BUSINESS INSIGHTS

ApiJect Announces Investment by Royalty Pharma and Jefferies

ApiJect Systems Corp. | May 19, 2022

ApiJect Announces
ApiJect Holdings, Inc., the parent company of ApiJect Systems, Corp., a medical technology public-benefit corporation transforming the fill and finish and delivery of injectable vaccines and medicines, announced today that it had completed a $111 million private round of investment.

This investment round values ApiJect at approximately $300 million.

The new round was led by Royalty Pharma and Jefferies Financial Group (NYSE: JEF), which acquired a revenue interest in addition to equity. Jefferies and ApiJect's other lenders also converted all of their debt into ApiJect equity, such that following this transaction, ApiJect has no debt on its balance sheet.

The funds will be used for continued development of ApiJect's proprietary Blow-Fill-Seal (BFS) plastic prefilled injection system, to deploy its equipment and proprietary technologies to licensees, and for general working capital purposes.  Royalty Pharma and Jefferies are represented on ApiJect's Board of Directors, along with ApiJect co-founders Jay Walker and Marc Koska, and Hanjin In, the CEO of Tae-Chang Industrial Co., Ltd., ApiJect's South Korean cannula supplier.

ApiJect is developing an innovative portfolio of drug delivery devices using high-speed BFS manufacturing, which is recognized by the FDA as an advanced aseptic process that forms, fills and seals a single unit dose in a continuous, automated manufacturing step.  BFS technology greatly reduces the risk of contamination and error during one of the most critical steps of drug production. BFS is cost-efficient for short and long runs, and highly suitable to scale quickly in order to meet unexpected spikes in demand such as for a rapid response to population-scale health emergencies.  Advancements developed by ApiJect for temperature management now enable BFS manufacturing of a vast array of sterile injectable drugs, including ultra-cold mRNA vaccines.

"This is an important day for injection device innovation, and, with that, the future health of billions of people throughout the world.  The investment provided by Royalty Pharma and Jefferies supports further development of an injection technology that can scale rapidly and efficiently to meet global demand for injectable medicines."

ApiJect Chief Executive Officer Jay Walker 

Mr. Walker further said: "We welcome Royalty Pharma's commitment to the ApiJect mission.  Royalty Pharma has a proven track record in selecting successful partners and in assisting in advancing its partners' goals. We could not ask for a better strategic partner from within the pharma industry. In Jefferies, we have a partner that has been with us from virtually the beginning of ApiJect."

"We are delighted to form this win-win partnership with ApiJect," said Pablo Legorreta, Royalty Pharma's Founder and Chief Executive Officer. "The global pandemic highlighted the clear unmet need for a new kind of prefilled syringe that can be rapidly produced to respond to public health threats, and at massive scale that would be capable of delivering hundreds of millions, potentially billions, of doses to people in the U.S. as well as globally. ApiJect is developing a truly innovative technology, that could transform the manufacturing and delivery of life-saving injectable drugs in a way that would also make these medicines safer and more readily accessible for patients around the world."

"We are proud of our association with ApiJect and believe strongly that their solutions will be a positive gamechanger in many of the most critical aspects of improving health globally," said Rich Handler, CEO of Jefferies.

The first potential device made on the ApiJect Platform is the Prefilled ApiJect Injector, a single-dose prefilled injector designed to efficiently deliver a 0.5mL dose into a patient with a simple squeeze of the BFS container by the healthcare professional. This new type of prefilled injector will be ApiJect's first product submitted for regulatory review and approval. The Prefilled ApiJect Injector and its manufacturing process include

  • An aseptically filled single-dose container, designed to enable efficient and intuitive injection administration.
  • A pen-needle-style hub that turns the BFS container into an injection device.
  • Innovations in temperature management to expand the range of medicines and vaccines suitable for BFS packaging.

ApiJect recently launched its Technology Development Center in the greater Orlando area to bring to the U.S. critical capabilities for device design and engineering, and BFS mold development, as well as for small-scale manufacturing of single-dose, prefilled injectors and other injectable devices. Its purpose is to dramatically reduce the time and processes necessary for product development. ApiJect's Technology Development Center supports the company's existing fill-finish lines at its manufacturing partner site in South Carolina, which currently has the capacity to produce up to 540 million single-dose prefilled injectors annually.

About ApiJect Systems
ApiJect Systems, Corp., is a public-benefit medical technology company working to use our platform to bring more prefilled, single-dose injections to patients everywhere. The ApiJect Platform enables pharmaceutical and biotech companies to design scalable prefilled injectors and efficiently fill-finish them with their injectable drug products. This can be done either on one of their own Blow-Fill-Seal packaging lines with ApiJect-licensed technology, or at one of ApiJect's world-class manufacturing partners.

Spotlight

Freddy White, Director, European Pharmaceutical Review & Drug Target Review speaks with Tim Freeman, Managing Director, Freeman Technology at Pittcon 2014…


Other News
BUSINESS INSIGHTS

SCA Pharma Names Louis Pace as Chief Financial Officer and Chief Information Officer

SCA Pharma | July 15, 2022

SCA Pharma, a nationally recognized leader in the 503B compounding pharmaceuticals outsourcing industry providing quality, service, and value to hospitals nationwide, has announced today the addition of Louis Pace as Chief Financial Officer and Chief Information Officer. Pace brings over 30 years of experience serving several successful private equity backed businesses in functional and P&L leadership roles. Most recently, Mr. Pace served as Chief Financial Officer at Orchid Orthopedic Solutions where he successfully led strategy deployment efforts that focused on growth and profitability improvement. "I am extremely excited to welcome Louis to the team and to partner with him as we continue to accelerate growth at SCA Pharma. SCA Pharma is committed to providing innovative solutions for our 503B customers that help health systems manage their drug supply chain and pharmacy operations more efficiently. That evolution requires a more strategic and diversified approach, which suits Louis' background. Louis will manage our finance and accounting teams as well as our information technology strategy. He will concentrate on prioritizing internal and external business opportunities." Scott Luce, CEO of SCA Pharma "I am looking forward to working with the exceptional team at SCA Pharma. I am excited to build on SCA Pharma's current success and be a part of the company's future growth," said Louis Pace. Mr. Pace holds an AB in Economics from Harvard University and an MBA from Northwestern Kellogg Graduate School of Management. About SCA Pharma SCA Pharma is a nationally recognized leader in the FDA 503B outsourcing industry, specializing in providing the highest quality sterile admixture services and pre-filled syringes to hospital and health-care facility pharmacies. The company serves all therapeutic areas of pharmacy — including critical care, labor and delivery, anesthesia, and pain management — and maintains a wide portfolio of products, including ready-to-use and drug-shortage medications.

Read More

BUSINESS INSIGHTS

Glaukos Licenses Iveena’s Investigational Keratoconus Therapy

iVeena and Glaukos | August 25, 2022

iVeena Delivery Systems Inc. a clinical stage biopharmaceutical company with developmental products in keratoconus and pediatric myopia, has entered into a strategic licensing agreement with Glaukos Corporation that grants Glaukos an exclusive global license to develop and commercialize IVMED-80, a pharmacologic treatment for keratoconus. Keratoconus, a rare corneal disorder, is the leading cause of primary full-thickness corneal transplantation in the United States. IVMED-80 is a proprietary disease modifying topical eye drop with orphan drug designation that upregulates lysyl oxidase and induces pharmacologic corneal crosslinking to strengthen the cornea and treat keratoconus. In a 6-month phase 1/2a clinical study, IVMED-80 met its primary endpoint of a statistically significant reduction in baseline-adjusted Kmax of 1.0 D relative to placebo. “We are pleased to complete this agreement with Glaukos. This deal validates the technology we have developed at iVeena to induce corneal crosslinking pharmacologically via eyedrops. Glaukos is a strong partner to complete development of this product where, if approved, patients will have an additional keratoconus treatment option.” iVeena CEO Jerry Simmons As part of the agreement Glaukos paid $10 Million upfront and will assume all costs associated with development and regulatory activities on IVMED-80. In addition, deal terms include the potential for both development and sales milestone payments as well as royalties on sales to iVeena. About iVeena iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena has licensed its lead asset to Glaukos Corporation, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first in class, investigational eyedrop formulation for pediatric myopia where it plans to initiate a first in human clinical trial early 2023. About Glaukos Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and has since developed a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.

Read More

BUSINESS INSIGHTS

Everest Medicines Appoints Rogers Yongqing Luo as Chief Executive Officer to Lead Next Stage of Company Growth

Everest Medicines | September 19, 2022

Everest Medicines a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has appointed Rogers Yongqing Luo as Chief Executive Officer of the Company, effective immediately. Mr. Luo will also serve as an Executive Director on Everest's Board of Directors. Mr. Luo brings to Everest more than 25 years of experience in the healthcare industry with an extensive leadership track record across clinical development, regulatory affairs and commercialization. Previously, Mr. Luo served as President and General Manager, Greater China at Brii Biosciences and CEO of TSB Therapeutics where he spearheaded the rapid registration approval, GMP certification and successful commercialization of the amubarvimab/romlusevimab combination, the first COVID-19 neutralizing antibody treatment in China. Prior to that, he was Global Vice President and China General Manager at Gilead Sciences where he led the clinical development, regulatory approval and successful commercial launch of eight innovative therapeutics, and efforts that rapidly expanded patient access across China. Mr. Luo previously oversaw the successful launch of several high-profile medicines. He managed sales, marketing, government affairs and market access functions for various leading multinational pharmaceutical companies including Roche and Novartis, and worked two years at Novartis headquarter in Switzerland. "As Everest Medicines continues to evolve our business strategy and expand our novel product pipeline at a rapid pace, we are thrilled to have Rogers join the Company to lead Everest through its next phase of growth in becoming a fully-integrated biopharma company in China. With his robust background as a top executive at both biotech startup and large multinational pharma companies, Rogers brings to Everest a unique set of expertise including comprehensive scientific insight, proven outstanding leadership and excellent commercialization capabilities in patient access, and a demonstrated history of successfully advancing early- and late-stage innovative pipeline to commercial launch in Greater China. In particular, Rogers' leadership will strengthen Everest's new product development and commercial capabilities as we progress toward potential approvals of our late-stage anchor product candidates, including Nefecon, Xerava, etrasimod and mRNA vaccines. We look forward to leveraging Rogers' leadership and industry expertise to generate long-term growth and success across the business." Mr. Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group "I'm very excited to join Everest and I look forward to working with this talented, world-class team of scientists and industry professionals to further the Company's industry leadership. We will continue to advance our late-stage pipeline towards commercialization and with our strong balance sheet, we aim to execute synergistic business development deals to accelerate our path to become an integrated biopharma," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We will continue to invest into our discovery platform to build an innovative therapeutic pipeline for the benefit of patients with unmet needs in Greater China and other Asia Pacific markets, and to create sustained, long-term value for our shareholders." About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.

Read More

BUSINESS INSIGHTS

Tasly Pharmaceuticals and Mauna Kea Technologies Announce Joint Venture and Licensing Agreements

Mauna Kea Technologies | July 12, 2022

Mauna Kea Technologies inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy platform, and Tasly Pharmaceuticals announced the execution of an agreement to form a Joint Venture. Under terms of the agreement, Tasly and Mauna Kea will form a Joint Venture that will (i) commercialize selected Cellvizio indications in China, (ii) develop and commercialize Cellvizio globally in the fields of Neurology and Neurosurgery, and (iii) manufacture Cellvizio units for the Chinese market. The JV will utilize both existing distribution partners and its own network of China-based marketing professionals to accelerate market adoption. In exchange for contributing licenses and other intellectual property to the JV, Mauna Kea will receive cash payments totaling $10 million, a 44.1% equity interest in the JV, and a 5-year commitment to purchase minimum quantities of Cellvizio systems and probes. Mauna Kea’s equity holdings are net of shares issued to Cenponts Tech Limited in consideration for strategic advisory services provided in connection to the transaction. The Joint Venture will be majority owned and funded by Tasly and jointly managed by Tasly and Mauna Kea. The Joint Venture will be in an immediate position to leverage Mauna Kea’s position as global leader in probe and needle-based confocal laser endomicroscopy, with its FDA clearance for neurosurgery applications, its broad regulatory clearances in the Chinese market as well as its significant installed based in leading hospitals in China. “We are delighted to partner with Tasly Pharmaceuticals, a life sciences leader in Asia-Pacific with a global presence. This transaction both expands the addressable market for Cellvizio and increases Mauna Kea’s capacity to invest further in product and clinical development, including molecular imaging and artificial intelligence. This announcement builds on the strategic repositioning we announced in December 2021 and our emphasis on forming capital-efficient partnerships that leverage the commercial reach of global biopharma and medtech firms while increasing patient access to Cellvizio.” Sacha Loiseau, Ph.D., founder and Chairman of Mauna Kea Technologies Kaijing Yan, Chairman of Tasly Pharmaceuticals Group, commented: “The field of biomedical engineering is an important part of Tasly Pharmaceuticals’ second growth curve strategy. The cooperation with Mauna Kea Technologies will enable us to quickly access large markets in China addressed by the multiple clinical applications of Confocal Laser Endomicroscopy. The recent advances in molecular imaging with Cellvizio are also of great interest to us since Tasly Pharmaceuticals could assist the Joint Venture in developing new combinations of Cellvizio with novel molecular markers, aligned with our vision of providing integrated solutions from diagnosis to treatment. We very much look forward to a fruitful and rich collaboration with Mauna Kea Technologies.” About Tasly Pharmaceuticals Group Adhering to the business mission of "To share the joy of health with all", Tasly has always been promoting the integrative development of traditional Chinese medicine and modern medicine. Tasly continuously focuses on the three disease fields of cardio-cerebro-vascular diseases, digestive and metabolic diseases and tumors, which have the largest market share and the fastest development in China. It is committed to providing drug R&D that is urgently needed for clinical use and even addresses the unmet needs in China's clinical market. By leveraging the coordinated development advantages of modern TCM, biological medicine and chemical medicine, it carries out the strategic layout of innovative drugs and continues to maintain its leading position in the industry and the development momentum of R&D and innovation. About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions.

Read More