IHS Global Insight Perspective | |
Significance | Takeda has snapped up the rights of marketing J&J's AD treatment galantamine in Japan. Meanwhile, a tie-up with AMAG will see it bag the development and marketing rights of anaemia therapy Feraheme in five main regions. |
Implications | Feraheme will join hematide in Takeda's late-stage pipeline for anaemia treatment, however, galantamine is more likely to fill in a relatively empty space in the field of AD therapies. |
Outlook | The two compounds, which are in or close to the regulatory stage, are expected to bring Takeda a strong boost to its product portfolio in the near-to-medium terms. |
Japan's largest drug maker Takeda today announced that it has bagged two new drugs, namely anaemia treatment Feraheme (ferumoxytol) and Alzheimer's disease (AD) drug R-113675 (galantamine), to its product portfolio through collaborative deals with U.S. firm AMAG and Johnson & Johnson's Janssen divisions respectively.
Takeda Inlicenses Galantamine's Marketing Rights in Japan
Developed by Janssen Pharmaceutical (Belgium), galantamine works with dual mechanism affecting both acetylcholinesterase inhibition and nicotinic acetylcholine receptor enhancement that increases concentration of key brain neurotransmitter acetylcholine. Janssen Pharma (Japan) filed for the drug's regulatory approval to Japan's Ministry of Health, Labour and Welfare (MHLW) in February 2010. Currently, galantamine has been marketed in over 70 markets worldwide following the securing of its first approval from Europe in 2000. Based on its agreement with Janssen, Takeda will co-market the drug in the Japanese market if the MHLW nod is granted. In return, Takeda will make payments to Janssen Pharma and Janssen Pharmaceutica including an upfront fee and milestones from potential launch and annual sales of the product. Furthermore, Takeda will also pay the Janssen divisions a sales-based fixed rate. Further details of the financial arrangements are not available.
IDA Treatment Feraheme's Rights in Five Regions Also Snapped Up
On a separate deal, Takeda also inked an agreement with AMAG to inlicense the development and marketing rights for the latter's Feraheme injection for intravenous (IV) use in all therapeutic indications in five regions, namely Europe, Canada, Turkey, the Commonwealth of Independent States and Asia Pacific excluding Japan, China and Taiwan. In return, Takeda will pay AMAG a US$60-million upfront and potential development and commercialisation milestone of up to US$220 million. In addition, Takeda will also pay tiered, double-digit royalties based on net sales in the licensed territories to AMAG. Feraheme is already approved in the United States for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease. Its filings in Europe and other markets are expected to be made in mid-2010.
Outlook and Implications
The inlicensing of the two products is set to see Takeda expand its product pipeline especially in the field of mental health and blood-based diseases. Currently, a main drug candidate for anaemia treatment in Takeda's pipeline is hematide, which the company is conducting Phase III clinical trial for in the treatment of anaemia in chronic renal failure patients together with U.S. partner Affymax (see United States - Japan: 22 February 2010: Takeda, Affymax Initiate Phase III Study on Hematide for Anaemia in Chronic Renal Failure Patients). On the other hand, galantamine is poised to boost Takeda's portfolio if the marketing application goes smoothly, as the company has only one early-stage compound developed for this indication. From a perspective of corporate strategy, the active external collaborations will also complement Takeda's in-house development in its bid to beef up a promising product line-up for short-to-medium-term growth following the prospect of imminent patent expiry of leading blockbuster Actos (pioglitazone).