Russian biotechnology company BIOCAD prepares to enters the European market

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The largest Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines. So far, there are seven molecules in the European portfolio of BIOCAD. This are innovative and biosimilar products, which could be used in treatment of melanoma, breast, stomach, kidney and lung cancer, rheumatoid arthritis, psoriasis and multiple sclerosis.

“The presence of Russian innovative medicines on the European market depends on the speed of approval process in the EMA (European Medicines Agency) which correlate with readiness to provide sufficient documents from manufacturer. BIOCAD is the only pharmaceutical company in Russia, which is ready to provide dossiers for its medicines according to ICH CTD format in the shortest possible time, “says Dmitry Morozov, general director of BIOCAD biotechnological company. In addition, the advantage of BIOCAD is its own production plant, which the company builds in Finland, in the city of Turku.

Currently, the Russian pharmaceutical company BIOCAD has not only biosimilars and generics in its pipeline, but also original molecules for the treatment of oncological and autoimmune diseases. The company invests in clinical trials of all this products. The last preparations are underway for conducting European Phase III clinical trials of adalimumab biosimilar and the original anti-IL-17 molecule. The preliminary agreement for the distribution of adalimumab in the European Union countries is planed to be signed in Frankfurt at CphI exhibition.

“As for the EU countries, where the approval of biological product goes under centralized procedure through the European Medicines Agency, taking into account the need for local clinical trials, we expect to get marketing authorization for biological products in 2021,” says Dmitry Morozov. In addition, in 2021, the generics of oncology drugs – docetaxel, paclitaxel, pemetrexed and irinotecan – will also enter the European countries.

BIOCAD is interested in licensing innovative products from small companies on mutually favorable terms for the Russian market. During the visit to Frankfurt, Russian experts will discuss with their Swiss colleagues the prospects of collaboration on a drug against hard-to-treat chronic viral infections based on a molecule obtained in the laboratories of the Swiss company. In addition, the company plans to sign a preliminary agreement on the licensing of an immune-oncology molecule with a pharmaceutical company from Germany. This drug will be used in combination therapy of some cancers along with the original BIOCAD medicine.

Novartis announces the planned acquisition of Advanced Accelerator Applications to strengthen oncology portfolio

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Novartis has announced, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera® , a first-in-class RLT product for neuroendocrine tumors (NETs). Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. The transaction would strengthen Novartis’ oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs.

“Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” said Bruno Strigini, CEO, Novartis Oncology. “With Lutathera we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.”

Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera is under review in the U.S. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.

The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1. The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability. The study met its primary endpoint with Lutathera achieving statistically significant and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy (hazard ratio 0.21, 95% confidence interval: 0.13-0.33, p<0.0001). At the time of study publication in the New England Journal of Medicine (January 2017), median PFS in the control arm was 8.4 months and had not yet been reached in the Lutathera arm.

In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (NETSPOT® and SomaKit TOC(TM)). AAA had sales of EUR 109 million in 2016.

ARaymondlife continues to develop and commercialize its RayDyLyo® range collaborating with Dara Pharmaceutical Packaging.

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• RayDyLyo®, an innovative device for vial capping

ARaymondlife is a pharmaceutical company GMP EU, specialized in plastic injection molding and fastening solutions. Its technological expertise is applied to develop innovative solutions for the pharmaceutical laboratories (for human health and veterinary medicine) and the medical industry.
Since 2012 ARaymondlife has been offering its own range of patented all plastic caps as an alternative to aluminum crimped closures. RayDyLyo® is more than a product; it is a solution that simplifies and improves the process security of the vial capping operation. Several packaging options are available in bulk or in nests to meet the market’s diverse needs. The trend toward ready-to-use components and filling vials directly in nests makes RayDyLyo® a very well-adapted solution.
RayDyLyo® eliminates the need for crimping by pre-assembling the stopper in the cap and closing the vial by simple vertical pressure, either automatically or manually.

• The first filling line adapted for RayDyLyo®

ligne DARA_AR - copieDara Pharmaceutical Packaging was showing the first vial filling line specially adjusted for filling and capping vials with RayDyLyo® at the CPhl in Frankfurt (24-26 October 2017).The Spanish company responded to ARaymondlife’s request to develop a suitable machine for feeding the all-in-one solution (a stopper pre-assembled in the plastic closure) and the specific parts needed to adapt the line.
Pre-assembling the stopper upstream simplifies the process compared to a traditional line by eliminating thestopper placing and crimping operations and saves space in the clean room.

« We believe that this first filling line will be introduced to the market progressively, but we are convinced that this product will gain significant market share in the medium term. DARA new vials filling lines, are ready to implement this new technology. Also and this is the most important thing, DARA old machinery, due to its modularity construction, allows an easy, economical and fast retrofit, to combine this new RayDyLyo® system with the traditional stopper and alu cap technology. RayDyLyo® is a highquality product that fits perfectly with Dara’s filling lines. » Joan Melé, Dara Pharmaceutical Packaging Commercial Director.

For its development, ARaymondlife has already concluded other partnerships, in particular with the “Matrix Alliance”, on the initiative of Vanrx Pharmasystems, allowing to propose an aseptic filling solution in a fully robotized isolator, or more recently with Disposable-Lab Eurofins Amatsigroup to offer to biotechs and pharmaceutical companies a global solution for the aseptic filling of innovative biological products.
“We want to continue to develop industrial partnerships such as the one with Dara Pharmaceutical Packaging because we are convinced that we are stronger together and that the answers we bring to the market are more relevant,” explains Nicolas Thivant, President of ARaymondlife.

• Innovation and diversity are part of ARaymond’s DNA

Discovering new markets where its know-how and its potential for innovation make sense has been the driving force behind ARaymond’s development for more than 150 years. As one of the world leaders in fastening and assembly solutions for the automotive industry, it has gradually transferred its skills and expertise to new markets: Truck, Industrial, Energies, Agriculture and Life.
« We believe in ARaymondlife’s potential because it is an ambitious project driven by the passion and involvement of the people who lead it and it respects the values of our company. We are convinced that our employees’ enthusiasm and motivation will make a difference over the long term, » says François Raymond, General Director of the ARaymond Network. For the company, diversification also means ensuring its stability and independence despite the political and economic uncertainties that may affect a sector or a country.

Catalent Collaborates With Grid Therapeutics To Develop A Novel Targeted Immuno-Oncology Therapy

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Catalent Pharma Solutions has signed a multi-year agreement with Grid Therapeutics, LLC, for the development and manufacture of Grid’s lead therapeutic candidate for the treatment of solid tumors. Grid is an oncology-focused biotech company building on the innovative science first developed by Edward F. Patz, Jr. MD, and his team of scientists at Duke University Medical Center.

Under the agreement, Catalent Biologics will employ its proprietary GPEx® cell line technology to develop cell lines and manufacture antibodies with a view to optimizing the process for cGMP bulk drug production. The project will be undertaken at Catalent’s state-of-the-art Madison, Wisconsin, biomanufacturing facility.

Grid’s research is based upon a novel approach to identify specific tumor immunoglobulin G (IgG) antibodies from patients with early stage cancer. Grid used a unique strategy to obtain the sequence of its lead IgG3 antibody directly from B cells in cancer patients.

“Grid Therapeutics is excited to partner with Catalent to develop this novel, human-derived antibody for the treatment of cancer. We feel Catalent Biologics is well positioned to bring this novel antibody to the clinic,” commented Edward F. Patz, Jr. M.D., CEO of Grid Therapeutics.

“Catalent regularly and successfully partners with innovator companies looking to bring new, important therapies to market faster, and a patient derived IgG3 monoclonal antibody would be a significant advancement in optimized treatments,” commented Mike Riley, Vice President & General Manager of Catalent Biologics.

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. To date, seven GPEx-based antibody and protein products are approved and marketed, and 34 therapeutic candidates are currently in the clinic across the world.

Gx® InnoSafeTM: Optimal for pharmaceutical companies and healthcare professionals

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Gerresheimer was presenting at CPhI Worldwide in Frankfurt (Germany) an integrated and passive safety system for the prevention of unintentional needlestick injuries.

With their exposed cannulas, used syringes are an omnipresent source of danger in doctor’s surgeries, labs, or hospitals. Existing needle protection systems reduce the risk of injury for the user, but require additional effort for filling on the part of the pharmaceutical companies and with respect to the use of the syringe by healthcare professionals. With Gx® InnoSafeTM, Gerresheimer now offers a syringe with an integrated and passive safety system that prevents unintentional needle stick injuries, excludes the possibility of accidental reuse and takes the needs of pharmaceutical companies and health care professionals equally into account.

One careless movement is enough for healthcare professionals to injure themselves on unprotected, used syringe cannulas or come into contact with aggressive active ingredients. In the most adverse case, this can result in serious infections. There is also a danger that already used syringes may accidentally be used a second time. Gx InnoSafe provides reliable protection against needlestick injuries and eliminates the possibility of reuse. In contrast with many existing solutions, the needle protection mechanism is thereby activated automatically and requires no further handling steps by the end user. This thus involves a so-called passive needle protection system. Also of advantage to the pharmaceutical companies is the processing of the Gx InnoSafe syringes, which can take place on existing filling lines in the nested state without significant changes. An additional assembly step of a safety system, as is usual on the market, is dispensed with.

SerThe user wants to have a safety system which remains the injection process unchanged, ensures an intuitive and ergonomical handling and does not require any additional operating steps for securing the cannula prior to disposal. The Gx InnoSafe safety system is installed like a standard needle shield in the clean room on Gx RTF glass syringes in the context of the manufacturing process. The syringe body is completely visible in order to be able to optimally see and check the presence of the active agent, its purity and the administering. The injection itself is administered as usual. Following the removal of the ergonomic sealing cap with integrated flexible needle shield, the syringe is positioned at the injection point, the cannula inserted into the tissue and the active ingredient injected like with a conventional syringe. An accidental triggering of the safety system is prevented, as the mechanism isn’t preloaded prior to the injection. The system is first activated with the piercing of the cannula and then automatically ensures when removing the syringe from the injection point that the safety mechanism is permanently locked. In this way, the cannula is reliably covered and reuse of the syringes is excluded.

For the pharmaceutical company, Gx InnoSafe offers advantages for the filling process of ready-to-fill syringes. The safety system is installed fully automatically like a standard needle shield in the clean room onto Gx RTF glass syringes and checked to 100 percent by visual inspection for potential needle piercing and safety system position. The syringes are then packaged, sealed and sterilized with ethylene oxide gas including the safety system in a 100 hole tray (nest) and in a tub. They can be processed on existing filling lines without additional preparation and assembly steps. The design of the safety mechanism ensures that unintended activation while filling, packaging, and transport is avoided. The flexible needle shield is available in all customary available elastomers for pharmaceutical applications. With the introduction of the new product line Gx InnoSafe is available for the 1.0 ml long RTF glass syringe with a ½“ cannula. Additional syringe variants will follow.

Gx® and RTF® are registered trademarks of the Gerresheimer Group. InnoSafe is a pending trademark of the Gerresheimer Group.

Stiplastics opens a new factory in Saint-Marcellin (France) dedicated to the future of healthcare

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Stiplastics, the specialist designer, developer and producer of plastic solutions for the pharmaceutical industries and the health and e-health sectors has opened its new factory in Saint-Marcellin. A total of €8.6 million has been invested in this site, enabling the company to pool all its operations and meet its customers’ various requirements, especially in terms of the increasing demand for connected health.


A cutting-edge production tool

The 10,000 m2 site in Saint-Marcellin in the French département of Isère includes the company’s administrative headquarters, design office and production workshops (injection, assembly, storage) where manufacturing is based on lean management principles. It has:

– A dedicated injection workshop with 23 electric injection moulding machines weighing 30 to 300 T
– An automated assembly area (camera inspections, robot stations) and storage area
– A test centre with a dedicated injection moulding machine

In response to the rise of e-health, Stiplastics has also set up a new electronics workshopequipped with special tools including test benches. This 150 m² space is protected from ESD (Electro Static Discharge) by a controlled environment essential for handling electronic components.
The increasing prominence of connected care has also prompted the company to set up IoC  [Internet of Care]®. This label and unit is dedicated to designing, developing and producing ehealth medical devices, with the main aim of significantly improving treatment and patient comfort.

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Stiplastics is therefore now able to design and manufacture medical devices, add electroniccomponents, test them and then pack them ready-to-use for delivery.

‘In 2013, we drew up a development plan forecasting almost doubled sales in five years. This investment will enable us to meet our targets since we are still on track for turnover of €23 million by the end of 2018. It would not have been possible to build this new site so quickly without the effective contribution made by our staff, which I would like to acknowledge, and the unfailing support of the local authorities, especially the Pays de Saint-Marcellin Community of Municipalities and the City of Saint-Marcellin, who I would like to sincerely thank,’ says Jérôme Empereur, CEO of Stiplastics.

‘Since 2014, when we entered a true partnership with Stiplastics, immense progress has been made with connected health, a sector that gives much hope, especially in terms of allowing patients to continue living at home. This public health issue is particularly challenging for less urban local authorities like our own. We are therefore happy and proud to have supported and gained the loyalty of an innovative company involved in the future of healthcare. Its dynamism adds to the appeal of our community of municipalities and, we hope, will encourage other companies to set up in our booming region set in an ideal location at the foot of the Vercors mountains near major motorway links,’ explains Frédéric de Azevedo, head of the Saint-Marcellin Vercors Isère Communauté community of municipalities.

Walgreens Boots Alliance to enter into long term global supply agreement with Fareva

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Walgreens Boots Alliance today announces a binding offer from Fareva for a ten-year global agreement for the manufacture and supply of own beauty brands and private label products, including products for sale in the USA. The proposed agreement will create a partnership to provide Walgreens Boots Alliance with a core multinational manufacturing and development resource, enabling the Company to accelerate its global product strategy.

Under the terms of the offer, Fareva will take ownership of BCM, Walgreens Boots Alliance’s contract manufacturing business, which operates factories in the UK, France and Germany.

Fareva manufactures in 11 countries, including the USA, and has significant research and development capabilities.

The proposed agreement, which is subject to Works Council consultation and regulatory approval, is expected to be completed by the end of calendar year 2017.