Nottingham, U.K., Dec. 11, 2018 – Quotient Sciences, a leading drug development services organization, and Druggability Technologies (DRGT), a specialty pharmaceutical company, announced a collaboration today to utilize Quotient Sciences’ integrated Translational Pharmaceutics® platform to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib using proprietary super-API compositions developed by DRGT. This will be Quotient Sciences first Translational Pharmaceutics® program delivered from its U.S. operating facilities.

Within the program of work, DRGT is accessing Quotient Sciences' unique Translational Pharmaceutics® platform. This involves the development of amorphous spray-dried formulations and GMP clinical trial manufacturing in Philadelphia followed by clinical dosing and taste assessment at the Quotient Sciences clinical pharmacology unit in Miami. The program is fully adaptive, which will enable DRGT to optimize the drug product in response to emerging clinical data. Quotient Sciences will then seamlessly scale up the selected product to support pivotal patient trials.

Translational Pharmaceutics® transforms the traditional model of outsourcing to disparate contract CDMOs and CROs by integrating formulation development, real-time adaptive GMP manufacturing, and clinical research. It is proven to accelerate development timelines and reduce overall costs and has been applied in over 350 programs for customers worldwide. In 2017, Quotient Sciences established the capability to run Translational Pharmaceutics® programs in the U.S. Following a Critical Path Innovation Meeting with the FDA’s Office of Translational Sciences, and meetings with local institutional review boards, Quotient is now delivering programs in the U.S.

"We have significantly expanded our CDMO and CRO operations in the U.S. and are now performing integrated programs in the world’s largest R&D market," said Mark Egerton, Ph.D., CEO of Quotient Sciences. “This offers significant advantages to our customers. We are delighted to support DRGT in accelerating DRGT-46 as a new treatment for acute and chronic pain.”

Gábor Heltovics, CEO of DRGT, added, “We are very pleased to be working with Quotient Sciences on this accelerated development project with our proprietary super-API technology. The Company's tight integration of formulation, manufacturing and clinical research services has enabled DRGT to execute an efficient development plan with a single outsourcing partner and, most importantly, reduce our time to market.”

Quotient Sciences' comprehensive drug product expertise spans all types of oral dosage forms, a broad range of solubilization technologies, and high potency handling capabilities.

Nottingham, U.K., Apr. 05, 2018 — Quotient Sciences, the drug development services organization, announces that it has completed the integration and rebrand of Pharmaterials, a contract development and manufacturing organization (CDMO) based in Reading, U.K.

Pharmaterials, now Quotient Sciences - Reading, will play a key role in expanding and strengthening Quotient Sciences' service portfolio from preclinical formulation development through to commercial manufacturing, and support the continued growth of the Quotient Sciences Translational Pharmaceutics® platform.

The Reading business has a strong reputation in the development of small molecule drug products for oral and inhaled delivery and bolsters Quotient Sciences' formulation development and manufacturing services. The 48,000 sq ft. facility includes an additional 13 GMP manufacturing suites, high potency containment capabilities, and expertise across all key solubilization technologies including spray drying, hot melt extrusion, lipidic systems, and micronization.

Quotient Sciences continues to focus on delivering an innovative portfolio of services that are proven to shorten development timelines, reduce associated costs and accelerate the delivery of new medicines to patients globally.

Practical and operational considerations related to paediatric oral drug formulation: An industry survey

For over 15 years, US and EU regulations have ensured that medicines developed for children are explicitly authorised for such use with age-appropriate forms and formulations, implying dedicated research.

To shed light on how these regulations have been adopted by pharmaceutical companies and how various aspects of paediatric oral drug formulation development are currently handled, an exploratory survey was conducted. Topics included: general company policy, regulatory aspects, dosage form selection, in-vitro, in-silico and (non-)clinical in-vivo methods, and food effects assessment. The survey results clearly underline the positive impact of the paediatric regulations and their overall uptake across the pharmaceutical industry.

Even though significant improvements have been made in paediatric product development, major challenges remain. In this respect, dosage form selection faces a discrepancy between the youngest age groups (liquid products preference) and older subpopulations (adult formulation preference). Additionally, concerted research is needed in the development and validation of in-vitro tools and physiology-based pharmacokinetic models tailored to the paediatric population, and in estimating the effect of non-standard and paediatric-relevant foods.

The current momentum in paediatric drug development and research should allow for an evolution in standardised methodology and guidance to develop paediatric formulations, which would benefit the pharmaceutical industry and regulators.

Read the article featured in International Journal of Pharmaceutics

"The pharmaceutical industry is being revolutionised by the utilisation of digital technologies. Chemistry 4.0 describes this digital transformation and how its delivery is paving the way for the industry’s next stage of development."

This article explores the range of digital technologies which are now being employed across the drug development pathway. Quotient's Sr. Director of Science & Technology, Gareth Jenkins, and Head of Drug Substance, Paul Quigley, share their insights on Chemistry 4.0 and the digital transformation of the pharmaceutical industry.

Read the full article on TKS

Evecxia Therapeutics Reports Favorable Data From a Phase 1 Single-Ascending Dose and Multiple-Ascending Dose Trial of Adjunctive EVX-101 in Healthy Volunteers Treated With a First-Line Antidepressant

The Phase 1 trial of EVX-101 in healthy volunteers was conducted at Quotient Sciences - Nottingham.

April 10, 2023 - Evecxia Therapeutics, Inc. announced favorable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a double-blind, placebo-controlled Phase 1, a two-part single ascending dose (SAD) and multiple ascending dose (MAD) trial of EVX-101 in healthy volunteers treated with escitalopram. The Company further announced the planned design of a Phase 2 adjunctive EVX-101 trial in patients with major depressive disorder (MDD) responding inadequately to a first-line antidepressant (selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)).

EVX-101 is a novel, proprietary gastro-retentive, sustained-release tablet formulation of 5-hydroxytryptophan (5-HTP), the natural precursor to serotonin, and low-dose carbidopa. EVX-101, administered in addition to a first-line antidepressant, is intended to elevate extracellular serotonin beyond the first-line antidepressant effect, which convergent clinical pharmacology, brain imaging, and neuroanatomical data support would augment antidepressant efficacy. In EVX-101, the 5-HTP dose is fixed at 250 mg, while variable levels of carbidopa control 5-HTP plasma exposure levels.

The Phase 1 trial was conducted at Quotient Sciences’ Nottingham, UK facility.

Continue Reading

Collaboration Expedites Human Clinical Trials for COVID-19 Drug Candidate

NOTTINGHAM, U.K., and PITTSBURGH, April 28, 2020 – A collaboration to accelerate the development of a lead COVID-19 drug candidate into human clinical trials was announced today by Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, and CytoAgents, Inc., a privately held biotechnology company focused on the development of pharmaceutical products for the treatment of viral infectious diseases. The partnership will focus on utilizing Quotient Sciences' integrated service portfolio to support the rapid development of CytoAgents’ lead COVID-19 drug candidate, GP1681, for Phase I and II in 2020.

Scientific consensus is building that severe illness caused by COVID-19 and other infectious diseases is triggered by a phenomenon known as “cytokine storm,” an excessive immune response that attacks the body. GP1681 is a small molecule inhibitor of cytokine release in activated human immune cells and has been shown to safely modulate the natural immune response by tamping down various cytokines. GP1681 addresses an unmet need for therapeutic treatment by targeting the underlying cause of life-threatening symptoms associated with cytokine storm, which can cause more harm than the virus itself.

“Our mission is to create a powerful, lasting solution, not just for the current crisis but for any respiratory epidemic, thereby saving lives and reducing the strain on healthcare facilities,” said Teresa Whalen, RPh, CEO, CytoAgents. “Working with Quotient Sciences is a major milestone for CytoAgents in its accelerated path for a universal treatment for COVID-19-related or any respiratory epidemic.”

Mark Egerton, Ph.D., CEO of Quotient Sciences, said, “The COVID-19 pandemic has caught humanity off guard, and we need to act swiftly to bring new medicines to patients around the world. We are delighted to support CytoAgents with the product development of GP1681.”

Under the scope of the agreement, CytoAgents will access Quotient Sciences' formulation and manufacturing expertise to develop and rapidly supply drug product for Phase I and II testing in 2020. In parallel, Quotient Sciences will work to develop a scalable solid oral dosage form for larger patient trials and commercialization. The program will be conducted at Quotient’s facility in Garnet Valley, PA, which has specialized drug handling and containment suitable for highly potent drug candidates.

About Quotient Sciences

Quotient Sciences is an innovative global pharmaceutical development, clinical, and commercial manufacturing organization providing services to the pharmaceutical and biotech industries. A combination of specialized skills and agile integrated processes enables Quotient Sciences to develop customized solutions that dramatically reduce the time and cost of getting drugs to market. Everything we do is driven by a deeply held belief, shared across the entire organization, that molecules need to become cures — fast.

About CytoAgents

CytoAgents is a privately held biotechnology company focused on the development of innovative pharmaceutical products for the treatment of COVID-19, influenza, viral infectious diseases and conditions that cause acute respiratory distress. Using a novel, host-directed approach, our lead compound, GP1681, targets the underlying cause of life-threatening respiratory distress, cytokine release syndrome, by modulating the body’s natural immune response to sickness or disease. We are committed to developing first-in-class, best-in-class products that meet a major medical need now and into the future.

Miami, FL/June 22, 2020 - Quotient Sciences, a global pharmaceutical development, clinical and commercial manufacturing organization, announced today the completion of a $1 million pharmacy and laboratory expansion at its Miami, FL clinical pharmacology facility. 

The expanded pharmacy capabilities offer customers a quick and cost-effective way to start clinical testing, without the need for extensive CMC investment or API consumption at this early stage of development. Dose preparations can be made in “real-time”, enabling clients to make seamless adjustments to the dose or formulation and respond to changes in the first-in-human (FIH) protocol design.

The pharmacy’s compounding capabilities are differentiated in the marketplace as they are uniquely integrated with Quotient Sciences' broader formulation development and GMP clinical trial manufacturing capabilities at sites in the US and UK. This combined offering helps clients efficiently bridge from a fit-for-purpose Phase I formulation to a patient-friendly GMP drug product for subsequent Proof-of-Concept (POC) trials. All of this can deliver an accelerated timeline without the need for the customer to have to work with multiple vendors.

"Quotient Sciences is focused on providing our clients with solutions to get new medicines to patients faster." said Mark Egerton, CEO of Quotient Sciences. “When starting clinical development, our customers have a choice between pharmacy preparations or GMP drug product manufacturing. At Quotient, all options and program configurations are available for our clients, to help them reach their development milestones in the timeliest and most cost-effective way.”

The state-of-the-art pharmacy was built to ISO Class 5 and ISO Class 7 standards, following USP <795>, USP <797>, and USP <800> compounding guidelines to support both sterile and non-sterile drug programs. The facility is equipped with the necessary handling capabilities for highly potent and high-risk molecules, supporting a variety of oral and parenteral dosage forms. The pharmacy is located within Quotient Sciences clinical pharmacology facility, which features 144 clinical beds for performing first-in-human and other Phase I healthy volunteer trials.

For those with challenging molecules, clients can also leverage Quotient Sciences biopharmaceutics and formulation development expertise including a full range of solubility enhancement technologies including lipidic systems, micronization, spray drying, and hot melt extrusion, to produce solubilized intermediates and final dosage forms.

ANA Therapeutics, a Silicon Valley-based biotech startup, and Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, announced a partnership to support the manufacturing of ANA Therapeutics’ drug candidate, ANA001 (niclosamide capsules), which they are developing as a potential treatment for COVID-19. As part of the collaboration, Quotient Sciences will scale up the capsule formulation, characterize and optimize the manufacturing process and ensure continuity of drug product through clinical trials.

Laboratory experiments have shown niclosamide stops SARS-CoV-2, the virus that causes COVID-19, from replicating, making it a promising candidate for reducing the spread of COVID-19. Niclosamide was previously approved by the FDA as a treatment for tapeworm. Although not currently marketed in the U.S., it is on the World Health Organization’s List of Essential Medicines and has been used for decades to safely treat millions of people around the world.

“We have selected Quotient Sciences as our development and manufacturing partner and our plan is simple,” said Andrew Bartynski, COO, ANA Therapeutics. “Niclosamide has the potential to be an effective antiviral agent to combat COVID-19, and our top goal is to complete a clinical trial to determine its efficacy in treating patients with COVID-19. Quotient Sciences' speed and agility will play a key role in reaching that important milestone.”

Mark Egerton, Ph.D., CEO of Quotient Sciences, said, “We are proud to partner with ANA Therapeutics in their pursuit of a treatment to fight this coronavirus pandemic. Our experience and flexible manufacturing approaches will enable ANA Therapeutics to initiate clinical testing in an accelerated timeframe.”

Under the scope of the agreement, ANA Therapeutics will access Quotient Sciences' formulation and manufacturing expertise to develop and rapidly supply drug product for pivotal clinical trials in Q3 2020. The program will be conducted at Quotient Sciences' facility in Garnet Valley, Pennsylvania.

As of January 2021, ANA Therapeutics has been acquired by NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company.

NOTTINGHAM, U.K.; Feb. 9, 2021 – Quotient Sciences, the drug development and manufacturing accelerator, announced that it has acquired Arcinova, the U.K.-based multiservice contract development and manufacturing organization (CDMO). With over 40 years of experience and 160 employees, Arcinova provides drug substance, drug product and bioanalysis services to over 200 pharma and biotech customers worldwide.

The acquisition expands Quotient’s service portfolio and will enable the integration of drug substance, drug product and clinical testing capabilities all under one organization — extending the 12-month drug development timeline savings already delivered by Quotient’s flagship platform Translational Pharmaceutics®. By cutting through silos and integrating a range of capabilities, outsourced development programs can be further simplified and accelerated, consistent with Quotient’s belief that molecules need to become cures, fast.

“I’d like to congratulate the Arcinova team on building an exciting business, and I am thrilled to be joining forces. Both businesses are similar in culture and aspire to help customers accelerate molecules from candidate selection through development and on to commercial launch,” said Mark Egerton, Ph.D., CEO of Quotient Sciences. “I’d also like to take this moment to thank our private equity partner, Permira, for supporting our ambitious growth plans.”

Professor Ian Shott, CBE, co-founder and executive chairman of Arcinova, said: “Since inception, we set out to build a unique organization that accelerates the development of new medicines for patients in need. We are delighted to move on to the next stage with Quotient as the perfect partner for Arcinova. Deep science, agility, flexibility and the drive for customer service excellence are the cornerstones of both businesses. I look forward to working with the Quotient team and Permira to deliver even greater value for our customers.”

As part of the deal, Arcinova’s minority equity partner, BGF, will exit the business, having backed its growth since 2018. Mark Bryant, BGF, said: “It has been a privilege to support the expansion of Arcinova’s world-leading CDMO facility at such a critical part of its growth journey. We wish the team all the best as it moves to the next stage with Quotient Sciences.”

RBC Capital Markets acted as exclusive financial advisor to Quotient Sciences. PwC provided financial and tax due diligence services and Latham & Watkins provided legal counsel. BGF received legal counsel from Weightmans. KPMG served as corporate finance adviser for Arcinova, and Womble Bond Dickinson provided legal counsel.

The CRO Leadership Awards recognizes the top performing outsourcing organizations in the drug development arena. For 2021, Quotient Sciences has been recognized with multiple 2021 CRO Leadership Awards, including two Champion Awards. 

For the 2021 CRO Leadership Awards, Clinical Leader and Life Science Leader teamed up with Industry Standard Research (ISR) to determine award recipients. 60 contract research organizations (CROs) were assessed on 20+ performance metrics in ISR’s annual CRO Quality Benchmarking survey. Survey participants were recruited from pharma and biopharma companies of all sizes and were screened for decision-making influence related to working with contract research organizations. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that survey responses are based on actual involvement with CROs and clear experiential data. 

The Company received leadership awards in five of the overall six categories. The categories included: Capabilities, Compatibility, Expertise, Reliability, Quality, and Phase IV, each further divided into three groups – Big Pharma, Small Pharma, and Overall. Additionally, champion awards are given to companies that score 11/2 standard deviation more above the weighted average in each of the categories and are deemed “top performers”.

Champion Award Winning Categories:

• Expertise (Overall)
• Quality (Overall)

Leadership Award Winning Categories:

• Capabilities (Overall, Small Pharma)
• Compatibility (Overall, Small Pharma)
• Expertise (Overall, Small Pharma)
• Reliability (Overall, Small Pharma)
• Quality (Overall, Small Pharma)