Digital & Documentation Transformation Key to Pharma, Manufacturing and Energy Survival Amidst COVID-19

Sdcexec | April 28, 2020

Last week, the U.S. energy sector faced a severe blow as the value of oil to be delivered in May dropped to a staggering -$37.60 per barrel—the first negative close in history. Pharma and manufacturing industries are facing similar wake-up calls for a future riddled with uncertainty. But the key to maintaining operations during and after the coronavirus crisis revolves around digital transformation and document management for processes, analytics, and an agile workforce, according to Brian Sallade, the CEO of engineering and information management firm Kinsmen Group. "COVID-19 reveals the problems of onsite-only data location access, lack of digital access, and paper or manual processes," Sallade says. "This slows information exchange, decreases accuracy, and elevates operational risk.

Spotlight

This 2+ minute animation provides a simple explanation of the process for manufacturing a biopharmaceutical drug. It includes a description of "upstream" fermentation and "downstream" capture and purification of the biologic product, using monoclonal antibodies as an example. The animation shows where Repligen bioprocessing products fit into the biomanufacturing process.

Spotlight

This 2+ minute animation provides a simple explanation of the process for manufacturing a biopharmaceutical drug. It includes a description of "upstream" fermentation and "downstream" capture and purification of the biologic product, using monoclonal antibodies as an example. The animation shows where Repligen bioprocessing products fit into the biomanufacturing process.

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PHARMA TECH

Xeris Biopharma Announces Research Collaboration and Option Agreement With Horizon Therapeutics plc for XeriJect™ Formulation of Teprotumumab

Xeris | November 24, 2022

Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that it has entered into a research collaboration and option agreement with Horizon Therapeutics plc. Under the terms of the agreement, Xeris will use its proprietary formulation technology platform, XeriJect™, to develop an ultra-concentrated, ready-to-use, subcutaneous injection of teprotumumab and Horizon will have an option to license the Xeris technology. Teprotumumab is the first and only medicine approved by the U.S. Food and Drug Administration for the treatment of Thyroid Eye Disease a serious, progressive and potentially vision-threatening rare autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the United States. Xeris will receive an upfront payment, and may be entitled to receive development milestones, regulatory milestones, and salesbased milestones, as well as royalties based on future sales if the commercial license option is exercised. Specific financial terms of the agreement were not disclosed. “We are excited to announce our collaboration with Horizon for the development of a subcutaneous formulation of teprotumumab using our XeriJect technology to potentially enhance the patient experience and delivery of the treatment for Thyroid Eye Disease. This partnership demonstrates the potential value of our technology to enable large molecule subcutaneous injections that provide a more patient friendly regimen that is effective, safe, and more convenient, with potential for improved adherence.” Paul R. Edick, Chairman and CEO of Xeris About XeriJect™ XeriJect formulations are innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >400mg/mL, enable small volume subcutaneous injections and do not settle on storage. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing. About Xeris Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.

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PHARMACY MARKET

Pfizer Completes Acquisition of Biohaven Pharmaceuticals

Pfizer and Biohaven Pharmaceuticals | October 04, 2022

Pfizer Inc. announced the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC® ODT an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults. The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide receptor antagonists including Rimegepant Approved in the United States under the trade name NURTEC® ODT, in adults for both the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine Approved in the European Union under the trade name VYDURA® for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month Zavegepant New Drug Application for intranasal spray for the acute treatment of migraine under U.S. Food and Drug Administration review, with a Prescription Drug User Fee Act goal date in 1Q 2023 "We are proud to build on Pfizer’s legacy of delivering breakthrough medicines for patients living with complex pain disorders. The success of NURTEC® ODT coupled with Biohaven’s CGRP pipeline will strengthen Pfizer’s innovative Internal Medicine pipeline through 2030, and beyond. Combined with Pfizer’s global reach, this acquisition increases our potential to bring new treatment options to patients with migraine – a disease which affects over 1 billion people worldwide. Aamir Malik, Executive Vice President, Chief Business Innovation Officer, Pfizer Pfizer acquired all of the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for a total transaction consideration of approximately $11.6 billion. As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer. Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. distributing Biohaven Ltd.’s shares to Biohaven’s shareholders. Biohaven Ltd., a new company that retained Biohaven’s non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker “BHVN”. About Migraine Worldwide, more than one billion people suffer from migraine, which predominately affects women.i Findings from the 2019 Global Burden of Disease study indicate that migraine is one of the worlds leading causes of disability.ii Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound and sensitivity to light. About Rimegepant Rimegepant targets a key component of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec® ODT for the acute treatment of migraine in adults in February 2020 and for the preventive treatment of episodic migraine in adults in May 2021. Nurtec® ODT is taken orally as needed, up to once daily for acute treatment, and every other day for preventive treatment. The maximum dose in a 24 hour period is 75 mg. About Zavegepant Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from the NOJECTION® Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The FDA has accepted for review a New Drug Application (NDA) for zavegepant nasal spray, with a PDUFA date in 1Q 2023. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.

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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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