CGRP receptor

SAN DIEGO--( BUSINESS WIRE )--Nuvie Bio, a new clinical-stage biopharmaceutical company dedicated to addressing the most pressing unmet medical needs in migraine and related neurological diseases, announced completion of a first-in-human trial with NVI-100, the company’s lead investigational drug for the acute treatment of migraine. NVI-100 is a first-in-class water-soluble peptide antagonist for the calcitonin gene-related peptide (CGRP) receptor delivered via a patient-friendly autoinjector for the acute treatment of migraine. The Phase 1 study in healthy volunteers has shown that NVI-100 is well-tolerated and achieves rapid, high and consistent plasma levels. Nuvie Bio plans to file an Investigational New Drug (IND) application for NVI-100 later this year, clearing the way for the start of its Phase 2 clinical trial. “ We are developing the first rapidly absorbed subcutaneous CGRP receptor antagonist, with the goal to provide rapid relief from migraine to millions of people who are not satisfied with existing therapies,” said Pierre Rivière, Ph.D., co-founder and CEO of Nuvie Bio. “ We are extremely pleased with the results of the NVI-100 Phase 1 study. The human pharmacokinetics data support that NVI-100 is the first CGRP receptor antagonist with the potential to deliver fast, high and consistent efficacy, which combined with the tolerability associated with this clinically validated mechanism of action, could profoundly transform the acute treatment of migraine.” “ It is an exciting time to be involved in caring for people with migraine because of the significant advancements in treatments we have seen in recent years,” said Richard B. Lipton, M.D., Professor and Vice Chair of Neurology, Albert Einstein College of Medicine, and director, Montefiore Headache Center. “ NVI-100 has the potential to be the next breakthrough in acute treatment, providing rapid relief of migraine through subcutaneous administration with the high tolerability we associate with CGRP-targeted therapies.” Nuvie Bio was co-founded by Pierre Rivière, Ph.D., CEO; Frank Porreca, Ph.D., CSO; and David Dodick, M.D., chair of the scientific advisory board. Their combined expertise spans basic and clinical science in migraine and peptide therapeutics research and development. Working alongside them is a senior management team that has significantly contributed to previous therapeutic innovations in migraine. Originally discovered by Ferring Pharmaceuticals, NVI-100 (also known as AXN-001, FE205030) is now under exclusive worldwide development and commercialization rights by Nuvie Bio. About Migraine Migraine is the second most disabling neurological disease globally, disproportionately affecting women (about 3:1 female:male prevalence ratio). Migraine impacts over one billion people worldwide and accounts for over 45 million disability-adjusted life-years (DALYs). One DALY represents the loss of the equivalent of one year of full health. Despite recent advancements in migraine treatment, patients and healthcare providers continue to seek better acute treatments, particularly those offering “speed to relief that is tolerable.” About Nuvie Bio Nuvie Bio is a clinical-stage biopharmaceutical company on the forefront of innovation in neuroscience. Meaning "New Life," Nuvie Bio’s mission is to offer a better life to millions of people impacted by migraine and related neurological diseases. Nuvie Bio’s lead investigational drug, NVI-100, is a first-in-class water-soluble peptide CGRP receptor antagonist to be given subcutaneously by autoinjector for the acute treatment of migraine. NVI-100 is designed to deliver fast relief that patients can tolerate, eliminating the need to choose between efficacy and tolerability. The company is led by an executive team with decades of neuroscience and migraine product development and commercialization experience and is supported by a scientific advisory board of preeminent experts in migraine and brain disorders. For more information, visit www.nuviebio.com .

QULIPTA is now the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved to prevent migraine across all frequencies, including episodic and chronic. Expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities. Approval was based on a pivotal Phase 3 clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days. AbbVie is the only pharmaceutical company to offer three treatments across the full spectrum of migraine to help patients living with this debilitating disease. MONTRÉAL, May 8, 2024 /CNW/ - AbbVie (NYSE: ABBV) announced today that Health Canada has approved QULIPTA (atogepant) for the prevention of migraine in adults who have at least four migraine days per month.1 QULIPTA is the first and only oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved to prevent both episodic and chronic migraine. "QULIPTA has been helping thousands of Canadians living with episodic migraine since December 2022. Now, QULIPTA offers a new option for those with the most challenging-to-treat chronic migraine," says Rami Fayed, Vice President and General Manager, AbbVie Canada. "With this approval, AbbVie is the only pharmaceutical company with three treatments across the entire migraine spectrum, including QULIPTA as a preventive treatment for both episodic and chronic migraine, BOTOX® (onabotulinumtoxinA) our foundational preventive treatment for chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for migraine attacks." QULIPTA's expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction of -6.9 from baseline in mean monthly migraine days compared to placebo of -5.1 across the 12-week treatment period.2 The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19.2. "Chronic migraine is incredibly debilitating for my patients. It makes day-to-day activities often unbearable, and isolates you from friends, family, and work," says Dr Ian Finkelstein, Medical Director of the Toronto Headache & Pain Clinic. "I have observed QULIPTA's ability to alleviate the challenges posed by episodic migraine in many of my patients, resulting in improved functionality, impressive response rates, and sustained efficacy. I'm excited to see Health Canada's approval of QULIPTA for chronic migraine and to be able to offer another treatment option to patients to help them successfully prevent their migraines." QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine. The overall safety pro QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including nausea, constipation, diarrhoea, and fatigue.1 "Bringing new migraine-specific medications to Canadians living with migraine is critical as so many have yet to find the relief they seek," says Wendy Gerhart, Executive Director of Migraine Canada. "Chronic migraine is a constant struggle for too many. We are pleased to see the approval of QULIPTA for this indication providing another safe and effective option and are confident it will have a positive impact on our community." About Migraine Migraine is a complex neurological disease with recurrent attacks that lasts 4-72 hours. It can be defined by symptoms such as moderate to severe pain intensity, nausea, vomiting, photophobia and phonophobia.3 An estimated 2.7 million Canadians are reported diagnosed with migraine, however the number of people living with migraine is much higher.4 Episodic migraine is characterized as having less than 15 headache days per month, while 15 headache days or more per month, is considered chronic.5 About QULIPTA (atogepant) QULIPTA (atogepant) is the first and only oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of episodic and chronic migraine. QULIPTA is an orally administered, small-molecule, selective calcitonin gene-related peptide (CGRP) receptor antagonist that blocks the binding of the CGRP to its receptor. CGRP is a neuropeptide that may play a role in migraine pathophysiology.1 For important safety information, please consult the QULIPTA Product Monograph. About AbbVie in Neuroscience At AbbVie, our commitment to people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow AbbVie Canada on X, Instagram, or LinkedIn. For more information on AbbVie's complete migraine portfolio, please visit SOURCE AbbVie Canada Company Codes: NYSE:ABBV

Pfizer reported better-than-expected first-quarter revenue and raised its full-year profit outlook on Wednesday, benefiting from its broad cost-cutting programme, a smaller-than-feared drop in sales of its oral COVID-19 antiviral Paxlovid, and strong performance from some of its other products.The pharma now expects to book adjusted earnings of $2.15 to $2.35 per share for the year, up from its prior guidance of $2.05 to $2.25 per share. Pfizer also reiterated its previous revenue forecast of $58.5 billion to $61.5 billion.Paxlovid softens post-pandemic blowIts COVID-19 products, the vaccine Comirnaty it shares with BioNTech and oral antiviral Paxlovid, saw significant sales decreases as demand has sunk to new lows. However, the declines were less severe than anticipated.Paxlovid booked $2 billion in sales for the quarter, down 50% from the same period a year ago, yet coming in well above the $762.5 million analysts were expecting. The company recorded a $771-million favourable adjustment due to the return of unused Paxlovid treatment courses by the US government. Meanwhile, Comirnaty generated $354 million, down 88% from the year-earlier period and falling short of projections of $496.5 million.Oncology boost from SeagenExcluding COVID-19 products, Pfizer said revenue for the first quarter rose 11%. Growth was partly fueled by the company's $43-billion acquisition of Seagen, whose legacy products including the targeted cancer therapies Padcev and Adcetris contributed a combined $742 million in quarterly revenue. However, Adcetris sales still fell short of analyst expectations.Other non-COVID-19 products that helped spur sales growth included the blood thinner Eliquis (+9% to $2 billion), the Vyndaqel family of cardiomyopathy drugs (+66% to $1.1 billion), and the Prevnar pneumococcal vaccine franchise (+6 to $1.7 billion).However, Pfizer's new RSV vaccine Abrysvo saw just $145 million in sales, far short of analysts' estimate of $360 million, while the breast cancer drug Ibrance posted an 8% decline in revenue to $1.1 billion.Cost cuts fuel outlook raise"We believe stronger new launch performance and further progress on the pipeline will be necessary to change the current narrative on the stock," commented JP Morgan analyst Chris Schott.Pfizer said its updated profit guidance "takes into consideration our confidence in delivering on our cost realignment programme target," adding it is on track to deliver at least $4 billion in savings by the end of the year.First-quarter sales totaled $14.9 billion overall, which was 20% lower than the same period a year ago, while net income was down 44% at $3.1 billion.Pipeline cutsMeanwhile, the drugmaker also culled some programmes from its pipeline, including discontinuing development of VTX-801, a gene therapy candidate partnered with Vivet Therapeutics that was in Phase I for Wilson's disease. In addition, it scrapped potential new indications for its S1P inhibitor Velsipity (etrasimod) in atopic dermatitis and alopecia areata, as well as a migraine prevention programme for its oral CGRP receptor antagonist Zavzpret (zavegepant), all of which had reached Phase II testing.