When contacted today the Sept 8th, 2010, Biodel Inc’s (NASDAQ: BIOD) one of the two Manufacturer’s of Linjeta(Previously known as VIAJect, Biodel's more-rapid-acting insulin formulation), Albany Molecular Research, Inc. stated that it intends to respond to the FDA today in regard to the recent warning letter it received, dated August 17, 2010, from the U.S. Food and Drug Administration (the "FDA") in connection with the FDA's inspection of AMRI's pharmaceutical manufacturing facility located in Burlington, Massachusetts. AMRI’s Director of Investor Relations, Peter Jerome stated “We intend to submit our response to the FDA today, September 8th.
AMRI has already informed Biodel (NASDAQ: BIOD) that the FDA inspection that resulted in this warning letter was unrelated to the review of Biodel's NDA for Linjeta (Previously known as VIAJect), but rather was related to the review of another sponsor's product candidate. It should also be noted that Biodel has also previously disclosed that it is working with Wockhardt Ltd., its second contract manufacturer producing finished Linjeta product, to develop the disposable pen for use with Linjeta and that it intends to conduct the majority of its future Linjeta manufacturing with Wockhardt Ltd.
Biodel also recently announced that Linjeta™ (pronounced lin-JET-uh) will replace VIAject as the proposed trade name for Biodel's most advanced product candidate. The change follows FDA's review and acceptance of Linjeta™ as an alternative name for Biodel's more-rapid-acting insulin formulation that is currently under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Application date(or FDA decision date) of October 30, 2010.
Speaking about the trade name change, Dr. Errol De Souza, Biodel 's president and chief executive officer, stated: "Today's news reflects the continued progress of the Linjeta™ new drug application through FDA review and is an important milestone in our effort to commercialize this new drug candidate."
With little over seven weeks remaining before the FDA’s decision on its more-rapid-acting insulin formulation, Linjeta, we expect Biodel’s shares to pick up momentum and remain volatile going into the decision date, given its ultra low float, low market cap and high short interest.
