Category: Science

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Healthcare Lifestyle Regulations & Security Science

FDA seeks to solve clinical trial delays by accelerating patient recruitment

The entire research, development, and approval process of a new drug by the Food and Drug Administration (FDA) can range between 12 to 15 years.

 

Drug companies seeking to sell a drug in the U.S. must first test it and then send it to the Center for Drug Evaluation and Research (CDER), following which a team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling, and subsequently approves the drug if the benefits outweigh the risks. After approval, the researcher can begin clinical trials on volunteers.

 

Phase 1 trials determine medication safety and dosing in 20-100 individuals, while Phase 2 trials assess safety and performance in several hundred individuals. Phase 3 trials further assess safety, performance, and side effects in 300-3,000 individuals. Only about 25% of medications move forward in the FDA approval process after Phase 3 trials.

 

“There are several persistent challenges and pitfalls in bringing new drugs to the market. For proper planning and risk mitigation, the clinical trial operational strategy needs to begin six to nine months before the trial begins. It needs to be a front-loaded effort to minimize the biggest risk factors first,” says Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, a company that specializes in significantly accelerating the process of bringing new medicines or vaccines to patients who need them.

 

Based on studies, patient recruitment issues are the cause of 85% of clinical trial delays, with 80% of trials being delayed by at least a month. Each day of delay potentially costs between $600,000 and $8 million in lost revenues.

 

Clinical trial recruitment faces several challenges at the site level, such as outdated patient databases, and failure to enroll patients because of complex eligibility criteria. Other challenges include unqualified or unresponsive patients, patient location, and lack of interest.

 

“Persistent pain points plague every clinical trial, such as the inevitable protocol amendments that need to be planned for rather than reacting to them as a surprise—which can exponentially delay the process and increase the costs. Clinical Trial operations need to be focused on the right aspects at the right time, especially up front,” explains Dr. Rajasimha.

 

Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics can speak on the following:

  • What are the different phases of the drug approval process by the FDA?
  • What are the challenges in bringing new drugs to market?
  • What are the persistent challenges faced in clinical trials for the testing of drugs?
  • What are the factors that affect clinical trial recruitment and participation?

 

About Jeeva Informatics

The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/

 

 

To speak with Dr. Harsha Rajasimha, contact me via khelms@jotopr.com or call 727-777-4619

Media Inquiries:

Karla Jo Helms

JOTO PR™

727-777-4619

jotopr.com

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Healthcare Lifestyle Science

Experts say ergonomics crucial in combating musculoskeletal disorders

Musculoskeletal Disorders

The World Health Organization reports that musculoskeletal conditions affect approximately 1.71 billion individuals worldwide, and are the leading cause of disability globally, with low back pain being the single leading cause of disability in 160 countries.

 

Disabling musculoskeletal conditions affect approximately 127.4 million people in the U.S., which is over a third of the U.S. population.

 

Musculoskeletal care accounts for one-sixth of employer-sponsored plan dollars and a $600 billion expense to the U.S. economy.

 

The pain can lead to the joints being affected, leading to osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, and spondylarthritis. In addition, bones may also be affected by osteoporosis, osteopenia, and associated fragility fractures or traumatic fractures. Chronic musculoskeletal disorders may also lead to depression, anxiety, and decreased quality of life.

 

Some of the causes of musculoskeletal disorders are poor posture while sitting and working long hours – a condition prevalent among dental surgeons and ENT specialists.

 

“A good dental provider does everything they can to relax their patients during any dental procedure, frequently at the expense of their own physical well-being. Dentists and hygienists assume awkward postures while performing repetitive tasks, positioning themselves rigidly to maintain precise movements to minimize patient discomfort,” notes Adrian LaTrace, CEO of Boyd Industries, the market leader in the design and manufacture of highly reliable, innovative dental and medical operatory equipment.

 

People suffering from musculoskeletal pain tend to miss out on work for an average of 8.2 days, which is double the sick days of an average worker. This figure goes up to 13 days for individuals with musculoskeletal pain and mental health needs.

 

Experts suggest good ergonomics are a necessity to protect against musculoskeletal disorders. The aim of ergonomics is to alleviate stress and eradicate injuries and disorders linked to improper posture and alignment, muscle overuse, and repetitive movements. Proper workplace ergonomics reduce musculoskeletal problems by 61% and lost workdays by 88%.

 

“Workplace ergonomics in the dental industry needs to be ubiquitous, from the front desk to the treatment chair and surrounding dental operatory equipment. The benefits of an ergonomic office depend upon the individual needs of each member of the entire team,” emphasizes LaTrace.

Adrian LaTrace, CEO of Boyd Industries can speak on the following:

  • What are the factors leading to the increase in musculoskeletal disorders?
  • What are some of the conditions that may result from musculoskeletal pain?
  • Which professions are most prone to musculoskeletal disorders?
  • How can ergonomics help in reducing the risks of musculoskeletal disorders?
  • What are the benefits of proper ergonomics in the workplace?

About Boyd Industries
For 65 years, Boyd Industries has been the innovative market leader in the design and manufacture of dental and medical operatory equipment. Their high-quality and reliable equipment has been the choice of dental specialty practices and dental surgery offices. The rapidly expanding Ear, Nose, and Throat market now seeks its reputation for quality and innovation. Boyd equipment is specifically designed to provide maximum practice productivity while incorporating ergonomic characteristics for the doctor, staff, and patient. As an original equipment manufacturer, they use a vertically integrated approach to ensure their process meets high-quality standards. This approach allows Boyd to control each step of component fabrication and product assembly. Boyd’s products include a full line of dental exam, treatment and surgical chairs, dental delivery systems, LED exam and surgical lighting, custom sterilization and storage cabinetry, doctor or assistant seating, and other accessories. Boyd was named the Senate Small Business of the Week in November 2020 and is a ten-time winner of the Townie Choice Award for excellence in orthodontic operatory equipment. Built to last. Built for you. Built by Boyd.

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Art & Life Business Culture Economics Lifestyle Science

Siegel Egg Co. names Matt Whitney as new CEO

BETHESDA, Md. & EVANSTON, Ill. — (BUSINESS WIRE) — Siegel Egg Co. “(Siegel” or “the Company)” has named Matt Whitney as Chief Executive Officer.

 

Whitney succeeds Matt Saunders, who will retire with this transition. Siegel is a portfolio company of Rotunda Capital Partners “(Rotunda),” a middle-market private equity firm investing in family and founder-owned value-added distributors.


“I am thrilled to bring Matt onto our team,” Saunders said.

 

“We have been actively searching for the right leader to take the baton from me and drive Siegel to future heights. With Rotunda’s continued backing, Matt’s successful background in the food distribution industry will enable us to deliver significant value to our customers and vendor partners while pursuing a multitude of growth opportunities.”

 

“We are excited to welcome Matt to Siegel,” said Dan Lipson, Managing Partner at Rotunda.

 

“Siegel is a regional leader that is poised for accelerated growth, and Matt’s leadership and experience are exactly what we need to continue building on the Company’s strong history and dedication to customer service.”

 

In addition to the appointment of Matt, Ken Siegel, who ran the Company for over 30 years and is a significant stakeholder, will re-engage with the Company as a Senior Advisor to the leadership team for this next stage of growth.

 

He said, “Siegel has been in my family for almost 100 years, and I couldn’t be more excited to have Matt join the team as the next leader of the business.”

 

Whitney has been a leader in the food distribution industry for over a decade. He joins Siegel after serving as Chief Growth Officer of UNFI, the largest publicly traded wholesale distributor of specialty food in the United States. Prior to that, he spent almost eight years at Sysco, most recently as Corporate Vice President of Field Transformation and Executive Vice President of the Boston Division. Prior to that, he was a Partner at the Lucas Group and Principal at the Parthenon Group. Whitney holds a BA from Tufts University and an MBA from the Tuck School of Business at Dartmouth College.

 

“I am excited to join an organization as respected as Siegel, with almost 100 years of history and reputation,” Whitney said. “I look forward to working closely with the Siegel team, Ken and Rotunda to engage with our customer and vendor partners to accelerate Siegel’s position as a leader in the industry.”

 

About Siegel Egg Co.

Founded in 1924, Siegel is a one of New England’s leading distributors of egg, dairy and bakery ingredients primarily serving commercial bakeries and food service institutions. The Company operates out of a single facility in Billerica, Mass., to distribute over 2,300 SKUs to customers in New England, Connecticut, New Jersey and New York. For more information, visit www.siegelegg.com.

 

About Rotunda Capital Partners

Rotunda Capital Partners is an operationally oriented private equity firm focused on transforming family-founder owned companies into dynamic, data-driven platforms able to achieve and manage significant growth. Since its founding in 2009, Rotunda has partnered with management teams to build great businesses within three primary sectors: value-added distribution, asset-light logistics and industrial, business and residential services. Rotunda strives to achieve replicable results by implementing its Rotunda Performance System to create strategic alignment, develop lean processes and create robust, data-driven infrastructures. For more information, visit www.rotundacapital.com.

Contacts

Jill Lafferty

Rotunda Capital Partners

(847) 280-1295

jill@rotundacapital.com

Categories
Business Healthcare Lifestyle Science

DWK Life Sciences completes acquisition of Assem-Pak | Aluseal

WERTHEIM, Germany — (BUSINESS WIRE) — DWK Life Sciences (“DWK”), a leading global manufacturer and supplier of laboratory glassware, plasticware, and primary packaging solutions, has completed the acquisition of Assem-Pak | Aluseal (“Assem-Pak”), a U.S. company based in Vineland, New Jersey.

 

Assem-Pak, which was founded 23 years ago and currently employs 110 people at their New Jersey facility, specializes in the production of premium rubber stoppers and aluminum seals as well as premium services such as washing, cleaning, assembling, and kitting of primary packaging for the Life Science market.

The acquisition will allow DWK to broaden its range of customizable packaging solutions for the Life Science industry segment, enabling it to support customers at every critical step of their development process. Assem-Pak also strengthens DWK’s value proposition of providing bundled solutions, allowing organizations to consolidate and simplify their complex supply chains.

 

DWK’s recent investments in its plants in Rockwood (U.S.) and Holzminden (Germany) have increased its manufacturing capability for glass vials across the U.S. and Europe. With the addition of Assem-Pak, DWK continues its expansion plan to further strengthen its presence in the Life Science packaging solutions market.

 

“I’m excited that Assem-Pak has joined the DWK family to enhance our vision of being a leading packaging solutions provider. Assem-Pak’s combination of manufacturing expertise and service offerings is a great addition to our already extensive global production and service footprint. This acquisition will allow DWK to capitalize on increasing demand for custom solutions to meet the complex needs of the Life Science industry,” said Armin Reiche, CEO of DWK Life Sciences.

 

Jeff Schempp, CEO of DWK Life Sciences LLC (North America) added: “The combination of Assem-Pak’s manufacturing capabilities in rubber stoppers and aluminum seals combined with DWK’s global market access makes this a perfect fit for both companies. We’re happy to have a great team join the DWK Group to help us achieve our objectives for years to come.”

 

About DWK Life Sciences

DWK Life Sciences is the leading global manufacturer and provider of precision labware as well as primary packaging solutions for Life Science Research, Applied Sciences and Diagnostics, and Pharmaceutical markets.

 

With over 35,000 products, the company’s offering includes the most comprehensive range of premium laboratory glassware together with a complementary portfolio of plastic products. They are manufactured at 12 global sites and marketed under the acclaimed brands DURAN®, WHEATON®, and KIMBLE®.

 

Worldwide, our 1,900 employees are dedicated to developing and delivering superior products and services to meet the highest expectations of customers in laboratories and production environments around the world. To learn more, visit www.DWK.com.

 

DWK Life Sciences is a portfolio company of One Equity Partners.

 

About One Equity Partners

One Equity Partners (“OEP”) is a middle market private equity firm focused on the industrial, healthcare, and technology sectors in North America and Europe. The firm seeks to build market-leading companies by identifying and executing transformative business combinations. OEP is a trusted partner with a differentiated investment process, a broad and senior team, and an established track record generating long-term value for its partners. Since 2001, the firm has completed more than 300 transactions worldwide. OEP, founded in 2001, spun out of JP Morgan in 2015. The firm has offices in New York, Chicago, Frankfurt and Amsterdam. For more information, please visit www.oneequity.com.

Contacts

Cortney Ecklor, Digital Marketing Manager

cortney.ecklor@dwk.com
phone: 865.399.6047

Categories
Healthcare Lifestyle Science

Blue Earth Diagnostics announces additional results from phase 3 SPOTLIGHT trial of investigational PET imaging agent 18F-rhPSMA-7.3 in biochemical recurrence of prostate cancer

− Results at the American Urological Association’s 2023 Annual Meeting (AUA2023) –

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced additional results from its completed Phase 3 SPOTLIGHT trial of 18F-rhPSMA-7.3 in recurrent prostate cancer, among a subgroup of patients who had undergone primary treatment with radiation therapy only.

 

It evaluated the overall Detection Rates (DRs) of 18F-rhPSMA-7.3 at patient level and stratified by anatomical region, Gleason score, baseline Prostate Specific Antigen (PSA) levels and PSA doubling time. 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The results were reported in a moderated poster presentation at the American Urological Association’s 2023 Annual Meeting (AUA2023), in Chicago, Ill.


“The ability to determine the extent and location of recurrent prostate cancer to inform appropriate clinical management for these men is key for physicians and their patients, because up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years,” said Brian T. Helfand, MD, Chief of Division of Urology, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group.

 

“The utility of conventional imaging for the localization of recurrence is limited, and relapse after curative-intent radiation therapy remains a considerable clinical burden. Precise imaging techniques are required to identify areas of involvement in order to facilitate delivery of optimized management for patients. These findings from the Phase 3 SPOTLIGHT subgroup study showed high detection rates by majority read for 18F-rhPSMA-7.3 across all regions. In particular, the finding that 43% (33/76) of men had distant extra-pelvic recurrences has important implications for clinical management, as procedures such as salvage prostatectomy would be futile in those cases.”

 

“These results from the Phase 3 SPOTLIGHT trial in biochemically recurrent prostate cancer are included in our New Drug Application for 18F-rhPSMA-7.3 PET imaging currently under review by the U.S. Food and Drug Administration, and we are pleased that they are being presented to the urology community at AUA 2023,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “18F-rhPSMA-7.3 represents a new class of PSMA-targeted PET radiopharmaceuticals, with early studies showing a high binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity. The compound is part of Blue Earth Diagnostics’ comprehensive prostate cancer portfolio, which includes other compounds and this investigational rhPSMA compound for potential use in diagnostic PET imaging and targeted radiopharmaceutical therapy.”

 

The findings presented at AUA included analyses of clinical factors impacting DRs for 18F-rhPSMA-7.3 as evaluated by three blinded central readers: DRs, overall patient-level detection rate, and regional-level analyses, stratified by Gleason score, baseline PSA levels and PSA doubling time. For example, results showed that among the subgroup (n=76) of patients in the Evaluable PET Scan Population who had undergone primary treatment with radiation therapy for prostate cancer, the overall patient-level DR was 99% (75/76) and consistently high across the three independent readers (range 93-99%). Recurrence by region was 76% (58/76) for the prostate, 25% (19/76) for pelvic lymph nodes and 43% (33/76) for extra-pelvic recurrences. As noted previously, no serious adverse reactions were attributed to 18F-rhPSMA-7.3 PET in the SPOTLIGHT study. Of the 391 patients who received 18F-rhPSMA-7.3 in the SPOTLIGHT study, 16 (4.1%) patients had at least one treatment-emergent adverse event that was considered possibly related/related to 18F-rhPSMA-7.3. The most frequently reported events were: hypertension: 1.8% (n=7); diarrhea: 1.0% (n=4); injection site reaction: 0.5% (n=2), and headache: 0.5% (n=2).

 

The SPOTLIGHT trial (NCT04186845) was a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Key results for 18F-rhPSMA-7.3 PET were previously presented at ASCO GU in February 2022,1 with additional results announced at AUA in April 20222, at SNMMI in June 20223 and at ASTRO in October 20224.

 

The findings were discussed in a moderated poster presentation at AUA 2023 on April 29, 2023, “18F-rhPSMA-7.3 Detection Rates in Patients with Recurrence of Prostate Cancer Following Primary Treatment with Radiation Therapy: Results SPOTLIGHT Study,” by Brian T. Helfand, MD, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group. Full session details and the abstract are available in the AUA online program HERE.

 

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease and (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

 

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.

 

1Schuster, DM, SPOTLIGHT Study Group, J. Clin. Onc. 2022; 40 (6_suppl):9-9.

2Fleming, MT, SPOTLIGHT Study Group, J. Urol. 2022; 207 (5_suppl):31047.

3Kuo, P, SPOTLIGHT Study Group, J. Nucl. Med. 2022; 63 (2_suppl):2539.

4Lowentritt, B, SPOTLIGHT Study Group, Int. J. Radiat. Oncol. Biol. Phys. 2022; 114(3):S130-S131.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0) 7917 536939

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business Healthcare Lifestyle Science

Teva and MedinCell announce FDA approval of UZEDY™ (risperidone) extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, for the treatment of schizophrenia in adults

  • This new treatment provides adults living with schizophrenia a long-acting formulation that offers flexible 1- and 2-month dosing intervals1
  • In a Phase 3 clinical trial, UZEDY demonstrated up to 80% reduction in risk of schizophrenia relapse versus placebo1
  • UZEDY is a subcutaneous injection from a pre-filled syringe with a 21-gauge needle

 

PARSIPPANY, N.J. & TEL AVIV & PARIS — (BUSINESS WIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults.

 

UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1

“UZEDY embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse,” said Richard Francis, President and CEO of Teva. “The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. This milestone is a testament to advancing our robust biopharmaceutical pipeline of innovative medicines that aim to support more people living with mental health disorders and neurological diseases in the coming years.”

 

Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment,2 most commonly due to suboptimal adherence to treatment with oral antipsychotics. Each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.3,4

Schizophrenia is a chronic, progressive and severely debilitating mental health disorder that affects how one thinks, feels and acts.5 This approval is based on data from two Phase 3 trials evaluating UZEDY in patients with schizophrenia: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).

 

“The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit,” said Christophe Douat, CEO of MedinCell. “We are committed to supporting patients through innovative therapy options. It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of UZEDY. Our technology reaching commercial stage marks the start of an exciting new era for MedinCell and we are extremely proud to share this very special moment with all our employees and shareholders.”

 

The use of novel SteadyTeq technology in UZEDY controls the release of risperidone over time. The initiation of treatment requires no loading dose or oral supplementation. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1

 

“Treatments for schizophrenia are largely prescribed as daily oral medications, which can present challenges with adherence due to missed doses. Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia,6 so there’s a role for therapies that are dosed in one- or two-month dosing intervals to help prevent relapse,” said Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, NY. “As a clinician, I am excited to now have a new treatment option that reduces the risk of relapse1 for this complex disease and helps address some of the barriers around receiving schizophrenia treatment.”

 

CLICK HERE TO ACCESS THE COMPLETE PRESS RELEASE

 

About Schizophrenia

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts. Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition. Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women. The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization. Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology. Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.

 

About UZEDY

UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use rather than intramuscular use, is indicated for the treatment of schizophrenia in adults. In clinical trials, UZEDY reduced the risk of relapse by up to 80%. UZEDY administers risperidone through copolymer technology under license from MedinCell that allows for absorption and sustained release in the first subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.1 For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.

 

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, biosimilar 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.

 

About MedinCell

MedinCell is an innovative pharmaceutical company with a portfolio of long-acting injectable products, from development to market, in various therapeutic areas. MedinCell proprietary technology BEPO® (licensed to Teva under the name SteadyTeq) makes it possible to control the delivery of a drug at a therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities. www.medincell.com

 

1 UZEDY™ (risperidone) extended-release injectable suspension, for subcutaneous injection Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.

2 Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric disease and treatment, 14, 205–223.

3 Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.

4 Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The American journal of psychiatry, 170(6), 609–615.

5 Patel, K. R., Cherian, J., Gohil, K., & Atkinson, D. (2014). Schizophrenia: overview and treatment options. P & T: a peer-reviewed journal for formulary management, 39(9), 638–645..

6 Kane JM, Correll CU. Optimizing treatment choices to improve adherence and outcomes in schizophrenia. J Clin Psychiatry. 2019;80(5):IN18031AH1C. doi:10.4088/JCP.IN18031AH1C.

Contacts

IR Contacts

Ran Meir, +1 (267) 468-4475

Yael Ashman, +972 (3) 914 8262

Sanjeev Sharma, +1 (973) 658 2700

PR Contacts

Kelley Dougherty, 1 (973) 832-2810

Eden Klein, +972 (3) 906 2645

MedinCell France

David Heuzé (Head of Communication), +33 (0) 6 83 25 21 86

david.heuze@medincell.com

Louis-Victor Delouvrier (NewCap – IR), +33 (0) 1 44 71 98 53

medincell@newcap.eu

Nicolas Merigeau (NewCap – Media Relations), +33 (0) 1 44 71 94 98

medincell@newcap.eu

Categories
Business Healthcare Science

Seres Therapeutics and Nestlé Health Science announce FDA approval of VOWSTTM (fecal microbiota spores, live-brpk) for prevention of recurrence of C. difficile infection in adults following antibacterial treatment for recurrent CDI

– First and only FDA-approved orally administered microbiota-based therapeutic, validating Seres’ microbiome platform –

– Phase 3 ECOSPOR III study demonstrated that 88% of treated individuals were recurrence-free at 8 weeks –

– Opportunity to address prevention of recurrence of C. difficile infection in adults with rCDI, including first recurrence, following antibacterial treatment –

– VOWST product availability expected in June –

– Conference call at 8:30 a.m. ET tomorrow –

 

CAMBRIDGE, Mass. & HOBOKEN, N.J. — (BUSINESS WIRE) — Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science  announced Thursday  the U.S. Food and Drug Administration (FDA) approval of VOWSTTM (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is not indicated for the treatment of CDI.


“Since being founded by Flagship Pioneering over a decade ago, Seres has led the development of microbiome therapeutics, and today’s FDA approval of VOWST as the first orally administered microbiota-based therapeutic for the prevention of recurrent C. difficile infection marks a tremendous milestone for the patient community, and for Seres. We are deeply grateful to the patients, caregivers, clinical investigators, and employees who contributed to the discovery, development, and approval of VOWST,” said Eric Shaff, President and Chief Executive Officer at Seres. “With VOWST, we and Nestlé Health Science have the opportunity to prevent recurrence in a broad group of adult rCDI patients, including those who have experienced a first recurrence.”

 

“Our strategic collaboration with Seres is part of Nestlé Health Science’s ongoing commitment to advancements in the gastrointestinal space to address unmet patient needs,” said Greg Behar, Chief Executive Officer, Nestlé Health Science. “Our teams have vast experience in gastrointestinal disorders and are poised to engage with healthcare professionals to start addressing this critical need for patients. We expect VOWST to be available in June and look forward to helping patients.”

 

Recurrent CDI represents significant unmet need and is a leading cause of hospital-acquired infection that can result in severe illness and death.1 Based on data from the U.S. Centers for Disease Control and Prevention (CDC), the companies estimate 156,000 episodes in the U.S. in 2023.

 

“Recurrent C. difficile infection is a highly debilitating and life-threatening disease, and antibiotics alone do not address the underlying cause of rCDI, dysbiosis of the gut microbiome,” said Carl Crawford M.D., Assistant Professor of Clinical Medicine at Weill Cornell Medical College. “The approval of VOWST provides an important new oral treatment option for this disease, and I am pleased to now be able to offer this medicine to recurrent CDI patients.”

 

“Recurrent C. difficile infection significantly impacts patients’ quality of life, both physically and emotionally, leaving many living in tremendous fear of future recurrences. Patients have been waiting for new treatment options that address a key concern: prevention of an additional CDI recurrence,” said Christian John Lillis, Executive Director at Peggy Lillis Foundation for C. diff Education and Advocacy.

 

VOWST Phase 3 Study Data

The FDA approval of VOWST was supported by a robust Phase 3 development program that included the ECOSPOR III and ECOSPOR IV studies. VOWST was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA.

 

ECOSPOR III was a multicenter, randomized, placebo-controlled study in individuals with rCDI, the results of which were published in the New England Journal of Medicine.2 The study’s primary objective was to demonstrate the reduction of CDI recurrence with VOWST. In ECOSPOR III, VOWST was shown to reduce CDI recurrence at eight weeks, with approximately 88% of individuals recurrence-free at eight weeks post-treatment, compared to 60% in participants who received placebo.2 In addition, at six months post-treatment, 79% of the VOWST group were demonstrated to be recurrence-free, compared to 53% in the placebo group.3 No treatment-related serious adverse events were observed in the active arm and the frequency of treatment-related adverse events was similar between the VOWST and placebo arms. The most common adverse reactions through eight weeks in VOWST treated participants versus placebo were solicited events of abdominal distention (31.1% VOWST versus 29.3% placebo), fatigue (22.2% VOWST versus 21.7% placebo), constipation (14.4% VOWST versus 10.9% placebo), chills (11.1% versus 7.6% placebo), and unsolicited event of diarrhea (10.0% versus 4.3% placebo).4

 

ECOSPOR IV was an open-label, single arm study evaluating VOWST in 263 adult participants with rCDI. Study results were published in the JAMA Network Open.5 The ECOSPOR IV study results contributed to the VOWST safety database and supported product approval.

 

Seres and Nestlé Health Science are committed to helping appropriate patients who have been prescribed VOWST obtain access. Additional details about VOWST access programs will be available at launch.

 

Joint Commercialization Agreement

In July 2021, Seres and Nestlé Health Science entered into an agreement to jointly commercialize VOWST in the U.S. and Canada. Nestlé Health Science is leveraging its global pharmaceutical business and assuming the role of lead commercialization party, including the utilization of its existing infrastructure, gastrointestinal sales force and payer access team.

 

Seres is due to receive a $125 million milestone payment from Nestlé Health Science associated with the FDA approval of VOWST. Upon VOWST commercialization, each company will be entitled to share equally in commercial profits and losses.

 

Conference Call Information

Seres’ management will host a conference call tomorrow, April 27, 2023, at 8:30 a.m. ET. Accompanying slides will be posted on the Seres website prior to the call. To access the conference call, please dial 773-305-6867 (domestic) or 866-400-0049 (international) and reference Conference ID 1937506. To join the live webcast, please visit the “Investors and News” section of the Seres website at www.serestherapeutics.com.

 

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

 

INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST

INDICATION

VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

Limitation of Use: VOWST is not indicated for treatment of CDI.

 

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.

 

Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.

 

ADVERSE REACTIONS

The most common adverse reactions (reported in ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).

 

To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.

 

DRUG INTERACTIONS

Do not administer antibacterials concurrently with VOWST.

 

Please see Full Prescribing Information and Patient Information

About Recurrent C. difficile Infection (rCDI)

Recurrent C. difficile infection is a gastrointestinal infection caused by C. difficile bacteria. rCDI is linked to dysbiosis of the gastrointestinal microbiome and is associated with increased mortality. CDI has been characterized as an Urgent Health Threat by the Centers for Disease Control and Prevention (CDC). rCDI results in a substantial burden on the healthcare system1 with the average rCDI-related annual costs per patient at approximately $43K.6

 

About Seres Therapeutics

Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWSTTM, obtained U.S. FDA approval in April 2023 as the first orally administered microbiota-based therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestlé Health Science. Seres is also developing a novel class of multifunctional fermented bacterial consortia designed to functionally interact with host cells and tissues to treat disease. For more information, please visit www.serestherapeutics.com.

 

About Nestlé Health Science

Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 12,000 employees around the world, with products available in more than 140 countries. For more information, please visit www.nestlehealthscience.us.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the timing of commercial launch, the availability of VOWST, the commercial success of VOWST; and other statements which are not historical fact.

 

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; the unknown degree and competing factors of market acceptance for VOWST; the competition we will face; our ability to protect our intellectual property; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), on March 7, 2023, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 

References:
  1. Rodrigues R, Barber GE, Ananthakrishnan AN. A Comprehensive Study of Costs Associated With Recurrent Clostridium difficile Infection. Infect Control Hosp Epidemiol. 2016;38:196-202. DOI: 10.1017/ice.2016.246
  2. Feuerstadt P, Louie TJ, Lashner B, et al. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. N Engl J Med. 2022;386:220-9. DOI: 10.1056/nejmoa2106516
  3. Cohen SH, Louie TJ, Sims M, et al. Extended Follow-up of Microbiome Therapeutic SER-109 Through 24 Weeks for Recurrent Clostridioides difficile Infection in a Randomized Clinical Trial. JAMA. 2022;328:2062. DOI: 10.1001/jama.2022.16476
  4. VOWSTTM.Prescribing Information. Seres Therapeutics, Inc.; 2023.
  5. Sims MD, Khanna S, Feuerstadt P, et al. Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial. JAMA Network Open. 2023;6(2):e2255758. DOI: 10.1001/jamanetworkopen.2022.55758
  6. U.S. Bureau of Labor Statistics. CPI Inflation Calculator. U.S. Bureau of Labor Statistics. Published 2022. https://www.bls.gov/data/inflation_calculator.htm. CPI inflation adjusted to March 2023.

Contacts

Seres IR and PR Contact:
Carlo Tanzi, Ph.D.

ctanzi@serestherapeutics.com

Nestlé Health Science PR Contact:
Lindsay Yanek

lindsay.yanek@us.nestle.com

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Culture Environment Lifestyle Local News Programs & Events Science

Mercer County Park Commission celebrates Earth Day, Arbor Day by planting trees

Green industry organizations and professionals celebrate Arbor Day Friday, April 28 with the collaborating event of planting of 20 “Jersey Grown” native trees by the Mercer County Park Commission – John A. Roebling Memorial Park at the Hamilton-Trenton border.

Photo: A group from ISLES Climate Corps plant trees and shrubs at Mercer Meadows.

Volunteers will gather at the Spring Lake section of the park, off Sewell Avenue, at 10:30 a.m. to plant native trees appropriate for the site conditions.

The Park Commission looks forward to hosting the NJ Nursery and Landscape Association (NJNLA), The NJ Chapter of the International Society of Arboriculture, Richard A. McCoy Horticultural Services LLC, the Northeast Organic Farming Association of NJ and the NJ Green Industry Council and thanks them for their generous donation of native trees.

A tree planting demonstration will be given by McCoy Horticultural Services as part of the volunteer planting event.

The Park Commission’s Stewardship Department celebrated Earth Day by hosting volunteer groups to help plant native trees and shrubs last week.

Photo: Staff from First Trust Bank plants native trees and shrubs along the Lawrence -Hopewell Trail in Mercer Meadows

 

The volunteer groups included ISLES Climate Corps, First Bank staff from Lawrence Township, Students from the College of New Jersey, Tulpehaking Nature Center staff and New Jersey Watershed Ambassadors.

 

With the help of these generous organizations, over 600 native plants were installed at Mercer Meadows in Pennington, NJ. Over the course of three weeks, a total of 1,400 native shrubs and trees will be planted to replace invasive vegetation that was removed from Mercer Meadows.

 

The County thanks all the volunteers for their hard work!

Categories
Business Healthcare Lifestyle Science Technology

Johnson & Johnson to participate in the Bernstein 39th Annual Strategic Decisions Conference

NEW BRUNSWICK, N.J. — (BUSINESS WIRE) — Johnson & Johnson (NYSE: JNJ) will participate in the Bernstein 39th Annual Strategic Decisions Conference on Wednesday, May 31st, at the New York Hilton Midtown in New York.

 

Joaquin Duato, Chairman of the Board and Chief Executive Officer will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time).

This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

 

A webcast replay will be available approximately 48-hrs after the live webcast.

Contacts

Investor:
RA-JJCUS-InvestorRel@ITS.JNJ.com

Media:
media-relations@its.jnj.com

Categories
Farewell Services Regulations & Security Science

Best’s Insurance Law Podcast addresses how materials science impacts insurance claims

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best and Best’s Insurance Professional Resources have released the latest installment of the Best’s Insurance Law Podcast series, which examines timely insurance issues from a legal perspective.

 

The latest episode features David Reigner, from expert service provider S-E-A, where he discusses why materials are part of every forensic investigation and how this impacts forensic investigations and insurance claims.

 

S-E-A is a qualified member in Best’s Insurance Professional Resources, an insurance industry resource that has featured qualified legal counsel, independent insurance adjusting services and expert service providers since 1929.

 

Listen or subscribe to the Insurance Law Podcast.

 

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 Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

John Czuba
Managing Editor,
Professional Resources
+1 908 439 2200, ext. 5673
john.czuba@ambest.com