Company Updates PS433540 Development Plan and Announces Additional Cost Reductions
PRINCETON, N.J., July 31, 2008 (PRIME NEWSWIRE) -- Pharmacopeia (Nasdaq:PCOP) today announced results for the quarter ended June 30, 2008 and further plans related to the clinical development of PS433540.
Based on input from Key Opinion Leaders, potential corporate partners, and the investment community, Pharmacopeia announced today that it intends to pursue diabetic nephropathy as the primary indication for PS433540, the lead compound from its Dual Acting Receptor Antagonist (DARA) program. Dual Acting Receptor Antagonism is thought to have particular utility in diabetic nephropathy as emerging preclinical and clinical data support that angiotensin and endothelin work together to cause damage to the kidneys(1-3). Dual blockade of angiotensin and endothelin at their respective receptors may offer additive or synergistic effects in slowing kidney disease progression(4).
With the decision to pursue diabetic nephropathy as the primary indication for PS433540, and after fully evaluating the safety and efficacy data reported from the Phase 2a study of PS433540 for hypertension, Pharmacopeia also announced today a reduction in the number of subjects in the ongoing Phase 2b study of PS433540 in subjects with hypertension. The objective of the Phase 2b study is to evaluate 200 mg and 400 mg of PS433540 versus placebo while also comparing efficacy and safety data to irbesartan. Pharmacopeia expects to report upon approximately 250 patients versus the 375 patients originally planned. The decision to reduce the number of subjects in the Phase 2b study was not based on the occurrence or anticipated occurrence of adverse events. Although data from the Phase 2b study remains blinded, the data to date has a similar safety profile to that observed in the Phase 2a trial. Pharmacopeia expects this randomized, double-blinded, placebo and active-controlled, parallel-group, Phase 2b study in subjects with Stage 1 and Stage 2 hypertension to be completed in the fourth quarter of 2008.
"The Phase 2a study of PS433540 provided robust efficacy data in hypertension, and we are confident of its potential ability to become a novel treatment for diabetic nephropathy," stated Joseph Mollica, Ph.D., Chairman of the Board and Interim President and Chief Executive Officer of Pharmacopeia. "Our decision to develop PS433540 for diabetic nephropathy is based on clinical fit with the mechanism of action and the level of unmet medical need for diabetic nephropathy treatments. There are approximately 3 to 4 million people in the U.S. alone with diabetic kidney disease and several times this number worldwide. About 20 to 30 percent of all patients with diabetes will develop evidence of nephropathy. We are enthusiastic about the therapeutic potential of PS433540 and the other candidates in our pipeline and will continue to consider opportunities to partner PS433540 as well as evaluate corporate strategic alternatives," he continued.
To facilitate Pharmacopeia's ability to progress its assets in clinical development, the company expects to further reduce its workforce in the third quarter. In May 2008, Pharmacopeia had announced a reduction of approximately 15 percent of its workforce through attrition and termination of positions. The company will continue to fulfill its contractual commitments to its corporate partners.
As a result of its reduction in operating expenditures, Pharmacopeia expects the cash burn for the quarter ending December 31, 2008 to be approximately $10 million exclusive of restructuring related expenditures. The company expects its quarterly cash burn to be less than $10 million in 2009. In addition to its ongoing cost saving efforts, the company believes it has a number of opportunities to generate cash, including establishing a partnership for PS433540, the continued success of its discovery efforts on behalf of partners, future development milestones and potential royalties for the several clinical candidates discovered by Pharmacopeia that are being advanced by partners such as Schering-Plough and Bristol-Myers Squibb (BMS) and, when appropriate, accessing the capital markets.
SECOND QUARTER 2008 FINANCIAL RESULTS
At June 30, 2008, Pharmacopeia had cash, cash equivalents and marketable securities of $44.4 million, compared to $71.3 million at December 31, 2007. The cash burn for the quarter ended June 30, 2008, was $17.1 million. As of June 30, 2008, Pharmacopeia had deferred revenue of $46.2 million relating to research and development activities that are to be performed by the company subsequent to June 30, 2008.
Pharmacopeia reported a net loss of $15.6 million, or ($0.53) per basic and diluted share, for the quarter ended June 30, 2008, compared to a net loss of $6.9 million, or ($0.26) per basic and diluted share, for the quarter ended June 30, 2007. In the six months ended June 30, 2008, Pharmacopeia reported a net loss of $27.3 million, or ($0.92) per basic and diluted share, compared to a net loss of $16.9 million, or ($0.63) per basic and diluted share for the same period in 2007.
Pharmacopeia's net revenue was $5.9 million for the quarter ended June 30, 2008, compared to $5.0 million for the quarter ended June 30, 2007, an increase of 19%. Net revenue for the six months ended June 30, 2008 was $12.1 million, compared to $11.3 million in the six months ended June 30, 2007, an increase of 7%. These increases were primarily due to increased revenue recognized under Pharmacopeia's agreements with Schering-Plough, GSK and BMS offset by lower milestone revenue in 2008.
Collaborative research and development expense was $7.2 million for the quarter ended June 30, 2008, compared to $5.7 million for the quarter ended June 30, 2007, an increase of 27%. For the six months ended June 30, 2008 and 2007, collaborative research and development expense increased 39% to $15.1 million, compared to $10.9 million in the prior year.
