Servier acquires Shire’s Oncology business to gain direct commercial access in the US

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Servier acquires Shire’s Oncology business for a total consideration of $2.4 billion, in cash, upon completion. The transaction covers the transfer of Shire’s Oncology business including in-market products ONCASPAR® (pegaspargase), a component of multi-agent treatment for acute lymphoblastic leukemia (ALL) and ex-U.S. rights to ONIVYDE® (irinotecan pegylated liposomal formulation), a component of multi-agent treatment for metastatic pancreatic cancer post gemcitabine based therapy. The portfolio also includes two early stage immuno-oncology pipeline collaborations. Servier’s products will be commercialized in the United States through a newly-created subsidiary, SERVIER Pharmaceuticals LLC. Closing is expected in the second or third quarter of 2018 after obtaining authorizations from the competent competition authorities.

“The acquisition of Shire’s oncology franchise enables Servier to meet its strategic ambitions to become a key player in oncology globally. It is a major step in the transformation of the Group, allowing us to establish a direct commercial presence in the US, as well as to strengthen our portfolio of marketed products in the ex-US territories where Servier is already present. Our goal is to bring these life-saving treatments to greater numbers of cancer patients around the world”, said Olivier Laureau, President of Servier Group. “We thoroughly look forward to welcoming Shire’s dedicated oncology teams who will join Servier after the closing.”

Flemming Ørnskov, M.D., M.P.H., Shire Chief Executive Officer, commented: “This transaction is a key milestone for Shire, demonstrating the clear value embedded in our portfolio. While the Oncology business has delivered high growth and profitability, we have concluded that it is not core to Shire’s longer-term strategy. We will continue to evaluate our portfolio for opportunities to unlock further value and sharpen our focus on rare disease leadership with selective disposals of non-strategic assets”.

Servier is already present in the United States through several agreements with private and public partners and the Servier BioInnovation office. Located in the heart of Cambridge’s global life sciences hub, this new facility, opened in February 2018, is dedicated to identifying new R&D opportunities and intensifying Business Development & Licensing (BD&L) activities in the United States.

Amgen Announces Rhode Island Will Be Location Of First US Next-Generation Biomanufacturing Plant

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Amgen has announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the United States, will employ Amgen’s proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets.

A next-generation biomanufacturing plant incorporates multiple innovative technologies into a single facility, and therefore is built in half the construction time with approximately one half of the operating cost of a traditional plant. Next-generation biomanufacturing plants require a smaller manufacturing footprint and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

“Amgen has three decades of experience in biologics manufacturing, and we are proud of our track record of providing a reliable supply of high-quality medicines for patients around the world,” said Esteban Santos, executive vice president of Operations at Amgen. “We are pleased to build the first commercial scale, next-generation biomanufacturing plant in the U.S., leveraging Amgen’s capabilities and incorporating the latest technologies.”

A comprehensive evaluation of global locations was conducted to select the location. Following recent U.S. federal tax reform, which provides company incentives to invest in innovation and advanced technologies, Amgen made the decision to locate the new plant in the U.S. Rhode Island was selected based on the historical success of the Amgen West Greenwich manufacturing facility, its capabilities and talented workforce, and quality of living for staff and potential to grow. The biomanufacturing plant will be built on the current Amgen Rhode Island 75-acre campus and is expected to create approximately 150 additional highly-skilled manufacturing positions and approximately 200 construction and validation jobs.

“I am thrilled that Amgen is planning to expand and bring new, highly skilled jobs to Rhode Island and further enhance the State’s life sciences community and manufacturing expertise,” said Rhode Island Governor Gina Raimondo. “We welcome Amgen’s future health care advancements for patients around the world that will come from this new biomanufacturing plant.”

Amgen opened its first next-generation biomanufacturing plant in Singapore in 2014. This type of plant offers a highly flexible, modular design which can be replicated in future facilities, which enables Amgen to increase production capabilities reliably with greater speed, productivity and flexibility. Within the plant, the equipment is portable, smaller and disposable, which provides greater flexibility and speed when manufacturing different medicines simultaneously. This eliminates costly and complex retrofitting inherent in standard facilities and allows Amgen to respond to changing demands with increased agility, ultimately impacting the speed at which a medicine is available for patients.

“We are excited that Amgen Rhode Island was chosen as the location to build the new biomanufacturing plant,” said Tia Bush, vice president of Operations at Amgen Rhode Island. “It is a testament to our skilled, dedicated workforce and Amgen’s continued presence in Rhode Island, which will enable ongoing collaborations with local academic institutions and the broader Rhode Island community.”

The existing Amgen Rhode Island plant was licensed by the U.S. Food and Drug Administration in September 2005 and houses one of the world’s largest mammalian protein manufacturing facilities. The facility manufactures commercial and clinical bulk drug substance. Amgen has invested more than $1.5 billion in its Rhode Island site, adding more than 500,000 square feet of manufacturing, utility, administrative and laboratory space to the campus. There are 625 full-time staff members employed at the Amgen Rhode Island campus.

Tekni-Plex granted patent for first-of-its-kind Sniff Seal technology

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Tekni-Plex has been granted a patent for its Sniff Seal® technology which is the first liner to enable scent permeation through an induction seal closure liner without affecting the seal or compromising the contents.

Brand owners are constantly looking for ways to create product differentiation. Consumers are also interested in enhancing their purchasing experience. Sniff Seal technology is an ideal way for the consumer to experience a scent in the retail aisle without compromising the seal or the product contents. A wide variety of product categories, including food, beverage, personal care, cosmetics can benefit from the technology.

“There are many instances where consumers want to know what a product actually smells like before putting it in the shopping cart. Unfortunately, there are times when consumers peel back seals or remove fitments to experience the scent before buying. When a package is returned to the shelf in a compromised condition, it is no longer sellable. As a result, the retail industry experiences a significant amount of loss annually,” explains David Andrulonis, senior vice president and general manager, Tri-Seal, a Tekni-Plex business unit.

Sniff Seal liner technology eliminates the problem because it provides the olfactory experience without removing the seal. This means that the tamper and/or pilfer evidence remains in place and the product integrity is maintained.

An extensive range of products can benefit from this technology. Imagine being able to experience the smell of fresh peanut butter or mango-scented shampoo or spring-fresh deodorant in a retail aisle without removing a seal or a fitment? That’s what Sniff Seal brings to the purchasing experience,” Andrulonis said.

Fareva opens its new analytical building dedicated to high potent technology

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Fareva has just opened its new analytical building dedicated to high potent technology on its site of Excella, Germany, welcoming 88 working spaces. This 7 m€ investment targets to support new chemical entities registration, quality by design studies, with the ability to handle molecules with an OEL < 1 µg/m³.

It will be completed in Q2 2019 with the addition of a Gerteis roller compactor that allows to manufacture up to 30 kg batches from clinical to commercial phases for 2,5 m€. It has been designed to be certified for Europe, Japan, Korea, USA and other markets.

Fareva APIs is also competing a major investment of 25 m€ on its French site of La vallee, to manufacture OEB4 APIs. First production is expected in August 2018.

Almac Group Recognised with CMO Leadership Awards

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Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced it has been awarded CMO Leadership Awards for the sixth consecutive year.

The CMO Leadership Awards recognises top outsourcing partners, determined by feedback from sponsor companies who outsource manufacturing. Each year, the awards are presented by Life Science Leader and Industry Standard Research (ISR) during an annual award ceremony which celebrates drug development and manufacturing.

Almac Pharma Services received three awards at the prestigious celebratory event held on 21 March in New York which recognised its capabilities, overall compatibility and outstanding quality at small pharma level.

The global organisation recently announced the completion of a £20 million investment in its cold chain management capabilities with the opening of a 95,000sq ft custom built cold store facility at its global headquarters in Northern Ireland. The new facility complements Almac’s existing global drug product capabilities by boasting over 3,000 pallet spaces including -15°C to -25°C storage capacity, additional 2°C – 8°C secondary production rooms, 3PL processing areas and a custom designed clinical labelling suite.

Adam Schroeder, Director Business Development, Almac Pharma Services commented “Once again, we are delighted to receive these awards which recognises continued investment in our global capabilities and solutions. This achievement strengthens our commitment to better serve our clients, and ultimately patients worldwide, thereby maintaining our position as a global leader in the life sciences sector.

Duma Standard container now available with child-resistant Duma Handy cap made out of one component

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Gerresheimer presented its Duma Standard CR (child-resistant) container with Handy Cap CR at Pharmapack last month in Paris. This is the company’s first snap-on cap with child-resistant (CR) solution. The snap-on cap is a one-component-system compared to more conventional child-resistant screw-cap solutions that are made of two components.

“I’m a father myself and I know how curious children are,” says Niels Düring, Global Executive Vice President Plastic Packaging. “You have to be very careful because they’ll play with anything they can get their little hands on. So it’s vital for drugs to be supplied in childproof packaging.”

Only the 40 ml version of the new Duma Standard CR container is cur-rently available with the Handy Cap CR. Other sizes can be supplied upon request.

Children experiment with everything and that includes medicines – mummy’s tablets could well be some sort of tasty treat, after all. This means tablets should be stored out of the reach of children. This is much easier said than done, however. It is all too easy to leave a box of tablets behind on the kitchen table where your child can play with it.

Packaging like the new Duma Standard CR container with its child-resistant cap is designed to prevent young children from getting hold of items like medicines that could be harmful to their health. Many products that could pose a threat to young children’s health are required to incor-porate a safety device under national and international law. ISO standard 8317 (2015) applies in Europe and US 16 CFR section 1700.20 in the U.S.

ISO 8317 (2015)

ISO 8317 (2015) is the international standard for reclosable child-resistant packaging. It governs both pharmaceutical and technical chem-ical products.

The standard describes two test procedures, which any packaging to be tested must be subject to. One test is run with a group of up to 200 youngchildren aged between 42 and 51 months. They must not be able to open the packaging, which is filled with a harmless replacement substance. At the same time, a test group of older people aged between 50 and 70 must
be able to open and reclose it without imparing the child-resistant func-tion. Packaging will only meet the requirements of ISO 8317 (2015) if the tests demonstrate that they are safe for children and user-friendly for the elderly, as defined in the standard.

The test

During the test, children have an initial five minutes to try opening the packaging. Afterwards, they are shown how to open it once without any explanation. They then have another five minutes to try opening it.

The packaging is deemed child-resistant if no more than 15 percent of children are able to open it within the first five minutes. A maximum of 20 percent of children are permitted to succeed in getting at the contents of the packaging for the entire duration of the test.

If only a few young children manage to open the packaging, the test group could be reduced to fewer than 200 children as part of the sequen-tial evaluation process.

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Tests with older people aged between 50 and 70

During the test, the participants have an initial five minutes to try opening the packaging. They are not shown how to do so besides the instruction on the packaging. In the second phase, they only have one minute to try and open it. The packaging is deemed suitable for older people as long as at least 90 percent of the test group are able to open and reclose it again without imparing the child-resistant function within a reasonable amount of time.

The test group is designed to include 100 people, of whom 25 are aged between 50 and 54, 25 between 55 and 59, and 50 between 60 and 70. 70 percent of each of these age groups should be female.

The US 16 CFR section 1700.20 regulation also stipulates the requirements child-resistant packaging must meet. These are similar to the standards applicable in Europe but are even more extensive for medicines.

 

 

Novartis teams up with Harvard to develop next generation biomaterial systems to deliver immunotherapies

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Novartis has announced that it is teaming up with scientists from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Dana-Farber Cancer Institute to develop biomaterial systems for its portfolio of immuno-oncology therapies.

The licensed biomaterial systems aim to overcome barriers that have hampered traditional cancer vaccines, including their limited duration of action and lack of targeting to specific cancer cells. Through many years’ work, researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), the Wyss Institute, and Dana-Farber have engineered the biomaterial systems with an aim to provide sustained delivery of immunotherapies and target specific types of cancer. Novartis will further collaborate with the team at the Wyss Institute to advance development of the biomaterial systems, investigating their use to deliver agents from its broad and deep portfolio of second-generation immunotherapies.

“Our collaborators have combined the fields of immuno-oncology and material science to develop novel platforms for delivering immunotherapies to combat cancer,” said Jay Bradner, President of the Novartis Institutes for BioMedical Research (NIBR). “We look forward to collaborating with the Wyss Institute to further develop this technology in conjunction with our growing immunotherapy portfolio.”

The licensing agreement with Harvard’s Office of Technology Development and the collaboration with the Wyss Institute support Novartis’ efforts to develop combination immunotherapy regimens. New immunotherapies have benefited subsets of cancer patients, presenting opportunities to develop new immuno-oncology treatment strategies to help more patients [1]. Novartis is developing combination immunotherapies in clinical trials.

The implantable and injectable systems are made of biodegradable materials that assemble into porous, three-dimensional structures. In lab experiments, the systems release cell-recruiting factors to attract host dendritic cells and present tumor antigens to those specialized immune cells, intending to bolster immune responses to cancer [2]. While these systems have yet not been proven in human clinical trials, they hold great promise because of their potential to serve as engineered microenvironments to educate the immune system about cancer and initiate immune responses against tumors over a sustained period of time.

The technologies licensed under this agreement for target-specific applications are owned or co-owned by Harvard University, Dana-Farber, and the University of Michigan.

Therapeutic application of mAbs will increase in near future, says GlobalData

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Ever since the first commercial monoclonal antibodies (mAbs) was approved in 1986 for human therapeutic purposes, mAbs have been increasingly used in several areas of healthcare. According to GlobalData, a leading data and analytics company, the total number of clinical trials involving mAbs witnessed a robust 115% growth between 2007 and 2016.

The company’s Clinical Trials Database provides a review of company-sponsored, interventional, observational, and expanded-access clinical trials of Monoclonal Antibodies (mAbs) across the globe for the past 10 years from 2007 to 2016.

Marco Borria, PhD, senior clinical trials analyst at GlobalData said, “Even though phase II trials outnumbered all other trials, phase I studies have grown faster than all other phases during the review period.”

During the review period, 57% of trials were completed, out of which 76% reported results. Among these, 79% achieved their primary endpoints.

Out of all the trials initiated, Roche has emerged as the lead sponsor, with the company’s bevacizumab as the most investigated drug. The other top industry sponsors were Novartis, Eli Lilly, Amgen, AbbVie, Pfizer, Bristol-Myers Squibb, Genentech, J&J, and GSK.

Oncology was the top therapy area in terms of number of clinical trials, followed by immunology, central nervous system, musculoskeletal disorders, and gastrointestinal. The most common indication under investigation in these trials was rheumatoid arthritis, followed by solid tumors and non-small cell lung cancer.

There is a near-even split between multinational and single-country trials across the period. However, in the last three years multinational trials outnumbered the trials conducted in a single country.

In terms of clinical trials by geographies, Europe accounted for almost 50% trials, followed by North America, Asia-Pacific, South and Central America and the Middle East and Africa.

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“As phase I studies have proliferated more than other phases, the number of new interventions appear to be on the rise across a wider range of therapy areas and indications”, concluded Dr. Borria.

Plastibell : an expert in Medical Devices

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On February 7 and 8, Plastibell attended the Pharmapack show, a key event in the pharmaceutical packaging and drug delivery calendar.

Plastibell (headquarters in Izernore, France), is an expert when it comes to injection molding and assembly, producing a broad range of complex plastic products for different industries.
The company is internationally active with seven industrial sites in four countries.
The Healthcare Division accompanies its customers in the development of Medical and In Vitro Diagnostics Devices (MD/IVD), from the earliest design stage, right through production.

Stiplastics launches an adjustable spoon designed to dispense mini-tablets

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Always at the forefront of innovation, the Isère SME is anticipating rapid growth of this new galenic device.

Stiplastics, specialised in creating, developing and producing plastic solutions for the pharmaceutical industries and the health and e-health sector, has developed a new spoon which makes dispensing mini-tablets easy.

Very simple to use, this first multi-dispensing device can be used to dispense from 1 to 24 mini-tablets. Simply select the desired dose by dipping the spoon into the jar containing the tablets and then withdraw it filled with the prescribed number of mini-tablets. Any patient contact with the medicine is avoided, thus offering total hygiene and safety.

This new galenic solution, the micro-tablet, meets the obligation of the pharmaceutical laboratories to develop paediatric forms as imposed by the European Regulation (No. 1901/2006) which entered into force in January 2007 and which stipulates that, when the pathology is not specific to adults, any new medicine must also be offered in a paediatric version for the five following classes:

– Preterm infants
– New-born infants from 0 to 27 days
– Very young children from 1 to 23 months
– Children from 2 to 11 years
– Adolescents from 12 to 16 or 18 years.

“The studies we carry out and feedback from our customers, patients and health professionals have encouraged us to develop this spoon because we are convinced that the micro-tablet form is one that is going to develop strongly in the near future. Since it is the smallest solid form that can be administered individually, it allows subdivisions of the dosage and therefore a very accurate dose to be administered with a high concentration of active ingredients and few excipients. This has several advantages such as ease of use, a reduction in swallowing problems and the ability to adapt the dose according to physiological parameters, thereby reducing the risk of over or under-dosing. This is of particular interest in the treatment of rare diseases or in paediatrics. It also provides a solution for adults experiencing swallowing problems such as the elderly. This first device is ready for production and it is fully in line with our philosophy of facilitating and making the everyday life of patients and health professionals more pleasant” Virginie Delay, Marketing Director & STICARE BU Manager, stated.