 The General Assembly’s House and Senate Finance Committees have begun joint interim meetings to consider reform of the State’s sales tax. A broader package of comprehensive tax reform legislation was considered, but not enacted, by the Assembly in the 2009 Session. Legislative leaders have indicated that the interim study will focus initially on sales tax and may be expanded to other types of state taxes if circumstances warrant. The committees are authorized to report recommendations to the 2010 General Assembly, which will convene in May.
NCBIO is monitoring the interim meetings closely. To date, deliberations have focused on taxation of a targeted array of service products, including personal services such as beauty care, auto repair, and entertainment. Of key importance to NCBIO members is a companion proposal to expand the North Carolina sales tax to include maintenance and repair services. NCBIO has advised legislators that such a tax would be disproportionately burdensome to technology-intensive manufacturing businesses as well as research and development activities that utilize analytical, robotic and other types of equipment.
Discussions between NCBIO and Senate Finance Committee staff during the 2009 regular session led to proposed statutory language that would exempt from any new tax on services maintenance and repair of depreciable capital equipment. The proposed exclusion did not address leased equipment. NCBIO is seeking comments from members regarding the typical costs, terms and structure of such leases. To discuss this matter further, contact NCBIO President Sam Taylor at staylor@ncbioscience.org.
Although not yet proposed or discussed by legislators, NCBIO also will monitor the committees’ deliberations closely for developments potentially affecting clinical research services, prototypes and prototyping services, as well as existing sales tax provisions establishing favorable treatment for R&D equipment, manufacturing equipment, and supplies for medical testing laboratories. The State presently taxes purchases of manufacturing and R&D equipment at 1% or $80 per item, whichever is lower. The general rate of sales tax currently ranges from 7.75% to 8.25%
At their initial meeting November 3rd, the joint committees received background briefings on the State’s existing sales tax structure. The committees also learned about national trends in state sales tax policy from Dr. William F. Fox, Director of the Center for Business and Economic Research at the University of Tennessee at Knoxville. Dr. Thomas advised legislators to avoid taxation of business-to-business services, but to otherwise focus on broadening the sales tax base and utilizing resulting revenues to lower sales tax rates. North Carolina currently taxes the sale of most goods, and a limited array of services, such as electric power and telecommunications.
“Raising Capital and Finding New Sources of Revenue” will be the focus of NCBIO’s next Emerging Companies Forum meeting, scheduled for Wednesday, November 18th, from 8:30 a.m. to 9:45 a.m. at NCBIO’s offices at the CED Entrepreneurship Center, 100 Suite 106, Capitola Drive, Durham.
Three local venture capital leaders will be on the panel – Garheng Kong, General Partner – Intersouth Partners; Sean McCarthy – Senior Principal, Pappas Ventures; and Clay Thorp – General Partner, Hatteras Venture Partners. Dr. Robert Schotzinger – President and CEO of Viamet Pharmaceuticals and the new NCBIO Chairman – will moderate the panel.
All NCBIO members and their guests are invited to attend the program. The event is sponsored by Hughes Pittman & Gupton, LLP. RSVP to Jennifer Fong by email of call 919-281-8960, by November 16th.
J. Greg Davis has been elected Chairman of the Board and Cindy Clark has been appointed President of the North Carolina Advanced Medical Technologies Center of Innovation (NC AMTC). The NC AMTC is a new non-profit corporation established to promote the growth of North Carolina’s advanced medical technologies industry. The NC AMTC has been awarded a four-year, $2.5 million grant from the North Carolina Biotechnology Center’s Centers of Innovation Program. NCBIO led a statewide effort to establish the NC AMTC, including the preparation of a preliminary business plan.
“This is the culmination of three years of intensive planning and market research,” said Sam Taylor, President of NCBIO. “We are delighted to have Greg’s 22 years of wisdom and guidance leading the board of directors and Cindy’s exceptional entrepreneurial talents to promote the growth and development of the advanced medical technologies industry in North Carolina.”
 Greg Davis (left) is an experienced medical device executive with broad global and functional experience in finance, manufacturing, sales and general management. Greg is currently the CEO of Tryton Medical, Inc. Prior to joining Tryton Medical, Greg was president of Guidant Japan. Greg also managed Guidant’s product portfolio in thirteen Asian countries and was instrumental in the start up and management of an FDA-regulated, Class III manufacturing facility in Dorado, Puerto Rico. Greg started his career in various financial management roles with Cardiac Pacemakers Incorporated and Eli Lilly in the United States and Puerto Rico.
 Cindy Clark, J.D., (left) has over 17 years of experience launching and leading early-stage life science companies. Most recently, she was the CEO of Sirga Advanced Biopharma, Inc., and NanIO Biosciences, Inc., and she remains on their boards of directors. She has held senior management positions at Phase Biosciences, Erimos Pharmaceuticals, MedCases, Bell Atlantic Internet Solutions, CV Therapeutics, and Univax Biologics (now NABI).
“Cindy was selected after an extensive, nation-wide search for the new Center’s founding president,” said Davis. “The hiring committee was impressed with her entrepreneurial experience and demonstrated ability to build alliances and deliver results.”
The advanced medical technologies industry, which includes devices, diagnostics, imaging agents and other medical technologies, is a rapidly growing component of North Carolina’s life science sector -- with over 400 companies statewide.
“It is an honor to have been chosen to be one of the leading champions for this industry,” said Clark. “I look forward to sharing many exciting announcements in the coming months as we launch this new organization. The AMT industry will be a driving force in the North Carolina life sciences community in the years to come.”
The Biotech Manufacturers Forum (BMF) continues its efforts to improve workforce readiness and hands-on job training. BMF Program Manager Bruce Kaylos has been coordinating the work of a committee for NCBioImpact (the training consortium of the NC State University BTEC program, BRITE at NC Central University and the NC Community College System BioNetwork) to update goals for the initiative.
NCBIO and its NCBioImpact partners have convened several industry and educational system committees to: (i) develop and validate job descriptions, skills and competency requirements; (ii) map skills and competencies to existing courses offered by BTEC, BRITE and BioNetwork; (iii) provide industry feedback on courses; (iv) develop a marketing committee to increase visibility of the program; and (v) provide industry feedback to the NCBioImpact institutions.
BMF continues to hold quarterly meetings focusing on best practices in the industry, including interaction with vendor members to promote innovation. BMF members have also focused on legislative issues such as water allocation, incentives and tax reform. For more information about BMF issues and meetings, contact Bruce Kaylos.
 North Carolina's Bev Perdue was among governors from nine states and Puerto Rico who signed a joint letter in support of Congressional enactment of a law giving biopharmaceutical companies twelve years of market exclusivity to pay for their investments in innovative biologics.
Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), noted the support of the Governors and other groups in a statement urging members of the U.S. House and Senate to support the twelve-year incentive. The Governors told congressmen and senators that that data exclusivity for biosimilars is a “critically important issue [with] a direct economic impact on our states, our nation's public health, our economic success, and our global leadership in biomedical research.”
PhRMA’s statement regarding the letter was released October 19th. The letter was also signed by the governors of Massachusetts, Connecticut, Colorado, Delaware, Maryland, Oregon, Rhode Island and Washington.
 More than twenty company representatives attended this year’s North Carolina annual dinner for AdvaMed 2009 participants. The dinner was hosted by the new North Carolina Advanced Medical Technologies Center of Innovation and sponsored by McGuireWoods. “Everyone was enthusiastic about the new NC AMTC,” said Cindy Clark, President of the NC AMTC. “We received plenty of input and advice on new programs and activities that are in the planning stages for North Carolina in the next two years.”
AdvaMed 2009 attracted more 1000 attendees and featured discussions of hot legislative topics affecting the advanced medical technologies community – including health care reform and proposed changes to the Food and Drug Administration’s 510k approval process. FDA officials and other advisors reassured AdvaMed participants that proposed 510k changes are likely to only affect a small group of applicants, and should not be implemented until after two internal studies are completed later next year. It was noted that review of the 510k process had been on FDA’s agenda for several years, but had been delayed because of the "small" number of applicants. Conference attendees were urged to give input to the 510k study process.
The conference also featured Ernst and Young’s annual industry report. According to the report, United States and European AMT companies raised 38% less capital in 2008 than in 2007. The decline was steeper if two out-sized European deals are excluded -- 53% in the US and 44% in Europe. The E&Y report noted that the IPO market in 2008 was virtually non-existent, and that AMT deals were down by 40.6%. Deal values were not significantly affected (down only 3% from 2007). The report encouraged companies to use capital efficiently, demonstrate value, address regulatory change, and embrace business model innovation. A copy of the E&Y report, "Pulse of the Industry Medical Technology Report 2009" is available in the North Carolina Biotechnology Center library.
 Fusing Science, Technology and Industry Leaders will be the theme of the two-day Biotech 2010 conference. The event, co-hosted by CED, NCBIO and the North Carolina Biotechnology Center will include world-class speakers, a variety of panels on industry topics and trends, and networking opportunities for life science leaders.
Featured speakers include: Steven Krognes, Chief Financial Officer of Genetech, Inc.; Ernest Mario, Chairman and CEO of Capina; and Allen D. Roses, MD, Jefferson-Pilot Professor of Neurobiology and Neurology, Director of the Deane Drug Discovery Institute, and Senior Scholar at the Duke University Fuqua School of Business.
Now in its 19th year, the Biotech 2010 conference will provide opportunities to learn about global health, personalized medicine, the current funding environment and more. Hear from renowned life science CEOs on new opportunities during changing times and gain insight from industry innovators, thought leaders and policy makers. Click here for registration information.
The North Carolina Association for Biomedical Research (NCABR) is providing more career information to students with the addition of several videos to its bioscience education website. The three videos were developed with input from numerous North Carolina educators and give middle and high school students insight into a typical day in the life of three biopharmaceutical careers: process development scientist, process engineer and process technician.
The videos are three-and-a-half to five minutes long and include salary information and education requirements can be streamed or downloaded for free from NCABR’s Bioscience Clearinghouse website. The videos are accompanied by a teacher guide containing lesson plans, take-home student activities and recommended high school courses for the respective careers.
The videos were funded by the Biogen Idec Foundation and were filmed at North Carolina State University’s Golden LEAF Biomanufacturing Training and Education Center, in Raleigh.
Please have your organization’s media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
Argos Therapeutics made two presentations at the AIDS Vaccine 2009 conference, detailing positive viral load, immune response and safety data from an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate. AGS-004 is a product of the company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden. The presentations contained important results, including a favorable safety profile for AGS-004, the ability to induce partial to complete viral load control in the absence of antiretroviral therapy (ART) during a 12-week structured treatment interruption (STI), and a potent and diverse immune response to AGS-004 treatment. The AGS-004 results are unprecedented for an immunotherapeutic candidate in HIV and, if confirmed in an upcoming randomized study, could lead to a new treatment paradigm for HIV.
Hatteras Venture Partners has announced that the recent sales of B.R.A.H.M.S. Holdings GmbH to Thermo Fisher Scientific for $470 million and ESBATech AG to Alcon, Inc. for $150 million upfront plus $439 million in clinical milestone payments has resulted in a full return of paid-in capital for Hatteras Venture Partners II, LP (HVP II, formerly Hatteras BioCapital Fund, LP). With this return of capital and the remaining thirteen investments in the fund, HVP II is one of the best performing venture capital funds in its class, as compared to the benchmarks for 2004 venture capital funds. "This is a great outcome for Hatteras and all of the limited partners in Hatteras Venture Partners II," said John Crumpler, General Partner of Hatteras. "It is clear that our partnership with HBM will be a financial success. The fund is already one of the best performing venture funds of its vintage, and we still have 13 more investments that have not yet been realized."
Hughes Pittman & Gupton, LLP has announced that Amy Stafford received the Rookie of the Year Award from the Raleigh Chapter of the National Association of Women in Construction. Stafford, a tax in-charge accountant at HPG, focuses on clients within the construction and real estate industries and is a member of the firm's state and local taxes service team. "It is a tremendous honor to be recognized by the NAWIC," said Stafford. "The organization does so much to promote education and community involvement, and I am glad to be able to assist in this."
Christy L. Shaffer, Ph.D., President and CEO of Inspire Pharmaceuticals, Inc., has received the Breath of Life Award, which is the most important recognition awarded to an individual or company by the Cystic Fibrosis Foundation (CFF) for extraordinary commitment and contributions to support the work of the CFF. Dr. Shaffer was presented the award at the 23rd annual North American Cystic Fibrosis Conference in Minneapolis, MN. "Dr. Christy Shaffer has been an extraordinary advocate for those with cystic fibrosis (CF), both through her role as President and CEO of Inspire Pharmaceuticals, as well as her tireless efforts to help the CF Foundation raise funds to support vital programs," said C. Richard Mattingly, Executive Vice President and Chief Operating Officer of the Cystic Fibrosis Foundation. "She is truly a person of commitment, great heart and enormous kindness, and we treasure her."
Kryosphere has received a second round of investment and passed the milestone of having stored over two million biosamples. The company is the region's first independent biorepository and has successfully maneuvered through the turmoil of the economic chaos to close a Series B financing round from angel investors. "This is a significant accomplishment. From what we hear around the Triangle, we may be one of two or three companies that have closed an angel-backed round this entire year," says Eric Hallman, CEO of Kryosphere. "Closing this Series B round demonstrates that our investors recognize the same potential we see – a growing demand for biorepository services here in the RTP and beyond. Now that we have proved the model works, this investment allows us to realize our potential and really grow the business."
Stiefel (a GlaxoSmithKlein company) hosted its first annual Dermatology Research Symposium on October 24th at the Rizzo Center in Chapel Hill. The goal of this symposium was to bring together physicians and academia from the Research Triangle Park area and dermatology community to listen to speakers present their latest research. This meeting was solely focused on research and innovations in dermatology.
Talecris Biotherapeutics has received approval from the U.S. Food and Drug Administration for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology. Like PROLASTIN, the market leader for over 20 years, PROLASTIN-C is indicated for the treatment of alpha1-antitrypsin (AAT) deficiency, a genetic condition in which low levels of this essential protein can result in emphysema. The active protein in PROLASTIN-C increases or "augments" protein levels in AAT-deficient patients at risk for developing emphysema.
PROLASTIN-C delivers twice the active protein per milliliter as PROLASTIN, cutting infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min. Clinical studies have shown that PROLASTIN-C and PROLASTIN are equally effective at raising AAT levels in the blood, and that the adverse event profile of PROLASTIN-C is consistent with that of PROLASTIN. The most common drug-related adverse reactions observed at a rate of >/=1% in subjects receiving PROLASTIN-C were chills, malaise, headache, rash, hot flush and pruritus. "PROLASTIN-C is an example of the significant investments Talecris is making in research and development and manufacturing," said Steve Petteway, Ph.D., executive vice president, Research and Development. "Our single-minded goal is advancing the care of patients who rely on our products."
Targacept, Inc has released data from a highly successful Phase 2b trial of TC-5214 as augmentation treatment for Major Depressive Disorder. Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide. In the trial, the add-on TC-5214 arm (TC-5214 + citalopram) outperformed the add-on placebo arm (placebo + citalopram) on the primary outcome measure, the Hamilton Rating Scale for Depression-17, or HAM-D, and all of the secondary outcome measures, with high statistical significance.
Targacept, Inc., has also announced the pricing of an underwritten public offering of 2,200,000 shares of its common stock. Deutsche Bank Securities will act as sole manager for the offering. Targacept has granted Deutsche Bank Securities an option to purchase an additional 320,000 shares of common stock to cover over-allotments, if any. The offering is being made pursuant to an effective shelf registration statement that Targacept previously filed with the Securities and Exchange Commission.
 BIO Reacts to Renewable Energy Proposal
Treating renewable energy the same as fossil energy thwarts the goal of reducing climate change, according to Brent Erickson, executive vice president of BIO’s Industrial & Environmental Section. Erickson was reacting to publication in Science magazine (Searchinger et al, “Fixing a Critical Climate Accounting Error,” Science, v326, 527-528) of a proposal to count international emissions against U.S. renewable biomass production.
“Biofuels and biomass energy recycle atmospheric carbon, while fossil energy takes carbon that has been stored for millions of years in the earth and releases it into the atmosphere,” said Erickson. “The policy proposed distorts this simple fact. It also fails to take into account that well-managed biomass production can sequester more carbon in the soil than is released into the atmosphere through combustion of biofuels and bioenergy. Biomass carbon can also be sequestered in production of bio-based products. The U.S. Environmental Protection Agency’s analysis earlier this year shows that well-managed cellulosic sources of biomass can actually take more CO2 from the air, and sequester it in the soil, than is released through combustion in automobiles.”
November 18
NCBIO Emerging Companies Forum, 8:30 – 9:45 am. NCBIO CED Classroom, 100 Capitola Drive, Durham. Venture Panel discussing “Raising Capital and Finding Other News Sources of Revenue. Contact jfong@ncbioscience.org for more information or to register.
November 17 - 18
2009 Duke MBA Health Care Conference on at Duke University’s Fuqua School of Business in Durham, North Carolina. This year’s conference, titled “Defying Uncertainty: Changing the Future of Healthcare” will address important forces impacting healthcare in the wake of the current healthcare reform. Click here for more information.
December 3-4
SEBIO Investor Forum, Charleston, SC. The annual conference, designed to stimulate venture investment in the region, offers an “early-stage” event focused on preparing newly emerging companies for raising venture capital and a “presenting companies” event, which showcases a second group of young companies that have already completed one “round” of institutional financing.
December 9
Biotech Forum, 5:30 – 8:00 pm. Sponsored by CED and the North Carolina Biotechnology Center. North Carolina Biotechnology Center, RTP.
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