Fabior (tazarotene) Foam, 0.1% is a patent-protected topical product indicated for the treatment of acne, the largest dermatology indication in the US affecting up to 50 million Americans every year1. Sorilux (calcipotriene) Foam, 0.005% is a patent-protected topical product indicated for mild to moderate plaque psoriasis affecting up to 6 million Americans each year1.
Both Fabior and Sorilux will be marketed through Mayne Pharma’s Specialty Brands Division and existing sales team. Re-launch for both products is expected in FY17. During the intervening period GSK will continue to distribute Fabior and Sorilux under a transition services arrangement.
The non-US dermatology assets will continue to be distributed by GSK in the short term and Mayne Pharma will seek to out-license these products to new partners.
Rationale for the acquisition
Mayne Pharma’s CEO, Mr Scott Richards said “This acquisition will strengthen Mayne Pharma’s position in the US dermatology market, diversify future branded earnings and create new opportunities for growth. Both Fabior and Sorilux are a strategic fit with the existing Doryx franchise and participate in attractive and growing markets. We believe both products are differentiated assets with compelling clinical data that physicians and patients will appreciate.”
“Mayne Pharma is very attracted to the underlying fundamentals of the US dermatology market. The acquisition will leverage existing commercial infrastructure across functions including sales and marketing, customer service, compliance, medical affairs and contracts administration. We also expect to leverage the new foam capability in future branded and generic product development programs.”
Mayne Pharma expects the products to contribute modest incremental EBITDA in FY17 and have significant potential for growth in future years.
“The addition of ON Light Sciences’ innovative technology allows us to better meet the needs of aesthetic practices that focus on energy-based devices,” said Philip Burchard, CEO of Merz Pharma Group. “We have a vision to be the most innovative company in aesthetics, and this acquisition clearly complements our growing and diversified global portfolio, which includes the Ultherapy® and Cellfina™ devices.”
The DeScribe® Transparent PFD Patch is placed over tattoos prior to irradiation, allowing physicians to treat tattoos more efficiently by enabling rapid multiple laser passes in a single treatment session. It also provides significant optical clearing of tissue, protects the epidermis and inhibits potentially infectious back-splatter and fumes. In a recent clinical trial1, laser tattoo removal patients reported not only less discomfort, but faster healing post-treatment with the DeScribe® Transparent PFD Patch.
“Merz North America’s robust aesthetic portfolio continues to strategically grow through innovative products addressing conditions with fast growing demand such as tattoo removal. This latest addition to our offerings underscores the strong commitment we have to growing our US business by responding quickly to market demands,” Merz North America President and CEO Bill Humphries said.
Tattoo removal is one of the fastest-growing laser procedures (109,641 performed in 2014), up 74 percent since 2012, as reported by the American Society of Dermatologic Surgery (ASDS), and new developments in medical device technology are encouraging more individuals to consider tattoo removal procedures more seriously.
Market research indicates that an increase in tattoo prevalence is correlated with rising levels of “tattoo regret.” According to a July 2015 study conducted by laser manufacturer Syneron-Candela, 33% of tattoo wearers in the US have at least one tattoo they would consider removing or would definitely like to have removed.
“We look forward to joining Merz and expanding awareness and use of the DeScribe Transparent PFD Patch. We share Merz’s commitment to innovation that directly and positively impacts patient health and welcome the opportunity to be part of its strong product line-up.” David Sell, President and CEO of ON Light Sciences said.
“Merz continues to actively seek opportunities to partner with or acquire companies such as ON Light Sciences,” said Hans-Jörg Bergler, Head of Corporate Development for Merz Pharma Group. “Through a focused corporate development strategy and our Merz Corporate Venture Capital Initiative, we remain actively engaged in funding innovative and category-building technologies within the aesthetics space.”
Current OLS customers should continue to place product orders via the ON Light Sciences’ website at www.onlightsciences.com.
The South Carolina Biotechnology Industry Organization (SCBIO) will work with the South Carolina Department of Commerce on a strategic plan that includes attracting more life sciences sectors to the state, says Wayne Roper, president of SCBIO, which was formed in 2004 and became a self-sustaining membership-driven trade association six years ago.
“We have the expertise and the interest in developing the job,” Roper says. “We know how to get the most bang for our buck in economic development.”
The partnership will begin with an inventory of life sciences companies and assets in the state, including on-site visits to pharmaceutical, medical device, research, diagnostic and medical equipment companies and their suppliers.
Next, SCBIO and state officials will identify opportunities to attract more human life-sector companies to the state, and then they’ll support the commercialization of research for South Carolina universities, Roper says.
The state is developing expertise in biopharmaceutical manufacturing, which is a burgeoning field, created by small companies, he says.
This type of manufacturing fills a huge need as some predict that half of all prescriptions will be biopharmaceuticals within the next four years, Roper says. “We’re talking about drugs for rheumatoid arthritis, cancer, diabetes, for autoimmune diseases; these are the treatments.”
South Carolina is well positioned to attract life science industries that fit within existing companies and infrastructure, without competing with Boston or North Carolina’s Research Triangle Park, Roper says.
Ultimately, the initiative could result in more high-paying jobs and the development of more business relationships and supply chains.
“We’re going to find companies that fit with South Carolina’s economy and ability to support and grow,” he says. “The field is vast.”
The privately owned kSep was formed in 2011 as a spinoff of Durham-based KBI Biopharma, which was itself acquired in 2015 by JSR Group, CMIC Holdings and Inovation Network Corporation of Japan. SSB said it would keep the company’s five employees and continue operations from the Morrisville site.
kSep has developed and markets single-use, fully automated centrifugation systems used for manufacturing biopharmaceuticals, such as vaccines, cell-based therapeutics and monoclonal antibodies.
Reinhard Vogt, member of SSB’s Board, called kSep’s centrifuges “a very innovative, single-use cell separation technology that perfectly complements our offering for downstream bioprocessing. Our clients will greatly benefit from the unique ability to collect, wash and concentrate cells quickly and reduce both the time and cost of downstream purification steps.”
Sunil Mehta, president and CEO of kSep, said the deal “will significantly speed up our internationalization and business growth. SSB will provide access to considerably more customers, especially in Asia, a market we haven’t developed yet.”
Bamboo shareholders received $150 million up front, and could be in line for another $495 million depending on milestones. Earlier this year, Pfizer had acquired 22 percent of Bamboo’s fully diluted equity for $43 million.
Bamboo has fewer than 40 employees, and nearly all have been offered positions within Pfizer, according to a Pfizer spokesman.
Bamboo is developing potential treatments for rare diseases related to neuromuscular conditions and those affecting the central nervous system. The acquisition significantly expands Pfizer’s gene therapy portfolio.
The startup is built on 30 years of work done by Jude Samulski and Xiao Xiao of UNC-Chapel Hill. According to data from the N.C. Biotechnology Center, Bamboo is one of several companies that spun out of Asklepios Biopharmaceutical (“AskBio” for short), which has received more than $700,000 in grants and loans from the biotech center to support its research and commercial development.
“The field of gene therapy research has made tremendous strides in recent years, and we are pleased to be able to further enhance our leadership position in this area through this transaction with Bamboo,” said Mikael Dolsten, president of Pfizer Worldwide Research and Development, in a statement. “We believe that gene therapy may hold the promise of bringing true disease modification for patients suffering from devastating diseases, and we hope to see this promise come to fruition – through new and existing in-house capabilities and potential partnership opportunities – in the years to come.”
Gene therapy addresses the root cause of diseases caused by genetic mutation and holds medical promise particularly for rare diseases.
The partnership, announced Thursday, will kick off with a study of the existing companies and assets within the industry statewide, lasting nine months. That study will include visits to companies and suppliers in South Carolina, according to a release. The partnership aims to grow the industry and create more biomedical jobs in South Carolina.
The public agency and private industry group will “commit financial and in-kind resources” to each other for the partnership, according to the agreement both signed. The agreement is in effect from Aug. 1, 2016 until July 30, 2017, and requires each to contribute $50,000 between Oct. 2016 and May 2017.
SCBIO will also be able to partner with regional chamber of commerce alliances, including the Upstate SC Alliance, to help build relationships between biotechnology and life science companies.
“Our relationship with Upstate SC Alliance has successfully created a seamless connection with biomed prospects from initial contact to location. And it has resulted in a Bio Task Force to build better client and customer connections,” said Craig Walker, an SCBIO executive board member and CEO of VidiStar, in the release. “We look forward to doing that statewide.”
Orthobiologics Market Opportunity and Amend Surgical Business Development
Of the more than three million musculoskeletal procedures performed annually in the US, about half involve bone grafting. The global bone graft substitute market was valued at $1.9 billion in 2010 and is forecast to reach $3.3 billion in 2017.
In December of last year Amend Surgical acquired the rights to an FDA approved, patent protected bone graft product line, NanoFUSE® Bioactive Matrix. The product will be distinct in the orthobiologics market because of its unique and powerful combination of 45S5 Bioactive Glass and demineralized allograft bone matrix. As a part of the acquisition Amend Surgical also received the rights to NanoFuse® BA which will be submitted to the FDA for approval in 2016. Company management’s extensive experience and network within the global spine, orthopedic and dental fields will facilitate rapid adoption for both of these foundation products.
Amend Surgical CEO Robby Lane said, “Our goal is to advance the science of orthobiologics with novel and disruptive bone graft substitutes. The Sid Martin Biotechnology Institute will provide Amend Surgical the foundational support necessary to continue and expand our robust commercialization and research initiatives.”
Mark S. Long, Director of Sid Martin Biotechnology Institute, stated, “Here at the Institute we specialize in helping startups that are developing and introducing new innovations and solutions. We are happy to welcome Amend Surgical. With the company’s expertise, they are on an upward trajectory to new growth and expansion.”
The Sid Martin Biotechnology Institute has facilitated the launch and acceleration of more than 60 successful companies that have garnered over $13.5 billion in venture capital and revenues. The Institute offers startups collaborative, open laboratory workspace combined with financial, technical and human resources to nuture startups’ growth and success.
Amend Surgical was admitted to the Institute’s bio-business program through the fast track admissions process. Prospective startups may submit an inquiry form through the Institute’s website www.sidmartinbio.org and management will make contact to walk them through the admissions process.
The business plan competitions will provide a total of $125,000 to five startups across Virginia in the biotechnology, health, energy, agriculture and security sectors.
Applications for businesses are now being accepted at http://www.virginiavelocitytour.org
Each stop will highlight a region’s strength ending with public pitch competitions in Roanoke, Richmond, Hampton Roads, Northern Virginia and Charlottesville. In each competition, eight entrepreneurs will pitch their business plans to local judges for $25,000 in equity-free grant prizes.
Each stop will focus on a specific industry that highlights a regional strength, including energy, STEM, biotechnology/health, cybersecurity and agriculture.
Each day the entrepreneurs will participate in public and private events, including roundtables and visits to local incubators.
“We believe that the future of entrepreneurship will be more aligned with the Chesapeake Bay than the San Francisco Bay,” Ross Baird, CEO of Village Capital, said in a statement. “Over 75 percent of venture capital goes to California, Massachusetts and New York, and the entrepreneurs who get funding are likely to be solving problems that make the lives of well-off people a little easier. When you look at the industries that really matter for our society in the long term – agriculture, energy, health and others – Virginia is leading the way.”
Village Capital, which is partnering with Virginia to plan the tour, is a Washington, D.C.-based nonprofit that trains and invests in seed-stage companies providing business solutions in agriculture, energy, education, financial inclusion and health.
The awards support life science research, technology commercialization and entrepreneurship throughout North Carolina. They also help companies and universities and attract additional funding from other sources.
The latest quarter closes out a fiscal year in which the Center made 92 awards totaling about $7.5 million. Of those awards, 18 were company loans totaling $3.7 million and 74 were university grants totaling $3.8 million.
A brief overview of the Center’s overall loan history, and the follow-on funding totals for NCBiotech portfolio companies, is in an adjacent news story: http://wraltechwire.com/many-companies-go-from-ncbiotech-loans-to-big-investments/15866753/
The Center awarded six company loans totaling $1.2 million in the fourth quarter of FY2016.
TARGET PharmaSolutions of Chapel Hill received a $500,000 Strategic Growth Loan to help the company develop its unique database to improve pharmaceutical development through a better understanding of patients and their reactions to new drugs.
The Center awarded 13 major grants totaling about $1.2 million in the fourth quarter of FY2016.
Other awards made in the fourth quarter of FY2016 include:
Eleven Industrial Internship Program awards of $3,000 each to sponsor business or bioscience interns at the following companies: BaseTrace, bioMASON, Chiesi USA, Gilero, NovaTarg Therapeutics, Panacea BioMatx, Rheomics (now called Redbud Labs), SafeRay Spine, SmartGene, Surgilum and Tecan US.
Four Biotechnology Event Sponsorships totaling $10,960 to support events hosted by NCSU, UNC-CH, Western Carolina University and Winston-Salem State University.
Two Biotechnology Meeting Grants totaling $12,700 to support scientific meetings hosted by UNC-CH and WFU Health Sciences.
Arthrex already employs more than 2,200.
“More and more manufacturing companies are choosing to invest and create new opportunities in our state because of our work to cut taxes and make it easier for job creators to succeed,” Scott said. “I look forward to seeing Arthrex’s continued growth as we work to make Florida first for jobs.”
Arthrex has been based in Naples since 1991 and has developed more than 9,500 products and surgical procedures to advance minimally invasive orthopedics. It trains surgeons at its medical education facility in Naples and more than 90 percent of Arthrex’s products are manufactured in the United States.
It’s been named one of the Top 100 Best Companies to Work For by Fortune Magazine and was No. 3 out of the 15 Best Workplaces in Manufacturing and Production in the country.
Florida is ranked second nationwide for FDA-registered medical device manufacturing facilities. It is home to more than 1,100 biotech, pharmaceutical and medical devices companies, and more than 46,000 health care establishments.
“To have a global medical device leader like Arthrex make this kind of investment shows their confidence in Collier County,” said Kristi Bartlett, vice president of economic development for the Greater Naples Chamber of Commerce. “The ripple effect of Arthrex’s physical expansion and the jobs created contributes greatly to our region’s growing economic strength. This is a prime example of the fruits of having a robust business retention and expansion effort.”
Enterprise Florida, the state’s principal economic development organization, brought the proposed project to Collier County in April.
The Collier County Board of County Commissioners in May approved more than $1 million in incentives for the Arthrex project. Of that money, $560,000 was local support as the project qualified for the county’s Qualified Target Industry Tax Refund program.
This requires Arthrex to create 560 new jobs in Collier County that will provide high-wage, value-added employment to Collier County citizens with an average annual wage of $54,000 and average annual benefits of $17,000. An additional $600,000 was awarded in local support because the project qualified for the state’s Quick Action Closing Fund, which requires Arthrex create the jobs and meet its capital investment obligations.
“Collier County is so lucky to have a company like Arthrex that has become a true community partner,” said commission chair Donna Fiala. “Arthrex has been a long and trusted friend of Collier County and has always delivered beyond expectations.”