Altus near the bottom of its range (low in early June) ~$12 and yesterday an 8-K disclosing loss of Orphan Drug status for ALTU-135.
>>3-Jul-2007
On June 28, 2007, Altus Pharmaceuticals Inc. (the "Company") was notified by the Office of Orphan Products Development of the Food and Drug Administration ("FDA") that the orphan drug designation granted in 2002 to ALTU-135 for the treatment of pancreatic insufficiency was being revoked. The FDA based its decision on a finding that if one includes all patients with HIV/AIDS who suffer from fat malabsorbtion in this indication, the patient population in the United States appears to exceed 200,000 persons and is thus ineligible for orphan drug designation.
We believe that only a subset of patients with HIV/AIDs have fat malabsorbtion due to pancreatic insufficiency and that our original filing was intended to be within the 200,000 person limit for this disease condition; however, the FDA concluded otherwise.
The principal anticipated advantage to the Company of an orphan drug designation is the availability of tax credits and the abatement of new drug application filing fees. In addition, the holder of the first new drug application approval also receives marketing exclusivity for a period of seven years over other products that contain the same drug or active ingredient. We are not aware of other products in development that are the same drug as ALTU-135 for orphan drug purposes. Given these facts and circumstances, the Company may consult with the Office of Orphan Products Development. If we conclude that re-filing with a more precisely defined indication has merit, we have the right to submit an application on or before the filing of a new drug application. We may also conclude that the advantages of continuing to seek orphan drug designation may not be warranted. <<
Not one of ML's better calls! Best sell signal I've seen in a while, issued a week or so after the high:
finance.yahoo.com
Always be dubious when one of the underwriters issues a glowing report shortly after the IPO. The flippers will exit on that stuff.
Nevertheless, the company is probably worth a look now, and should maybe get its own thread.
Cheers, Tuck |
