Released by FDA: 3/26/01.  Posted by FDA:  3/28/01

JD Bernardy, J.D. 
Vice President, Regulatory Affairs 
Praecis Pharmaceuticals Incorporated 
One Hampshire Street 
Cambridge, MA 02139

RE:   Plenaxis^TM (abarelix for injectable suspension) 
         NDA [confidential, deleted by FDA]
         MACMIS ID 9856

Dear Mr. Bernardy:

This letter concerns Praecis Pharmaceuticals Incorporated’s (Praecis) dissemination of a journal advertisement for its investigational new drug, Plenaxis (abarelix for injectable suspension).  The advertisement is titled “NewThinking in Prostate Cancer: #1 in a series. Surge and flare: is there really a difference?”  The advertisement appears in the March 2001 issue, of The Journal of Urology.  As part of its monitoring program, the Division of Drug Marketing, Advertising and Communications (DDMAC) has reviewed this advertisement and has concluded that it is false or misleading, in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations.  Our specific objections follow,

Your advertisement is in violation of the Act because it implies that your investigational drug is superior to other available treatment options for prostate cancer.  For example, your advertisement presents that “surge” is “an acute biochemical (PSA) or hormonal (T, LII, FSH) increase after LHRH agonist initiation” and that “clinical flare” is “a clinical worsening of symptoms due to LHRH agonist- inducted T surge.”  Your advertisement also includes the claim “Despite the drawbacks of testosterone (T) exposure on hormonally sensitive prostate cancer, the past decade of LHRH agonist use has resulted in a general acceptance of T surge when initiating therapy.”  The advertisement concludes “Ultimately, T surge can cause unnecessary risks to some patients. There are options to help guard against the potential effects of T surge, but the question remains: why not avoid it altogether?”  This statement is followed by the claim “Amgen Praecis-changing the future of prostate cancer therapy.”  These statements, following the differences between surge and clinical flare, suggest that Praecis is developing a new product for prostate cancer that is not an LHRH agonist, and that this product avoids testosterone surge and its consequences.  Therefore, this presentation suggests that Praecis’ new product will he superior to and safer than LHRH agonists.

The regulations state that an investigational new drug may not be promoted as being safe and effective for the uses under investigation.  Your advertisement is violative because it includes promotional claims of efficacy and safety for a particular thug that is under investigation for use in the specific therapeutic area.

Requested Action

Praecis should immediately discontinue these and all other promotional materials for Plenaxis that contain the same or similar claims or presentations.  We request that Praecis respond, in writing, with its intent to comply with the above.  DDMAC should receive your written response no later than April 9, 2001.  This response should list all similarly violative materials with a description of the method for discontinuation and the discontinuation date.

If you have any questions or comments, please contact me by facsimile at (301)594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD-42,  Rm.17B-20, 5600 Fishers Lane, Rockville, MD 20857.   DDMAC reminds you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID #9856 in addition to the NDA number.

Sincerely,

Barbara S. Chong, Pharm.D., BCPS 
Regulatory Review Officer 
Division of Drug Marketing, 
      Advertising, and Communications