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12/19/11 7:44 PM

#133369 RE: acgood #133360


A couple of things from the call:
. The agreement doesn't prohibit Watson from pursuing Biosimilars for Amgen products and they have the right of first refusal should Amgen choose to come out with an Authorized Generic.
. Global arrangement, they expect products in Europe before the US (but also mentioned other countries in passing such as Brasil).
. They were looking for partners for the past 15 months or so. Said a lot of companies had the products in their portfolio some were limited financially (50%) others by scientific or manufacturing capability.
. There is a finite number of products associated with the deal.
. Think some areas may get approved on single study (though this was in response to multiple indications for a single drug).
. Don't rule out doing other deals but further down the road.
. Amgen is doing all the manufacturing.


12/20/11 11:15 AM

#133392 RE: acgood #133360

I expected more comments from this board on the AMGN-WPI tie-up. As far as I can tell, this is not a deal that any of the regulars on this board would have expected.


08/05/12 8:34 PM

#146644 RE: acgood #133360

Synthon will get a cut of Herceptin FoB developed by AMGN/WPI; it also seems to have a competing compound for T-DM1 (see bottom):

Nijmegen, the Netherlands, 18 July 2012 – Synthon today announced that it has entered into a global license agreement with Amgen Inc. (NASDAQ:AMGN) and Watson Pharmaceuticals, Inc. (NYSE:WPI) for Synthon’s trastuzumab, being developed as a biosimilar to Herceptin, which is currently approved for treatment of breast cancer and gastric cancer. Earlier this year, Synthon successfully completed a Phase I clinical trial in Europe showing bio-equivalence between its trastuzumab biosimilar and Herceptin. The company was preparing for a confirmatory Phase III trial for Europe with this compound.

Under the agreement, Watson has acquired the license to the biosimilar program and has contributed it to the Amgen/Watson biosimilars collaboration. Amgen and Watson will assume responsibility for all future development work worldwide, including Phase III clinical trials, as well as global manufacturing and commercialization. Synthon will provide transitional support as set forth in the agreement. The deal entitles Synthon to an initial payment and potentially a milestone fee and royalties on net sales. Synthon will also receive compensation for its transitional support activities under the agreement. Synthon has retained rights to move forward independently with a HER2-targeted antibody-drug conjugate (ADC) candidate using its proprietary Linker-Drug technology.