House, the Senate and the presidency.

AdvaMed President and CEO Stephen Ubl told reporters that members of the conservative Blue Dog and New Democrat coalitions have been receptive to AdvaMed's concerns. Only 14 members from either group have cosponsored the bill to overturn Riegel. And with the number of other issues, including health care reform, already facing the House Energy and Commerce Committee and Senate health committee, AdvaMed government affairs director Brett Loper said, it's ?not outside the realm of possibility? that the legislation won't get off the ground. It didn't last year.

The AdvaMed officials discussed the bill during a meeting with reporters Wednesday (April 15). The American Association for Justice, one of the bill's leading supporters, declined to discuss its legislative strategy or identify the members or coalitions it has targeted.

Ubl said passage of the Riegel bill would be a major setback for innovation. Venture capital is already difficult to find, he said, and the threat of expensive litigation would only make the situation worse. And because the Riegel decision only applies to products with premarket approval, overturning it could open up litigation involving the most innovative types of devices, he said. Most products go through the less rigorous 510(k) clearance process, and those devices are still subject to tort suits under a previous Supreme Court decision.

?This flawed legislation contemplates a regulatory scheme that would undermine the safety and effectiveness determinations of the FDA with respect to complex medical devices -- for reasons that may or may not be medically and scientifically sound,? AdvaMed and 17 other industry groups stated in a March 31 letter to both parties' House and Senate leadership.

Officials said the adverse effects of the Riegel bill would fall largely on small businesses -- an argument that might not have made much difference to the Supreme Court justices but could be much more salient with members of Congress. Industry has also sought to downplay the level of protection afforded by Riegel. Ubl said the case's impact has been exaggerated through ?so many myths being propagated by the other side.?

AdvaMed chief counsel Christopher White said the Riegel decision was not ?a sea change in the law,? an argument the industry has made before. Although Riegel was only decided last year, AdvaMed says overturning it would effectively reverse 30 years of regulatory and legal precedent. Robert Weiner, a partner at Arnold & Porter, said the trend picked up after 1996, when the Supreme Court issued its 510(k) ruling. That decision hinged on the differences between the PMA and 510(k) processes, and Weiner said it hinted at support for preemption in the former context even though it didn't address the issue directly.

The Supreme Court only agreed to hear Riegel because of a division among lower courts, but White said it was a ?minimal split.? Only three courts -- two state Supreme Courts and the 11th U.S. Circuit Court of Appeals -- came down against preemption, he said.

The plaintiffs' bar disputes AdvaMed's claim of a long pro-preemption history. Sue Steinman, policy director at the American Association for Justice, was unfamiliar with the extent of circuit-court divisions but said the Supreme Court read into medical device law a restriction that Congress never intended to impose. The law prohibits state ?requirements? that go above and beyond FDA regulations, and the court said in Riegel that damages in tort suits count as a ?requirement.?

Lawmakers who helped write the statute in question filed a brief in Riegel stating that they only intended to preempt state statutes, not product liability actions. Justice Antonin Scalia, who wrote the majority opinion, was dismissive of that brief in a speech about the case (see related story, March 31, 2008). Steinman, however, said the stated intent of lawmakers who wrote the bill ought to carry more weight with colleagues deciding whether to accept the Supreme Court's interpretation.

Steinman said AdvaMed is overstating the effects of preemption on innovation. PMA devices on the market today were developed before Riegel and therefore before the issue was fully resolved. She also said the Riegel decision gives medical devices a stronger legal shield than almost any other industry.

?Why are they so special?? she said.

The AdvaMed officials, however, emphasized during the media briefing that only about 2 percent of all devices are PMA rather than 510(k) products. They also noted that manufacturers can still be sued over PMA devices if the products are manufactured improperly. State courts can also continue to hear parallel claims, or suits in which the state law mirrors a federal regulation. AdvaMed has made the same points about the scope of the Riegel decision in its meetings on Capitol Hill. -- Sam Baker