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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

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
Business Economics Healthcare Lifestyle Perks Regulations & Security Science Travel & Leisure

Johnson & Johnson announces launch of Kenvue Inc. IPO roadshow

NEW BRUNSWICK, N.J. — (BUSINESS WIRE) — Johnson & Johnson (NYSE: JNJ) today announced that Kenvue Inc. “(Kenvue),” a wholly owned subsidiary of Johnson & Johnson comprising its Consumer Health Business, has launched a roadshow for the initial public offering “(IPO)” of 151,204,000 shares of its common stock.

 

Kenvue expects to grant the underwriters a 30-day option to purchase up to an additional 22,680,600 shares of its common stock to cover over-allotments, if any. The IPO price is currently expected to be between $20.00 and $23.00 per share. Kenvue has applied to list its common stock on the New York Stock Exchange under the symbol “KVUE.”

 

After the completion of the IPO, Johnson & Johnson will own 1,716,160,000 shares of Kenvue’s common stock, representing 91.9% of the total outstanding shares of Kenvue’s common stock (or 90.8% if the underwriters exercise in full their over-allotment option).

 

Goldman Sachs & Co. LLC, J.P. Morgan and BofA Securities are acting as joint lead book-running managers for the IPO. Citigroup, Deutsche Bank Securities, BNP Paribas, HSBC, RBC Capital Markets and UBS Investment Bank are acting as book-running managers for the IPO and BBVA, ING, IMI – Intesa Sanpaolo, Santander, UniCredit Capital Markets, Academy Securities, Independence Point Securities, Ramirez & Co., Inc., R. Seelaus & Co., LLC and Siebert Williams Shank are acting as co-managers for the IPO.

 

A registration statement on Form S-1 relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The IPO will be made only by means of a prospectus. A copy of the preliminary prospectus relating to the IPO may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316, or by emailing: prospectus-ny@ny.email.gs.com; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204, or by emailing: prospectus-eq_fi@jpmchase.com; or BofA Securities, NC1-022-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, North Carolina 28255, telephone: 1-800-294-1322, or by emailing: dg.prospectus_requests@bofa.com.

 

This press release is neither an offer to sell nor a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful.

 

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest, most diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

 

Cautions Concerning Forward-Looking Statements

This release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: the timing and details of the IPO, the number of shares to be offered in the IPO, the expected price at which such shares will be offered, the grant of the over-allotment option and whether the underwriters will exercise such option, the number of shares to be held by Johnson & Johnson following the IPO and the expectations relating to the listing of Kenvue’s common stock on the New York Stock Exchange. Readers are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: Johnson & Johnson’s ability to satisfy the necessary conditions to consummate the separation of Kenvue on a timely basis or at all; Johnson & Johnson’s ability to successfully separate Kenvue and realize the anticipated benefits from the separation; Kenvue’s ability to succeed as a standalone publicly traded company; economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including unexpected clinical trial results, additional analysis of existing clinical data, uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; the impact of business combinations and divestitures; challenges to patents; the impact of patent expirations; the ability of Johnson & Johnson to successfully execute strategic plans, including restructuring plans; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws, global health care reforms and import/export and trade laws; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements”, and in Johnson & Johnson’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this press release speaks only as of the date of this press release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Contacts

Investor Relations:
Jessica Moore (Johnson & Johnson)

investor-relations@its.jnj.com

Tina Romani (Kenvue)

Kenvue_IR@kenvue.com

Categories
Healthcare International & World Lifestyle Science

Quizartinib NDA review for patients with newly diagnosed FLT3-ITD positive AML extended by FDA

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

 

The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023 to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) included in this application. No additional efficacy or safety data has been requested.

 

“We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “Quizartinib was shown to improve overall survival when added to standard chemotherapy and continued as monotherapy and has potential to change the standard of care for patients with newly diagnosed FLT3-ITD positive AML.”

 

The NDA is based on results from the QuANTUM-First trial, which demonstrated that quizartinib combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and continued as monotherapy following consolidation, resulted in a statistically significant and clinically meaningful improvement in overall survival in adult patients with newly diagnosed FLT3-ITD positive AML compared to chemotherapy alone. The results of QuANTUM-First were presented at the 2022 European Hematology Association (EHA) Congress.1

 

The safety of quizartinib combined with intensive chemotherapy and as continuation monotherapy in QuANTUM-First was generally manageable with no new safety signals observed. The incidence of grade ≥3 QT prolongation events was low, with uncommon ventricular arrythmia events. Overall, the risk of QT prolongation was manageable with ECG monitoring, quizartinib dose modification and correction/elimination of additional risk factors.

 

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled global phase 3 study evaluating quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens. Eligible patients, including those who underwent hematopoietic stem cell transplant (HSCT), continued with quizartinib or placebo for up to 36 cycles.

 

The primary study endpoint was overall survival. Secondary endpoints include event-free survival, post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD minimal residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints, also were evaluated. QuANTUM-First enrolled 539 patients at 193 study sites across Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

 

About FLT3-ITD Positive Acute Myeloid Leukemia

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.2 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.3,4 In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023 with the five-year survival rate reported at 30.5%.4,5

 

A number of gene mutations have been identified in AML, and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common, observed in up to 37% of all newly diagnosed patients.6,7 Approximately 80% of FLT3 mutations in AML are FLT3-ITD (internal tandem duplications), an oncogenic driver mutation that presents with a high leukemic burden.7,6 Patients with FLT3-ITD positive AML tend to have a particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.6 The five-year survival rate for patients with FLT3-ITD positive AML has been reported at approximately 20%.8

 

The conventional treatment for fit patients with newly diagnosed AML is intensive induction and consolidation chemotherapy, with or without targeted therapy, and HSCT for eligible patients.9

 

About Quizartinib

Quizartinib is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.6

 

Regulatory applications for quizartinib in newly diagnosed FLT3-ITD positive AML are currently under review in Europe, Japan and the U.S. based on the results of the QuANTUM-First trial. The FDA has granted Priority Review and Fast Track Designation to quizartinib for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy. Orphan Drug Designation has been granted to quizartinib for the treatment of AML in Europe, Japan and the U.S.

 

Quizartinib is approved for use in Japan for the treatment of adult patients with relapsed/refractory AML that is FLT3-ITD positive, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan. The quizartinib clinical development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3-ITD positive AML in Europe and North America and several phase 1/2 combination studies as part of a strategic collaboration with The University of Texas MD Anderson Cancer Center.

 

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit: www.daiichisankyo.com.

 

References

1 Erba H et al. EHA Library. Presidential Symposium. 06/11/22; 356965; S100

2 Global Cancer Observatory. Population Fact Sheet: World. Updated March 2021.

3 Dong Y et al. Exp Hematol Oncol. 2020;9:14.

4 American Cancer Society: Key Statistics for Acute Myeloid Leukemia. Updated January 2023.

5 National Cancer Institute SEER Program. Cancer Stat Facts: Acute Myeloid Leukemia
6 Daver N et al. Leukemia. (2019) 33:299–312.

7 Patel JP et al N Engl J Med. 2012 Mar 22;366(12):1079-89.

8 Frohling et al. Blood. (2002) 100 (13): 4372–4380.

9 Daver et al. Blood Cancer J. 2020;10(10):107.

Contacts

Media Contacts:

Global/US:
Jennifer Brennan

Daiichi Sankyo, Inc.

jbrennan2@dsi.com
+1 908 900 3183 (mobile)

Japan:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Categories
Business Healthcare Lifestyle Science Special/Sponsored Content

Rocket Pharmaceuticals to participate in upcoming Investor Conferences

CRANBURY, N.J. — (BUSINESS WIRE) — Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that Company management will participate in the 22nd Annual Needham Virtual Healthcare Conference and Chardan’s 7th Annual Genetic Medicines and Cell Therapy Manufacturing Summit.

 

Participation details are as follows:

22nd Annual Needham Virtual Healthcare Conference

Fireside Chat Presentation

Date: April 18, 2023

Time: 8:45 a.m. ET

 

Chardan’s 7th Annual Genetic Medicines and Cell Therapy Manufacturing Summit

Fireside Chat Presentation

Date: April 25, 2023

Time: 9:00 a.m. ET

A webcast of both events will be available under “Events” in the Investors section of the Company’s website at https://ir.rocketpharma.com/.

 

About Rocket Pharmaceuticals, Inc.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) is advancing an integrated and sustainable pipeline of investigational genetic therapies designed to correct the root cause of complex and rare disorders. The Company’s platform-agnostic approach enables it to design the best therapy for each indication, creating potentially transformative options for patients afflicted with rare genetic diseases. Rocket’s clinical programs using lentiviral vector (LV) based gene therapy are for the treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, and Pyruvate Kinase Deficiency (PKD), a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia. Rocket’s first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon Disease, a devastating, pediatric heart failure condition. Rocket also has preclinical AAV-based gene therapy programs in PKP2-arrhythmogenic cardiomyopathy (ACM) and BAG3-associated dilated cardiomyopathy (DCM). For more information about Rocket, please visit www.rocketpharma.com.

 

Rocket cautionary statement regarding forward-looking statements

Various statements in this release concerning Rocket’s future expectations, plans and prospects, including without limitation, Rocket’s expectations regarding the safety and effectiveness of product candidates that Rocket is developing to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Danon Disease (DD) and other diseases, the expected timing and data readouts of Rocket’s ongoing and planned clinical trials, the expected timing and outcome of Rocket’s regulatory interactions and planned submissions, Rocket’s plans for the advancement of its Danon Disease program, including its planned pivotal trial, and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as “aim,” “anticipate,” “believe,” “can,” “continue,” “design,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “will give,” “seek,” “will,” “may,” “suggest” or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket’s ability to monitor the impact of COVID-19 on its business operations and take steps to ensure the safety of patients, families and employees, the interest from patients and families for participation in each of Rocket’s ongoing trials, patient enrollment, trial timelines and data readouts, our expectations regarding our drug supply for our ongoing and anticipated trials, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, our ability to submit regulatory filings with the U.S. Food and Drug Administration (FDA) and to obtain and maintain FDA or other regulatory authority approval of our product candidates, Rocket’s dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, our competitors’ activities, including decisions as to the timing of competing product launches, pricing and discounting, our integration of an acquired business, which involves a number of risks, including the possibility that the integration process could result in the loss of key employees, the disruption of our ongoing business, or inconsistencies in standards, controls, procedures, or policies, our ability to successfully develop and commercialize any technology that we may in-license or products we may acquire and any unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in Rocket’s Annual Report on Form 10-K for the year ended December 31, 2022, filed February 28, 2023 with the SEC and subsequent filings with the SEC including our Quarterly Reports on Form 10-Q. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Media
Kevin Giordano

kgiordano@rocketpharma.com

Investors
Brooks Rahmer

investors@rocketpharma.com

Categories
Education Healthcare Lifestyle Local News Science

Leading NJ public health school announces new health and risk communication certificate

TCNJ’s Public Health department offers new all-online Health & Risk Communication certificate.

 

“Our department wants to arm public health and non-profit communities with the skills they need to succeed…”

— Slyvia Twersky, PhD, MPH, TCNJ Public Health Asst. Professor

 

EWING, N.J. – In March, a new report announced 2021 as a 58-year high for maternal mortality. The same study pointed out delayed preventive care during COVID and continued disparities in social determinants of health as key contributors.

 

As at-risk communities face mounting health challenges, the School of Nursing and Health Sciences (SNHS) at The College of New Jersey (TCNJ) is preparing students to help people pursue healthier lives with a new graduate certificate in health and risk communication.

 

Consisting of four courses, the new program will teach students how to develop, implement, and evaluate health communication plans — from research to program testing. Students will learn about health communication campaigns in community contexts, social media, digital health platforms and interactive video games.

 

TCNJ Public Health and Communication Studies professor, John C. Pollock, PhD, expands on the benefits of this new program, saying, “This innovative graduate certificate offers robust training in creating, implementing, and evaluating professional health communication campaigns. Taught by health communication scholars and professionals, certificate courses employ knowledge about message formation and communication to teach students how to alleviate suffering, reduce risky behavior, and promote health equity.”

 

Credits generated from this certificate can be applied to a Master’s in Public Health degree from TCNJ. TCNJ’s Public Health program ranks number two in New Jersey.

 

TCNJ Public Health Assistant Professor and Graduate Program Director, Sylvia Twersky, PhD, MPH, adds, “Our department wants to arm public health and non-profit communities with the skills they need to succeed and thrive in their jobs and create healthier communities. This certificate in health and risk communication helps us do that. As a completely online program, it can meet the needs of today’s busy professionals. It is also compatible with an MPH in Health Communication, so if a student wants to convert the certificate into a master’s degree, they have a clear path forward.”

 

The School of Nursing and Health Sciences’ Dean Carole Kenner explains, “This new health and risk communication certificate is an example of how our Public Health program empowers students to positively impact surrounding communities during and after their college experiences. Whether for a full Master’s degree or skills improvement, our diverse certificate offerings give anyone the opportunity to advance their knowledge and empower others.”

 

The School rebranded in 2022 to reflect its robust and diverse, cross-disciplinary health science curricula.

 

TCNJ’s School of Nursing and Health Sciences educates aspiring health professionals to become future leaders across the healthcare industry. Faculty work closely with local healthcare partners to provide students with applicative skills and foundational knowledge. The nationally acclaimed school is dedicated to preparing individuals—through programs in nursing, public health, exercise science and physical education teaching—for the many rewards of guiding people, communities, and populations toward improved health outcomes. The School is nationally recognized as a Healthy People 2030 Champion.

 

Contact Information:

Crothers Consulting | info@crothersconsulting.co | (800) 831-3840

Source: TCNJ School of Nursing and Health Sciences

Categories
Business Healthcare International & World Science

Stemmer Distribution optimizes communications infrastructure with Avaya – Delivering 50% cost savings and enhanced employee experiences

Largest Dental Product Distributor in France Harmonizes Communications Solutions with Avaya Cloud Office® by RingCentral

 

MORRISTOWN, N.J. — (BUSINESS WIRE) — Avaya, a global leader in solutions to enhance and simplify communications and collaboration, today announced Stemmer Distribution, the largest distributor of dental products in France, has successfully harmonized and modernized its communications infrastructure with the help of Avaya Cloud Office® by RingCentral. Stemmer Distribution sought a new, more modern communication solution that met all the needs of reachability and mobility, while rationalizing costs for the present and future.

Avaya partner, Artelcom, conducted a technical and functional audit of the entire existing communications infrastructure, identifying various strategies for the evolution of the communications solutions for the 250 employees spread over six business units in France. Stemmer Distribution chose the Avaya UCaaS solution, Avaya Cloud Office, which met the group’s specifications, providing an intuitive, easy-to-use solution that is perfect for their mobility needs.

 

“We had considered migrating to a hosted solution in a datacenter, but the feedback from our provider Artelcom convinced us of the reliability and flexibility of the Avaya Cloud Office public cloud solution,” explains Alexandre Sicard, Infrastructure Manager, Stemmer Distribution. “In just a few months, we migrated to an innovative and high-performance cloud solution. Avaya Cloud Office has allowed us to harmonize and modernize our communication infrastructure while providing a more intuitive and mobile-friendly solution for our employees. We have been able to reduce our telecom budget, delivering cost savings without compromising on performance. Avaya Cloud Office truly embodies innovation without disruption.”

 

Thanks to the Avaya Cloud Office solution, Stemmer Distribution has reduced its cost-per-user by 50%, while harmonizing the communications infrastructure to deliver a consistent experience for employees and customers. The solution also facilitates simplified management and administration for the IT Department, allowing them to focus on more strategic projects.

 

“Today’s businesses are evolving their processes and a cloud communications platform provides everything employees need to be effective communicators, all on a single device, from anywhere they may be,” said Tim Sherwood, GVP of Product and Offer Management, Avaya. “Avaya Cloud Office is one of the ultimate solutions for today’s businesses seeking seamless communication and collaboration, with enterprise grade voice, video, messaging, meetings, and conferencing capabilities. With Avaya Cloud Office, customers can have their entire workforce on a single system, enabling easy collaboration and efficient operations, whether in-office, remote, or mobile. By simplifying communication and delivering greater cost savings, Avaya Cloud Office is the perfect choice for businesses seeking a competitive edge in today’s fast-paced world.”

 

The success of the solution in France has opened the possibility of deploying the Avaya Cloud Office solution in other European organizations to modernize their businesses.

 

Additional Resources

 

About Avaya

Businesses are built by the experiences they provide, and every day millions of those experiences are delivered by Avaya. Avaya is shaping the future of customer experiences, with innovation and partnerships that deliver game-changing business benefits. Our communications solutions power immersive, personalized, and memorable customer experiences to help organizations achieve their strategic ambitions and desired outcomes. Together, we are committed to helping grow your business by delivering Experiences That Matter. Learn more at http://www.avaya.com.

 

About Stemmer Distribution

The Stemmer Distribution Group is the largest distributor of dental products in France.

It supplies all health professionals in the dental sector with consumables, laboratory products, equipment and equipment repair services. Founded in 1978 by Armand Stemmer, the company has experienced strong growth and has since established itself in 8 European markets: Portugal, Spain, Italy, United Kingdom, Belgium, Switzerland and the Netherlands. The Stemmer Group, headed by Vivian Stemmer (CEO), is organized around three Business Groups: Distribution, Innovation and Digital.

 

Cautionary Note Regarding Forward-Looking Statements

This document contains certain “forward-looking statements.” All statements other than statements of historical fact are “forward-looking” statements for purposes of the U.S. federal and state securities laws. These statements may be identified by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “our vision,” “plan,” “potential,” “preliminary,” “predict,” “should,” “will,” or “would” or the negative thereof or other variations thereof or comparable terminology. These forward-looking statements are subject to a number of factors and uncertainties that could cause the Company’s actual results to differ materially from those expressed in or contemplated by the forward-looking statements. Such factors include, but are not limited to, risks attendant to the bankruptcy process, including the Company’s ability to emerge successful from the Company’s voluntary cases under chapter 11 of the United States Bankruptcy Code, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2021, subsequent quarterly reports on Form 10-Q filed with the SEC and other public statements made from time-to-time. These risks and uncertainties may cause the Company’s actual results, performance, liquidity or achievements to differ materially from any future results, performance, liquidity or achievements expressed or implied by these forward-looking statements. The Company cautions you that the list of important factors included in the Company’s SEC filings may not contain all of the material factors that are important to you. In addition, in light of these risks and uncertainties, the matters referred to in the forward-looking statements contained in this report may not in fact occur. The Company undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

 

All trademarks identified by ®, TM, or SM are registered marks, trademarks, and service marks, respectively, of Avaya Inc. All other trademarks are the property of their respective owners.

 

Source: Avaya Newsroom

Contacts

Alex Alias, Avaya

alalias@avaya.com

Categories
Culture Environment Healthcare Lifestyle Local News Programs & Events Science Weather & Environment

Mercer Mosquito Control reminds residents about spring cleanup

As warmer weather fast approaches, the Mercer County Mosquito Control Unit advises that now is the perfect time to clear your property of any unused objects that may hold water and harbor mosquitoes.

 

If removing containers is not possible, they should be stored properly so as not to collect water. Containers such as tires, buckets, children’s toys, corrugated downspout extensions, birdbaths, potted plant saucers, and neglected swimming pools or ornamental ponds are all suitable habitats for mosquitoes.

 

Some species of mosquitoes thrive in containers that hold very small amounts of water (as little as a bottlecap), which can easily be overlooked and become problematic, especially after plants around your property develop foliage.

 

The Mosquito Control Unit encourages everyone to routinely survey their property and remove standing water.

 

Please remember: STANDING WATER + 7 DAYS = MOSQUITOES.

Categories
Business Culture Digital - AI & Apps Environment Healthcare Lifestyle News Now! Technology

Devashish Saxena joins Imperial Dade as Chief Digital Officer to support company’s continued growth

JERSEY CITY, N.J. — (BUSINESS WIRE) — Imperial Dade, a leading distributor of food service packaging and janitorial supplies, announced that Devashish Saxena has joined the company as its first Chief Digital Officer. He will be focused on identifying how the organization can use the latest digital technologies to create a world-class omnichannel customer experience powered by data science.


For over 20 years, Devashish Saxena has built digital organizations and guided them in making data-driven decisions to deliver business impact. With a software engineering background, Devashish focuses on human beings and their role in the digital journey.

 

Most recently Devashish led digital transformation as Vice President, Chief Digital Officer at PPG, a Pittsburgh-based coatings manufacturer. Prior to his time at PPG, Devashish served as Vice President, Global Digital Business and E-commerce at Rexel, a France-based omnichannel distributor of electrical supplies. Prior to Rexel, he led the digital journeys at UK-based Premier Farnell (now part of Avnet) and Texas Instruments in Dallas.

 

“Devashish is an excellent addition to our organization, contributing his expertise and passion to further develop and execute our digital strategy,” said Charlie D’Elia Jr., Chief Commercial Officer of Imperial Dade.

 

“Digital transformation has a critical role to play in our disciplined growth plans, and his experience and leadership will be invaluable in the years ahead.”

 

“I am so happy to join the amazing team at Imperial Dade,” said Devashish.

 

“They are passionate about serving our customers and are doing so in a familial and entrepreneurial manner. I really appreciate the warm welcome from everyone I have met thus far and look forward to leading the company on its digital transformation journey.”

 

About Imperial Dade

Founded in 1935, Imperial Dade serves more than 90,000 customers across North America. Since Chairman Robert Tillis and CEO Jason Tillis acquired the company in 2007, the company has grown both organically and through acquisitions to become a leader in the disposable food service and janitorial supplies industry. For additional information, please visit www.imperialdade.com.

Contacts

Laura Craven

305-805-2716

Categories
Business Culture Healthcare Lifestyle Local News News Now! Programs & Events

As COVID-Era SNAP Benefits End, HelloFresh Increases Support to Help Those Facing Food Insecurity

  • 100,000 additional meals will be donated to food banks across the country
  • HelloFresh announces the temporary opening of an additional free Community Fresh Market in Colorado

 

NEW YORK — (BUSINESS WIRE) — HelloFresh, the world’s leading meal kit company and food solutions group, announced today an increase in their “Beyond the Box” program to support food banks as COVID-19 SNAP benefits have expired.

 

As part of its mission to support those facing food insecurity, the company pledges to provide 100,000 additional meals across a number of its brands – HelloFresh, Green Chef, and EveryPlate – this Spring to food banks and non-profit partners around the country – an extension to their existing donation programs.


The Supplemental Nutrition Assistance Program (SNAP) provides assistance to 41 million people suffering from food insecurity by providing them a monthly benefit to use on food purchases. At the start of the COVID-19 pandemic, as millions of people lost their jobs, SNAP benefits were temporarily increased to help low-income families. The supplemental benefits expired this February, as a signal that the pandemic is coming to an end. This month, the average SNAP household has seen at least $95 less in benefits, with some seeing a reduction of $250 or more.

 

“While an end to the pandemic is a welcome note, many families continue to face food insecurity, especially with record inflation contributing to higher food costs,” said Jeff Yorzyk, Senior Director of Sustainability for HelloFresh US. “Many people are turning to their local food banks to help fill the void – unfortunately some of which are not equipped for the influx. Our goal is to help our partners put healthy, nutritious food on the tables of as many Americans as possible in this time of need.”

 

HelloFresh is donating 100,000 extra meals, including meal kits, ready-to-heat dinners and nutritious sides to food banks including Table to Table in New Jersey, Second Helpings Atlanta in Georgia, Tarrant Area Food Bank in Texas and St. Mary’s Food Bank in Arizona. The company is also increasing support by adding a second temporary Community Fresh Market in Colorado. This farmer’s market style distribution, hosted by Denver-based hunger relief organization, We Don’t Waste, will be open bi-weekly from April through July, to whoever needs it and will provide a variety of fresh produce, proteins and dairy items at no cost.

 

“This is a critical time for our community. With the reduction of SNAP benefits on top of rising inflation for food, we’ve seen food insecurity increase and demand for our programs has skyrocketed. We’ve seen a 63% increase in attendance at the Community Fresh Markets from this time last year. And seniors, experiencing an even greater reduction in benefits, have nearly doubled in attendance,” said Arlan Preblud, Founder and Executive Director for We Don’t Waste. “We’re now providing food access to over 10,000 individuals each month through these markets. We Don’t Waste is really grateful to work with partners like HelloFresh. They are helping us provide consistent food access to help strengthen our community.”

 

Beyond the Box helps those in need

HelloFresh aims to change the way people eat, forever, inclusive of those facing food insecurity. Their US-based social impact program called Beyond the Box, focuses on reducing food waste and creating a more equitable food system for those in need.

 

The program consists of their “Meals with Meaning” initiative, launched in 2020, as a response to the pandemic and elevated rates of food insecurity. To date, Meals with Meaning has provided more than 4 million free meal kits to individuals in need, with each kit containing HelloFresh ingredients and step-by-step recipe cards to create home-cooked meals.

 

Through the remainder of the year, HelloFresh will increase their Meals With Meaning donations in Newark, New Jersey. In partnership with the City of Newark and food-rescue organization, Table to Table, this site represents the company’s first and largest Meals with Meaning program.

 

“More than 850,000 people in New Jersey depend on federal food assistance to sustain themselves or their families,” said Amiri Baraka, Jr., Chief of Staff for the City of Newark. “With inflation so high, individuals are struggling to put food on the table right now. We need to ensure that those who need help have access to it. We’re incredibly grateful for companies like HelloFresh who are partnering with us to fill this critical need.”

 

HelloFresh also continues to focus on its sustainability and social impact efforts by contributing nearly 19 million pounds of surplus food in the US in 2022, supporting more than 40 food banks and pantries across the country.

 

To learn more about HelloFresh’s Beyond the Box program, including Meals with Meaning, visit https://www.hellofresh.com.

 

About HelloFresh

HelloFresh is the world’s leading meal-kit company. Founded in Berlin in November 2011, the Company now operates across 18 international markets. In 2022, HelloFresh furthered their mission to “change the way people eat forever” by delivering more than 490 million meals to customers across the U.S. HelloFresh was voted the Most Trusted Meal Kit Delivery Service in America in 2021 and 2022 by Newsweek. HelloFresh has offices in New York, Chicago, and Boulder. For more information, visit www.hellofresh.com.

Contacts

Press

Abigail Dreher 860-922-4598
Associate Director, Corporate Communications prusa@hellofresh.com
HelloFresh US www.hellofresh.com