Astellas highlights broad pipeline, set for push into arthritis

Astellas has given investors an update on its research pipeline, including a new rheumatoid arthritis treatment entering phase III trials.

The Japanese pharma company provided its R&D update at a meeting Tokyo on 10 July, highlighting drugs in oncology, anaemia, bladder care, antibiotics as well as rheumatology and other areas.

The company has a strong presence in two fields, urology and transplantation, but is seeking to grow its presence in areas such as oncology to increase revenues.

Astellas has recently launched prostate cancer drug Xtandi (enzalutamide) and overactive bladder treatment Betmiga (mirabegron), which has helped sales grow more than 8 per cent in the EMEA region in FY2013.

The company's key late-stage drug is ASP015K, a JAK inhibitor for the treatment of rheumatoid arthritis that has recently completed phase IIb studies.

The company is preparing to start the phase III programme in Japan, looking at the drug with and without methotrexate. ASPO15K will be up against other JAK inhibitors, including Pfizer's Xeljanz, already on the market in the US, as well as Lilly's pipeline contender baricitinib. Astellas drug will have to show a strong performance in phase III trials in order to gain traction in the RA field, which is highly competitive.

Sef Kurstjens, chief medical officer, provided a development overview of the following compounds:

• In June 2013, Astellas and Medivation received EU marketing approval for Xtandi (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in men whose disease has progressed on or after docetaxel therapy. The company is now looking to extend Xtandi's licence to chemotherapy-naïve metastatic prostate cancer. Development progress for the clinical trials for the treatment of breast cancer were also highlighted at the meeting.

• Phase II results of roxadustat (ASP1517/FG-4592) showed the compound is effective in treating anaemia correction and maintenance in both dialysis and non-dialysis patients with chronic kidney disease. In collaboration with FibroGen, six phase III studies will support the European filings for both dialysis and non-dialysis indications.

• A global phase III programme is now underway evaluating the safety and efficacy of the concomitant use of Vesicare (solifenacin) and Betmiga (mirabegron) for overactive bladder.

• Astellas has submitted a US new drug application for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.

In May last year, Astellas signed a deal with Amgen to develop and commercialise five Amgen pipeline medicines in Japan. Development updates for three of those products were also highlighted at the meeting, including rilotumumab (AMG 102) for gastric cancer, evolocumab (AMG 145) for hyperlipidemia, and romosozumab (AMG 785) for osteoporosis.

"Our late stage-pipeline is strong and tightly aligned to our commercial strategy," commented Ken Jones, president and chief executive, Astellas Pharma EMEA. "R&D is a major priority in Europe, with scientists from more than 30 countries working at our drug development centre in the Netherlands. Research undertaken here and around the world is helping develop a wealth of investigational products that will support the company's continued growth in the EMEA region and globally."

Wataru Uchida, PhD, senior vice president, drug discovery research, discussed the company's research initiatives, potential new therapeutic areas, and novel technology platforms. The technology platforms it is using include ClearPath, ADC and regenerative medicine. In addition, Uchida discussed the pre-clinical research achievements for ASP2215, a potential treatment for leukaemia, and ASP8273, a potential treatment for non-small cell lung cancer patients with EGFR mutations.

Yoshihiko Hatanaka, president and chief executive at Astellas says the company will look to maximise the value of the product portfolio, pursue operational excellence and enhance innovation through reshaping the company's research framework, and developing network research systems by utilising external resources.

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