What This Skin Cancer Drug Approval Really Means to Merck

Thursday’s market reaction may be muted, but this is considered a first-in-class and the approval looks very hurried compared to others.

What is said to separate this drug from others in the cancer fighting field is that it uses a protein to boost the immune system to fight against the cancer as opposed to doing all the work itself.

Here is what matters for Merck shareholders: Keytruda is expected to generate around $1.5 billion in 2017 sales, according to a Bloomberg report. Merck’s market cap is around $173 billion, and its expected sales from Thomson Reuters are $42.7 billion in 2014 and $41.4 billion in 2015.

Keytruda’s improvement in survival or disease-related symptoms has not yet been established. Although the drug has been approved, Merck is still conducting ongoing Phase 2 and 3 clinical studies in advanced melanoma to offer more confirmatory evidence for Keytruda. About 36% of patients that were in the trial taking Keytruda suffered serious adverse reactions. The treatment is generally expected to cost $12,500 per patient on a monthly basis or roughly $150,000 for the year.

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If you want to know why this is important, the Skin Cancer Foundation shows just how important the need for more approved skin cancer drugs happens to be. The Skin Cancer Foundation’s figures include some of the following data points:

• Skin cancer is the most common form of cancer in the United States with over 3.5 million skin cancers in over two million people diagnosed annually.
• There are more new cases of skin cancer each year than the combined numbers of cancers of the breast, prostate, lung and colon.
• Treatment of nonmelanoma skin cancers increased by nearly 77% between 1992 and 2006.
• Over the past three decades, more people have had skin cancer than all other cancers combined.
• One in five Americans will develop skin cancer in the course of a lifetime.
• 13 million white non-Hispanics living in the US at the beginning of 2007 had at least one nonmelanoma skin cancer, typically diagnosed as basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
• Basal cell carcinoma is the most common form of skin cancer; an estimated 2.8 million are diagnosed annually in the US. BCCs are rarely fatal, but can be highly disfiguring if allowed to grow.
• Squamous cell carcinoma is the second most common form of skin cancer. An estimated 700,000 cases of SCC are diagnosed each year in the US.
• The incidence of squamous cell carcinoma has been rising, with increases up to 200% over the past three decades in the US.
• 2% or so of squamous cell carcinoma patients (3,900 to 8,800) died from the disease in the US in 2012.
• Between 40% and 50% of Americans who live to age 65 will have either BCC or SCC at least once.
• Actinic keratosis is the most common precancer, affecting more than 58 million Americans.
• Approximately 65% of all squamous cell carcinomas and 36% of all basal cell carcinomas arise in lesions that previously were diagnosed as actinic keratosis.
• About 90% of nonmelanoma skin cancers are associated with exposure to ultraviolet radiation from the sun.

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Merck closed down by 0.6% at $60.08 on Thursday, but the stock hit a 52-week high of $61.00 earlier in the day. Without the impact of this drug’s weighting on analysts, the consensus price target is $61.83.