| NC Biotechnology Center Increases Loan Funding for Emerging Companies |
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Start-up biotech companies may qualify for up to $1 million in loans under a program unveiled by the North Carolina Biotechnology Center. The funds give early-stage companies a boost before they become competitive for venture-capital investment. Separate loans support company inception, certain types of research and corporate growth. The overall dollar amounts are more than two times larger than in years past.
"Building a viable biotechnology company requires years of struggle and millions of dollars," said John Richert, vice president of the Business and Technology Development Program, "and the costs keep rising. So we've not only increased the caps on these offerings, but we've also made some revisions to fill funding gaps and to stay ahead of the changing dynamics of the marketplace."
The revisions became effective July 1 and were a product of conversations with NCBIO, members of the venture-capital community, university technology-transfer offices and with entrepreneurs to learn how the Biotechnology Center could improve its support of companies at different stages of development.
"NCBIO commends the Center for its expansion of these important programs," said Sam Taylor, President of NCBIO. "We are particularly excited by the strong leadership that the Center's new President, Norris Tolson, has provided on the issue of small company capitalization. We look forward to continuing to collaborate with the Center's leadership team on matters of importance to industry."
The first change was to eliminate two programs that awarded either $25,000 or $50,000 to fund corporate spin-outs or university start-ups. Those two programs are now replaced with the Company Inception Loan of $50,000. The business-inception package also includes a $50,000 Technology Enhancement Grant for technology-transfer offices at North Carolina universities. "That's to help them make technologies they may have on their shelves more licensable," said Richert.
In the research-loan offerings, the Biotechnology Center's Small Business Innovation Research Bridge Loans fill the gap between phases of federal SBIR funding. The loans are now capped at $150,000, twice as large as before. The maximum for Small Business Research Loans, which support applied research, has increased from $150,000 to $350,000.
Company access to the Strategic Growth Loans has also been effectively doubled. A company meeting clear milestones defined in a $250,000 Strategic Growth Loan is now eligible for a second $250,000 infusion through the same program. Companies were formerly limited to one award. The loans still require matching investment from a qualifying investment fund.
The Business and Technology Development Program has provided more than $16 million in loans and other support to more than 100 startup companies statewide since the Biotechnology Center was established in 1984. That investment has resulted in more than $1.6 billion in additional dollars from venture capital, federal grants, cooperative business agreements and other sources. That's a return of $100 for every dollar invested -- a major reason North Carolina is the third-largest biotechnology state in the United States.
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| Legislature Adjourns Productive Session for Life Sciences |
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The North Carolina General Assembly adjourned its 2008 short session on July 18, wrapping up another positive session for North Carolina's life science sector. In all, the Assembly appropriated more than $20 million in new dollars to life science development programs in the State. Funds earmarked in 2008 budget legislation include -
In related spending, legislators approved $35 million to complete planning and begin materials acquisition for a new Biomedical Research Imaging Center at the University of North Carolina at Chapel Hill and $3 million in additional funding for the Joint School of Nanoscience and Nanoengineering at North Carolina A&T State University and the University of North Carolina at Greensboro.
The Assembly reduced funding for Governor Mike Easley's One North Carolina Small Business Program, which provides matching grants to companies winning federal SBIR/STTR awards, from $5 million to $3.5 million in 2008-09. NCBIO will work with other technology-based trade associations in 2009 to restore funding to the program.
Legislators also expanded or reauthorized several tax credits important to life science companies, including -
The legislature also declined to adopt several tax changes with potentially negative consequences for life science companies, including mandatory combined reporting requirements for North Carolina corporate income tax payers.
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| NCBIO Planning Committee Approves Goals for Medical Technologies Center |
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 NCBIO has completed its first major milestone in planning for a new North Carolina Advanced Medical Technologies Center. In July, the Organization's planning project steering committee approved a set of draft goals and strategies for the proposed Center.
The Committee tentatively adopted three major goals for the new Center -
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Helping North Carolina advanced medical technology companies more efficiently locate required talent and services
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Working with existing economic development entities to attract out-of-state investment, development partners, and new advanced medical technology companies to North Carolina
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Helping to stimulate the creation of new advanced medical technology companies based on local resources and assets.
The Committee's report also outlines a variety of strategies and activities for the Center's advancement of its goals.
The next step in the planning project is to vet the draft goals with leaders of industry, university and economic development entities that are active in the state's emerging advanced medical technologies cluster. Feedback from these interviews will be used to finalize the Center's proposed goals and strategies and provide the basis for a detailed business plan. NCBIO members interested in commenting on the proposed goals should contact Sam Taylor.
NCBIO has received a $100,000 planning grant from the North Carolina Biotechnology Center to support development of a business plan for the proposed Center. NCBIO expects to submit the plan to NCBC officials in November. If the plan is accepted, the Biotechnology Center could grant up to $2.5 million in launch funding for the new entity. |
| Member News |
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Please have your organization's media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
Biolex Therapeutics, Inc. and MRC Technology (MRCT) have announced that MRCT has successfully completed the humanization of a novel antibody targeting CD20, indicated in non-Hodgkin's lymphoma and rheumatoid arthritis. Biolex is applying its proprietary glycosylation optimization technology to the antibody, BLX-301, to enhance efficacy and potency of the product candidate and potentially reduce certain side effects. Biolex will retain all development and commercialization rights to the humanized antibody, and MRCT will receive regulatory milestone payments and royalties upon its successful development.
BioLink Life Sciences, Inc., has announced that the U.S. Patent Office has awarded three patents for BioLink's four novel epilepsy drugs. "Most epileptic patients take valproate drugs like Depakote® to treat their disease," BioLink's President Deanna Nelson noted. "Current valproate drugs cause nausea, lethargy, weight gain, and other more serious side effects. In contrast, each of BioLink's four new valproates is formulated to cause fewer side effects while providing the valproate drug that the patient needs."
Entegrion continues to strengthen its leadership team with the addition of Michael Galiger as its new manufacturing and engineering manager. Galiger has more than 10 years of experience in medical and consumer products industries. At Entegrion, Galiger will be focused on product scale up, technology transfer and regulatory controls. "We are already benefiting from Michael's exceptional experience in international management and engineering within the medical device industry," said Stan Eskridge, Entegrion's president and CEO.
Hutchison Law Group PLLC, has completed its annual survey of the compensation practices at venture-backed technology and life science companies in North Carolina. A total of 28 companies participated in the 2008 survey. All participants are located within North Carolina and have received equity financing from an institutional investor or equity financing of at least $500,000 from angel investors. The survey measures compensation, benefits and general employee policies among the top eight executive-level positions typically associated with technology and life science companies. Additionally, this year's report also includes information regarding the composition and compensation of the Board of Directors and Board of Advisors. The executive summary provides a general overview of the entire report including sample compensation data for Chief Executive Officers in North Carolina.
J. Scott Merrell has joined the Hutchison Law Group. Merrell will serve as Of Counsel in the firm's Corporate Practice Group. In this new role, Merrell will serve as Counsel to the CEO and Board of Governors of RTI International, an independent, nonprofit research institute based in Research Triangle Park, North Carolina. Since 2003, Merrell served as Senior Vice President, Secretary and Chief Legal Officer at RTI International.
Christy L. Shaffer, Ph.D., President and CEO of Inspire Pharmaceuticals made a presentation at the Collins Stewart Fourth Annual Growth Conference on July 8 in New York City. An archived version of the webcast presentation is available through the company weblink for a limited time.
Inspire Pharmaceuticals, Inc. has announced modifications to the clinical protocol for TIGER-2, the Company's ongoing second Phase 3 trial with denufosol tetrasodium for the treatment of cystic fibrosis (CF). In consultation with key experts, the company determined that a longer treatment period of 48 weeks is appropriate based on the progressive improvement from baseline in FEV1 observed in patients who received denufosol in both the 24-week, placebo-controlled period of TIGER-1, as well as the 24-week open-label safety extension. Importantly, based on further analysis of preliminary data available in July 2008 from patients who received denufosol for the full 48 weeks, the mean change from baseline in FEV1 more than doubled compared to the 24-week trial endpoint
Targacept, Inc. a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, has announced that it has initiated a Phase 2b clinical trial of TC-5214 as an augmentation therapy in subjects with Major Depressive Disorder (MDD).
TC-5214 is a broad spectrum neuronal nicotinic receptor (NNR) antagonist and represents a promising new mechanism in development for the treatment of MDD.
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| At the National Level |
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U.S. Housing Bill Includes Provision to Help Start-Ups
Hundreds of biotechnology start-ups will be encouraged to utilize an incentive for capital investments as a result of a provision included in the Housing Bill (H.R. 3221) passed by the by the Congress in July and signed by President Bush.
"Many biotech companies whose products are not yet on the market will be in a stronger position to carry out clinical trials and product development because of this provision," said Jim Greenwood, president and CEO of the Biotechnology Industry Organization. "This provision encourages companies to make new investments this year, accelerating the development of new life-saving therapies, and creating new jobs."
"In championing this provision, Senators Stabenow and Voinovich have advanced the medical options for hundreds of patients who will benefit from access to new biotech therapies," continued Greenwood.
Bonus depreciation was enacted into law earlier this year and is designed to encourage companies to make capital investments that will help spur economic growth. Yet many companies that do not expect to pay tax this year, in part due to the economic downturn, would receive no benefit regardless of how much they invest.
The provision will provide these companies a limited investment incentive by allowing the companies to utilize accumulated AMT or R&D credits in lieu of the bonus depreciation to which they would otherwise be entitled. Like bonus depreciation, this provision is not a new tax benefit. It simply allows companies to use credits today that they could otherwise use in the future, based on the new capital investments that would have qualified under bonus depreciation.
Venture-Backed Companies Get Nod in Senate SBIR Bill
Small businesses that are majority-backed by venture capital, many of which are producing biotech therapies and cures, will be eligible for a portion of Small Business Innovation Research (SBIR) grants under a bill (S.B. 3362) reported out of the Senate Committee on Small Business in July. The bill reauthorizes the SBIR program for 14 years.
"Thousands of small companies are pursuing biotech innovations that can improve human health, expand our food supply, and provide new sources of energy," said Jim Greenwood, president and CEO of the Biotechnology Industry Organization. "They may not yet have product revenue, but they have tremendous potential - and are precisely the kinds of efforts the SBIR program was intended to foster."
In 2003, the Small Business Administration reinterpreted SBIR eligibility criteria to exclude companies that are majority-backed by venture capital. Because of the long and expensive process of bringing biotech innovations to market, venture capital often comprises the majority of their funding stream.
Historically the SBIR program has provided critical financial support to biotech companies while its rigorous review process has conferred a high level of credibility. Of the 252 FDA-approved biologics, 32% of those companies received at least one SBIR/STTR award.
AdvaMed Offers Business Solutions Program
AdvaMed is offering the benefits of the AdvaMed Business Solutions program to NCBIO members. NCBIO members may have access to a similar set of program through BIO. AdvaMed provides additional offerings targeted to medical technology members. Interested members do not need to be AdvaMed members. View AdvaMed Business Solutions for more information.
Report on Industrial Biotechnology
Innovative research and development in industrial biotechnology is the key to future productivity and competitiveness for U.S. chemical and biofuels companies according to the findings of the U.S. International Trade Commission fact-finding report, "Industrial Biotechnology: Development and Adoption by the U.S. Chemical and Biofuel Industries."
Brent Erickson, executive vice president of BIO's Industrial and Environmental Section, said, "U.S. chemical and biofuel companies can keep their competitive edge in the world economy by developing new products from renewable resources, creating cleaner, more sustainable manufacturing processes, and reducing their costs by adopting industrial biotechnology. Industrial biotech companies are steadily introducing a range of new products - including plastics, advanced biofuels, and chemicals - made from renewable resources instead of petroleum. Industrial biotechnology also enables these companies to develop cleaner, environmentally sustainable processes for manufacturing products by reducing use of energy and resources, producing fewer byproducts, and eliminating toxic waste. Reducing environmental impacts, including greenhouse gas emissions, will be a key to maintaining future competitiveness for U.S. chemical and biofuel companies."
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| Calendar |
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August 18-20, 2008. Duke Bioinformatics Workshop. Durham, NC. The finished sequence of the human genome represents an invaluable resource that will greatly accelerate scientific research. This workshop provides its participants with the expertise to efficiently explore this myriad of information. For more information.
September 9-10, 2008. BioPharm America 2008. Atlanta, GA Based on the same winning formula used in EBD Group's distinguished European partnering conferences BIO-Europe and BIO-Europe Spring®, BioPharm America is expected to become the premier stand-alone biopharmaceutical partnering event in North America. For more information
September 21-24, 2008. AdvaMed 2008, Washington DC. Designed by industry, for industry, AdvaMed 2008 is the premier medical technology conference and exhibition for business leaders, policymakers, investors, news media, patient advocates, and industry stakeholders from around the world. For more information.
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Legislators Enact Drought Bill |
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Legislators acted in the waning days of the 2008 Session to substantially strengthen drought-related powers of the Governor and other officials. NCBIO worked throughout the Session to provide legislators input on the drought package.
Under the legislation adopted as House Bill 2499, state leaders now are authorized to direct local water systems to implement drought response measures and can expedite emergency interconnections between systems to address economically damaging local water shortages. The new law also strengthens water use reporting requirements and directs state environmental agencies to adopt rules to promoting reuse of treated water as an alternative to wastewater discharge. The legislation does not impose new requirements on industrial water users.
"NCBIO believes that the key to limiting economic dislocations associated with future droughts lies in encouraging more widespread water conservation today," said NCBIO President Sam Taylor. "We worked closely with legislators and other interest groups to assure that ongoing water conservation remains a viable strategy for local water systems' drought planning."
Legislators have commissioned an interim study of state water allocation policy to guide further water-related law-making in 2009. Managers of the study have asked for NCBIO's input regarding effects of water policy on the state's growing life science industry. NCBIO members interested in working on this matter should contact Sam Taylor.
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NCBIO This Month
