Innocoll Pharmaceuticals | July 07, 2022
Innocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, announced the publication of the results of Study BU-002-IM evaluating the safety and efficacy of POSIMIR® for infiltration use in 107 patients undergoing arthroscopic subacromial decompression. The peer-reviewed paper, entitled “SABER-Bupivacaine Reduces Postoperative Pain and Opioid Consumption After Arthroscopic Subacromial Decompression: A Randomized, Placebo-Controlled Trial,” was published online on May 17, 2022 in the Journal of the American Academy of Orthopedic Surgeons Global Research & Reviews.
According to the report, POSIMIR 5 mL administered into the subacromial space at the end of arthroscopic subacromial decompression surgery in this double-blind, randomized, controlled, multicenter study, reduced mean postoperative pain on movement over 72 hours by 1.3 points on a 0-10 scale compared with vehicle control, a relative reduction of 20%. Simultaneous improvements in postoperative opioid use during the same 72-hour period provided evidence that the observed pain reduction was clinically meaningful. The median time to first request for opioid rescue medication was 12.4 hours among patients treated with POSIMIR compared with 1.2 hours in patients who received vehicle control. The median total opioid consumption in intravenous (IV) morphine milligram equivalents over 72 hours was 4.0 mg in the POSIMIR group vs 12.0 mg in the vehicle control group. The proportion of patients who were opioid free at 72 hours was 40% in the POSIMIR group vs 16% in the vehicle control group.
As reported in the paper, the most common treatment-emergent adverse events were headache, nausea, musculoskeletal pain, cardiac disorders, skin and subcutaneous tissue disorders, injury and procedural complications, general disorders and administration site conditions and respiratory, thoracic, and mediastinal disorders. Of 2 serious adverse events reported among patients in these treatment groups, only 1 occurred during the immediate 2-week postsurgical follow-up period, and none was considered related to treatment. There were no TEAEs leading to study discontinuation.
“These very compelling results, demonstrating up to three days of local analgesia after a single intra-operative injection, make POSIMIR an important new tool in treating postoperative pain from arthroscopic subacromial decompression,” said Sten Rasmussen, MD PhD, Professor and Head of Department of Clinical Medicine, Aalborg University, Denmark, the senior author and a principal investigator in the POSIMIR study.
“We are excited to publish the positive results of this pivotal clinical trial of POSIMIR, the second approved product in our portfolio of nonopioid, extended-duration, locally-acting analgesics for postsurgical pain control. As the only company with two non-opioid extended release bupivacaine products on the market, we look forward to bringing POSIMIR to the orthopedic community,”
Louis Pascarella, Innocoll President and Chief Executive Officer
POSIMIR for infiltration use contains more bupivacaine in a single dose than any other approved, sustained-release bupivacaine product. It employs a proprietary extended-release technology that enables the continuous release of bupivacaine, a non-opioid local anesthetic, directly to the surgical site for 3 days after administration. POSIMIR was approved in February, 2021 by the US Food and Drug Administration. POSIMIR is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Use in any other surgical procedure is investigational. POSIMIR is a registered trademark of Innocoll Pharmaceuticals Limited.
About Subacromial Decompression Shoulder Surgery
Subacromial decompression is a type of shoulder surgery used to treat impingement syndrome, a common repetitive-use injury that causes pain when the arm is raised over the head. The procedure is performed arthroscopically, meaning that several small incisions are made in the skin and muscle of the shoulder through which a camera (arthroscope) and surgical instruments are inserted during surgery. Arthroscopic subacromial decompression is generally performed as outpatient surgery, and most patients go home within a few hours of surgery. The most intense pain typically occurs during the first 3 days and is often managed with a combination of nerve block and oral opioids. There are over 600,000 surgeries involving arthroscopic subacromial decompression performed each year in the U.S.
About Innocoll Pharmaceuticals Limited
Innocoll Pharmaceuticals Limited is a global biotech pharmaceutical company headquartered in Athlone, Ireland and is a subsidiary of Innocoll Biotherapeutics Holding Limited. The Innocoll group of companies is focused on the development and commercialization of pharmaceutical technologies to meet some of today’s most important healthcare challenges.
About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion Group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, Gurnet is able to deliver differentiated results for its investors and partners.
Catalent, Inc | July 06, 2022
Catalent, Inc. the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced changes to its operating structure and executive leadership team that went into effect July 1. This new organizational structure includes a shift from four reporting segments to two, each representing roughly half of the total company revenue.
According to Alessandro Maselli, Catalent’s President and Chief Executive Officer since July 1, the segment changes reflect evolving customer and industry trends and position the company to deliver its next level of growth and achievement.
“Our industry continues to demonstrate steady growth, and this new structure will allow us to be more agile in meeting and anticipating customer needs and expectations. Among other benefits, it will create commercial synergies for our customers, as they will be better able to access the full range of Catalent services applicable to their molecules.”
Dr. Aris Gennadios was named Group President of Catalent’s newly formed Pharma and Consumer Health segment. The new segment consolidates the company’s prior Softgel & Oral Technologies segment, which Gennadios had led since 2013, and its Oral & Specialty Delivery and Clinical Supply Services segments.
“Combining our businesses focused on the development and supply of pharmaceutical and consumer health products will provide our customers with more integrated solutions, streamlined service, and simplified delivery of the solutions they need to accelerate their path to patients and consumers,” said Dr. Gennadios.
The new Pharma and Consumer Health segment will encompass the offerings of the three prior segments, including the company’s market-leading softgels, Zydis® fast-dissolve technologies, gummy dosage forms, clinical development and trial supply services, and global pharma manufacturing platforms. Dedicated teams will focus on Catalent’s pharmaceutical, consumer health, and clinical development and supply solutions to further drive value for customers and the opportunity for accelerated growth of these businesses.
The scope of Catalent’s other reporting segment, Biologics, continues without any change.
This organizational restructuring has also been accompanied by a few additional leadership changes. Jonathan Arnold, who previously served as President, Oral & Specialty Delivery, since 2017, is Catalent’s new Senior Vice President, Chief Commercial Officer, and Head of Transformation. He will be dedicated to ensuring a best-in-class customer experience and working closely with others on the leadership team to optimize the company’s growing portfolio.
Additionally, Steven Fasman, who previously served as Senior Vice President and General Counsel since 2014, will be Catalent’s Executive Vice President and Chief Administrative Officer, a newly created position. Mr. Fasman will oversee certain administrative functions of the company, including legal & compliance, information technology, engineering, procurement, governmental affairs, and various ESG-related departments.
Finally, Karen Flynn has announced her decision to retire from her role as Catalent’s Senior Vice President and Chief Commercial Officer. “Karen has played a critical role on the Executive Leadership Team since joining Catalent in early 2020. I am immensely grateful for her leadership, innovative thinking, and steadfast commitment to the company,” said Maselli.
About Catalent, Inc.
Catalent, Inc. an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is the industry’s preferred partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 19,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year.
UCB, Inc. | September 02, 2022
UCB, a global biopharmaceutical company, today announced that it will present 20 abstracts across its dermatology portfolio at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy, September 7-10. The abstracts, accepted for poster presentation, underscore UCB's commitment to delivering innovative solutions that aim to address the unmet needs of people living with dermatological diseases.
"We are proud to present new data from our expanding dermatology portfolio at the 31st EADV Congress. At UCB, our ambition is to transform the lives of people living with severe diseases such as psoriasis and psoriatic arthritis, and the strength of scientific data at this year's congress reaffirms our long-standing commitment to raising standards of care," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
Key data to be presented on UCB's investigational product bimekizumab include new results from the BE BRIGHT open-label extension study evaluating maintenance of response with bimekizumab through three years in patients with moderate to severe plaque psoriasis who responded at week 16 during Phase 3 clinical studies. New analysis of pooled safety data from up to three years of treatment with bimekizumab in the treatment of moderate to severe plaque psoriasis across Phase 2 and 3 clinical trials will also be presented. Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S. and it is not approved by the U.S. Food and Drug Administration (FDA).
For CIMZIA® (certolizumab pegol), data to be presented include three-year data from three Phase 3 trials evaluating the association of patient-reported outcomes (Dermatology Life Quality Index, DLQI 0/1) with relative skin clearance improvements (Psoriasis Area and Severity Index, PASI) in subgroups of adult patients with moderate to severe plaque psoriasis.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB).
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Enteris BioPharma | September 13, 2022
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation announced the publication of a new white paper in Drug Development & Delivery entitled, "Key Considerations in Oral Delivery of Peptides – Factors to Consider While Evaluating Oral Administration."
The paper, authored by John Vrettos, PhD, Director of Formulation Development for Enteris BioPharma, and Kalpana Ramakrishnan, PhD, Manager of Business Development for Enteris BioPharma, explores the barriers to developing oral delivery of peptides and how pharmaceutical companies can overcome them. Oral administration of peptides offers several advantages while treating chronic conditions such as diabetes and obesity as they are less invasive and more cost effective compared to injections.
"Molecule size, potency, and solubility are some of the key physicochemical properties that determine a peptide's suitability for oral delivery. The healthcare industry is in need of enabling drug delivery technologies with the capability to overcome barriers in oral delivery of peptides. Importantly, orally delivered medications may encourage patient compliance compared with more invasive approaches to administering drugs. Approximately 75% of peptides are delivered by injective routes, including subcutaneous injections which can be painful and difficult to incorporate into a daily routine."
Dr. Vrettos continued, "Enteris' Peptelligence® platform offers a 'triple-action' solution comprised of our enteric coating, protease inhibitor, and permeation enhancer. When combined, these technologies have demonstrated an ability to improve the solubility and permeation of orally delivered peptides. These properties can potentially enable oral delivery of some peptide drugs for the first time, and we are excited to share our knowledge on oral delivery of peptides through this informative whitepaper."
Peptelligence is a novel formulation technology designed to enhance the oral delivery and bioavailability of selected drugs by enhancing the permeation of such compounds that are typically injected, including peptides and BCS class III and IV small molecules, and preventing their breakdown in the digestive tract.
About Enteris BioPharma
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation offering total integrated contract development and manufacturing services for innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®, and contract manufacturing (CMO) services using non-proprietary technologies. The company's proprietary technologies have been the subject of numerous feasibility studies and active development programs, some of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option.