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West Announces Landmark Collaboration with Corning in Pharmaceutical Injectable Drug Delivery

On January 25, 2022 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported an exclusive supply and technology agreement with Corning Incorporated (NYSE: GLW) (Press release, West Pharmaceutical Services, JAN 25, 2022, View Source [SID1234606779]). The new collaboration includes a multimillion-dollar investment to expand Corning’s Valor Glass technology to enable advanced injectable drug packaging and delivery systems for the pharmaceutical industry with the goal of advancing patient safety and expanding access to life-saving treatments.

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By combining West’s industry-leading NovaPure components, with Daikyo Flurotec coating technology, and Corning’s Valor Glass and Velocity Vials, the strategic collaboration will enable new, advanced pharmaceutical packaging solutions. The collaboration optimizes the materials science and manufacturing expertise of both companies to help bio-pharma producers navigate the complex regulatory environment and mitigate risk in bringing drugs to market.

"West and Corning have developed this exceptional collaboration to offer leading elastomer-glass system solutions for the containment and delivery of injectable medicines," said Eric M. Green, President and Chief Executive Officer, West. "At West, we value the state-of-the-art products offered by Corning and are excited to build together the next generation of integrated packaging and delivery innovations."

This portfolio of new elastomer-glass system offerings and supportive data services will utilize West’s NovaPure components along with Corning’s Valor Glass technology. West’s NovaPure components adhere to Quality by Design principles and processing, representing the highest standards in pharmaceutical components. For customers, it provides the assurance of components with the tightest specifications applicable within today’s formulation and manufacturing process capabilities at West. Corning’s Valor Glass is intended to enhance the storage and delivery of drugs, providing more reliable access to state-of-the-art medicines essential to public health. Valor Glass packaging can enable increased throughput and offers high chemical durability, strength, and damage resistance.

"This partnership and investment enable the development and industry-leading solutions that enhance patient safety, increase quality and reliability in highly regulated markets, and ensure greater capacity for life-saving drugs. West is a great partner. The combination of Corning’s Valor Glass, along with West’s NovaPure components, is a win-win for customers and patients all over the world," said Wendell P. Weeks, Chairman and Chief Executive Officer, Corning.

ORIC Pharmaceuticals Announces Regulatory Clearance of Clinical Trial Application for ORIC-114 in Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications

On January 25, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported clearance of its Clinical Trial Application (CTA) by the regulatory authorities of the Republic of Korea for ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations (Press release, ORIC Pharmaceuticals, JAN 25, 2022, View Source [SID1234606777]).

"This marks our third IND/CTA regulatory clearance in the last eight months and further demonstrates the productivity and commitment of our team as we expand our clinical portfolio to advance our mission on behalf of patients," said Jacob M. Chacko, M.D., president and chief executive officer. "We are encouraged by the brain penetrant properties and selectivity that ORIC-114 has demonstrated in preclinical studies, and we look forward to advancing the program into a Phase 1 study in the coming months. As we enter 2022, we are well positioned with five expected clinical updates across four clinical programs through the first half of 2023, and with cash and investments to fund our operating plan into the first half of 2024."

About ORIC-114

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated systemic tumor regressions and strong intracranial antitumor activity in various EGFR exon 20 insertion NSCLC and HER2-positive breast cancer models. ORIC-114 also compares favorably in head to head in vivo studies versus multiple approved and clinical stage EGFR exon 20 and HER2 inhibitors. The company plans to initiate a Phase 1b single agent study in patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and will allow patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial data from this trial in the first half of 2023.

Merck Announces Second-Quarter 2022 Dividend

On January 25, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the second quarter of 2022 (Press release, Merck & Co, JAN 25, 2022, View Source [SID1234606776]). Payment will be made on April 7, 2022 to shareholders of record at the close of business on March 15, 2022.

Johnson & Johnson Reports Q4 and Full-Year 2021 Results

On January 25, 2022 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2021 (Press release, Johnson & Johnson, JAN 25, 2022, View Source [SID1234606775]). "Our 2021 performance reflects continued strength across all segments of our business. Guided by Our Credo, I am honored to assume the role of CEO, leading our global teams in continuing our work to deliver life-changing solutions to consumers, patients, and health care providers" said Joaquin Duato, Chief Executive Officer . "Given our strong results, financial profile, and innovative pipeline we are well positioned for success in 2022 and beyond."

FULL YEAR 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide adjusted operational sales increased 3.8%* primarily driven by over-the-counter (OTC) products including TYLENOL analgesics and digestive health, in addition to NEUTROGENA and AVEENO products in Skin Health / Beauty primarily due to COVID-19 market recovery. The growth was partially offset by external supply constraints mainly impacting Skin Health / Beauty.

Pharmaceutical
Pharmaceutical worldwide adjusted operational sales grew 13.6%* driven by DARZALEX (daratumumab), a biologic 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, and INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. Also contributing to growth were sales of the Janssen 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.

Medical Devices
Medical Devices worldwide adjusted operational sales grew 16.8%*, driven primarily by the market recovery from COVID-19 impacts and the associated deferral of medical procedures in the prior year across all of our businesses including Surgery, Interventional Solutions, Vision and Orthopaedics.

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 and information available in the Investors section of the company’s website at news releases, as well as www.factsabouttalc.com,www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

FULL-YEAR 2022 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.

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.

Incyte Provides Update on Parsaclisib and MCLA-145

On January 25, 2022 Incyte (Nasdaq:INCY) reported updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), and MCLA-145, its CD137/PD-L1 bispecific antibody co-developed under a global collaboration and license agreement with Merus (Press release, Incyte, JAN 25, 2022, View Source [SID1234606774]).

Incyte is withdrawing the New Drug Application (NDA) for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). The decision to withdraw the NDA follows discussions with U.S. Food and Drug Administration (FDA) regarding confirmatory studies to support an accelerated approval, which Incyte determined cannot be completed within a time period that would support the investment. The withdrawal of the NDA is a business decision and is not related to any changes in either the efficacy or safety of parsaclisib. The decision impacts only the FL, MZL and MCL indications in the U.S., and does not affect other ongoing clinical trials in the U.S. or other countries.

Additionally, as part of its ongoing portfolio prioritization and capital allocation review, Incyte has decided to opt-out of the continued development of MCLA-145. Incyte will continue to collaborate with Merus and leverage their platform to develop a pipeline of novel agents.

About Parsaclisib

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and in a Phase 3 study for autoimmune hemolytic anemia (AIHA). Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are also underway.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.