Vilsack also said USDA will be providing new guidance and direction on organic production to all USDA agencies in support of organic agriculture and markets. USDA is now asking each agency to routinely address the needs of the organic sector in their programs and services where appropriate. The National Organic Program has supported the continued growth of America’s organic sector, which has been increasing market share each year and now is a more than $30 billion industry. Vilsack noted that accurate data is the biggest obstacle for developing better crop insurance options for organic farmers and expressed his desire that Congress help USDA make further progress by renewing the 2008 Organic Data Initiative as part of a new Food, Farms and Jobs bill.

“Organic agriculture is one of the fastest growing segments of American agriculture and helps farmers receive a higher price for their product as they strive to meet growing consumer demand,” said Agriculture Secretary Tom Vilsack. “These new options will extend the safety net provided by crop insurance and provide fair and flexible solutions to organic producers. Coupled with the new guidance for agencies to support this growing sector, USDA recognizes that organics are gaining market share and is helping boost this emerging segment.”

New crop-insurance pricing options will be available to organic producers who grow crops under guaranteed contracts beginning with the 2014 crop year. This contract price option allows organic producers who receive a contract price for their crop to get a crop insurance guarantee that is more reflective of the actual value of their crop. They will have the ability, where available and at their choice, to use their personal contract price as their price election or to choose existing crop insurance price elections. This contract price option will be available for between 60 and 70 crops in the 2014 crop year and this contract price feature will be available to the majority of insured organic crops. RMA is also changing organic transitional yields (t-yields) so they will be more reflective of actual organic farming experience, starting with the 2014 crop year.

All crops are being evaluated for establishing organic prices for the 2014 crop year. Current pricing options only allow farmers to insure organic crops at the conventional prices, with the exception of eight crops (corn, soybeans, cotton, processing tomatoes, avocados, and several fresh stone fruit crops) that already have premium organic price elections. RMA is working to provide organic price elections for six to ten crops in 2014. Oats and mint are two crops that have already been selected for organic price elections in 2014, and apricots, apples, blueberries, millet, and others are still under consideration.

USDA’s Agriculture Marketing Service last year announced the Organic Literacy Initiative, a public outreach and employee training program to help connect current and prospective organic operations with appropriate USDA resources. To date, over 14,000 USDA employees have taken the basic training on USDA’s role in organic agriculture. The new guidance will further improve USDA agencies’ ability to incorporate the needs of the growing organic sector into their programs and services. These combined actions should result in staff better equipped to help organic farmers obtain technical and financial assistance, insure crops and livestock, access research findings, secure loans, develop conservation practices, find current organic price information, and access local, regional, and international markets. Through this effort, agencies will also better understand the scope and rigor of the certification process and how it complements their own programs.

Organic certification allows farmers and ranchers to receive premium prices for their value-added products. Over the past 10 years, the number of certified organic farms and businesses in the United States has expanded to approximately 17,750, representing a 240 percent increase since USDA first began collecting this data. Similarly, the retail value of the organic industry grew almost 9.5 percent in 2011 to $31.4 billion. Organic foods continue to gain market share in the food industry, climbing to 4.2 percent of U.S. retail food sales in 2011.

USDA has already made several changes to better serve organic customers, including offering more flexible microloans and improving Federal crop insurance programs. To help open new markets for U.S. farmers and ranchers, USDA has streamlined trade with multiple foreign governments. These trade partnerships allow U.S. organic products to be sold as organic in Canada, the European Union, Taiwan, and Japan without maintaining certification to multiple standards. Expanding the reach of U.S. organic products creates opportunities for small businesses and increases jobs for Americans who grow, package, ship and market organic products.

USDA is responsible, under the Organic Foods Production Act of 1990 (OFPA), for establishing national standards for organically-produced agricultural products. The National Organic Program has been critical for the development of clear standards and enforcing a level playing-field for organic businesses, which has lead to expanded trade opportunities to create new markets for U.S. organic businesses. These standards assure consumers that products with the USDA organic seal meet consistent, uniform standards. For additional information about the USDA National Organic Program, visit www.ams.usda.gov/NOP.

Crop insurance is sold and delivered solely through private crop insurance agents. Contact a local crop insurance agent for more information about the program. A list of crop insurance agents is available at all USDA Service Centers or on the RMA web site at www.rma.usda.gov/tools/agents/.

“The process of moving a product from concept to finished goods on the loading dock requires a broad skill set. Each step also means a new vendor with different concerns, requirements and terminology. Even seasoned corporate product developers seldom get exposed to the entire process. We want to provide attendees with an overview of the challenges and semantics that they will encounter at each step of the way,” Roland explained.

He went on to say that his firm’s experiences with the Montie Gear line and Montie Design work for corporate clients and entrepreneurs provides a real world context and examples for the class.

“We’re keeping the class size very small to allow for extensive interaction and sharing,” Roland added.

Spread over two days to allow for meaningful interaction with Roland, the seminar provides an overview of product development, patent, prototyping, product manufacturing, and sales, as well as low-cost marketing and public relations tools to develop a “buzz” about the final product.  The event will take place at the Montie Design offices in Morrisville on Tuesday, June 11, and Thursday, June 13. Cost of the seminar is $250 plus a $7.50 registration fee; reservations can be made online at http://www.eventbrite.com/event/6546126641.

Roland is President Emeritus of the Carolinas PDMA (Product Development and Management Association,) and a member of the Carolinas IDSA (Industrial Designers Society of America) with over 20 years experience in product design and manufacturing.

Montie Design operates its main Research Triangle design shop as well as a secondary manufacturing facility in Spring Creek, N.C., north of Asheville. In addition to helping clients bring over 750 creations to life, the firm enjoys great success with its own Montie Gear line of outdoor equipment it sells directly to consumers. Montie Gear developed out of an internal review of best practices to take a product idea from concept all the way to marketing and sales. The X-Rest, a unique portable shooting accessory, was the “test product” the Montie Design staff came up with to help hunters and shooting enthusiasts gain access to a lightweight, stable platform that weighed only a couple pounds.

The Montie Design team began researching the consumer marketplace, and determined an opening for the product. Soon after they synthesized a buffet of design concepts, utilizing their mechanical design best practices, and designed the X-Rest from the inventor’s point of view, conceptualizing a design and selecting materials that could keep costs down in order to reach a price point attractive to consumers. The team came up with a winning design, found a vendor that could deliver a prototype, pursued testing and design improvements, and eventually released the X-Rest for testing and evaluation by outdoor industry experts.

Positive feedback pushed the design team to begin marketing the X-Rest with a limited budget and added a page for the X-Rest on the company website. Once articles and reviews started appearing, the team saw a rise in traffic and, more importantly, sales.

Success bore additions to the Montie Gear line including a slingshot; ultralight knife; multi-purpose tree hook archery rest for sturdy support of a bow, crossbow, or rifle with a sling; camp rack designed to hold pots, lids, serving bowls and utensils off the ground to dry after cleaning; and new variations of the popular X-Rest and AR-Rest shooting supports for hunters and recreational shooters.

More information about Montie Design is available online at www.montie.com. The X-Rest and other products from the Montie Gear line are available online at www.montiegear.com.

About Montie Design
Montie Design is an innovation and commercialization firm with core competencies in mechanical engineering and industrial design. Active in the product design, defense, and technology sectors, we leverage years of industry leadership and extensive technical capabilities to help clients take products from concept to marketplace that are economical to manufacture, elegant and robust. Montie Design is a North Carolina company headquartered in the Research Triangle region with clients across the country and overseas. We are dedicated to economic development throughout our home state and furthering excellence in design and engineering. For more information, visit www.montie.com.

Neonova brokers cloud applications and services for rural and regional ISPs and thousands of small businesses nationwide. The company serves more than 500,000 end users on behalf of its ISP affiliate partners spanning 38 states. Over the last two years, NeoNova has added more than 40 ISPs to its customer roster as well as hundreds of value added resellers (VARs). This growth led to the creation of 50 new jobs across the country.

The new and more open office space in Raleigh will support the company’s further growth and technology collaboration with customers and strategic partners. It also will allow NeoNova to continue hiring talented professionals to develop, deploy, and support its growing portfolio of cloud-based services and applications.

NeoNova’s new address is 1201 Edwards Mill Road, Suite 102, Raleigh, N.C. 27607.

About NeoNova Network Services
NeoNova empowers rural and regional broadband providers, technology partners and small businesses with 21st century cloud-based technologies. We help service providers and businesses grow by delivering a wide array of subscriber, network management, and professional services leveraged by a powerful service delivery platform and backed by the industry’s top professionals. NeoNova also is an authorized premier reseller of the Google Apps™ and Google Apps for Business™ suite of communication tools. Visit www.neonova.net, Facebook or Google +, and follow @NeoNova_NNS on Twitter.

“Whereas ‘traditional’ agencies rise and fall based purely on their ability to sign a great number of clients, deliver products and then walk away, The Marketing Machine succeeds by getting to know our clients and their businesses, and becoming a valued, long-term member of their internal team,” Paul Spinak, company president, said.

When Spinak launched the company in 1998, he did so to create an environment for doing what he liked to do, while retaining control over his time. He has always considered himself a critical thinker with a creative edge, finding balance in applying it to a business where he can share his unique skills with others.

“Although my day-to-day has changed substantially, I still serve as creative director, touching all the work that flows through the agency for continuity, and, to be quite honest, for pure pleasure,” he said, adding, “Through The Marketing Machine, I have a professional creative outlet to help businesses grow and develop into what they want to be. Honestly, I feel lucky and grateful.”

Over the years, The Marketing Machine’s strength and knowledge have been based on the diversity of its clients, and as a result, the agency has surrounded itself with a talented group of people with varying skill sets. These marketing and branding professionals have developed effective tools and methodologies to take a project from concept to marketplace with corporate branding, direct mail, email marketing, graphic design, website design, advertising campaigns and marketing collateral.

The services The Marketing Machine provides to its clients are diverse, exemplified by businesses like CenterEdge Software, a nationally renowned entertainment facility solutions provider. This long-term account started with email marketing and transitioned into a complete name rebrand, eventually evolving even further to where The Marketing Machine is handling all of the CenterEdge outreach and marketing budget.

Another client, the AKC Canine Health Foundation, needed help to move forward in the promotion of its new Canine Athlete Fund initiative. The Marketing Machine helped the organization launch the initiative to raise money for researchers focusing on developing proper conditioning, nutrition, training and rehabilitation specific to the growing number of canine athletes, and the agency continues to assist the AKC with quarterly newsletters and tapping into new markets for fundraising.

The Marketing Machine’s services are sought after by clients for numerous reasons, according to Spinak, not least of which is for the firm’s expertise in managing resources. The AKC Canine Health Foundation, for example, has a fully qualified in-house marketing staff, but more initiative and drive than they can handle. Instead of pouring resources into hiring more staff, they outsource to The Marketing Machine to accomplish their goals effectively, on-time and within budget.

Creative services is another hallmark The Marketing Machine is known for, according to Spinak, who pointed to clients like CenterEdge Software being run by smart, technology-oriented individuals who may not have the creative chops of someone who lives and breathes graphic design and branding for a living.

“As much as we’re known for our creative abilities and experience managing resources, it’s our flexibility that sets us apart,” he said, adding, “Our setup as a hybrid agency is a direct reflection of the flexibility that businesses need to have. Just as someone like the AKC Canine Health Foundation needs us sometimes, but doesn’t need us others, we are able to meet their needs as they ebb and flow.”

Moving into its next 15 years, The Marketing Machine is committed to continuing to address every project with open communication and a high level of professionalism. Taking great pains to invest in talented staff and supportive technological resources to ensure each client’s project is managed in a thoughtful, timely manner, the agency’s staff and leadership is focused on ensuring that each customer gets individualized attention in the areas of creative, production, traffic control, account coordination, strategy and project management. With a talented account executive leading the way, The Marketing Machine’s award-winning, in-house creative team carefully blends knowledge, experience and technical know-how with unparalleled imagination and originality to craft ideal marketing and branding solutions, on-time and on-budget.

For more information about The Marketing Machine, visit theMmachine.com.

About The Marketing Machine
The Marketing Machine is your go-to partner for comprehensive branding, marketing expertise and strategy, campaign planning, project management and graphic-design solutions. We are an innovative creative services agency specializing in helping our customers grow their businesses, whether it’s a company getting serious about their marketing or a high-profile nonprofit or corporation whose marcom staff is wearing too many hats and needs a reliable partner. The Marketing Machine boasts years of experience and expertise working with business owners, C-level executives and marketing directors as an outsourced member of their internal team, enabling TMM to address every project with open communication and a focus on professionalism. Our creativity-friendly business structure and location in the heart of the action in downtown Raleigh help create an environment of excitement and innovation in our team that is passed along to our clients in the work we do. Learn more about how you can start building and maintaining a strong brand at theMmachine.com.

Jeff was introduced to the technology and business worlds when as a teenager he earned a reputation for being the “go-to” guy for installing sophisticated car stereo systems; he soon had friends paying for his services. Another early job was selling educational books in Texas — an invaluable experience in building his own business in a new market, which fostered a foundation of hard work and integrity. Jeff spent six years in the broadcasting industry, building and managing sales teams.

In 1982 Jeff joined the newly formed Telephone Systems of Asheville, a division of MB Haynes Corporation, which quickly became the dominant telephone equipment, data wiring and fiber optics provider in the area. In 1995, TSAChoice’s original management team of Bill Arledge, Jeff Lowdermilk, and Dan Higgins bought the company from MB Haynes and continue to lead the company to this day, organizing it into the region’s largest business technology integrator in Western North Carolina. 2011 marked TSAChoice’s expansion into upstate South Carolina, serving businesses in Greenville, Greer, Spartanburg, Easley, Anderson, Woodruff, and surrounding areas, from its Greenville, SC office.

TSAChoice is the largest business technology integrator in Western North Carolina and expanded into Upstate South Carolina in 2011. TSAChoice’s more than 60 highly trained technology professionals and support staff deliver turnkey telephone, computer, network, audio-visual, and security solutions from a single source. For more information about TSAChoice, call (828)254-4464 or visit www.tsachoice.com.

“We are thrilled to offer Community Corkboard’s customers a Finder411 platform premium member service opportunity, delivering needed visibility and new customers that previously had been out of financial reach.” says Steve Doyle, Finder411’s CEO & President

Small local businesses face tough competition against national chains and brands in both online consumer purchases and advertising.  Finder411 and The Community Corkboard recognized this need, creating a product that offered exclusive visibility to the “little guys”.

“While the business model for The Community Corkboard was unsustainable given today’s challenging public school system climate, our intent of supporting local business and services remains the same.” says CEO Jim Jidar.  “We are grateful to offer a tool like Finder411 to those businesses who believed in our mission.  Finder411 is an excellent answer for small locally-owned businesses.”

About Finder411
Finder411 is an “online stomping ground” for those eager to find, patronize, and engage with their local small business community. Highly social and immersive, it’s for those ready to keep their money local and support people who make up the fabric of our communities.  The platform’s multiple forms of social media will cause a positive ripple effect for participating businesses.

Privately and locally owned Finder411 has a refreshing subscription-based business model vs. online advertising, with prices attainable for local small businesses.  Franchises, chains, exclusively online, and direct marketing companies will be excluded from the site. Finder411, in beta phase, offers unique stories and immersive photos for local business while offering today’s savvy consumers a valuable, easy and fun tool to support their favorite small businesses. For more information on how to join Finder411 as a Triangle-based small local business, please visit http://finder411.com.

“Mary has proven to be invaluable to BlueStripe, and was already instrumental in leadership and management of the company’s engineering team,” said Chris Neal, BlueStripe CEO. “It was a natural step for her to rise within the organization to lead our outstanding team of software engineers and drive dynamic innovation in designing superior software.”

Before joining BlueStripe, Boose held several technical and managerial positions with IBM, including serving as Senior Software Engineer in the WebSphere Portal organization. Boose also held technical leadership positions with NetIQ Corporation (now Attachmate).

“BlueStripe presents a unique opportunity for me to play a pivotal role in the development of the next generation of IT management, at a time when the industry is starting to recognize the true potential for transaction monitoring,” said Boose. “I look forward to using my new role to advance BlueStripe’s solutions and solidify the company’s position as the market leader in innovative transaction performance management solutions.”

About BlueStripe Software

BlueStripe Software is a leading provider of Transaction and Application Monitoring Solutions for IT Operations and Support teams. BlueStripe’s flagship Transaction and Application Performance Management software, called FactFinder, deliversTransaction Monitoring, Application Performance Monitoring, and Server Monitoring together in a single tool, tracking transactions end to end across the data center and through the cloud. This transaction-centric Application Managementapproach allows IT Operations teams to know where Transactions go, where they get stuck, and why. For additional information, please visit http://bluestripe.com.

About Crown Nutraceuticals:

Crown Nutraceuticals is engaged in the development, manufacturing and marketing of popular nutraceuticals and supplements.

The global nutraceuticals product market is massive — reaching over $142.1 billion in 2011 and the industry is projected to reach $204.8 billion by 2017, with a projected annual growth rate of 6.3% from 2012 to 2017. Asia Pacific (including Japan) is expected to have the second largest market share after North America by 2017. Crown Nutraceutical’s objective is to rapidly expand its business in the nutraceuticals and supplement market.

About Crown Marketing:

Crown Marketing’s Controlled Drug Delivery Technology (CDDT) holds patents for a novel controlled-release technology, harnessing the principles of chaos theory along with precise mathematical formulas for precise and programmable diffusion delivery.

The spectrum and reliability of pharmacokinetic profiles achievable with this technology is superior to currently marketed formulations. Its simple design allows for a high level of flexibility in matching chrono-therapeutic requirements. Cost-efficiencies in the commercial manufacturing process, when compared to other drug delivery technologies, may constitute its most important competitive advantage.

The objective of intelligent drug delivery design amounts to maximizing the percent of the time drug plasma levels are within the therapeutic range and avoiding patient exposure to potentially toxic (High) or sub-therapeutic (Low) levels.

Crown’s cost-effective application of controlled delivery technologies will play a major role in the expansion of the pharmaceutical, OTC and nutraceuticals industry through our ability to improve on the performance of immediate release products in a manner tangible to manufacturers and consumers.

More information can be found at: www.crowncddt.com

Both websites are published by Global Media Strategies to help technology professionals around the world get timely news and information about the life sciences, medical technology, biotech, cleantech, computers, innovation and entrepreneurs, high tech and education.  Fresh, original articles and user-submitted news items are updated daily, while banner ads help generate web traffic for businesses looking to get in front of technology decision makers.

Global Media Strategies has been specializing in getting businesses and organizations in front of target audiences via proven effective communication tools and methodologies since 2007. With clients across the United States and overseas, the firm operates out of the technology-rich Research Triangle Park region of North Carolina. The greater RTP area is a hotbed of innovation and economic growth, and is home to some of the leading life sciences and technology firms in the world.

Held at the Gaylord National Convention Center, TechConnect World houses four world-class technical events focused on advancements in Nanotech, Microtech, Biotech, Cleantech and the technology overlap between these converging domains. This year’s TechConnect World is co-located with the National SBIR Conference, designed to accelerate the commercialization of American innovation by providing the world’s largest on-site matchmaking program with investors and corporate development partners. The joint events will showcase more than 20 federal agencies and their top funded innovations including: Department of Energy, Department of Defense, National Institutes of Health, National Science Foundation, National Institute of Standards and Technology, NASA, NSF, and many more.

As technologies commercially mature from the purely research stage, they are advanced into the TechConnect Summit and partnering programs in which IP and Early-stage companies are reviewed and selected by the organization’s board of corporate and investment partners. Through events and strategic partners, TechConnect increases the innovation pipeline, helps partners find new licensing and business opportunities, and matches corporate and investment partners to top vetted technologies from around the world. More information is available online at www.techconnectworld.com.

Global Media Strategies provides PR and media relations services to small startup operations and large established firms. Each client is given premier service and individualized attention, regardless of size, industry, or type of services required. The types of clients served represent a wide variety of life sciences and technology market sectors such as clinical pharmacology, pharmaceutical manufacturing, analytical instrumentation, biomedical product manufacturing, clinical pharmacology, healthcare technology, pharmacovigilance, technology transfer, intellectual property law, product design and development, software and information technology.

For more information about Global Media Strategies visit www.gmsinnovate.com.

About Global Media Strategies
Global Media Strategies is an innovative PR and media relations firm specializing in getting businesses and organizations in front of target audiences via proven effective communication tools and methodologies. The strategic communication plans Global Media Strategies builds for clients helps support positioning in new and emerging markets, maximizing publicity to increase brand awareness and drive sales. Global Media Strategies operates out of the technology-rich Research Triangle Park region of North Carolina, a hotbed of innovation and economic growth, and home to some of the leading life sciences and technology firms in the world. For more information, visit www.gmsinnovate.com.

About NCTechNews
NCTechNews is a professionally edited online news publication helping members of the North Carolina technology community share information with peers, customers, prospects, investors and the general public. Fresh, original articles and user-submitted news items are updated daily. The goal of NCTechNews is to solicit engaging content from a wide variety of businesses and organizations in the medical technology, life sciences, biotech, green tech, computers, and general technology industries to build a stronger community in North Carolina and contribute to economic growth. NCTechNews supplements quality technology reporting provided by respected media outlets throughout North Carolina. The publication is designed as an extraordinarily powerful means of quickly and effectively reaching a great number of people locally, nationally and globally. For more information visit www.NCTechNews.com.

About Global TechWire
Global TechWire is a professionally edited online news publication helping technology professionals around the world get timely news and information about the life sciences, medical technology, biotech, cleantech, computers, innovation and entrepreneurs, high tech and education. Fresh, original articles and user-submitted news items are updated daily, complimented by news feeds from respected media sources. Developed to supplement quality technology reporting provided by respected media outlets throughout the world, Global TechWire is designed as an extraordinarily powerful and effective means of reaching a great number of people locally, nationally and globally with news items that may be otherwise overlooked by larger mainstream news operations. Regardless of the size of tech concern or how long a tech business has been in operation, anyone can contribute content for consideration of publication in Global TechWire absolutely free. Simply add info@global-tech-wire.com to press distribution lists. For more information visit www.global-tech-wire.com.

Continued progress was made in the development of BDSI’s two buprenorphine-containing products with the completion in January 2013 of the safety study for BUNAVAIL for the treatment of opioid dependence.  The study, which included 249 patients who were switched from Suboxone to BUNAVAIL, demonstrated the ease of use and tolerability of BUNAVAIL.

In addition, recruitment continued toward a late 2013 or early 2014 completion of the two ongoing Phase 3 studies for BEMA Buprenorphine for the treatment of chronic pain, which are being conducted in conjunction with BDSI’s partner, Endo Health Solutions.

At March 31, 2013, BDSI had $49.7 million in cash compared to $63.2 million at December 31, 2012 and $32.1 million at March 31, 2012.  Cash used in operations for the first quarter of 2013 totaled $13.5 million.  Research and development costs were $12.0 million in the first quarter of 2013, compared to a corresponding $4.7 million in the first quarter of 2012.  The current quarter increase over the prior year first quarter is due primarily to additional research and development costs associated with the concomitant running of the BUNAVAIL and BEMA Buprenorphine late stage development programs.  Also contributing to the increase was the recording in March 2013 of $2.1 million of in-process R&D associated with the license discussed below for Clonidine Topical Gel from Arcion Therapeutics (Arcion).

In addition to clinical development activities, BDSI also made an important stride forward in building its pipeline of products for the treatment of pain with the acquisition of patented Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN).  BDSI entered into a worldwide licensing agreement with privately held Arcion, where BDSI will develop and commercialize Clonidine Topical Gel.

The effectiveness of Clonidine Topical Gel was previously assessed in reducing pain in PDN in a double-blind, placebo-controlled, Phase 2 study.  A significant treatment difference was seen in the pain intensity (p=0.01, n=63) in the planned subset analysis of diabetic patients who had documented evidence of functioning pain receptors in the skin of the lower leg.  At a minimum, this supports its effectiveness in diabetic patients with functioning pain receptors in the skin which accounts for approximately one-third to one-half of the nearly 26 million people that according to the American Diabetes Association are suffering from PDN.  BDSI plans to prepare for a confirmatory study in the latter part of 2013 which could lead to data availability by the end of 2014.  The PDN market is highly under-served by existing products, such as the oral medications Lyrica and Cymbalta.  BDSI estimates annual peak sales potential for the product in excess of $300 million in the U.S.

Under terms of the agreement, BDSI made an upfront payment of $2 million to Arcion in the form of unregistered shares of BDSI common stock.  No further milestone payments are due to Arcion until successful completion of the clinical development program and the filing of a New Drug Application (NDA).

“BDSI continues to make remarkable progress in advancing its pipeline of BEMA products, BUNAVAIL and BEMA Buprenorphine, toward key milestones, while executing an exciting licensing agreement for Clonidine Topical Gel to extend our pipeline of products in pain,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  “We are excited about the potential of our product portfolio and are committed to working aggressively toward our primary objective of filing the NDA for BUNAVAIL in mid-summer.”

Anticipated 2013 Milestones

BDSI is focusing its resources on achievement of the following key milestones:

Submission of BUNAVAIL NDA for opioid dependence.  Based on demonstrating bioequivalence in the pivotal pharmacokinetic study and positive results in the safety study, BDSI anticipates it will submit an NDA to the FDA for BUNAVAIL in mid-summer 2013.
BUNAVAIL commercialization opportunities.  BDSI will continue to evaluate its strategic options for the commercialization of BUNAVAIL, which include partnership, internal approaches or a combination of these.  BDSI expects to finalize its strategy in the second half of 2013.
Recruitment of two Phase 3 studies for BEMA Buprenorphine.  BDSI and Endo expect to continue recruitment in the two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naïve patient groups.  The trials are expected to complete in late 2013 or early 2014.  Upon completion of study enrollment and database lock for each trial, and the acceptance of filing of the NDA with the FDA, BDSI is expected to receive milestone payments from Endo totaling $30 million.
Commence Confirmatory Study for Clonidine Topical Gel.  BDSI plans to prepare for a confirmatory study in the latter part of 2013 which could lead to data availability by the end of 2014.
Re-introduction of ONSOLIS in the U.S.  In March 2013, BDSI and its commercial partner Meda submitted a proposal to FDA to reintroduce ONSOLIS for the treatment of breakthrough cancer pain into the U.S. marketplace following previously reported appearance issues with the product.  If approved by FDA, the original ONSOLIS formulation may be on the market during the second-half of 2013 while stability data is collected on a newly formulated version of ONSOLIS.  These data may be submitted to FDA before the end of the year, and if approved, could allow introduction of the new formulation sometime in 2014.
Exploration of potential new products and technologies.  In addition to advancing its lead products in development, BDSI is also, as in the past, exploring the application of its BEMA drug delivery technology to additional pharmaceuticals.  In addition, BDSI continues to investigate potential new products and technologies to complement and diversify its existing portfolio.

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.  BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.

BDSI’s pain franchise currently consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it is marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer.  The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).  BDSI’s second pain product using the BEMA technology, BEMA Buprenorphine, is currently in Phase 3 trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Health Solutions.  BDSI’s third pain product in development is Clonidine Topical Gel for the treatment of painful diabetic neuropathy, which is licensed from Arcion Therapeutics.

Additionally, BDSI is developing BUNAVAIL, a high dose formulation of buprenorphine in combination with naloxone for the treatment of opioid dependence.  Both BEMA Buprenorphine and BUNAVAIL are in Phase 3 clinical development, and Clonodine Topical Gel is in Phase 2 clinical development.

BDSI’s headquarters is located in Raleigh, North Carolina.  For more information visit www.bdsi.com.