The IPO proceeds will provide capital as VTI broadens and accelerates its US launch of its NaturalVue Multifocal (MF) daily disposable contact lenses for adults with presbyopia (age-related loss of near vision), and children with myopia (near-sightedness) and launch additional contact lens products.
Visioneering Technologies’ Senior Vice President of Sales and Marketing, Mr Tony Sommer, will lead the growth of the sales force. Mr Sommer was the head of sales for the US Vision Care division at Bausch & Lomb, one of the largest multi-national contact lens companies. The funds raised in the IPO are intended to further build out the US sales force to approximately 45 direct sales representatives over the 12 months following listing, and to build inventory that will support the expanded sales effort.
The NaturalVue MF contact lens has been cleared by the US Food and Drug Administration (FDA), and a pilot launch in the US market commenced in 2015 generated strong interest. Within 12 months of the pilot launch commencing, demand for the NaturalVue MF contact lenses far outpaced VTI’s ability to supply product with its then limited infrastructure, and 90 per cent of patients who had been using the lenses long enough to use up their supplies reordered, indicating strong repeat purchasing.
While bone is a natural composite of collagen and hydroxyapatite, its nanostructure is not duplicated in any available bone substitutes. In natural bone, the collagen is intimately associated with crystals of hydroxyapatite, which form within nanoscopic spaces of the collagenous network and leave the fibers embedded with mineral.
University of Florida researchers have developed a process for mineralizing collagen substrates using a polymer-induced, liquid-precursor process, which generates an artificial bone substitute that closely mimics the composition and structure of natural bone. Prior to this discovery, no other groups have been able to achieve high mineral loading when attempting to mineralize collagen.
This revolutionary process will allow Amend to fabricate a highly mineralized, load-bearing, bioresorbable, collagen hydroxyapatite composite that will serve as a pioneering technology in the area of artificial bone.
“We look forward to working with the strong management team at Amend as they further develop this technology to meet an important health need,” stated David Day, assistant VP and director, UF Office of Technology Licensing. “This is a clear example of how academic researchers and the commercial sector can work together for the benefit of the broader community.”
“Amend Surgical is excited about our new partnership with UFRF and the commercial promise of Biomimetic Bone,” said Robby Lane, CEO of Amend Surgical. “Biomimetic Bone will be a complementary product line to our NanoFUSE® family of products and we will initiate development and commercialization work on this important research immediately.”
NeoGenomics excels in providing custom developed Immunohistochemistry (IHC) assays to be used in clinical trials, companion diagnostics and clinical testing. Automated IHC workflows, quantification, and interpretation tools remove variability of pathology scoring criteria and will allow researchers and pathologists a higher level of analytical consistency to standardize biomarker analysis for global clinical trials and clinical testing.
Douglas VanOort, Chairman & CEO for NeoGenomics commented, “Continual innovation and automation of our testing services helps us provide increasingly more efficient and effective services for our clients. Our relationship with Definiens has allowed us to further automate some of our important immunohistochemistry services for clinical trials and for clinical testing, and we are looking forward to leveraging this relationship further. NeoGenomics is committed to being a leader in innovation, and to providing the most advanced and highest-quality testing services for all of our Pharmaceutical and Clinical clients.”
Thomas Heydler, CEO at Definiens, said, “We are excited to further expand our long-lasting relationship with NeoGenomics by introducing cutting-edge solutions to the clinical trial services workflow and to further expand pathology automation used in routine clinical testing. Our products and services support the development of new assays for clinical trials to help answer the most relevant questions in drug development. Definiens’ unique solutions also play a key role in helping to make clinical decisions with interpretation of lab developed tests.” Thomas Colarusso, VP Business Development and Strategy at Definiens, adds, “We expect Definiens Tissue Phenomics solutions will provide strategic value and new insights for existing and novel esoteric biomarker tests that NeoGenomics will use in both routine clinical assays and in clinical trials.”
The company chose this strategic location to facilitate more efficient expansion and service of the critical U.S. market, to enhance access to Latin America, and to capture the benefits of Broward County’s business environment. When completed, this facility – located in Miramar, FL – will be one of the largest manufacturing projects in South Florida. The site will also house the packaging operations of Aveva Drug Delivery Systems. Construction on the building is underway and expected to be completed in early 2019.
“Expanding our footprint in the U.S. is a central component of our strategy for global growth and reflects the critical importance of the U.S. and Latin American markets to our success, as well as our confidence in the future of the American manufacturing and biopharmaceutical sector,” said Apotex CEO and President, Dr. Jeremy B. Desai. “With generic and biosimilar medicines playing an increasingly vital role in reducing the cost of drugs, Apotex will continue making strategic investments in R&D and American manufacturing to deliver high-quality, affordable medicine to patients, healthcare providers and stakeholders in the U.S. and around the world. In addition, due to U.S. regulations, we are only permitted to manufacture controlled substances in the U.S. when serving this market, so expansion in Canada was not feasible.”
The significant investment by Apotex reinforces the success that Greater Fort Lauderdale, Broward County, and the State of Florida have achieved in attracting the world’s most innovative life science companies, and cultivating an environment where leaders in that industry can grow and thrive. South Florida is currently home to approximately 1,500 bioscience businesses and institutions that employ more than 26,000 people and generate over $4 billion in sales, according to recent estimates. The concentration of biomedical companies in Greater Fort Lauderdale, supported by a vibrant network of regional universities and research facilities, creates the ideal ecosystem for Apotex to establish a strong foundation for future expansion and growth.
“Over the past several years, Greater Fort Lauderdale/Broward County has worked to develop this region into the destination of choice for the most advanced companies in the biomedical field,” said Bob Swindell, president and CEO of the Greater Fort Lauderdale Alliance. “We congratulate Apotex on this bold investment and commit our ongoing support in the company’s continued growth and success.”
Broward County Mayor Barbara Sharief added, “As the home to a thriving community of innovative, purpose-driven companies and dedicated researchers, we are incredibly proud of the role that Broward County plays in supporting the development of life saving treatments for vulnerable patients throughout the world. We welcome Apotex as a new member of the Broward County family and look forward to a long and fruitful relationship.”
Miramar Mayor Wayne Messam said, “With one of the fastest growing economies in the nation, Miramar remains an attractive city for companies to grow and prosper. Our city has been intentional in attracting target market firms like Apotex. Miramar is so excited about the opportunity to partner with Apotex in their expansion. It will create hundreds of high paying jobs for our city and residents and will help to fuel an already thriving economic position for Miramar and the region.”
The new program, to be managed by NCBiotech, will support distinguished postdoctoral fellowships in North Carolina university research laboratories providing advanced scientific training in gene therapy-related research.
Absent or faulty proteins linked to genetic mutations cause numerous devastating diseases, making gene therapy an increasingly important treatment strategy.
Pfizer’s portfolio in North Carolina has grown in recent years. The company already operates a pharmaceutical manufacturing facility in the Lee County community of Sanford, and in August 2016, it acquired leading-edge gene therapy company Bamboo Therapeutics, Inc. in Chapel Hill.
With that acquisition, Pfizer gained the expertise of Bamboo’s world-renowned co-founder, R. Jude Samulski, Ph.D., director of the Gene Therapy Center at the University of North Carolina at Chapel Hill. The deal also included an 11,000-square-foot facility for the highly specialized manufacturing of recombinant adeno-associated viral vectors.
Pfizer is one of several biopharmaceutical companies that have added high-profile gene therapy acquisitions, and several partnerships with biotechnology companies and leading academic institutions, to its R&D portfolio. Numerous other North Carolina scientists and companies are also making significant inroads into gene therapy, gene editing and related applications, many with NCBiotech support. For example, Samulski was recruited to UNC in 1993 as part of a $430,000 NCBiotech grant. Additionally, Bamboo’s former parent company received more than $700,000 in Biotech Center grants and loans.
Gene therapy advances require specific skills in addition to deep scientific knowledge. The fellowship program being established with Pfizer’s funding aims to boost that talent pipeline, with talent that has already proven to be exceptional in North Carolina. Such funding will enable NCBiotech to provide two-year fellowship support to postdoctoral scientists. The funding will afford the Center the ability to cover salaries, benefits, materials, professional development and travel for such postdoctoral scientists. The Center will encourage competitive applications from scientists interested in establishing research careers in gene therapy and related research activities.
The Biotech Center will also create and manage a related gene therapy Exchange Group. It will join some 25 other exchange groups designed to unite North Carolina-based academic and industry scientists with shared professional interests. The Gene Therapy EG will include these new postdoctoral fellows, their mentors, and others interested in the burgeoning gene therapy sector.
“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 unique fellowship program,” said Mikael Dolsten, M.D., Ph.D., president of worldwide research and development at Pfizer. “We believe that gene therapy may hold the promise of bringing true disease modification for patients suffering from devastating diseases, and North Carolina is uniquely positioned to help us take advantage of collaborative opportunities that can develop the specialized talent we’ll need.”
Doug Edgeton, president and CEO of the Biotech Center, said he was deeply honored that Pfizer targeted North Carolina, and the Center, for the groundbreaking fellowship program.
“Pfizer embraced the opportunity to work with us given we’ve proven for more than 30 years that we have the expertise and success metrics to maximize impact,” said Edgeton. “We not only have outstanding research institutions across our state, but we also have a well-respected culture of partnering and collaboration that allows us to be nimble and responsive. This is a wonderful example.”
Pre-clinical studies conducted at Sweden’s Karolinska Institute have demonstrated that Vycellix’s molecules significantly enhance cancer targeting cytotoxic lymphocytes such as cytotoxic T cells and natural killer cells (NK cells). The Moffitt team, led by James J Mulé, Ph.D., Associate Center Director for Translational Science, will conduct additional studies evaluating each molecule’s respective ability to improve genetic modification of cancer immune lymphocytes and increase their killing capacity.
According to Dr. Mulé, “We are intrigued by the potential to make genetic modification processes more efficient and to ‘super-charge’ targeted T cells and NK cells by inducing significantly increased loads of cancer-killing granules. We look forward to evaluating how these molecules can improve a broad array of important cell-based cancer immunotherapies we are advancing at Moffitt.”
The Gator100, named after the University of Florida’s mascot, recognizes and celebrates the 100 fastest-growing businesses in the world that are either owned or led by University of Florida graduates. The annual award is sponsored by the University’s Entrepreneurship & Innovation Center and Warrington College of Business. The winning companies were announced earlier today at the Gator100 Awards Gala at the University of Florida.
“We are grateful to the University of Florida for its ongoing support as we have evolved from a small startup to a publicly traded company actively enrolling patients in two critical trials to evaluate gene therapies for rare ocular conditions,” said Sue Washer, President and CEO of AGTC. “We are proud to be recognized alongside so many accomplished and diverse peers who are making a positive impact across a diverse group of leading industries.”
AGTC was originally located within the University of Florida’s Sid Martin Biotechnology Incubator and the company maintains extensive ties to the University through multiple Sponsored Research Agreements, covering basic research projects and supporting pre-clinical and clinical development for new product candidates.
“We congratulate AGTC for earning the top spot in the 2017 Gator100,” said Jamie Kraft, Director of the Entrepreneurship & Innovation Center at the Warrington College of Business. “The company’s continued growth reflects its leadership in the development of innovative gene-based therapies that have the potential to dramatically improve lives. We are proud to continue to partner with a company that is making an impact on patients and the biotechnology industry.”
Hammock Pharmaceuticals is using a novel drug-delivery technology to improve the effectiveness of traditional medicines for a variety of conditions, starting with bacterial vaginosis, a common infection caused by an over-abundance of bacteria in the vagina. More than 21 million women suffer from bacterial vaginosis in the U.S.
The company this month announced a license agreement with MilanaPharm and its sister company, TriLogic Pharma, of Tallassee, Ala., for exclusive global rights to their hydrogel technology. Hydrogel is a co-polymer that transforms from a liquid to a gel at body temperature, allowing it to adhere to body tissues.
When formulated with antibiotics or other active ingredients, the hydrogel can improve drug efficacy by staying in the body longer than traditional gels and creams.
Because its bio-adhesive property extends drug delivery from hours to days, the technology has the potential to transform the effectiveness and efficiency of active drugs including antibiotics, says Hammock CEO William R. Maichle. And because it’s not an oral formulation, systemic side effects are avoided.
Hammock’s two lead products for bacterial vaginosis are hydrogel-based formulations of metronidazole and clindamycin, two antibiotics that have been used safely in millions of patients for many years, but with limited results.
“We have to do a better job treating this disease,” Maichle says. “Women are hesitant to see their doctor because they’re embarrassed, but they need to understand they’re not alone. The fact is almost 30 percent of women of childbearing age in the US have bacterial vaginosis. And because our delivery technology is so innovative, we will be able to offer these women a one-dose treatment that’s nearly twice as effective as what’s on the market today.”
In a pilot study, Hammock’s clindamycin gel showed an 88 percent cure rate for bacterial vaginosis, significantly higher than the 40 to 60 percent cure rates of current treatments, Maichle says.
Hammock expects to begin a Phase 3 clinical trial of clindamycin and metronidazole gel formulations in the second half of 2017.
If the formulations pan out, they could bring greater relief to the millions of American women aged 15 to 49 who suffer each year from bacterial vaginosis, the most common infection of the vagina. At least half the time, women with bacterial vaginosis have no symptoms, but those who do have symptoms typically notice an odorous discharge. Some patients experience itching.
According to the Centers for Disease Control and Prevention, bacterial vaginosis can increase a woman’s risk of contracting sexually transmitted diseases including HIV, and also increase the risk of premature deliveries in pregnant women.
“It’s unfortunate that bacterial vaginosis is so widely misunderstood and is almost an unmentionable subject,” Maichle says, explaining that it’s often mistaken for a venereal disease and can carry a stigma that keeps women from getting treatment and inhibits their social lives.
“We are confident that we have a better solution to help these women not only get back to their lives more effectively, but get there with a lot less disruption,” he says.
The gel formulations are intended to be a single-dose treatment given by a doctor or the patient using a pre-filled applicator similar to those used to insert tampons. The gel is bioabsorbable, meaning it eventually dissolves and is cleared from the body in urine.
Maichle says Hammock anticipates executing licensing agreements for the two formulations outside the United States in 2017. Patents for the hydrogel technology have been granted in the United States, the European Union and China, with additional patents pending that would grant exclusivity through 2035.
The annual global market for topical bacterial vaginosis treatments is estimated to be $300 million. Including the oral antibiotic treatments, the global market is over $500 million.
Hammock is developing another hydrogel formulation, called HPI-1216, for relief of pain caused by radiation cystitis, a frequent complication of radiation therapy for pelvic tumors or bladder cancer. Radiation treatments can damage the bladder, causing pain, frequent urination and other effects.
The active ingredient in HPI-1216 is lidocaine, a numbing agent that has been used widely to relieve pain since its discovery in 1946.
The formulation would be instilled in the bladder through a catheter. It would adhere to the bladder wall, where it would release lidocaine continuously “over days, and hopefully weeks,” Maichle says.
Hammock is working on a final formulation now and plans to begin a small clinical trial by the end of the year, he says.
Maichle started the company in April 2016 after holding leadership roles at three other pharmaceutical companies.
“Hammock is my fourth start-up company in the bioscience industry, and it is definitely the one I’m most excited about,” he says.
Most recently he was president of Tribute Pharmaceuticals U.S., which merged with Chapel Hill-based Pozen to form Aralez Pharmaceuticals. Prior to that he was CEO of Nautilus Neurosciences before it was sold to Depomed. Previously he was chief operating officer of ProEthic Pharmaceuticals before it was sold to Kowa Pharmaceuticals.
Maichle, who has lived in Charlotte since 1999, says he chose to locate Hammock in the Queen City because of its “great healthcare system,” long roster of financial companies and deep hiring pool.
“Not only is Charlotte a great place to live and raise a family, it’s a perfect place to start a company,” he says. “There are so many talented, highly educated people living in our area, and that number is only increasing.”
Corie Curtis, executive director of the North Carolina Biotechnology Center’s Greater Charlotte Office, couldn’t agree more.
“We’re so delighted to add Hammock Pharmaceuticals to the growing life science community in the Greater Charlotte area,” said Curtis. “Our region is home to a diverse collection of biotech assets. At the Biotech Center we repeatedly hear domestic and international companies cite the region’s educated and increasing talent pipeline as a significant consideration in selecting Charlotte for location or expansion. Through collaborative effort, the Biotech Center is able to help foster an environment conducive to the successful growth of companies like Hammock.”
Maichle’s management team at Hammock includes three other executives with decades of experience:
Including the management team, Hammock has five employees and several consultants. It will hire more staff when this year’s clinical trials begin and as more commercial-stage products are added to its pipeline, Maichle says.
The company is financed by a recent convertible debt round funded by the management team and individual investors. Maichle says Hammock will embark on a Series A equity financing round in the next month or so.
The company is also in discussions with potential strategic partners in the U.S. and is looking for partners in other major global markets. New partnerships could attract more strategic financing than a typical equity or venture deal would bring, he says.
If Hammock in-licenses more commercial-stage products, it will likely turn to debt financing, Maichle says.
Approximately $80 million from the federal government will be combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities. As part of continuing efforts to help revitalize American manufacturing and incentivize companies to invest in new technology development in the United States, ARMI will lead the Advanced Tissue Biofabrication (ATB) Manufacturing USA Institute on behalf of the Department of Defense.
Under the umbrella of Manufacturing USA, a public-private network that invests in the development of world-leading manufacturing technologies, ARMI will work to integrate and organize the fragmented collection of industry practices and domestic capabilities in tissue biofabrication technology in order to better position the US relative to global competition. ARMI will also focus on accelerating regenerative tissue research and creating state-of-the-art manufacturing innovations in biomaterial and cell processing for critical Department of Defense and civilian needs.
“We need to develop 21st century tools for engineered tissue manufacturing that will allow these innovations to be widely available – similar to how a 15th century tool (the printing press) allowed knowledge to spread widely during the Renaissance,” said inventor Dean Kamen, ARMI’s chairman.
ARMI’s efforts are supported by forty-seven industrial partners, twenty six academic and academically affiliated partners, and fourteen government and nonprofit partners. The ARMI partnership continues to grow.