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What Impact has Coronavirus had on Doing Healthcare Deals?

by Tom Whelan and Dr. Nikolaus von Jacobs | Jul 28, 2020 | Health M&A, Health Private Equity, Life Sciences

In the fifth and final installment of McDermott’s HPE Europe 2020 Summer Webinar Series, McDermott partner Tom Whelan hosted a discussion with Marc Benatar of Apax Partners, Markus Peterseim of Alvarez & Marsal, and fellow McDermott partner Dr. Nikolaus von Jacobs to examine how the Coronavirus (COVID-19) pandemic is affecting deal making in the healthcare industry.

Whelan led the group through a wide-ranging conversation centered on five key pandemic deal impact areas: pricing, process, timing, regulation and future prospects. Read on for discussion highlights, and click here to access the full webinar.

Pricing

“You’ve clearly seen a polarization,” Benatar said. “Nonessential businesses were hit hard by the lockdown effect and remain impacted, while those that were related to essential elements of healthcare were hit but started to experience a catch-up at the beginning of May and are already getting close to the normal run rate volume. I think that businesses that demonstrated that they are related to an essential part of the healthcare offering and that they can survive this type of crisis have almost strengthened their value. Those businesses that we know have experience with this first wave and those that are getting even more prepared for the next one will probably attract the highest valuations.”

COVID-19 has had a significant impact on the due diligence process, Peterseim noted. “When you’re advising investors on commercial or operations due diligence, there are always questions such as, ‘What will be the new normal of profitability? Will it be a swift [...]

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What is the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe?

by Dr. Stephan Rau | Jul 27, 2020 | Digital Health, Health Private Equity, Life Sciences

In the fourth installment of McDermott’s HPE Europe Summer Webinar Series 2020: What’s the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe? moderator and McDermott partner Dr. Stephan Rau and industry experts Karthic Jayaraman of TPG Capital, Max Müller of Bayer, Ben Faircloth of L.E.K. Consulting and Dr. Ulrich Wandschneider, former CEO of Asklepios AG, currently at Trilantic Capital Partners and Supervisory Board member of BioNTech SE, the Nasdaq-listed developer of COVID vaccine, headquartered in Germany, discussed the impact that COVID-19 and the government measures to address it have had on investments in healthcare and life sciences in Europe.

“I think it’s about as interesting a time as any in my last 20 years investing,” said Jayaraman. “People are beginning to focus a lot more on innovation, the speed of innovation and how innovation is brought to market. I think the question is, “How can we continue to reward innovation, both by simplifying the process by which it’s made possible and how we value it?”

“New developments in digital health have become more and more attractive as people have had faster access to care and governments have understood that some of their regulations needed to be adjusted,” added Müller.

Jayaraman agreed. “There has been an acceleration of the provision of care through telehealth services and any kind of remote administration of care. It’s probably been an acceleration of two-plus years collapsed into months. I also think we’re going to see some vigorous [...]

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Top Takeaways: Critical Business Considerations for Life Sciences and Medical Device Companies During COVID-19

by McDermott Will & Emery | May 5, 2020 | FDA, Life Sciences

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting products, services, facilities and distribution channels to aid in the pandemic response. Simultaneously, they must maintain shareholder value, navigate highly complex regulatory hurdles and compliance obligations while rethinking strategies for growth in a post-COVID-19 world. McDermott Will & Emery and EY co-hosted a webinar to discuss critical COVID-19-related operational, regulatory and legal developments. Below are top takeaways from the program. For a deeper dive into these issues, listen to our webinar recording.

FDA enforcement discretion is a flexible, risk-based approach, not a free pass. Companies operating under FDA’s enforcement policies to provide COVID-19 countermeasures should have a strategy to ensure that products comply with the standard applicable requirements if the products will still be in distribution after the public health emergency ends. FDA will prioritize areas for follow-up and review after this crisis; clear documentation and protocols describing deviations from standard FDA procedures or requirements will be important in a post-COVID-19 environment.
Clinical trials remain an important FDA priority, and COVID-19 presents an opportunity to transform the clinical development model. The agency has been very flexible in terms of the approaches it is taking to allow trials to continue, including through the use of technology, such as remote patient monitoring, video consent and telemedicine, as well as the use of home health. [...]

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Anticompetitive Conduct in Biologics – An Enforcement Priority with FTC and FDA

by Lisa P. Rumin, Jon B. Dubrow and McDermott Will & Emery | Feb 5, 2020 | FDA, Life Sciences

This blog was originally published on McDermott’s Antitrust Alert Blog.

On February 4, 2020, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for biologics and reduce manufacturers’ use of false or misleading statements or promotional communications concerning the efficacy or safety of biosimilars and other biologics. This guidance appears to be part of the Trump administration’s effort to reduce the cost of medications for consumers, as it is aimed at increasing the level of competition biosimilars can offer and raising awareness of the safety and efficacy of biosimilars.

The fast-growing biologics market has become an important sector of the healthcare and pharmaceutical industry. According to the joint guidance, private insurers spent over $125 billion on biologics in 2018 alone. Biologics treat many serious conditions that often lack alternative treatment options. Although Congress enacted an abbreviated FDA-approval process for biosimilars nearly a decade ago, adoption of biosimilars has been relatively slow. The FTC and the FDA will focus on competition for biologics in hopes of improving patient access to important treatment options and curbing costs. The joint guidance highlights the agencies’ efforts to transfer recent investigatory and enforcement efforts to biologics markets.

The joint guidance sets forth goals for which the FTC and the FDA will agree to collaborate in their efforts to support adoption of biosimilars and enhance competition in biologics markets. These goals build on [...]

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FDA 2019 Year in Review

by Alva C. Mather, Anisa Mohanty, Michael Ryan and Vernessa T. Pollard | Jan 13, 2020 | FDA, Life Sciences

2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and mandates required by the 21st Century Cures Act (Cures Act), and navigated leadership and staffing changes at many levels. Most notably, Commissioner Scott Gottlieb resigned on April 5. Norman Sharpless and Brett Giroir served as acting interim commissioners following Commissioner Gottlieb’s resignation. On December 17, Congress swore in Commissioner Stephen Hahn, a radiation oncologist and former chief executive of MD Anderson Cancer Center.

This Special Report reviews notable actions that shaped FDA-regulated industries and products last year, and offers insight into the agency’s 2020 priorities and expected actions in a number of areas, including:

Digital health;
Streamlined product approvals;
Evolving evidentiary thresholds for product approvals;
Strategic enforcement;
And much more.

Click here to read the full report.

Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

by McDermott Will & Emery and Anisa Mohanty | Aug 22, 2019 | FDA, Life Sciences

In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research and increase the involvement of patients and their perspectives in research and the product development process. The Cures Act specifically provided the US Food and Drug Administration (FDA) authority to modernize product development and review, and create greater efficiencies and predictability in product development and review. In June 2018, in response to this congressional mandate and corresponding new authorities, as well as reauthorizations of FDA’s user fee agreements, FDA made a series of announcements for a proposal to modernize new drug development.

Highlights of FDA’s initial proposal included:

Focusing on recruiting talent across disciplines;
Building multidisciplinary teams for more efficient collaboration;
Prioritizing operational excellence through a single and consistent review process;
Improving knowledge management through enhancements to information technology and honed expertise within review divisions;
Emphasizing safety and risk-benefit analysis before and after approval; and
Incorporating the patient voice into product development.

As articulated by former FDA Commissioner Scott Gottlieb, “[a] principal aim of these proposed changes is to elevate the role of . . . scientists and medical officers to take on even more thought leadership in their fields.” The agency contemplates implementing organizational and structural changes that make drug review divisions more therapeutically-focused [...]

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Proactive Due Diligence Considerations for Life Sciences Dealmakers

by McDermott Will & Emery | Jul 3, 2019 | Digital Health, FDA, Life Sciences, Life Sciences Private Equity, Reimbursement

In today’s competitive and fast-paced life sciences dealmaking environment, buyers and investors are often unable to spend as much time on due diligence as they might like. Market players are often highly focused on the science itself and, as a result, may pay less attention to issues such as supply chain, intellectual property components and reimbursement. However, addressing these topics at the due diligence stage is critical—they can cause a deal to unravel if left unexamined, regardless of the strength of the science.

Due diligence standards and considerations vary significantly across life sciences subsectors— pharma, medical devices, digital health and AI are each governed by unique regulatory structures and operate in very different deal landscapes. Buyers and investors are well advised to consider end-game issues such as reimbursement options, protection for valuable IP and pathways to commercialization early in the planning process. Framing the areas of diligence focus around the value drivers of their target deal model and key contract elements requiring verification will allow buyers to leverage their diligence findings into an informed, forward-thinking action plan.

Reimbursement. When evaluating a potential life sciences transaction, it is never too early to start thinking about reimbursement. Due diligence should take into account the commercialization channel for the product and include engagement with data sources on alternative therapies and their reimbursement. If the product in view is entering an existing market, conversations with reimbursement specialists can help a buyer determine the best path to reimbursement. A product that is opening a new [...]

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Opportunities in Outsourced Pharmaceutical Services

by Kristian A. Werling | Jun 13, 2019 | Health Private Equity, Life Sciences, Life Sciences Private Equity

Pharmaceutical outsourcing has emerged as a robust—and rapidly growing—subsector of the life sciences industry. As the push for efficiency continues, more pharmaceutical, biotech and medtech companies are turning to contract research organizations (CROs), contract development organizations, medical affairs outsourcing and other service providers for help bringing products to market, manufacturing and distributing products, and improving quality. This trend is creating exciting new opportunities for investors in this burgeoning space.

Several factors are driving this growth in pharmaceutical services outsourcing:

Pharma companies are becoming more comfortable with outsourcing. Of outsourced service providers, CROs have the highest penetration, with approximately 50 percent of clinical trials outsourced. Other areas of outsourcing are far less penetrated, however, offering ample opportunity for investment. Consider researching opportunities in health economics or outcomes research market access, for example.
The current health care/pharma environment is rich for pharma outsourcing. Biotech is thriving: capital is readily available, and the US Food and Drug Administration regulatory environment for approval of new products is favorable. On the pharmaceutical front, ongoing consolidation has fostered an efficiency mindset. And across the health care and life sciences space, big data is being harnessed in new ways that make outsourcing easier and more efficient than ever.
We are in a period of great market fragmentation. The market is starting to skew toward earlier stage rather than big pharma companies. Trials also are increasingly designed with an emphasis on subpopulations and advanced analytics (such as specialty drugs targeted to specific genotypes). Traditional pharma often lacks [...]

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Collaborative Transformation: Life Sciences Partnerships – Delivering Deals that Work

by McDermott Will & Emery | May 22, 2019 | Life Sciences

The life sciences marketplace has been ripe for collaboration for the past decade, but new players, new technologies and new regulations are changing the space. Traditional life sciences companies are working together in new and exciting ways, bringing a variety of deal structures and new complexities into the landscape. Our Collaborative Transformation podcast episode “Driving the Deal: Life Sciences Partnership Opportunities, Pitfalls and Impact” with Emmanuelle Trombe and Gary Howes explores these issues in depth. Below are key takeaways from the episode, which you can listen to in full here.

It’s not just new players changing the space—it’s new approaches by traditional players. “It’s not only about pharma and biotech,” Trombe said. “We are seeing collaboration with health care players such as payers, insurers and providers.” Technology companies are also entering the space, bringing financial and philanthropic investments to the table. “People are still trying to do the same things, but they’re getting there in slightly different ways,” Howes said. Collaborations are also shifting from exclusive collaborations to more open collaborations, where partners are more closely involved in the product lifecycle, co-developing products and sharing technology, data and profits.

Bridging the gap between different industry cultures is crucial to building a successful collaboration. Product lifecycles and regulatory regimes vary across industries, but the gap between technology and health care/life sciences is particularly broad. “Life sciences health care companies looking at a lifecycle for their [...]

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Dealmaking in Life Sciences – Valuations and Partnerships that Work

by Jed Gordon | Dec 27, 2018 | Health M&A, Health Private Equity, Life Sciences

Technology companies are pouring unprecedented capital, time and energy into the health care and life sciences industry, and are reshaping the deal landscape in the process. The top 10 US tech companies have made $4.7 billion in acquisitions in the health care space since 2012, according to CB Insights. Key market factors driving health care joint ventures and mergers and acquisitions include the merger of molecular science and computer technology, a growing focus on patient-centric care, increased mobility of consumer health products and services, and deep capital markets. In this fast-paced, proactive deals environment, traditional health players have exciting—and disruptive—new opportunities to enter into unexpected partnerships and pursue transformative innovation.

With Great Disruption Comes Great Opportunity

A helpful analogy for understanding the role of tech companies in this rapidly evolving sector is Uber’s disruption of the ride-hailing industry. When Uber came on the scene, on-demand ride-hailing was only available through taxicabs, and frequently only available in major cities. Now on-demand ride hailing is available through numerous companies and in areas that previously did not have such services available. Ride-hailing companies have also expanded their services offering to include food delivery.

Tech companies entering the health industry today are doing the same thing: reimagining and redefining the fundamentals of consumer access to health care. These companies often have deep insight into distribution and consumer purchasing behavior, and are willing to invest more capital and take on more risk than traditional health industry players [...]

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