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.

Catalent To Acquire Cook Pharmica For $950 Million

Catalent

Catalent has reached an agreement to acquire Bloomington, Indiana-based Cook Pharmica LLC, an integrated provider of drug substance and drug product manufacturing and related services. The acquisition will strengthen Catalent’s position as a leader in the rapidly growing area of biologics development and analytical services, manufacturing, and finished product supply.

Cook Pharmica is a privately held, biologics-focused contract development and manufacturing organization with capabilities across biologics development, clinical and commercial cell culture manufacturing, formulation, finished-dose manufacturing, and packaging. Founded in 2004 as a division of the Cook Group, Cook Pharmica today operates a world-class, 875,000 square foot development and manufacturing facility in Bloomington. For the twelve months ended June 30, 2017, Cook Pharmica generated $179 million in revenue.

“The complementary biologics development, biomanufacturing, and fill-finish capabilities of Catalent and Cook Pharmica will provide biopharmaceutical firms with a single, integrated partner supporting a wide range of clinical and commercial needs,” said John Chiminski, Chair and CEO of Catalent. “We are very excited to join forces with the talented Cook Pharmica team in Bloomington, Indiana and plan to invest aggressively there, in our rapidly expanding Madison, Wisconsin facility, and in the rest of the Catalent Biologics network to build a true global leader in the biologics market, which will help us to improve the lives of patients around the world.”

Mr. Chiminski added, “This acquisition is also a recognition of the hard work, dedication, and community spirit of the team who have helped Cook Pharmica grow, and of the Bloomington area, which is such a terrific home for this fast-growing business. We look forward to strengthening Cook Pharmica’s partnership with the community in the years to come as we further strengthen our leadership position in biologics.”

Catalent Biologics currently offers a global site network, including a state-of-the-art biologics development and biomanufacturing facility in Madison; fill-finish services in Brussels, Belgium and Limoges, France; SMARTag® conjugation technology in Emeryville, California; and a network of biologics analytical locations.

Cook Pharmica’s Bloomington facility has extensive biomanufacturing capacity and deep expertise in sterile formulation and fill/finish across liquid and lyophilized vials, prefilled syringes, and cartridges. It perfectly augments Catalent’s expertise in cell line engineering, bioconjugate development, analytical services, biomanufacturing, prefilled syringe, and blow/fill/seal technologies.

Upon completion, Cook Pharmica’s over 750 associates, including its experienced executive team, will join Catalent’s network of more than 30 sites across five continents with more than 10,000 team members and complement Catalent’s existing biologics capabilities, alongside its other leading capabilities in oral, inhalation, and consumer health.

Unither Pharmaceuticals will attend the CPhI Worldwide 2017 in Frankfurt, Germany

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Meet Unither at Stand 4.1C80 on the 24-26 October 2017. This international partnering conference will be an excellent occasion to learn about their latest innovation: the orodispersible solutions. The orodispersible dosage forms have been developed to improve swallowing of oral dosage forms particularly for patients with dysphagia such as geriatric and pediatric population. 

Sanner invests in Bensheim production facility

Sanner

One year after its start, Sanner has successfully completed the “future project production area South”. During the project, the entire machine park in this area was replaced with 14 injection-molding machines of the latest generation. The Sanner team completed the project on schedule and within the designated budget. “Our goal was to further automatize production and consequently increase capacities and efficiency,” says Dirk Mähr, Managing Director of Sanner GmbH. “A goal we have definitely achieved.”

With this expansion, the company is taking another important step towards future-oriented production at its headquarters in Bensheim. The new injection-molding machines ensure faster processes and can be further automatized at any time. The packaging specialist is thus optimally equipped for the challenges of industry 4.0, as well as for further optimization projects. Over the next few years, Sanner will also consequently expand its portfolio in the areas of capsules and desiccant packaging.

“During the modification, we were also able to significantly reduce energy consumption in production in line with the Sanner sustainability concept,” Mähr adds. This includes, amongst others, a renewed media supply for cooling water and compressed air, a better raw material supply and the installation of new cranes. Thanks to new lighting and a reduced noise level, Sanner employees also benefit from easier workflows and better working conditions.

Nemera receives Drug Manufacturing Authorization for its Neuenburg plant, in Germany

Nemera

Important achievement for Nemera, now able to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for Autoinjectors.

On 4th September, Nemera received from the German Government Drug Administration (Government Presidium, Tübingen) the Pharmaceutical Drug Manufacturing Authorization according to §13 AMG (German Drug & Medicinal Product Law) at its Neuenburg manufacturing facility in Germany. The certification gives the manufacturing plant the approval to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for autoinjectors.

This approval reflects Nemera’s commitment to quality in developing and manufacturing drug delivery devices.

The Authorization is an important achievement. It confirms that Nemera meets the highest standards required to ensure the manufacturing and testing of the above-mentioned drug, as well as medicinal and medical products. The pharmaceutical drug manufacturing certification is a required regulatory step, in order to allow Nemera to provide a complete set of services and additional support, for the development and manufacturing of pharmaceutical combination products and drug delivery devices to our customers

“Achieving this pharmaceutical drug manufacturing approval is highlighting our commitment to ensure the safety of our drug delivery devices for the benefit of patients. It is also the confirmation that our quality systems and processes are meeting consistently regulatory requirements and patient expectations.” commented Christian Meusinger, Quality Vice-President of Nemera.

Neuenburg plant has been manufacturing high quality products since 1953.
With more than 20,000 sqm of built up area, the plant has Class 8 clean rooms and more than 400 employees, to guarantee a 7/7 and 24h/24 production.
Neunburg plant produces billions of Injection molded parts and assembled devices every year.

Neuenburg quality management key achievements are:

• Short reaction times
• Detailed and comprehensive root cause analysis
• Elimination of quality problems
• Reduction of scrap rates
• Elimination of inefficiencies
nemer

Gx® InnoSafeTM: customized for manufacturers and users

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Gerresheimer presents at CPhI Worldwide in Frankfurt (Germany) an integrated safety system for the prevention of needlestick injuries

With their exposed cannulas, used syringes are an omnipresent source of danger in medical practices, 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 medical personnel. With Gx InnoSafe, Gerresheimer introduces a syringe with an integrated safety system for the avoidance of needlestick injuries that fulfils the current requirements of the pharmaceuticals industry and of users equally.

One careless movement is enough for medical specialists 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 additional actions. This thus involves a so-called passive needle protection system. Also of advantage to the pharmacists is the processing of the Gx InnoSafe syringes, which can take place on existing lines in the nested state without significant changes. An additional installation step of a safety system, as is usual on the market, is dispensed with.

The user wishes a safety system that leaves the familiar injection procedure unchanged, is intuitive and can be operated ergonomically, and which requires no additional manual activation to secure the cannula prior to disposal. The Gx InnoSafe  safety system is installed like a standard seal in the clean room on Gx RTF glass syringes in the context of the manufacturing process. The syringe body itself remains completely visible, so that the presence, filling level, and state of the active ingredient, as well as the injection procedure can be inspected without obstacles. The injection itself is administered as usual. Following the removal of the ergonomically optimized sealing cap with the integrated flexible needle shield, the syringe is positioned at the injection point, the cannula inserted into the tissue to be administered and the active ingredient injected as with a conventional syringe. An accidental triggering of the safety system isn’t possible, as the mechanism is completely relaxed prior to the injection. The system is first activated with the pricking 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 renewed use of the syringes is impossible.

bacFor the pharmaceuticals company, Gx InnoSafe offers advantages for the filling process of ready-to-fill syringes. The safety system is positioned fully automatically in the RTF process and visually inspected with an X-ray check to 100 percent for correct positioning. The syringes, including the safety system,  are packed in perforated trays and tubs and then sterilized with ethylene oxide gas. They can be processed on existing filling lines without additional preparation and assembly steps. Here too, the design of the safety mechanism ensures that unintended activation while filling, packaging, and transport is avoided. 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.

From October 24 to 26, Gerresheimer will be at CPhI Worldwide in Frankfurt (Germany) in hall 4.2 at booth D02.

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

Merck Set to Join Forces with Project Data Sphere to Pioneer Global Big Data Alliance

News 2

Merck has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck KGaA, Darmstadt, Germany’s, Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain.

“The ultimate goal of our alliance with Project Data Sphere is to unleash the power of big data to bring value to cancer patients,” said Belén Garijo, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. “Merck KGaA, Darmstadt, Germany, is deeply committed to investing in initiatives that push the boundaries of cancer research, that we hope will accelerate the discovery, development and delivery of innovative treatments to all who need it.”

The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.

“Big data is changing the face of healthcare as we know it, and advances in our ability to collect data, share and analyze it has already led to ground-breaking work,” said Dr Martin J. Murphy, CEO of Project Data Sphere LLC. “The joint force of Merck KGaA, Darmstadt, Germany, and Project Data Sphere will aim to connect and empower a truly global oncology community with these big data and analytical capabilities. We are excited about the Global Oncology Big Data Alliance initiative and the continuing engagement of a diverse community focused on finding solutions for cancer patients.”

Investment in the initiative builds on Merck KGaA, Darmstadt, Germany’s, commitment to rewarding innovation and creative thinking that could further advance the field of medicine, and begins a new chapter for global oncology innovation. Since 2014, the company has awarded a total of €4 million to further research in oncology through the Grant for Oncology Innovation award, which has engaged over 1,000 investigators worldwide, generated 12 winning research proposals from leading academic institutions, and generated seven high impact manuscripts.

OncoQR ML’s Vaccine Platform closes the Final Gap in the Immunological Attack against Cancer

T-cells attacking cancer cell  illustration of  microscopic photos

OncoQR ML GmbH has announced that even a single therapeutic vaccine based on its proprietary S-TIR™ platform technology, is able to induce the killing of tumor target expressing cells by simultaneously activating all possible immunological pathways (humoral and cellular).

Scientific Breakthrough

By showing this, the Austrian Biotech is the first company* to succeed in controlling all the relevant immune checkpoints that prevent the immune system from attacking and defeating cancer.

Whereas current passive checkpoint specific immunotherapy lacks tumor cell specificity with the risk of massive autoimmune reactions, this new active therapy is totally tumor target specific.

Geert Mudde, PhD, inventor of the S-TIR™ technology and OncoQR’s Chief Scientific Officer, said, “We are proud and excited to have finally demonstrated the ability to activate and use the full potential of the patient’s own immune system to eradicate cancer. Previously, we had already shown all forms of antibody mediated tumor killing – now we have the definite proof that our S-TIR™ vaccines are able to simultaneously induce and activate tumor specific T Cell killing as well. With our approach, the tumor has no more chance to escape the immune system – it is attacked from all possible sides at the same time.”

Economical Aspects

Christof Langer, Chief Executive Officer of OncoQR ML, said: “These spectacular results confirm the viability and huge potential of our proprietary S-TIR™ platform. Besides constituting a significant milestone in the development of our immunotherapy platform technology, to our knowledge, no other anti-cancer drug has shown comparable results so far. The new data are not only spectacular from a scientific point of view: The S-TIR technology will also break the trend that new cancer therapies have to be unethically expensive. Our therapeutic vaccines are designed to have low cost of goods which is paired with a personalized low treatment frequency at low treatment dose. Drugs based on our technology can be used as monotherapy but can also be combined with existing therapies (like chemotherapy). Therefore, all in all, groundbreaking news for patients, and healthcare organizations, but of course also for us and our future partners.”

Aptar Pharma to Highlight Key Innovations Addressing Today’s Megatrends in Drug Delivery at CPHI Worldwide in Frankfurt, Germany

Aptar

Aptar Pharma, a leading drug delivery systems provider, is pleased to once again be a main exhibitor at CPhI Worldwide 2017, which takes place in Frankfurt, Germany from October 24 – 26. For many years, Aptar Pharma has had a significant presence at this major event in the pharmaceutical industry.

This year, the Aptar Pharma booth, located at stand No. 42F10, Hall 4.2., will feature an innovation area showcasing seven healthcare technology megatrends, including a special connectivity hub, which will be dedicated to the growing field of connected healthcare solutions.

In addition to exhibiting at CPhI Worldwide, Aptar Pharma will present three Pharma Insight Briefings that will highlight its latest innovations and developments in the following drug delivery system areas:

 

Innovative Respiratory Solutions for Expanding Your Product Portfolio

Portrait 1Guenter Nadler, Director of Business Development at Aptar Pharma, will deliver an insightful talk on innovative respiratory solutions on the first day of CPhI Worldwide. As a global rise in allergies and air pollution have led to a significant increase in upper respiratory tract diseases, typical over-the-counter medications and household remedies cannot always fulfil the needs of today’s on-the-go lifestyle.

As one of the leading drug delivery system providers for the development of dispensing solutions for pharmaceutical cough and cold applications, Aptar Pharma’s proven nasal spray and Bag on Valve systems have become the treatment standard in the industry.
During the talk, attendees will learn more about how these systems meet today’s requirements for compliant patient treatment.

Join Guenter’s Briefing on Tuesday, October 24 at 10:30 at the Innopack Zone, G1A3.

 

Driving Better Patient Outcomes with Connectivity

Portrait 2Sai Shankar, Director Business Development – Connected Devices at Aptar Pharma, will present the company’s second Pharma Insight Briefing at CPhI Worldwide.

Using a patient-centric design approach, Aptar Pharma supports Pharma companies worldwide with custom-made solutions, including connected technologies, for the treatment of respiratory diseases including asthma and COPD. The findings of a study recently conducted by Aptar Pharma on its integrated connected pMDI, as well as the company’s connected health devices portfolio that support respiratory treatment for patients, will be among the topics presented at this briefing.

Join Sai’s talk on Tuesday, October 24 at 15:50 at the Innopack Zone, G1A3.

 

Setting New Standards for Coated Stoppers

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Arnaud Fournier, Business Support Manager for Injectables at Aptar Pharma, will exclusively introduce PremiumCoat ™, a coated stopper which represents a step change in the provision of elastomeric stoppers with an unrivalled, market leading reduction in particulates, and is Aptar Pharma’s response to the growing challenges to developing more sensitive drugs in the pharmaceutical market.

Join Arnaud’s presentation on the latest development in Aptar Pharma’s Premium Injectables portfolio on Wednesday, October 25 at 10:30 at the Innopack Zone, G1A3.

With over 42,000 Pharma professionals attending CPhI Worldwide every year, Aptar Pharma welcomes the opportunity to meet with their valued customers and business partners, exchange with key opinion leaders in the Pharma industry and showcase their latest key innovations.

Join Aptar Pharma at booth No. 42F10, Hall 4.2, where their team of experts will be pleased to give an overview of their wide product portfolio that provides innovative drug delivery systems, components and services covering a broad range of delivery routes.

Lilly and Nektar Therapeutics announce alliance to develop a novel autoimmune therapy

Lilly Ok

Eli Lilly and Company and Nektar Therapeutics have announced a strategic collaboration to co-develop NKTR-358, a novel immunological therapy discovered by Nektar. NKTR-358, which achieved first human dose in Phase 1 clinical development in March of 2017, has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

NKTR-358 is a potential first-in-class resolution therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.

“We look forward to working with Nektar to study this novel approach to treating a number of autoimmune conditions,” said Thomas F. Bumol, Ph.D., Senior Vice President of Biotechnology and Immunology Research at Lilly. “NKTR-358 is an exciting addition to our immunology portfolio and reinforces Lilly’s commitment to sustain a flow of innovative medicines in our pipeline.”

Under the terms of the agreement, Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones. Lilly and Nektar will co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development. The parties will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar. Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis. Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization. Nektar will have an option to co-promote in the U.S. under certain conditions.

“We are very pleased to enter into this collaboration with Lilly as they have strong expertise in immunology and a successful track record in bringing novel therapies to market,” said Howard W. Robin, Nektar’s President and Chief Executive Officer. “Importantly, this agreement enables the broad development of NKTR-358 in multiple autoimmune conditions in order to achieve its full potential as a first-in-class resolution therapeutic.”