TraceLink: Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain

Healthcare Packaging | October 17, 2019

TraceLink, an integrated digital supply network, announces the launch of the Digital Network Platform. Built on top of the TraceLink Digital Supply Network, and designed for the rapid development of applications utilizing its multi-enterprise collaboration and data sharing capabilities, TraceLink’s Digital Network Platform is meant to drive innovation and enable the creation of new supply chain operating models centered around the patient. The TraceLink network is used to track serialized medicines as they move from production to the patient. With the launch of the Digital Network Platform, TraceLink customers will be supposed to have access to a new class of network orchestration and analytics applications in order to unlock even more value from their digitalized supply chains and provide the power to orchestrate patient outcomes in new ways.

Spotlight

Regulatory teams at life science companies are finding that
effective regulatory information management (RIM) has become critical to their operations.

Spotlight

Regulatory teams at life science companies are finding that
effective regulatory information management (RIM) has become critical to their operations.

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BUSINESS INSIGHTS

Citius Pharmaceuticals, Inc. Secures $3.6 million through New Jersey Economic Development Program

Citius Pharmaceuticals, Inc. | November 22, 2022

Citius Pharmaceuticals, Inc. a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has been selected to participate in New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss Program, and will receive $3.6 million in non-dilutive capital through the New Jersey Economic Development Authority. Citius expects to receive the funds by late 2022 or early 2023. "This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey's NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application for I/ONTAK," Jaime Bartushak, Chief Financial Officer of Citius About the Technology Business Tax Certificate Transfer Program The NOL Program enables participants to sell their New Jersey net operating losses and unused R&D tax credits to unrelated profitable corporations for cash. The NJEDA and the New Jersey Department of Treasury's Division of Taxation jointly administer the NOL Program, which has routinely been hailed as a "lifeline" by entrepreneurs seeking capital for their companies. The average award for companies approved to sell their net operating losses through the program in 2022 was over $3.1 million. Thirty-six percent of program applicants are private businesses, while the remaining 64 percent are publicly traded companies. To date, more than $1.17 billion in funding has been distributed to over 570 technology and life sciences companies since the program's inception in the late 1990s. About the New Jersey Economic Development Authority The New Jersey Economic Development Authority serves as the State's principal agency for driving economic growth. The NJEDA is committed to making New Jersey a national model for inclusive and sustainable economic development by focusing on key strategies to help build strong and dynamic communities, create good jobs for New Jersey residents, and provide pathways to a stronger and fairer economy. Through partnerships with a diverse range of stakeholders, the NJEDA creates and implements initiatives to enhance the economic vitality and quality of life in the State and strengthen New Jersey's long-term economic competitiveness. About Citius Pharmaceuticals, Inc. Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma for which a BLA has been submitted. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids.

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PHARMA TECH

Eyenovia Announces $15 Million Credit Facility with Avenue Venture Debt Fund

Eyenovia, Inc. | November 30, 2022

Eyenovia, Inc. a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the company has entered into a $15 million credit facility with the Avenue Venture Opportunities Fund, L.P. The financing is intended to support manufacturing in anticipation of a MydCombi launch and clinical supply for ongoing programs. Per the terms of the agreement, Eyenovia received $10 million of gross proceeds at closing. The additional $5 million will be available, at the company’s option, should MydCombi™ be approved for marketing in the U.S. by the Food and Drug Administration by August 2023. The Avenue facility replaces the company’s Silicon Valley Bank facility, which was recently paid off. “We are pleased to have the support of Avenue through this credit facility at terms which create minimal dilution as compared to a traditional equity capital raise. Together with our existing cash on-hand, we expect the additional capital provided by this facility to fund our operations through at least late 2023 or early 2024, or through value creating milestones, including the potential approval of MydCombi™ and preparations for the possible submission of a New Drug Application for our novel presbyopia treatment, MicroLine™.” Michael Rowe, chief executive officer of Eyenovia “We are pleased to provide this financing to Eyenovia as we believe its Optejet dispensing technology truly differentiates the company from its peers and offers great potential across a broad range of high value ophthalmic indications,” stated Chad Norman, Senior Portfolio Manager of the Avenue Venture Debt Fund. Eyenovia’s current pro-forma unrestricted cash balance, including approximately $9.5 million of net proceeds from this facility, is approximately $25.5 million. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. About Avenue Venture Opportunities The Avenue Venture Debt Fund seeks to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies. The Avenue Venture Debt Opportunities Fund focuses generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt fund is part of the larger group of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets estimated to be approximately $12.3 billion as of October 31, 2022.

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PHARMACY MARKET, PHARMA TECH

Sanofi and Innate Pharma Expand Collaboration for Natural Killer Cell Therapeutics in Oncology

Sanofi and Innate Pharma | December 19, 2022

Innate Pharma SA and Sanofi announced an expansion of their collaboration, with Sanofi licensing a natural killer cell engager program targeting B7H3 from Innate’s ANKETTM. Sanofi will also have the option to add up to two additional ANKETTM targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Innate and Sanofi signed a first NK cell engagers collaboration in 2016 for the generation and evaluation of up to two bispecific NK cell engagers, which are currently being evaluated by Sanofi’s R&D team, with one of these molecules already in clinical studies. “At Sanofi, we are exploring the potential of NK cells for cancer immunotherapy, a key pillar for our oncology strategy. Our relationship with Innate aligns with our commitment to work with promising French companies and supports our ambition to develop a diverse portfolio of next-generation NK cell engagers, highly synergistic with Sanofi’s allogeneic NK cell platform, engineered lymphokines that stimulate NK cells, and growing Immuno-oncology pipeline. As a leading global company with roots in France, we are proud to collaborate to support the French healthcare ecosystem.” Valeria Fantin, Ph.D., Global Head of Oncology Research at Sanofi Yannis Morel, Ph.D., Executive Vice President, Product portfolio strategy & Business development at Innate Pharma “Building on the success of our existing collaboration on hematologic targets, we are pleased to expand and strengthen our partnership with Sanofi on NK Cell Engagers with the addition of up to three new programs, including in solid tumors. Sanofi’s investment in Innate further validates the value of our ANKETTM platform and its potential to address multiple tumor types. By incorporating various tumor antigen binders, NK Cell Engagers are a versatile technology that may provide new options for patients and offer clinical benefit across multiple cancers, whilst also maintaining a good safety profile. This agreement also highlights Innate’s strategy to build a broad portfolio of ANKET programs addressing different types of cancer.” Under the terms of the new license agreement, Innate will receive €25m upfront payment and up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales. Closing of the transaction is subject to HSR approval. About ANKETTM ANKETTM is Innate's proprietary platform for developing next-generation, multi-specific natural killer cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. It leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells. Our latest innovation, the tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors a tumor antigen and an interleukin-2 receptor via a single molecule. About 2016 Sanofi/Innate research collaboration and licensing agreement In 2016, Sanofi and Innate entered into a research collaboration and licensing agreement for the generation and evaluation of up to two bispecific NK cell engagers, using technology from Innate Pharma and Sanofi’s proprietary bispecific antibody format as well as tumor targets. A Phase 1/2 clinical trial by Sanofi is ongoing, evaluating IPH6101/SAR’579 the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, in patients with relapsed or refractory acute myeloid leukemia B-cell acute lymphoblastic leukemia or high-risk myelodysplastic syndrome. In the summer 2022, Sanofi had made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies. IPH6401/SAR’514 is a BCMA-targeting NK cell engager using Sanofi’s proprietary CROSSODILE® multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKETTM proprietary platform. Under the terms of the original license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales. To date, €13m milestone payments to Innate have been announced. About Sanofi’s approach to NK therapies in oncology At Sanofi, we are exploring the intrinsic abilities of Natural Killer cells to create new immunotherapies for patients with cancer. Natural Killer cell-based therapies are a key pillar within Sanofi’s Oncology strategy. By activating the innate power of NK cells, Sanofi is advancing a diverse and complementary range of NK-based therapeutics to transform immune biology. The breadth of our modalities and unique strength to innovate end-to-end maximizes the therapeutic possibilities for more people with cancer. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. 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