May 17, 2020

Milestone Pharma has completed its $55 million Series C round

pharmaceutical
Medicine
pharmaceutical
Medicine
Catherine Sturman
4 min
Headquartered in Canada, Pharmaceutical company Milestone Pharma has completed its $55 million Series C financing. The clinical stage drug development c...

Headquartered in Canada, Pharmaceutical company Milestone Pharma has completed its $55 million Series C financing. The clinical stage drug development company has focused on developing etripamil, which can be administered to terminate paroxysmal supraventricular tachycardia (PSVT) episodes in patients when necessary. The condition affects over 1.5 million people, and amounts to over 600,000 healthcare claims in the US each year.

The round has been led by Novo Holdings A/S and included new investors, Forbion Capital Partners, and funds managed by Tekla Capital Management. The company also received participation from existing investors Domain Associates, Fonds de solidarité FTQ, BDC Capital, Pappas Capital, and GO Capital.

The funding will help develop advance etripamil into its Phase 3 development, supporting further clinical trials and the production of clinical and commercial supplies, as well as expanding the company’s current resources.

"Following our successful Phase 2 study results, we have been actively planning for the progression of etripamil into the next phase of development to further evaluate its potential as the only patient-administered treatment for the acute termination of paroxysmal supraventricular tachycardia," said Joseph Oliveto, Milestone's President and Chief Executive Officer.

"With financing in place by such seasoned and well-respected healthcare investors, Milestone is well positioned to advance and optimize this cutting-edge, novel approach for treating PSVT and potentially reduce the associated frequency of expensive emergency room visits and patient burden it causes each year."

In conjunction with this financing, joining Milestone's Board of Directors will be Nilesh Kumar, PhD, of Novo Ventures US Inc., which provides consulting services to Novo Holdings A/S, and Marco Boorsma, PhD, of Forbion Capital Partners. Daniel Omstead of Tekla Capital Management will be an observer to the Board of Directors. 

So, who are the investors?

Novo Holdings A/S

A leading private science venture capital investor company, Danish company Novo Holdings continually aim to improve the lives of thousands globally through investing in life science companies which focus specifically on the development of new drugs and procedures, which can help diagnose and treat diseases.

Established in 1999, the company has gained international exposure, and is located in Copenhagen, San Francisco, Boston and London. It is owned by the Novo Nordisk Foundation, and the holding company is Novo Group

Forbion Capital Partners

Capital venture firm Forbion Capital Partners helps to further develop life science companies within the pharmaceutical industry, and is located in both Europe and the US. Similarly, to Novo Holdings, the company also seeks to invest in companies which are developing key solutions and products that can treat and control diseases, in areas such as cancer, central nervous system pain management and liver disease, amongst others.

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Tekla Capital Management

Tekla Capital Management LLC is a registered investment adviser based in Boston, Massachusetts and is the investment adviser for four closed-end funds, Tekla Healthcare Investors, Tekla Life Sciences Investors, Tekla Healthcare Opportunities Fund and Tekla World Healthcare Fund. The Funds predominately invest in the securities of public and private healthcare companies.

Domain Associates

Established back in 1985, Domain Associates was one of the original investors within the life-sciences industry, and has primary investment areas in pharmaceuticals, diagnostics and medical devices which highlight significant growth potential. Since its inception, the company has more than $2.7 billion in capital raised, and has supported over 250 companies in their advancements.

Fonds de solidarité FTQ

Situated in Canada, Fonds de solidarité FTQ has become key in placing key investment within Canada’s economy. With pharmaceuticals becoming an area of increased interest in the region, it is no surprise that Quebec’s largest development capital investment network has looked at investing in Milestone Pharma’s clinical developments.

As of May 31, 2017, the organisation had a net asset value of $13.1 billion, and has helped create and protect 186,440 jobs. The Fonds is a partner in more than 2,700 companies and has 645,664 shareholder-savers.

BDC Capital

A subsidiary of the Business Development Bank of Canada (BDC), BDC Capital works to support Canadian entrepreneurs. The company’s Capital's Healthcare Venture Fund invests in Canadian companies which increase healthcare productivity by reducing healthcare costs while improving patient health.

Pappas Capital

Founded in 1994, Pappas Capital invests exclusively in the life sciences sector - biotechnology, biopharmaceuticals, drug delivery, medical devices and related ventures - across the United States and Canada. Since 2014, three portfolio companies founded or co-founded by Pappas have been sold to large pharmaceutical companies: CoLucid Pharmaceuticals, bought in March 2017 by Eli Lilly for nearly $1 billion; Afferent Pharmaceuticals, for which Merck paid $500 million upfront and $750 million in milestones; and Lumena Pharmaceuticals, purchased by Shire for more than $300 million.

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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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