BUSINESS INSIGHTS

Vifor Pharma drives transformation with divestment of non-core finished drug manufacturing to CordenPharma

Vifor Pharma Group | December 17, 2021

Vifor Pharma Group announced the divestment of its finished drug product manufacturing business to CordenPharma, a full-service Contract Development & Manufacturing Organization of APIs, Excipients, Drug Products, and associated Packaging services. This decision reinforces Vifor Pharma’s strategy to transform the company into a multi-brand commercial organization, focusing on its core capabilities in-licensing, partnering and commercializing products in nephrology, and to further grow and maximize opportunities of its iron portfolio.

In support of our ambitious growth strategy, optimizing our manufacturing footprint will enable us to build an even stronger, more efficient organization focusing on core capabilities in nephrology, and to maximize and leverage our market-leading expertise and intellectual property in iron deficiency. With CordenPharma, we have found the best suitable solution for our manufacturing employees and the drug production activities in Fribourg, Ettingen and Lisbon. With this agreement, Vifor Pharma is well positioned to continuously drive the company sustainably and profitably over the long term, for all our stakeholders.”

 Abbas Hussain, CEO of Vifor Pharma

Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma said: “The acquired Vifor Pharma sites have competent teams with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities. By incorporating these three Vifor Pharma manufacturing facilities into our global network, we look forward to not only supplying Vifor Pharma as a manufacturing partner, but also closing gaps in our service offering for oral solid dosage drug product manufacturing and increasing our overall capacity. In addition, this acquisition further strengthens our fully-integrated solutions to our customers.”

Under the terms of the signed share purchase agreement, CordenPharma acquires all shares in Vifor SA, Fribourg, and OM Pharma SA, Lisbon, thus taking over Vifor Pharma’s finished drug product manufacturing operations at the three sites. The divestment will trigger an asset impairment, to be reported with Vifor Pharma’s 2021 financial results. The companies have agreed not to disclose financial terms of the agreement.

CordenPharma will integrate the new facilities into its existing CDMO network of Current Good Manufacturing Practice and R&D plants across Europe & the US, and organize the operations of the Fribourg, Ettingen and Lisbon sites under its Small Molecule Platform. It plans to utilize the existing manufacturing workforce, while continuing to produce and supply Vifor Pharma products. Vifor Pharma’s Swiss and Portuguese country commercial organizations, located in Fribourg and Lisbon, will remain with Vifor Pharma Group. Vifor Pharma and CordenPharma will jointly ensure long-term continuity of supply for customers and patients who depend on them.

This divestment, including all financial implications, has been disclosed to CSL Limited in the course of the due diligence process preceding the publication of the pre-announcement of the public tender offer by CSL Limited on 14 December and in so far has no impact on such tender offer.

Vifor Pharma and CordenPharma anticipate closing the transaction in Q1 2022, contingent on customary closing conditions.

About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange 

About CordenPharma
CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group, is a full-service partner in the Contract Development & Manufacturing of APIs, Excipients, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products.




Spotlight

Today’s powerful and actively evolving computational tools enable sponsors and regulators to understand potential drug characteristics and subject responses earlier in development, with greater certainty. Model-based approaches support timely, confident decisions across the development and regulatory lifecycle by gathering disparate sources of information about a drug, its competitors, target disease and patients into a mathematical knowledge framework.


Other News
BUSINESS INSIGHTS

ColubrisMX, Inc. Announces Corporate Rebranding to ENDOQUEST Robotics™

ColubrisMX | July 01, 2022

ColubrisMX, Inc., developer of the world's first flexible endoluminal robotic system which enables scar-free and less invasive surgical procedures, announced that the Company has rebranded to ENDOQUEST Robotics™. The Company also announced the simultaneous launch of its new website, www.endoquestrobotics.com. "Since being founded, our company has made rapid progress in the development of technologies that represent historic advances in endoluminal surgery, with the potential to bring millions of patients access to procedures that are less invasive and scar-free. This rebranding as ENDOQUEST Robotics reinforces our commitment to being the leader in innovation in flexible robotic technology for a wide range of needs in endoscopic surgeries in the years ahead." Kurt Azarbarzin, Chief Executive Officer of ENDOQUEST Robotics ENDOQUEST's advanced robotic platform enables therapeutic endoscopists and surgeons to perform endoluminal surgeries through the body's existing lumens, eliminating the need for incisions that lead to visible scarring. ENDOQUEST's Endoluminal Surgical System combines the flexibility of conventional endoscopy with the advantages of traditional surgical techniques that can improve control and precision. The Company's proprietary endoscope is a flexible and steerable overtube that functions as a robotic delivery system able to deliver two surgical instruments and a flexible videoscope to a surgical target. With the enhanced capabilities of the ENDOQUEST ELS System, advanced endoscopists and surgeons can access locations in the digestive tract through a body's natural orifice using traditional surgical techniques not previously possible. "Following completion of our successful $76 million Series C financing, we remain very encouraged by the growing levels of investor, gastroenterologist and surgeon interest in our ELS System technology and are working aggressively to advance this development program to an Investigational Device Exemption filing with the U.S. Food and Drug Administration," Azarbarzin added. "We look forward to providing an update on our progress on July 1, 2022 at the Society of Robotic and Digital Surgery's Annual Meeting at the Disney World Yacht and Beach Club Resort in Lake Buena Vista, Florida." About ENDOQUEST Robotics ENDOQUEST Robotics has developed the ENDOQUEST Endoluminal Surgical System, the world's first endoluminal robotic surgical system that makes it possible for therapeutic endoscopists and surgeons to perform upper and lower gastrointestinal surgery less-invasively through a trans-oral or trans-anal approach. ENDOQUEST's robotic platform combines the flexibility of endoscopy that is able to navigate the curvature of patients' anatomy with instrumentation that allows the physician to use a conventional two-handed surgical technique. The ENDOQUEST ELS System has further potential applications in a range of minimally invasive surgeries including appendectomy and cholecystectomy that can be performed with no external incisions.

Read More

BUSINESS INSIGHTS

ClinChoice Raises $150 mm Series E Round Financing, Further Strengthening its Global Services Capabilities

ClinChoice | July 05, 2022

Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot Capital. Proceeds of the financing will be used to fund the Company's continued business expansion and innovative service offering worldwide. Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot Capital. Proceeds of the financing will be used to fund the Company's continued business expansion and innovative service offering worldwide. As a full service clinical-stage CRO, ClinChoice serves the global market by providing integrated one-stop clinical development services to emerging biopharmaceutical, medical device and consumer health clients around the world. ClinChoice has over 3000 employees worldwide covering most of drug development hotbeds in US, China, multiple countries in Europe and Southeast Asia. With over 25 years of high-quality services, ClinChoice has completed more than 1,000 Phase I-IV full-service clinical projects and supported over 100 innovative drug registrations, clinical design and development. ClinChoice strictly adheres to GCP and ICH standards and has developed robust SOPs recognized by more than 50 large multinational companies, all of which have passed multiple inspections and audits by major regulatory agencies around the world. "We thank the investors for their trust in ClinChoice. This round of capital investment fully validates ClinChoice's rapid growth and future potential in the field of clinical CRO. With the new round of financing, we will further enhance our innovative service offering and continue business expansion by organic growth and M&A, in order to better serve our clients worldwide." Global Chairman and CEO of ClinChoice, Mr. Ling ZHEN Dr. Hongbin ZHOU, Co-Chief Investment Officer of Legend Capital, said, "We would like to express our gratitude for trusting in Legend Capital and we are excited to be part of ClinChoice, together with the Management Team and the existing shareholders, including Lilly Asia Ventures, Goldman Sachs. We are very positive on the growth outlook of the CRO industry. As a rapidly growing CRO, ClinChoice has built an excellent platform combining global expertise with deep knowhow across key local markets, to support innovation. Going forward, we will work closely with the management team to improve its existing business, attract industry talent and launch new strategic initiatives." About ClinChoice ClinChoice is a global clinical CRO, providing high-quality Integrated One-stop Service Offerings for new bio-pharmaceutical and medical device clients worldwide. Our Service Offerings cover Clinical Operation, Project Management, Biostatistics, Data Management, Biostatistical Programming, Regulatory Affairs, Medical Affairs, Feasibility Research, HGRAC Submission, Clinical Safety Management, Site Management Organization, Nature Medicine/Traditional Chinese Medicine and Phase I Clinical Research, etc. Now, ClinChoice has over 3,000 employees worldwide covering most of drug development hotbeds in US, China, multiple countries in Europe and Southeast Asia. Since its inception, ClinChoice has completed multiple rounds of financing, with investments from renowned institutional investors including Goldman Sachs, Lilly Asia Ventures, and DFJ Dragon Fund. About Legend Capital In April 2001, Legend Capital was established as a fund manager under Legend Holdings, focusing on the early-stage VC and growth-stage PE investment. Since its establishment, Legend Capital has been adhereing to internationally accepted standards to create best practices in fund management and operation. With a proven track record of more than 20 years, it now has full experience in fund management and operation and has built an extensive partner ecosystem across the entire investment chain.

Read More

BUSINESS INSIGHTS

BD TO ACQUIRE PARATA SYSTEMS TO ENTER NEW PHARMACY AUTOMATION SOLUTIONS MARKET

BD | June 07, 2022

BD a leading global medical technology company, and Frazier Healthcare Partners, a leading private equity firm focused exclusively on the health care sector, today announced a definitive agreement for BD to acquire Parata Systems, an innovative provider of pharmacy automation solutions, for $1.525 billion. Parata's portfolio of innovative pharmacy automation solutions power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience. Significant macro trends such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacists are driving demand for intelligent workflow solutions. Through the use of automation and advanced software, pharmacists can focus more of their time on higher value clinical work and patient interactions to help improve medication adherence, medication safety and patient outcomes. The transaction will be complementary to BD's solutions in medication management with a new set of technologies across the care continuum, including acute care health systems, retail pharmacies, long-term care and home settings. Parata provides BD access to a new $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. Together with BD, the company expects Parata's solutions to outpace market growth through BD's commercial footprint, global scale and innovation capabilities. "Parata expands BD's solutions to a new area of the high-growth pharmacy automation space and is a prime example of BD executing our disciplined M&A strategy. Parata has a highly attractive financial profile and compelling value proposition that meets all of our rigorous investment criteria on growth, profitability and returns. With the addition of Parata, BD further advances our 2025 growth strategy around smart, connected care and enabling new care settings. We look forward to welcoming the talented Parata team to BD." Tom Polen, chairman, chief executive officer and president of BD Rob Kill, chief executive officer of Parata added, "BD and Parata share a common purpose with closely aligned cultures. We are very proud of the company the team has built at Parata over the past 21 years and feel BD is a great home for our company, innovative solutions and technology, and Parata's team members. The combination with BD will further advance our purpose of powering pharmacies to help people lead healthier lives." About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. About Parata Systems Parata provides pharmacy technology solutions to reduce costs, enhance patient safety and improve the patient experience by offering a comprehensive pharmacy automation portfolio with medication adherence packaging, high-speed robotic dispensing technologies and pharmacy workflow solutions. About Frazier Healthcare Partners Founded in 1991, Frazier Healthcare Partners is a leading private equity firm focused exclusively on the healthcare sector. With over $7.1 billion in total capital raised, Frazier has invested in more than 200 companies with transaction types ranging from buyouts of profitable healthcare services companies to venture capital and company creation. Frazier has a philosophy of partnering with strong management teams while leveraging its internal operating resources and network to build exceptional companies. Frazier has offices in Seattle, WA, and Menlo Park, CA, and invests broadly across the U.S., Canada, and Europe.

Read More

BUSINESS INSIGHTS

FDA Accepts Dupixent® (dupilumab) for Priority Review in Adults with Prurigo Nodularis

Regeneron Pharmaceuticals, Inc. | May 31, 2022

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® Medical (dupilumab) to treat adults with prurigo nodularis, a chronic skin disease that causes extreme itch and inflammatory skin lesions. The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. The adverse event more commonly observed with Dupixent was conjunctivitis. The FDA grants Priority Review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings around the world are also planned in 2022.The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Prurigo Nodularis People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option. About Dupixent Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Dupixent is approved for use in certain patients with atopic dermatitis, asthma, CRSwNP or eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in the European Union and Japan and more than 60 countries. More than 400,000 patients have been treated with Dupixent globally. About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes Dupixent, REGEN-COV® (casirivimab and imdevimab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™. Dupilumab Development Program Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

Read More

Spotlight

Today’s powerful and actively evolving computational tools enable sponsors and regulators to understand potential drug characteristics and subject responses earlier in development, with greater certainty. Model-based approaches support timely, confident decisions across the development and regulatory lifecycle by gathering disparate sources of information about a drug, its competitors, target disease and patients into a mathematical knowledge framework.

Resources