FibroGen founder Neff dies suddenly as drug he championed racks up milestones

FiercePharma | August 26, 2019

After founding FibroGen in 1993 and leading the company for 26 years, chairman and CEO Thomas B. Neff passed away over the weekend unexpectedly. His death comes as FibroGen nears the critical U.S. and European filings for its Astellas- and AstraZeneca-partnered oral anemia med roxadustat, which recently won its second approval in China. With Neffs death, FibroGen has appointed 9-year board member James Schoeneck as its interim CEO. The company is seeking a world-class replacement to take the helm. Neff leaves a legacy of innovation and dedication that has been rarely matched in this industry, FibroGens board said in a statement. He founded the company in 1993 and his work led to the development of roxadustat and pamrevlumab, which is in testing for fibrosis and associated diseases. “The board of directors, management team, and employees, deeply mourn his passing, and extend our heartfelt sympathy and condolences to his family,” the statement added. Monday’s sad news comes right on the heels of roxadustat’s second approval in China for anemia patients not on dialysis. The drug won an approval there last December for anemia in dialysis patients, its first in the world.

Spotlight

Prescription drugs have become a key factor in workers’ compensation. Accounting for one of every six medical dollars, pharmacy’s impact on disability duration, return to work and claim settlement outweighs the benefit’s dollar expense. Each year pharmacy is the subject of much research on the part of such august organizations as the California Workers’ Compensation Institute National Council on Compensation Insurance, the Workers’ Compensation Research Institute, and others.

Spotlight

Prescription drugs have become a key factor in workers’ compensation. Accounting for one of every six medical dollars, pharmacy’s impact on disability duration, return to work and claim settlement outweighs the benefit’s dollar expense. Each year pharmacy is the subject of much research on the part of such august organizations as the California Workers’ Compensation Institute National Council on Compensation Insurance, the Workers’ Compensation Research Institute, and others.

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EyePoint Pharmaceuticals announced a debt refinancing with Silicon Valley Bank for $45 million in credit facilities

EyePoint Pharmaceuticals, Inc. | March 10, 2022

A pharmaceutical company, EyePoint Pharmaceuticals, Inc.dedicated to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced that it has entered into a loan agreement with Silicon Valley Bank to replace its existing credit facility with CRG Servicing LLC for senior secured credit facilities for $45 million (CRG). A $30 million term loan facility and an asset-based revolving credit facility of up to $15 million will be used to replace the existing approximately $40.5 million in liabilities under the previous CRG credit facility, according to the provisions of the new deal. The new facility represents a considerable improvement in economics, lowering the loan interest rate from 12.5 percent to a blended rate of around 5%, saving an estimated $2.8 million in annualized interest. The Silicon Valley Bank agreement stipulates the following: • A $30 million term loan facility with an interest rate equal to the higher of I the Wall Street Journal prime rate plus 2.25 percent or (ii) 5.50 percent. For the first two years of the term loan facility, just interest payments will be required; and • A $15 million asset-based revolving credit facility pays interest at the Wall Street Journal prime rate. The revolving credit facility's availability will be constrained by a borrowing base value of the Company's accounts receivable. “We are very pleased to enter into the new loan agreement with Silicon Valley Bank and replace our existing credit facility with improved economic terms. After strong execution in 2021, we ended the year with over $210 million of cash and investments, positioning EyePoint for these new credit facilities and further improving our balance sheet. We are grateful for the support of our partners at CRG, and we look forward to continued execution of our plan to meet near-term milestones and drive shareholder value.” George O. Elston, Chief Financial Officer of EyePoint Pharmaceuticals "We are delighted to support EyePoint in their pursuit of helping patients with serious eye disorders facing significant unmet need,” said Lauren Cole, Head of East Coast Biotech Credit Solutions at Silicon Valley Bank. “Their pipeline candidate, EYP-1901, a potential six-month intravitreal treatment targeting wet age-related macular degeneration, is a great example of what their proprietary Durasert® technology may accomplish." The terms of the new credit facility with Silicon Valley Bank will be disclosed in the Company's Annual Report on Form 10-K, which is scheduled to be filed with the Securities and Exchange Commission on or before March 11, 2022. The Company has $211.6 million in cash and investments as of December 31, 2021, including over $230 million from two successful follow-on equity offerings in 2021.

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PHARMA TECH

Confo Therapeutics Enters Collaborative Agreement with Regeneron

Confo Therapeutics | December 01, 2021

Confo Therapeutics announced that it has entered into a collaborative agreement with Regeneron Pharmaceuticals, Inc. whereby Confo’s technology platform, which uses conformationally selective VHH antibodies – ConfoBodies® – to stabilize GPCRs in disease-relevant conformations, will be applied with the goal of enabling the discovery of novel therapeutic antibody drug candidates. The agreement will leverage Confo’s expertise in addressing two GPCR targets for which functional antibodies are needed. Confo will be entitled to an upfront payment, research funding, and potential clinical, regulatory, and commercial payments. Further details regarding the agreement have not been disclosed. Confo’s ConfoBody-based technology platform aims to overcome the limitations of drug discovery on GPCRs, the largest and most diverse group of membrane receptors targeted by approximately 30% of all commercialized drugs. “With ten medicines approved by regulatory authorities, Regeneron is regarded in our industry as one of the most effective antibody discovery and development companies, with a successful track record of translating scientific insight into effective and innovative treatments. Working with them underscores the significant potential of our technology platform, in particular our new application to generate antibody drug candidates, and its promise to unveil GPCR drug targets and overcome a range of limitations of current approaches,” Cedric Ververken, Chief Executive Officer of Confo Therapeutics Christel Menet, Chief Scientific Officer of Confo Therapeutics added: “We value this opportunity to showcase the strength of this new addition to our technology suite and participate in what we hope will be the development of successful new antibody-based therapies. Parallel to this, we continue on our own drug development path, and drive innovative small molecule and biological therapeutics into our own pipeline.” About Confo Therapeutics Confo Therapeutics’ unparalleled technology stabilizes functional conformations of GPCRs to uncover a wide range of previously inaccessible drug targets. This platform combined with the pharmacologic and biologic insight it provides, allows Confo to build a multi-indication pipeline of drug candidates with the vision of transforming therapeutic outcomes for patients with severe illnesses lacking disease-modifying treatments. Confo Therapeutics was spun out of Vrije Universiteit Brussel and VIB in 2015. Supported by international life-science focused investors and led by an experienced team of entrepreneurial professionals and scientists from successful biopharmaceutical companies, Confo Therapeutics benefits from the rich scientific and innovative ecosystem in Belgium.

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PHARMACY MARKET

PCI Pharma Services Announces the Closing of Its Acquisition of LSNE

PCI Pharma Services | December 15, 2021

PCI Pharma Services a leading global contract development and manufacturing organizatio announced the closing of the previously announced acquisition of Lyophilization Services of New England, Inc. a premier contract development and manufacturing organization headquartered in Bedford, New Hampshire. This acquisition is a key step for PCI, as LSNE will expand PCI’s breadth of services as a global CDMO, building on its expertise in specialty manufacturing, clinical trial supply and pharmaceutical packaging. PCI is now able to offer integrated large and small molecule solutions for its clinical and commercial clients, including global manufacturing capabilities in complex formulations, high potency, sterile fill-finish, and lyophilization, an important manufacturing process commonly used with injectable and biologic therapies. Founded in 1997, LSNE has an impressive history of serving global pharmaceutical, biotechnology and medical device companies. LSNE is differentiated by its high-quality cGMP aseptic fill-finish capabilities, and expertise in and ability to scale lyophilization. LSNE brings to PCI five FDA-approved facilities in the U.S. and Europe with a sixth expecting approval early in the new year. The closing of this acquisition, along with the capital commitments for significant capacity expansion and PCI’s recently announced construction of a New England Clinical Center of Excellence, will also help create a centralized hub for its Northeast clients. The injectable CDMO market is a high-growth segment outpacing the overall pharmaceutical outsourcing market and PCI is making significant investments, like this acquisition, to respond to the evolving industry landscape. This is PCI’s fourth acquisition in three years, reinforcing the company’s commitment to add new capabilities and scale to help its clients continue bringing life-changing therapies to patients all over the world. About PCI Pharma Services PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.

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