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merck & co. inc. (MRK) Key Developments

Merck & Co. Inc. and Sun Pharmaceutical Industries Ltd. Enter into Licensing Agreement for Tildrakizumab

Merck & Co. Inc. and Sun Pharmaceutical Industries Ltd. through their respective subsidiaries, announced an exclusive worldwide licensing agreement for Merck's investigational therapeutic antibody candidate, tildrakizumab, (MK-3222), which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80 million. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.

Merck Announces Data from Pivotal Phase 3 Fracture Outcomes Study for Odanacatib, an Investigational Oral, Once-Weekly Treatment for Osteoporosis

Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck's investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial (LOFT), odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The results from this trial were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Houston, Texas. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo. In the study, odanacatib significantly reduced osteoporotic fracture risk In LOFT, odanacatib significantly reduced the risk of three types of osteoporotic fractures compared to placebo in the primary efficacy analysis, and also reduced the risk of the secondary endpoint of clinical vertebral fractures. Specifically, compared to patients receiving placebo, patients who received odanacatib had a: 54% relative risk reduction of new and worsening morphometric (radiographically-assessed) vertebral fractures (p<0.001); 47% relative risk reduction of clinical hip fractures (p<0.001); 23% relative risk reduction of clinical non-vertebral fractures (p<0.001); and 72% relative risk reduction of clinical vertebral fractures (p<0.001). In addition, treatment with odanacatib led to progressive increases over five years in bone mineral density (BMD) at the lumbar spine and total hip. Compared to placebo, the change in BMD from baseline at five years with odanacatib for lumbar spine was 11.2% (p<0.001) and for total hip was 9.5% (p<0.001). Prior to the start of the study, certain adverse events of interest were identified for adjudication: morphea-like skin lesions, systemic sclerosis, serious respiratory infections, osteonecrosis of the jaw, atypical femoral shaft fractures, delayed fracture unions, atrial fibrillation and major adverse cardiovascular events (MACE). Adjudicated morphea-like skin lesions occurred more frequently on odanacatib: in 12 patients in the odanacatib group (0.1% incidence) and 3 patients in the placebo group (<0.1% incidence). These skin lesions resolved or improved after discontinuation of the study drug. Adjudicated atypical femoral shaft fractures were reported for 5 patients in the odanacatib group (incidence of 0.1%) and not reported in patients in the placebo group. No meaningful differences were observed in adjudicated events of systemic sclerosis, serious respiratory infections or delayed fractured unions between groups. There were no adjudicated cases of osteonecrosis of the jaw. Adjudicated atrial fibrillation was reported in 92 patients in the odanacatib group (incidence of 1.1%) and 80 patients in the placebo group (incidence of 1.0%). In the MACE analysis, events were reported for 215 patients in the odanacatib group and 194 patients in the placebo group (hazard ratio 1.12 (95% confidence interval (CI) 0.93, 1.36)). There were 271 deaths reported in the odanacatib group and 242 deaths in the placebo group (hazard ratio 1.13 (95% CI 0.95, 1.35)); this numeric difference does not appear to be related to a particular reported cause or causes of death. There was a numeric imbalance in adjudicated strokes with more events occurring in the odanacatib group. Based on the adjudication committee assessment, 109 patients in the odanacatib group experienced stroke (incidence 1.4%) and 86 patients (incidence 1.1%) in the placebo group (hazard ratio 1.28 (95% CI 0.97, 1.70)). Investigator-reported cerebrovascular events occurred in 305 patients in the odanacatib group (incidence 3.8%) and 290 patients taking placebo (incidence 3.6%) (hazard ratio 1.06 (95% CI 0.91, 1.25)). Merck continues to collect data from the blinded extension study and is planning additional analyses of data from the trial, including an independent re-adjudication of major adverse cardiovascular events, in support of regulatory submissions.

Merck & Co Appoints Giri Giridhar as Senior Director (Finance) and Board Member for the Global Pharma India Arm

Merck & Co appointed Giri Giridhar as senior director (finance) and board member for the global pharma company's India arm, after a four-year stint with Wockhardt Ltd.

U.S. Food and Drug Administration Approves Merck & Co.'s Keytruda in the United States for the Treatment of Advanced and Unresectable Malignant Melanoma

Merck & Co.'s Keytruda is approved in the United States by U.S. Food and Drug Administration for the treatment of advanced and unresectable malignant melanoma.

Merck Receives Accelerated Approval of KEYTRUDA(R) (Pembrolizumab), the FDA-Approved Anti-PD-1 Therapy

Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA(R) (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. KEYTRUDA is the anti-PD-1 (programmed death receptor-1) therapy approved in the United States and received FDA's Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need. For the recommended 2 mg/kg dose based on data in 89 patients, the overall response rate was 24% (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At the time of analysis, 86% (18/21) of patients with objective responses had ongoing responses with durations ranging from 1.4+ to 8.5+ months, including eight patients with ongoing responses of 6 months or longer. 14% (3/21) had progression of disease 2.8, 2.9, and 8.2 months after initial response. KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to fight advanced melanoma. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumor cells and healthy cells. Immune-mediated adverse reactions occurred with KEYTRUDA including pneumonitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered. Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. Female patients of reproductive potential should be advised of the potential hazard to a fetus. The company is conducting ongoing Phase 2 and 3 clinical studies in advanced melanoma, which are designed to provide further confirmatory evidence for KEYTRUDA in this indication. Merck plans to make KEYTRUDA available within one week from FDA approval. The approval of KEYTRUDA was based on data from a multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease. Key eligibility criteria included prior treatment with ipilimumab (two or more doses at 3 mg/kg or higher) and a BRAF or MEK inhibitor, if BRAF V600 mutation-positive; and disease progression within 24 weeks following the last dose of ipilimumab. Patients were randomized to receive 2 mg/kg (n=89) or 10 mg/kg (n=84) of KEYTRUDA every 3 weeks until unacceptable toxicity or disease progression that was symptomatic, was rapidly progressive, required urgent intervention, occurred with a decline in performance status, or was confirmed at 4 to 6 weeks with repeat imaging. The major efficacy outcome measures were confirmed overall response rate as assessed by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and duration of response. Tumor response was assessed every 12 weeks.


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