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.
Through the AGTC-Bionic Sight collaboration, the companies seek to develop a new optogenetic therapy that leverages AGTC’s deep experience in gene therapy and ophthalmology and Bionic Sight’s innovative neuro-prosthetic device and algorithm for retinal coding.
In patients with normal vision, light enters the retina through the photoreceptor cells. These cells then convert the light into electrical signals and pass them through the retina to the brain. The signals are transmitted in a neural code that the brain uses to create images. In patients without functional photoreceptors, the first step is seriously impaired, causing blindness.
Using optogenetics to stimulate the remaining healthy cells in the retina and Bionic Sight’s neuroprosthetic device to stimulate those cells with the retina’s neural code, AGTC and Bionic Sight will seek to restore normal neural signaling in patients with visual deficits or blindness due to retinal disease.
“AGTC is excited to combine our expertise in gene therapy and ophthalmology with Bionic Sight’s transformative device that incorporates the retina’s neural code to improve the lives of patients with retinal disorders,” said Sue Washer, President and CEO of AGTC. “Bionic Sight has demonstrated an ability to mimic normal image formation in preclinical studies and we believe there is a potential to achieve an outcome for patients that greatly exceeds what is currently possible with prosthetic or gene therapy approaches in late stage degenerative retinal diseases.”
The Bionic Sight device combines a camera with proprietary software to convert incoming images into a “retinal code” that is capable of activating the optogenetic protein delivered by AAV gene therapy. Activation of this protein causes the targeted cells to fire in specific patterns recreating images the brain can detect.
“We’re very enthusiastic about this opportunity to collaborate with AGTC, and recognize the potential of their proprietary gene delivery technology to support our clinical development program,” said Sheila Nirenberg, Ph.D., Professor in the Department of Physiology and Biophysics at Weill Medical College of Cornell University and the founder of Bionic Sight. “AGTC’s AAV-based delivery platform has been validated in multiple pre-clinical and clinical studies, and we believe our combined technologies and capabilities have the potential to contribute significantly to patients affected by severe vision impairment.”
Emmaus, headquartered in Torrance, CA, is a biopharmaceutical company engaged in the discovery, development, and commercialization of innovative treatments and therapies, primarily for rare and orphan disease. Initial product development efforts are focused on Sickle Cell Disease (SCD), a genetic disorder.
In November 2016, Emmaus announced that the U.S. Food and Drug Administration (FDA) set a Prescription Drug User Fee Act (PDUFA) date of July 7, 2017 for a decision on Emmaus’ New Drug Application (NDA) for its flagship product, an orally-administered pharmaceutical grade L-glutamine (PGLG) product for the treatment of SCD.
The LOI contemplates that Generex will acquire 51% of the issued and outstanding equity securities in the capital of Emmaus in exchange for $225,000,000 in a combination of cash and shares of Generex common stock.
Dr. Yutaka Niihara, MD, MPH, Emmaus’ Chief Executive Officer, stated: “It is with great anticipation that we have forged this relationship with Generex, setting the stage for great successes for both companies and their stockholders.”
“We at Generex very much look forward to working with Dr. Niihara and his team at Emmaus,” commented Joseph Moscato, Generex President & Chief Executive Officer. “Our objective will be to help Emmaus build on the solid scientific successes it has already enjoyed with a view to achieving myriad product commercializations.”
Hema Diagnostic Systems
HDS, a Florida corporation headquartered in a Food and Drug Administration (FDA)-registered facility in Miramar, Florida, develops, manufactures, and distributes proprietary in-vitro rapid diagnostics tests that address the global medical community’s need for simple, accurate, and affordable rapid diagnostic tests for infectious diseases such as HIV, tuberculosis, malaria, hepatitis, syphilis, typhoid, dengue, and others.
Pursuant to a formal Acquisition Agreement, Generex has acquired 51% of the issued and outstanding equity securities in the capital of HDS in exchange for shares of Generex common stock.
Dr. Jason Terrell, MD, Generex’s new Chief Scientific Officer and Medical Director, stated: “I’m thrilled to see Generex make this Hema Diagnostic Systems acquisition, along with its strong team and proven track record. Global utilization of diagnostics is always limited by cost and accessibility. HDS addresses these limitations through its affordable, rapid result, point-of-care platform technology systems. Generex and HDS will work together to expand the existing catalog of tests by applying the platform to additional areas of unmet need. This partnership has the potential to deliver a consistent stream of valuable products to patients worldwide.”
The awards will support life science research, technology commercialization and entrepreneurship throughout North Carolina and help universities and companies attract additional funding from other sources.
Three companies received Small Business Research Loans totaling $750,000. These funds support applied research critical to the development of products, processes or tools with clear commercial potential.
Clinical Sensors of Research Triangle Park received $250,000 to accelerate product development and partnering activities for a sensor that rapidly measures nitric oxide in patient blood to help improve the detection of sepsis, a severe response to bacterial infection sometimes referred to as “blood poisoning.”
Biorg of Winston-Salem received $250,000 to develop a liver-cancer model for drug safety and efficacy testing that promises improved predictive accuracy and reduced reliance on animal testing.
MAA Laboratories of Raleigh received $250,000 for proof-of-concept studies for two new cancer therapies based on formulation technology first developed at North Carolina State University.
Lucerno Dynamics of Morrisville received a $300,000 Strategic Growth Loan. SGLs help companies reach specific and meaningful milestones that will enable them to obtain further funding from investors and/or to commercialize their products. Lucerno’s is for commercialization of its quality assurance and quality control system for PET and CT scans. The technology is designed to reduce the likelihood that compromised scan images are used in patient care. The work will include clinical studies at 10 sites, three of them in North Carolina.
University R&D Grants
Fayetteville State University (on behalf of principal investigator Shirley Chao, Ph.D.) received a Technology Enhancement Grant for $74,800. This grant program is for university technology transfer offices to support research and other commercially important activities that will make a technology licensable. FSU will use its grant to develop CannaMix, a selective natural pest control product derived from hemp seeds that hinders insect development and reproduction but does not harm animals such as fish.
Three universities received Biotechnology Innovation Grants totaling $290,509. These grants support studies that enable commercialization of early-stage life science inventions at universities.
NCSU (principal investigator Ke Cheng, Ph.D.) received $100,000 for development of a new magnetic device called MitraMag to repair leaky mitral heart valves in dogs and humans.
Duke University Medical Center (principal investigator Nandan Lad, M.D., Ph.D.) received $100,000 to test new designs for cranial shunts that drain excess brain fluid resulting from head trauma, disease or congenital defect.
Elon University (principal investigator Daryl Lawson, D.Sc.) received $90,509 to develop a medical device that uses heat and electrical stimulation to treat non-healing diabetic foot ulcers.
Meeting and Event Grants
Three universities and one research organization received Biotechnology Event Sponsorships and Biotechnology Meeting Grants totaling $20,950.
High Point University received $3,000 for the 114th North Carolina Academy of Science annual meeting and research conference, scheduled for March 24 and 25. The conference will bring together diverse groups of high school, undergraduate and graduate students and faculty from public and private institutions in North Carolina to present their original scholarly research.
The University of North Carolina at Chapel Hill received $10,000 for the Carolina Nanoformulation Workshop, scheduled for March 13 through 17. The annual scientific workshop will focus on challenges and opportunities in drug development, and enables interaction between academic and industrial scientists.
UNC also received $3,000 for the 2017 Integrative Vascular Biology and UNC McAllister Heart Institute Annual Research Symposium on March 7. The symposium will expose the local scientific community to new data generated by cardiovascular researchers in the Research Triangle area.
UNC Charlotte received $3,000 for the National Donor Day Symposium: Conversations of the Heart on Feb. 14. The symposium will explore the many dimensions of organ donation, procurement, placement and preservation.
Underwriters Laboratories received $1,950 for the Personalized Health and Wellness Symposium in March. The symposium will bring innovation and safety experts together for discussion of advancements in biotechnology.
The Centers for Disease Control and Prevention estimates between 700,000 to 1.4 million people in the United States have chronic Hepatitis B virus infections, with an estimated 20,000 new infections every year.
The research collaboration will include the design, construction and characterization of multiple vaccine candidates by combining the preS VLP technology from Georgia State and GeoVax’s MVA-VLP vaccine platform. Unique VLP design and functional assays developed by Dr. Ming Luo, professor in the Department of Chemistry at Georgia State, and performed in collaboration with Peking University Shenzhen Graduate School, will provide key information on vaccine effectiveness.
“My team’s efforts continue to unveil the molecular mechanism of immune responses to HBV infection and we are excited to partner with GeoVax to further the development of a Hepatitis B therapeutic vaccine,” said Dr. Luo. “Globally, chronic Hepatitis B affects more than 240 million people and contributes to nearly 686,000 deaths worldwide each year. By joining forces with GeoVax, we will apply our highly complementary sets of expertise in an effort to address the problem.”
The vaccine will be based upon generating the preS VLP using the GeoVax’s novel MVA-VLP vector platform, which has been proven safe in multiple human clinical trials of the company’s preventive HIV vaccine. This platform is also being used to develop preventive vaccines against Zika virus and hemorrhagic fever viruses, such as Ebola, Sudan, Marburg and Lassa.
“We are fortunate to have the collaboration with nearby Georgia State University and Dr. Ming Luo,” said Farshad Guirakhoo, chief scientific officer at GeoVax. “The combined technologies and already defined functional assays will serve to rapidly test this innovative concept.”
Deals of the Year are awarded to one or more companies or institutions for the most significant financial or commercial transactions closed from November 1, 2015-October 31, 2016. The recipients will receive their awards at the Georgia Bio Annual Awards Dinner January 26, 6 pm to 9 pm, at the Westin Atlanta Perimeter North. Now in its 19th year, the Georgia Bio annual awards dinner brings together industry leaders to advance the growth of the life sciences industry and foster strategic partnerships that can create a healthier world. Other leading companies, executives, researchers and dedicated individuals will receive Georgia Bio Awards at the dinner. Learn more and register at www.gabio.org/awards.
The recipients are: Alimera Sciences, Inc.; Arbor Pharmaceuticals, LLC; Axion BioSystems, Inc.; Clearside Biomedical, Inc.; and CryoLife, Inc.
Arbor Pharmaceuticals, LLC
In May 2016, Arbor Pharmaceuticals, LLC (“Arbor”) announced that it had signed a definitive agreement under which the company acquired XenoPort for $7.03 per share in cash, or a total equity value of approximately $467 million. As part of this acquisition, Arbor gained the commercialization rights to Horizant (gabapentin enacarbil) and a pipeline of products in late-stage development. Horizant is also being studied as a potential treatment for patients with alcohol use disorder through a collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Arbor is currently focused on the cardiovascular, hospital, pediatric, and neuroscience markets as well as generics through its Wilshire division. The company has over 700 employees including sales professionals promoting its products to physicians, hospitals and pharmacists. Arbor currently sells over twenty FDA approved products with over thirty more in development. For more information, visit www.arborpharma.com.
Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of implantable living tissues and medical devices used in cardiac surgical procedures. CryoLife markets and sells products in more than 80 countries worldwide. CryoLife is being honored for its January 2016 acquisition of On-X Life Technologies Holdings, an Austin, Texas-based, privately held mechanical heart valve company. For additional information about CryoLife, visit www.cryolife.com.
Axion BioSystems, Inc.
Axion BioSystems, a life science company located in Atlanta, GA, has developed the industry’s first high-throughput microelectrode array (MEA) product line. MEAs are used for the in-vitro investigation of networks of electrically active cells (e.g. neurons, cardiac cells, muscle cells etc.) for screening compounds, chemicals, toxins etc. When combined with modern cell culture technologies, Axion’s platform allows scientists to model human heart-beats and brain activity in a dish. Axion’s products are used by pharmaceutical and biotech companies, governmental agencies, and universities for drug safety, drug discovery, and disease modeling assays. In May 2016, Axion Biosystems closed a $6 million equity financing round which included funds from the Georgia Research Alliance Venture Fund. Funds will be used to grow Axion’s core life science instrumentation product line. For more information, visit https://www.axionbiosystems.com/.
Initial Public Offering & Private Financing
Clearside Biomedical, Inc.
Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a publicly traded, ophthalmic biopharmaceutical company that envisions a world without blindness. Clearside relentlessly pursues transformative, elegant, precise solutions to restore and preserve vision. Clearside is developing advanced clinical and pre-clinical candidates using a proprietary treatment approach offering unprecedented access to the back of the eye through the suprachoroidal space (SCS™). This offers potentially meaningful treatment benefit to patients suffering from sight threatening diseases like uveitis, retinal vein occlusion, diabetic macular edema and wet age-related macular degeneration. Clearside is being honored for the December 2015 closing of a $20 million Series C financing and the June 2016 announcement of the pricing of its initial public offering of 7,200,000 shares of its common stock at a public offering price of $7.00 per share. For more information, visit http://clearsidebio.com/.
Alimera Sciences, Inc.
Alimera Sciences, a pharmaceutical company located in Atlanta, Georgia that focuses on diseases affecting the back of the eye, or retina, closed on an underwritten public offering of its common stock in August of 2016 for gross proceeds of $26.5 million. For more information, visit http://www.alimerasciences.com/.
For a list of past Georgia Bio award recipients, click here.
Georgia Bio (www.gabio.org) is the state’s life science industry association whose members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services.