INCY's INC424 Meets Goal - Analyst Blog

Recently, Incyte Corporation (INCY) announced positive top-line data on pipeline candidate INCB18424 (also known as INC424) from a pivotal phase III trial, COMFORT-I. COMFORT-I was conducted to study INCB18424 for the treatment of patients with myelofibrosis (MF), a rare bone marrow disorder. The study met both the primary and secondary endpoints with high statistical significance.The trial was conducted under the US Food and Drug Administration's (FDA) Special Protocol Assessment (SPA) program.

The primary endpoint was a comparison of the response rates of the patients treated with INCB18424 and those on placebo. The 42% response rate in INCB18424 treated patients is a huge benefit versus less than 1% in placebo-treated patients. Response rate is defined as the percentage of patients achieving a 35% or greater reduction in spleen volume at 24 weeks as measured by MRI or CT scanning.

The trial also met the key secondary endpoint (symptomatic improvement) with statistical significance. No new safety signals emerged in the trial. The most common side effects of treatment with INCB18424 were anemia and thrombocytopenia, or a lack of blood platelets. The results of the COMFORT-I trial were consistent with data from a previously reported phase II pilot trial. 

Per the SPA agreem ent, the company can receive approval in the US based on COMFORT-I alone. Incyte plans to file a New Drug Application (NDA) for INCB18424 for MFin the second quarter of 2011. Incyte assumes a six-month review period with launch by the end of 2011. If approved, INCB18424 will the first FDA approved medicine for the treatment of this life threatening disease.

Results from COMFORT-I are expected to be presented at the American Society of Clinical Oncology (ASCO) in 2011.

Incyte is developing INCB18424 in partnership with Novartis (NVS). While Incyte has retained exclusive rights for the development and potential commercialization of INCB18424 in the US, Novartis has responsibility for its future development and commercialization outside the US.

Novartis is conducting the COMFORT-II trial for the same indication. COMFORT-II is the pivotal phase III trial for European marketing authorization. Results from this trial are expected in early 2011. COMFORT-II is also expected to provide supportive data for approval and labeling in the US.

Incyte enjoys orphan drug status from both the FDA and the European Medicines Agency (EMEA) for INCB18424 for the MF indication.

We believe the successful commercialization of the MF drug will be a path-breaking achievement for the company.

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).

INCB18424, an oral janus-associated kinases (JAK) antagonist, is also being evaluated in late-stage studies for the treatment of patients suffering from advanced polycythemia vera (PV) who are not responding to hydroxyurea, and essential thrombocythemia (ET). There are currently no approved specific therapies for MF, PV or ET, which collectively constitute major myeloproliferative diseases.

Our Take

We currently have a Neutral recommendation on Incyte, which is supported by a Zacks #3 Rank (short-term Hold rating). We are impressed by the progress made by the company's pipeline. Potential catalysts could be in the form of positive COMOFRT-II data, NDA filing for INCB18424, and full data presentations at ASCO.  Furthermore, the strong potential of the pipeline candidates has attracted big players such as Pfizer (PFE), Novartis and Eli Lilly (LLY) to enter into agreements with the company. 

 
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