Incyte, FDA Agree on Study Design - Analyst Blog

Recently, Incyte Corporation (INCY) entered into an agreement with the US Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a late-stage study (n~300) with its lead candidate INCB18424. The study will evaluate the candidate in patients suffering from advanced polycythemia vera (PV) who are not responding to hydroxyurea.

PV refers to a rare blood disease in which the body overproduces red blood cells. The extra red blood cells cause the blood to become thicker than normal thereby resulting in blood clots and blockages. This can result in a heart attack/stroke.

The SPA facilitates the official FDA evaluation of the protocols of a late-stage study intended to form the backbone of an efficacy claim and provides the sponsors of the study with a written agreement. This helps to substantiate that the design and analysis of the study are adequate to support a New Drug Application (NDA).

The US enrollment of the open label, multicenter global study (RESPONSE), conducted by Incyte in the US and partner Novartis (NVS) elsewhere, is expected to begin in October this year.  The study is designed to compare the safety and efficacy of INCB18424 to the physician's pick of the best available medication for the disease.

INCB18424, an oral janus-associated kinases (JAK) antagonist, is also being evaluated in late-stage studies for the treatment of patients suffering from myelofibrosis (MF). MF is a rare bone marrow disorder. Recently, the company presented encouraging data from a phase I/II study (n=153) of the candidate in MF.

Two late-stage studies, COMFORT-I (US trial) and COMFORT-II (European trial), are fully enrolled and are expected to be completed later this year. The studies are evaluating INCB18424 in patients suffering from MF.
 
Incyte expects to present top-line data from COMFORT-I in December 2010. However, results from COMFORT-I as well as COMFORT-II, for which Novartis is now responsible, are expected to be presented at the American Society of Clinical Oncology (ASCO) in 2011. The company expects to file a New Drug Application for the drug by in the first half of 2011. Incyte enjoys orphan drug status from both the FDA and the European Medicines Agency (EMEA) for INCB18424 for the MF indication.
 
Apart from MF and PV the candidate is also being studied in patients with essential thrombocythemia (ET). There are currently no approved specific therapies for MF, PV or ET, which collectively constitute major myeloproliferative diseases.

Our Recommendation

We have a Zacks #3 Rank (short-term Hold recommendation) on the shares. This implies that the stock is expected to perform in line with the broader US equity market over the next 1 - 3 months. We are Neutral on the stock in the long-term, which indicates that Incyte's shares are expected to replicate its short-term performance, but over 6+ months. Consequently, we advise investors to retain the stock over the time-period.
 
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