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# What They Are Saying: FTC’s Final HSR Premerger Rules Place Undue Burden on Competitive M&A Across Life Sciences
Oct 15, 2024 | , 
Leading organizations are expressing concern about the impact of the Federal Trade Commission (FTC)’s final , including the chilling effect it could have on biopharmaceutical and life sciences innovation.
While the agency revised certain policies included as part of the , leading organizations assert that the final policy still imposes a significant burden on life sciences companies that rely on competitive mergers and acquisitions (M&A) as a fundamental path to bring innovative new treatments and cures to market.
Highlights from key stakeholders are included below:
> *“According to the government’s own data, 98% of mergers do not raise competitive concerns. The increased burden the new rule imposes remains questionable. Increased bureaucracy will stifle innovation, reduce market efficiencies, and ultimately harm consumers who benefit from the competitive dynamics that mergers can foster.”*
>
> *–* 
> *“Despite some changes from the proposed rule, the final rule still imposes substantial costs, time, and administrative burdens on companies seeking to engage in M&A activities – including mergers, partnerships and licensing deals – which are fundamental to life sciences innovation… This will be especially devastating to our early-stage innovators and startups for whom M&A represents a path to necessary resources, investments and infrastructure needed to advance breakthroughs from the lab to patients.”*
> *“The final rule will chill mergers and acquisitions (M&A) and hamper Maryland’s technology and life sciences industries, which employ more than 300,000 Marylanders and generate billions of dollars in economic activity in our state. Above all, we believe in saving lives, securing our nation, and improving quality of life through innovation, and restricting M&A threatens to upend industry’s ability to do so.”*
> –  
> *“We are particularly concerned that small and early-stage biopharmaceutical companies will bear the brunt of these costs, which may be insurmountable as an estimated 80% of these companies operate without a profit. We urge our federal representatives to support a return to balanced and bipartisan public policies that are supportive of Indiana’s life sciences ecosystem, which requires pro-competitive mergers in order to continue pushing the boundaries of innovation, collaboration and growth.”*
> – 
> *“The final HSR rules as issued by the Federal Trade Commission will impose a significant burden on the future of New Jersey’s life sciences community and our ability to do what we do best – saving lives around the world by finding new treatments and cures in New Jersey.”*
> *“The increased burden of premerger reporting requirements will impose a significant burden on the life sciences ecosystem in Ohio and the ability for our state’s industry to bring discoveries from the lab to patients. Small and early-stage biopharmaceutical companies will bear the brunt of these costs, which may be insurmountable as an estimated 80% of these companies operate without a profit.”*
> – **Ohio Life Sciences**
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# Opinion: New Merger Enforcement Approach Jeopardizes Life Sciences Innovation in NJ
May 21, 2024 | , 
*How mergers and acquisitions drive innovative cures and New Jersey’s economy*
New Jersey has long been home to some of the world’s leading research-based biopharmaceutical companies. Many have made New Jersey a base for their global, North American, or U.S. operations. Aside from their contributions to human health and patients worldwide, our state’s biopharmaceutical community is responsible for 16% of New Jersey’s Gross Domestic Product, contributing $120.9 billion in total impact to our state economy annually. These economic benefits manifest in our skilled workforce and robust job opportunities, directly and through our statewide supply chain, making New Jersey a life sciences leader on the global stage.
However, recent policy changes by the Federal Trade Commission and Department of Justice could jeopardize our state’s status as a health care leader.
Life sciences’ mission is saving and improving lives by bringing innovative medicines to patients. To do this efficiently and effectively, these innovator companies rely on a life sciences ecosystem in which companies of all sizes, expertise, resources and capabilities play a significant role in bringing new treatments to patients. Mergers and acquisitions have, for decades, played a vital role in facilitating the dynamic process that brings discoveries from the lab to patients.
America’s competition policy framework has historically supported this process. It has yielded a productive, sustainable stream of new therapies and advances while benefitting New Jersey’s workforce and economy by creating and supporting jobs in our state. Unfortunately, the FTC and DOJ have cast a dark cloud over this process.
The agencies recently issued new guidelines that outline an increasingly aggressive approach to merger enforcement, while departing from many decades of bipartisan competition policy. The new guidelines are effectively a menu of options that agencies can use to challenge mergers and acquisitions, including challenges based on even highly speculative impacts on competition. The FTC has also signaled imminent changes to the , which stipulate the premerger waiting periods, notifications, and information disclosures that companies must abide by before a merger can be executed. The FTC’s proposed HSR rule changes – which are expected to be finalized imminently – could dramatically increase the time, costs and burden required of companies seeking to engage in M&A.
The FTC and DOJ are taking steps to weaken our thriving life sciences sector by introducing unnecessary risk to deals that are fundamental to having a productive life sciences ecosystem in New Jersey and across the country. The result: many small, emerging biopharma companies in New Jersey may no longer be able to pursue a mutually beneficial merger and acquisition agreement that ultimately brings new medicines to market.
Our state is a vibrant hub of life science and biopharma establishments, boasting the highest concentration of scientists and engineers per square mile in the U.S. and nearly 800 clinical trials in progress. The new merger and acquisition policies of the FTC and DOJ threaten to disrupt this thriving ecosystem.
We implore our federal representatives to recognize the potential damage these policies could inflict on New Jersey’s life sciences industry and to restore bipartisan balance to M&A enforcement in the life sciences. The future of our patients and our state’s economy depends on it.
* is president and chief executive officer of the HealthCare Institute of New Jersey.*
*This op-ed originally appeared on .*
# An Interview with AZBio President and CEO on Life Sciences M&A in Arizona
Jan 10, 2024 | , 
PULSE had a conversation with Joan Koerber-Walker, president and CEO of , which recently celebrated 20 years of supporting the growth of Arizona’s life science industry. Joan, who has led AZBio since 2011, has a vested interest in making Arizona a place where bioscience organizations can thrive and find success, while supporting economic growth at the local and state level. PULSE asked Joan for her perspective on how mergers and acquisitions (M&A) have impacted and benefited Arizona’s economic outlook and contributions to the state.
**Q1: How has the industry grown over the last decade and what are some distinguishing characteristics?**
**A1:** Arizona’s bioscience industry has undergone incredible growth in the last twenty years, growing from a nascent industry to one of the top emerging bioscience clusters in the United States, generating $38.54 billion in economic impact in 2021 alone. This growth is driven in part by our seminal  and the Arizonans across the life sciences, health care, business, academia and policy who have helped shape it. Over a two-decade period since the early 2000s, Arizona’s bioscience jobs have ; our universities’ bioscience R&D investment has  and venture capital investment in the Arizona biosciences has . We even reached a record high for venture capital funding in 2021, when we achieved $240 million in investments in bioscience firms.
**Q2: Have mergers and acquisitions (M&A) played a role in Arizona’s life science industry growth?**
**A2:** M&A has been an essential part of the development of Arizona’s bioscience sector and employment growth. Global leaders including BD, Exact Sciences, Medtronic and Roche grew their operations in Arizona after acquiring smaller Arizona companies and are now some of our largest life science employers. For the early investors in our young companies, these examples are a crucial investment incentive as well as a practical way for Arizona’s companies to take advantage of the synergies and capabilities that other larger, more established life science markets have at their disposal. I’ve seen companies across the state combine and utilize new technologies, research capabilities and expertise, leading to many breakthrough innovations for patients. Over the last fifteen years in particular, Arizona has seen a series of successful mergers and acquisitions that significantly impacted our cities and local communities. These companies are more than manufacturing powerhouses. They are strong community partners that support our patient organizations, provide mentoring opportunities for our students and work closely with our universities.
**Q3: Can you provide insights into the economic benefits of these acquisitions for the communities involved?**
**A3:** In 2021, Arizona’s bioscience industry grew rapidly and reached more than 36,000 jobs spanning 2,912 business establishments. Industry employment has grown by nearly 22 percent since 2018—twice the growth rate of the nation—with each of the five major subsectors adding jobs during the period. Arizona’s universities conducted $602 million in R&D activities in bioscience-related fields in 2020, fueled in part by steadily increasing NIH awards to Arizona institutions since 2018. Venture capital investments in Arizona bioscience companies increased significantly in 2021, and during the 2018-21 period totaled $565 million. Arizona inventors have been awarded 2,283 bioscience related patents since 2018, among the second quintile of states in patent activity. (Read the full report on Arizona’s bioscience industry .)
When thinking of significant local economic growth resulting from M&A, two distinct examples in two different cities come to mind.
In Tucson, a tissue diagnostics-focused biopharma organization called Ventana Medical Systems was acquired by  in 2008. Since that acquisition, the employment at the Tucson site has continued to grow, making Roche Tissue Diagnostics the largest private sector life science employer in southern Arizona. Roche hosts its annual Tucson Symposium which brings thought leaders and cancer experts around the future of cancer medicine to our state to share ideas and collaborate. This means that every year, Roche’s Tucson team and the city of Tucson play host to the world’s leading experts in diagnostics and oncology advancements, ultimately placing Arizona at the forefront of improving patients’ lives.
In Phoenix, the 2010 acquisition of Abraxis and  has also caused transformative growth in the area. The deal included Abraxis’ $70 million biologics manufacturing plant in Phoenix. When Celgene acquired Abraxis for $2.9 billion in 2010, the Phoenix plant grew further, added even more jobs and, by 2013,  by the Arizona Manufacturer’s Council. In 2019, Bristol Myers Squibb (BMS) acquired Celgene. BMS has continued to invest in the Phoenix facility, creating more jobs and, most importantly, manufacturing and delivering an important cancer treatment that is extending the lives of cancer patients worldwide.
**Q4: Are there specific examples of advances that emerged post-M&A in Arizona?**
**A4:** Through M&A, we see that companies are often able to utilize new technologies, research capabilities and expertise, all of which build up to the development of innovative health care breakthroughs. When innovative smaller companies are acquired by larger firms, they bring together their resources, expertise and research capabilities for the development of new therapeutics along with a global reach that delivers lifesaving treatments and cures to more patients. Examples of Arizona health innovations that are benefiting patients today include heart valves, pacemakers, insulin pumps, peripheral vascular devices, cancer medicines, and a wide range of diagnostic tests that provide patients and their physicians with critical health information.
**Q5:** **If the proposed changes to antitrust policy move forward, what impact do you anticipate them having on your members?**
**A5:** The ability for our companies to engage in M&A has been crucial to the life sciences and economic boom in Arizona. The diversity of our industry is one of our biggest strengths, and one that allows everyone to excel in their respective areas. If regulatory agencies were to begin applying undue scrutiny to these partnerships, it would stunt Arizona’s job and economic growth for our residents and risk shelving potential breakthrough innovation originating in our state. AZBio’s vision is for Arizona to be a top-ten life science state, and M&A will continue to be a core driver of our progress.
# Innovations Advanced by M&A: The First Therapy for Pompe Disease
May 1, 2024 | , 
*This blog is another installment in our series, Innovations Advanced by M&A, which underscores the importance of mergers and acquisitions in ensuring a competitive and vibrant biopharmaceutical landscape for patients. You can find previous blogs in this series here:* <
Traversing the path to bring a breakthrough medicine to patients is a unique, high-risk endeavor that can take over a decade. From the complex scientific and regulatory expertise required, to the enormous capital investment needed for state-of-the-art facilities and clinical trials, many companies cannot navigate this path alone. Mergers and acquisitions (M&A) are fundamental to shepherding medicines along the path to market, and to patients in need. Such was the case for a first-of-its-kind treatment for .
Pompe disease is a rare genetic disease that causes progressive muscle deterioration, with most patients passing away before their first birthday. Pompe disease was  by Dutch neurologist Dr. Johannes Pompe, but it wasn’t until 2006 that the first treatment for Pompe was brought to market. M&A helped make this long-anticipated breakthrough possible.
**The Role of M&A:**
In 1998, John and Aileen Crowley’s lives were changed forever when their 15-month-old daughter and newborn son were both diagnosed with Pompe disease. Acting quickly to save the lives of his children, John partnered with Pompe disease researcher Dr. William Canfield to found Novazyme, a small biotech based in Oklahoma City dedicated to bringing a treatment to patients with Pompe.
> *“We don’t consider any company to be the competition. The competition is the disease.”*
As Novazyme exhausted its initial start-up funding, the company sought additional investment and resources. In 2001, Novazyme was acquired by Genzyme, a commercial-stage company with extensive experience in genetic disorders – including Pompe disease. Through the combination of Novazyme’s specialized focus on Pompe disease with Genzyme’s clinical and commercial experience, the combined company could devote unprecedented expertise and resources to bring a Pompe therapy to market.
> *“Novazyme and Genzyme have a shared vision of bringing the very best medicine to very sick patients as quickly as possible. Genzyme’s infrastructure, resources, and extensive experience in the area of genetic disorders can powerfully support and accelerate the development of our technology and products. This merger is an important event for patients… and further advances our mission.”*
In 2006, under the direction of John and Dr. Canfield, the combined company found long-awaited success in , the first-ever FDA-approved therapy for Pompe disease. Over twenty years after the diagnoses that changed their lives, John and Aileen’s daughter and son, who both received Myozyme, .
> *“[Genzyme] helped to develop what became the first generation therapy that three years later the kids received, that they’ve been receiving now for 13 years.”*
The therapy that helped save the lives of the Crowley children, and others, illustrates the unique and fundamental role of M&A in supporting life sciences innovation, and how that innovation can often translate to life-changing therapies. With , pro-innovation M&A is critical to help support the next generation of biopharmaceutical breakthroughs for patients.