On October 19, 2021 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2021 (Press release, Johnson & Johnson, OCT 19, 2021, View Source [SID1234591524]). "Our third-quarter results demonstrate solid performance across Johnson & Johnson, driven by robust above-market results in Pharmaceuticals, ongoing recovery in Medical Devices, and strong growth in Consumer Health," said Alex Gorsky, Chairman and Chief Executive Officer. "In the face of evolving marketplace dynamics resulting from the effects of COVID-19 and other global trends, we have continued to demonstrate the responsiveness and agility required to meet the needs of our stakeholders, while also successfully investing in a pipeline of innovation and key commercial platforms to drive our future growth. I am incredibly proud of our Company’s transformative growth over the last decade. As I prepare to transition the role of CEO to Joaquin Duato in January, I want to extend my deepest gratitude to our colleagues around the globe who work tirelessly to deliver solutions to address the world’s most urgent and unmet healthcare challenges."

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OVERALL FINANCIAL RESULTS

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Excludes intangible amortization expense and special items

REGIONAL SALES RESULTS

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Note: values may have been rounded

THIRD QUARTER 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, increased 5.7%* primarily driven by over-the-counter (OTC) products. Major contributors to growth were TYLENOL and MOTRIN analgesics, upper respiratory products, and digestive health in OTC, and AVEENO in Skin Health / Beauty.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 13.8%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, and OPSUMIT (macitentan) an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression. Also contributing to growth was sales of the not-for-profit COVID-19 Vaccine (Ad26.COV2.S) for the treatment of the SARS-CoV-2 virus. This growth was partially offset by declines in U.S. sales of REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and INVOKANA (canagliflozin) for the treatment of adults with type 2 diabetes.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 7.6%*, driven by electrophysiology products in Interventional Solutions, wound closure products in General Surgery, surgical vision products and contact lenses in Vision, trauma, hips, and knees in Orthopaedics, and energy, endocutters, and biosurgicals in Advanced Surgery. Growth was partially offset by Spine, Sports & Other.

NOTABLE NEW ANNOUCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the company’s website at news releases.

Regulatory
Decisions

INVEGA HAFYERA (paliperidone palmitate) Receives FDA Approval For First and Only Twice-Yearly Treatment for Adults with Schizophrenia

(press release)

XARELTO (rivaroxaban) Plus Aspirin Receives FDA Approval For Expanded Peripheral Artery Disease (PAD) Indication to Include Patients After Lower-Extremity Revascularization (LER)

(press release)

UPTRAVI (selexipag) Receives FDA Approval For Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)

(press release)

Regulatory
Submissions

Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine 1

(press release)

Janssen Submits Application Seeking U.S. FDA Approval of STELARA (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis 1

(press release)

Other

Alex Gorsky to Transition Role of Chief Executive Officer of Johnson & Johnson to Joaquin Duato, Effective January 3, 2022

(press release)

Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson to Retire, Effective December 31, 2021 1

(press release)

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

(press release)

Johnson & Johnson Issues Statement on Nationwide Opioid Settlement Agreement

(press release)

DePuy Synthes Announces Introduction of the INHANCE Shoulder System, a First-to-Market, Fully Integrated Shoulder Arthroplasty System

(press release)

Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults

(press release)

Janssen Receives Positive CHMP Opinion for BYANNLI (six-monthly paliperidone palmitate) for the Maintenance Treatment of Schizophrenia in Adults

(press release)

Ethicon Announces ECHELON CIRCULAR Powered Stapler Associated with Major Reduction in Serious Complications Following Colorectal Surgery

(press release)

Johnson & Johnson Takes Steps to Equitably Resolve All Current and Future Talc Claims 1

(press release)

Janssen Receives Positive CHMP Opinion for RYBREVANT (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy 1

(press release)

Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee 1

(press release)

1Subsequent to the quarter

FULL-YEAR 2021 GUIDANCE:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures

Non-GAAP financial measure; excludes the impact of translational currency

Calculated using Euro Average Rate: July 2021 = $1.19 and October = $1.19 (Illustrative purposes only)

Non-GAAP financial measure; excludes intangible amortization expense and special items

Note: % may have been rounded

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.

On October 19, 2021 MASORI Therapeutics, a company focused on the pharmaceutical industry is applying artificial intelligence to achieve competitive advantage through the creation of innovative market solutions and Vyant Bio, Inc. ("Vyant Bio") (Nasdaq: VYNT), an emerging global drug discovery company that identifies small and large molecule therapeutics to treat central nervous system ("CNS") and oncology-related diseases, reported they entered into an agreement to pursue co-development and out-licensing partnerships with pharmaceutical and biotechnology companies (Press release, Vyant Bio, OCT 19, 2021, View Source [SID1234591546]). The MASORI Therapeutics team has decades of experience in all areas of drug discovery and development, including building biopharmaceutical commercial infrastructures and partnerships from concept to consummation.

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MASORI Therapeutics combines healthcare and best-in-class digital expertise that enables life sciences companies to leverage artificial intelligence, machine-learning, and virtual reality to achieve brand growth and better analysis, targeting, and execution. The company’s work with Vyant Bio will initially focus in Japan and will center on providing key insights into the application and intersection of their technologies to accelerate partnership-based therapeutic discovery and development.

"I am inspired by Vyant Bio’s commitment to innovation and the discovery of cures for intractable diseases," said Dane Hallberg, founder, executive chairman and chief executive officer of MASORI Therapeutics. "Vyant Bio embodies the tenets of MASORI Therapeutics, and we look forward to helping both companies drive and advance the development of new therapies that have the potential to make the greatest impact on patients."

Vyant Bio couples highly functional, complex in vitro human-based organoid platforms with advanced analytics and in vivo preclinical and regulatory expertise to bring the most promising compounds through the discovery pipeline. The company incorporates patient biology early in the discovery process to identify, validate, and de-risk new targets and compounds prior to clinical trials.

"Partnerships are central to scientific advancement, and for patients with CNS and oncology diseases, time is of the essence to uncover new treatments as quickly as possible," said Jay Roberts, president and chief executive officer of Vyant Bio. "Our relationship with MASORI Therapeutics will identify and drive drug development partnerships that leverage our capabilities to accelerate the discovery and delivery of such treatments."

On October 19, 2021 Aadi Bioscience, Inc. ("Aadi"), a privately-held clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that Founder, Chief Executive Officer and President, Neil Desai, Ph.D., will present at H.C. Wainwright’s 2nd Annual Precision Oncology Conference, which will be held virtually (Press release, Aadi Bioscience, OCT 19, 2021, View Source [SID1234592016]).

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Presentation Information:

Date: Wednesday, October 20, 2021

Time: 1 pm ET

To Listen to the Presentation:

The live webcast can be accessed here: View Source A replay will also be available at this link for 90 days and posted on Aadi’s website within the Investors & News/Events & Presentations section.

On October 19, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it has submitted an Investigational New Drug application (IND) and an accompanying application for Fast Track status with the U.S. Food and Drug Administration (FDA) for a planned Phase 2 study of the company’s drug Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer (Press release, AIM ImmunoTech, OCT 19, 2021, View Source [SID1234591508]).

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The planned AMP-270 clinical trial of approximately 250 subjects will be a Phase 2, randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen when added to SOC (standard of care) versus SOC alone for subjects with advanced pancreatic carcinoma recently treated with FOLFIRINOX chemotherapy regimen. Secondary objectives include comparing safety and tolerability.

Amarex Clinical Research will manage the AIM-sponsored study. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in The Netherlands are expected to be the primary study sites, although additional sites are anticipated.

Key support for both the study and the application for Fast Track status includes statistically significant clinical data in an Erasmus MC early-access program of 27 subjects where the overall survival of the Ampligen-treated cohort was 19.2 months from the start of FOLFIRINOX, compared to 12.5 months in the historical control group, for an increase in survival of 6.7 months. Additionally, several subjects are still alive more than three years later.

AIM believes that the clinical significance of these data as a treatment for pancreatic cancer provide Ampligen with a strong case for FDA Fast Track designation, which is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. A drug that has been granted FDA Fast Track status is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
AIM Chief Scientific Officer David Strayer, MD, commented, "Given the extensive work to date, we are well positioned to move aggressively and launch the Phase 2 trial of Ampligen upon approval of the IND. We could not be more enthusiastic about the outlook for this program given the compelling prior clinical data from Erasmus MC, which demonstrated a significant improvement in median overall survival, compared to a matched historical control group. Ampligen has also demonstrated a strong safety profile in numerous trials. At the same time, we are excited to have submitted our Fast Track application, which would confer a number of important benefits and potentially help accelerate approval."

AIM CEO Thomas K. Equels further commented, "Submission of our IND and Fast Track application are very significant milestones for the company and I would like to thank our entire team, as well as our clinical and regulatory advisors, for their tremendous efforts in preparing these carefully planned submissions. The rapid progress we have made is especially important given the devastating nature of pancreatic cancer. Further, both the FDA and the EMA have granted Ampligen orphan drug status in pancreatic cancer. This creates the potential for several years of market exclusivity. There is a significant unmet need for a safe and effective therapy for these patients, and we believe Ampligen holds enormous promise."

See:

AIM ImmunoTech Inc.’s Drug Ampligen Awarded FDA’s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer
AIM ImmunoTech’s Subsidiary Receives Orphan Medicinal Product Designation by the European Medicines Agency for Ampligen to Treat Pancreatic Cancer

On October 19, 2021 Targovax ASA, reported that members of its executive management team are invited to present and participate in upcoming conferences (Press release, Targovax, OCT 19, 2021, View Source [SID1234591525]).

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Økonomisk Ugebrev’s Life Science Investor conference
Date: 20 October 2021
Presenter: Lone Ottesen (CDO)
Time: 14:35 CET

Next Gen Immuno-Oncology Virtual Conference-UK/EU Edition
Date: 26 October 2021
Presenter: Victor Levitsky (CSO)
Time: 17:45 CET

Oncolytic Virotherapy Summit
Date: 28 October 2021
Presenter: Erik Digman Wiklund (CBO)
Time: 09:30 EDT / 15:30 CET