* The primary purpose of this 80 page comprehensive report (with 25 figures/tables) is to: (1) present an overview of the anemia market, (2) identify the key pharmaceutical and biotech companies involved in the anemia marketplace, (3) provide a competitive analysis and description of anemia products on the market and anemia drug candidates that have failed and that are still in development (best-in class anemia drug candidates & first-in-class anemia drug candidates), (4) summarize anemia clinical trials and anemia trial results (5) review which anemia markets should be targeted and how to best position an anemia drug candidate and (6) review key licensing deals for various anemia drug candidates.
* Over the past several years, the EPO class of drugs for treating anemia has faced market challenges. The key issues facing this class of drugs are safety issues, reimbursement issues in the U.S. as well as biosimilar competition in Europe and other regions. The current EPO market is primarily split between three key players: Amgen with Aranesp and Epogen, Johnson & Johnson with Procrit/Eprex and Roche with NeoRecormon/Epogin. Affymax's Omontys (peginesatide) marketed by Takeda was voluntarily recalled after post-marketing reports showed serious hypersentistivity reactions. Biosimilars of EPO are starting to make in-roads into the European market.
* AMAG's Feraheme, is a recently approved IV iron replacement therapy indicated for patients with chronic kidney disease (CKD) with iron deficiency anemia (IDA) that has a more convenient dosing than other iron based treatments.
* Given the sheer size of the anemia market, any new entrant that achieves even modest penetration should be able to garner substantial revenues. Novel agents which can enhance efficacy and safety, may provide benefit for hypo-responsive EPO patients and should make inroads into the existing EPO market. In particular, if new candidates prove to be safe and efficacious it should significantly expand the market volumes by deepening penetration in the pre-dialysis chronic kidney disease and chemotherapy induced anemia markets.
* Historically, licensing agreements for anemia pipeline products have commanded large premiums. Affymax and Fibrogen have forged significant licensing agreements with new entrants Takeda (deal size =US$637M) and Astellas (regional deal size = US$815M & Japanese deal size =US$338M). AMAG also forged a US$280M licensing deal with Takeda for its Feraheme product. Accerelon Pharma signed a US$242M licensing deal with Celgene in '11, specifically for anemia. The '11 Accerelon deal expanded upon its original Celgene US$1BN deal signed in '08 for cancer related bone loss. Xenon Pharma signed a two year US$51M agreement, in '06, for researching a novel anemia target with Roche.
* There are multiple key reasons justifying the development of novel first in class anemia products: (1) the anemia market is large, (2) the existing products on the market have been flagged with safety issues resulting in a reduction in their utilization , (3) there is a significant absence of late-stage, novel anemia products in development, (4) there is a historical precedence for signing large anemia licensing deals.
* Companies listed in this report: Amgen, Johnson & Johnson, Eli Lilly, GlaxoSmithKline, Takeda Pharmaceuticals, Astellas Pharma, Affymax, Fibrogen, AMAG Pharmaceuticals, BioSyent Pharma, Roche Pharmaceuticals, Shire, Sandoz, Hexal, Medice Arzneimittel Pütter GmbH & Co. KG, Hospira and Stada Arzneimittel AG Kyowa Hakko Kirin, JCR Pharmaceutical, Kissei, Therapure Biopharma, Wockhardt, Biocon, Shantha Biotech (A Sanofi Company), Reliant Life Sciences, Intas Biopharmaceutica Pvt. Ltd, CinnaGen/Zahravi, Gulf Pharmaceutical Ind. (JULPHAR), Zuventus, Hamni Pharmaceutical, Bioton S.A, Xenetic Biosciences, Serum Institute of India, Medgenics, Zydus Cadila, Prolong Pharmaceuticals, Akebia Therapeutics, Acceleron Pharma, Celgene, HemaQuest Pharmaceuticals, BioLink Life Sciences, Prometic Life Sciences, bluebird bio, Xenon Pharma, Emmaus Medical, Teva Pharmaceuticals, Lonza, Pfizer, Samsung Electronics (SEC), Samsung Biologics, Biogen Idec, Samsung Bioepis, Boehringer Ingelheim, Fujifilm, Kyowa Hakko Kirin, Baxter, and Momenta
The report originally written in November, 2012 was updated to include new anemia clinical updates on March, 2013 and the number of pages has increased from 64 to 80, and the number of figures/tables increased from 21 to 25.