Gilead rescinds orphan status request for COVID-19 drug

pharma news | March 26, 2020

Gilead has rescinded its request for orphan status for its potential COVID-19 antiviral remdesivir amid a furore over its pricing should it get to market. By asking for orphan status the US pharma sparked concerns that it would charge a premium price for remdesivir, which is being trialled against the disease. Remdesivir has been described by the World Health Organisation as the best hope for a therapy, at least until a vaccine is developed. Gilead decided to rescind the request for orphan status after drug pricing campaigners accused the company of gaming US drug laws to maximise any profits made from remdesivir should it get approved.

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Data analytics in pharma has altered the way pharmaceuticals were a few years back. In the current era of industry 4.0, big data analytics compelled enterprises to make decisions discriminatively because Artificial Intelligence and Machine Learning prove themselves.

Spotlight

Data analytics in pharma has altered the way pharmaceuticals were a few years back. In the current era of industry 4.0, big data analytics compelled enterprises to make decisions discriminatively because Artificial Intelligence and Machine Learning prove themselves.

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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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BUSINESS INSIGHTS, PHARMACY MARKET

Cellworks Announces Expansion Into Precision Pharma

Cellworks Group | January 13, 2023

Cellworks Group Inc., a pioneer in personalized therapy biosimulation, announced the introduction of its precision drug development business units. These units will use predictive biosimulation to shorten drug development time-to-market and revive previously researched but disapproved pharmaceutical assets. The two new business units will use Cellworks' computational biology model (CBM) and biosimulation platform to predict responses to pharmaceutical interventions in silico, streamlining the clinical trial by identifying suitable patients more quickly, thereby reducing the time and cost of developing successful pharmaceutical agents. Cellworks precision drug development: Pre-clinical stage Companion molecule development: The Cellworks platform can augment a drug's usability by finding companion molecules that improve performance when combined with the investigational agent. Biomarker development: Cellworks utilizes cell lines and historical patient data to uncover novel biomarkers for investigational agents. This may increase drug success rates by proactively identifying individuals who will respond to an agent. Indication expansion: By utilizing the Cellworks patient database of 100,000+ omics patient profiles and 1,800 oncology cell lines to examine the agent's effectiveness in different indications, the Cellworks platform can identify additional indications where an experimental treatment may be successful. Cellworks precision drug development: Clinical stage Drug revival and repurposing: The platform seeks to anticipate whether certain drugs cause a response, which may be used to identify whether shelved assets can be resurrected via suitable patient selection or the discovery of non-obvious reasons. Clinical trial biosimulation: Through biosimulation clinical trials, the Cellworks platform may anticipate humans' clinical response to pharmaceutical agents in weeks, yielding critical insight years ahead of a traditional clinical practice. Cellworks Platform and Computational Biology Model (CBM) The Cellworks platform biosimulates the impact of specific pharmacological molecules on a given patient or class of patients using the patient's genetic profile. To generate a customized or cohort-specific disease model, multi-omic data from a cohort or patient is fed into the Cellworks computational biology model (CBM). About Cellworks Group Cellworks is one of the leaders in precision medicine. The organization assists physicians and payers in navigating the most efficacious, cost-effective therapies for patients. Its primary therapeutic areas are oncology, immunology, dermatology, and infectious diseases. Its one-of-a-kind biosimulation platform is a unified representation of biological information gathered from disparate databases and used to find cures. The company has the world's strongest trans-disciplinary team of molecular biologists, cellular pathway modelers, and internet software technologists working towards a common goal, i.e., taking on significant diseases to improve patients' lives.

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BUSINESS INSIGHTS

Indivior To Acquire Opiant Pharmaceuticals

Indivior | November 21, 2022

Indivior PLC and Opiant Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Indivior will acquire Opiant for an upfront consideration of $20.00 per share, in cash plus up to $8.00 per share in contingent value rights that may become payable in the event that certain net revenue milestones are achieved during the relevant seven-year period by OPNT003 after its approval and launch. The transaction has been unanimously approved by the boards of directors of each company. "Our work in combatting addiction has never been more critical, with overdose deaths in the United States occurring at near record numbers1," said Mark Crossley, Chief Executive Officer of Indivior. "Opiant's portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior's strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery. The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing U.S. opioid and overdose epidemic and extends our leadership position in addiction treatments. We look forward to working with Opiant's talented team as we undertake our shared mission of changing patients' lives through access to life-transforming treatment for substance use disorders." Acquisition Strengthens and Extends Indivior's Position as a Leader in Addiction Treatment "We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines. This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees and our stockholders. It will enable us to leverage Indivior's global scale, commercial strength and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose." Roger Crystal, M.D., Opiant's President and Chief Executive Officer Opiant is a biopharmaceutical company developing treatments for addiction and drug overdose leveraging intranasal and injectable delivery technologies. Opiant contributed to the development of the formulation of NARCAN® Nasal Spray, a treatment to reverse opioid overdose. In addition to OPNT003, nasal nalmefene, the pipeline includes OPNT002, nasal naltrexone, which is currently in a Phase II trial to assess its potential as a treatment for alcohol drinking and cravings, and OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose ("ACO"). OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl. These powerful drugs are responsible for the surge of overdose deaths in the United States (103,000-plus overdose deaths reported in the latest annual period, of which over 75% were driven by opioids, mainly fentanyl and synthetic opioids1). OPNT003 is designed to be used by non-healthcare individuals and delivered intranasally. Observations from multiple clinical studies reinforce its potential rapid onset and long duration of action. Opiant received FDA Fast Track Designation for OPNT003 in November 2021 and is expected to complete its New Drug Application submission for OPNT003 with the FDA in the fourth quarter of 2022. Subject to approval by the FDA, anticipated approval for a fast-track application is third quarter 2023, with launch in the United States expected in the ensuing months. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

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