2009.06.07 – An Insight On Incyte Corp


Sun. June 07, 2009; Posted: 05:23 AM

The company will be participating in the Goldman Sachs 30th Annual Global Healthcare Conference on Tuesday, June 9. Incyte has no products on the market and has no new drugs to be launched in the immediate future, but has an interesting product pipeline.

Incyte will be advancing its investigational drug, INCB18424, for myelofibrosis into phase III testing in the U.S. in August 2009. The U.S. phase III trial of INCB18424 dubbed COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) was originally scheduled to begin in the first-half of 2009, but has been delayed by two months to August as it took time to establish the appropriate primary endpoint to support approval of a new treatment for myelofibrosis. The phase III European trial, COMFORT-II, is scheduled to begin enrollment this month.

Myelofibrosis is a disorder in which fibrous tissue replaces the blood-producing cells in the bone marrow, resulting in abnormally shaped red blood cells, anemia, and an enlarged spleen. The disease usually affects people between the ages of 50 and 70. There is currently no known cure for myelofibrosis other than stem cell transplantation and there are no adequately effective therapies.

Some of the treatments that are currently used to delay or relieve symptoms are the combination of male sex hormones (androgens) and the corticosteroid prednisone, blood transfusions, erythropoietin (a synthetic version of the hormone produced by the body) or darbepoietin, and chemotherapy drug hydroxyurea or interferon-alpha. When the spleen becomes extremely large and painful, it is removed or treated with radiation therapy.

On May 29, the company revealed that the single primary endpoint for its late-stage trial of INCB18424 will be the proportion of treated patients achieving a 35% reduction in spleen volume compared to patients receiving placebo. The company anticipates filing a New Drug Application for INCB18424 for myelofibrosis in late 2010 or early 2011 assuming positive results are achieved.

Myelofibrosis is a rare disease and it affects less than 200,000 people in the U.S. at any given time. Last November, the FDA granted orphan drug designation for INCB18424 for the treatment of patients with myelofibrosis.

The phase II trial results of INCB18424 have demonstrated unprecedented reductions in splenomegaly (enlargement of the spleen) which affects the majority of myelofibrosis patients and clinically meaningful improvements in the constitutional symptoms of the disease, including reductions in fatigue, night sweats, pruritus (ITCH | Quote | Chart | News | PowerRating), abdominal discomfort, poor appetite and cachexia (loss of body weight and muscle mass).

In addition to myelofibrosis, INCB18424 is also being evaluated in patients with mild to moderate psoriasis, polycythemia vera/essential thrombocythemia, rheumatoid arthritis, refractory prostate cancer, and multiple myeloma in a phase II setting.

Other active investigational drugs under phase II testing include INCB28050 for rheumatoid arthritis, INCB13739 for type 2 diabetes and INCB7839 for breast cancer.

On June 6, at the 69th Scientific Sessions of the American Diabetes Association being held in New Orleans, Incyte revealed phase IIb trial results of INCB13739, which demonstrated that treatment with once-daily doses of INCB13739 significantly improved glycemic control, as measured by hemoglobin A1c (HBA1C | Quote | Chart | News | PowerRating), insulin sensitivity and total-cholesterol levels.

INCB13739 is an orally bioavailable inhibitor of 11beta-hydroxysteroid dehydrogenase type 1, an enzyme that converts inactive cortisone into the potent biologically active hormone cortisol. Obesity and type 2 diabetes are metabolic problems caused by too much cortisol. By selectively inhibiting 11beta-HSD1 and reducing the level of cortisol in key metabolic tissues, INCB13739 has the potential to simultaneously target multiple cardiovascular risk factors in patients with type 2 diabetes.

According to Incyte, the current treatments for type 2 diabetes typically address individual components of the disease, and few therapies target the multiple risk factors that lead to the elevated cardiovascular risk associated with this condition.

Incyte had incurred losses from inception in 1991 through 1996 and in 1999 through 2008. As of March 31, 2009, the accumulated deficit totaled $1.2 billion.

The company’s fiscal year ends on December 31. During the first-quarter ended March 31, 2009, Incyte incurred a net loss of $40.0 million or $0.41 per share compared to a net loss of $40.2 million or $0.47 per share in the year-ago quarter.

Revenue, which includes contract revenue and license & royalty revenue, decreased to $0.7 million in the first-quarter of fiscal 2009 from $1.3 million in the comparable quarter a year before. Incyte did not recognize any contract revenue during the recent first-quarter.

Over the next few months, Incyte is slated to report a number of key events that are likely to impact its stock price. The final results from the phase IIb trial for topical INCB18424 in psoriasis are anticipated in the summer of 2009, while results of the phase II trial evaluating INCB7839 for breast cancer are expected to be released in the second half of 2009.

…Stay tuned!