Almac Discovery is Granted Orphan Drug Designation for ALM201 Programme in Ovarian Cancer

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Almac Discovery, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its drug candidate ALM201 in the treatment of ovarian cancer.

ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL. The development of ALM201 by Almac Discovery builds upon initial research work by Professor Tracy Robson who has shown that FKBPL is a naturally secreted protein with effects on a number of important tumour biology processes including cancer stem cells and angiogenesis.

Ovarian cancer ranks among the top ten diagnosed and top five deadliest cancers in most countries. Unfortunately, approximately 80% of patients present with advanced disease, therefore it is critical that clinicians are provided with as many treatment options as possible which can target this disease, either as a monotherapy or in combination with other treatments.

Dr Stephen Barr, Managing Director & President, Almac Discovery commented “The FDA’s Orphan Drug Designation of ALM201 in the treatment of ovarian cancer will allow for valuable assistance from the FDA during clinical development for either ourselves or our partners for this difficult to treat patient population.”

The FDA Office grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

Fareva Excelvision completed a 30 mEUR+ investment in ophthalmics manufacturing capabilities

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Fareva Excelvision has just completed the validation of its new versatile ointment / gel IWK line able to handle up to 10 g tubes made of tin, aluminium or polyfoil.

Additionally 2 new 4010 Rommelag BFS (Blow Fill Seal) line has been also validated in a new workshop to increase the site capacity close to 900 millions of single dose units per year. New flow packs machines also allow to package the strips in a convenient and safe way to protect the products from water evaporation and light, ensuring product integrity even in hot climates.

In addition to those major investments, Fareva is also able to fill the preservative free bottle technology of Nemera (Novelia system), including the manipulation of cyclosporine.

Fareva is also ready for serialization up to the level 4 to support all the new regulatory expectations.

If you want to know more about Fareva, please do not hesitate to contact pharma@fareva.com

Catalent Launches New OptiForm® Solution Suite To Offer Quick And Efficient Path From Late-Stage Discovery To Phase I Clinical Trials

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Catalent Pharma Solutions has announced the broadening of the scope of its multi-award winning OptiForm® Solution Suite platform to provide an efficient and seamless path from late-stage discovery to phase I clinical trials.

Designed to make it easier and faster for small and mid-sized innovators to develop better treatments, the new OptiForm Solution Suite service will now include more comprehensive candidate screening tools, Absorption, Distribution, Metabolism and Excretion (ADME) considerations and in silico Drug Metabolism and Pharmacokinetic (DMPK) modeling, additional bioavailability enhancing tools, materials for cGLP intravenous and oral toxicological studies, and cGMP materials for first-in-human studies.

Built on Catalent’s experience in early phase development, which has seen the company support more than 500 Investigational New Drugs (INDs), the new OptiForm Solution Suite integrates tools and services sequentially to deliver relevant data and an optimized development program to support a molecule’s progress towards the clinic.

“To ensure a program’s success, formulation selection needs to be guided by a phase-appropriate model that measures and evaluates the right data at the right time,” commented Julien Meissonnier, Catalent’s Vice President, Science & Technology. “The service provides innovators with a progressive, data-driven approach to maximize options that demonstrate in vivo efficacy and activity, acceptable safety margins in preclinical models, better downstream processing attributes, and optimal dose design for the intended patient group; supporting the selection of a development candidate with the best chances of success in the clinic and beyond.”

Gerresheimer will launch an innovative syringe safety solution through exclusive licence from West

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Gerresheimer will complete its product portfolio of prefillable syringes made of glass and plastics with an innovative, integrated, passive syringe safety solution, acquired through an exclusive licence from West Pharmaceutical Services, Inc.

“As a result of our long-standing partnership with the leading manufac-turer of packaging components and delivery devices for parenteral drugs we are pleased to have acquired the rights to market this innovative, new syringe safety solution, developed by West. By doing so, we will complement our very broad range of prefillable syringe solutions for biotech and other drugs,” said Uwe Röhrhoff, CEO of Gerresheimer AG.

Gerresheimer is a leading supplier of prefillable syringes made of glass and plastics with a broad product portfolio. The new safety solution is fully compatible with Gerresheimer’s well-established RTF (ready-to-fill) syringe portfolio. The solution is fully integrated and will be assembled on the syringe in the run of the RTF production process. It is compliant with standard nests and tubs, which enables the pharmaceutical company to use the standard filling process.

The high amount of needlestick-related injuries among healthcare workers has led to increasing demand for innovative safety solutions. International regulation has paved the way for more safety for healthcare workers and patients. The new Gerresheimer integrated safety syringe will address this market need by offering improved syringe processability and high-end user friendliness.

West will maintain its current safety solution portfolio of products, which are already commercially available. For more information, please visit www.westpharma.com
More information about Gerresheimer RTF syringes: www.gerresheimer.com/en/products/pharmaceutical-primary-packag-ing/syringes-made-of-glass

Aptar Pharma Extends its Child-Resistant Nasal Pump Manufacturing Capabilities in North America

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Aptar Pharma, the leading manufacturer of drug delivery systems for nasal applications worldwide, announces the installation of manufacturing capacity for its Child-Resistant and Senior-Friendly Classic Nasal Pump in their Congers, NY site.

Effective April 2017, a new assembly machine for Aptar Pharma’s Child-Resistant (CR) feature for nasal sprays was transferred from Aptar Pharma’s plant in Southern Germany to Congers, NY. This represents an important step in Aptar Pharma’s history, bringing its manufacturing capacity closer to the target market for which this pump has been successfully established.

Aptar Pharma’s Child-Resistant technology platform was developed primarily for the U.S. market when, in 2012, the U.S. Consumer Product Safety Commission (CPSC) issued a rule requiring Child-Resistant packaging for any over-the-counter or drug product containing the equivalent of 0.08 milligrams or more of imidazoline (16 CFR Part 1700.14), a formulation widely used in nasal decongestant topical sprays.

Less than two years after the rule’s announcement, Aptar Pharma introduced its newly-engineered Child-Resistant/Senior-Friendly nasal spray pump to the U.S. market, which successfully matched the CPSC requirements. This feat once more underscored Aptar Pharma’s worldwide reputation as an innovative leader and trusted partner in the pharmaceutical industry.

Aptar Pharma’s Child-Resistant Feature for nasal sprays effectively combines Child-Resistance (CR) and Senior-Friendliness (SF) with its intuitive and widely-accepted squeeze-and-turn technology. The positive market feedback and increasing demand for the Child-Resistant Feature over the last two years demonstrates that Aptar Pharma’s CRSF technology is the best-in-class solution available on the U.S. market. As of today, all major brands of nasal decongestant topical sprays in the U.S. come with Aptar Pharma’s Child-Resistant Feature.

According to Alex Theodorakis, President Aptar Pharma North America, “We are pleased to welcome the arrival of Aptar Pharma’s Child-Resistant assembly machine to our recently-expanded Congers, NY manufacturing site. This added manufacturing capacity enables us to offer the production of this key Child-Resistant/ Senior-Friendly feature to our customers domestically. Being closer to our customers continues to be of strategic importance to Aptar Pharma, and this new initiative enables us to continue to support our important North American marketplace and increase our demand reactivity.”
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Aptar Pharma Congers site, NY – Courtesy of Aptar Pharma

Nemera announces a research agreement with UFRT (University of Tours) on new nasal drug delivery treatments

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Nemera and the Research Center for Respiratory Diseases (CEPR) of Tours University (INSERM U1100) join forces in a partnership to enhance drug therapeutic effectiveness in the nasal cavity.

The number of applications through the nasal route is expanding. The development of systemic medicinal products through the nasal mucosa is increasing, as well as new treatments directly targeting the central nervous system (nasal administration allows avoiding the blood-brain barrier). The nasal route of administration is easily accessible; it allows a focused efficacy and an outstanding usability, making patients’ lives easier than other types of treatments.

The purpose of this partnership is to develop a new method of nasal administration.

This collaboration relies on the expertises of Tours University in respiratory pre-clinical and clinical research, as well and Nemera’s experiences in development of drug delivery devices.

Sanner GmbH has acquired Jaco S.A., based in Kirchheim, France. Through the merger Sanner now advances to the global market leader for effervescent packaging.

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Sanner is known as market leader for desiccant packaging in the global pharmaceutical and healthcare sector. The company Jaco S.A. is one of the leading manufacturers of printed and unprinted plastic tubes for effervescent tablets. “Our product portfolios complement each other ideally,” says Dirk Mähr, Managing Director of Sanner GmbH. “As a result of the merger, we have significantly strengthened our market position and have become the world market leader for effervescent packaging.” In 2016, Sanner generated annual sales of 63.7 million Euros, while Jaco S.A. achieved around 13 million Euros.

“Together, we offer our customers one of the most comprehensive ranges of tubes and closures, combined with numerous decoration possibilities. This allows us to operate as a system supplier in the future,” says Tharcisse Decker, Managing Director of Jaco S.A. “Apart from the strong French and European market, we are now also able to enter new markets such as the Middle East or Africa more effectively,” Dirk Mähr adds. Moreover, Jaco S.A.’s experience in printing technology can be used for new products, while Sanner’s competencies in research and development are of great advantage for joint, innovative projects.

The acquisition will have no effect on the employees or the production of both companies. Customers will be served by the sites in Bensheim and Kirchheim. The company name Jaco S.A. will remain unchanged for the time being. The former owners of Jaco S.A have withdrawn from business. The parties agreed on keeping the purchase price confidential.

New ISO 7 injection-blow moulding line at Union Plastic: UP PHARM® bottle

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For the last 60 years, Union Plastic has been renowned for its expertise in the field of plastic injection moulding particularly targeting the healthcare sector and, at the present time, offers the healthcare industries high-quality plastic products, ranging from dosing systems, to medical devices and including consumables for in vitro diagnostics. The company has just been equipped with a new injection-blow moulding line in an ISO 7 class environment for the manufacturing of a new bottle: UP PHARM®.

Union Plastic has made innovation a central priority for the last 2 years and, as such, has added a new area of expertise to its arsenal, injection-blow moulding. With this expertise, the company is now in a position to develop LDPE, HDPE and PE plastic bottles of volumes varying from 5 to 100 ml.

The first part of this electric machine is a pre-injection plastic processing section. The second consists of a triangular turret where, simultaneously, a first mould injects plastic to form preforms while another mould blows previously manufactured preforms unidirectionally so as to give them a hollow shape. Finally, at the same time, on the last side of the triangle, the hollow bottles manufactured using the first two moulds are ejected. These two moulds are characterised by their horizontal closure, unlike plastic injection moulds which are closed vertically.

Union Plastic now offers the supply of bottles blow-moulded with controlled processes, entirely in an ISO 7 class environment as per NF EN ISO 14644-1:2016. Blower ceilings equipped with high efficiency filters protect the zone where parts are injected. The parts are subsequently conveyed into an ISO 7 room for assembly and packaging.
This ISO 7 class environmental conditions are equivalent to Good Pharmaceutical Manufacturing Practices Class C. This particulate cleanliness is a real advantage for the healthcare sector since ISO 7 class bottle production makes it possible to reduce residual endogenous endotoxins after sterilisation.

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This distinctive offering can now compete with the rare panel of bottle suppliers who offers such an ISO 7 class quality level.

With this advantage, Union Plastic is targeting the ophthalmic and self-medication market, particularly bottles intended for the nose, mouth and ears containing active ingredients sensitive to ambient bacteria such as antiseptics or antibiotics.
A range of catalogue products is under development and will expand the offering of blow-moulded bottles
for the healthcare sector.

Almac Group Announces Publication of Prostate Cancer Metastatic Assay Validation

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Almac Group’s Diagnostics business unit has announced the Journal of European Urology has published results relating to its Prostate Cancer Metastatic Assay. The publication demonstrates the assay can be used to analyse primary prostate cancer FFPE samples to identify a molecular subgroup with a high risk of developing distant metastases. The assay therefore has the potential to guide the choice of therapy for patients presenting with primary prostate cancer.

Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostics and McClay Professor in Medical Oncology, Queen’s University Belfast commented “An unbiased discovery approach was used to identify a molecular subtype of primary prostate cancer that demonstrated metastatic biology. This approach has created a very robust assay with excellent performance, independent of clinical factors such as Gleason and CAPRA. We believe it will play a significant role in aiding clinicians to select the most appropriate therapy regimen for their patients.”

The study was conducted in conjunction with The Movember / Prostate Cancer UK funded Prostate Cancer Centre of Excellence at Queen’s University of Belfast and Manchester University along with Cardiff University, University College Dublin, Oslo University and the University of Surrey. Independent assay validation was performed using 322 radical prostatectomy samples with Metastatic Assay positive patients having increased risk of biochemical recurrence (Multivariable HR 1.62; p= 0.0092) and metastatic recurrence (Multivariable HR=3.20; p=0.0001). A combined model with CAPRA-S identified patients at increased risk of biochemical and metastatic recurrence superior to either model alone (HR=2.67; p<0.0001 and HR=7.53; p<0.0001) respectively. “The publication of this manuscript in a journal of this calibre represents a significant milestone in the assay’s development and with two additional manuscripts being prepared for submission, further milestones are expected to be reached later this year. The first is another clinical validation but this time using biopsy FFPE tissue and the second is analytical validation to demonstrate the assay can be transferred to several commercial platforms.” said Professor Paul Harkin, President and Managing Director, Almac Diagnostics. He went on to say “Almac has been at the forefront of RNA based genomic innovation for over 10 years and this assay represents just one of our innovative pipeline of predictive and prognostic tests”.