|Watson Provides Update on Generic Lidoderm® Application; Gilead Soars On "Striking" Clinical Trial Data|
|By Staff and Wire Reports|
|Friday, 03 February 2012 20:22|
In response to investment community speculation following release of the transcript of a pre-trial conference call related to its Lidoderm® patent challenge, Watson Pharmaceuticals, Inc. (NYSE:WPI) issued the following statement:
"Watson's abbreviated new drug application (ANDA) for a generic version of Lidoderm remains on track. We believe questions related to the site where a biostudy supporting the ANDA was conducted have been addressed to FDA's satisfaction. We continue to work closely with the FDA with the goal of timely approval. Watson has made public comments throughout the year regarding our Lidoderm application, including most recently at our analyst day on January 24th, where the Company restated our confidence that a tentative approval for generic Lidoderm will be received prior to the 30-month stay expiry on July 15, 2012.
"In order not to affect the pending patent litigation trial, it is our policy not to comment during litigation. Therefore, we will not provide additional comment on details that may arise during the trial."
Gilead Sciences (NASDAQ: GILD) released its Q4 earnings results. While the biotech giant missed analysts earnings estimates, sales numbers for the quarter came in slightly higher than projected. More importantly, Gilead management announced positive clinical data about a hepatitis C drug which the company acquired in its $10.8 billion takeover of Pharmasset. J.P. Morgan (NYSE: JPM) analysts are calling the newly released data "striking" and analysts across Wall Street are getting even more bullish on the name in light of the new information.
On the earnings front, GILD posted non-GAAP income of $743 million or $0.95 per share, versus $779.3 million or $0.97 per share, in the year ago period. This compared to analysts' consensus EPS estimates of $1.05. Revenues for the fourth quarter were up 10% to $2.20 billion compared to $2 billion last year. This came in slightly ahead of Street consensus revenue estimates of $2.18 billion.
While the miss on the bottom line and only very slight beat on the top line could be viewed as mildly disappointing, traders are focusing on some very positive clinical data which Gilead discussed on its conference call. On the call with analysts and investors, Gilead's chief scientific officer, Norbert Bischofberger, said that patients with genotype 1 hepatitis C, which is the most common form of the disease in North America, had no detectable signs of the virus after four weeks on a drug called PSI-7977 which was acquired in Gilead's buyout of Pharmasset.
PharmaGap Inc. (TSX VENTURE:GAP) (OTCBB:PHRGF) ("PharmaGap" or "the Company") today announced results from the most recent testing of its cancer drug Gap107B8 in mouse models of human ovarian cancer.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, will release fourth quarter and full year 2011 financial results after market close on Wednesday, February 29, 2012.
Threshold Pharmaceuticals, Inc (NASDAQ: THLD) Threshold to receive $25 million upfront, plus further potential milestones and royalties.