SEBIO News

New Crowdfunding Site Allows Public to Advance U.Va. Research Projects Through Targeted Donations

Gabrielle — Thu, 16 May 2013 17:08:03 +0000

CHARLOTTESVILLE, VA - U.Va. Innovation launched the University of Virginia’s first crowdfunding website this week, enabling alumni and others to make targeted, tax-deductible donations in support of specific research and development projects under way at the University.

“The University of Virginia is among the very first institutions of higher education to use philanthropic crowdfunding to advance university research,” said Thomas C. Skalak, vice president for research at U.Va. “It’s our hope that this innovative initiative will build on the success of the University’s proof-of-concept research programs and establish a new model for funding promising, early-stage research.”

The site, accessible at www.virginia.edu/useed, features videos and information about select translational research projects seeking funding to achieve specified milestones, such as the development of a prototype. Featured projects are currently seeking between $19,000 and $35,000 to advance clean-water technology and improve visualization of injuries following sexual assault.

The site will feature up to 10 translational research projects over the course of a six-month pilot initiative. The pilot is being administered by U.Va. Innovation in collaboration with University Development and several schools and programs across Grounds.

“U.Va. researchers are constantly problem-solving through innovation,” said W. Mark Crowell, executive director of U.Va. Innovation and associate vice president for research at U.Va. “Through this crowdfunding initiative, we’re creating opportunities for members of the community to be a part of advancing these exciting discoveries.”

U.Va. Innovation has partnered with USEED Inc., a crowdfunding start-up focused on philanthropic fundraising for higher education, to conduct the pilot initiative, in which researchers reaching their fundraising goals will receive 100 percent of funds raised. For projects falling short of their funding goals, U.Va. Innovation team members will work with project leaders to adjust project milestones so that available funding can advance the respective project.

The site launched with two projects, which have until June 27 to meet their funding goals.

“Clean Water by PureMadi,” led by Jim Smith, professor of civil and environmental engineering in the School of Engineering and Applied Science, in collaboration with faculty and student researchers in the College of Arts & Sciences, McIntire School of Commerce, School of Architecture, School of Medicine and School of Nursing, is raising $35,000 to make life-saving water purification tools more widely available in rural areas of South Africa, where access to clean water is limited.

“Reducing Inequity in Forensic Exams Following Sexual Assault,” led by Kathryn Laughon, associate professor in the School of Nursing, in collaboration with Shayn Peirce-Cottler in the Department of Biomedical Engineering and Cassandra Fraser in the Department of Chemistry, is raising $19,000 to identify a new forensic dye that will help medical professionals visualize sexual assault injuries more effectively on women of all skin tones.

“We know through a number of research studies that nurses and physicians conducting forensic exams following a sexual assault are finding fewer injuries in women with darker skin, and we have good reason to think that that’s simply a matter of the technology we’re using to visualize these injuries,” said Laughon, who is also a forensic nurse examiner.

“Raising a relatively small amount of research funding through crowdfunding would help us go a long way toward identifying a solution to this important problem.”

For information about the platform or projects, or to make a donation, visit www.virginia.edu/useed.

http://ow.ly/l6m8i

Area celebrates 10 years of biotechnology advances

Gabrielle — Fri, 10 May 2013 20:37:43 +0000

ALACHUA, FL — Imagine a future where every time you take your medications, your body sends a message to your doctor.

And your doctor also would know when you don’t take them.

This medical message in a bottle would come in an ibuprofen-sized capsule lined with wiring that would send a signal to your doctor that starts after you swallow the medication and it hits your gastric juices.

Inventions like this one — from Newberry-based company “etect” — are being developed, as the saying goes, right in our backyard.

But if you live in Gainesville, you’re entitled to that cliche. Thirty biotechnology companies housed at RTI Biologics in Progress Corporate Park in Alachua are giving the area an internationally recognized reputation in biotechnology, and Thursday, May 9th marked a 10-year anniversary celebration of these developments.

“The event began in our back patio 10 years ago,” said Patti Breedlove, the associate director of the Sid Martin Biotechnology Incubator.

Gradually, the event has expanded to include booths with more than 70 spin-off companies and outside vendors. It’s free and open to the public, and primarily a networking event, Breedlove said.

“It puts the spotlight on our growth in the biotechnology sector,” she said.

Biotechnology is the use of living organisms such as bacteria or enzymes for drugs and other applications. Those applications, as evidenced by the companies featured Thursday, span gene therapy to tissue repair and cancer therapy.

Eleven percent of the country’s biotech companies are based in Florida, and many of those are in this area.

Chantelle Gomez, a senior research associate with Applied Genetic Technologies Corp., explained on Thursday that the company is working on gene therapy for eye conditions that cause blindness. Scientists there have figured out a way to reverse these conditions by delivering healthy copies of the faulty genes to the ocular cells.

Unlike other therapies, with gene therapy, “It’s a one-time dose and you are cured,” Gomez said. She added that trials with the therapy have produced positive results, which bodes well for eventual FDA approval.

“We are at the very edge of getting approval,” Gomez said. The company was highlighted on Thursday for receiving $37.5 million in venture capital investments.

Gomez said that working on such cutting-edge and transformative therapies is inspiring and makes the “hum-drumness” of lab work worthwhile.

“When you step back, these people who couldn’t see before now can see, and we’re not slapping them with a $200,000-a-year therapy,” she said.

Breedlove added: “This is not just academic research. It gets to the market. So it’s a win for Gainesville, a win for Alachua, and really even a win for Florida.”

Those “wins” have reached national and international scale recently. Spinoff company Nanotherapeutics, based in Alachua, won a Department of Defense contract worth more than $200 million in March, and shortly thereafter, the University of Florida’s Sid Martin Biotech Incubator was named 2013 international Incubator of the Year by the National Business Incubation Association.

The DOD contract is expected to provide 150 new jobs with an average salary of $90,000.

Other highlights presented Thursday include $20.8 million in financing for AxoGen and Syngenta’s acquisition of Pasteuria Bioscience for $113 million.

Nancy Bryan, the new CEO and president of BioFlorida, the bioscience industry association representing the companies, which also sponsored Thursday’s event, said, “My goal is that by the 20th anniversary, Florida will not only be known for its sun, beaches and oranges but its vibrant life sciences community.”

http://ow.ly/kUXIl

Heat Biologics files $20M public stock offering

Gabrielle — Thu, 09 May 2013 14:33:20 +0000

CHAPEL HILL, NC - Chapel Hill drug development company Heat Biologics has filed to go public, joining a slew of companies such as Quintiles (NYSE: Q), Liposcience (Nasdaq: LPDX), PlyGem and Chimerix (Nasdaq: CMRX) to take the plunge in 2013.

The small company, characterized as an “emerging growth” business under the JOBS Act plans to raise about $20 million in the offering and trade on Nasdaq under the symbol “HEAX.”

Heat’s technology platform aims to trigger a patient’s own cells in fighting cancer — an alternative to side effect-heavy chemotherapy.

The company has virtually no revenue, and its primary investors include Brightline Ventures (19.6 percent ownership), Eckhard Podack (7.3 percent), Orion Holdings (19.6 percent) and Seed-One Holdings (15.1 percent). Square One Bank holds virtually all the assets of the company excluding the intellectual property rights.

Heat CEO Jeff Wolf owns nearly 38 percent of the company. The sole book running manager is Aegis Capitol Corp.

http://ow.ly/kRGY2

Quintiles Announces Pricing of Initial Public Offering

Gabrielle — Thu, 09 May 2013 14:28:25 +0000

RESEARCH TRIANGLE PARK, N.C.- Quintiles today announced the pricing of its initial public offering of 23,684,210 shares of its common stock at a price to the public of $40.00 per share. The shares of Quintiles common stock are expected to begin trading on the New York Stock Exchange under the single-letter symbol “Q” on May 9, 2013.

Quintiles is offering 13,125,000 shares of common stock, and selling shareholders are offering 10,559,210 shares of common stock. In addition, the selling shareholders have granted the underwriters a 30-day option to purchase up to an additional 3,552,631 shares of common stock. The offering is expected to close on May 14, 2013.

Morgan Stanley, Barclays and J.P. Morgan are serving as joint lead book-running managers for the offering. Citigroup, Goldman, Sachs & Co., Wells Fargo Securities, BofA Merrill Lynch and Deutsche Bank Securities are serving as book-running managers for the offering. Baird, William Blair and Jefferies are serving as lead co-managers, and Guggenheim Securities, Piper Jaffray, Raymond James, RBC Capital Markets and UBS Investment Bank are serving as co-managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on May 8, 2013. The offering of these securities is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, via telephone: +1 (866) 718-1649 or by email: prospectus@morganstanley.com; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone: +1 (888) 603-5847 or by email: barclaysprospectus@broadridge.com; or J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or via telephone: +1 (866) 803-9204.

http://ow.ly/kRG3N

New company springs from nanotech Liquidia

Gabrielle — Thu, 02 May 2013 19:49:17 +0000

DURHAM, NC - Nanotechnology firm Liquidia Technologies is spinning out a new ophthalmology-focused company, building on the success of a recent partnership with GlaxoSmithKline (NYSE: GSK).

Last year, an agreement with GSK regarding Liquidia’s vaccine and pulmonary technology paved a cash runway for other possibilities with the platform.

CEO Neal Fowler released the following statement today:

“Liquidia has had the great fortune of being able to demonstrate how our transformative product development and manufacturing platform can be applied to the development of very promising therapeutics in high growth areas. … Developing a structure that allows for the creation and financing of new companies is a great fit for the ophthalmology focused business and is a structure we will continue to consider with other assets and therapeutic areas as we go forward.”

Specifics of the new company were not disclosed, but the company did say the lead product for the new entity would be a glaucoma treatment, expected to enter into clinical studies in 2014. It shouldn’t come as a huge surprise to industry watchers, as Liquidia’s chief scientific officer, Benjamin Yerxa, gave a speech earlier this year on applying the technology to glaucoma.

Liquidia could not make any additional comments, but a spokesperson promised to release more information about the new company in the second quarter of this year.

In the meantime, Liquidia proper will remain focused on its vaccine and pulmonary product development platform, including work already initiated as part of the GSK collaboration.

Founded in 2004 as a UNC-Chapel Hill spinoff, Liquidia utilizes a technology platform called PRINT, a particle engineering system that Fowler says has multiple potential applications.

http://ow.ly/kEyKn

BioFlorida names Bryan CEO

Gabrielle — Thu, 02 May 2013 19:43:59 +0000

WEST PALM BEACH, FL – BioFlorida, the advocate for the state’s life sciences industry, named Nancy Bryan as president and CEO.

She replaces Russell Allen, who left to become the head of Georgia Bio. The West Palm Beach-based organization selected Bryan after conducting a national search.

She’s been in the industry for more than 25 years, including positions as senior vice president of commercial operations at NPS Pharmaceuticals, senior vice president of marketing and sales for Indevus Pharmaceuticals and head of commercial operations at Elan Pharmaceuticals for the global autoimmune franchise. She holds an MBA in marketing and business economics from Columbia University.

“After carefully considering all of the applicants, we are confident that Nancy will apply her outstanding business experience and leadership skills to help us build on the current momentum of Florida’s growing life sciences community,” stated Leslie Croland, chair of BioFlorida’s search committee and a partner with Duane Morris.

BioFlorida represents more than 3,000 companies.

http://ow.ly/kEy7e

Seeking a cure: MUSC biotech spinoff wages its own small war on cancer

Gabrielle — Tue, 30 Apr 2013 14:11:28 +0000

CHARLESTON, SC – Just inside the entrance to the Medical University of South Carolina’s Hollings Cancer Center is a tall, bronze sculpture of a wing.

Painted on the wall beside it is a stanza from an Emily Dickinson poem.

Hope is a thing with feathers

That perches in the soul

And sings the tune without the words

And never stops at all.

It’s an uplifting message for a place where patients, doctors and researchers stare down grave diseases and seek to overcome them.

Dr. Jim Norris, whose cramped third-floor office features an enormous computer screen among piles of papers, golf paraphernalia and boxes of green tea, is one of those researchers, one who’s been at it longer than most.

While global cancer prevalence has increased even as treatments have progressed during his quarter-century at MUSC, Norris still has hope — hope that a molecule he discovered several years ago may, several years from now, become a commercially viable drug, part of the mythical cure.

His acid ceramidase inhibitor, the most promising of his company SphingoGene’s three molecules, is still in the beginning stages of development. But in a PowerPoint presentation to potential investors in Boston this month, Norris said if the preclinical results hold, then SPG105, as the inhibitor has been tagged, “has standard-of-care blockbuster drug potential in the radiation treatment industry.”

That is, if it works, by preventing cancer cell proliferation, the drug would allow for lower-dose, higher-efficacy radiation, improving patients’ quality of life while reducing relapse and death rates.

“When we inhibit the enzyme,” Norris explained, “we get a cure.”

Cure?

Using the “C” word regarding cancer is tricky business. This month’s Time magazine cover claimed curing cancer is “now possible” thanks to “new cancer dream teams” and generated controversy in its wake.

Norris doesn’t buy the “dream team” idea. “The cure for cancer is going to come from little guys like me,” Norris said.

According to the plan, SphingoGene would start with prostate cancer, a common radiation target with almost a million cases treated annually worldwide, and then move on to applications for even more prevalent cancers such as those in the lung and breast.

According to the company’s commercialization plan, the total estimated worldwide market for SphingoGene’s products is projected to be between $1 billion and $5.2 billion per year, depending on market penetration, which would be on the high end if the drug eventually becomes standard of care. That’s a lot of lives extended and a lot of money for whoever’s selling the drug. But it comes with just as many “ifs.”

“Now, that’s completely hypothetical at the moment,” Norris, SphingoGene’s chairman and CEO, said last week. “But that’s the dream that we have.”

The problem is, some seven years and more than $2 million into a process that began with a National Cancer Institute grant, there’s still a long way to go and no money to get there.

Norris, who served as chairman of MUSC’s department of microbiology/immunology for a decade, said SphingoGene needs another $2 million just to get to the FDA’s doorstep to ask permission to do a clinical trial (i.e., test the drug on human patients).

“Five or six million dollars would really get us started toward knowing whether this is a good drug or not,” he said.

Ideal outcome

The SphingoGene team, including a veteran banker, have irons in the fire from a reformulated grant application Norris submitted to the National Institutes of Health this month to investment contacts around the country and beyond.

And last fall, a team of MUSC and College of Charleston students used SphingoGene’s portfolio to win the University of California-San Diego Rady School of Management’s Student Venture Open, a business plan competition.

But Norris can’t hold on much longer, lending his own money to the company. Paying for patent prosecution and license fees to MUSC “ain’t cheap,” he said, and the 69-year-old has his eye on retirement.

The ideal outcome, Norris said, is “develop this up through Phase II and then have Merck or Johnson & Johnson buy it, and we can go golfing, and they can develop it.”

But beggars, even with Ph.D. degrees and promising technology, can’t be choosers.

“I’m waiting for a grant or investor to come by,” he said. “I don’t care who does it. I just want to get it moving.”

To make that happen, he’ll need more than a wing and a prayer. But he’s not stopping yet.

Tranzyme Pharma and Ocera Therapeutics Announce Merger Agreement

Gabrielle — Tue, 30 Apr 2013 13:48:46 +0000

RESEARCH TRIANGLE PARK, N.C. — Tranzyme Pharma (Nasdaq:TZYM) (“Tranzyme”), a biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics, and Ocera Therapeutics, Inc. (“Ocera”), a privately held biopharmaceutical company developing novel therapeutics for liver diseases, today announced that they have entered into a definitive agreement under which Ocera will merge with a subsidiary of Tranzyme in an all-stock transaction. The merger is expected to create a NASDAQ-listed company focused on the development of novel therapeutics for patients with acute and chronic decompensated liver disease, an area of high unmet medical need. Upon closing, the company will be named “Ocera Therapeutics, Inc.” (the “Company”).

Concurrently with the execution of the merger agreement, the Ocera investor syndicate committed to a $20 million PIPE financing for the Company, which will close with the merger. All of Ocera’s largest preferred stock investors, including Domain Associates, Thomas McNerney & Partners, Sofinnova Ventures and InterWest Partners, have committed to participate in the PIPE financing.

“Following an extensive and thorough review of strategic alternatives, we believe the proposed merger with Ocera offers the best value for our stockholders”, said Vipin K. Garg, PhD, Tranzyme’s President and Chief Executive Officer. “We expect the merger will benefit from the substantial synergies of the combined management team’s extensive experience in drug development, specifically in hepatology, which will help accelerate the transition and allow for efficient execution of the development plan.”

Linda Grais, MD, President and Chief Executive Officer of Ocera, stated, “The merger and concurrent financing will allow the Company to continue to advance Ocera’s lead clinicalprogram, OCR-002, a differentiated product candidate for orphan liver diseases currently in Phase 2 development. This product candidate addresses a significant unmet need in the treatment of acute hepatic encephalopathy, and we look forward to the initiation of our Phase 2b trial later this year and additional Phase 2a data in 2014.”

OCR-002 has received Orphan Drug designation in the United States and Europe and has been granted fast track status by the U.S. Food and Drug Administration. We estimate that there are up to one million patients with cirrhosis in the United States, and approximately 150,000 hospitalizations occur annually due to complications of encephalopathy, costing the healthcare system approximately $7 billion every year. For more information about clinical trials related to OCR-002, please visit:www.clinicaltrials.gov.

Details of the Proposed Transaction
On a pro forma basis, prior to the financing transaction discussed below, based upon the number of shares of Tranzyme common stock to be issued in the merger, current Tranzyme shareholders will own approximately 27.4% of the Company and current Ocera shareholders will own approximately 72.6% of the Company. The final number of shares will be subject to adjustments at closing based on each company’s cash levels and other matters at closing. The transaction has been unanimously approved by the board of directors of both companies. The merger is expected to close in the third quarter of 2013,subject to approval by a majority of Tranzyme stockholders, review by the Securities and Exchange Commission and customary closing conditions as detailed in the merger agreement.

Concurrently with the execution of the merger agreement, Tranzyme entered into a securities purchase agreement pursuant to which certain investors agreed to purchase, and it agreed to sell, $20 million worth of its common stock at a price to be determined based on the weighted average trading price of Tranzyme’s closing price for the 10 days prior to the closing of the merger. The securities purchase agreement is conditioned on closing of the merger transaction and customary closing conditions as detailed in the securities purchase agreement, and contains customary representations, warranties, covenants and indemnities.

In connection with the merger, Tranzyme plans to effect a reverse stock split intended to increase its trading price to above the minimum requirements of Nasdaq for allowing the company to remain listed following the transaction. Whether Tranzyme will remain listed following the transaction depends on whether Tranzyme will satisfy all of the applicable Nasdaq requirements.

Stifel served as financial advisor, Goodwin Procter LLP served as legal counsel to Tranzyme and Skadden, Arps, Slate, Meagher & Flom LLP served as legal counsel to the special committee and the board of directors of Tranzyme with respect to the transaction. Reed Smith LLP served as legal counsel to Ocera with respect to the transaction.

Management and Organization
Following the merger, the Company will be headed by Linda Grais, MD, the current President and CEO of Ocera. The corporate headquarters will be located in San Diego, California. Clinical and regulatory operations will be led by Franck S. Rousseau, MD, Chief Medical Officer of Tranzyme, in the existing office in Research Triangle Park, North Carolina. The board of directors will be comprised of representatives from both the existing Ocera and Tranzyme companies, including Drs. Grais and Rousseau. Upon completion of the merger, Dr. Vipin K. Garg, Tranzyme’s President and CEO willdepart the Company to pursue other interests.

About OCR-002
OCR-002 (ornithine phenylacetate) is an ammonia scavenger designed to treat hyperammonemia and associated hepatic encephalopathy in patients with liver cirrhosis, acute liver failure and acute liver injury. OCR-002, through its dual mechanism of action, directly lowers circulating blood levels of ammonia by enabling alternate metabolic pathways in the muscle and kidney in patients with decompensated liver cirrhosis, and or liver failure from other causes. OCR-002 is being developed as an injectable formulation for hospitalized patients and as an oral formulation to treat and prevent recurrences of hepatic encephalopathy. Hepatic encephalopathy is an often-reversible neuropsychiatric abnormality observed in patients with liver disease; it is marked by a worsening of brain function when the liver is no longer able to remove toxic substances such as ammonia in the blood. Ammonia accumulation in the blood impairs brain cell function. Signs of hepatic encephalopathy include impaired cognition, uncontrolled movements and decreased levels of consciousness leading to coma and death due to brain swelling.

Planning is underway to initiate a Company-sponsored Phase 2b, randomized, double-blind, placebo-controlled, efficacy study of OCR-002 as a treatment for acute hepatic encephalopathy in hospitalized patients with liver cirrhosis. Enrollment is expected to begin in late 2013. OCR-002 also is the subject of two ongoing, externally-sponsored, Phase 2a studies in patients. Data from these studies are expected in 2014.

Biota Pharmaceuticals relos HQ to Atlanta

Gabrielle — Mon, 15 Apr 2013 19:47:48 +0000

ALPHRETTA, GA – A Northeast biopharmaceutical company is relocating its headquarters to Alpharetta as part of a consolidation and corporate restructuring.

Rockdale, Md.-based Biota Pharmaceuticals, Inc. [NASDAQ: BOTA] focuses on the discovery and development of anti-infective products to prevent and treat a number of serious and potentially life-threatening viral and bacterial infectious diseases.

Biota is developing drugs aimed at treatment of respiratory syncytial virus (RSV) disease and Hepatitis C (HCV) virus infections. Biota also has an advanced program for the treatment of human rhinovirus (HRV) infection.

Biota will initially employ about 20 at its Alpharetta headquarters.

Biota is led by two former executives at Inhibitex — an Alpharetta-based clinical-stage drug development company acquired by Bristol-Myers Squibb Co.

CEO Russell Plumb was president, CEO and CFO of Inhibitex, a clinical-stage drug development company. Biota’s executive vice president, Joe Patti was a co-founder of Inhibitex, and served as its chief scientific officer.

The two executives joined Biota, following the merger of Nabi Pharmaceuticals and Biota Holdings Ltd.

As part of the restructuring, Biota will shift its primary focus from early-stage research to clinical-stage development programs that it could independently advance into late-stage development.

Biota is also cutting its workforce by about 30 percent over the next several quarters. The cuts will be focused on the R&D unit, but will include other business units.

Biota anticipates to take a $2 million charge in the fourth quarter of its 2013 fiscal year (ending June 30) related to the cost of one-time termination benefits. The company expects to save $3.8 million in annual salaries and benefits on an ongoing basis.

http://ow.ly/k5vKM

Sanuwave lands patent for blood sterilization

Gabrielle — Thu, 11 Apr 2013 19:31:33 +0000

ALPHARETTA, GA - Sanuwave Health Inc. secured a patent for a blood sterilization technique involving external shock waves.

The Alpharetta, Ga.-based company develops extracorp real shock wave technology for chronic wound care, cardiovascular, neurological and orthopedic conditions. It reported Thursday the U.S. Patent and Trademark Officeapproved a patent called “Method and Devices for Cleaning and Sterilization with Shock Waves.” The patent relates to a new method that sterilizes blood by applying external shock waves to destroy blood pathogens contained in bags, pipes and tubes. The patent lasts to July 2031.

“This marks the first of many patents that we intend to add to our intellectual property portfolio to broaden the use of our technology beyond wound care and regenerative medicine,” said Joseph Chiarelli, Sanuwave CEO, in a statement.

“… This new patent protects a novel capability of our proprietary technology and has the potential to be a significant asset for our company. Blood sterilization represents a large, unmet medical need.”

Chiarelli said the company’s shock wave technology disrupts the outer membrane of bacteria and viruses to kill them.

http://ow.ly/jYLmS