On January 24, 2023 PharmaMar (MSE:PHM) has reported that its licensing partner, Adium Pharma, has received the full approval for commercialization for Zepzelca (lurbinectedin) by the Federal Commission for the Protection against Sanitary Risks of Mexico (COFEPRIS) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, JAN 24, 2023, View Source [SID1234626497]).

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This new approval of lurbinectedin is based on the monotherapy clinical data from the open-label, multi-center, single-arm clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.

In March 2021, PharmaMar and Adium Pharma signed a licensing agreement for lurbinectedin in Latin America. The Mexican approval of lurbinectedin has been preceded for Adium by the approval in November 2022 also in Ecuador.

These approvals allow Adium Pharma to commercialize lurbinectedin in Ecuador and Mexico in the following months. SCLC accounted for up to 15% of all lung cancer cases[1]. Most SCLC patients are already at the advanced stage upon diagnosis, resulting in poor prognosis.

On January 24, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.73 per share of the company’s common stock for the second quarter of 2023 (Press release, Merck & Co, JAN 24, 2023, View Source [SID1234626496]). Payment will be made on April 10, 2023, to shareholders of record at the close of business on March 15, 2023.

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On January 24, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported the clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI), for the treatment of advanced solid tumors (Press release, Kura Oncology, JAN 24, 2023, View Source [SID1234626493]). The Company intends to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 first-in-human study as a monotherapy and in combination with other targeted therapies.

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"Although we have seen significant advances in the development of targeted therapies for the treatment of various solid tumors, the reality is that most patients still eventually develop resistance and their cancer progresses on therapy," said Troy Wilson, Ph.D., J.D., President & Chief Executive Officer of Kura Oncology. "Over the past several years, we have pioneered the development of farnesyl transferase inhibitors as combination agents to prevent or delay emergence of resistance to certain classes of targeted therapy. Clearance of the IND for KO-2806 marks an important next step for this program, and we look forward to starting the Phase 1 study later this year."

The Phase 1 first-in-human study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 when administered as a monotherapy and in combination therapy in adult patients with advanced solid tumors. Following completion of the dose escalation as a monotherapy, Kura plans to evaluate KO-2806 in dose escalation combination cohorts in advanced solid tumors. The Company expects to initiate the Phase 1 study in the third quarter of 2023.

About KO-2806

KO-2806 is a potent next-generation inhibitor of farnesyl transferase designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. Kura has demonstrated encouraging clinical activity in HRAS-mutant head and neck squamous cell carcinoma (HNSCC) via farnesyl transferase inhibition with tipifarnib and is currently evaluating tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of HNSCC patients. In addition, preclinical data is supportive of FTIs in combination with other targeted therapies to potentially overcome or prevent emergence of drug resistance to certain classes of drugs.

On January 24, 2023 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2022. "Our full year 2022 results reflect the continued strength and stability of our three business segments, despite macroeconomic challenges," said Joaquin Duato, Chairman of the Board and Chief Executive Officer (Filing, 8-K, Johnson & Johnson, JAN 24, 2023, View Source [SID1234626492]). "I am inspired by our employees who make a difference in the health and lives of people around the world every day. As we look ahead to 2023, Johnson & Johnson is well-positioned to drive near-term growth, while also investing strategically to deliver long-term value."

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FULL YEAR 2022 SEGMENT COMMENTARY:

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Consumer Health

Consumer Health worldwide adjusted operational sales increased 3.9%* predominately driven by over-the-counter (OTC) products. Major contributors to growth in OTC were TYLENOL and MOTRIN analgesics, as well as upper respiratory products and digestive health products in the international markets. Additionally, Skin Health/Beauty adjusted operational growth was primarily driven by NEUTROGENA outside the U.S. Growth was partially offset by Oral Care in the international markets.

Pharmaceutical

Pharmaceutical worldwide adjusted operational sales grew 6.8%*, 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, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, and INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. This growth was partially offset by declines in sales of REMICADE (infliximab), a biologic approved for the treatment of several immune-mediated inflammatory diseases, IMBRUVICA (ibrutinib), an oral, once daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, and ZYTIGA (abiratone acetate), an oral, once daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

MedTech

MedTech worldwide adjusted operational sales grew 6.1%*, driven primarily by electrophysiology products in Interventional Solutions, contact lenses in Vision, and wound closure products in General Surgery.

NOTABLE NEW ANNOUNCEMENTS 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, as well as
www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

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 January 24, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that its fourth quarter and full year 2022 financial results will be released on Tuesday, February 7, 2023 after the markets close (Press release, Exelixis, JAN 24, 2023, View Source [SID1234626491]). At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 888-338-9509 (domestic) or 412-902-4281 (international) and ask to be joined into the Exelixis conference call to participate by phone.

A telephone replay will be available until 8:00 p.m. ET on February 9, 2023. Access numbers for the telephone replay are: 877-344-7529 (domestic) and 412-317-0088 (international); the passcode is 7374267. A webcast replay will also be archived on www.exelixis.com for one year.