Clinical experience with NOXAFIL IV in the primary treatment of invasive aspergillosis in high risk patients (hematopoietic stem cell transplant patients (including patients with GVHD), neutropenic patients with hematologic malignancies post –chemotherapy, solid organ transplant recipients and other immunosuppressed patients (including use in the ICU setting and use in patients recently hospitalized with COVID).
Clinical experience with NOXAFIL (with either the oral tablet, and/or IV solution) either in prophylaxis or treatment (including salvage treatment) of hematopoietic stem cell transplant patients (including patients with GVHD), neutropenic patients with hematologic malignancies post –chemotherapy, solid organ transplant recipients and other immunosuppressed patients (including use in the ICU setting).
Preclinical studies including global and regional azole susceptibility surveys, mechanisms of azole resistance, in vitro and in vivo models of relevant invasive mold infections, and PK/PD assessments in relevant invasive mold infections
PK/PD assessment of NOXAFIL (IV, tablet, IV-to-tablet) in special populations including pediatric and adult patients with GVHD, neutropenic patients with hematological malignancies post-chemotherapy, solid organ transplants recipients and other immunosuppressed patients (including use in the ICU setting)
Epidemiological studies evaluating burden of disease of Candida and Aspergillus or other rare mold infections in high-risk patient populations
Pharmacoeconomic, health services and/or outcomes research studies in approved indications
Antifungal Stewardship initiatives that explore the utility of NOXAFIL
Forward-looking statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
No Duty to Update
The information contained in this website was current as of the date presented. The company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date.