Biotech Values

[ThomasS]

MNTA: The following excerpts are very telling, imo:

"Aventis thus essentially asks FDA to categorically stop all review of enoxaparin ANDAs until such time (which may never come) that Aventis believes enoxaparin has been “adequately” characterized."
{IMO, Teva admits that it cannot characterize: "which may never come."}

"Teva, the world’s leading generic drug manufacturer, and the holder of hundreds of approved ANDAs, recognizes that compliance to compendial tests and specifications is not necessarily sufficient for approval of any ANDA, and that FDA may require additional tests and specifications beyond those mandated by the USP. However, as discussed below, Teva has conducted adequate and appropriate tests, and submitted the results of those tests to FDA via its ANDA, to demonstrate that its enoxaparin product is sufficiently the “same” as Lovenox® in all relevant respects to allow ANDA approval."
{"sufficiently the "same"" admits again the above lack of full characterization.}

"Teva’s enoxaparin oligosaccharide profile has been compared to that of Aventis’ Lovenox® using ion-pair HPLC- separation with TOF-MS methodology/detection. Results for polysaccharide chains with molecular mass less than 3,600 Da. indicate that both enoxaparin products show essentially the same variability. Moreover, the amino sugar composition of Teva’s enoxaparin has been compared to that of Aventis’ Lovenox® using HPLC methodology analysis of hydrolyzed enoxaparin preparations with post-column derivatization. Results show essentially identical amino sugar composition for both products..."
{Again, the verbage "essentially identical... essentially the same variability."}

"Nothing in Aventis’ petition provides a basis for FDA to refuse to review such data and approve Teva’s ANDA if, as expected, the results of Teva’s tests reveal sufficient sameness (but not necessarily exact chemical identicality) to Lovenox®."
{"But not necessarily exact..." This says it all, imo... that MNTA has raised the bar to exclude Teva. The best Teva can hope for is a generic which is not AB-rated.}

C. The Lack Of “Full Characterization” Of Enoxaparin Does Not Bar Generic Approvals
{Same as above comment. They may get a "Generic Approval," but perhaps not AB-rated.}

"Americans need generic drugs more than ever…” The economic benefits of availability of generic equivalents to Lovenox® can be estimated..."
{Irrelevant argument which belies Teva's unsuitability. They are asking the FDA to possibly fudge safety to save Americans $$$. If MNTA has an AB-rated product, the FDA cannot approve Teva as AB-rated unless they have fully characterized to the same extent as MNTA, even if MNTA did not FULLY characterize.}