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$MRK said that it's planning to submit a supplemental Biologics License Application (sBLA) to the U.S. FDA for KEYTRUDA (pembrolizumab) by the end of 2015 based on the findings from KEYNOTE-010 clinical trial. The company is also intending to submit a Marketing Authorization Application to the European Medicines Agency in early 2016.
Pharma company $MRK said the FDA has granted 'Breakthrough Therapy Designation' for Lenvima, a multiple receptor tyrosine kinase inhibitor developed by Eisai in combination with Merck's anti-PD-1 therapy Keytruda for the treatment of renal cell carcinoma. The FDA action was based on the results of a multi-center study conducted in US and Europe.
Merck today announced that it has received Breakthrough Therapy Designation from FDA for LENVIMA and KEYTRUDA. The combination therapy (LENVIMA & KEYTRUDA) is being jointly developed by Eisai and $MRK for treating patients with advanced and/or metastatic renal cell carcinoma. In 2017, approx. 63,990 new cases were estimated to have occurred in US.
Merck announced today that Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its cancer drug KEYTRUDA for treating patients with Urothelial Carcinoma, a type of bladder cancer. This approval helps $MRK to market KEYTRUDA for 4 types of cancer in Japan. The company plans to market KEYTRUDA in partnership with Taiho Pharmaceuticals.
Merck said today that the FDA has given consent to review a supplemental Biologics License Application (sBLA) for KEYTRUDA for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma. FDA has granted $MRK Priority Review status and expected to complete evaluation by April 3, 2018.
Merck has received FDA approval for ISENTRESS (raltegravir) to treat neonates who are affected by HIV-1. With this approval, newborns right from birth to four weeks (weighing at least 2 kg) can be treated with $MRK’s raltegravir. The drug is not recommended for pre-term newborns/infants weighing less than 2 kg, due to lack of clinical trials data.
Merck's Board has increased the quarterly dividend by $0.01 to $0.48 per share vs. $0.47 paid last quarter. Dividend will be paid on Jan. 8, 2018 with cut off set at Dec. 15, 2017. In addition, $MRK's Board has also authorized $10Bil of treasury stock purchase without setting any deadlines.
$MRK announced that it has received positive opinion from Committee for Medicinal Products for Human Use (CHMP) for its antiviral drug PREVYMIS (letermovir). The drug helps to prevent cytomegalovirus (CMV) infections and disease in adults previously exposed to this virus who have received an allogeneic hematopoietic stem cell transplant.
In addition to oncology and animal health domains, $MRK is prioritizing its investments on certain vaccines and HIV, which is believed to deliver long-term growth. Sales of cancer drug KEYTRUDA eclipsed $1Bil for the first time in 3Q, which makes it the 2nd largest product in the Merck’s portfolio. 55% of its sales come from lung cancer in the US.
$MRK's blockbuster cancer drug Keytruda sales nearly tripled touching $1.05Bil vs. 3Q16 and Hepatitis C drug Zepatier sales jumped 185% to $468MM. Due to pressure from generic drugs, cholesterol drugs Zetia and Vytorin sales halved to a combined $462MM. Veterinary medicines sales increased 15% to $1Bil.
$MRK reported a loss of $56MM in 3Q, primarily due to a $2.35Bil charge for a new partnership with AstraZeneca to market cancer drugs. The company also added that the cyberattack in June impacted sales by $135MM. Despite 2% drop in 3Q sales, $MRK has raised its FY17 outlook with non-GAAP EPS expected to be $3.91-3.97 and sales between $40-40.5Bil.
$A said its Dako PD-L1 IHC 22C3 pharmDx assay has an expanded label approved by the US FDA to aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA, an anti-PD-1 therapy manufactured by $MRK. These approvals mean these patients have the possibility of receiving a targeted anti-PD-L1 immunotherapy.
$MRK announced that Keytruda is the only programmed death (PD-1) drug with data to show it can improve overall survival rate in the second-line bladder cancer. Phase 3 results show that patients whose disease had progressed following platinum chemo treatment, Keytruda demonstrated an OS advantage vs. chemo with median follow-up of 22.5 months.
$MRK and Oxford University's Clinical Trial Service Unit announced the REVEAL study results of anacetrapib, the company's investigational cholesteryl ester transfer protein (CETP) inhibitor. Anacetrapib reduced the risk of major coronary events by 9% relative to placebo. $MRK is reviewing the results with external experts for filing NDA with FDA.