Biotech Bill Passes VA Legislature

SB 1338, the "omnibus" Biotech bill, is on its way to Governor Tim Kaine for his signature. Today, the House of Delegates passed the conference committee report 99-0 and the Senate approved it 38-2.

Despite the "blow-out" votes, this bill was in serious trouble as late as yesterday afternoon. Thanks to the amazing efforts of the patron, Senator Mark Herring (D-Loudoun) and Delegate Sam Nixon (R-Chesterfield), who led the negotiations with the various interest groups, a compromise was reached in time for final passage of the legislation.

Here is a link to the bill details and history.

VaBIO sincerely thanks all of the members and legislators who helped make this happen.

VA Biotech Bills Final Action Today

More than a year's work on proposals to help promote the bioscience and advanced technology industry in Virginia comes down to actions by the General Assembly today.

SB 1338, the "omnibus" biotech bill patroned by Senator Mark Herring, won advancement to a conference committee late yesterday afternoon. The Senate appointed Mark Herring, Don McEachin and Jill Vogel as conferees. House conferees are Mark Sickles, Sam Nixon and John O' Bannon.

The goal of VaBio is to help the advocates on both sides of the embryonic stem cell issue to find a compromise that leads to final passage.

VaBIO is grateful to several key members who have really worked hard to find a satisfactory compromise: Senator Ken Stolle of Virginia Beach and Delegate Sam Nixon of Chesterfield have really gone above the call of duty to help.

Luckily, there have only been two legislators so far who appear unwilling to look for a compromise. One Delegate from the Richmond area called the VaBio lobbyist "Dr. Mengele," a reference to a Nazi concentration camp doctor. More on that later!

VaBIO will post an update as soon as we have news to report.

Burrill to Lead $1B VC Fund at Bio Park in Minnesota

This is great news for Minnesota!

Rochester biotech park may get $1 billion capital boost

By THOMAS LEE, Star Tribune

February 23, 2009

The developer of an ambitious biosciences park north of Rochester in southeast Minnesota is close to a deal with a major investor in California to create a $1 billion venture capital fund to lure biotechnology start-ups to the state, sources say.

Steven Burrill, a prominent biotech venture capitalist based in San Francisco, will be the lead investor in the venture fund that will offer money to as many 30 companies that agree to move their operations to the Elk Run facility. Tower Investments, a California-based real estate investment firm that's developing the project in Pine Island, will contribute another $100 million to the fund.

Burrill did not return a phone call seeking a comment Monday; a Tower official declined to comment.

The Mayo Clinic in Rochester will also collaborate on the project, according to two sources who have knowledge of the project but are not authorized to speak for it. Gov. Tim Pawlenty and Tower Investments could call a news conference as early as this week, these sources said. Brian McClung, a Pawlenty spokesman, would confirm only that the governor spoke with Burrill about the project.

The renowned hospital and research center will steer start-ups founded on its technology to the biosciences center. The Mayo board of governors met last week to approve the initiative, according to sources.

Once the deal is completed, state leaders will use $50 million in federal stimulus money to renovate Hwy. 52 near the facility and issue another $2 million bond for improvements to water and sewer lines.

The planned 1.7 million-square-foot biotech park is on an elk farm off Hwy. 52 near Pine Island, about 15 minutes north of Rochester. As envisioned by Tower, start-up companies could test and manufacture biotech products such as medical devices, pharmaceuticals and animal vaccines.

A biotech jump-start

A $1 billion fund would significantly boost Minnesota's nascent biotech industry. The state, known mostly for medical devices, has struggled to attract venture capital money for biotech and pharmaceutical companies, forcing some start-ups to move out of Minnesota, experts say.

From 1995 to 2008, the state's average annual share of biotech venture capital investments was $4.4 million compared with the average of $8.1 million for all states receiving biotech funding, according to the MoneyTree Report from PricewaterhouseCoopers and the National Venture Capital Association based on data provided by Thomson Reuters.

"Minnesota policies that incent private investment in higher-risk start-up companies are lagging many competitor states and nations that support a growing biologic and biopharmaceutical industry at home and aboard," according to the Destination 2025 report released in January by the BioBusiness Alliance of Minnesota. "This is leading some companies to leave Minnesota or the country."

Tower executives and state and local officials say such a facility could help establish a biotech corridor along Hwy. 52, which connects the Mayo Clinic, the University of Minnesota Rochester and IBM Life Sciences research and development labs with the U's Twin Cities campus and the major medical companies in the metro area.

In 2007, the Mayo Clinic and the University of Minnesota inaugurated a $25 million, three-story genomics research facility at a Mayo building in Rochester. The collaboration, called the Minnesota Partnership for Biotechnology and Medical Genomics, hopes to speed the research and commercialization of projects such as anti-cancer drug development and treatments for heart disease, pancreatic cancer, neuromuscular diseases, auto-immune diseases, transplant rejection, drug addiction and tuberculosis.

Sources say Burrill, whose venture capital firm Burrill & Co. has $900 million under management, agreed to the project because of Mayo's participation. Widely considered one of the nation's most prominent biotech investors, Burrill has long wanted to work with Mayo, which owns a venerable brand and deep pool of intellectual property.

Since 1986, Mayo has signed more than 660 license agreements, filed more than 1,350 patent applications and received more than 300 patents for technology developed by its physicians. The hospital recently spun off Muve Inc., which is developing a device to closely monitor a person's movement and how many calories he or she burns.

Adam Brase, a Mayo spokesman, referred questions about the venture fund to Burrill. He denied that the hospital has any formal relationship with Tower and the Elk Run project.

"Mayo has had dialogue with Tower Investments throughout [a] period of time," Brase said. "When it comes to bioscience, Mayo is very supportive of any effort to expand bioscience development not only in southeast Minnesota but the [entire state]. We have a number of bioscience projects we're working on with a number of different partners. We continue to be committed to each of them."

Staff writer Norman Draper contributed to this report.

VCU Student's Stem Cells Cure MS Symptoms in Trial

From Fox News-- Amazing!

College Student With Multiple Sclerosis Symptom-Free After Stem-Cell Treatment

Monday , February 23, 2009

Edwin McClure, a Virginia Commonwealth University advertising graduate student, says a stem-cell study he participated in appears to have cured his multiple sclerosis symptoms.

McClure started showing symptoms of MS in 2000 when he was a senior in high school.

Although he initially thought it was just a cold, he knew the condition was more serious when his vision began blurring.

"It was like someone turning down the dimmer switch," McClure said.

When his neurologist told him he was showing the symptoms of MS, he was surprised and confused."

It threw me for a loop," McClure said. "This is a disease that typically hits 40-year-old white women and I'm like, 'I'm an 18-year-old black male.' Somebody didn't get the memo."

McClure said being hooked up to an IV for the steroid treatments forced him to confront this sickness. He suffered from extreme fatigue, allergy attacks, heat intolerance and bad balance. McClure said his symptoms made it difficult to spend time with his loved ones.

"It's a huge burden of being a constant burden to those around you," McClure said.

McClure's mother, Bernice McClure, said she was devastated but would not lose hope.

"I was hoping to find whatever was out there that was going to help him long-term," the woman said.

In 2005, Dr. Katarina Bilikova told Bernice McClure about the clinical trial, led by Dr. Richard Burt at Northwestern University.

The trial used the patient's own stem cells to regenerate the immune system and reverse the symptoms of MS. The trial consisted of 21 patients. According to the lead author of the study, this is the first study to show an actual reversal of the disease.

McClure flew to Evanston, Ill., to participate. During the course of the trial, doctors took out McClure's own stem cells and used them to grow more cells. He then was given a course of chemotherapy to wipe out his immune system.

The treatment took nearly a month. McClure called this time "the lock down period." He was not allowed to go anywhere or have any visitors. He continued his undergraduate classes online.

"The hardest part was thinking about all my friends. I was just staying home watching 'A Different World' re-runs," McClure said.

Meanwhile, he was able to keep his disease hidden from his friends back at school. He said he didn't want to tell anyone, for fear of seeming weak. McClure's hair started falling out after four weeks.

He said the one thing he thought about was his high school football coach.

"He always said, 'If your minds are weak, your bodies are weak', " McClure said.

It was this mantra that helped McClure decide to shave off his hair.

After the month was complete, McClure returned to the hospital. His harvested stem cells then were transplanted back into his body.

When his cell count started increasing and McClure's symptoms started getting better, he and his mother knew the trial might have worked. Three years later, McClure said his symptoms have disappeared.

"This is the first study to actually show reversal of disability," Burt told Bloomberg.com on Jan. 30. "Some people had complete disappearance of all symptoms."

The treatment will go through one more trial before it can become an approved treatment for MS. McClure is finishing his second year as a graduate student in advertising at VCU and said if it wasn't for the treatment, he never would have been able to handle the pressures of grad school.

"It opened up the fence that MS had me locked into," Edwin said. Edwin and his mother attribute the success of the treatment to their faith.

"Without having God in our lives, I don't think any one of us would have made it through,"Bernice McClure said.

McClure said, "I would have quit after my second semester."

McClure plans to graduate from the VCU advertising graduate program in May.

This story was filed by UWIRE, which offers reporting from more than 800 colleges and universities worldwide. Read more at www.uwire.com

Genome Web: NIH Stimulus $ Only for Existing Projects

NIH Stimulus Spending Focused Mostly on Existing Grants; No Funds to Restore Previous Cuts

NEW YORK (GenomeWeb News) – Some broad details are beginning to emerge from the National Institutes of Health about how it plans to spend the billions of dollars it will take in under the $789 billion economic stimulus package that President Obama signed in Denver earlier this week.

The NIH's plans include funding applications for programs that are already on hand and that are expected to make progress over the next couple of years, and creating a new program that will support research supplements. In addition, none of the money will be used to restore previous cuts to existing programs and grants, according to an academic official familiar with the NIH's plans.

While the NIH is "extremely grateful" for the $10.4 billion in extra funding it was granted, as Acting Director Raynard Kington said in a statement this week, the agency that is used to planning its grant programs in advance now faces a challenge in quickly reviewing projects and disbursing funds.

After five years of nearly flat funding, NIH now has to spend a windfall equivalent to thirty percent of its entire annual budget in about 20 months. NIH's planners "have been working around the clock to prepare for this possibility, to make the most effective, transparent, and immediate use of these extraordinary resources," said Kington.

While the Office of the Director has not yet made public its plans — although it is supposed to hold a conference call next week — what NIH officials have come up with so far are outlines of how the agency will dice up and distribute the funds, according to Tim Mulcahy, vice president for research at the University of Minnesota.

Mulcahy, who participated in a teleconference with Kington and Association of American Universities representatives this week, wrote in a memo that the focus of the funding structure will be to "preserve and create jobs … contribute to economic recovery … and deliver short-term investments that will have long-term impact."

He provided a breakdown on the entire amount of the one-time stimulus that has been allocated to NIH under the American Recovery Reinvestment Act. Mulcahy said that most of it — $8.2 billion — will go toward scientific priorities, including $7.4 billion to the institutes, centers, and the common fund. Another $800 million will go to the Office of the Director; $1 billion will go to the National Centers for Research Resources for renovations and repairs, and NCRR will use $300 million to buy equipment and instruments; $500 million will be available for facilities; and $400 billion will go toward comparative effectiveness research.

The $8.2 billion for research will be distributed in three ways. Some will support R01 applications that have already been reviewed, and those submitted in fiscal 2008 and 2009 that have been judged for merit but did not receive awards because of tight funding.

Some of the money will go to projects that speed up research in high-priority areas that are already being conducted under existing grants. These awards will be based on themes, such as equipment, training, and summer student jobs.

An estimate of between $100 million and $200 million will start a new program called NIH Challenge Grants. This program will solicit applications in focus areas determined by the institutes, and the awards will be based on peer review through a process that is currently under consideration.

The money will not be used to restore cuts to existing programs or grants, nor will it be assigned proportionally to particular priorities. Typical NIH grant mechanisms will be used, and the "process will be open and transparent."

The money has to be spent in the two years, and researchers should not seek funds if they can't plan on spending it in that time.

Those receiving funding also will be required to provide "significantly greater" detail about how many jobs were created or retained as a result of the award, according to Mulcahy's memo.

"We are well positioned to address the most vexing public health challenges of our time, while stimulating the economy in the 50 states and territories through 3,000 institutions we currently fund to conduct outstanding biomedical and behavioral research," Kington said in his statement.

Dave Moore, who is senior director for government relations at the Association of American Medical Colleges, told GenomeWeb Daily News on Thursday that he expects some of the NCRR's equipment funding to go into its shared instruments program, which covers the cost of lab tools costing between $100,000 and $500,000, and its high-end program, which covers the cost of equipment costing over $750,000.

"All off the institutes and centers have strategic plans and have high priority areas," said Moore. The medical research colleges and universities also "have plans in place and strategic priorities. Now the question is how to best address those priorities."

http://www.genomeweb.com/node/912154?emc=el&m=316502&l=1&v=006f7568c8

Sobral Resigns from VA Bioinformatics Institute

BLACKSBURG, Va., Feb. 23, 2009 - The founding director of Virginia Tech's Virginia Bioinformatics Institute, Bruno Sobral, will step down effective March 2. Sobral will remain on staff to continue his scientific work in cyberinfrastructure and pathosystems biology.

"Bruno's vision and extraordinary scientific talent have enabled the tremendous growth of VBI from only a concept in the late 90s to one of the two largest research institutes in the university today. We are grateful for his significant contributions in making VBI respected around the world," said Charles W. Steger, president.

Steger has asked Sobral, who is a world recognized scientist, to focus his efforts on securing large-scale grants critical to advancing the university's strategic research agenda and expanding the VBI sponsored-research portfolio.

With more than $97 million in active sponsored research and an annual budget of $27 million, VBI is one of the largest research centers at Virginia Tech. It employs about 240 people.

Sobral was appointed director in 2000. He is director of the PathoSystems Biology Group and the Cyberinfrastructure Group. He also holds appointments as Professor, Plant Pathology, Physiology and Weed Science and Adjunct Professor of Cancer Biology, Comprehensive Cancer Center, at Wake Forest University.

Paul Knox, former dean of the College of Architecture and Urban Studies will assume the role of interim director while the university undertakes an international search for the director. Knox is a University Distinguished Professor and serves as Senior Fellow for International Advancement.

VBI is a research institute dedicated to the study of the biological sciences. The research platform of VBI focuses on the "disease triangle" of host-pathogen-environment interactions.

Burrill: Biotech Now Profitable After 40 Years

From Steve Burrill:

Biotech Scores Black Ink
Stock prices have tanked, financial markets have seized and companies are laying off staff and putting promising projects on ice. In the midst of all of this grim news it’s easy to overlook an important milestone for the biotechnology industry. Peter Winter, editor of The Burrill Report, has been crunching the numbers and he says some 40 years after the industry began, it actually hit a major milestone in 2008 by turning profitable for the first time in its history. It’s not all good news by any means, but we talk to Winter about this major milestone for the industry, what we should make of it, and the emerging world of the biotechnology haves and the biotechnology have-nots.

http://www.burrillreport.com/article-1134.html

Report: Fetal stem cells trigger tumors in ill boy

From the AP:

WASHINGTON (AP) - A family desperate to save a child from a lethal brain disease sought highly experimental injections of fetal stem cells—injections that triggered tumors in the boy's brain and spinal cord, Israeli scientists reported Tuesday.

Scientists are furiously trying to harness different types of stem cells—the building blocks for other cells in the body—to regrow damaged tissues and thus treat devastating diseases. But for all the promise, researchers have long warned that they must learn to control newly injected stem cells so they don't grow where they shouldn't, and small studies in people are only just beginning.

Tuesday's report in the journal PLoS Medicine is the first documented case of a human brain tumor—albeit a benign, slow-growing one—after fetal stem cell therapy, and hammers home the need for careful research. The journal is published by the Public Library of Science.

"Patients, please beware," said Dr. John Gearhart, a stem cell scientist at the University of Pennsylvania who wasn't involved in the Israeli boy's care but who sees similarly desperate U.S. patients head abroad to clinics that offer unproven stem cell injections.

"Cells are not drugs. They can misbehave in so many different ways, it just is going to take a good deal of time" to prove how best to pursue the potential therapy, Gearhart said.

The unidentified Israeli boy has a rare, fatal genetic disease with a tongue-twisting name—ataxia telangiectasia, or A-T. Degeneration of a certain brain region gradually robs these children of movement. Plus, a faulty immune system leads to frequent infections and cancers. Most die in their teens or early 20s.

Israeli doctors pieced together the child's history: When he was 9, the family traveled to Russia, to a Moscow clinic that provided injections of neural stem cells from fetuses—immature cells destined to grow into a main type of brain cells. The cells were injected into his brain and spinal cord twice more, at ages 10 and 12.

Back home in Israel at age 13, the boy's A-T was severe enough to require that he use a wheelchair when he also began complaining of headaches. Tests at Sheba Medical Center in Tel Aviv uncovered a growth pushing on his brain stem and a second on his spinal cord. Surgeons removed the spinal cord mass when the boy was 14, in 2006 and they say his general condition has remained stable since then.

But was the boy prone to tumors anyway or were the fetal stem cells to blame? A Tel Aviv University team extensively tested the tumor tissue and concluded it was the fetal cells. Among other evidence, some of the cells were female and had two normal copies of the gene that causes A-T—although that boy's underlying poor immune function could have allowed the growths to take hold.

Using stem cells from multiple fetuses that also were mixed with growth-spurring compounds "may have created a high-risk situation where abnormal growth of more than one cell occurred," wrote lead researcher Dr. Ninette Amariglio of Sheba Medical. She urged better research to "maximize the potential benefits of regenerative medicine while minimizing the risks."

This brain disease wasn't conducive to stem cell therapy in the first place, said stem cell specialist Dr. Marius Wernig of Stanford University, who said it's unclear exactly what was implanted.

"Stem cell transplantations have a humongous potential," Wernig said. But "if people rush out there without really knowing what they're doing ... that really backfires and can bring this whole field to a halt."

Skin Cells Reprogrammed to Embryonic Cells then Turned Into Heart Cells

Scientists turn skin cells to embryonic state, then to heart cells

Feb 13, 2009
Milwaukee Journal Sentinel
Mark Johnson
Feb. 13, 2009

In work that extends science's power to alter the basic unit of a human being, researchers at the University of Wisconsin-Madison have taken skin cells that were reprogrammed back to their embryonic origin and grown them into functional, pulsing heart cells.

Moreover, the human heart cells grown using this technique were very similar to those grown from embryonic stem cells, the scientists reported Thursday in the journal Circulation Research.

Timothy Kamp, co-director of UW's Stem Cell and Regenerative Medicine Center and one of the authors of the new paper, said the reprogrammed heart cells made in the laboratory performed some key functions of the heart cells inside our bodies. They generated electrical pulses, and in response to these pulses, they contracted. It is the collective contraction of all these cells that enables the heart to beat.

"This is a proof-of-principle experiment, but it's not ready for prime time," Kamp said, cautioning that such manufactured heart cells are not yet safe for use in humans.

The cells, called cardiomyocytes, had once been skin cells. To turn cells from skin to heart, scientists first sent them back to the embryonic state by infecting them with viruses carrying genes, a method that could cause cancer.

Still, the reprogrammed cardiomyocytes offer researchers an immediate tool for studying heart diseases in a lab dish and testing drugs against them.

"This is probably the most exciting short-term application," said Christine Mummery, a professor of developmental biology at Leiden University Medical Center in the Netherlands, in an e-mail. She was not involved in the research.

No embryo needed

The new paper adds to a growing body of evidence suggesting that scientists can now obtain cells that perform just like embryonic stem cells without destroying a human embryo. Since teams led by James Thomson at UW and Shinya Yamanaka at Kyoto University showed in 2007 that human skin cells could be returned to the embryonic state, researchers have sought to determine whether the new technique can be used to make all of the more than 200 cell types in the body.

This versatility is one of the crucial powers of an embryonic stem cell, offering modern medicine a potential repair kit for illnesses such as Alzheimer's, diabetes and heart disease. In the last year, scientists have used reprogramming to make blood cells and motor neurons, the cells that transmit nerve impulses and make muscles contract.

"This is another piece of evidence to say, 'So far, so good,' but we still have a long way to go," Kamp said. "This is going to take time and multiple different investigators looking at multiple different cell types."

"I think this is highly important, so important that we had asked the same question," said John Lough, a professor and stem cell researcher at the Medical College of Wisconsin, who had been working independently on a similar project. "We've seen the beating heart cells here."

Similar technique used

Lough and two other Medical College researchers, Stephen Duncan and Ana Sepac, have also been trying to grow reprogrammed cells into heart cells and have succeeded using a different method than the one employed by Kamp's team at UW. Nonetheless, Lough declared himself delighted with the UW paper, saying it strengthens the case for a future study he has been planning.

Researchers at the Medical College and Children's Hospital of Wisconsin hope to use the reprogramming method to study congenital heart disease in children and have submitted a grant request for the project to the National Institutes of Health. They're particularly interested in hypoplastic left-heart syndrome, a condition that leaves newborn babies with an underdeveloped left side of the heart. The condition is fatal unless surgically corrected.

Genta Narazaki, a stem cell researcher at Kyoto University's Institute for Frontier Medical Sciences (OOTC:MCLS) , said the UW work "has great meaning," and should pave the way for studies that will help researchers better understand heart disease.

In the last year, scientists have collected and reprogrammed skin samples from patients with spinal muscular atrophy and Lou Gehrig's disease, turning the cells into motor neurons in order to study the illnesses in a lab dish. This technique can now be extended to heart disease.

"I think many groups are doing it right now," Mummery said. "We are."

Merck Buys Insmed's Follow-On Business

Insmed sells Colorado facilities and their FOB business to Merck. Story from FierceBiotech:

Merck acquires biosimilars in $130M pact
February 12, 2009 — 10:38am ET | By John Carroll
Merck signaled its clear intent to get aggressive about the biosimilar business with this morning's announcement that the pharma giant is buying Insmed's portfolio of follow-on biologics for $130 million in cash. Merck's BioInvest will take over the development of INS-19 and INS-20, both intended to mimic existing biologics that prevent infections in cancer patients receiving chemotherapy. INS-19 is in late-stage trials while INS-20 is in early-stage development.

In what may become a pattern for similar deals, Merck is paying $10 million down and the other $120 million when the deal closes. There are no milestones in the deal. Merck is also buying a 50,000-square foot manufacturing facility in Boulder, CO in the pact. Insmed, meanwhile, plans to continue to develop its protein therapies.

"Insmed's pipeline of follow-on biologic candidates presents the opportunity to expedite Merck's entry into the biologics marketplace as well as providing unique manufacturing resources and an experienced team of protein experts," said Frank K. Clyburn, senior vice president and general manager Merck BioVentures. "This agreement represents a strong strategic fit for Merck as we aggressively expand and advance our portfolio of developmental follow-on biologics."

Like other pharma companies, Merck has opted to get aggressive about developing follow-on therapeutics. Unlike traditional small molecules, there is no regulatory pathway established in the U.S. to develop biosimilars. But lawmakers have signaled their intent to take on the issue this year. And with big pharma companies jumping into the game, BIO may find itself up against some heavyweight lobbying efforts in Congress.

Clinical Data Running Out of Cash?

Randall Kirk, Adenosine Therapeutics, Avalon Pharmaceuticals...lots of Virginia and Maryland references in this article.

Clinical Data Running Low on Cash, Evaluating Options
February 11, 2009

Newsletter:
GenomeWeb Daily News

NEW YORK (GenomeWeb News) – Clinical Data disclosed in a 10-Q filing this week with the US Securities and Exchange Commission that its current cash and cash availability is sufficient to fund operations only through March 2009.

The firm, which is developing therapeutics and sells genetic tests through its PGx Health division, reported earlier this week that its third-quarter revenues declined 4 percent year over year to $10.1 million. The company also noted that as of the end of the quarter its cash and cash equivalents were $25.7 million.

Over the past six months, Clinical Data has acquired two drug firms: Adenosine Therapeutics and Avalon Pharmaceuticals. It also is in the process of conducting phase III trials for its antidepressant vilazodone, for which it hopes to file for US Food and Drug Administration approval by the end of the year.

Clinical Data said in the 10-Q that it anticipates the total remaining cash required to file the new drug application for vilazodone will be between $25 million and $30 million.

"As a result of the acquisition of Adenosine Therapeutics, components of the merger structure with Avalon and the positive acceleration of certain components of the vilazodone clinical trials, the company believes that its cash and cash availability will only be sufficient to fund its operations through March 2009," it said in the filing. "This is based on a steady state view of the company’s financials and does not assume any cash inflows from partnerships, disposition of non-core assets or other dilutive or non-dilutive financings."

Among the options Clinical Data said that it is considering to bring in additional funds are partnering opportunities with pharmaceutical or biotech companies for vilazodone, licensing certain development programs or patents from recently acquired Adenosine Therapeutics, the sale of non-core assets, and the sale of equity or debt securities.

In September 2008, the firm raised $25 million through the private placement of 1,514,922 shares of newly issued common stock to affiliates of Randal Kirk, chairman of the Newton, Mass.-based firm’s board of directors.

Clinical Data said that if it is unable to obtain additional financing or funds through partnerships or divestitures, it will be required to implement "aggressive cost-reduction strategies."