Psoriasis and cardio drugs drive Novartis’ Q1 sales

pharmaphorum | April 24, 2019

Novartis has begun 2019 at a sprint, upgrading its sales forecasts for the year after strong performances from psoriasis drug Cosentyx and cardiology medicine Entresto. The company’s revolutionary CAR-T cancer cell therapy Kymriah has also begun to gain traction after a slow launch, according to the Q1 figures. Novartis has forecast a $4.7 billion windfall next quarter from the company’s decision to spin off its Alcon eye care business as part of its new focus on innovative medicines and therapies under new CEO Vas Narasimhan. Novartis now expects core operating income growth at a high-single-digit percentage rate, with sales growing in the mid-single-digit percentage range. Before today’s results it had forecast net sales growing by a low- to mid-single-digit percentage, with core operating income up at a mid-single-digit rate. Figures show that first quarter net income rose 13% at constant exchange rates to $2.81 billion, ahead of expectations of around $2.76 billion consensus predicted by a poll cited by Reuters.

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Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg

Akorn Pharmaceuticals | August 17, 2022

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1 "We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics." Akorn President and CEO Douglas Boothe Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2 The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix. According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million. About Cetrorelix Acetate for Injection 0.25 mg Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called gonadotropin‐releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation. About Akorn Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products.

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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.

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SS&C Partners with Xcentuate to Support Customer Digital Transformation Journeys

SS&C | June 23, 2022

SS&C Technologies Holdings, Inc. announced a new partnership in the EMEA and APAC regions with Xcentuate, an award-winning international provider of digital productivity and performance solutions to the financial services, agricultural, pharma and public sectors. The partnership follows SS&C's recent acquisition of Blue Prism, the leading Robotic Process Automation provider, further demonstrating its commitment to the intelligent automation solutions market. Xcentuate, based in Dublin, Ireland, will serve as a consulting and implementation partner, acting as an extended team to advise, implement, support and deliver complex projects. "We are delighted to partner with Xcentuate," said Gautam Moorjani, General Manager, SS&C Intelligent Automation Solutions. "The EMEA and the Asia Pacific regions are markets with a lot of appeal - with resilient and developing economies and talented, skilled workforce. In addition, the potential for operational automation to transform how businesses work is significant." The partnership will enable SS&C to leverage Xcentuate's vast experience to access new potential customers, take new value propositions to market, develop point solutions to address current market needs, and enhance its specialized professional services to our customers. "The SS&C partnership is of significant strategic importance to us regarding our offer to the market. The breadth and depth of SS&C's expertise in financial services and healthcare technology are unmatched. In addition, this new partnership further broadens the suite of services we can offer to firms in EMEA and the Asia Pacific with an ambitious digital transformation agenda." Ray Bowe, Xcentuate founder and CEO About Xcentuate Headquartered in Dublin, Ireland, Xcentuate serves a range of industries including financial services, agriculture, pharma and public sector. Xcentuate works with customers in EMEA and Asia-Pacific regions to transform their business operations using a suite of best-in-class technology to deliver sustainable advantage. Combined with award-winning operational expertise and a track record of delivery, they support businesses in transforming their customer experiences and enabling them to optimise control and productivity while building an engaged, enthused workforce. About SS&C Technologies SS&C is a global provider of services and software for the financial services and healthcare industries. Founded in 1986, SS&C is headquartered in Windsor, Connecticut, and has offices around the world. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale and technology.

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Athira Pharma Announces Topline Results from ACT-AD Phase 2 Proof of Concept Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

Athira Pharma, Inc. | June 27, 2022

Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced topline results from its exploratory ACT-AD Phase 2 study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. Fosgonimeton is a small molecule designed to enhance the activity of Hepatocyte Growth Factor and its receptor, MET, which are expressed in the central nervous system to promote brain health and function. “Following compelling ERP P300 latency biomarker data from a small Phase 1b trial over eight days in Alzheimer’s patients on fosgonimeton monotherapy, this Phase 2 trial provides valuable insights into the nature of this novel intervention over 26 weeks. ACT-AD was designed as a learning study to further investigate the ERP P300 biomarker signal over 6 months, assess safety in a patient population more representative of the real world, by allowing the use of add-on standard-of-care acetylcholinesterase inhibitors (AChEIs, e.g., donepezil), and explore fosgonimeton’s effect on psychometric outcomes, including ADAS-Cog11, to inform the ongoing Phase 3 LIFT-AD study. To that end, this study achieved its goal,” said Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira. “The study was intended to show differences on the biomarker ERP P300 latency. This primary endpoint was not met by protocoled analysis, however a pre-specified subgroup analysis indicated a potential diminished effect of fosgonimeton when given in combination with AChEIs. A subsequent post hoc analysis of the data from patients on fosgonimeton monotherapy showed a meaningful improvement in both ERP P300 latency and cognitive performance compared to placebo at 26 weeks. “These data points are very encouraging as they indicate the expected pharmacological activity of fosgonimeton by parallel improvement on ERP P300 latency and ADAS-Cog11 and show a favorable safety profile over six months. This is the first time monotherapy fosgonimeton has shown an effect on ADAS-Cog11, suggesting a potential cognitive benefit. We will use these insights for a rational optimization of the ongoing LIFT-AD trial. We plan to seek advice from our scientific advisors, investigators, and ultimately regulators on how to expeditiously analyze and potentially adapt the LIFT-AD study,” Dr. Moebius “The data from the fosgonimeton monotherapy analysis are encouraging and show biologic activity that may support the potential role of the HGF/MET pathway in neurodegenerative diseases,” said Marwan Sabbagh, M.D., FAAN, professor of neurology at Barrow Neurological Institute, Phoenix, AZ. “ACT-AD adds to the body of literature suggesting ERP P300 latency as an important biomarker for cognitive status.”

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Janssen Supply Chain (JSC) is at the forefront of CM advancement, focusing on a more reliable process that will yield waste reduction and time to market savings especially important in the pharmaceutical industry in light of breakthrough therapies.

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