Can Zytiga Build on a Historic 2012?

Johnson & Johnson (JNJ 0.29%) may offer well-known personal-care products such as Listerine and Neutrogena, but it also boasts an impressive portfolio of market-leading therapeutic compounds. The health-care leader was one of the few to show growth in both worldwide pharmaceutical sales and earnings last year, which grew to $25 billion and $3.86 per share, respectively. It finds itself in an enviable position heading into 2013 as one of the best-positioned companies to tackle the patent cliff head-on.

Even with the recent success, there is no time to rest on laurels in the highly competitive landscape of pharma and biotech. The industry's most successful drugs are under constant pressure from other novel drugs and generics, which are either already on the market or timing their entrance for the moment exclusivity is lost. Luckily, 2012 showed that several new drugs are already shaping up to be critical driving forces in the company's future. Today, we will look at the cancer buster Zytiga.

Don't forget me!
If you were to look at a table of 2011 sales, you would see that Zytiga represented the smallest piece of the pie for Johnson & Johnson. You may think the drug isn't as important as last year's blockbusters Remicade, Stelara, or Velcade. Well, numbers can be misleading.

Zytiga was approved in April 2011 for patients with metastatic castration-resistant prostate cancer, or mCRPC, who have received prior chemotherapy containing docetaxel. The drug narrowly missed the blockbuster threshold in its first full year on the market in 2012 with $961 million in sales. In fact, it was the second most successful oncology drug launch in U.S. history behind only Roche's Avastin and easily the best in European history.

It's difficult to ignore growth like that, especially when Zytiga beat out Remicade for year-over-year sales growth:

Source: Johnson & Johnson 2012 earnings.

Zytiga had an impressive first year despite being approved in only one fairly limited indication for post-chemotherapy mCRPC, but recent trials give reason to believe it is just the beginning.

It gets better
In early 2012, a trial evaluating Zytiga in patients with mCRPC who had not received chemotheraoy was unblinded after an interim analysis demonstrated clinical benefit in various endpoints and favorable safety profiles -- every company's dream. Even with incomplete data, Zytiga received expanded approval for the new indication in December. It appears that no one at the FDA will be losing sleep over their decision after data released last week showed a near doubling in progression free survival over the control group.

There's always competition
The expanded approval gives a broader range of patients access to the drug, which could mean another stellar year of growth in 2013. Success is great, but you should still watch the competition.

As the first once-daily oral medication for prostate cancer, Zytiga had an immediate advantage over the field of injectable therapies. That is, until Medivation (MDVN) crashed onto the scene -- three months early -- with its oral medication Xtandi for post-chemotherapy use. Medivation's drug improved survival by five months, compared with Zytiga's 4.6 months, but it will also cost much more at $7,450 per month, compared with $5,495 per month for Zytiga. Both drugs are offered at a lower price point than injectables such as Sanofi's (SNY 1.15%) Jevtana, which costs $8,242 for three weeks of therapy.  

Foolish bottom line
Johnson & Johnson estimates that the overall U.S. prostate cancer market will grow to $3.6 billion in 2016 from just $1.8 billion in 2011. Zytiga's expanded approval opens up a larger slice of the market, while its price advantage over Xtandi should allow it to continue its dominance. The current article series on Johnson & Johnson's pharmaceutical segment has offered investors a glimpse into the company's future, but it's only one part of the health care giant's diverse business model. You may be wondering ...