Takeda Pharmaceuticals and Affymax ($AFFY) have sewn up another supply deal for their anemia drug Omontys. DSI Renal, one of the largest dialysis providers in the U.S., agreed to adopt Omontys to treat their patients with chronic kidney disease. It's another step forward for the companies in their bid to challenge Amgen's ($AMGN) hold on the anemia-treatment market.
Jeff Knapp, Affymax chief commercial officer, said, "This is of particular importance because it represents one of the largest dialysis providers in the U.S. DSI is probably closing in on 6,500 to 7,000 patients a year and we are delighted to have them use Omontys." Knapp, who was in San Francisco to present at the J.P. Morgan Healthcare Conference, said Affymax is hopeful the relationship will move rapidly from a pilot experience to a larger commercial relationship after DSI gets experience with the drug.
Developed by Affymax, Omontys was approved by FDA last March, becoming the first erythropoiesis-stimulating agent totally independent of Amgen, which markets Epogen and Aranesp, and partners with Johnson & Johnson ($JNJ) on Procrit. It's also the first to be injected once a month, rather than weekly or more often. It's also priced lower than Epogen, analysts say. Takeda is Affymax's marketing partner.
Affymax inked a deal with Fresenius, another big player in the dialysis market, in July. At the time, Fresenius said it would roll out Omontys at more than 100 dialysis centers and then expand use from there. The DSI deal is similar, with the provider planning to test Omontys at selected centers before adding it to the offerings across the company. Both deals include discounts and rebates; financial terms haven't been disclosed.
Jan 2013 - dsi & fresenius agreed to expand the use of omontys for 100 other dialysis centre
feb 2013 - 3 allergice reactions related death( not proved) reported from one fresenius centre and recall all omontys from mkt...fda was notified but totally surprised as call was from affy not from fda.
march- 2013 orwin decide to lay work force and amend the takeda contract talk about bk
may15th 2013 - he joined amgen sponsored ralypsa company as ceo ...
There is no SEC filling on delisting, Company has to serve notice through SEC filling for public if there going to delist it from NASDAQ.
AFFY is no longer a research company and all that expensive research Instruments worth Millions of $$ NO LONGER REQUIRED, So YAH ! Auction it. AFFY shall collect Millions of Royalties if Reintroduced in MKT. They need only Admin and Distribution staff....
Reintroducing Omontys do not requires research...It is FDA approved drug.
That includes cerrain small Press Media briebed by AMGN hedgees
Whats that 8K- No production so amend the supply contract with NEKTAR until reintroduction and pay 5.7Million penalty.
8K filling is justified. but important is OUTCOME OF INVESTIGATION
1. Was it Omontys is the cause of SO CALLED DEATH of 3 People ?
2. Complete recall of OMONTYS was required ?
Orwin joined AMGEN -RALYPSA was hurried decision ? No it was all calculated but Omontys RECALL was hurried decision for 3 deaths NOT CONFIRMED TO BE FROM OMONTYS.
8K Filling is to stop supply of Raw Material contract by XYZ or Production of Omotys by NEKTAR, Amend the contract and pay 5.7Million penalty. It has NOTHING to do with present ONGOING investigation on so called 3 (THREE) allergic reactions & reported deaths by Fresenius/AMGN sponsored dialysis centres and subsequent unilateral decision of COMPLETE OMONTYS WITHDRAWAL by presently Employed AMGEN-RALYPSA CEO.
FDA requirements and satisfaction for reintroduction of Omontys in USA is based on this investigation outcome and till that time NO PRODUCTION OR SUPPLY so AMEND THE CONTRACT.
Also the pending Approval decision by EMA has to depend on this investigation outcome. Which TAKEDA is in full control - And the MOVES BY CEO ARE traceable by even by any STUUUPPPIIDD PERSON.
AMGN deployed some money to SHORT after Hr. so that AFFY BIG BOY do not show up on Monday. They had no money to STOP BIG BOY when they bought 23Million today but they put 3Million short AH.
BIGBOY DON'T CARE .....MONDAY IT WILL OPEN $3
The restructuring with sale of “Quality Late Model Assets and Equipment.” brings cash for AFFY. Since Takeda has taken over the complete control and AFFY would just receive the royalties with just administrative and distribution work the list of “Quality Late Model Assets and Equipment.” are of no use and its only required for research based company. $46.6 Million of PRESENT CASH with these Sale could add upto another 30-40Million the company is well set for just operative structure with around 75Million cash,
Very Important issue here..................
It has nothing to do with present investigation on so called reported 3 deaths by Fresenius and subsequent unilateral decision of AMGEN Employed CEO or FDA requirements and satisfaction for reintroduction of Omontys in USA or the pending Approval by EMA.
Indicates going high
SHORTS must be tired by now 23.2Million shares ?