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Posts Tagged ‘Pharma’

IPO market wobbles, venture-backed M&A reverses downward trend

Monday, July 2nd, 2012

venturesourceA five-week initial public offering (IPO) drought broke late last week as the second quarter ended with 11 IPOs of U.S. venture-backed companies, nine fewer than the first quarter.

Mergers and acquisitions (M&As) of venture-backed companies fared better in the second quarter as deal activity picked up slightly over the first quarter reversing a downward trend in deals that had been seen over the previous six months, according to Dow Jones VentureSource.

IPO chart

Eleven U.S. venture-backed companies raised $7.7 billion through IPOs in the second quarter, a drop in offerings from the same period last year when 14 IPOs raised $1.7 billion.

During the same time, 110 U.S. venture-backed companies were acquired, a slight uptick from the 98 M&As in the first quarter of 2012 but a 6% decline in deal activity compared to the second quarter of 2011.

“Dreams of a stable public market that appeared to be becoming reality in the first quarter were dashed by the worsening economic situation in Europe and Facebook’s underwhelming and problematic public debut,” said Jessica Canning, global research director for Dow Jones VentureSource.

“The silver lining this quarter may be M&A as deals are up slightly over the first quarter and have a solid start for the third quarter when Microsoft’s acquisition of Yammer is expected to close.”

Silicon Valley Companies Dominate IPOs

Start-ups based in Silicon Valley accounted for 72% of venture IPOs in the second quarter, a much larger proportion than the first quarter when they accounted for 35% of IPOs.

Venture companies took a median of $89 million and 8.5 years to reach an IPO, which represents a 14% drop in capital raised and a decrease in time from 8.7 years during the same period a year ago.

Currently, 44 U.S. venture-backed companies are in IPO registration. Eleven of those companies registered in the second quarter.

Software M&A Picks Up, Pharma Falls

M&A chartInformation technology (IT) was the most active industry for M&A as 47 deals raised $5.3 billion, a 9% increase in deals and 40% increase in capital raised. Within IT, software companies were the primary target for corporate buyers who acquired 36 software start-ups, an uptick from the 28 deals completed during the same period a year ago.

With 21 deals, consumer services was the second most active industry for acquisitions. It edged out healthcare and business and financial services by three and two deals respectively. All three of these industries, however, saw a decline in M&A deals from the second quarter of last year.

Dramatic drop in healthcare deal activity

The healthcare industry saw the most dramatic drop in deal activity as the number of acquisitions fell from 25 in the second quarter of 2011 to 18 in the most recent quarter. The drop was largely driven by the biopharmaceuticals segment which saw deals fall from 16 to 5.

“Promising technology companies are still being courted by corporate buyers, but in healthcare, regulatory uncertainty is making acquirers wary,” said Zoran Basich, editor of Dow Jones VentureWire.

During the second quarter, 110 mergers, acquisitions and buyouts raised $13.6 billion, a 6% decrease in deals and a 4% increase in capital raised from the same period last year. The median price paid for a company rose to $100 million from $64 million in the second quarter of last year.

To reach an M&A or buyout, it took companies a median of $20 million in venture financing, 2% more than in the second quarter of 2011, and a median of 5.1 years, less time than the 5.7-year median a year earlier, to build the company.

Viamet Pharma closes $25M equity round for drug improvement tech

Tuesday, February 22nd, 2011

ViametMORRISVILLE, NC- Viamet Pharmaceuticals Inc. has raised $25 million in equity financing, according to a regulatory filing. The company focuses on enzymes  that contain a metal, typically zinc or iron. About ten percent of current drugs target these “metalloenzymes.” Viamet’s technology makes those drugs more effective and safer, the company has said.

The company, founded in 2005, raised a $4 million round in 2007 and an $18 million B round in 2009 from Novartis Option Fund and Lilly Ventures. Existing investors who participated included Durham-based Intersouth Partners and Hatteras Venture Partners, also of Durham.

The filing with the US Securities and Exchange Commission disclosing the current raise lists Intersouth, Haatteras, and Novartis Option Fund in Cambridge, Mass.; Lurie Investment Fund in Chicago; and Indianapolis’ Lilly Ventures, a venture capital subsidiary of Eli Lilly and Co.

Other investors in the company include Headlands Ventures and Astellas Venture Management.

According to the company’s website, Viamet develops traditional small molecule compounds that exploit validated metalloenzyme targets in the fields of infectious disease and oncology.  All of Viamet’s therapeutic programs target indications with blockbuster potential and where current therapies have significant clinical deficiencies that can be addressed by the company’s technology.

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Chase Pharmaceuticals injects $1.2M for Alzheimer’s treatment

Thursday, January 6th, 2011

Chase PharmaceuticalsWASHINGTON, DC – DC-based Chase Pharmaceuticals Corp. has injected $1.2 million in equity funding from a single investor, according to a regulatory filing.

Among directors cited as principals in the filing with the US Securities and Exchange Commission, are John Reher and Karoly Nikolich of California-based Brain Trust Accelerator Fund, which was the sole investor in its A round in 2010.

The company says it is an early stage, product based, specialty pharmaceutical company located in Washington DC, focuses on the identification and initial clinical development of better medications for the treatment of neurologic and psychiatric disease.

Chase PHarmaceuticals was founded in 2007.

Chase Pharmaceuticals’ lead drug is CPC-001. a treatment for patients with Alzheimer’s disease and other dementias of the Alzheimer type, scheduled to enter Phase I studies in healthy volunteers in the first quarter of 2011 and begin Phase II proof of principle trials in the target patient population by the first quarter of 2012.

In addition, the company says on its Web site that it maintains an interest in the acquisition and clinical development of early- to mid-stage product candidates of exceptional promise. Included are those for the treatment of Parkinson’s disease, depression and stroke as well as other therapeutically underserved disorders of the central nervous system.

Thar Pharmaceuticals adds $2.3M to targeted $9.64M raise

Tuesday, January 4th, 2011

ResearcherTAMPA, FL – Thar Pharmaceuticals, which has offices in Tampa and Pittsburgh, has raised $4.31 million toward a targeted $9.64 million sale of mixed securities, according to regulatory filings.

The company, which disclosed the offering in filings with the US Securities and Exchange Commission, raised just over $2 million of the offering last month and a new filing shows it has raised an $2.3 million toward the expanded goal of $9.64 million.

The company transforms drugs normally administered via intravenous IV into oral products, increasing their convenience and lowering the cost of treatment.

The company is one of three spinouts from Thar Technologies, formerly Thar Designs, founded by Dr. Lalit Chordia in 1990. The other two areThar Instruments, a provider for green analytical and preparative chromatography; Thar Process, a supercritical fluid technology company.

Maryland-based Supernus Pharma files for $100M IPO

Thursday, December 23rd, 2010

Supernus PharmaROCKVILLE, MD - Supernus Pharmaceuticals, which is developing central nervous system treatments, has filed for a $100 million initial public offering of stock.

The company plans to trade on Nasdaq under the symbol “SUPN.”

The venture-backed company has raised funding from New Enterprise Associates, OrbiMed Associates, and Abingworth Management. NEA holds 44.8 percent pre-IPO stake, the largest. The other two investors hold 17.9 percent each.

Formerly known as Shire Laboratories, the company develops drugs for the treatment of epilepsy, Parkinson’s disease, conduct disorders, depression, anxiety, and attention-deficit/hyperactivity disorders.

Novartis adding 100 jobs at NC facility

Thursday, December 23rd, 2010

NovartisHOLLY SPRINGS, NC – North Carolina has seen a small spate of job gains – many fueled by state and local incentives – the last months of 2010.  Now, Novartis (NYSE: NVS) says it will expand its vaccine production plant in Holly Springs, adding another 100 jobs.

The $36 million expansion of the billion dollar facility will qualify the company to receive up to $3.7 million in state tax incentives.

Swiss-based Novartis says the new jobs will pay an average of $106.200 a year plus benefits. High paying jobs such as those tend to bleed more money into the local economy, which is one reason biotech and life science firms are eagerly sought by regions internationally.

The announcement of the Novartis expansion follows recent good economic development news in the state from smart phone maker HTC, Enviva, and Arvato.

Virginia-based Innocoll implants $5.25M financing

Monday, December 13th, 2010

microscopeASHBURN, VA - Innocoll Holdings Inc.,  a global pharmaceutical company selling topically applied healthcare products and surgical implants, has raised $5.25 million via a mixed securities offering, according to a regulatory filing.

The company raised $4 million selling mixed securities in 2009 and a $30 million A round of financing in 2007 led by Camulos Capital, with participation from Newsmith Capital Partners and Morgan Stanley.

It disclosed the current offering in a filing with the US Securities and Exchange Commission.

Innocoll focuses on the development of biodegradable surgical implants and topically applied healthcare products. It develops, makes and sells its  products globally.

Its  pipeline includes the CollaRx Gentamicin Surgical Implant, and a drug to treat and prevent surgical site infections; and CollaGUARD/Collieva, a drug for the treatment of ulcers, burns, split-skin donor sites, and other dermal wounds requiring temporary dermatoplasty.

The company’s Web site appears to be under construction.

Email TJS Editor Allan Maurer: Allan at Techjournalsouth dot com.

Blacksburg-based Intrexon gets $37.5M financing shot in the arm

Monday, November 15th, 2010

IntrexonBLACKSBURG, VA -Intrexon has closed on a $37.5 million mixed securities offering,  according to a regulatory filing. The company’s D round attracted 65 investors. Intrexon is developing a cancer therapy that enhances the immune system.

In March, we reported that Intrexon had raised $17.4 million in its D round from 40 investors, according to a filing with the U.S. Securities and Exchange Commission. It disclosed the current financing amount in an amended filing with the SEC.

Intrexon  raised the $25 million from two investors in December 2009, according to an SEC filing, which we reported here in January.

It raised $10 million in June last year and previously raised $25 million in 2007 for a total of $77 million plus.

New River Management funds, managed by Third Security,  and NewVa Capital Partners have been the company’s primary investors.

Intrexon says its modular DNA control systems can enhance capabilities, improve safety and lower cost in human therapeutics, protein production, industrial enzymes and agbio.

Its most advanced immunomodulatory therapy is intended to control and enhance the immune-modulating performance of dendritic cells to treat solid tumor cancers.

It is also using its “UltraVector” system of modular DNA controls to enhance human protein production for therapeutic drugs.

It says its capabilities also represent “an unparalleled opportunity to develop protein production systems that can be embedded inside a patient’s body and then regulated through the dosing of our external small molecule activator.”

In September, the company bought the assets and operations of Avalon Pharmaceutical Inc., a subsidiary of Clinical Data Inc., and assumed the lease on its Germantown, MD bioassay facility.

The company’s headquarters is located at the Virginia Tech Corporate Research Center in Blacksburg, Virginia, which is also the primary site for its advanced transgene engineering operations. Intrexon has additional business and R&D operations located in Germantown, MD; San Francisco, CA; and Valley Forge, PA.

Atlanta biotechs Inhibitex, Cardiac Regeneration nab federal grants

Wednesday, November 3rd, 2010

InhibitexATLANTA – Inhibitex, Inc. (NASDAQ: INHX) has been awarded approximately $489,000 in grants under the Qualifying Therapeutic Discovery Project  Program. This program was created under the Patient Protection and Affordable Care Act of 2010 to provide tax credits or grants representing up to 50 percent of eligible qualified investments in therapeutic discovery projects during tax years 2009 and 2010.

Inhibitex was awarded the grants for FV-100, which is in Phase II clinical development for the treatment of shingles, and INX-189, a nucleotide polymerase inhibitor in Phase 1b clinical development for the treatment of chronic hepatitis C infections.

Cardiac Regeneration Technologies has  received notification from the U.S. Internal Revenue Service (IRS) that it was approved to receive a grant in the amount of $244,000 for CRT’s investment in an unprecedented myocardial regeneration therapeutic discovery project. In July 2010, the company applied for the grant under the Qualifying Therapeutic Discovery Project.

Biogen cutting staff, moving jobs to RTP facility

Wednesday, November 3rd, 2010

Biogen IdecRESEARCH TRIANGLE PARK, NC – Weston-MA-based Biogen Idec Inc. (Nasdaq:BIIB), which has more than 800 employees in the Research Triangle, is cutting its workforce by 13 percent and moving some jobs to North Carolina.

“The company will relocate its U.S. workforce from six current locations into three existing state-of-the-art facilities in Weston and Cambridge, Mass., and Research Triangle Park, NC. ,” the company said a statement.

The company has a manufacturing plant and research and development facility in the RTP and a customer service office in Durham.

Biogen said it will close its San Diego office, consolidate offices in Massachusetts, and move some jobs to NC, although it did not say how many.

It has a total of about 4,750 employees, and the cuts will affect approximately 617.

Four NC biotech firms land substantial federal grants

Wednesday, November 3rd, 2010

BiocrystRESEARCH TRIANGLE, NC – BioCryst Pharmaceuticals (Nasdaq:BCRX), which is developing drugs to treat infectious diseases and cancer, won $1.1 million in grants from the US Department of Health and Human Services, the largest won by three Research Triangle-based biotechnology firms.

The company received grants for its Peramivir, a flu drug, BCX4208, a gout treatment, Forodesine, a treatment for types of cancer that affect blood, bone marrow, and lymph nodes, and two pre-clinical projects.

Pozen (Nasdaq:POZN) will land $730,000 for three programs aimed at pain relievers that reduce complications from taking aspirin.

Raleigh-based DARA BioSciences (Nasdaq:DARA) will receive $500,000 to continue development of its treatments for Type 2 diabetes and for neuropathic pain in cancer patients.

Durham’s Oxygen Biotherapeutics well get $245,000 in grants to support its treatment for brain and spinal cord injuries.

The grants are from the Patient Protection and Affordable Care Act, which made about $1 billion in funding available to underwrite costs of drug development. The program made grants available for up to 50 percent of expenses related to selected drugs and was aimed at firms with fewer than 250 employees.

Emory, GA Tech tackle head, neck, pancreatic cancers with $4.7M grant

Tuesday, October 26th, 2010

GA TechATLANTA—Researchers at Emory University and the Georgia Institute of Technology will join forces against head and neck cancers and pancreatic cancer using two grants from the National Cancer Institute’s Cancer Nanotechnology Platform Partnerships (CNPP) program. The cooperative five-year grants totaling $4.7 million will be used to develop nanoparticles as diagnostic and therapeutic tools against cancers.

The first grant totals more than $2.3 million over five years and is awarded to Dong Moon Shin, MD, professor of hematology, medical oncology and otolaryngology and director of the Winship Cancer Chemoprevention program, and Mostafa El-Sayed, PhD, Regents professor of chemistry and biochemistry and director of the Laser Dynamics Laboratory at Georgia Institute of Technology.

Their project, titled “Toxicity and efficacy of gold nanoparticle photothermal therapy in cancer,” is aimed at head and neck cancer, which develops in the soft tissues of the mouth and throat.

“We are excited and grateful for the opportunity to combine our laboratories’ biological and chemical expertise and to develop gold nanoparticle phototherapy into an effective tool against head and neck cancer,” says Shin.

When a laser is tuned to certain wavelengths, gold nanoparticles will absorb the energy and convert it to heat, thanks to a phenomenon known as “surface plasmon resonance.” Directing the nanoparticles to “home in” on cancer cells enables the laser to selectively kill them.

Researchers plan to target the molecule EGFR (epidermal growth factor receptor), which is found on almost all head and neck cancers, by binding the gold nanoparticles to antibodies against EGFR. Studies in animals on the toxicity of gold nanoparticles and how fast they move within the body are necessary before application in humans.

The second NCI grant for nearly $2.4 million over five years will be used to develop magnetic iron oxide nanoparticles as tools against pancreatic cancer, one of the most deadly of all cancer types. The principle investigators are Lily Yang, MD, PhD, associate professor of surgery and Hui Mao, PhD, associate professor of radiology and Center for Systems Imaging, both at Emory University School of Medicine.

The project, titled “Theranostic nanoparticles for targeted treatment of pancreatic cancer,” aims to combine the function of MRI visualization with drug delivery capabilities for pancreatic cancer therapy and diagnosis (thera – nostics).

Using magnetic iron oxide nanoparticles developed by Yang and Mao and their teams, researchers plan to improve the delivery of chemotherapeutic agents by directing drug-carrying nanoparticles to the molecule uPAR (urokinase plasminogen activator receptor), which is prevalent in pancreatic cancer cells.

Magnetic iron oxide nanoparticles will be loaded with different types of drug molecules that can be released at the site of the tumor or even inside of the tumor cells. “These nanoparticles can be tracked by magnetic resonance imaging (MRI),” says Yang, “so we will test our ability to monitor drug delivery and treatment responses with imaging technology.”

Other institutions receiving CNPP grants are Cedars-Sinai Medical Center; Children’s Hospital of Los Angeles; University of North Carolina; Northeastern University; Northwestern University; Rice University; University of Cincinnati; University of Nebraska Medical Center; University of New Mexico Health Sciences Center; and the University of Utah.

Georgia-based Effcon MXR nabs $522K of targeted $3M raise for glaucoma drug

Thursday, October 21st, 2010

MARIETTA, GA – Effcon MXR, a company developing a once-a-day version of a drug used to treat glaucoma, has raised $552,000 of a targeted $3 million raise, according to a regulatory filing.

The company, founded a year ago, received the funds from five investors, according to a filing with the US Securities and Exchange Commission.

It is developing a one time a day reformulation of methazolamide, which treats glaucoma and other intraocular pressure disorders.

The company apparently does not have a web site.

SEBIO names life science firms presenting at its Investor Forum

Wednesday, October 20th, 2010

SebioATLANTA – Southeast BIO (SEBIO), a regional nonprofit organization dedicated to fostering the growth of the Southeast’s life sciences industry, has named the best life sciences deals in the Southeast, as determined by a Selection Committee comprised of regional and national venture capitalists.  These companies, both early- and later-stage, will participate in the upcoming SEBIO Investor Forum being held on November 3-4, 2010 at the Ritz-Carlton, Buckhead in Atlanta, Georgia.

Those companies chosen for the EARLY/Stage event are seeking their first rounds of venture capital and/or angel investment. During the Investor Forum, the companies will participate in an advisory session led by active early-stage investors.  The MAIN/Stage presenting companies have generally completed at least one round of institutional financing and will each have the opportunity to make a ten minute pitch to the full conference audience.

Since 1999, companies that have participated in the SEBIO Investor Forum have raised over $2.5 billion in public and private offerings.

SEBIO has also selected four finalists for its Fourth Annual BIO/Plan Competition, a program developed to promote the creation of new, fundable life science companies based in the Southeast. Working closely with technology transfer offices and entrepreneurs throughout the region, the competition brings forward opportunities from leading Southeastern research universities and research centers. The BIO/Plan Competition received forty applications earlier this year from all across the Southeast.

SEBIO 2010 MAIN/Stage Companies
Avancen MOD Corporation (Mt. Pleasant, SC)
EGEN, Inc. (Huntsville, AL)
Intelliject, Inc. (Richmond, VA)
InVasc Therapeutics, Inc. (Tucker, GA)
RFS Pharma, LLC (Tucker, GA)
Visioneering Technologies, Inc. (Alpharetta, GA)

SEBIO 2010 EARLY/Stage Companies
Ariste Medical, LLC (Memphis, TN)
Atlanta Catheter Therapies, Inc. (Atlanta, GA)
AXOXY Laboratories, LLC (Gainesville, FL)
Bioshape Solutions, Inc. (Research Triangle Park, NC)
CvergenX, Inc. (Tampa, FL)
Endomimetics, LLC (Birmingham, AL)
GeneCapture, Inc. (Huntsville, AL)
Grace Innovative Technologies, Inc. (Mobile, AL)
HemoSonics, LLC (Charlottesville, VA)
NeurOp, Inc. (Atlanta, GA)
Physcient, Inc. (Durham, NC)
Restorative Physiology Group, LLC (North Charleston, SC)
Scytel Research (Chapel Hill, NC)
Vascular Pharmaceuticals, Inc. (Cary, NC)
Vivo Biosciences, Inc. (Birmingham, AL)

SEBIO 2010 BIO/Plan Finalists:
FibroTherapeutics, Inc. (Medical University of South Carolina)
NRG Biotechnology (Morehouse School of Medicine)
Reactive Diagnostics, Inc. (Georgia Institute of Technology)
SPECTROPATH Medical (Emory University)

Neuronex launches with $1.5M A round to develop CNS drugs

Friday, October 8th, 2010

NeuronexMORRISVILLE, NC – Neuronex Inc. has raised $1.5 million in Series A funding and was awarded a $250,000 Small Business Research Loan from the North Carolina Biotechnology Center to launch the company focused on developing drugs for central nervous system diseases and disorders.

The former management team for Addrenex Pharmaceuticals, one of the Research Triangle Park’s great success stories that sold to Shionogi Pharma last year and provided investors with multiple returns on their investment in less than three years, has launched the firm. The funding round was opened in August with an initial goal of raising $1 million and is already oversubscribed by the original investors in Addrenex, demonstrating confidence in the management team and their past success.

The company has licensed a lead product for the treatment of epilepsy and is already on a path to begin clinical trials before year end. Discussions are underway with other pharmaceutical companies and an academic center to rapidly build a portfolio of other products.

Neuronex is following the same fast-track model that led to the success of Addrenex.  “The same core management team is taking the same strategic approach with our new company,” said CEO Dr. Moise Khayrallah.

“Our business model is built around having a laser focus on our goals and speed through clinical development. Our strategy is to leverage our expert team of employees and consultants to identify and develop drug candidates for indications with a high probability of technical success and a clear development and regulatory path to approval.”

“We see excellent potential for Neuronex, based in part on the track record of its management team that architected the Addrenex success,” said Peter Ginsberg, vice president of business and technology development for the Biotechnology Center, which also provided loans in the formative stages of Addrenex. “The company’s lead product is targeted at an important poorly addressed population of epilepsy patients.”

Slate Pharmaceuticals raises $2M to treat aging problems

Wednesday, September 29th, 2010

DURHAM, NC – Durham-based Slate Pharmaceuticals Inc. has raised $1.99 million selling mixed securities, according to a regulatory filing. The company focuses on products to treat certain afflictions of maturing men and women.

Slate, founded in 2007 by a team of experienced pharmaceutical executives, currently markets Testopel, a treatment for low testosterone in men, in the United States.

Principals named in the filing with the US Securities and Exchange Commission disclosing the funding include Trygive Mikkelsen of T+T Holdings, a private investment company; and William Dahl, vice chair and co-foudner of Golden Pond Healthcare, Darien, CT.

The company raised $2.79 million in January, according to another filing with the SEC.

Durham-based Argos Therapeutics near close on $6M raise

Wednesday, September 22nd, 2010

Argos TherapeuticsDURHAM, NC – Argos Therapeutics, has raised $4.85 million of a targeted $6 million mixed securities offering, according to a regulatory filing.

Argos investors Lumira Capital, Forbion Capital Partners, CDP Capital, Intersouth Partners, Aurora Capital, and GeneChem, Mizuho Capital, Morningside Group and Japan Asia Investment Co.

The company raised a $35.2 million C round led by TVM capital in 2008. Formerly Merix BioScience Inc., the company has raised approximately $80 million in backing since 1997. The company disclosed the current offering in a filing with the US Securities and Exchange Commission.

The company is developing therapies that attempt to bring the immune system to bear on cancer and infections. It says the new approach offers real promise in the fight against many of the deadliest maladies.

Argos acquired its original dendritic cell technology from Duke University and Rockefeller University and has significantly improved it. It based on optimizing a patient’s own dendritic cells—the most potent stimulators of the immune system—to trigger a patient-specific immune response. They “program” the cells to recognize the patient’s specific cancer or virus.

The result is a specifically personalized immunotherapy.

Argos Therapeutics reported positive Phase II clinical trial results of its individualized HIV treatment at the AIDS Vaccine 2009 Conference.

The company said its AGS-004 had “unprecedented results” for its immunotherapy. The company plans additional Phase II testing to confirm the results, which tested for safety of the treatment and its impact on a patient’s viral load.

See TechJournal South’s 2009 profile of Argos for more information on its technology.

BARDA awards $51M anthrax vaccine contract to Maryland’s Emergent Biosolutions

Friday, September 17th, 2010

Emergent BiosolutionsThe U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) awarded a $51 million contract to Emergent BioSolutions, Inc., of Rockville, MD,  for the development of a new anthrax vaccine using the protective antigen  to stimulate a protective immune response that neutralizes the anthrax toxins.

Anthrax preparedness remains one of BARDA’s top priorities. This contract builds on HHS investments in antibiotics, antitoxins, and vaccine development for anthrax. It highlights the department’s commitment to develop a next-generation, recombinant anthrax vaccine. Consistent with the recent HHS medical countermeasure review, this program enhances the pipeline of potential products and increases the overall chances of success of developing a new vaccine.

In the first two years of the contract, Emergent will develop the final vaccine formulation and test its stability. HHS can extend the contract annually for up to three years to support scale-up and optimization for large-scale manufacturing and additional animal studies needed to apply for U.S. Food and Drug Administration approval of the vaccine. If the government extends the contract for all three years, the total five-year contract value could be $186.6 million.

This advanced research and development contract was awarded using a flexible federal government contracting tool known as a Broad Agency Announcement. This Broad Agency Announcement (BAA-BARDA-09-34) provides a way to identify innovative and promising technologies for advanced development across the chemical, biological, radiological and nuclear research areas of interest.

The current research areas of interest include vaccines, antitoxins, therapeutics, antimicrobial drugs, radiological/nuclear threat countermeasures, chemical threat countermeasures, and clinical diagnostic tools.

BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing of the vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health medical emergencies including chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.

The medical countermeasure review

Dyadic closes on final $1M of $4M private placement

Tuesday, September 7th, 2010

DyadicJUPITER, FL – Dyadic International Inc. (Pink Sheets: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of specialty enzyme products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, has received an additional $1 million to complete its previously announced private placement of convertible subordinated secured promissory notes. That brings its gross proceeds to $4 million.

Dyadic expects to use proceeds from this offering for working capital including continued investments in research and development and new product introductions, and general corporate purposes.

Dyadic’s President and CEO, Mark Emalfarb, said,  “The $4 million raised through the offering of these convertible notes, in combination with our current cash position, we believe provides Dyadic with sufficient capital to operate its business through the end of next year based on our current level of sales and without any additional licensing or other incremental revenue-generating events.”

It will continue to seek additional license sales and collaborations, he added.

Vaccine maker Medicago building $42M facility in RTP

Tuesday, August 10th, 2010

MedicagoRESEARCH TRIANGLE PARK, NC – Vaccine developer Medicago USA has won a $21 million Defense Advanced Research Projects Agency grant to develop a 90,000 square foot facility in Research Triangle Park to make vaccines from tobacco plants and virus-like-particles (VLPs). The $42 million project will demonstrate the company’s ability to make 10 million doses of flu vaccine a month.

Eventually, the project will create hundreds of jobs.

This DARPA project is an accelerated and integrated effort to deliver effective production of pandemic influenza in the United States.  The Accelerated Manufacture of Pharmaceuticals (AMP) program seeks to identify new ways to produce large amounts of high quality vaccine protein in less than 3 months in response to emerging and novel biologic threats.

Current methods of making flu vaccine from eggs is time-consuming and must be started well in advance of the flu season with researchers essentially guessing which strains will be active.

Rapid production possible

During the recent H1N1 influenza outbreak, Medicago’s rapid plant-based VLP vaccine technology was able to successfully develop a vaccine candidate in less than a month after identifying the H1N1 strain and is therefore one of the few technologies that can provide a solution in the case of a pandemic.

Andy Sheldon, President and CEO of Medicago, said, “This DARPA funding is also perfectly in line with our development plan for both our pandemic and seasonal influenza products as we will now have a US facility ready to participate in the $7 billion pandemic and seasonal influenza markets.

In addition, our U.S. facility will provide us enhanced access to the various grant programs in the U.S.A. and we will be ready to take part in these additional funding opportunities.”

Hundreds of jobs coming

“It’s vitally important to our Homeland Security that we have a robust domestic vaccine supply, and this facility will add to our production capacity helping mitigate future threats,” said Congressman David Price.

“Medicago’s facility will ultimately bring hundreds of good paying jobs to the region, and DARPA’s investment in this project is another significant contribution to local recovery efforts. This is a welcome confirmation that the Triangle continues to lead the way delivering innovative high-tech products and creating the jobs that will power a 21st Century economy.”

Rep. Price is the Chairman of the House Homeland Security Appropriations Subcommittee.

Medicago USA Inc. is a wholly owned subsidiary of Quebec-based Medicago Inc. (TSX: MDG).

The strategic collaboration is a $42 million project in which DARPA contributes $21 million, Medicago $7.5 million and Alexandria Real Estate Equities Inc. (‘Alexandria’) $13.5 million.

Alexandria Real Estate Equities is the largest owner and leading provider of high-quality environmentally sustainable real estate, technical infrastructure, and services to the broad and diverse life science industry focused in the leading life science clusters

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