Author: Julie Kaloides

Global contract development and manufacturing organisation (CDMO) Kindeva Drug Delivery has expanded its operations at Charnwood Campus, in a deal expected to support Kindeva’s continued growth in the UK.
The US-headquartered company will take over a state-of-the-art research and development facility at Charnwood Campus, and a further 20,000 square feet of office space at the site.
Formerly 3M Drug Delivery Systems, Kindeva specialises in solving complex drug delivery and combination product challenges for its pharmaceutical and biotechnology customers, and currently employs over 500 staff in the UK across its two sites at Charnwood Campus, its Loughborough plant, and its Clitheroe plant. The company formulates, develops, and manufactures therapies used by patients suffering from serious health conditions including respiratory illnesses, central nervous system disorders, and cancer.
Charnwood Campus is now home to four blue-chip organisations including Almac, 3M, Kindeva, and global diagnostics company PerkinElmer.
Commenting on the deal, Gosia Khrais, Charnwood Campus Commercial Director says: “Kindeva’s expansion is great news for both the Charnwood site and the local area, with the company’s ambitious growth plans set to create new office-based roles as well as safeguard hundreds of highly valuable scientific jobs in Loughborough and the East Midlands.
“The deal is another significant milestone in our long-term development plan and further reinforces the East Midlands’ and Loughborough’s reputation for outstanding pharmaceutical research and development.
“With a strong legacy of more than 60 years of pharmaceutical innovation, Kindeva is a well-established business and a significant player in the global drug development and delivery pharmaceutical industry,” she adds. “We feel honored the company has chosen to expand its operations at Charnwood as well as support us in playing our part in the UK’s economic recovery.”
“As a growing CDMO and life sciences company, Kindeva thrives on our base of well-trained, highly-qualified leaders in scientific research and development,” said Aaron Mann, CEO of Kindeva Drug Delivery. “The Charnwood campus provides a state-of-the-art laboratory design to support our industry-leading talent. Importantly, the proximity to general management offices promotes cross-functional collaboration between our R&D team and other areas of the business, enabling consistent feedback of customer needs and insights into our R&D activities.”
Councillor Jonathan Morgan, Leader of Charnwood Borough Council, said: “This is excellent new for Charnwood Campus and the borough. I am delighted that not only are a significant number of jobs being safeguarded, but more are being created, which is important as we look to the future and recovery from the pandemic. One of the Council’s top priorities is to support the growth of the local economy and sites like Charnwood Campus will play a key role in that growth.”
Charnwood Campus is the first and only Life Sciences Opportunity Zone in the UK and part of the Loughborough and Leicester Science and Innovation Enterprise Zone.

Pittsburgh, PA and St. Paul, MN—Viatris Inc. (NASDAQ: VTRS) and Kindeva Drug Delivery L.P. today announced that the U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version of Symbicort^® based on an Abbreviated New Drug Application (ANDA). Symbicort is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
Viatris CEO Michael Goettler commented: “The FDA’s tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients. It also further demonstrates our deep commitment to continuing to leverage our scientific and regulatory expertise for a wide range of noncommunicable and infectious diseases. Our success with this partnership and approval underscores how Viatris intends to execute and optimize our Global Healthcare Gateway^® as a Partner of Choice™ for companies such as Kindeva to expand access to medicines for patients worldwide.”
Viatris President Rajiv Malik added: “I am very proud of this important regulatory milestone as it once again demonstrates our strong scientific and regulatory teams’ continued success. This only further enhances our confidence that through the Global Healthcare Gateway^® and partnerships, like this one with Kindeva, we will continue to build and commercially launch robust branded and complex generic portfolios.”
The FDA provided tentative approval at this time due to ongoing patent litigation. On March 2, 2021, the U.S. District Court for the Northern District of West Virginia found that the asserted claims of AstraZeneca’s Symbicort patents, U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137, are not invalid for obviousness. Viatris and Kindeva disagree with the district court decision. While the trial court decision prevents commercial launch at this time, the companies intend to file an appeal to continue vigorously defending their position that the patents are invalid. Viatris and Kindeva are committed to bringing a generic Symbicort to market as soon as possible.
“This FDA tentative approval reflects the strength of the partnership between Viatris and Kindeva, and further demonstrates Kindeva’s industry-leading capabilities in formulation, development, and manufacturing of complex combination products,” said Aaron Mann, CEO of Kindeva Drug Delivery. “Once final FDA approval is achieved, Kindeva looks forward to providing Viatris with reliable, quality supply from our state-of-the-art commercial filling and packaging lines in our Northridge, California facility.”
Viatris has not planned any revenue for 2021 from generic Symbicort, and the product’s potential launch revenue was not included in the company’s recently announced 2021 financial guidance.
Symbicort had U.S. branded sales of $3.5 billion for the 12 months ending January 2021, according to IQVIA.

New York, NY—Altaris Capital Partners, LLC (collectively with its affiliates, “Altaris”) announced today that it has entered into an agreement to acquire the prescription pharmaceuticals business (“Rx”) of Perrigo Company plc (NYSE; TASE: PRGO) for total consideration equal to approximately $1.55 billion. The acquisition is expected to close in calendar year 2021, subject to customary closing conditions.
Perrigo’s Rx business is a leader in the generic prescription pharmaceutical industry and has more than 1,300 employees across six locations in the United States and Israel. The company’s diversified and specialized portfolio consists of over 200 product families and 800 SKUs, with a focus on extended topical dosage forms, including creams, ointments, lotions, gels, foams, liquids and nasal sprays.
The company has a long track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. In addition, Rx is a market-leading provider of pharmaceutical products and medical equipment in Israel. Following closing of the transaction, Perrigo Rx will be renamed and headquartered in the United States.
“I am thrilled that we are working with Altaris to establish Perrigo’s Rx business as an independent company,” said Sharon Kochan, President of Rx. “This is a very important and exciting milestone that will enable us to focus on executing our ambitious plans and growth strategy. Altaris’ healthcare specialization and experience with similar business separations will bring unique, fresh and relevant perspectives as we embark on the next phase of our journey.”
George Aitken-Davies, Co-founder and Managing Director of Altaris, commented, “We are delighted to be partnering with the management team and employees of Perrigo’s prescription pharmaceuticals business.” Garikai Nyaruwata, Managing Director of Altaris, added, “Given our experience in the pharmaceutical sector and track record of corporate carve-out transactions, we believe we are well-positioned to support the Rx business as it becomes a standalone company focused on its mission of developing and marketing affordable pharmaceutical products.”
Altaris is an investment firm focused exclusively on the healthcare industry with $5.2 billion of equity capital under management. Altaris targets companies that deliver value to the healthcare system by improving patient outcomes, eliminating unnecessary costs, increasing efficiency and aligning stakeholder incentives. Since inception in 2003, Altaris has made more than 40 platform investments. Altaris is headquartered in New York, NY. For more information, please visit www.altariscap.com.
J.P. Morgan is serving as lead financial advisor and Lead Left Arranger and Goldman Sachs & Co. is serving as financial advisor and Arranger to Altaris. Schiff Hardin LLP and Cleary Gottlieb are providing legal counsel to Altaris. Perrigo is being advised by Centerview Partners LLC and Wachtell, Lipton, Rosen & Katz LLP.

Nashville, TN—Clearwater, the leading provider of Enterprise Cyber Risk Management and HIPAA Compliance solutions for the healthcare industry, announced today that Will Pendleton has joined the company as Vice President, Business Development. In this new role, Mr. Pendleton will focus on continuing to grow the company’s presence as a top partner to private equity firms and attorneys seeking to ensure their portfolio companies and clients have strong cybersecurity and HIPAA compliance programs.
For the past four years in a row, Clearwater has been rated the top Compliance and Risk Management solutions provider in Black Book Market Research’s annual healthcare industry survey, which in 2020 received responses from 2,424 security professionals representing 705 provider organizations. Attorneys and private equity firms focused on the healthcare industry have long recognized Clearwater as a leader as well.
“Based on all I’ve seen over the years, Clearwater’s risk analysis methodology and software are in the best-of-breed tier and can be seriously considered by any organization striving to meet regulatory requirements in performing HIPAA risk analysis,” says Leon Rodriguez, Former Director of the U.S. Department of Health and Human Services Office for Civil Rights and Partner, Seyfarth Shaw LP.
Mr. Pendleton comes to Clearwater from Curex Capital, a biotech/pharma-focused hedge fund where he was responsible for the financial analysis of the company’s portfolio. Prior to his time at Curex, he managed corporate development activities for Cumberland Pharmaceuticals, a publicly traded pharmaceutical company. He also served as a sales executive for ExamOne, a Quest Diagnostics’ subsidiary. Mr. Pendleton is based in Nashville, TN, where he has lived since earning an MBA with honors from the Owen Graduate School of Management at Vanderbilt University.
“We are very excited to bring Will on board and apply even greater focus and energy toward our work with attorneys and private equity firms,” says Clearwater’s Chief Sales Officer Dan Pruyn. “Healthcare attorneys recommend Clearwater to their clients because they know our solutions go deeper and further to protect their clients, and private equity firms are recognizing the same thing when it comes to protecting their portfolio companies.”

New York, NY—Cornell Capital LLC (“Cornell Capital”) and Trilantic North America, two leading private investment firms, today announced that they have agreed to acquire Fastaff Travel Nursing^® (“Fastaff”) and U.S. Nursing Corporation^® (“U.S. Nursing”).
This acquisition is part of a broader effort by Cornell Capital and Trilantic North America to build a leading tech-enabled platform for healthcare staffing, following three other recently announced acquisitions in the space: trustaff Management, Inc. (“trustaff”), a leading provider of traditional travel nurse and allied healthcare staffing services; CardioSolution, a managed services offering providing cardiologists and support personnel to hospitals; and Stella.ai, Inc. (“Stella”), an AI-driven online marketplace for employers and job seekers that brings cutting-edge technology expertise to the staffing sector. With the addition of Fastaff and U.S. Nursing, the combined company will create an industry-first platform, leveraging data science and automation to meet client needs across traditional nurse staffing, rapid response, strike preparedness and job action services to accelerate growth.
Founded in 1989, Fastaff and U.S. Nursing have provided hospitals with staffing solutions for more than three decades. Fastaff pioneered the practice of Rapid Response℠ travel nurse staffing and has since grown to become the leading provider of temporary nurses to help hospitals provide continuous, high-quality patient care in urgent and crucial situations nationwide. U.S. Nursing is the largest provider of strike preparedness and job action staffing services for hospitals with unionized workforces. Together, Fastaff and U.S. Nursing partner with many of the nation’s largest and most prestigious healthcare facilities, as well as small community hospitals, using a scalable, centralized infrastructure and shared technology.
“We are excited to add Fastaff and U.S. Nursing to further diversify our innovative healthcare staffing platform, whose enhanced technology and AI will help drive future growth,” said Stephen Trevor, Partner of Cornell Capital, and Jeremy Lynch, Partner of Trilantic North America. “We have been impressed by the performance of Fastaff and U.S. Nursing for their health system customers both prior to and during the global pandemic. With each company’s track record of execution and deep hospital relationships, we look forward to partnering together as we continue to build an industry-leading organization and grow this platform organically, geographically and through additional acquisitions.”
Thomas H. Lee Partners, L.P. (“THL”), current owners of Fastaff and U.S. Nursing, will remain investors in the combined company.
“We invested in Fastaff and U.S. Nursing in 2015 with a thesis behind the increasingly mission-critical nature of their urgent and crucial staffing services to their hospital partners,” said Megan Preiner, Managing Director at THL. “During the global pandemic, the importance of these services has only been amplified, and these two brands have been able to consistently deliver nurses to their customers during these times of unprecedented demand. We are excited to remain partnered with the Fastaff and U.S. Nursing teams in this next evolution as the combined new entity will allow for continued efficiency and automation of the nurse staffing experience for their customers.”
“For more than three decades, Fastaff has been a premier provider of Rapid Response℠ travel nurse staffing, and U.S. Nursing has been the industry leader in comprehensive job action consulting and staffing solutions,” said Bart Valdez, Fastaff and U.S. Nursing CEO. “Our team has the utmost confidence that partnering with Cornell Capital and Trilantic North America will help us build on our unique market position delivering experienced nurses for urgent hospital needs. Bringing the capabilities of our two brands to this larger platform will accelerate organic growth, allow for greater product and service innovation, and position the combined company to help meet the nation’s expanding healthcare staffing needs.”
“Combining Fastaff and U.S. Nursing to our recent acquisitions of trustaff and CardioSolution on one platform will increase the scale and diversity of staffing opportunities we can deliver to both clients and healthcare professionals,” said Adam Zoia, who has been named CEO of the combined company. “I look forward to applying superior technology to these best-in-class businesses and teams to strengthen their brands and accelerate growth at this critical moment for the industry across our country.”
Financial terms of the transaction were not disclosed. The transaction is expected to close in March 2021, subject to regulatory approvals and other customary closing conditions.
Davis Polk & Wardwell LLP is acting as legal advisor to Cornell Capital. Kirkland & Ellis LLP is acting as legal advisor to Trilantic North America. Lincoln International is acting as financial advisor to Fastaff and U.S. Nursing, and Ropes & Gray LLP is acting as legal advisor.

CSafe has engaged local partnerships to establish its first hub operation in Luxembourg and a third in Italy to support local customers.
CSafe Global, the innovation leader in temperature-controlled container solutions for the transport of life-enhancing pharmaceuticals, is once again expanding their global footprint opening two new hub operations in Luxembourg and Florence, Italy.
Partnering with DB Schenker in Luxembourg, CSafe has approximately 2,500 square-feet / 232 square-meters of warehouse space to clean and store RKN and RAP containers. In Florence, the company has extended an ongoing partnership with BCube to secure approximately 10,000 square-feet / 929 square-meters for CSafe containers.
With the addition of these new hub locations, Europe now has the most CSafe operations facilities in the world. “These locations round out a robust CSafe network across Europe,” noted Tom Weir, CSafe COO. “We continue to evaluate the need for additional locations in Europe and around the world to ensure we make the most strategic investments that will optimize operations and service for our customers,” he continued.
CSafe continues to deliver on its mission to the highest quality temperature-controlled containers in the industry to ensure pharmaceuticals and biologics are delivered to patients in optimal condition for maximum efficacy. By investing in best-in-class facilities in strategic locations worldwide, CSafe can provide top tier service to customers in their local area.

Saint Paul, MN—Minnetronix Medical, Inc. a leading medical technology and operations partner to global medical device companies, announced today a majority recapitalization with Altaris Capital Partners, LLC. Altaris, an investment firm focused on the healthcare industry, actively manages $4.9 billion of equity capital and has been a minority investor in Minnetronix since 2015.
“Throughout our relationship with Altaris, we have achieved many milestones as a company,” said Jeremy Maniak, Minnetronix CEO. “Now, with our expanded partnership, we are excited to accelerate our strategy and move into the next stage of growth at Minnetronix.”
Headquartered in Minnesota, Minnetronix focuses on product development and manufacturing across the full product life cycle with specialized expertise in key technology segments, including RF energy, fluid and gas management, optical systems, and stimulation and wearable devices. The company also recently launched its whole product solutions, offering ready-made products and solutions for customers to add to their portfolios, as evidenced by the FDA-approved MindsEye™ Expandable Port for critical access in interventional neurosurgical procedures.
Minnetronix’ holistic, solutions-driven approach is unique in the industry. The company maximizes clinical performance, improves product quality, and lowers costs for its customers by eliminating waste through integrated development, manufacturing and supply chain processes.
“We are excited to expand our partnership with Minnetronix and build on the company’s rich heritage of accelerating medical device innovation for its customers,” said Jim O’Brien, managing director at Altaris. “We look forward to working with the Minnetronix team to support the company’s next phase of growth.”
Fox Rothschild LLP acted as legal counsel for Minnetronix. Schiff Hardin LLP acted as legal counsel for Altaris.

Kindeva Drug Delivery (Kindeva) announced that Shawn Cavanagh has joined Kindeva’s Board of Directors. The appointment of Mr. Cavanagh is effective as of January 1, 2021. Mr. Cavanagh, with over 30 years of experience in the pharmaceutical services industry, will serve as a valuable and strategic advisor to Kindeva.
Mr. Cavanagh has held senior leadership roles at multiple contract development and manufacturing organizations (CDMOs). He brings to Kindeva a highly relevant set of experiences with global, integrated CDMOs that specialize in innovative and complex drug products. Most recently, he was President, Chief Operating Officer, and member of the Board of Directors at Cambrex Corporation. During his time at Cambrex, Mr. Cavanagh was integral in driving industry-leading growth and ultimately taking the company private in December 2019.
“Shawn’s deep knowledge of the entire drug lifecycle will help Kindeva as we continue to build the industry’s leading complex drug CDMO,” said Aaron Mann, CEO of Kindeva. “I welcome him to our Board of Directors and look forward to working with him on the strategic opportunities in front of Kindeva.”
“Kindeva has a leading reputation in the formulation, development, and commercial supply of complex drugs and combination products,” said Mr. Cavanagh. “I’m excited to support the company as it completes its transition from 3M and continues along its exciting growth trajectory.”
Mr. Cavanagh has also held leadership roles at Lonza, where he served as President of Lonza Bioscience, and Cambrex Bioproducts, a business that was sold by Cambrex to Lonza in 2007. He holds a degree in Chemical Engineering from the University of New Hampshire.

HealthTronics has named Bill Linder its new Chief Executive Officer.
Linder was formerly President of Development for Surgical Care Affiliates (SCA), a leader in outpatient surgical care with more than 230 ambulatory surgery centers across the U.S. At SCA, he held several senior operational and business development roles within executive leadership. In 2017 and 2016, he was named a Rising Star in Healthcare by Becker’s Hospital Review and Becker’s ASC Review. Prior to joining SCA, Linder held sales leadership roles with Harden Healthcare and Apria Healthcare.
“HealthTronics has established itself as a top provider of specialized mobile medical therapies and highly trained personnel to physicians and health systems who utilize these solutions throughout the U.S.,” Linder said. “I look forward to working with my teammates to make HealthTronics a premier partner for the mobile medical therapies we provide and an employment destination for top talent.”
Linder said his focus going forward includes strengthening HealthTronics’ partnerships with independent medical groups and health systems, enhancing our patient experience through superior clinical quality and expanding into new markets.
“In this time of COVID-19, it is particularly important that our mobile solutions are helping healthcare systems and physicians deliver specialized care in optimized settings in a cost effective manner,” said Linder.

New York, NY—Altaris Capital Partners, LLC (“Altaris”) is pleased to announce the recapitalization of CSafe Global (“CSafe”, or the “Company”) with an investor group, including funds managed by Frazier Healthcare Partners. As part of the transaction, Altaris will continue to maintain a minority position in the Company.
Based in Ohio, CSafe Global is a provider of cold chain packaging solutions that address the global supply chain needs of the biopharmaceutical industry. CSafe’s containers are designed to maintain high-value and temperature-sensitive biopharmaceutical cargo within precise ranges, often for extended periods of time in extreme external conditions. The Company has two core business units which operate under the brands CSafe and AcuTemp, both of which provide high performance solutions in their respective “Active” and “Passive” container markets.
Altaris initially acquired CSafe in January 2015 after identifying the need for more advanced cold-chain logistical capabilities for next-generation therapeutics, including biologics, vaccines, and gene and cell therapies. In October 2016, Altaris completed a recapitalization of CSafe with Thomas H. Lee Partners and maintained a minority ownership position in the Company.