For this month’s Innovation That Matters, we interviewed Heow Tan, Chief of Quality and Technical Operations at Pharmacyclics. Tan joined Pharmacyclics in 2012 and has headed their Global Quality, CMC Development, Global Manufacturing, Supply Chain, and International Operations. Pharmacyclics lead product, ibrutinib, with the trade name Imbruvica™, is one of the early molecules to receive US FDA Breakthrough Therapy Designation for oncology and the only drug to receive three Breakthrough Therapy Designations from the US FDA. The cooperation for manufacturing activities between Pharmacyclics and WuXi-STA intensified about one year prior to the first approval of Imbruvica in November 2013 for its use in mantle cell lymphoma patients. Imbruvica received a second approval for use in chronic lymphocytic leukemia patients in February 2014. Currently Imbruvica is clinically advanced in 35 countries and being tested in eight different types of B-cell malignancies.
Can you begin by outlining the therapeutic need IMBRUVICA addresses for patients?
Tan: Imbruvica is approved for patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) who have received at least one prior treatment. Imbruvica is the first-in-class orally dosed inhibitor of Bruton’s tyrosine kinase (BTK)—a signaling protein that is critically important for the activity of B-cells (immune cells that produce antibodies to help fight infection). By inhibiting the signal, Imbruvica has shown clinical benefits for patients with these diseases. Most recently we stopped our latest study, Resonate, at the interim analysis because of the significant advantage in overall survival and progression-free survival that Imbruvica provided against the standard of care ofatumumab.
How smooth was the transition from clinical development to commercial production?
Tan: It has gone very well. When Imbruvica was still in development, we sought out partners with expertise in both clinical and commercial supply, such as WuXi’s subsidiary Shanghai Syn-The-All. We took this approach to be more efficient and to ensure we maintain a reliable supply of Imbruvica to patients.
What is Pharmacyclics’ mission?
Tan: Great question! Our mission is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life, and resolve serious unmet medical healthcare needs. We exist to make a difference for the betterment of patients, and we believe these are important times to do just that.
What is next for Pharmacyclics and Imbruvica?
Tan: We’re continuing to develop Imbruvica for multiple indications. Between our partner, Janssen Biotech Inc., and ourselves, we are conducting 44 clinical trials, of which 11 are Phase III registration studies. By the end of this year we are looking for a full Phase III label in CLL in the US and also for our first European approval. In the meantime, we continue to work diligently work on our development program. There are a lot of trials that will read out in the coming months and years. Each will provide valuable data about the benefits Imbruvica can provide to our patients.
Right now we have approximately 500 employees at Pharmacyclics. We all are working hard to advance Imbruvica so it can potentially help all patients with B-cell malignancies (blood cancer). We truly appreciate the relationship we have developed with our partners at WuXi, and we thank for your support in helping us to provide valuable care to patients in need around the world.