A Doctor's point of view, April 11, 2013: A VINDICATION
It has been awhile since my last post but I saw it fit to write the following today:
1-as mentioned before, the issue with Omontys is ONLY allergic reaction experienced by a VERY SMALL number of users. Otherwise there is nothing inherently wrong with the drug itself as it works just FINE and nearly 25000 relatively ill CKD folks on dialysis have used it to their benefit and without any unwanted consequences. Allergic reactions are just that, allergic reactions; they can be overcome in a number of ways and there is almost no drugs currently in the market that does not cause allergic reaction in certain people.
2-Takeda is highly regarded with many drugs in the market / pipelines and very savvy group of scientists and researchers/doctors; The fact that they were willing to go out of their way and agree to such a lop-sided agreement with Affymax, "assuming full responsibility for Omontys" while agreeing to pay millions of "milestone payments" as well as a lifetime of royalties tied to net sales both in US and the rest of the world, is an absolute vindication of #1 above: Omontys is a great drug with some issues common to many drugs that will be back in the market in a big way under the leadership of Takeda with definitely even better prospects that before the recall.
3-For those that knock this drug for profits reasons please don't; Omontys is a wonderful drug that is able to help thousands of CKD patients live a more normal life free of persistent and daily fatigue and weakness by getting once a month injection.
4-Fans of Omontys, specially the doctors and dialysis centers, will be excited to see that not only the current investigation of the Omontys but also the future production, distribution, and marketing of the drug is now being assumed by a much more powerful company such as Takeda; this will also help Affymax's bottomline more than before the recall. Also the hope will now be that the investigation will be wrapped up sooner under Takeda's leadership.
Takeda would not have signed onto such an agreement if they did not already know for sure that the investigation can be completed shortly with Omontys vindicated with proper precautions and back in the market. This is a billion dollar drug after all.