Replies to post #108498 on Biotech Values

[mouton29]

<<I wonder what will come out of the Amphastar suit. I think it will backfire on Amphastar. The FDA has been kind enough not to publicly say their version of Lovenox sucked, but Amphastar might just be forcing the FDA to do so under oath. We and the market might get a little color on how far off Momenta's competition is. But I'm clueless as to timing of the suit. >>

Not much has happened in the lawsuit. I've looked at the complaint and it relates to the FDA "seizure" of "semi-purified heparin" that Amphstar has been attempting to import to use in its FDA application.
The complaint contains various allegations of unfair behavior on the part of the FDA. I will e-mail it to Dew and he can post it if he thinks it is worth the effort. The answer has not been filed, yet, I copy and paste the docket sheet below

Somewhat more juicy, apparently Amphastar hired the well-known firm of private investigators, Kroll, to investigate Janet Woodcock and another FDA official. See

http://www.politico.com/news/stories/0310/35212.html

Date Filed # Docket Text
10/25/2010 1 COMPLAINT against FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS ( Filing fee $ 350, receipt number 4616033675) filed by AMPHASTAR PHARMACEUTICALS, INC.. (Attachments: # 1 Civil Cover Sheet)(jf, ) (Entered: 10/26/2010)
10/25/2010 SUMMONS (5) Issued as to FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS, U.S. Attorney and U.S. Attorney General. (jf, ) (Entered: 10/26/2010)
10/25/2010 2 LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests NONE by AMPHASTAR PHARMACEUTICALS, INC. (jf, ) (Entered: 10/26/2010)
10/26/2010 3 NOTICE of Appearance by Gerald Cooper Kell on behalf of All Defendants (Kell, Gerald) (Entered: 10/26/2010)
11/05/2010 4 MOTION for Preliminary Injunction by AMPHASTAR PHARMACEUTICALS, INC. (Attachments: # 1 Declaration Declaration of Stephen A. Campbell, # 2 Exhibit Exhibit 1, # 3 Exhibit Exhibit 2, # 4 Exhibit Exhibit 3, # 5 Exhibit Exhibit 4, # 6 Exhibit Exhibit 5, # 7 Exhibit Exhibit 6, # 8 Exhibit Exhibit 7, # 9 Exhibit Exhibit 8, # 10 Exhibit Exhibit 9, # 11 Exhibit Exhibit 10, # 12 Exhibit Exhibit 11, # 13 Exhibit Exhibit 12, # 14 Exhibit Exhibit 13, # 15 Exhibit Exhibit 14, # 16 Exhibit Exhibit 15, # 17 Exhibit Exhibit 16, # 18 Exhibit Exhibit 17, # 19 Text of Proposed Order Proposed Order)(Pierce, Anthony) (Entered: 11/05/2010)