iBio (NYSE American:IBIO) has developed an industry-leading plant-based gene-expression technology to rapidly produce high levels of proteins used for making biologics at its contract development and manufacturing organization (CDMO) plant at College Station, Tex. “Our CDMO business has extensive monoclonal antibody experience that can take a product candidate from lab to launch,” Robert Kay, executive chairman and CEO, says in an interview with BioTuesdays. “We can take a product from the earliest stages -- feasibility and pilot development -- through preclinical and clinical support, and all the way to full-scale manufacturing, without going outside our CDMO, eliminating delays, uncertainties and expenses for transfer of technology and other matters commonly required at other CDMOs” he adds. In addition, iBio can leverage its CDMO business into a “financial interest in the products being developed by collaborators that utilize iBio’s technology platform,” he points out. “This may include revenue, profit sharing, an equity stake and royalties under license agreements.” iBio’s 139,000-square-foot plant was largely funded by DARPA (the U.S. government’s Defense Advanced Research Projects Agency) in 2011 at a cost of $68-million, to be a rapid manufacturer of therapeutics and vaccines in the event of a bioterrorism attack or pandemic outbreak. “We modified the facility and it can now handle parallel development of multiple products,” he says. Mr. Kay explains that iBio’s technology platform makes plant-based biopharmaceuticals through a four-step process:
“This is dramatically different from mammalian cell approaches,” he says, noting that iBio CDMO can reduce time at each stage of development, compared with mammalian cell systems, leading to a potentially speedier product launch. “We have the capability to conduct early product candidate screening faster, more economically and more broadly than mammalian cell cultures, which gives the candidate a greater likelihood of success,” he adds. “Because each plant operates as a mini-bioreactor, we can scale up simply by growing and transfecting more plants to reach larger scale production rather than suffer the torturous process of growing cell lines and investing in more or larger stainless steel bioreactors.” Mr. Kay says the total time to a GMP run at iBio CDMO is about 12 months, which is some six months faster a mammalian cell platform. “The ingenuity of the iBio process provides iBio with higher margins than the mammalian cell approach, without increasing the price to the client,” he adds. “We can have multiple revenue sources at various stages of development, from early lead screening to selection and optimization, to manufacturing product for clinical trials for multiple products in a single year.” Reduced time at each stage of development speeds product launch He says iBio does not plan to use its CDMO plant for extended manufacturing to support a single product. “We have the capability to help a client design and build a captive manufacturing plant for a successful product to which we would provide technology transfer services and, if desired, manufacturing services.” Mr. Kay says, “iBio’s IP is protected by issued patents in various countries and 14 years of know-how and trade secrets, which allows us to service the needs of clients in any plant-based drug production system.” iBio’s technology has been validated in early-stage studies that were financed by DARPA for an H1N1 influenza vaccine; by the Bill and Melinda Gates Foundation for H5N1 influenza and malaria vaccines; by the Sabin Vaccine Institute for a hookworm vaccine; by the NIH for an anthrax vaccine; and by an agency of Brazil’s Ministry of Health for a yellow fever vaccine. According to Mr. Kay, at iBio’s request, an affiliate of Kenneth Dart’s Eastern Capital fund was invited to acquire the Texas CDMO facility, with iBio and Eastern Capital forming iBio CDMO LLC. It is 70% owned by iBio and 30% by Eastern Capital, which also has a substantial stake in iBio. According to industry forecasts, the market for biopharmaceutical outsourced development spending is expected to hit $31-billion by 2019, up from $26-billion in 2016. The market for small- and mid-sized biopharmaceutical company outsourced development is expected to keep pace, reaching an estimated $11-billion in 2019, compared with $8-billion in 2016. iBio has 124,000 square feet of manufacturing space at its CDMO plant, with a current operating capacity of 2.2 million plants that can generate 150 kg of therapeutic API protein a year. “If all of the capacity were used for production of monoclonal antibodies, the annual commercial manufacturing revenue would be in the range of $120-million to $150-million,” Mr. Kay suggests. However, the facility was designed to enable expansion of the CDMO in two stages, beginning with increasing its pilot space to essentially double its annual capacity to perform feasibility studies - a six-month project that would cost about $2.9-million, which “we would more than recover in a single year,” he adds. The second stage of a future expansion, costing about $22-million, would double capacity to 4.4 million plants that would produce 300 kg of API a year. “By doubling the current plant, we could generate annual revenue in the range of $240-million to $300-million,” Mr. Kay suggests. “If we are successful in continuing to build our pipeline, we are one-to-two years away from exhausting current capacity,” Mr. Kay says. In its proprietary product segment, Mr. Kay says the company temporarily slowed development of its lead drug candidate, IBIO-CFB03, as it focused on restructuring the business model of the CDMO segment. IBIO-CFB03 is in development for the treatment of systemic sclerosis, idiopathic pulmonary fibrosis (IPF), and localized scleroderma, and has received orphan drug designation from the FDA. The prevalence of systemic sclerosis is between 123,000 and 245,000 people in the U.S. and EU. Preclinical data indicate IBIO-CFB03’s potential use for both inhibition and reversal of fibrosis, which would make it a “hugely valuable drug, if successful,” he says. Mr. Kay points to Roche’s 2014 $8.3-billion acquisition of InterMune in 2014, the developer of the IPF drug Esbriet, and Roche’s subsequent launch of the drug, which ultimately failed to have a meaningful impact on reversing fibrotic disease or increasing overall survival. • • • • •To connect with iBio, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2R40Zlp
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Marc Wayne, Co-Managing Director of Canopy Health Canopy Health Innovations, the research subsidiary of Canopy Growth (TSX:WEED; NYSE:CGC) that focuses on the development of therapeutic and natural health cannabis products, will get a big boost from a blockbuster $5-billion (Canadian) investment by Constellation Brands (NYSE:STZ) in Canopy Growth, a world-leading diversified cannabis and hemp company. “Constellation Brands clearly has a strong interest in our research that supports the development of beverages containing cannabinoids, but that’s only the tip of the iceberg,” Marc Wayne, co-managing director of Canopy Health, says in an interview with BioTuesdays. “The additional capital is very beneficial. It will serve to expand and accelerate our other industry-leading research programs.” Mr. Wayne says that in addition to informing innovative beverage development, Canopy Health is developing and conducting rigorous clinical programs to generate data to support broad global market access of its Spectrum branded medical line. Product-specific data also serves to enhance global IP protection for its cannabis-based products. Dr. Mark Ware, CMO of Canopy Growth and Co-Managing Director of Canopy Health Dr. Mark Ware, chief medical officer for Canopy Growth and co-managing director of Canopy Health, points out that pain management, insomnia and mood-related disorders represent priority therapeutic areas for the company, explaining that “many of these overlap, so patients with chronic diseases may have issues with two or all three of these areas.” Within pain disorders, Dr. Ware says that Canopy Health is conducting clinical trials in fibromyalgia and cancer pain, as well as general muscular and skeletal pain syndromes. For consumer products, Canopy Health also applies the core principles of evaluating pharmacodynamics, dose response and safety to a range of potential products from beverages to topical and inhalation agents. “The principles of pharmacology are applied to products in all areas of development,” he adds. Canopy Health has developed a unique ‘hub and spokes’ research model to facilitate and oversee global research activity. Canada acts as the central research ‘hub’ that monitors global research strategy, supply relationships, regulatory filings, product safety, scientific information and intelligence. As the ‘spokes’ of the model, Canopy Health has core research teams and regional operations in South America, Europe, UK, Africa and Australia that manage academic partnerships, regional IP, research sites and patient recruitment. In addition, Canopy is one of the few companies developing cannabis-based drug and OTC products for companion animals through its affiliate, Canopy Animal Health, which is conducting Health Canada-approved trials with a focus on palliative care, anxiety, appetite stimulation and pain management. “We are working with top research organizations that have veterinary drug development experience. These animal studies also serve to support our work in humans. It’s highly strategic,” Mr. Wayne points out. As part of its human therapeutic program, Canopy Health is investigating multiple formulations across what the company calls the “cannabis spectrum,” and how the ratio of THC-to-CBD, the two main active ingredients in cannabis, can be harnessed to develop products that improve patients’ lives. In its three lead placebo-controlled clinical trial programs, Canopy Health is assessing the safety and efficacy of a range of cannabinoid compounds in sleep, fibromyalgia and social anxiety disorder. “These multicenter trials in Canada are some of the largest that have been conducted in these areas,” Dr. Ware contends. “We hope to take all three programs to the end of Phase 2b in the 2019-2020 time frame in order to establish dosing, safety and proof-of-concept efficacy. If the data are strong, we would not rule out the possibility of an external partnership for a Phase 3 trial, or we could proceed on our own,” he adds. According to industry estimates, the global pain market is forecast to reach $77-billion by 2023, on a projected 4% compound annual growth rate between 2017 and 2023. In addition, the global insomnia and generalized anxiety disorder markets are expected to reach $5.5-billion and $7.5-billion, respectively, by 2023. To support clinical drug development, Canopy Health is also conducting multiple Phase 1 studies for its therapeutic and consumer products to evaluate pharmacokinetic and pharmacodynamic data in healthy volunteers. Outside of Canada, the company has partnered with British drug policy think-tank, The Beckley Foundation, to establish Beckley Canopy Therapeutics as a stepping-stone for Canopy Health’s expanded, European-focused research capacity. Mr. Wayne says the British partnership aims to combine Canopy Growth’s cannabis expertise and supply with The Beckley Foundation’s strong research heritage and world class scientific partnerships to develop clinically validated and licensed cannabis-based medicines and natural health products, with a strong focus on intellectual property protection. “The regulatory climate for starting cannabinoid clinical trials is extremely positive,” Dr. Ware points out. “Medical regulators are very interested in hearing from companies that are proposing serious and credible research with cannabis because this is what patients and the medical community is expecting.” Citing the first FDA-approval of a cannabis-based drug, GW Pharmaceuticals’ Epidiolex for the treatment of childhood epilepsy, Dr. Ware says that as far as regulatory agencies are concerned, “it’s the science that does the talking.” • • • • •To connect with Canopy Health, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2GnrvCj Zuga Medical readying U.S. rollout of ZugaLink cloud platform to support digital dentistry12/4/2018 Chan Wang, Founder and CEO Closely-held Zuga Medical expects to roll out its digital dental implant solution, known as ZugaLink, across the U.S. in 2019. “Digital dentistry is the future of dentistry, with computer-aided design (CAD), computer-aided manufacturing (CAM) and 3D printing enabling production of customized dental components right in the dentist’s office,” founder and CEO, Chan Wang, says in an interview with BioTuesdays. ZugaLink, which is now being offered in China, is a digital platform designed to interconnect dental procedures with technology, translating images to precision products so dentists can focus more on their patient than learning software, ordering, and managing mega-files, she adds. “ZugaLink, for the first time, integrates traditional dental practices, such as software, equipment, hardware and procedures in a single, integrated source,” Dr. Wang contends. “We have developed processes and components that simplify dental implant procedures so that general dentists can perform them at about the cost of putting in a bridge.” Dr. Wang explains that the company’s implant solution begins with training dentists to extract a tooth to optimize an implant; use a bone graft plug to optimize bone structure for surgery; use digital planning and a surgical guide to reduce risk and improve quality; and perform an implant procedure that maximizes a dentist’s time. Dentists using ZugaLink can upload a patient’s cone beam computed tomography (CBCT) and intraoral scans or send a patient’s impression to the Zuga Design Center, where an implant plan, surgical Z-guide, and temporary restoration are prepared. “We make 3D-printed components from the scans, which we send to a dentist,” she says, adding that the “surgical guide is a piece of plastic based on those scans that fits into a patient’s mouth, with highly precise holes for dentists to insert implants in place with a high degree of precision.” Dentists also can use Zuga tool kits, which facilitate proper drilling techniques, in conjunction with the Z-guide to perform the surgery. Post-surgery, a dentist can choose one of Zuga’s restorative components to complete the case. If a dental office has 3D printing capabilities, she says the Z-guide can be printed in the office, with a dentist making the final assembly to perform an accurate implant. In addition to individual customization of digital implants and restorations, which now include bone regeneration materials and customized prosthetics, Zuga Medical plans to expand into digital orthodontics, esthetics dentistry and other related fields, which would include 3D clear braces and a 3D whitening tray, custom splints, and anti-snoring devices by the end of 2019. In 2013, Zuga Medical received FDA approval for its product line of implants, abutments and tool kits to allow general dentists to perform implant procedures that were historically done primarily by oral surgeons. The company designs and manufactures dental implants and accessories at a plant in Northeast Ohio. While the ZugaLink cloud-based system does not require FDA approval, the company needs regulatory clearance for its bone graft material because the plug is embedded in the human body. “We can launch ZugaLink in the U.S. independent of the bone graft, but we hope to introduce the plug in 2021,” Dr. Wang suggests. Zuga primarily differentiates itself from competitors with the ZugaLink functionality, the ZugaLink mobile application and the Zuga digital design center, which provides services to reduce dentist’s time away from patients. Zuga Medical Others Cloud Data Management YES NO Mobile Ordering YES NO Review Full Planning on mobile YES NO Expert Consulting YES NO Knowledge Center YES NOAccording to industry estimates, the dental service market in the U.S. represents an $811-billion market opportunity, with the dental device market valued at about $134-billion. Those estimates dwarf the market in China, where the dental service market stands at some $30-billion, but has been growing at an average annual rate of 21% since 2014, as well as a $20-billion dental device market. Zuga Medical launched ZugaLink in China in September and its mobile app in November. The mobile app, which is another differentiator of Zuga Medical, allows dentists to use all the capabilities of ZugaLink, with the exception of uploading CBCT and intraoral scans to the Zuga Design Center. Dr. Wang, who has extensive alumni relationships with dental leaders in China, cites compelling demographics for the company’s market opportunity in China. Among individuals aged 35-to-44, more than 88% have dental disease, with only 8% being treated. And among individuals aged 65-to-74, more than 98% have tooth decay, 75% have missing teeth and only 2% are being treated. “We believe [the number of] implants will grow from one million a year to five million in China in the next five years,” she adds. While preventative dentistry is virtually non-existent in China, she suggests that 150 million middle class people are seeking and able to pay for quality dental services. Zuga Medical currently has relationships with more than 1,000 dental practices in China. The company is forecasting a breakeven bottom line for 2019 on revenue of nearly $7-million, climbing to net income of about $13-million on revenue of $46-million for 2022. Zuga Medical has a $15-million private fund-raising in progress, with a $9-million lead investor in place. Proceeds are earmarked to expand sales and marketing in China and the U.S., continue development of Zuga’s bone graft plug and design software and repay debt. • • • • •To connect with Zuga, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas https://ift.tt/2Ud8JQP |
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