Articles » 2006 » July / August 2006 » Astellas


#16. Astellas Pharma



3-11, Nihonbashi-honcho 2-chome, Chuo-ku
Tokyo, 103-8411
Japan
Tel: (81) 3 3244 3000
Fax: (81) 3 3244 3272
www.astellas.com



Headcount 15,000  
Year Established 2005  
Pharma Revenues $7,503 -3%
Total Revenues $7,782 -3%
Net Income $917 +65%
R&D Budget $1,257 +6%


Drugs Approved/Launched
Drug Indication
vaprisol euvolemic hyponatremia
prograf prevent organ rejection in heart transplant recipients
funguard antifungal pediatric (in Japan)
vesicare overactive bladder


Drugs Pending Approval
Drug Indication
rsd 1235 atrial fibrillation
vaprisol hyponatremia
candin systemic fungal infections (in EU)
conivaptan hypervolemic hyponatremia
tacrilimus organ rejection (in EU)
micafungin fungal infection (in EU)


Drugs in Phase IIB and Beyond
Drug Indication
fg-2216 anemia
ym617 lower urinary tract syndrome
ym086 diabetic nephropathy
ym026 type 2 diabetes
ym177 post surgical pain
ym1170 GERD
fk506 myasthenia gravis
fk199b insomnia


Top Selling Drugs
Drug Indication Sales (+/- %)
prograf kidney, liver rejection $1,240 19%
harnal BPH $888 2%
lipitor cholesterol $810 7%

Account for 38% of total pharma sales,    up from 36% in 2004.

PROFILE



Astellas is the first first-timer in this year’s Top 20 Pharma list. The company, formed by the merger of Yamanouchi and Fujisawa on April 1, 2005, is the #2 Pharma company in Japan. Astellas sold or spun off its non-pharma businesses to focus on the ethical market, and in April 2006 established Astellas Pharma Chemicals as an API supplier.

As part of the transition of the merger, Astellas made an executive shift in April 2006, moving executive vice president Masafumi Nogimori to president and chief executive officer. Dr. Toichi Takenaka, who was serving in that role, became co-chairman, a position he shares with Dr. Hatsuo Aoki. Dr. Takenaka was president and CEO of Yamanouchi and was responsible for the company’s focus on the ethical drug market. Mr. Nogimori was a 36-year veteran of Fujisawa.

Focused on urology, immunology and transplant-related inflammation, Astellas launched several products in its first year: Vesicare (overactive bladder treatment; Japan), Vaprisol (IV treatment for euvolemic hyponatermia; U.S.), and Mycamine (antifungal; co-marketed with Roche in the U.S.). Vaprisol and Mycamine are both sold to the hospital market, and Astellas has several other Phase III products for that arena. The company also co-markets Lipitor in Japan, which helps boost the bottom line.

At the end of March 2006, Astellas boosted its dermatology offerings by acquiring the worldwide marketing rights to Amevive, a chronic plaque psoriasis treatment, from Biogen Idec. Amevive yielded $48 million for BI in 2005 sales.

The company believes it may have a blockbuster on its hands with FG-2216, an oral treatment for anemia that it is co-developing with FibroGen. FG-2216 is currently in Phase II trials for renal anemia and chemotherapy-induced anemia. Both companies are fully aware of the multi-billion dollar market for injectable treatments for these (think EPO). Astellas contends that the drug could reach nearly $1 billion in European sales, given the company’s established urology and renal transplantation infrastructure on that continent. It acquired marketing rights in Europe, the CIS, the Middle East and South Africa in April 2006 for $300 million upfront, as well as $465 million in milestones and $50 million in FibroGen stock. Astellas acquired Japanese marketing rights to the compound in June 2005.

The company’s other potential blockbuster, RSD1235 (atrial fibrillation), faced a setback in June 2006 when the FDA refused to accept the drug’s application. U.S. co-developer Cardiome contended that the rejection was due to presentation issues, not clinical data. The two companies are planning to resubmit in 3Q2006. Cardiome and Astellas will be have to maximize sales in a hurry (assuming the drug gets approved a year or so after filing), because RSD1235’s main patent expires in 2013.

Still, Astellas is working hard at developing a strong pipeline, with internal and in-licensed prospects galore.