May 17, 2020

Sanofi enters into negotiations to sell its European generics unit

pharmaceutical
pharmaceutical
Catherine Sturman
2 min
Janssen Sciences
Sanofi and Advent International have entered into exclusive negotiations under which Advent would acquire Zentiva, Sanofi’s European generics business...

Sanofi and Advent International have entered into exclusive negotiations under which Advent would acquire Zentiva, Sanofi’s European generics business for €1.9 bn.

The company will aim to work in collaboration with Sanofi to form a new independent operation and support the Zentiva management team by investing in the company’s operations, production facilities and R&D pipeline. 

“Following a comprehensive review of strategic options for our generic unit in Europe, we have determined that transferring this business to Advent is the best option to ensure its long-term success,” said Olivier Brandicourt, Chief Executive Officer, Sanofi.           

“We have long been attracted to the generics pharmaceutical sector as it enables more people to access high quality treatments by lowering their cost. We believe that Zentiva is a great platform, full of talented people, who we can invest behind to build a new, independent, European generics leader” jointly commented Tom Allen, Managing Director and co-head of Advent International’s European Healthcare team and Cédric Chateau, Managing Director and head of Advent International in France.

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Headquartered in Prague, Zentiva reaches over 40mn patients in 25 European countries. Its integrated value chain and pan-European commercial footprint makes it one of the largest generics players in Europe.

The transaction is expected to close by the end of 2018.

“The sale price for Zentiva is decent, but nothing that extraordinary,” commented Jerome Schupp, fund manager at Geneva-based Prime Partners.

“Sanofi will probably re-invest the proceeds in looking to make pharma or biotech acquisitions. They are looking to strengthen their pipeline, which is a bit weak at the moment.”

Sanofi has undergone a number of mergers and acquisitions. From its $11.6bn deal to acquire Bioverativ, as well as its $4.8bn takeover of Ablynx, the company is looking at further markets where it views long-term value.

Whilst the European generic drugs market continues to grow, fierce competition and escalating healthcare costs globally are causing shares to remain volatile, further impacting sales.

 

 

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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