Intertek Expands Pharma Services Facility

pharmtech | May 01, 2019

Intertek, a provider of total quality assurance, has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, United Kingdom, through the acquisition of a new 20,000 sq. ft facility. The new facility doubles the current footprint of the company’s laboratory and is under development. The newly expanded facility is expected to open towards the end of 2019 and should provide capacity for more than 100 additional employees, which the company will recruit over a four-year period, it was revealed in a May 1, 2019 press release. This new facility is located adjacent to the company’s current good manufacturing practice (GMP) laboratory and will expand the inhalation and nasal testing resources. Additionally, it will provide a dedicated laboratory space that will focus on formulation development of inhaled biologics aimed at meeting the increasing demand from global clients.

Spotlight

I n recent years, biopharmaceutical companies large and small have become increasingly reliant on the contract research organisation (CRO) sector and other clinical services specialists to provide research services across the breadth of their R&D operations. The fi nancial crisis had a signifi cant impact on CRO companies, with sponsors scaling back trial programmes, particularly in the early-stage segment covering preclinical activities and Phase I trials.


Other News
PHARMA TECH

ILC Dover Announces North America Expansion to Meet Growing Demand

ILC Dover | March 11, 2022

ILC Dover LP specializing in innovative single-use and chemical workflow solutions for biotherapeutics and pharmaceutical processing, announced plans to significantly expand production capabilities in its Juarez, Mexico facility. This expansion is in response to the Company’s unprecedented growth in its life sciences business and entry into sterile liquid handling and chemicals content market. This investment will generate additional production capacity for its single-use powder storage, single-use fluid storage, and fluid transfer solutions and is scheduled to come online later this year. It also dovetails with recent acquisitions of critical sterile liquid production to provide broader workflow solutions for the Company’s growing customer base. The expansion in Juarez will complement the current global manufacturing footprint in Frederica DE, Durham NC, Stockport UK, Rossens Switzerland, and Blarney Ireland for its pharma and biotherapeutics customers. “Expansion in Juarez is an investment in our customers’ success and the next step in ILC Dover’s global growth journey. It strengthens our partnership with key pharmaceutical and biotherapeutics customers around the world — solidifying our ability to expand our presence in critical products for life-saving therapies, improve lead times, and securing our customers’ supply chain in North America. Most importantly, this expansion strengthens our position as a valuable and vertically integrated partner for our life science customers — supporting customers to continue to improve and optimize their workflows.” Corey Walker, CEO of ILC Dover Operational in Mexico since 2013, the addition of 20,000 sq ft of new Class 6 and 7 clean room space will support multi-site production of solutions for the biotherapeutic, cell & gene therapy, and pharmaceutical markets. ILC Dover’s Juarez site will use the same processes, raw materials, and equipment as other sites in the global network to provide redundant supply and reduced lead times for customers — consistent with the Company’s global quality system. This most recent expansion showcases ILC Dover’s commitment to growing its life science solutions for its global customer base. The Company acquired two strategic businesses this past year to accelerate its trajectory in critical life science applications: sterile solutions manufacturer KSE Scientific and medical contract design and manufacturing company Flexan. The proven capabilities and synergies offered with the addition of both companies enable ILC Dover to link single-use solutions and chemical solutions across its customers’ workflows. About ILC Dover ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the (aero)space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947. About New Mountain Capital New Mountain Capital is a New York-based investment firm that emphasizes business building and growth, rather than debt, as it pursues long-term capital appreciation. The firm currently manages private equity, public equity, and credit funds with over $35 billion in assets under management. New Mountain seeks out what it believes to be the highest quality growth leaders in carefully selected industry sectors and then works intensively with management to build the value of these companies.

Read More

PHARMA TECH

IACTA Pharmaceuticals and TALLC Corporation Announce Strategic Collaboration to Utilize Novel SmartCelle Topical Delivery Technology

IACTA Pharmaceuticals, Inc. | December 16, 2021

IACTA Pharmaceuticals, Inc. an innovation leader in ophthalmic therapeutics, and TALLC Corporation Inc. a pioneering ophthalmology company focused on the growing unmet needs of patients with corneal and retinal conditions, announced that they are entering into a strategic collaboration and licensing agreement. The agreement grants IACTA the use of TALLC’s proprietary SmartCelle™ micellar technology, a novel platform for pan-ocular drug delivery, for future clinical development. IACTA plans to utilize TALLC’s SmartCelle technology to deliver one or more of its novel ophthalmic therapeutics, as well as co-develop new ophthalmology therapeutic candidates that leverage IACTA’s formulation and clinical expertise with TALLC’s novel delivery technology. The collaboration also includes an option agreement, granting IACTA exclusive rights to negotiate a separate license agreement for the right to co-develop TALLC’s lead product candidate TA-A001, a novel anti-inflammatory anti-angiogenic molecule with analgesic properties in various disease state models. “I am thrilled to be able to partner with TALLC, a company with a shared vision focused on addressing the growing and significantly underserved ocular pain market. IACTA was formed with the mission of developing and commercializing innovative ocular therapies through novel compounds and utilizing leading drug delivery technologies, and we view this collaboration as the perfect synergy to realize the full potential of our ophthalmology pipeline. We are excited to explore how best to deploy the SmartCelle technology within our current pipeline, as well as the future co-development opportunities this partnership provides.” Damon Burrows, Chief Executive Officer of IACTA Pharmaceuticals TALLC’s proprietary SmartCelle pan-ocular drug delivery technology employs 30nm micelles that enable delivery of difficult to formulate drugs into corneal and retinal tissues after topical delivery. The company’s pipeline is led by SmartCelle TA-A001, a novel CB2 receptor activator, delivered topically to treat the effects of dry eye syndrome and age-related macular degeneration. “We are delighted to partner with the IACTA team for this important program. IACTA, with its in depth scientific and commercial understanding of the ophthalmic space is an ideal partner for TALLC as we drive towards further commercialization of the SmartCelle platform and TA-A001,” said Damon Smith, Ph.D., Chief Executive Officer of TALLC. “We look forward to working closely with the IACTA team and to co-developing SmartCelle versions of the IACTA pipeline.” About TALLC, Inc. TALLC is a Montreal-based developer of ophthalmic medicines actively engaged in the commercialization of SmartCelle TA-A001, and its pipeline of SmartCelle-delivered drug candidates, as treatments for acute and chronic inflammation. Focused initially on unmet needs in inflammatory front of eye indications, TALLC plans also to develop SmartCelle TA-A002 and TA-A003 in other chronic conditions including macular degeneration and glaucoma. SmartCelle enables pan ocular delivery of drug candidates by topical application directly to the ocular surface, by injection or by insufflation. About IACTA Pharmaceuticals, Inc. IACTA is an innovation leader in ophthalmic therapeutics, led by former top executives from one of the leading eye care companies in the world. The company currently has four products in development for major market opportunities. IC 800 is a novel, non-opioid, dual enkephalinase inhibitor, being studied for the treatment of acute ocular pain. In addition, IACTA’s IC 265, is a SYK kinase inhibitor being developed as a potential novel treatment for dry eye disease.

Read More

BUSINESS INSIGHTS

MRM Proteomics, Inc. and Agilent Technologies, Inc.: A Collaboration for Progress

MRM Proteomics, Inc. | February 04, 2022

MRM Proteomics, Inc. (MRMP) and Agilent Technologies Inc. are excited to announce their new co-marketing agreement aimed to further advance the capabilities of quantitative proteomic applications and thereby help the scientific community make impactful, novel scientific discoveries. This new partnership will provide a complete solution for quantitative protein and metabolite analysis. Agilent’s advanced expertise and state-of-the-art mass spectrometry technology, along with MRMP’s leadership and experience in peptide and metabolite quantitation will enable the development of new tools and technologies to advance the field of multi-omics. MRMP has developed an array of easy-to-use assay kits designed for “absolute” protein and metabolite quantitation in clinical and/or research biological samples, incorporating Agilent’s robust and sensitive HPLCs and mass spectrometers for analyte separation and detection. The new Agilent 6495C LC/MS Triple Quad, coupled online to an Evosep One HPLC system, allows for higher multiplexity, enabling a greater number of metabolites and proteins to be quantified in significantly less time. Via this partnership, MRMP is excited to develop novel kits specifically designed for the Agilent/Evosep platform, including biological pathway- and disease-specific kits, useful to those in the multi-omics field. Additionally, MRMP commits to hosting regular hands-on and virtual workshops focused on teaching innovative techniques in targeted quantitative proteomics. Participants will learn the essentials of proteomics workflows, sample preparation methodologies, Agilent’s LC/MRM-MS set-up, and data analysis using the popular, open source and readily available Skyline software™. Training in the operation of the Evosep LC system will be included in these programs. Quote from Jennifer Gushue, Associate Vice President of Mass Spectrometry Marketing “The new targeted proteomics workflows that have been developed through our collaboration with MRM Proteomics and Evosep will improve quantification of protein targets in clinical research and accelerate drug development in sample limited environments,” said Jennifer, “This collaboration highlights the capabilities of our 6495 LC/MS Triple Quadrupole as a winning combination with Evosep and MRM proteomics for targeted proteomics and our commitment to driving answers for the toughest analytical challenges.” “We are impressed with the scanning speed of the Agilent 6495C triple quad MS and the quantitation accuracy that has been repeatedly demonstrated with the MRM Proteomics kits. This combined workflow demonstrates great potential for future clinical research studies.” Dr Nicolai Bache, Head of Applications, Evosep

Read More

BUSINESS INSIGHTS

KemPharm Announces Strategic Acquisition of Arimoclomol from Orphazyme, Expanding its Rare CNS Diseases Pipeline

KemPharm | May 16, 2022

Arimoclomol is an NDA-stage, revenue-generating investigational drug candidate being developed for the treatment of Niemann-Pick disease type C a rare progressive neurodegenerative disease KemPharm plans to refile the New Drug Application (NDA) for arimoclomol in NPC with the U.S. Food and Drug Administration as early as the First Quarter of 2023 CELEBRATION, Fla., May 15, 2022 KemPharm, Inc. a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, announced a definitive agreement with Orphazyme A/S to acquire arimoclomol, an orally-delivered, first-in-class heat shock protein (HSP) amplifier being developed as a treatment for Niemann-Pick disease type C (NPC). NPC is a rare progressive neurodegenerative disease that impacts children, adolescents, and adults, and is characterized by an inability of the body to transport cholesterol and lipids inside of cells, which leads to the abnormal accumulation of these substances within various tissues of the body, including the brain. Arimoclomol is currently being made available to NPC patients in the U.S., France and Germany under Orphazyme’s Early Access Programs (EAP). Under the terms of the agreement, KemPharm will purchase substantially all of the assets and operations of Orphazyme, including arimoclomol, for a cash payment of USD $12.8 million. The Company expects to finance the cash payment with a revolving line of credit secured by KemPharm’s balance sheet. KemPharm intends to retain the majority of Orphazyme’s current employees. In addition, KemPharm has agreed to assume an estimated reserve liability equal to approximately USD $5.2 million, which is an estimated future rebate due to the French regulatory authorities based on the revenue generated from the EAP in France. For the year ending December 31, 2022, the EAP is expected to generate at least USD $12 million in revenue based upon enrollment in France as of March 2022. The EAP is expected to remain in place until arimoclomol becomes commercially available in each of the current EAP markets. The transaction is expected to close on or before June 1, 2022, subject to customary closing conditions and approval by Orphazyme’s creditors and the Danish bankruptcy court. Canaccord Genuity LLC acted as a strategic advisor to KemPharm for the transaction. “This strategic acquisition of arimoclomol is a transformative event that significantly expands our rare CNS disease development pipeline, bringing to KemPharm an NDA-stage, revenue-generating product upon which we intend to build commercial capabilities that allow KemPharm to create and retain value for the benefit of shareholders. Moreover, the financial structure of the acquisition combined with the revenue currently being generated by arimoclomol from the early access program in France affords us the opportunity to acquire the asset in a capital efficient manner that has the potential to create positive cash flow, while incurring no shareholder dilution.” Richard Pascoe, Executive Chairman of KemPharm Arimoclomol is administered orally and has been studied in ten Phase 1, four Phase 2, and three pivotal Phase 2/3 trials. Arimoclomol has received Orphan Drug Designation (ODD) for NPC in the United States and the European Union. Arimoclomol has received Fast-Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Rare Pediatric Disease Designation (RPDD) from the FDA for NPC. If approved in the U.S., arimoclomol would also be eligible to receive a Pediatric Priority Review Voucher. On June 17, 2021, Orphazyme received a Complete Response Letter (CRL) from the FDA regarding its NDA for arimoclomol for the treatment of NPC. Orphazyme also withdrew its European Marketing Authorisation Application (MAA) for arimoclomol for the treatment of NPC ahead of a final vote and opinion by the Committee for Medicinal Products for Human Use. “The acquisition of arimoclomol aligns perfectly with our strategy to build KemPharm’s value via the advancement and commercialization of novel treatments that address rare CNS conditions, including our lead clinical candidate, KP1077 in idiopathic hypersomnia,” stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We have carefully evaluated the CRL issued by the FDA and the minutes from the subsequent Type A meeting, as well as the data that has been generated from the development work performed to date. We believe the efficacy signal for arimoclomol in NPC is convincing and that there is a viable regulatory path that could enable a successful NDA resubmission. KemPharm has significant experience with challenging regulatory situations, having successfully led or participated in three FDA product approvals, two of which followed an initial CRL. We welcome the opportunity to work with the FDA on the resubmission of the NDA for arimoclomol in NPC, which we expect to file as early as the first quarter of 2023.” NPC is a rare progressive lysosomal storage disorder characterized by an inability of the body to transport cholesterol and lipids inside of cells. This leads to dysfunction in organs such as the brain, spleen and liver. NPC can range from a fatal disorder within the first few months after birth (neonatal period) to a late onset, chronic progressive disorder that remains undiagnosed well into adulthood. Disease progression is irreversible in all patients, and loss of neuro-cognitive function adversely impacts their daily life. The mean age of death is 13 years (Bianconi, 2019), and there are no approved treatments for NPC in the United States. “NPC is an ultra-rare, inherited neurodegenerative disease that affects people of all ages from infancy to adulthood, and leads to progressive impairment of mobility, cognition, speech, and swallowing, culminating in premature death,” said Marc Patterson, MD, Professor of Neurology, Pediatrics and Medical Genetics at Mayo Clinic. “Therapies to treat NPC are desperately needed, and there is hope that a treatment such as arimoclomol could provide a solution to patients around the world who are living daily with the disease. It is encouraging that there is an opportunity to continue the regulatory process for arimoclomol with the FDA.” About KemPharm KemPharm is a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system diseases through its proprietary LAT® platform technology. KemPharm utilizes its proprietary LAT® platform technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of idiopathic hypersomnia (IH) and other CNS/rare diseases. In addition, the U.S. Food and Drug Administration (FDA) has approved AZSTARYS®, a new once-daily treatment for ADHD in patients age six years and older containing KemPharm’s prodrug, serdexmethylphenidate (SDX), which is being commercialized by Corium, Inc. in the U.S., and APADAZ®, an immediate-release combination product containing benzhydrocodone, KemPharm’s prodrug of hydrocodone, and acetaminophen, which is being commercialized by KVK-Tech, Inc. in the U.S.

Read More

Spotlight

I n recent years, biopharmaceutical companies large and small have become increasingly reliant on the contract research organisation (CRO) sector and other clinical services specialists to provide research services across the breadth of their R&D operations. The fi nancial crisis had a signifi cant impact on CRO companies, with sponsors scaling back trial programmes, particularly in the early-stage segment covering preclinical activities and Phase I trials.

Resources