Cambrex | September 05, 2022
Cambrex today announced the completion of the first phase of its $30 million investment in its small molecule active pharmaceutical ingredient manufacturing facility in High Point, North Carolina. The newly constructed space adds analytical and chemical development laboratories totaling 30,000 square feet and provides future workspace for 85 analytical and chemical development scientists. These laboratories will support the development of APIs to be manufactured in the facility's current clinical manufacturing area, as well as the future expanded clinical manufacturing and commercial manufacturing suites.
"With the growing number of therapies in clinical development and trend toward more targeted therapeutics, including orphan drugs, this expansion is preparing Cambrex to support the growing demand for small-scale API manufacturing. Our expansion goes beyond providing capacity – it provides state-of-the-art technology and laboratory equipment, an energy efficient infrastructure, and an ideal space for our scientific experts to work side-by-side with our clients."
Tom Loewald, CEO, Cambrex
Phase 2 of the project is ongoing and will approximately double the facility's manufacturing capacity with the addition of clinical and commercial manufacturing suites with reactors up to 2,000 liters. The new commercial area will provide an ideal scale for the manufacturing of orphan drugs and niche therapies, while larger volume products developed at the facility can be manufactured commercially at one of Cambrex's larger scale facilities in Iowa and Sweden. This expansion follows Cambrex's 2021 investment in the Cambrex High Point continuous flow R&D center of excellence, including expanded capabilities for continuous flow process development, manufacturing, and scale up.
Cambrex continues to expand its capabilities and capacity across its North American and European network to meet the growing demand for outsourced product development and manufacturing services.
Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing.
Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, stability storage, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.
AbbVie | September 19, 2022
AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of risankizumab for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
"We continue to raise the bar in researching treatments for immune-mediated gastroenterological conditions through more stringent and innovative clinical trial design, such as the first time a Phase 3 trial has reported co-primary endpoints, endoscopic response and clinical remission. With the recent CHMP recommendation for risankizumab in Crohn's disease, we're getting closer toward helping patients find sufficient disease control for this disruptive condition."
Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie
AbbVie's application for the approval of risankizumab in Crohn's disease is supported by data from three Phase 3 clinical trials — ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study).1,2 Across all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission.1,2,5-10 This includes statistically significant improvements in these endpoints at week 12 compared to placebo with 600 mg intravenous infusions for the ADVANCE and MOTIVATE induction studies.1,8,9 Additionally, a significantly greater proportion of patients treated with risankizumab 360 mg subcutaneous injections achieved endoscopic response and clinical remission at 52 weeks compared to placebo (patients treated with placebo after risankizumab induction) in the FORTIFY maintenance study.2,10 Safety results of risankizumab in Crohn's disease were consistent with the known safety profile of risankizumab, with no new safety risks observed.1,2,8-13
"Living with Crohn's disease can pose many challenges and significantly impact a patient's health-related quality of life," said Marc Ferrante, M.D., Ph.D., Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium. "Risankizumab could be an encouraging option for adult patients that continue to have moderately to severely active Crohn's disease and I look forward to the European Commission's final decision."
Use of risankizumab in Crohn's disease is not approved in the European Union, and its safety and efficacy remain under evaluation.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.3,4 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.3,4 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.14,15
About the ADVANCE and MOTIVATE Inductions
Studies, and the FORTIFY Maintenance Study1,2,8-10
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of risankizumab 600 mg and 1200 mg as induction therapy, and risankizumab 180 mg and 360 mg as maintenance therapy in subjects with moderately to severely active Crohn's disease. Topline results of the ADVANCE and MOTIVATE induction studies were announced in January 2021 and topline results of the FORTIFY maintenance study were announced in June 2021.
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.11,16 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.11,16 The approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the European Union is 150 mg (either as two 75 mg prefilled syringe injections or one 150 mg prefilled pen or prefilled syringe) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter.11 The use of risankizumab in Crohn's disease is not approved in the European Union and its safety remains under review with the global regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.12,13,17
EU Indications and Important Safety Information about SKYRIZI® (risankizumab)11
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.
SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.
About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.
Glaukos | September 12, 2022
Glaukos Corporation an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases announced a significant milestone as its iStent® family of technologies have now been implanted in more than one million procedures worldwide. This market-leading milestone is a testament to the decades of investment from Glaukos as the corporate founder and pioneer of the now well-established micro-invasive glaucoma surgery (MIGS) marketplace.
“One million iStents implanted is a tremendous accomplishment and I’m grateful to Glaukos for their continued dedication, investment and pioneering spirit to advance the development of innovative glaucoma technologies designed to improve the treatment paradigm for the benefit of patients worldwide,” said Ike Ahmed MD, Professor, Department of Ophthalmology and Visual Sciences at John A. Moran Eye Center in Utah, United States and Chief Innovation Officer at Prism Eye Institute in Toronto, Canada. “As one of the early adopters, I have experienced first-hand how iStent, as the first MIGS device, and subsequent generations have fundamentally revolutionized the way we think and treat glaucoma over the last decade. Today, the disease state is more manageable, and we are intervening earlier with micro-invasive surgical options. It’s been an incredible journey thus far and I’m excited to see what the future holds for our glaucoma patients.”
“iStent technologies have allowed me to change the way I treat my patients for the better. Before the introduction of iStent and MIGS, we were limited to eye drops, which we know to be problematic for patients, or invasive surgery that carried more risk than needed for mild-to-moderate glaucoma. iStent filled that gap between eye drops and invasive surgery. In my practice today, iStent inject W is my most commonly used surgical option for glaucoma patients undergoing cataract surgery. We now have patient data out past 9 years in my practice showing the iStent is still effective and safe at lowering IOP and reducing medications. I’m eagerly anticipating the exciting future innovations from Glaukos.”
John Berdahl, MD, Vance Thompson Vision, South Dakota
“I am proud of this tremendous achievement for our company and the MIGS marketplace, reflecting decades of investment and successful advancement of our strategic vision to transform the treatment of chronic, debilitating eye diseases through development of novel, sustainable therapies,” said Thomas Burns, Glaukos chairman and chief executive officer. “I would like to recognize our customers and employees around the world who have poured countless hours into making this market-leading achievement a reality and am grateful for their continued support going forward as we strive to create transformative platform technologies designed to improve the standard-of-care and meet unmet patient needs.”
Glaukos is proud to be the corporate pioneer and global market leader in MIGS, with its family of iStent technologies supported by more than 200 peer-reviewed publications, 20 plus years of clinical and commercial experience and more than one million iStent devices implanted worldwide since its inception. The company believes it offers the industry’s most comprehensive offering of minimally-invasive, tissue-sparing glaucoma solutions, supporting its goal to provide a full range of options to fit surgeons’ individual glaucoma treatment algorithms that offer the most favorable short- and long-term benefit-to-risk calculus at every stage of disease progression, from ocular hypertension through refractory disease, and in both combo-cataract and standalone procedures. Glaukos remains dedicated to innovation and bringing customers around the world best-in-class technologies to serve their patients, continuing to invest upwards of 30% of revenue back into R&D, including new product development. A significant number of clinical studies for both current and future products are ongoing, with additional studies commencing in the near future.
Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.
About iStent inject W Trabecular Micro-Bypass System (U.S.)
Indication for Use: The iStent inject W Trabecular Micro-Bypass System Model G2-W is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma.