Author: Michelle Dryden

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Business Healthcare Science

Teva announces FDA approval of AUSTEDO® XR (deutetrabenazine) extended-release tablets, a new once-daily formulation of AUSTEDO® (deutetrabenazine) tablets

  • New once-daily AUSTEDO XR regimen now approved in 6, 12, and 24 mg tablet strengths
  • AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibitor approved for both tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD) indications1,2
  • AUSTEDO is the only VMAT2 inhibitor with 3-year long-term data for both TD and HD chorea1,2

 

TEL AVIV, Israel & PARSIPPANY, N.J. — (BUSINESS WIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO XR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO.

 

“The approval of AUSTEDO XR is a reflection of our ongoing innovation for people living with TD and HD chorea,” said Eric Hughes, MD, PhD, Executive Vice President of R&D and Chief Medical Officer at Teva. “For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address.”

 

Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice. It will be available in three extended-release tablet strengths – 6 mg, 12 mg, and 24 mg – and can be taken with or without food. The new tablet strengths provide an updated regimen which may result in a decreased pill count for patients compared to the twice-daily formulation.

 

“Today’s approval marks an exciting milestone for patients with TD and HD chorea,” said Sven Dethlefs, PhD, Executive Vice President, North America Commercial at Teva. “Our commitment to patients suffering with these diseases is unwavering and we will continue our mission to address the needs of patients with neurodegenerative disorders.”

 

Since 2017, Teva has been supporting patients with TD and HD chorea and their prescribers by providing an effective treatment. AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibitor with 3-year data for both the TD and HD chorea indications. TD is a highly debilitating movement disorder affecting one in four people who take certain mental health treatments. Chorea associated with HD is involuntary, random and sudden, twisting and/or writhing movements associated with this devastating disease.

 

AUSTEDO XR is expected to be available in the U.S. later this year.

 

About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets

AUSTEDO XR/AUSTEDO is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia (TD) and for the treatment of chorea associated with Huntington’s disease (HD). AUSTEDO XR is the once-daily formulation of AUSTEDO. TD is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals. HD is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington’s disease and occurs in approximately 90% of patients. Chorea can have a significant impact on daily activities and progressively limit peoples’ lives. Safety and effectiveness in pediatric patients have not been established.

 

INDICATIONS AND USAGE

AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

 

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

 

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.

 

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.

 

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

 

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

 

Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

 

Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

 

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

 

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.

 

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

 

Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.

 

Please see accompanying full Prescribing Information, including Boxed Warning.

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at www.tevapharm.com.

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of AUSTEDO (deutetrabenazine) tablets and AUSTEDO XR (deutetrabenazine) extended-release tablets; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO, AJOVY® and COPAXONE®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

_____________________________

1 Hauser, R. A., Barkay, H., Fernandez, H. H. et al. Long-Term Deutetrabenazine Treatment for Tardive Dyskinesia is Associated with Sustained Benefits and Safety: A 3-Year, Open-Label Extension Study. Frontiers in Neurology (2022). https://doi.org/10.3389/fneur.2022.773999.

2 Frank, S., Testa, C., Edmondson, M.C. et al. The Safety of Deutetrabenazine for Chorea in Huntington Disease: An Open-Label Extension Study. CNS Drugs (2022). https://doi.org/10.1007/s40263-022-00956-8.

Contacts

IR

United States
Ran Meir

(267) 468-4475

Yael Ashman

972 (3) 914-8262

PR

United States
Doris Yiu

(973) 265-3752

Yonatan Beker

(973) 917-0851

Categories
Business

AM Best downgrades Issuer Credit Rating of Mercury General Corporation and its core subsidiaries; upgrades Credit Ratings of reinsured subsidiaries

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has downgraded the Long-Term Issuer Credit Ratings (Long-Term ICR) to “a” (Excellent) from “a+” (Excellent) and affirmed the Financial Strength Rating (FSR) of A (Excellent) of certain members of Mercury Casualty Group (Mercury). Additionally, AM Best has upgraded the FSR to A (Excellent) from A- (Excellent) and the Long-Term ICRs to “a” (Excellent) from “a-” (Excellent) of the three members of the American Mercury Insurance Group that were previously rated as a separate rating unit but now are reinsured by Mercury Casualty Company (Brea, CA) and rated as part of Mercury.

Concurrently, AM Best has downgraded the Long-Term ICR to “bbb” (Good) from “bbb+” (Good) of the organization’s publicly traded ultimate parent, Mercury General Corporation (MGC) (Los Angeles, CA) [NYSE: MCY]. AM Best also has downgraded the Long-Term Issue Credit Rating to “bbb” (Good) from “bbb+” (Good) of MGC’s $375 million, 4.4% senior unsecured notes, due 2027.

 

The outlook of these Credit Ratings (ratings) is stable. See below for a listing of the companies.

 

The ratings of Mercury reflect the group’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management (ERM).

 

The Long-Term ICR downgrades of Mercury and MGC consider their significant earnings deterioration in 2022, driven by unfavorable operating performance resulting from increased claim frequency and from severity caused largely by inflationary trends, as well as declining investment performance driven by investment market volatility. Furthermore, Mercury’s weakened underwriting performance has been exacerbated by its concentration in California, where the regulatory environment was challenging in 2022, particularly with respect to the company’s and other insurers’ difficulty in achieving premium rate increases, especially with respect to the private passenger auto line of business, which comprises most of Mercury’s underwritten portfolio.

 

AM Best notes that Mercury has implemented detailed strategic initiatives to restore underwriting profitability, which include rate and non-rate actions. In January 2023, Mercury received regulatory approval for a California personal automobile rate increase of 6.9%, effective March 2023, which should strengthen its prospective underwriting performance. AM Best expects the group’s earnings to improve gradually in 2023.

 

The Long-Term ICRs have been downgraded to “a” (Excellent) from “a+” (Excellent) and the FSR of A (Excellent) affirmed with stable outlooks for the following members of Mercury Casualty Group:

 

  • Mercury Casualty Company
  • Mercury Insurance Company
  • California Automobile Insurance Company
  • California General Underwriters Insurance Company, Inc.
  • Mercury Indemnity Company of Georgia
  • Mercury Insurance Company of Georgia
  • Mercury Insurance Company of Illinois
  • Mercury Indemnity Company of America
  • Orion Indemnity Company

 

The FSR has been upgraded to A (Excellent) from A- (Excellent) and the Long-Term ICRs upgraded to “a” (Excellent) from “a-” (Excellent) with stable outlooks for the newly added reinsured affiliates of Mercury Casualty Company:

 

  • American Mercury Insurance Company
  • American Mercury Lloyds Insurance Company
  • Mercury County Mutual Insurance Company

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Billiah Moturi
Financial Analyst
+1 908 439 2200, ext. 5509
billiah.moturi@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159

christopher.sharkey@ambest.com

Alan Murray
Associate Director
+1 908 439 2200, ext. 5535
alan.murray@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Culture Lifestyle

How trusted communications superheroes are winning the battle against fraud and operational inefficiency to protect customers and the bottom line

iconectiv executives showcase how communication service providers are mitigating fraud, caller ID spoofing, smishing, illegal robocalling, network inefficiency and more

 

  • What’s the News: Years of rapid technology and regulatory innovation have created major revenue streams and market opportunities for service providers. They have also increased the need for new ways to mitigate fraud, errors and inefficiencies.
  • Why it Matters: Fraud like illegal robocalls, nuisance calls and messaging spam undermine consumer trust, creating business challenges for service providers, their enterprise customers and consumers. In the shadows of service providers globally, a squadron of advanced and intelligent superheroes are diligently working to keep the integrity of the communications infrastructure and the relevancy of the communication channels intact.

 

BRIDGEWATER, N.J. — (BUSINESS WIRE) — Consumers and businesses depend on voice calls and SMS not only to communicate, but also to enable security safeguards such as two-factor authentication for bank accounts. That’s why fraudsters also look to voice and SMS for illegal robocalling, smishing, account takeovers, PBX hacking, one-ring scams and other types of communication fraud.

By mitigating fraud, a squadron of trusted communication superheroes are using their powers to help service providers protect their customers and their bottom line. They are equally vigilant about combatting the operational challenges that are the unfortunate byproducts of the rapid technology and regulatory innovation that benefits consumers and business alike.

 

At MWC Barcelona 2023, iconectiv executives will highlight the work of the industry’s Superheroes—who are propelling the communications industry’s momentum by keeping people connected, businesses running and commerce flowing. They will also discuss the progress that service providers, regulators and associations such as CTIA, ATIS and GSMA are making to protect businesses and consumers and boost operational efficiency. For example:

 

  • Not knowing a customer’s identity is expensive, especially for service providers forced to cover the cost of one-ring scams as well as other PBX hacking, international revenue share fraud (IRSF), interconnection-related revenue leakage and fraudulent roaming calls to premium-rate services. iconectiv TruNumber Protect gives service providers intelligence for telephone numbers worldwide, cutting down one-ring scam calls and text messages.
  • Service providers will invest $900B in their networks from 2021 to 2025, of which more than 80% will be on 5G. Keeping customers happy while knowing what equipment and capabilities they have and don’t have means systems must work together across business units, domains and locations. A naming standard like iconectiv TruOps Common Language® accomplishes this by identifying and protecting network assets in a consistent manner.
  • Each year, 252 million wireless subscribers around the world change their phone service provider, which means service providers are dealing with increasing account turnover, which also opens the door to fraud. iconectiv TruNumber Routing allows service providers to instantly validate the terminating service provider and determine the optimal, least-cost route to a successful call.

“Illegal robocallers and other fraudsters aren’t the only villains attacking the trusted communications ecosystem. They’re joined by network and asset management complexities that undermine service providers’ bottom lines, making it challenging to continue innovating,” said Richard Jacowleff, iconectiv CEO. “But those villains are losing the battle on every front thanks to the growing legion of Trusted Communication Superheroes. From porting numbers to rolling out 5G, they’re thwarting fraudsters, restoring consumer trust and ferreting out inefficiency and inaccuracy needed to accelerate digital transformation efforts and move conversation commerce forward.”

 

MWC Barcelona 2023 attendees can learn more by visiting iconectiv in Hall 2 at Stand 201MR or by scheduling a meeting via events@iconectiv.com.

 

About iconectiv

Your business and your customers need to access and exchange information simply, seamlessly and securely. iconectiv’s extensive experience in information services and its unmatched numbering intelligence helps you do just that. In fact, more than 2 billion people count on our platforms each day to keep their networks, devices and applications connected. Our cloud-based Software as a Service (SaaS) solutions span network and operations management, numbering, trusted communications and fraud prevention. For more information, visit www.iconectiv.com. Follow us on Twitter and LinkedIn.

Contacts

Media Contact:
Sharon Oddy

iconectiv

+1-732-699-5130/908-809-2268

soddy@iconectiv.com

Casey Bush

Global Results Communications

+1-949-689-9550

iconectiv@globalresultspr.com

Categories
Environment Lifestyle Science Technology

FulcrumAir announces successful completion of pilot program to install BFDs using the latest in drone and robotic technology

WELLINGTON, CO. — (BUSINESS WIRE) — FulcrumAir is very pleased to announce that we have very successfully installed more than 1,500 Power Line Sentry Hawk Eye™ BFDs under a pilot program for Atlantic City Electric, which serves about 560,000 customers across southern New Jersey. The work was done by FulcrumAir, working in collaboration with MJ Electric, in South Jersey on five transmission lines in high-risk bird collision areas.


Patrick Arnell, CEO of FulcrumAir said, “We are very proud that Atlantic City Electric put the faith in us to demonstrate our industry leading technology. We have been working extremely hard on this for over five years and are excited to introduce it to the Pepco Holdings family of companies, which includes Atlantic City Electric.”

 

BFDs are installed on overhead wires where there is a risk of avian mortality and power outages due to bird strikes. By adopting the innovative installation technology developed by FulcrumAir, the Pepco Holdings companies can accelerate the implementation of their Avian Protection Programs due to the ease in which FulcrumAir’s equipment can be deployed. Road closures are no longer required to accommodate bucket trucks, helicopters are no longer required, and power outages no longer need to be taken.

 

Atlantic City Electric officials said that the pilot went very well, and they hope to have Fulcrum install more. “Atlantic City Electric is committed to providing safe and reliable service to our customers and communities, and a key part of that is the protection of wildlife and the environment,” said Cristina Frank, principal environmental program manager at Pepco Holdings, which includes Atlantic City Electric. “The successful pilot installation of BFDs took place where we have had known bird collision challenges. We see bird diverters installed by Fulcrum as an effective solution to protecting birds and look to leverage this innovative approach across Pepco Holdings.”

 

Atlantic City Electric is a unit of Exelon (Nasdaq: EXC), a Fortune 200 company and the nation’s largest utility company, serving more than 10 million customers. Atlantic City Electric provides clean, safe, reliable, and affordable energy service to approximately 560,000 customers in southern New Jersey.

 

FulcrumAir is a leader in the development Ariel Robotic Solutions for the Power line industry. New products are under development and will be released soon – stay tuned.

Contacts

For more information please do not hesitate to contact either:

Patrick Arnell

President/CEO

parnell@fulcrumair.com
(403) 617-0109

Greg Newara

Executive VP of Sales and Business Development

gnewara@fulcrumair.com
(561) 222-3846

Categories
Business Healthcare Lifestyle Local News Science

Investigational therapy UGN-102 may be delivered at home for the treatment of bladder cancer

–In a Small Feasibility Study, UGN-102 Achieves a Complete Response in 75% (6 of 8) Patients

–UGN-102 is Being Studied in Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

 

PRINCETON, N.J. — (BUSINESS WIRE) — UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced preliminary results of a study to assess the feasibility of home instillation of UGN-102 (mitomycin) for intravesical solution, an investigational therapy in development for primary chemoablation of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment.

 

“Many bladder cancer patients are elderly and suffer from comorbidities that make frequent office visits for treatment a real burden,” said study investigator David Morris, M.D., F.A.C.S., Urologist at Urology Associates PC, Nashville, TN. “Moving healthcare out of the clinical setting and into a patient’s home would represent a new treatment paradigm for bladder cancer, which may reduce clinic and hospital costs while increasing patient comfort and convenience.”

 

Eight patients were enrolled and treated with UGN-102 by 4 investigators. Median age was 75 years (range 55-84). Six patients completed treatment (6 doses), and 2 patients discontinued the study (5 doses and 4 doses, respectively) due to adverse events (AEs) unrelated to treatment. All 8 patients were evaluable for treatment response, and 6 of 8 (75%) achieved a complete response 3 months after starting treatment. The 2 patients who discontinued were assessed as non-responders. Treatment-related AEs were mild to moderate in severity (most common: dysuria and fatigue in 2 patients), and 3 patients with significant comorbidities had a serious AE, all of which were unrelated to treatment with UGN-102.

 

Patients, nurses and investigators completed home instillation feasibility questionnaires. These standardized feasibility questionnaires highlighted that all 8 patients preferred at-home to in-office treatment, and 5 of 6 patients recommended UGN-102 home instillation instead of transurethral resection of bladder tumors (TURBT). Home instillation was reported as feasible for visiting nurses, and 3 of 4 investigators considered at-home treatment “not different” than in-office treatment.

 

“As a urologic oncologist, I feel confident that the home instillation study results, appearing on the heels of our Phase 2 program and following the complete enrollment of our pivotal Phase 3 ENVISION study for UGN-102, provide us with even more reasons to believe that our novel approach to treating LG-IR-NMIBC has the potential to address genuine unmet needs of patients with bladder cancer,” said Arie Belldegrun, M.D., Board Chair of UroGen.

 

The study enrolled patients with recurrent LG-IR-NMIBC who agreed to receive UGN‑102 at home. Six weekly doses of UGN-102 were administered. The first dose was administered on-site by a physician and the five remaining doses were administered at home by a visiting nurse. Patients were followed for AEs and treatment response was evaluated by visual observation, for cause biopsy, and urine cytology 3 months after treatment initiation. Complete response was defined as the absence of disease by white light cystoscopy, cytology, and histopathology.

 

“This study is another example of how UroGen continues to advance its mission to pioneer the way urothelial cancers are treated,” says Liz Barrett, President and Chief Executive Officer, UroGen. “2023 will be a pivotal year for UroGen as we report on the ATLAS study of UGN-102 and start combinatorial treatments in the Phase 1 study of UGN-301. UroGen is in a strong position to achieve leadership in uro-oncology.”

 

About LG-IR-NMIBC

Approximately 800,000 people are living with bladder cancer in the U.S., of that 80,000 suffer from LG-IR-NMIBC. Patients with LG-IR-NMIBC face a future of recurrence and additional surgeries. Currently, the only primary treatment available is a surgical procedure known as TURBT, which requires anesthesia. Every time TURBT is performed it may impose more burden and serious risks on patients, including pain, bleeding, infection and injury (including perforation).

 

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.

 

About UroGen Pharma Ltd.

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first commercial product, and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with LG-IR-NMIBC, are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.

 

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the Home Instillation Study of UGN-102, and the encouraging results from this study; the design and potential benefits of UGN-102 for the treatment of LG-IR-NMIBC, including benefits related to at home administration; the ongoing Phase 3 ENVISION trial and the design, timing and potential benefits thereof; UroGen’s plans to submit an NDA for UGN-102 and the expected timing thereof; UroGen’s optimism regarding the clinical potential of UGN-102, including UroGen’s belief that UGN-102 meets unmet needs of patients with bladder cancer; UroGen’s expectations for 2023, including that 2023 will be a pivotal year, the reporting on the ATLAS study of UGN-102 and start of combinatorial treatments in the Phase 1 study of UGN-301; management’s belief that UroGen is in a strong position to achieve leadership in uro-oncology; the potential of UroGen’s proprietary RTGel® technology to improve therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary results from the Home Instillation Study of UGN-102 may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety or other complications thereof, including the Phase 3 ENVISION trial; unforeseen delays that may impact the timing of progressing clinical trials and reporting data; the ability to obtain regulatory approval within the timeframe expected, or at all, and to maintain regulatory approval; complications associated with commercialization activities; UroGen’s ability to attract or retain key management, members of the board of directors and personnel; the labeling for any approved product; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s product and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; and UroGen’s RTGel technology may not perform as expected and UroGen may not successfully develop and receive regulatory approval of any other product that incorporates our RTGel technology. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Form 10-Q filed with the SEC on November 10, 2022 and other filings that UroGen makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.

Contacts

INVESTORS:
Vincent Perrone

Sr. Director, Investor Relations

vincent.perrone@urogen.com
609-460-3588 ext. 1093

MEDIA:
Cindy Romano

Director, Communications

cindy.romano@urogen.com
609-460-3583 ext. 1083

Categories
Business

Best’s Market Segment Report: Hard market gives way to changing dynamics for U.S. Directors and Officers insurers

OLDWICK, N.J. — (BUSINESS WIRE) — A key question in the U.S. directors and officers (D&O) insurance segment is whether carriers can sustain their recent, more favorable results given less aggressive pricing amid high social inflation and inflationary economic pressure, according to a new AM Best report.

The Best’s Market Segment Report, “Hard Market Gives Way to Changing Dynamics for D&O Insurers,” states that aggressive double-digit pricing increases in 2020-2021 benefited current bottom-line results. However, rate and price softening has become the norm and has led to declining premiums because of improving loss trends. In addition, competition in the D&O segment has risen, as established markets defend their positions on renewals and new entrants make their presence felt.

 

Despite decelerating pricing increases of between 7-8%, D&O liability direct premium written decreased to $9.7 billion for the first nine months of 2022 from $10.3 billion in the same prior-year period, driven by a decrease in exposure. With year-over-year D&O liability premiums dropping and resulting premiums growing at a level slightly below economic inflation, the segment could be susceptible to the continuing effects of social inflation on existing open claims.

 

“The pandemic-driven court backlogs has lengthened the tail on liability claims for D&O insurers. The high number of cases litigated and the duration of litigation may result in elevated legal expenses, raising defense and cost containment expenses. If social inflation drives an increase in ultimate incurred losses, D&O insurers’ bottom line would be impacted negatively,” said Christopher Graham, senior industry analyst, AM Best.

 

The number of IPOs declined dramatically in 2022, according to the report, down to just 110 from 968 in 2021. Just as the IPOs fueled premium growth over the prior two years, the substantial cutback in IPOs is a key driver behind the drop in D&O liability direct premium in 2022. Many companies that purchased D&O insurance for first-dollar coverage are instead buying only excess insurance, taking premium away from the overall marketplace.

 

“If severity does not improve as claims work their way through the court system, some insurers may find that the less conservative pricing stance taken during 2022 and into 2023 is not supported by actual results and could cause the winds of change to blow in a direction that is once again not favorable for policyholders,” said David Blades. associate director, industry research and analytics, AM Best.

 

To access this market segment report, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=328792.

 

A video discussion about this market segment report is available at http://www.ambest.com/v.asp?v=ambdandoreport223.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by AM Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Christopher Graham
Senior Industry Analyst
+1 908 439 2200, ext. 5743
christopher.graham@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

David Blades
Associate Director, Industry Research and Analytics
+1 908 439 2200, ext. 5422
david.blades@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Regulations & Security

Bronstein, Gewirtz & Grossman, LLC notifies shareholders of Canoo, Inc. (GOEV) investigation

NEW YORK — (BUSINESS WIRE) — $GOEV #classaction — Attorney Advertising–Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Hennessy Capital Acquisition Corp., which merged with Canoo, Inc. (“Canoo” or “the Company”) (NASDAQ: GOEV) on December 22, 2020. Such investors who continue to hold to the present are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: www.bgandg.com/goev.

The investigation concerns whether Hennessy Capital Acquisition Corp. failed to provide relevant information to its shareholders before the merger.

 

If you are aware of any facts relating to this investigation or hold Canoo shares, you can assist this investigation by visiting the firm’s site: www.bgandg.com/goev. You can also contact Peretz Bronstein or his Law Clerk and Clients Relations Manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.

 

Bronstein, Gewirtz & Grossman, LLC represents investors in securities fraud class actions and shareholder derivative suits. The firm has recovered hundreds of millions of dollars for investors nationwide. Attorney advertising. Prior results do not guarantee similar outcomes.

Contacts

Bronstein, Gewirtz & Grossman, LLC

Peretz Bronstein or Yael Nathanson

212-697-6484 | info@bgandg.com

Categories
Business

Item 9 Labs Corp. positioned for significant growth with expanding Cannabis Dispensary Franchise, Unity Rd.

Franchise builds Colorado presence; lays roots in New Jersey, Oklahoma, and South Dakota, ahead of approaching international acquisition

 

PHOENIX — (BUSINESS WIRE) — $INLB #cannabis — Unity Rd., the national cannabis dispensary franchise from Item 9 Labs Corp. (the “Company)” (OTCQX: INLB), enters 2023 on the heels of a banner year comprised of multiple dispensary openings and continued U.S. development, alongside an approaching transformational acquisition that will bring the brand into an international market and turn it into a top 10 global cannabis retailer.


Unity Rd. celebrated the following milestones and achievements in 2022:

 

  • Opened multiple shops and entered new development markets across the United States:
  • Item 9 Labs. Corp. signed a definitive agreement to acquire Sessions Cannabis (“Sessions”): In May, the Company signed a definitive agreement to acquire Sessions Cannabis, one of Canada’s largest cannabis retail franchisors. With an exponential increase in future store count to a combined 50-plus units across North America, the approaching acquisition will establish Item 9 Labs Corp. as the largest global and publicly traded cannabis franchise company. Sessions currently generates more than CA$80 million in annual systemwide sales and is continuing to grow rapidly with multiple openings already slated for the coming months. The Company expects the transaction to close in spring 2023.
  • Item 9 Labs Corp. announced it signed an Asset Purchase Agreement (“APA”) to acquire The Herbal Cure: Item 9 Labs Corp. signed an APA in March to acquire The Herbal Cure, a medicinal and recreational dispensary and cultivator operating in the desirable Washington Park neighborhood of Denver. Upon closing the acquisition, and subject to applicable approvals, the 1,500 square-foot dispensary will be transitioned over to Unity Rd. and become the brand’s future flagship location.
  • Unity Rd. named a ‘Best Cannabis Company to Work For’ by Cannabis Business Times: The first true national cannabis dispensary franchise brand in the U.S. was recognized as one of the ‘Best Cannabis Companies to Work For’ in the “dispensary” category of industry-leading publication, Cannabis Business Times’ 2022 list in March.

 

Additionally, Mike Weinberger, a founder of Unity Rd. and the brand’s former Chief Franchise Officer, was appointed to Chief Executive Officer of Item 9 Labs Corp. in November. His appointment marked the Company’s transitional steps forward as it prepares for its future as an international cannabis franchisor. Weinberger is a 20-plus-year franchise industry veteran who co-founded Unity Rd. in 2018 and grew the brand to more than 20 entrepreneurial groups that are driving development across 10-plus states.

 

“We are building a dedicated, national network of local dispensary owners with the right franchisees, who are excited to be early cannabis entrepreneurs, see the possibilities that lie ahead, and are eager to make a difference in their communities,” said Unity Rd. CEO Mike Weinberger. “Our Unity Rd. brand thrived last year with development across multiple U.S. markets and has promising acquisitions in the works that are key pieces in our overall business plan. We believe our ongoing efforts will significantly increase Unity Rd.’s footprint, and global brand presence, while staying true to our focus of keeping dispensary ownership in the hands of local entrepreneurs.”

 

Unity Rd. is actively seeking qualified franchise partners across several U.S. markets—including Colorado, Maine, Maryland, Michigan, Mississippi, New Mexico, Oklahoma, Virginia and Vermont.

 

To learn more about the Unity Rd. franchise opportunity, contact franchise@unityrd.com, call 720-923-5262 or visit unityrd.com.

 

ABOUT UNITY RD.:

Unity Rd. is the first national cannabis dispensary franchise model in the U.S. Since launching in 2018, Unity Rd. has always had one mission and vision in mind for the cannabis industry: to inspire confidence in the benefits of cannabis for all. From consumers to entire communities and investors, Unity Rd. was founded on the belief that everyone has a place in the budding $28 billion industry. The result: high-quality cannabis products guests can rely on that are sold in shops run by local entrepreneurs who are backed by Unity Rd.’s collective 200 years of legal cannabis and franchising experience. An industry pioneer, Unity Rd. is the retail franchise from Item 9 Labs Corp. (OTCQX: INLB). The franchise has been named one of the top cannabis retail leaders in the nation by MJBizDaily, became the first concept of its kind to become a member of the International Franchise Association (IFA) and was named one of the “Best Cannabis Companies to Work For” in the dispensary category of Cannabis Business Times’ 2023, 2022 and 2020 lists. Unity Rd. currently has four shops open and multiple agreements signed with 20-plus entrepreneurial groups who are developing the brand across 10-plus states. For more information, visit unityrd.com.

 

ABOUT ITEM 9 LABS CORP.

Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States. The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency and well-being. Headquartered in Arizona, the company is currently expanding its operations space up to 640,000-plus square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit item9labscorp.com.

 

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties, including, but not limited to, risks and effects of legal and administrative proceedings and governmental regulation, especially in a foreign country, future financial and operational results, competition, general economic conditions, proposed transactions that are not legally binding obligations of the company and the ability to manage and continue growth. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual outcomes may vary materially from those indicated. Important factors that could cause actual results to differ materially from the forward-looking statements we make in this news release include the introduction of new technology, market conditions and those set forth in reports or documents we file from time to time with the SEC. We undertake no obligation to revise or update such statements to reflect current events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contacts

Media Contact:
Klaudia Rudny

Item 9 Labs Corp.

PR & Content Specialist

krudny@unityrd.com

Investor Contact:
Item 9 Labs Corp.

800-403-1140

Investors@item9labscorp.com

Categories
Business

AM Best Places Credit Ratings of Argo Group International Holdings, Ltd. and its subsidiaries Under Review with developing implications

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has placed under review with developing implications the Long-Term Issuer Credit Rating (Long-Term ICR) of “bbb-” (Good) and the associated Long-Term Issue Credit Ratings (Long-Term IR) of Argo Group International Holdings, Ltd. (Argo Group) (Pembroke, Bermuda). Concurrently, AM Best has placed under review with developing implications the Financial Strength Rating of A- (Excellent) and the Long-Term ICRs of “a-” (Excellent) of its operating subsidiaries. At the same time, AM Best has placed under review with developing implications the Long-Term ICR of “bbb-” (Good) and the Long-Term IRs of Argo Group US, Inc. (headquartered in San Antonio, TX). (See below for a detailed listing of the companies and Credit Ratings [ratings].)

The rating actions follow the announcement that Argo Group and Brookfield Reinsurance Ltd. have entered into a definitive merger agreement whereby Brookfield Reinsurance Ltd. will acquire Argo Group in an all-cash transaction valued at approximately $1.1 billion. The sale has been approved by Argo Group’s board of directors, is subject to shareholder and regulatory approvals, and is expected to be completed in the second half of 2023.

 

The under review with developing implications status reflects the need for AM Best to assess fully the financial and operational impacts of the acquisition on Argo Group’s rating fundamentals. The ratings will remain under review pending completion of the acquisition, and until AM Best can complete its assessment of Argo Group’s post-acquisition rating fundamentals.

 

The FSR of A- (Excellent) and the Long-Term ICRs of “a-” (Excellent) have been placed under review with developing implications for Argo Group International Holdings, Ltd.’s operating subsidiaries:

  • Argo Re Ltd.
  • Agronaut Great Central Insurance Company
  • Agronaut Insurance Company
  • Agronaut-Midwest Insurance Company
  • ARIS Title Insurance Corporation
  • Colony Insurance Company
  • Peleus Insurance Company
  • Colony Specialty Insurance Company
  • Rockwood Casualty Insurance Company
  • Somerset Casualty Insurance Company

 

The following indicative Long-Term IRs available under various shelf registrations have been placed under review with developing implications:

Argo Group International Holdings, Ltd. —
— “bbb-” (Good) on senior unsecured debt

— “bb+” (Fair) on subordinated debt

— “bb” (Fair) on preferred stock

Argo Group US, Inc. —
— “bbb-” (Good) on senior unsecured debt

— “bb+” (Fair) on subordinated debt

Argo Group Statutory Trust —
— “bb” (Fair) on preferred stock

The following Long-Term IR has been placed under review with developing implications:

Argo Group US, Inc. —
— “bbb-” (Good) on $143.75 million 6.5% senior unsecured notes, due 2042

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Jieqiu Fan
Associate Director
+1 908 439 2200, ext. 5372
jieqiu.fan@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Daniel Ryan
Senior Director
+1 908 439 2200, ext. 5325
daniel.ryan@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Lifestyle Science Technology

inTEST Corporation to participate in the Alliance Global Partners Tech Conference

MT. LAUREL, N.J. — (BUSINESS WIRE) — inTEST Corporation (NYSE American: INTT), a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, security, and semiconductor “(semi),” today announced that Nick Grant, President & CEO, and Duncan Gilmour, Chief Financial Officer, will be available for investor meetings at the Allied Global Partners Tech Conference on Thursday, Feb. 16.

 

About inTEST Corporation

inTEST Corporation is a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, and security, as well as both the front-end and back-end of the semiconductor manufacturing industry. Backed by decades of engineering expertise and a culture of operational excellence, inTEST solves difficult thermal, mechanical, and electronic challenges for customers worldwide while generating strong cash flow and profits. inTEST’s strategy leverages these strengths to grow organically and with acquisitions through the addition of innovative technologies, deeper and broader geographic reach, and market expansion. For more information, visit www.intest.com.

Contacts

inTEST Corporation

Duncan Gilmour

Chief Financial Officer, Treasurer and Secretary

Tel: (856) 505-8999

Investors:

Deborah K. Pawlowski

Kei Advisors LLC

dpawlowski@keiadvisors.com
Tel: (716) 843-3908