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Catalent Biologics Supports DiaMedica’s New Treatment for Chronic Kidney Disease

GPEx technology has been shown to be particularly suited to the development of a high-expressing cell line for this difficult-to-express protein, compared to other approaches that DiaMedica had tried previously.

SOMERSET, N.J. (PRWEB) January 23, 2020
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today welcomed the news that DiaMedica Therapeutics has received U.S. Food and Drug Administration (FDA) approval to commence Phase 2 clinical trials of its lead candidate, DM199, for chronic kidney disease (CKD). On behalf of DiaMedica, Catalent has produced a cGMP batch of the drug at its Madison, Wisconsin facility to support the trial using its proprietary GPEx® cell line development technology. DiaMedica intends to initiate participant enrollment in the clinical study in the next few weeks.
Catalent’s proprietary GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies to clinical manufacturing, through to commercial-scale production. Twelve biopharmaceutical drugs have been approved using Catalent Biologics’ GPEx technology, with more than 120 additional therapeutic candidates in ongoing clinical trials. In addition to Madison, the Catalent Biologics network also includes a second drug substance development and manufacturing site in Bloomington, Indiana. Both state-of-the-art facilities can provide clinical and commercial manufacturing for GPEx and non-GPEx cell lines. The Bloomington facility and the company’s European sites in Brussels, Belgium and Anagni, Italy also provide clinical and commercial drug product manufacturing for biologics.
“GPEx technology has been shown to be particularly suited to the development of a high-expressing cell line for this difficult-to-express protein, compared to other approaches that DiaMedica had tried previously,” commented Michael Riley, Region President, Biologics North America. “We look forward to working with DiaMedica on this exciting and important candidate, as well as potentially others in DiaMedica’s future development pipeline.”
In addition to the proven GPEx platform, Catalent recently announced the launch of its next-generation cell line development technology, GPEx® Boost. GPEx Boost enhances the existing technology through multiple improvements, including utilization of a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line. The combination of technology and platform enhancements has resulted in improved ability of cells to produce high titers and increase specific productivities of a protein of interest.
GPEx Boost has been shown to improve titers up to four-fold, potentially to 10 g/L for standard monoclonal antibodies, while maintaining the stability benefits offered by the traditional GPEx platform. In addition, benefits have been observed in cell growth and viability. Developmental timelines for projects can be shortened and made more efficient by combining this new platform with the rapid screening capabilities of Berkeley Lights’ Beacon® optofluidic platform, and ambr® automated micro bioreactors. The first customer has already signed up to leverage the technology for a Fc-fusion protein.
For further information visit biologics.catalent.com.
About Catalent BiologicsFor more than two decades, Catalent Biologics has built capabilities and experience in development, manufacturing, and analytical services for new biological entities, gene therapies, biosimilars, and antibody-drug conjugates. Catalent has worked with 600+ mAbs and 80+ proteins, and to date, 12 biopharmaceutical drugs produced using GPEx® cell line development technology have been approved and marketed, with more than 120 ongoing clinical trials utilizing therapeutic candidates developed using the GPEx® platform. A further 25 commercially-approved products have employed Catalent Biologics’ capabilities through to aseptic fill/finish. Catalent’s latest addition, Paragon Gene Therapy, provides industry-leading capabilities and expertise in the development and manufacturing of adeno-associated virus (AAV) vectors, next-generation vaccines and oncolytic virus production. Its manufacturing facilities in Baltimore, Maryland have produced over 100 GMP batches across 40 clinical and commercial programs. Using advanced technology and tailored solutions for clinical through commercial supply, Catalent Biologics brings better biologic treatments to patients, faster.
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com.
More products. Better treatments. Reliably supplied.™
About DiaMedica Therapeutics, Inc.DiaMedica Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing novel treatments for chronic kidney diseases and neurological disorders. DiaMedica’s shares are listed on The Nasdaq Capital Market under the trading symbol “DMAC.”

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Catalent to Discuss Ways of Increasing Accuracy and Speed in Assay Development at CASSS WCBP Symposium

SOMERSET, N.J. (PRWEB) January 21, 2020
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that Christopher Hepler, Manager, Catalent Biologics Analytical Development, has been invited to speak on ways to improve assay development at the upcoming CASSS WCBP symposium, which will be held at the Mayflower Hotel, Washington, D.C. on Jan 28 – 30, 2020.
On Tuesday, Jan. 28 at 12:50 p.m., Mr. Hepler will present “Conversion of a Potency Assay from Cell-Based Binding to AlphaLISA®”*, and using a case study, explain how the AlphaLISA® platform can develop a relative potency assay that, is more accurate, quicker and easier to execute than the original FACS-based assay.
Mr. Hepler received his bachelor’s degree in animal science and master’s degree in physiology from North Carolina State University, and has been working in the pharmaceutical and biopharmaceutical industry for more than 25 years. He is experienced in automation, as well as cell and molecular biology assay development, optimization, and validation. Mr. Hepler joined Catalent in 2016, and in his current role, manages the Biologics department for the Morrisville, RTP site.
For further information on this event, visit http://www.catalent.com/events/casss-wcbp/
To arrange a meeting with Mr. Hepler or any of the other Catalent experts attending the event, contact Richard Kerns at NEPR – richard@nepr.agency
*AlphaLISA is a registered trademark of PerkinElmer LAS, Inc.
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
More products. Better treatments. Reliably supplied.™

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Catalent Launches FlexDirect™ Direct-to-Patient Clinical Supply Services

“FlexDirect increases the options available to study sponsors and offers increased flexibility in distribution, reducing the strain on clinical sites by offering a pharmacy-based service and promoting patient retention.

SOMERSET, N.J. (PRWEB) January 14, 2020
Catalent, a global leader in clinical supply services, today announced the launch of FlexDirect™, a new direct-to-patient service for clinical trials. The FlexDirect service provides sponsors with the choice of site-to-patient distribution, or Catalent’s new pharmacy-to-patient service, both of which can be combined with standard distribution of clinical supplies to offer a customized hybrid approach as needed. Catalent’s pharmacy service is located within the same facility as standard distribution, enabling clinical supplies distributed to both clinical sites and directly to patients to originate from a single location, eliminating the need to maintain separate inventories.
The FlexDirect service offers benefits to both sponsors and patients undertaking clinical trials. For sponsors, direct-to-patient distribution of clinical supplies (patient kits) supports improved recruitment and retention of patients by delivering treatments directly to their homes, removing barriers such as transportation challenges and addressing the constraints of underlying health conditions that may hinder patients’ visits to clinical sites. The service also makes trials more patient-centric by improving convenience, supporting busy lifestyles and reducing the number of clinical visits that are necessary. Site-to-patient services are available in the U.S. and Europe. Pharmacy-to-patient services are accessible in the U.S. via Catalent’s on-site pharmacy at its Philadelphia location, offering sponsors a streamlined and compliant solution that eliminates the need for clinical sites to physically receive, store and dispense patient kits.
“The nature of clinical trials has evolved, but the needs for a trial to maintain patient engagement and ensure dosing regimens are adhered to remain paramount, and direct-to-patient supply reduces the burden of patients to visit clinical sites and maintain participation,” explained Kristen DeVito, Global Director Clinical Supply Services. “FlexDirect increases the options available to study sponsors and offers increased flexibility in distribution, reducing the strain on clinical sites by offering a pharmacy-based service and promoting patient retention.”
The Philadelphia facility is the largest site in Catalent’s global clinical supply network, and in 2018, celebrated 20 years of operations. Originally constructed in 1969, the facility was renovated in November 1998 to add clinical packaging, storage and distribution capabilities to the commercial packaging service already in place. Since then, it has increased its storage and distribution capacity and grown from 45,000 to 200,000 square feet. In April 2019, a $5.5 million expansion program at the site was completed, offering increased storage space, additional cold chain packaging areas, and a new clinical label design and printing area.
For further information on Catalent’s Clinical Supply Services business, visit http://www.clinical.catalent.com.
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,000 people, including over 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com.
More products. Better treatments. Reliably supplied.™

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Catalent Completes Purchase of Biologics Fill-Finish and Oral Solid Dose Facility in Anagni, Italy

The Anagni facility supplements our European commercial supply capabilities and will integrate well with our existing global early development and clinical supply sites to smooth the transition from development to commercial supply.

SOMERSET, N.J. (PRWEB) January 07, 2020
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced the completion of the purchase of Bristol-Myers Squibb’s biologics, sterile, and oral solid dose product manufacturing and packaging facility in Anagni, Italy.
The 28,000 square-meter (305,000 square-feet) facility has a demonstrated track record in technical transfers and successful commercial product launches. It offers extensive capabilities in aseptic liquid and powder filling for biologics and sterile products across multiple vial sizes, and comprehensive primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile, and biologics products. Catalent has also announced that it plans to make further investments in the site’s growth.
“The Anagni facility supplements our European commercial supply capabilities and will integrate well with our existing global early development and clinical supply sites to smooth the transition from development to commercial supply,” commented Alessandro Maselli, Catalent’s President and Chief Operating Officer. “Anagni provides our European customers with great biologics and oral dose capabilities that can help us reduce time-to-market, simplify tech transfers, and minimize program risk.”
As part of the acquisition, Catalent will continue to manufacture the existing Bristol-Myers Squibb product portfolio currently produced at the site.
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
More products. Better treatments. Reliably supplied.™

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Catalent to Host Workshop to Discuss Accelerating Early Drug Development through Consultant Collaboration

SOMERSET, N.J. (PRWEB) December 17, 2019
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced it will host a workshop for drug development consultants titled, “How to Effectively Work with a Development Partner – From a Consultant Standpoint”, at its facility in San Diego, on Jan. 8, 2020.
The workshop will feature presentations from two experienced industry consultants: Alan F. Parr, Pharm.D., Ph.D., Managing Member, BioCeutics LLC whose discussion “Prepare Your Clients for Success: Tips and Strategies to Avoid Dangerous Pitfalls in Consulting”, will explain how a client’s primary goal and focus will impact the strategy used in the development of their asset; and Jim Spavins, Principal, Spavins Consulting LLC, who will present “Integrating the Business, Regulatory and Scientific Needs of a Client” and discuss how drug development relies on the integration of multi-disciplinary scientific, business and regulatory activities. He will explain how consultants should provide advice and services to support all three in order to successfully support a client’s program.
Also speaking at the event will be Lisa Caralli, Director of Science and Technology, Catalent, who will use case studies to show how consultants can help their clients get through early phase development faster, and avoid critical pitfalls in early drug development in her presentation, “Using the Developability Classification System and physiologically-based pharmacokinetic Modeling Tools to Select the Right Formulation Strategy when Transitioning Small Molecules from Discovery to the Clinic”.
Following the workshop, attendees will be given a tour of Catalent’s San Diego facility, which is one of three global centers of excellence in oral dose early-phase development focusing on preclinical to clinical Phase 2b formulation, analytical, and manufacturing solutions for orally delivered small molecules.
Dr. Parr is the former Director of Biopharmaceutics at GlaxoSmithKline, and has held various roles including formulation scientist and formulation manager. He has worked in the field of pharmaceutical sciences for 33 years, where his responsibilities ranged from development of formulations from early development through to scale up of commercial-scale batches.
Mr. Spavins has almost 40 years’ experience developing and bringing innovative new medicines to patients and is former senior vice president of Pfizer’s pharmaceutical sciences organization.
Ms. Caralli has over 27 years of industry experience, and in her role at Catalent, works with pharmaceutical companies to identify appropriate development pathways for early development drug candidates. She has previously held roles at Ionis Pharmaceuticals and Amylin Pharmaceuticals, and began her career at the Immune Response Corporation. Ms. Caralli holds a bachelor’s degree in biochemistry from the University of California at Davis, Davis, California.
For more information and to register for the event, visit https://www.catalent.com/events/how-to-effectively-work-with-a-development-partner-from-a-consultant-standpoint/
To arrange a meeting with any of the attending Catalent experts at the event, contact Richard Kerns at NEPR – richard@nepr.agency.
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including over 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
More products. Better treatments. Reliably supplied.™

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Catalent Launches New CTSuccess™ Service to Guide Sponsors to Smarter Clinical Trial Supply Planning

The aim of CTSuccess is to use the experience we have as a company in supplying materials for thousands of trials to identify the characteristics of a project upfront and highlight potential risk factors that may arise.

SOMERSET, N.J. (PRWEB) December 12, 2019
Catalent, a global leader in clinical supply services, today announced the launch of its new CTSuccess™ clinical trial planning service, designed to support trial sponsors with earlier, more proactive and robust clinical supply chain planning, and reduce the risk of delays and budget overspend common to clinical trials as they progress.
The CTSuccess service uses Catalent’s proprietary StartScore™ evaluation tool to calculate the complexity of a potential clinical project across more than a dozen specific and objective study characteristics. The StartScore model was developed by the company’s in-house supply chain experts based on actual performance data. The risk-based score generated by the tool helps sponsors gain advance understanding of the appropriate level of clinical supply management oversight needed to help get their project started on time and maintain momentum as the study progresses.
“No two studies are the same, and each carries its own unique risks and presents individual challenges, but the aim of CTSuccess is to use the experience we have as a company in supplying materials for thousands of trials to identify the characteristics of a project upfront and highlight potential risk factors that may arise,” commented Kristen Devito, Global Director, Catalent Clinical Supply Services. “Once these risks have been identified then a project team can be put together combining the necessary expertise to provide the integrated services and tailored support to ensure continuity of supply from beginning to end.”
Catalent’s clinical supply network includes nine cGMP-certified clinical packaging facilities across North America, Europe and Asia, and more than 50 strategically-located depots around the world, providing local and regional options for clinical storage, distribution, expiry update and relabeling services, and clinical returns management.
To find out more about Catalent’s clinical supply services, visit http://www.clinical.catalent.com
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
More products. Better treatments. Reliably supplied.™

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Catalent Partners with Bridge Therapeutics on Formulation, Development and Production of New Opioid Addiction Treatment

This new formulation will provide improved administration characteristics. With many formulations being unpleasant to patients, this fast-dispersing Zydis formulation could potentially increase compliance with Medication-Assisted Treatment (MAT) and thus better clinical outcomes

SOMERSET, N.J. and BIRMINGHAM, Ala. (PRWEB) December 10, 2019
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that it has completed clinical production of Bridge Therapeutics Inc.’s (Bridge) opioid addiction development therapeutic product, BT-219, and executed an Exclusive Licensing Agreement to use Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology. Bridge currently intends to seek approval from the U.S. FDA for BT-219 under the “505(b)(2)” regulatory submission pathway as well as a possible future single entity buprenorphine product.
Catalent’s Zydis ODT technology is a unique, freeze-dried tablet that disperses almost instantly in the mouth without water. Zydis is recognized as one of the world’s best performing ODTs and has well-established advantages over conventional oral dosage forms, including improved patient compliance, adherence and convenience. Bridge’s exclusive license of the Zydis technology will initially apply to the U.S., with the potential to expand to other nations.
BT-219, or Bunalz™, is an investigational new drug (IND) which applies the Zydis delivery technology to buprenorphine and naloxone, which are the active ingredients in the Suboxone® prescription medication for opioid addiction. Buprenorphine, being a Schedule III medication, is considered safer and less addictive than methadone, which is classified as a Schedule II medication. It has also been shown that buprenorphine is six-times safer than methadone with regard to overdose risk among the general population.[1]
“Catalent has a proven track record in working with partners to bring new therapies to market quickly and we look forward to working with Bridge as they pursue approval for this important and exciting new development product,” commented Jonathan Arnold, President of Catalent’s Oral and Specialty Delivery business unit. He added, “The Zydis technology platform has been shown to be very versatile and effective in developing easy-to-administer dose forms for innovators and to date, more than 36 products have been launched using Zydis technology in over 60 countries.”
Dr. Greg Sullivan, Chief Medical Officer of Bridge Therapeutics, continued, “This new formulation will provide improved administration characteristics. With many formulations being unpleasant to patients, this fast-dispersing Zydis formulation could potentially increase compliance with Medication-Assisted Treatment (MAT) and thus better clinical outcomes”. He added, “In addition to assisting the needs of the general population, utilizing the Zydis formulation technology lessens the chance of an institutionalized patient being able to divert the medication for untoward purposes.”
Catalent’s 250,000 sq. ft. site in Swindon, U.K. houses the company’s Zydis development and manufacturing operation, which produces over one billion tablets annually and employs more than 600 people. In March 2019, Catalent announced a $27 million investment to commercialize its next-generation ODT technology, Zydis® Ultra, which allows an increased drug load and taste masking to be incorporated into the Zydis dosage form.
[1] https://bmjopen.bmj.com/content/5/5/e007629
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
More products. Better treatments. Reliably supplied.™
About Bridge TherapeuticsBridge Therapeutics is an innovative, late-development-stage specialty pharmaceutical company pursuing FDA approvals of its investigational drugs BT-205 and BT-219. BT-205 is a patented (U.S. Patent #8410092) drug combination for the treatment of chronic pain in opioid-experienced patients. BT-205 is a unique combination of two chronic pain drugs — the partial-agonist opioid buprenorphine and the NSAID meloxicam. Also, under development is BT-219, a state-of-the-art formulation of Buprenorphine and Naloxone for the treatment of opioid dependence. BT-219 utilizes Catalent’s Zydis® Orally Disintegrating Tablet (ODT) technology. Bridge Therapeutics’ goal is to help combat the opioid crisis by making its treatments available for use.

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Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity

Catalent’s Zydis® orally disintegrating tablets

We believe that Catalent’s Zydis technology could give Ethicann’s pharmaceutical cannabinoids a distinct advantage in the marketplace, allowing patients to ‘self-dose’ if approved to optimize therapeutic effect.

SOMERSET, N.J. (PRWEB) December 03, 2019
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that it has entered into a partnership with Ethicann Pharmaceuticals Inc. (“Ethicann”), a Calgary-based pharmaceutical company using botanically sourced cannabinoid oils to formulate prescription drugs. The program will initially focus on using Catalent’s proven Zydis® orally disintegrating tablet technology to develop a new combination pharmaceutical-grade cannabidiol (CBD) and tetrahydrocannabinol (THC) product that, if approved, would treat patients suffering from multiple sclerosis (MS) spasticity.
One of the more common symptoms of MS, muscular spasticity causes feelings of stiffness and a wide range of involuntary muscle spasms in patients. Ethicann will investigate the new Zydis product for the treatment of patients who have shown inadequate response to other symptomatic treatments or who have difficulty tolerating the side effects of other treatments.Ethicann currently intends to seek approval from the U.S. FDA for this developmental therapeutic product under the “505(b)(2)” regulatory pathway and, for Canada, an expedited approval pathway not requiring extended clinical studies.
Ethicann plans to work with Catalent to leverage the Zydis delivery platform for other cannabinoid-based products as they approach clinical studies, including a combination of THC and CBD for the treatment of chemotherapy-induced nausea and vomiting (CINV), chronic pain, post-traumatic stress disorder (PTSD), and opioid mitigation.
Commenting on the partnership, Jonathan Arnold, President of Catalent’s Oral and Specialty Delivery business unit, stated, “CBDs and THCs are notoriously insoluble and poorly bioavailable so a Zydis sublingual dosage form provides a drug delivery solution by avoiding first pass metabolism.” He added, “Catalent has a proven track record in working with partners to bring new therapies to market quickly and we look forward to collaborating with Ethicann as it prepares for these important studies.”
Bruce Mackler, Ph.D., J.D., Ethicann’s President continued, “We believe that Catalent’s Zydis technology could give Ethicann’s pharmaceutical cannabinoids a distinct advantage in the marketplace, allowing patients to ‘self-dose’ if approved to optimize therapeutic effect.”
Catalent’s 250,000 sq. ft. site in Swindon, U.K. houses the company’s Zydis development and manufacturing operation, which produces over one billion tablets annually and employs more than 600 people. The company recently began work on extending the facility to allow for the commercialization of its proprietary Zydis Ultra® technology, which allows an increased drug load and taste masking to be incorporated into each dose.
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including over 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com.
More products. Better treatments. Reliably supplied.
About EthicannEthicann Pharmaceuticals develops cannabinoid-based ethical pharmaceuticals for treatment of a variety of disorders. Headquartered in Calgary, AB Canada, Ethicann’s pipeline includes treatments for MS spasticity, chemotherapy-induced nausea and vomiting, chronic pain, post-traumatic stress disorder (PTSD) and opioid mitigation. Ethicann’s competitive advantages include botanically-sourced cannabinoids and unique drug delivery systems.

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Catalent to Supply BeiGene’s BTK Inhibitor BRUKINSA™ (zanubrutinib)

Our Kansas City facility has an extensive track record in supporting the development and launch of multiple fast-track designation medicines, especially cancer therapies.

SOMERSET, N.J. (PRWEB) November 21, 2019
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that it had entered into a long-term commercial supply agreement with BeiGene, Ltd., a biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer. Under the agreement, Catalent will manufacture BRUKINSA™ (zanubrutinib) [1], a Bruton’s tyrosine kinase (BTK) inhibitor that has recently received accelerated approval from the United States Food and Drug Administration (FDA), as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.[2] BRUKINSA is now commercially available in the U.S.
Catalent’s Kansas City, Missouri site has supported BeiGene’s program since 2016, from formulation development and clinical trial supply, onto commercial supply for the U.S. and, subject to further approvals, other markets.
“Our Kansas City facility has an extensive track record in supporting the development and launch of multiple fast-track designation medicines, especially cancer therapies.” commented Jonathan Arnold, President of Catalent’s Oral and Specialty Delivery business. He added, “We are pleased to have worked with BeiGene toward this important first approval and we look forward to commercial launch in the U.S., and to supporting BeiGene as they seek further approvals.”
Commenting on the FDA’s accelerated approval, John V. Oyler, Chairman, Co-Founder, and CEO of BeiGene, said, “The FDA approval of BRUKINSA, following the previously granted Breakthrough Therapy designation in this indication, validates it as an important treatment option for people with relapsed or refractory MCL. We hope this is the first of many approvals for BRUKINSA as we continue to evaluate its potential in other hematologic cancers.”
[1] BRUKINSA is a trademark of BeiGene, Ltd.[2] BRUKINSA (zanubrutinib) Prescribing Information. beigene.com/PDF/BRUKINSAUSPI.pdf. BeiGene, Ltd; November 14, 2019.
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com.
More products. Better treatments. Reliably supplied.™
About BeiGeneBeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in China, the United States, Australia and Europe, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets BRUKINSA™ (zanubrutinib) and in China, the Company markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) under a license from Celgene Corporation. [i]
[i] ABRAXANE®, REVLIMID® and VIDAZA® are registered trademarks of Celgene Corporation.

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Catalent Appoints Corporate Development and Science Leaders to Drive Growth and Innovation

Mike Grippo, Senior Vice President, Strategy and Corporate Development at Catalent

Since our IPO in 2014, we have completed seven acquisitions and are expected to close the acquisition of an oral dose and biologics facility in Italy, from Bristol-Myers Squibb, before the end of the calendar year.

SOMERSET, N.J. (PRWEB) November 19, 2019
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced it has appointed Mike Grippo as Senior Vice President, Strategy and Corporate Development. In this newly created role, Mr. Grippo will be responsible for identifying and evaluating organic and inorganic growth opportunities across Catalent that will drive long-term shareholder value. He will report to John Chiminski, Catalent’s Chair and CEO.
Mr. Grippo joined Catalent as Vice President of Corporate Development in 2016, and in his new role will oversee the strategy and corporate development functions of the company, as well as Catalent’s scientific team.
Alongside his appointment, Julien Meissonnier has been named as Vice President and Chief Scientific Officer, and will report to Mr. Grippo. In this new role, Mr. Meissonnier will join the executive leadership team, leading Catalent’s new product development and technology innovation programs. He will also head up the company’s scientific community and customer advisory partnerships to help improve formulation and adoption of drug delivery technologies. Mr. Meissonnier will continue to co-chair the Catalent Applied Drug Delivery Institute to leverage emerging new therapeutic modalities.
“Since our IPO in 2014, we have completed seven acquisitions and are expected to close the acquisition of an oral dose and biologics facility in Italy, from Bristol-Myers Squibb, before the end of the calendar year,” commented John Chiminski. “The decisions to make strategic investments in areas such as biologics, gene therapy, and spray drying have been driven in large part by the work of our Corporate Development team, led by Mike Grippo in partnership with key leaders across the business.” He added, “During his long career with Catalent, Julien has been instrumental in driving excellence across the R&D community, notably through the launch of the Scientific Resource Center serving the business’s team of approximately 2,400 scientists and technicians. He will promote open innovation within the organization, and we welcome both to the executive leadership team.”
Prior to joining Catalent, Mr. Grippo was Vice President of Corporate Development for CR Bard. Prior to CR Bard, he held a similar leadership role with Hill-Rom Holdings. Earlier in his career he also held positions with SG Cowen and UBS Securities. Mr. Grippo holds a bachelor’s degree from Princeton University and earned an MBA in Finance from New York University.
Before his appointment as Vice President and Chief Scientific Officer, Mr. Meissonnier previously held the position of Vice President, Science and Technology, and before that led Catalent’s European softgel R&D team. He holds an engineering degree in physico-chemistry from the ENSI in Caen, France.
About CatalentCatalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
More products. Better treatments. Reliably supplied.™

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