EQT Private Equity and Mubadala to acquire Envirotainer, the leading global provider of mission-critical biopharma transport services

admin June 7, 2022

As part of their broader strategic partnership, EQT Private Equity and Mubadala Investment Company to make a majority investment in Envirotainer, a global provider of mission-critical cold chain transportation solutions for pharmaceuticals
Envirotainer enables access to life-saving pharmaceuticals and vaccines via reliable and efficient cold chain solutions, and is the global leader in active temperature control for air transportation of temperature-sensitive pharmaceuticals
EQT Private Equity and Mubadala will support Envirotainer in its next phase of growth, by accelerating expansion in core markets and APAC in particular, scaling the newly launched CryoSure offering, investing in new technologies and continuing to roll-out third generation Releye platform

EQT is pleased to announce that the EQT X fund (“EQT Private Equity”), and Mubadala Investment Company (“Mubadala”), have agreed to acquire Envirotainer (the “Company”), the global leader of mission-critical, proprietary temperature-controlled supply chain solutions for the transportation of biopharmaceuticals, from Cinven and Novo Holdings. The enterprise value amounts to around EUR 2.8 billion.

Envirotainer was founded in 1985 in Stockholm, Sweden, where its headquarters, R&D and production are based. Envirotainer designs, manufactures and leases active temperature-controlled containers, used primarily for air freighting biopharma products. With a fleet of circa 6,700 containers globally and approximately 375 employees in 20 countries, the Company is the global leader in active temperature control for air transportation of temperature-sensitive pharmaceuticals. Envirotainer has more than 600 customers worldwide, including many global blue-chip pharma and biotech companies.

Millions of people across the globe depend on the safe delivery of biopharmaceuticals that require temperature control to maintain their integrity and quality. Today, lack of access to medicines is a cause for distress that disproportionately impacts underserved communities, whose situation is likely to be exacerbated by chronic diseases resulting from changing diets and lifestyles, as well as from air and water pollution. Envirotainer expands access to vital pharmaceuticals and vaccines through its patient-safe, reliable and efficient cold chain solutions, which also offer one of the lowest carbon footprint solutions in the industry.

EQT Private Equity and Mubadala will seek to support Envirotainer in its next phase of growth by accelerating expansion in APAC and continuing growth in its other core markets, and will leverage EQT’s local-with-locals approach and Mubadala’s global network to do so. Building on the sector-related expertise of EQT’s network and Mubadala, EQT Private Equity and Mubadala will help scale the newly launched CryoSure offering and continue the successful roll-out of third-generation Releye platform, while investing behind new technology innovations, digitalization and sustainability in its operations.

Ali Farahani, Partner within EQT Private Equity’s Advisory Team, said, “The temperature-controlled distribution of pharma products offers very attractive and thematic exposure to the fast-growing biopharma end-market. Envirotainer is an integral part of the global pharmaceutical infrastructure and the clear global market leader with significant scale advantages, superior operations and industry-leading performance and customer satisfaction. The company has a clear purpose of enabling access to life-saving pharmaceuticals and offers reusable solutions with significantly less CO₂ emissions compared to traditional air-freight solutions. We continue to see significant growth potential ahead and are excited to partner with the management team to unlock the full potential together with our partners at Mubadala.”

Camilla Macapili Languille, Head of Life Sciences for Mubadala, said, “Envirotainer plays a mission-critical role in the healthcare ecosystem by ensuring the safe and reliable delivery of drugs from pharma companies to hospitals, clinics, and ultimately, patients. Their extensive international footprint ideally positions Envirotainer to meet the pharma industry’s growing need for global temperature-controlled distribution and as the undisputed market leader, they are continuing to pioneer developments in the sector with forward-thinking R&D innovation. We have strong conviction in the company’s growth trajectory and will work closely with management and our partners at EQT to ensure its long-term success.”

Peter Gisel-Ekdahl, CEO, “We are pleased with the confidence that EQT and Mubadala have shown us by investing in the company and look forward to closely collaborating to further develop the business. This long-term partnership will strengthen Envirotainer and help us deliver on our purpose of enabling access to life-saving pharmaceuticals. At the same time, this investment, from such esteemed investors, confirms the strength of Envirotainer’s business model and the company’s very exciting future.”

EQT and Mubadala were advised by Jefferies International (M&A), McKinsey & Company (commercial), White & Case (legal), and KPMG (financial, tax, operations).

The transaction is subject to customary conditions and approvals and is expected to close in Q3 2022. With the acquisition of Envirotainer, EQT X (target fund size of EUR 20.0 billion and hard cap of EUR 21.5 billion) will be 0-5 percent invested based on its target fund size. EQT X will be activated and start charging management fees upon the closing of its first transaction, currently expected to be the closing of the acquisition of Envirotainer. EQT IX is currently 80-85 percent invested, following recent portfolio company add-on acquisitions, and continues to be in its commitment period but management fees will, following activation of EQT X, be based on net invested capital.

Contact
EQT Press Office, press@eqtpartners.com, +46 8 506 55 334

The information contained herein does not constitute an offer to sell, nor a solicitation of an offer to buy, any security, and may not be used or relied upon in connection with any offer or solicitation. Any offer or solicitation in respect of EQT X will be made only through a confidential private placement memorandum and related documents which will be furnished to qualified investors on a confidential basis in accordance with applicable laws and regulations. The information contained herein is not for publication or distribution to persons in the United States of America. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold without registration thereunder or pursuant to an available exemption therefrom. Any offering of securities to be made in the United States would have to be made by means of an offering document that would be obtainable from the issuer or its agents and would contain detailed information about the issuer of the securities and its management, as well as financial information. The securities may not be offered or sold in the United States absent registration or an exemption from registration.

About EQT
EQT is a purpose-driven global investment organization with EUR 77 billion in assets under management across 36 active funds. EQT funds have portfolio companies in Europe, Asia-Pacific and the Americas with total sales of approximately EUR 29 billion and more than 280,000 employees. EQT works with portfolio companies to achieve sustainable growth, operational excellence and market leadership.

More info: www.eqtgroup.com
Follow EQT on LinkedIn, Twitter, YouTube and Instagram

About Mubadala Investment Company
Mubadala Investment Company is a sovereign investor managing a global portfolio, aimed at generating sustainable financial returns for the Government of Abu Dhabi.

Mubadala’s $284 billion portfolio spans six continents with interests in multiple sectors and asset classes. It leverages its deep sectoral expertise and long-standing partnerships to drive sustainable growth and profit, while supporting the continued diversification and global integration of the economy of the United Arab Emirates.

More info: www.mubadala.com

About Envirotainer
Envirotainer is the undisputed global market leader in secure cold-chain solutions for intercontinental transport of pharmaceuticals. The company develops, manufactures, and offers leasing of innovative

container solutions and dewars for cryogenic shipping, including validation, support, and service, for pharma products that require a controlled environment. Thanks to a truly global presence with the world’s largest active container fleet, the most extensive network, and more than 35 years of industry expertise, Envirotainer is able to meet the customers’ need for innovative and reliable solutions – available from any location to any destination. The company operates through an open, global network of airlines, forwarders and couriers and the headquarters is located outside of Stockholm, Sweden.

For more information, please visit  www.envirotainer.com

Categories: News

Tags: Logistics Pharmacie

A consortium of Carlyle and PAI Partners to acquire Theramex from CVC

admin March 28, 2022

London, UK, 28 March 2022 – Global investment firms PAI Partners and Carlyle (NASDAQ: CG) today announce that they have agreed to acquire Theramex, the leading global specialty pharmaceuticals company focused on women’s health, from CVC Capital Partners VI (“CVC”).

Theramex was created following the carve-out of a portfolio of women’s health pharma products in 2018, and has subsequently developed into one of the largest specialty pharma platforms dedicated to women and their health. The company provides patient-focused solutions across contraception, fertility, menopause, and osteoporosis with the aim of providing patients with products that can support them through their life journey. Under CVC Funds’ ownership, Theramex has focussed on building loyal relationships with physicians through its dedicated sales force, investing in digital capabilities and executing a successful M&A agenda to bring new products to market in the future, resulting in double digit revenue and EBITDA growth since 2018. The company now serves more than six million women in 57 countries across EMEA, APAC and South America, and employs approximately 480 people (~60% of whom are women).

With the support of Carlyle and PAI Partners, Theramex will seek to expand its diverse suite of products across existing and adjacent therapeutic areas and accelerate international expansion. The investment in Theramex builds on Carlyle’s long-term global focus on Healthcare, a sector in which the firm has invested $15 billion to date. Carlyle has significant expertise in scaling global Pharma businesses, such as iNova, Curia and PPD, and specifically in women’s health, through its investment in Millicent Pharma. Similarly, PAI will utilise its deep sector experience in healthcare to support Theramex’s growth trajectory. Healthcare is one of PAI’s four core sectors of focus, in which the firm has made ten investments, including in pharmaceutical companies, Ethypharm and Ipsen.

Robert Stewart, CEO of Theramex said: “I am delighted to have the support of both Carlyle and PAI Partners investing in the business, which will allow us to further accelerate our growth. I also want to thank CVC for being such a fantastic partner over the last years. Together, we have built one of the world’s largest pharmaceutical companies dedicated solely to women’s health, improving lives and ensuring these important products are made available to all who need them.”

Sebastien Veil and Andreas Kumeth, both Partners at PAI, said: “We were attracted to Theramex given its strong heritage in women’s health and outstanding reputation for delivering effective and safe solutions that support and care for women around the world. We look forward to leveraging PAI’s extensive healthcare network and capital to support organic and inorganic growth initiatives for Theramex and partnering with the management team to support the continued expansion of the platform.”

Lubna Qunash and Philipp Meyer, both Managing Directors of the Carlyle Europe Partners advisory team, said: “We believe that Theramex’s long-standing and established position as a women’s health champion with a broad and complementary product portfolio are distinctive attributes which position the business well for continued success. This acquisition demonstrates our strategic commitment to the Healthcare sector in Europe, and together with PAI, we look forward to partnering with the Theramex management team and utilising our significant resources and global network to support their international growth ambitions.”

Cathrin Petty, a Managing Partner and Global Head of Healthcare at CVC, said: “Theramex has been at the forefront of raising awareness and delivering better therapies for women across the globe, particularly in relation to menopause, endometriosis and osteoporosis. As a team, we are very proud to have supported the fantastic Theramex leadership, from the head office through supply chain experts, through to the country leadership and our dedicated sales force – all of whom have a dedication to making a difference to women’s lives. We wish the team every success in the next chapter of growth.”

Carlyle and PAI Partners were jointly advised by Morgan Stanley, Jefferies and Greenhill & Co (M&A), and Linklaters and Allen & Overy (Legal), and PwC (Financial). CVC was advised by Rothschild & Co, HSBC (M&A) and Latham & Watkins (Legal), and EY (Financial), and IQVIA (Commercial).

The financial terms of the transaction are not being disclosed.

Categories: News

Tags: Pharmacie

Nordstjernan acquires Finnish diagnostics company Aidian

admin February 22, 2022

Nordstjernan has signed an agreement to acquire the Finnish in-vitro diagnostics company Aidian from funds that are managed by the Nordic private equity firm Axcel. Aidian is a leading global player in the growing market for point-of-care diagnostics. The company develops, manufactures and sells instruments and tests that are used in such fields as primary care to provide quick and accurate test results. Aidian’s offering of tests addresses several global health problems such as antimicrobial resistance (AMR), diabetes and colorectal cancer. Aidian has tests that are intended to reduce unnecessary prescriptions of antibiotics, which is a driver behind the growing threat from AMR and antibiotic-resistant bacteria.

Aidian was established in 1974 as a subsidiary of Orion, a Finnish pharmaceuticals company. In addition to its headquarters in Espoo, Finland, Aidian has a local presence in another twelve countries and a global presence via distributors in over 60 export markets. The company has over 250 employees and reported sales of approximately EUR 100 million in 2021.

“We are very pleased to have been able to make this investment. Aidian has a strong product offering as well as a leading position in the global market for point-of-care diagnostics, and the company’s instruments and tests help to address several global health challenges. We are impressed by the work that Axcel has done to establish Aidian as a leading player in the field of point-of-care diagnostics and we look forward to continuing to develop Aidian and supporting the company and its management over the long-term in its important efforts concerning many central health issues,” says Nordstjernan’s CEO Peter Hofvenstam.

“We now very much look forward to joining Nordstjernan, an organization well known for its professional and long-term development of businesses within healthcare and other industries,” says Aidian’s CEO Juho Himberg.

Nordstjernan has worked for some time to expand its investment focus in the healthcare sector, which after the acquisition of Aidian will consist of five holdings that represent over 25 per cent of Nordstjernan’s net asset value.

Completion of the transaction is expected in Q1 2022.

The parties have agreed not to disclose the conditions of the transaction.

Peter Hofvenstam
President and CEO
Nordstjernan AB

Questions will be answered by:

Peter Hofvenstam, CEO, Nordstjernan
E-mail: peter.hofvenstam@nordstjernan.se

Stefan Stern, Head of Communications, Nordstjernan
Telephone: +46 70 636 74 17
E-mail: stefan.stern@nordstjernan.se

Nordstjernan is a family-controlled investment company whose business concept is to be an active owner that creates long-term value growth. More information about Nordstjernan can be found on www.nordstjernan.se.

Aidian is a Finnish company in the field of in-vitro diagnostics. Aidian is headquartered in Espoo, Finland, and has global sales via a local presence and distributors. More information on Aidian can be found at www.aidian.eu.

Categories: News

Tags: Pharmacie

CVC Credit supports the acquisition of Pharmathen by Partners Group

admin January 25, 2022

CVC Credit is pleased to announce that it has co-arranged the unitranche debt facilities, featuring an ESG margin ratchet, to support Partners Group’s acquisition (on behalf of its clients) of Pharmathen, a leading European pharmaceutical company, which closed on 20 January 2022. CVC Credit will support the continuing growth strategy of the business through its European Direct Lending Strategy, which focuses on lending to established European medium and large companies with proven business models.

Founded in 1969, Pharmathen is a leading contract development and manufacturing organization (“CDMO”) specialized in advanced drug delivery technologies for complex generic pharmaceutical products. With best-in-class research and development (“R&D”) expertise, the company is a specialist in “sustained release” technologies that improve patient compliance and have led to a broad portfolio of products ranging from slow-releasing oral medicines, ophthalmics, to innovative long-acting injectables. Pharmathen’s differentiated business-to-business model serves a blue-chip customer base of more than 215 generic pharmaceutical companies from two manufacturing facilities in Greece. The company’s highly diversified product portfolio of c.80 commercialized products are supplied to patients in more than 85 countries worldwide.

Miguel Toney, Partner at CVC Credit, commented: “CVC Group’s network was invaluable to our work on Pharmathen’s financing. Notably, the private equity healthcare and local teams’ experience and insight of the market confirmed Pharmathen’s credentials as an industry-leading provider with an R&D-led approach and an unmatched first-to-market track record. We are pleased to support Partners Group and Pharmathen’s high quality management team to execute the company’s exciting growth plans.”

Categories: News

Tags: Pharmacie

Agilitas backs buyout of Prodieco Advanced Engineering Solutions

admin December 30, 2021

Agilitas, the pan-European mid-market private equity firm, today announces the completion of the buyout of Prodieco Advanced Engineering Solutions (the “Company” or “Prodieco”), the largest independent global provider of high-performance blister tooling change parts for the pharmaceutical industry.

Prodieco was founded in 1962 and has been a leader in precision engineering for over 60 years, designing, manufacturing, and supplying bespoke precision blister tooling change parts for blister packaging lines for pharmaceutical, animal and consumer health market products. Headquartered in Dublin, Ireland, it offers high-quality and innovative solutions to its customers, with market leading delivery times and customer service. Prodieco employs in excess of 230 highly skilled people globally and provides its products and services to customers in over 55 countries across multiple continents.

The Company helps address the growing demand for oral solid dose medication and the related growing regulation around safety, such as child resistant and senior friendly, tamper proof or high barrier packaging materials. By doing so, it provides safer and more effective ways for patients to take their medication. Its unrivalled expertise stems from decades designing and manufacturing precision products for all makes and models of blister packaging lines. This equips the Company with a unique understanding and engineering insight into the best possible tool design for each unique format, where success is dependent on high integrity design and extremely precise manufacturing tolerances.

Prodieco represents the latest example of Agilitas’s approach of backing ambitious management teams in high-quality and defensible businesses, with opportunities for multi-dimensional business transformation and a strong alignment between shareholder value and fundamental positive purpose to society or the environment.

Saad Akram of Agilitas, who will be joining the Board of Prodieco, commented: “Prodieco’s state of the art products and relentless focus on quality provide a fantastic platform with which to accelerate the Company’s growth to date and bring about step changes in performance. This Company is well-positioned within a rapidly growing market, and we are excited to support the management team’s vision to become the leading independent provider of precision tooling and parts to the life sciences industry.”

Mike O’Hara, incoming CEO of Prodieco, commented: “Agilitas’s deep sector knowledge and unequivocal support of Prodieco’s mission makes them the ideal partner to take the business forward into the next phase of growth. Agilitas’s support will be crucial in realising our ambition of becoming a globally renowned brand and delivering safe and innovative precision engineered solutions to an increasing number of pharmaceutical customers globally.”

Martin Calderbank, Managing Partner of Agilitas, said: “Prodieco’s sophisticated products are essential for ensuring medicines are securely packaged and are thus a key part of protecting patients and keeping people healthy. Together with the management team, we will seek to further improve Prodieco’s ability to develop and deliver the highest-quality blister tooling solutions and hope to bring its precision engineering skills to new markets to benefit more end patients.”

Media enquiries to: Greenbrook Communications – Alex Jones, James Madsen, and Teresa Berezowski

+44 20 7952 2000 | agilitas@greenbrookpr.com

Categories: News

Tags: Pharmacie

Carlyle Enters into Definitive Agreement to Sell Sunsho Pharmaceutical Co., Ltd to Towa Pharmaceutical Co., Ltd.

admin December 17, 2021

Tokyo, Japan, December 17, 2021 – CJP SP Holding, L.P., an investment fund operated and managed by global investment firm Carlyle (NASDAQ: CG), signed an agreement to sell 100% of its investment in Sunsho Pharmaceutical Co., Ltd (“Sunsho Pharmaceutical”), a contract manufacturing company of health & nutrition (“H&N”) and pharmaceutical products, to Towa Pharmaceutical Co., Ltd. (“Towa Pharmaceutical”), a company specializing in research and development, production, and marketing of generic drugs. The transaction is expected to be completed in February of 2022.

Headquartered in Shizuoka, Sunsho Pharmaceutical is one of the largest contract manufacturers in Japan for soft capsules, seamless capsules, and other dosage forms for H&N and pharmaceutical use. The company focuses on producing absolute quality products and applies state-of-the-art contract manufacturing technology to create cutting-edge formulations and capsules.

CJP SP Holding, L.P. acquired a 100% stake in Sunsho Pharmaceutical in August of 2014 through Carlyle’s third Japan buyout fund, Carlyle Japan Partners III, having recognized the company’s strong growth potential as a contract manufacturer in a steadily growing H&N market in Japan. Carlyle also saw the potential for value creation with Sunsho Pharmaceutical and within the H&N market in Japan by leveraging its local team knowledge, global platform strengths and deep experience in the healthcare and consumer sectors.

Through Carlyle’s ownership, Sunsho Pharmaceutical strengthened its management structure and governance, initiated the launch of a new factory and research and development facility to enhance production capabilities, diversified its business portfolio to cater to new customers, and significantly increased its global revenues by bolstering and expanding its overseas business. Carlyle also worked closely with Sunsho Pharmaceutical’s management team to help drive innovation and co-create new value-add products and solutions with customers.

Carlyle will transition full ownership to Towa Pharmaceutical to support Sunsho Pharmaceutical’s next phase of growth.

Carlyle has made 31 investments in Japan since entering into the market in 2000 and this will be the 20th exit to date. Carlyle has a well-established history of investing in the healthcare sector, both in Japan and globally, investing more than US $14.7 billion of equity in over 80 deals in the global healthcare sector as of September 30, 2021. Healthcare investments in Japan include Qualicaps Co., Ltd., and Solasto Corporation.

***

About Carlyle

Carlyle (NASDAQ: CG) is a global investment firm with deep industry expertise that deploys private capital across three business segments: Global Private Equity, Global Credit and Global Investment Solutions. With $293 billion of assets under management as of September 30, 2021, Carlyle’s purpose is to invest wisely and create value on behalf of its investors, portfolio companies and the communities in which we live and invest. Carlyle employs more than 1,800 people in 26 offices across five continents.

Further information is available at www.carlyle.com. Follow Carlyle on Twitter @OneCarlyle.

About Sunsho Pharmaceutical

Sunsho Pharmaceutical is a company that plans, develops, and conducts contract manufacturing of H&N and pharmaceutical products, being a leading player of the H&N market in Japan. Sunsho Pharmaceutical has full-line factories in Shizuoka and offers contract manufacturing and packaging of soft capsules, seamless capsules, and other dosage forms. In addition to its manufacturing capability and technology, Sunsho Pharmaceutical has top-class ability in R&D technology, sales force and quality control system. The company has various certificates including cGMP, GMP, and HACCP. The company was founded in 1993 and currently employs 690 individuals.

For more information, visit the company website at: https://www.sunsho.co.jp/en/

Media Contacts:

Carlyle
Lonna Leong
+852 9023 1157
lonna.leong@carlyle.com

Kekst CNC
Jochen Legewie / Minako Otani
+81 3 5156 0185 / +81 3 5156 0190
carlyle@kekstcnc.com

Categories: News

Tags: Pharmacie

Vifor Pharma to acquire Sanifit to further strengthen late-stage pipeline in nephrology

admin November 22, 2021

Vifor Pharma to acquire Sanifit, a clinical-stage cardio-renal biopharmaceutical company focused on treatments for progressive vascular calcification disorders, complementing and strengthening the Group’s growing nephrology portfolio
Sanifit’s lead compound, SNF472 is a novel, first-in-class inhibitor of vascular calcification in phase 3, developed for the treatment of calcific uremic arteriolopathy (CUA) and peripheral artery disease (PAD) in patients with end-stage kidney disease
Purchase price includes an upfront payment of EUR 205 million, precommercial milestones for up to EUR 170 million and progressive commercial milestones

Vifor Pharma and Sanifit Therapeutics, a clinical-stage cardio-renal biopharmaceutical company focused on treatments for progressive vascular calcification disorders, today announced the companies have entered into a definitive agreement. Vifor Pharma will acquire Sanifit, for the continued development and commercialization of SNF472, a novel, first-in-class inhibitor of vascular calcification for the treatment of CUA and PAD in patients with end-stage kidney disease. There are currently no approved medicines indicated for CUA or for PAD specifically in this population. SNF472 has already been granted orphan drug designation for the treatment of CUA and PAD by the US Food and Drug Administration and for CUA by the European Medicines Agency.

Under the terms of the acquisition agreement, Vifor Pharma will acquire 100% of the outstanding shares in Sanifit Therapeutics, receiving full global rights for SNF472, further enhancing the company’s portfolio of innovative assets. Shareholders of Sanifit will receive an upfront payment of EUR 205 million, clinical, regulatory and market access milestones for up to EUR 170 million and tiered sales-based milestones that could reach mid to high triple digit EUR millions at peak sales.

“Today’s exciting announcement helps us to build on our strong nephrology pipeline to help end-stage kidney disease patients globally”, commented Abbas Hussain, Chief Executive Officer of Vifor Pharma Group. “Through the acquisition of Sanifit and its lead compound SNF472, we will further expand our growing nephrology pipeline into vascular calcification, a major cause of morbidity and mortality in patients with end-stage kidney disease. SNF472 is the only novel asset addressing a great unmet medical need for end-stage kidney disease patients with calcific uremic arteriolopathy and peripheral artery disease. We look forward to bringing this highly promising, innovative treatment option to over 330,000 patients in the US and Europe, living with CUA or PAD, as soon as possible.”

Joan Perelló, Ph.D., Chief Executive Officer of Sanifit, said; “From the very beginning, Sanifit has been a pioneer of new approaches to treat calcification disorders, a huge area of unmet need. This agreement is a testament to the enduring commitment of our dedicated team and investors, as well as our unique approach to combat vascular calcification, which originated from the University of the Balearic Islands. We are excited to join forces with Vifor Pharma, which has a world-renowned commitment to patient focused cardio-renal therapies. Vifor Pharma is the ideal partner to take the development of Sanifit’s calcification franchise forward and bring these novel treatments to patients as quickly as possible.”

Sanifit conducted a phase-IIb trial (CaLIPSO) to assess the effect of SNF472 on slowing arterial calcification, a major risk factor for cardiovascular disease in dialysis patients. The trial met its primary endpoint in reducing coronary artery calcium progression in patients treated with SNF472, compared to patients receiving placebo over a 52-week period. SNF472 is currently in phase-III trials in CUA in patients on dialysis, to measure primary endpoints for wound healing and pain. A phase-III trial in PAD in patients on dialysis, is planned to commence in 2022.

Closing of the transaction is contingent on customary closing conditions, including the FDI procedure in Spain and merger filings in certain countries, and is expected to take place in Q1 2022.

Categories: News

Tags: Pharmacie

ANI Pharmaceuticals Completes Acquisition of Novitium Pharma, Significantly Enhancing R&D Capabilities and Scale of Generics and CDMO Businesses

admin November 22, 2021

Combined company creates generics growth engine with technical capabilities to bring complex, high-value products to market in efficient and cost effect manner
Proven track record with largest number of Competitive Generic Therapy (CGT) approvals
Deep pipeline with a focus on niche opportunities, including 505(b)(2) candidates in Oncology and Hypertension
Pro-forma September 30, 2021 YTD revenues are $202.5 million and non-GAAP EBITDA $66.6 million
Founders Samy Shanmugam and Chad Gassert to join Executive Team and Mr. Shanmugam to join Board of Directors
Immediately accretive to Adjusted non-GAAP earnings per share
New capital structure in place

BAUDETTE, Minn., November 22, 2021–(BUSINESS WIRE)–ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that it has completed the previously announced acquisition of Novitium Pharma, a privately held, New Jersey-based pharmaceutical company with development, manufacturing, and commercialization capabilities.

“Today marks a major milestone for ANI and the many patients who rely on our high-quality, cost-effective medications. With the completion of this acquisition, we bring on board a world-class R&D engine in the generic and 505 (b)(2) sectors, and a highly-compliant U.S. based manufacturing facility, positioning us well for sustainable long-term growth. Novitium has continued to perform in-line or above our investment thesis since deal signing on March 9^th with thirteen new product approvals, strong quarter-on-quarter EBITDA growth and a successful FDA GMP inspection completed in July 2021,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

“ANI is thrilled to welcome the expertise and leadership of Novitium’s founders, Samy Shanmugam, Chad Gassert and Vijay Thorappadi, along with over 100 talented and dedicated employees, who have joined the ANI team. Our robust product pipeline includes several more CGT and 505 (b)(2) candidates and will be further expanded to maximize the value of our bolstered R&D engine,” concluded Lalwani.

Samy Shanmugam, co-founder of Novitium and ANI’s new Head of Research & Development and Chief Operating Officer of New Jersey Operations added, “Today is an exciting day for all of our employees, as we combine the complementary strengths of our two platforms. We are energized by today’s events and look forward to strong contributions in driving the future success of an united ANI.”

“ANI’s new capital structure, comprised of the recently completed $75 million equity raise and the closure of a new $300 million Term Loan-B, $40 million revolver and $25 million PIPE, gives the Company significant flexibility in supporting the integration of Novitium into ANI, ensuring a strong Purified Cortrophin^TM Gel commercial launch and will propel the next phase of growth for ANI,” stated Stephen Carey, Senior Vice President and Chief Financial Officer of ANI.

Compelling Investment Thesis

Proven R&D Engine Fuels Sustainable Growth

Novitium has a strong pipeline with 20+ new product launches planned in the next 18 months, including products with U.S. Food and Drug Administration (FDA) Competitive Generic Therapy designation. Novitium received thirteen approvals since March 2021, several of which were limited competition launches. Novitium’s proven R&D leadership team of Samy Shanmugam, Chad Gassert and Vijay Thorapaddi will drive the combined company’s R&D engine.

Expands ANI’s R&D Pipeline Focused on Niche Opportunities

Novitium has expanded the 505 (b)(2) portfolio beyond the three initial 505(b)(2) candidates in Oncology and Hypertension. The combined company has also expanded dosage forms to include injectables and gels.

Enhances scale of CDMO Business & U.S. Based Manufacturing Capacity.

Novitium adds nine new customers to ANI’s growing CDMO business. Additionally, Novitium brings a U.S. based, state-of-the-art manufacturing facility enhancing manufacturing capabilities and CDMO opportunities.

Compelling Financial Profile

Immediately accretive to Adjusted non-GAAP earnings per share. The acquisition diversifies ANI’s revenue base by contributing to each of its reporting segments: Generics, Contract Manufacturing, Royalties/Other and, following the launch of Novitium’s 505(b)(2) pipeline products, the Brand segment.

The Transaction has satisfied customary closing conditions, and received approval from shareholders and relevant regulatory agencies, including clearance under the Hart-Scott Rodino Antitrust Improvements Act. As previously announced, the U.S. Federal Trade Commission (the FTC) has accepted the proposed consent order in connection with ANI’s definitive agreement to acquire Novitium Pharma. The divestitures required by the FTC of development rights to one generic drug and assets with respect to another generic drug are immaterial to the Company’s business and have been completed. The acceptance by the FTC satisfies all required antitrust clearances needed to be obtained for the acquisition.

Terms of the Transaction and Debt Re-Financing

Under the terms of the transaction, the Purchase Price is comprised of (i) a cash payment of $89.5 million and (ii) the issuance of 2,466,654 common shares of ANI equity. Novitium is also eligible to receive (i) $25 million in contingent payments upon the achievement of financial targets related to Generics products and filing of certain ANDAs and (ii) $21.5 million in contingent payments upon the achievement of financial targets from the 505(b)(2) products.

Commensurate with the completion of the transaction, ANI retired its existing Term Loan-A credit facility (including the repayment of $200.1 million of face value outstanding) and closed a new $300 million Term Loan-B and a $25 million PIPE investment with Ampersand Capital Partners. The new credit facility also includes a $40 million revolver that is un-drawn at this time. The new debt financing is secured by substantially all the assets of ANI and its subsidiaries.

Advisors

Bourne Partners, Truist Securities and Houlihan Lokey acted as financial advisors to ANI Pharmaceuticals. SVB Leerink acted as financial advisor to Novitium Pharma and its shareholders. Hughes Hubbard & Reed LLP were ANI’s legal advisors and Orrick, Herrington & Sutcliffe LLP acted as legal advisors to Novitium and its shareholders.

About ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. For more information, please visit www.anipharmaceuticals.com.

Forward Looking Statements

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the development, manufacturing and commercialization of future product candidates and any additional product launches from the Company’s generic pipeline, those relating to expansion of the R&D engine, expected growth and similar statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; the use of single source suppliers and the time it may take to validate and qualify another supplier, if necessary; increased competition and strategies employed by competitors; the ability to realize benefits anticipated from acquisitions; costs and regulatory requirements relating to contract manufacturing arrangements; the ability of the Company to successfully maintain manufacturing capabilities and adequate commercial quantities of Cortrophin Gel at acceptable costs and quality levels; broad acceptance of Cortrophin Gel by physicians, patients and the healthcare community; the acceptance of pricing and placement of Cortrophin Gel on payers’ formularies; delays or failure in obtaining future product approvals from the U.S. Food and Drug Administration; general business and economic conditions, including the ongoing impact of the COVID-19 pandemic; market trends for our products; regulatory environment and changes; and regulatory and other approvals relating to product development and manufacturing.

More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211122005977/en/

Contacts

Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Media:
Angela Salerno-Robin
dna Communications
312-445-8219
ASalerno-Robin@dna-comms.com

Categories: News

Tags: Pharmacie

Bridgepoint to sell HTL

admin November 12, 2021

Montagu, a leading European private equity firm, has entered into exclusive negotiations with Bridgepoint, to acquire HTL Biotechnology (“HTL” or “the company”), an international, fast-growing biotech and industrial firm leading the development and production of innovative pharmaceutical grade biopolymers. Financial terms of the transaction are not being disclosed.

Founded in 1992, HTL has developed a state-of-the-art biopolymers platform which provides customised, pharmaceutical grade biopolymer solutions to leading pharmaceutical and medical device companies worldwide. Its products are used in therapeutic areas such as ophthalmology, rheumatology, urology, dermatology, and medical aesthetics. The company is recognised as the world pioneer in industrialising the bioproduction of hyaluronic acid.

Montagu’s deep sector expertise coupled with the company’s strong healthcare capabilities and organisational foundation will enable HTL to consolidate its global leadership and continue to provide exceptional value to its clients and end-users.

Yvon Bastard, CEO of HTL, commented, “We look forward to partnering with Montagu. Their extensive experience in the healthcare field, will allow us to accelerate our growth, continue to innovate, and realise our international ambitions.”

Guillaume Jabalot, Director at Montagu, said: “HTL represents several key features of a Montagu deal, demonstrating a competitive and defensible core business in an attractive market. The management team has accelerated growth and innovation through R&D, which have reinforced the company’s leadership position globally and opened new growth avenues. We are proud to be partnering with HTL and its employees and supporting them in being at the forefront of innovation in the biopolymers sector and improving patients’ lives.”

Vincent-Gael Baudet, Partner, Bridgepoint, said: “We’re delighted to have worked with the HTL management team to drive the transition of the company to become a biotechnology platform of scale, and a leading R&D partner to pharmaceutical companies across the world. We wish the management team every success as they embark on the next exciting chapter.”

Categories: News

Tags: Pharmacie

swissfillon, a leader in sterile filling of complex pharmaceuticals, joins 3i-backed ten23 health and enhances the combined company’s integrated offering to its customers

admin October 25, 2021

3i Group plc (“3i”) today announces that swissfillon, a leader in sterile filling of complex pharmaceuticals, is joining ten23 health, a pure-play, patient-centric and sustainable biologics drug product contract development and manufacturing organisation (“CDMO”).

Founded in 2013 by Daniel Kehl and based in Visp Switzerland, swissfillon is a FDA and Swissmedic approved drug product-focused CDMO. The company is a leader in the sterile filling of complex pharmaceuticals into innovative containers and devices, such as pre-filled syringes, cartridges and vials.

The combined business of ten23 and swissfillon will provide an integrated offering for sterile drug product development and manufacturing of biologics, challenging molecules and dosage forms, offering customers an integrated suite of services. Prof. Dr. Hanns-Christian Mahler will serve as CEO of the combined entities under the ten23 health umbrella. Daniel Kehl, founder of swissfillon, will remain with the business in a key leadership role and will help to lead ten23’s new infrastructure engineering projects that are of great strategic importance for the further development of the combined offering.

The biologics CDMO market is a c.$15bn market which is growing strongly and is characterised by a high degree of fragmentation. Increased outsourcing of key services is anticipated, driven by underlying biologics market growth, development of new advanced therapeutics such as cell & gene therapies, continued emergence of small, virtual, biotechs and increasing need for large pharma to access expertise and capacity. The combined ten23 and swissfillon will also be well positioned as biologics modalities mature and move from bulk vials into formats that facilitate better routes of administration for patients.

Daniel Kehl, current CEO of swissfillon: “We look forward to joining ten23 health’s world-class team. There is a great strategic fit between our deep expertise in sterile drug product manufacturing for complex pharmaceuticals and ten23 health’s focus on the development and manufacturing of injectable treatments. By pooling our expertise, we will be able to further expand our market position for injectable treatments. The swissfillon team looks forward to continue advancing under the ten23 health umbrella and providing our combined group of customers with excellent support and customisable solutions.”

Hanns-Christian Mahler, CEO of ten23 health commented: “I would like to welcome Daniel and the swissfillon team to ten23 health. Sterile fill and finish services are expected to experience significant growth over the coming years. This rising demand is driven by expanded drug development pipelines, incorporating more complex, large-molecule products and therapies that require specific expertise for both development and sterile production. This is precisely why we expect ten23 health’s services, now including swissfillon, to be in great demand. At ten23 health, we are very pleased that we can now offer this sought-after know-how to biotech start-ups and pharmaceutical companies from one single source”

Richard Relyea, Partner, 3i added: “The acquisition of swissfillon fits with our strategy of investing organically and with M&A to build ten23 health into an integrated biologics-focused CDMO. Following the acquisition of swissfillon, ten23 health will be one of a limited number of biologics CDMOs focused on both formulation development and fill & finish, with a particular focus on high value therapeutics.”

Download this press release

– Ends –

For further information, contact:

3i Group plc
Kathryn van der Kroft Media enquiries	Tel: +44 20 7975 3021 Email: kathryn.vanderkroft@3i.com
Silvia Santoro Shareholder enquiries	Tel: +44 20 7975 3285 Email: silvia.santoro@3i.com

About 3i Group

3i is a leading international investment manager focused on mid-market Private Equity and Infrastructure. Its core investment markets are northern Europe and North America. For further information, please visit: www.3i.com

About ten23 health

ten23 health, headquartered in Basel, Switzerland, is the human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups: we develop, manufacture, and test tomorrow’s medicines. We support our clients in developing differentiated, stable, usable and safe injectable treatment options for patients. ten23 health combines the latest scientific findings with our proven and tested world-class industry and regulatory expertise to forge new paths for supporting our clients. We provide our innovative services in a fair and sustainable manner, respecting people’s health and the future of our planet.

About swissfillon

swissfillon, based in Visp, Switzerland, is a leading CDMO for high precision sterile drug product manufacturing, filling complex pharmaceuticals into innovative containers and devices. The company provides innovative pharma manufacturing solutions to satisfy previously unmet market and patient needs. Thanks to its first-class filling technology and drug product manufacturing expertise, swissfillon offers its services to a broad customer portfolio supporting biotech start-up companies as well as established pharma companies.

Regulatory information

This transaction involved a recommendation of 3i Corporation, a US wholly owned subsidiary of 3i Group.

Categories: News

Tags: Pharmacie

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Compelling Investment Thesis

Terms of the Transaction and Debt Re-Financing

Advisors

About ANI Pharmaceuticals, Inc.

Forward Looking Statements

Contacts

Bridgepoint to sell HTL

swissfillon, a leader in sterile filling of complex pharmaceuticals, joins 3i-backed ten23 health and enhances the combined company’s integrated offering to its customers