Emergent Biosolutions Inc. said it has secured exclusive right to manufacture and sell VaxInnate Corp.'s pandemic influenza vaccine candidate in the United States.

Under a license agreement with VaxInnate, Emergent Biosolutions acquired exclusive U.S. commercial rights to next generation pandemic influenza vaccine candidate.

This license enables Emergent to fulfill the requirement to secure a pandemic influenza vaccine candidate under its contract with the Biomedical Advanced Research and Development Authority (BARDA), the company noted.

Maryland policymakers have taken encouraging steps the past two years to strengthen the state’s technology and life sciences economy.

Two years ago, they expanded access to capital for early-, mid- and late-stage growth companies through the InvestMaryland program.

Last year, they accelerated the transfer of novel technologies from universities into the hands of private companies through the Maryland Innovation Initi

Every day, inside our body, there is a war going on. Microscopic invaders of one kind or another try to make a meal of us, and our immune system fights back, seeking out the invaders and destroying them. One of our body’s most important foot-soldiers in this war is the T cell, a type of white blood cell with receptors that can recognize foreign substances. Like all white blood cells, T cells originate in the bone marrow, but then they migrate to an organ called the thymus (hence the “T” in “T cell”), where they evolve into specialized immune system warriors. Mature T cells, which leave the thymus and circulate around the body, come in different types. One type, the cytotoxic T cell, specializes in attacking and killing cells of the body that are infected by viruses, bacteria, or cancer.

Emergent BioSolutions Inc. (NYS: EBS) announced today that it has signed a license agreement with VaxInnate Corporation under which Emergent acquired the exclusive right to manufacture and sell VaxInnate's pandemic influenza vaccine candidate in the United States. The product candidate, a recombinant vaccine, has the potential to be produced quickly, at high yields and in a cost-effective manner. This license enables Emergent to fulfill the requirement to secure a pandemic influenza vaccine candidate under its contract with the Biomedical Advanced Research and Development Authority (BARDA), which established Emergent as a Center for Innovation in Advanced Development and Manufacturing (Center) in June 2012. VaxInnate will continue to develop its pandemic influenza vaccine candidate under its current BARDA contract and Emergent will manufacture the pandemic influenza vaccine candidate using flexible manufacturing technology.

The U.S. Small Business Association (SBA) published a final rule on Thursday that will implement changes to the Small Business Innovation Research (SBIR) program, such as eligibility criteria that now includes companies that are majority-owned by multiple domestic VCs. The rule is implementing the SBIR/STTR Reauthorization Act, which was signed into law this year and extended the SBIR program through Sept. 30, 2017. The changes take effect on Jan. 28, 2013 (see BioCentury, Oct. 17, 2011).

The Johns Hopkins Bloomberg School of Public Health was awarded a four-year, $5 million grant from the Bill & Melinda Gates Foundation to promote the effective use of oral cholera vaccine around the world. The Delivering Oral Vaccine Effectively (DOVE) program will provide relief agencies and governments with technical assistance on how to use oral cholera vaccine, evaluate current vaccine-use practices and develop new field surveillance methods for monitoring and controlling outbreaks of the disease.

Cholera is an infectious disease caused by drinking unsanitary water. The disease is estimated to be responsible for between 100,000 to 200,000 deaths worldwide each year and infects as many as 2.5 million people annually. The oral cholera vaccine is over 70 percent effective and costs $1.85 per dose, but is not yet widely used in preventing outbreaks.

CytImmune and AstraZeneca have entered into an agreement to study the feasibility of a new cancer nanomedicine that will bind an oncology compound from AstraZeneca to CytImmune's CYT-6091 nanomedicine platform.

CYT-6091, which is comprised of gold nanoparticles bound with an immune avoiding molecule (PEG-Thiol) and tumor necrosis factor alpha (TNF), has been successfully tested at the National Cancer Institute, Bethesda, MD in a phase I clinical trial in advanced-stage cancer patients. As seen in that study, the gold nanoparticles trafficked to tumors, not to healthy tissue, resulting in an improvement in the safety of systemically administered TNF formulated as CYT-6091.

The pharmaceutical giant AstraZeneca­ is expected to announce this week that its oncology unit in Waltham is collaborating with a Maryland company to develop an innovative cancer therapy. The proposed treatment involves delivering powerful cancer drugs on the backs of gold nanoparticles made by CytImmune, of Rockville, Md., that are so tiny 5,000 of them can fit in the width of a human hair.

At that size, the gold flecks make a particularly good vehicle because they can easily carry other molecules, like cancer drugs. They are also believed safe to use in the body.

Reston-based New Atlantic Ventures, which invests in technology start-ups, has launched its fourth venture capital fund.

The New Atlantic Venture Fund IV expects to raise $125 million, with its first investors contributing $42.5 million in the fund's initial sale last week.

New Atlantic Ventures currently holds stakes in more than two dozen start-ups, including six in the Washington area. It currently has $230 million in capital under management.

As we anticipate a new year characterized by unprecedented interest in healthcare innovation, pay particular attention to the following three emerging tensions in the space.

Tension 1: Preventive Health vs Excessive Medicalization

A core tenet of medicine is that it’s better to prevent a disease (or at least catch it early) than to treat it after it has firmly taken hold.   This is the rationale for both our interest in screening exams (such as mammography) as well as the focus on risk factor reduction (e.g. treating high blood pressure and high cholesterol to prevent heart attacks).

A Maryland corporation established to help accelerate the commercialization of new technologies has awarded nearly $300,000 to three Johns Hopkins-related projects that hold promise for ushering new medical devices to the marketplace.

In its first round of investments, the Maryland Innovation Initiative (MII) on Dec. 19 awarded three awards to BOSS Medical LLC, a Johns Hopkins University start-up company, and to two School of Medicine faculty members who are working on other medical devices.

Clear Guide Medical LLC is readying its first product, a medical device used in minimally invasive ultrasound surgeries that will be for sale in early 2014. Federal and state grants received this year aided the commercialization process for the Johns Hopkins spinoff, which hopes to receive another state grant early next year.   

The Baltimore life sciences company received a total of $550,000 from the federal National Institutes of Health and National Science Foundation, in 2011 and 2012, and $125,000 from the Maryland Technology Development Corp. in 2010 and 2012. It is waiting to hear about another grant from the latter, for $100,000.

Lonza today announced together with Sartorius Stedim Biotech (SSB), a leading international pharmaceutical and biotech supplier, a long-term global collaboration, supply and distribution agreement in the field of cell culture media. Cell culture media are growth substances and nutrients for cells or microorganisms and are required in every biopharmaceutical manufacturing process.  

In the agreement, SSB will assume global sales and marketing of media and buffers used in the manufacture of protein-based therapeutics and vaccines, while Lonza will continue to carry out development, manufacture and logistics operations for these products. New product development will be mutually performed. The cell culture media, which are usually sold in liquid or powder form to biopharmaceutical customers, are to be successively converted to packaged forms as ready-to-use, pre-filled SSB sterile single-use bags. Furthermore, Lonza and SSB have agreed that these cell culture media will be sold under both brands in a co-branding arrangement. Lonza will maintain commercial responsibility for global sales and marketing of media used for research purposes and in the manufacture of cell-based therapeutics and gene therapy as well as for manufacturing for any of Lonza’s custom manufacturing customers.  

Join us for the upcoming Tech Transfer Speakers Series event on January 9th, 2013:

"Do You Know the Export Control Regulations Impacting Your Technology Business?"

How well do you know the export control regulations affecting the technology industry? Right now there are dramatic changes to the export control requirements that technology firms need to be aware of to avoid fines. Questions such as: Do I need a license from the government to have a foreign national work on my technology here ? How can I find out if my technology requires a license for its export ? What about fundamental and basic research- is a license required ? Will I need to have an export license for government contracts ? If I have an office overseas working on research, is an export license required ? These questions and more will be addressed.

Presenter:

Stephen Hall
Senior Policy Analyst
Office of Exporter Services, Bureau of Industry and Security
United States Department of Commerce

For more information, and to register: http://techtransferspeakers.eventbrite.com/

Investment in research & development in the U.S. life science industry will turn a corner in 2013 after three years of reduced spending, if a new market analysis is correct.

In their 2013 R&D Funding Forecast (PDF), research and development organization Battelle and R&D Magazine propose that U.S. life science companies will bump up their total R&D spending from $181.6 billion in 2012 to $189.3 billion in 2013. Better access to healthcare information, via data analysis, will accelerate and enhance pharmaceutical R&D and adoption of connected health technologies, they say.

In an unexpected move that could have significant implications for Maryland, Sen. Barbara A. Mikulski will be named the first female chair of the powerful Senate Appropriations Committee on Thursday.

The Baltimore native and Maryland Democrat, who had been the most senior member of the U.S. Senate without a committee gavel, was suddenly in line to head the influential spending panel following behind-the-scenes maneuvering for chairmanships that played out after the death Monday of its former chairman, Sen. Daniel Inouye of Hawaii.

The Democratic caucus is expected to formally approve her chairmanship Thursday.

Two Johns Hopkins researchers and a medical device company are the first recipients of grants from the Maryland Innovation Initiative.

The Innovation Initiative, a program intended to promote commercialization of university research, awarded $300,000 to the three recipients.

Maryland's second-in-command on economic development matters will step into the top job in January when the current secretary leaves for the private sector, state officials announced Wednesday.

Dominick Murray, who joined the Maryland Department of Business and Economic Development six years ago, will succeed Christian S. Johansson as secretary of the agency. Johansson is heading to Baltimore-based Laureate Education, a company that runs universities worldwide, after nearly four years as agency chief.

Both officials were praised by the Maryland Chamber of Commerce on Wednesday for their work on entrepreneurship and efforts to give businesses more of a voice.

Blend Therapeutics, a 1-year-old pre-clinical biotech focused on oncology drugs, has raised $16 million in Series B financing and named the former head of Sunovion Pharmaceuticals as its new CEO.

The $16 million round was led by NanoDimension, and existing investors Flagship Ventures and New Enterprise Associates also took part.

MedImmune, the global biologics arm of AstraZeneca, announced that it has signed an in-licensing agreement with Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) for Progenics’ Clostridium difficile late-stage preclinical program.  The agreement was led by MedImmune’s Infectious Diseases & Vaccines Innovative Medicines (iMed) Unit.

Clostridium difficile infections are the leading cause of hospital-acquired bacterial infections in the U.S. and are associated with more than 20,000 deaths and more than $1 billion in healthcare costs annually. The disease causes severe diarrhea in patients and significantly lengthens the time patients stay in the hospital, leading to poorer outcomes. MedImmune’s program for this property will assess the potential efficacy and safety of treatment of the infection with investigational monoclonal antibodies targeting toxins that mediate the disease.

NHLBI Funding and Research Opportunities

The following funding opportunities from the NHLBI or other components of the National Institutes of Health, might be of interest:

Request for Applications (RFAs):

• RFA-HL-13-026: Mechanisms of HIV-Related Lung Disease (U01)
• RFA-HL-13-028: Mechanisms of HIV-Related Lung Disease Data Coordinating Center (DCC) (U01)

Program Announcement (PA):

• PA-13-041: Collaborative Activities to Promote Metabolomics Research (Admin Supp)

Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.

University of Maryland System’s Diverse Space Offerings Provide Sterilization Technology Company the Ability to Grow Locally

Baltimore, MD, December 18, 2012 – The University of Maryland (UM) BioPark announced today that Noxilizer, Inc., a sterilization technology company, is the latest advancing life sciences company to sign a lease for space within the BioPark. Noxilizer relocates to the UM BioPark from the bwtech@UMBC Research and Technology Park in Baltimore County to accommodate the company’s explansion plans.

Said Jane Shaab, UM Research Park Corporation Senior Vice President, “Noxilizer’s move to the UM BioPark symbolizes the diverse space offerings within the University of Maryland system. This move also adds to our mix of growing technology businesses, research centers, and educational offerings.”

CONGRATULATIONS to 20 INNoVATE 2012 graduates—celebrating completion of their unique commercialization training program--co-sponsored by UMBC, NSF & JHU-- in Rockville last night. (See class below)

- Gaurav Basu (Skin-S)
- David Beylin (Brain Biosciences Inc.)
- Kostyantyn Bobyk (MyoTherapeutics, LLC)
- Eva Chin (MyoTherapeutics, LLC)
- Gina Devasahayam (GenetikSignal, Inc.)
- Ghadeer Hasan (Relocation Support Services)
- Lawrence Jones (TelaSense)
- Dun Liang (ViDDx)
- Saravana Murthy (Onc-Marcare)
- Oluwadamilola Ogunyankin (Jifad Fuels)
- Ping Qiu (NoInfection Pharmaceutical)
- Zelicia Read (Vital-Sight, Inc.)
- Anthony Saleh (Nitron Therapeutics)
- Colleen Sico (InnoSico, LLC)
- Andrew Stewart (Tolerogenix)
- Raimon Sunyer (TelaSense)
- Rajesh Thangapazham (Skin-S)
- Leonard Wayne (ExTenebris Optics, LLC)
- Christopher van de Wetering (Chesapeake Cellular)
- Mark Ziats (NeuroNetDx)

University of Maryland, Baltimore said Monday it reached its $650 million fundraising goal, a record for the school.

The campaign, launched in fiscal 2005, has supported several campus projects, including construction of a new campus center, improvements at the law school, an endowed scholarship for nursing students and nearly twice as many endowed chairs and professorships at the School of Medicine.

Two little-hyped drugs developed by Human Genome Sciences Inc. and Sucampo Inc. (Nasdaq: SCMP) have won Food & Drug Administration nods.

The approval of HGS' Raxibacumab as a treatment and prevention for inhaled anthrax and the supplemental approval of Sucampo's Rescula, for glaucoma and ocular hypertension, both represents wins for Maryland biotech.

Startups are coming out of the woodwork to vie for InvestMaryland cash. Under a business plan competition, the state-run investment program is offering prizes of $100,000 to three early-stage companies.

Prizes will go to a company in the life sciences, one in the IT space and one in a general category.

Not surprisingly, a whopping 259 startups applied — a colorful bunch that includes entities such as BodyCount LLC, A.I.R. Lawn Care and Fraud Sniffr, as well as some more traditional tech and biotech companies, according to an official list. About 10 percent of the companies that applied are from out of state.

Dr. Gene Green, a senior executive within Johns Hopkins Medicine's doctors group, has been appointed president of Suburban Hospital in Bethesda.

He replaces veteran hospital chief Brian Gragnolati, who will now turn his attention full-time to his corporate duties as senior vice president in charge of the system's Community Division. The division includes Suburban, Howard County General Hospital and Sibley Memorial Hospital in D.C.

Two Baltimore-area startups have received a total of $300,000 from InvestMaryland.

Plasmonix Inc., a life sciences company based at bwtech@UMBC Research & Technology Park, received $100,000 from the startup funding initiative. Bambeco, an eco-friendly home decor and furniture company in South Baltimore, received $200,000. Bambeco previously got $400,000 from InvestMaryland in November.

In total, the program has given out about $1.65 million.

More than three years on from the end of the Great Recession, only six states have regained employment levels enjoyed prior to the recession, and 17 states are still more than 5 percent below their pre-recession employment levels. As many state economies continue to struggle through the lingering effects of the Great Recession, a question commonly asked is, “What is this seemingly invisible force that prevents the economy from returning to prerecession and especially 1990s growth rates?” In other words, why is it that, despite massive monetary and fiscal stimulus, employment seems locked in a persistent malaise? Some argue that the problem is a lack of consumer demand and that more federal government stimulus spending is the answer. Others argue that it is uncertainty over the massive national debt and that fiscal austerity is the answer.

However, one diagnosis that has gone largely unnoticed holds that this invisible force is the decline in the competitiveness of the U.S. economy in the global marketplace. As ITIF points out in Innovation Economics: The Race for Global Advantage, this decline has been a relatively untold story over the past decade, although its symptoms have clearly manifested in the dramatic fall in manufacturing employment and investment since 2000. The failure of the United States to adapt to a global economy that is evermore dependent on knowledge and innovation for growth—the so-called “New Economy”—is causing traded sector firms, and manufacturers in particular, to look to other, more competitive countries when it comes to choosing locations. And this loss of traded sector activity, including jobs and investment, holds back the entire U.S. economy and its component state economies as well.

Fred Hutchinson Cancer Research Center and GlaxoSmithKline PLC (GSK) today announced a partnership to develop therapeutics to treat an inherited form of muscular dystrophy.

The goal of the new agreement is to develop a small-molecule-based medicine to potentially reverse facioscapulohumeral muscular dystrophy, or FSHD, by inhibiting the activity of a protein that is incorrectly expressed by the DUX4 gene in people with the disease. The protein activity is what damages muscle cells and leads to progressive muscle weakness and atrophy in FSHD patients.

In a press statement which Yemen Post received a copy of, GlaxoSmithKline GSK welcomed the publication of the third Access to Medicine (ATM) Index, which measures the performance of the top 20 pharmaceutical companies on their efforts to improve access to medicines and healthcare in developing countries. GSK was ranked a top of the Index in 2012 for the third time of publishing, scoring highest in four categories including general access to medicine management, research and development activity, capability advancement and drug donation and philanthropy.

“In Yemen and across the developing world, GSK is committed to finding new and innovative ways to ensure access to medicines,” said Mr Omar Mulhi, Country Manager, GSK Yemen. “We are collaborating with government, NGOs and other private-sector companies to improve people’s health and well-being no matter where they live, while continuing to expand our business and invest in research.”

New Enterprise Associates has co-led an $11 million first round investment in Galera Therapeutics Inc., a biotech company focused on the development of breakthrough drugs targeting oxygen metabolic pathways in cancer, fibrosis and other human diseases, the company announced.

New Enterprise Associates and Novartis Venture Fund (NVF) co-led the round with Correlation Ventures also investing. Proceeds will be used to expand clinical development of Galera’s small molecule therapeutics.

A set of new initiatives put forward in further detail Friday by the National Institutes of Health could have far-reaching implications for faculty members, graduate students and postdoctoral researchers conducting biomedical research.

The plans, first proposed in June by three working groups, are intended to strengthen and shape the biomedical research work force in the coming decades, focusing especially on diversity issues and on training for rising postdoctoral researchers and graduate students.

Many details of how the goals would be pursued are still unclear, although the NIH on Friday approved a rough implementation plan. The plans, likely to be enforced through grant guidelines, will encourage institutions to adopt individual development plans for all research trainees, and require them to track outcomes for all research trainees, from undergraduates through postdoctoral researchers. They would also create a new grant program for innovative approaches to research training, increase stipends for postdoctoral students, and provide more funding for grants to encourage research independence sooner.

Maryland's TEDCO and a team of entrepreneurs are planning to launch a new $20 million cybersecurity fund early next year, according to Executive Director Robert Rosenbaum.

The state-sponsored investment group plans to formally announce the cyber fund in January. Rosenbaum declined to name the sponsors, whom he described as "a couple of young guys that built a fairly large cybersecurity company and sold it." The capital — assuming they are successful in raising it — would be used to invest in early-stage cyber startups, both those building products and those selling services, he said.

A Hunt Valley venture capital firm is the first to receive funds from the state’s new $84 million InvestMaryland program.

Grotech Ventures will receive $12 million to invest in early-stage companies. If the recipients are successful, Grotech will return 100 percent of the principal investment and 80 percent of its profits to the state’s general fund.

This week’s announcement marks the next major step for the program, a key economic development initiative of Gov. Martin O’Malley (D) that the General Assembly approved in 2011. The state raised the $84 million this year through an online auction of tax credits to insurance companies that operate in Maryland.