Pomalyst Takes the Stage

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Its parent has one of the longest and varied histories in the annals of medicine. Its sibling is a star raking in billions of dollars every year. And now it stands ready to take the stage on its own.

What is "it"? The answer is Pomalyst -- Celgene's (NASDAQ: CELG  ) most recently approved drug. In previous articles in this series, we reviewed the company's other drugs currently on the market -- Revlimid, Vidaza, Thalomid, Abraxane, and Istodax. Now it's Pomalyst's turn.

Like Revlimid, Pomalyst is an analog of Thalomid. In 2001, just a few years after Celgene obtained approval for Thalomid in treating a condition associated with leprosy, a Boston researcher discovered that 3-amino-thalidomide showed promise in limiting the growth of cancer cells.

Celgene initially called the drug Actimid or CC-047. The company had phase 1 clinical trials under way by 2004. In 2006, Celgene announced plans to advance the drug to phase 2 studies targeting treatment of sickle cell anemia, myelofibrosis, and prostate cancer. Those plans eventually included another phase 2 study for multiple myeoloma. 

It was that added study and other studies for multiple myeloma that saw the best results. The drug, renamed by that point as pomalidomide, advanced into phase 3 trials. Those trials also went very well and led to Celgene filing for U.S. and European regulatory approval in 2012.

After years of clinical studies, the Food and Drug Administration approved pomalidomide, now branded as Pomalyst, for treatment of relapsed or refractory multiple myeloma on Feb. 8, 2013. Patients taking Pomalyst must have previously tried Celgene's top drug, Revlimid, and Velcade -- developed by Johnson & Johnson (NYSE: JNJ  ) and Takeda.

Celgene rightly views Pomalyst as a complementary product to Revlimid. Physicians will start multiple myeloma patients first on either Revlimid or Velcade. If one drug doesn't work as well as desired, the patients will switch over to the other drug. If progression of the disease continues after trying both of these drugs, patients will probably either be given Pomalyst or Onyx Pharmaceuticals' (UNKNOWN: ONXX.DL  ) Kyprolis. While Pomalyst and Kyprolis will technically be rivals, both drugs should prove quite successful with a large unmet need in the third-line and fourth-line treatment of multiple myeloma.

Meanwhile, Celgene has launched its Pomalyst Risk Evaluation and Mitigation Strategy, or REMS, program to restrict distribution of the drug. Like its parent compound, Thalomid, Pomalyst presents serious fetal risks and should not be taken by pregnant women.

Even if no other possibilities existed for Pomalyst, U.S. approval for multiple myeloma represents a significant market potential. However, other opportunities abound. Perhaps the biggest is the expected decision by European regulators in the second half of 2013.

Results from phase 3 studies of Pomalyst in treating myelofibrosis are anticipated within the next few months. If those findings are positive, Celgene will move forward quickly with regulatory filings in the U.S. and Europe for this second indication for the drug.

Pomalyst appears to be on track to eventually hit annual sales between $1 billion and $2 billion. If that happens, the drug would by far eclipse the success of Thalomid. While it would still trail well behind the $3.8 billion annual sales achieved by Revlimid, that's still an excellent opportunity for Celgene. And not a bad family tradition.

Can Celgene continue to soar?
Every in-the-know biotech investor has an eye on Celgene. Shares have skyrocketed this year as the company outlined a plan to almost triple its profits in only a few years. But should you buy the story Celgene is selling? Make sure you understand the key opportunities and risks facing this company by picking up The Motley Fool's brand new premium report on Celgene. To claim your copy today -- along with a free year of updates -- simply click here now.

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