cafepharma’s detailpiece

At the Wachovia Healthcare Conference, yesterday, Celgene (NASDQ: CELG)CFO, Dave Gryska, delivered good news for Celgene investors and patients. The company is generating significant cash flows (900 million) and generated $1.4 billion in total revenue. This exceeded guidance at the beginning of ‘07 projecting $1.3 billion. Additionally earnings per share (EPS) for ‘07 of $1.06 will exceed guidance of $1.00.

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The success of Revlimid was a major contributor to the attractive revenue and cash flows. Additionally, Celgene has completed a build out of capabilities in Europe that should begin generating returns in 2008, and they expect to close the acquisition of Pharmion in March of ’08. The transaction has already cleared regulatory hurdles in the U.S. and Europe.

It looks like 2008 will be another good year for Revlimid. It was approved for myelodysplastic syndromes (MDS) and multiple myeloma (MM) in Australia. Canada also approved Revlimid for MDS. Additionally, the company will present new Revlimid data in 2008 that is expected to expand Revlimid labeling and use.

Data from a study in newly diagnosed MM patients shows that Revlimid slows time to progression and some patients were progression free. There were also encouraging partial and total response rates.

A study recently published in the New England Journal of Medicine, reports that the median overall survival time is up to 35 months. The overall message from the studies is that patients on Revlimid are living longer, with better quality of life and Revlimid is delivered via a more attractive oral pill form vs. infusion/injection, etc.

Celgene believes that Revlimid is the top selling drug for MM in the U.S. for first year post launch. They expect that it will be overall market leader in the U.S. for 2008.

The potential market for Revlimid is very large. There are 300,000 MM and MDS patients in the U.S. and Europe combined. When all of the potential treatment approvals are considered, the potential patient population for the U.S., Europe, and Japan, is 1.5 million. By capturing only a part of this market, Revlimid would become a multi billion-dollar drug. 

While Revlimid is the company’s current growth engine, they also have a pipeline that includes additional products in the oncology/hematology arena and in the inflammation, psoriasis markets. Several of these therapies are already in phase II trials.

One of these is CC-4047. CC-4047 is a more potent Imid than Revlimid. It has a multi-factorial mechanism of action that includes, angiogneisis inhibition, modulation of levels of key pro-inflammatory and regulatory cytokines, and immune cell co-stimulation (e.g., T cells, NK cells).

Another promising candidate is CC-10004. This drug is in Phase II trials for the treatment of psoriasis and other chronic inflammatory diseases. Early studies demonstrated an excellent side effect profile and significant activity in psoriasis patients. The drug is more attractive than some current biologic (it is not a biologic) treatments because it is taken in pill form.

2008 should be an exciting year for Celgene and its investors. Although the integrating a new company (Pharmion) always leads to some disruption and friction, the company is poised to reap rewards from investments in Europe and Japan and to possibly expand labeling and patient base for Revlimid. While drug development is always a gamble (even in late stages), Celgene’s experience in bringing novel drugs to market gives it an advantage in developing a very promising pipeline.

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