surf1944
17 years ago
Pharmacopeia's First-in-Class Investigational Therapy PS433540 Achieves Statistically Significant Reductions in Blood Pressure in Hypertensive Patients
Friday May 16, 7:30 am ET
Single Molecule with Dual Mechanism May Offer Novel Approach to Blood Pressure Management
NEW ORLEANS, May 16 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP - News), an innovator in the discovery and development of novel small molecule therapeutics, announced today that PS433540, its first-in-class Dual Acting Receptor Antagonist (DARA), showed statistically significant blood pressure reductions in a Phase 2a study in patients with mild to moderate hypertension. PS433540 is being developed as a potential treatment for both hypertension and diabetic nephropathy and is a novel blood pressure product candidate that possesses two validated mechanisms of action in a single molecule. The data will be presented today at the Recent and Late Breaking Clinical Trials Session at the American Society of Hypertension (ASH) Twenty-Third Annual Scientific Meeting and Exposition in New Orleans.
The Phase 2a study met its primary endpoint by showing a statistically significant reduction in mean 24-hour systolic ambulatory blood pressure over placebo. The study also showed statistically significant improvements over placebo in mean 24-hour diastolic ambulatory blood pressure as well as seated blood pressure. In this double-blind, placebo-controlled study, patients treated with 200 mg of PS433540 once daily experienced a 12/9mmHg drop in mean 24-hour systolic and diastolic blood pressure and those treated with 500 mg experienced a 15/10mmHg drop in mean 24-hour systolic and diastolic blood pressure. These reductions were highly statistically significant vs. placebo (P<0.001). Mean seated office systolic and diastolic blood pressure, the typical blood pressure measure, was also evaluated, with observed blood pressure drops of 17/11mmHg with the 200 mg dose and 17/10mmHg with the 500 mg dose (P<0.001 vs. placebo).
Once-daily treatment with 200 or 500 mg of PS433540 was well tolerated. Most of the adverse events reported were mild or moderate in severity and included headaches and minor musculoskeletal and respiratory complaints. All of these events occurred with similar frequency in the three treatment groups. There was one case of peripheral edema in the placebo arm and one case of peripheral edema in one of the treated arms. There were no increases in liver enzymes above 2 times the upper limit of normal. On average, liver enzyme levels tended to decrease from baseline in the treated arms. There were no serious adverse events on PS433540 treatment. Three subjects discontinued therapy for adverse events, all of which were in the placebo group.
The leading, single-therapy antihypertensives across a broad range of classes, according to their labels, have the ability to lower seated office blood pressure up to 12/8mmHg.(1) Data show that a 2mmHg reduction in blood pressure decreases the average death rate from coronary heart disease by an estimated 4 percent and stroke by 6 percent.(2)
"These positive results indicate that PS433540 may be a unique new treatment option for physicians and patients," said Joel Neutel, M.D., Associate Professor of Medicine in the Department of Medicine at the University of California in Irvine, and Medical Director of Clinical Pharmacology at the Orange County Research Center in Tustin, CA, who was the lead investigator of the Phase 2a study. "The magnitude of the blood pressure reductions we saw in this study were very impressive, and we look forward to further evaluating the benefits of this novel compound."
An estimated 73 million Americans suffer from high blood pressure, a major risk factor for cardiovascular events and heart disease.(3) More than half of people diagnosed and treated with high blood pressure never reach suggested treatment goals and those who do often require two or more medications.(4) PS433540 is the first and only compound specifically designed to incorporate two proven mechanisms -- endothelin (ETA) and angiotensin (AT1) receptor blockade -- in one molecule to treat high blood pressure.
"We are very pleased with the results of this important Phase 2a trial and look forward to future studies which will further assess the potential of PS433540, perhaps even beyond blood pressure lowering," said Joseph A. Mollica, Ph.D., Chairman of the Board and Interim President and Chief Executive Officer of Pharmacopeia. "We believe PS433540's dual mechanism of action may have a positive effect on diabetic kidney disease."
Patients with diabetes are at an increased risk for many complications, including high blood pressure and diabetic kidney disease. Up to 73 percent of patients with diabetes have been or are being treated for high blood pressure,(5) and an estimated 20-30 percent of diabetic patients will progress to diabetic kidney disease,(6) a devastating disease that may require patients to undergo dialysis or a kidney transplant.(7)
Pharmacopeia recently initiated a 12-week, Phase 2b clinical trial with PS433540 to evaluate the compound's safety and efficacy at three different doses versus placebo in 375 subjects with Stage I and Stage II hypertension. The study will also compare blood pressure reductions for each dose with irbesartan. Pharmacopeia anticipates completion of the Phase 2b trial at the end of 2008.
About the Phase 2a study
In this prospective study, 234 men and women with Stage I and Stage II hypertension entered into a single blind placebo run-in period for 3-4 weeks, after which 114 were randomized to receive double blind study medication for four weeks. At the time of the database lock, 108 subjects were available for evaluation, 93 of whom had both baseline and follow-up ambulatory blood pressure measurements (placebo: 25; PS433540 200mg: 35; PS433540 500mg: 33). The primary endpoint was the subjects' change from baseline in mean 24-hour systolic ambulatory blood pressure after 4 weeks of treatment. Additionally, investigators evaluated 24-hour diastolic ambulatory blood pressure and mean seated office systolic and diastolic blood pressure as well as a number of other endpoints.
Investor event at ASH
Pharmacopeia will host a meeting for investors today, Friday, May 16th at 7:00am CDT (8:00am EDT) to review the Phase 2a study results from its PS433540 program, including a presentation by Joel Neutel, M.D., the study's lead investigator. A live webcast and 90-day archive of the presentation can be accessed on the Investors section of the company's website at http://www.pharmacopeia.com.
surf1944
17 years ago
Pharmacopeia Announces Fourth Quarter and Year-End Financial Results for 2007
Thursday February 28, 4:00 pm ET
Company advances DARA in the clinic, adds SARM clinical program and achieves milestones in GSK alliance
PRINCETON, N.J., Feb. 28 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP - News) today announced results for the quarter and year ended December 31, 2007, and highlighted several important therapeutic developments and corporate milestones achieved since the completion of the third quarter of 2007.
During the fourth quarter of 2007, the company achieved the following milestones:
-- Pharmacopeia announced additional positive results from the company's Phase 1 multiple ascending dose (MAD) study of its lead internal product candidate, PS433540 (DARA). The data demonstrated that PS433540 produced statistically significant, dose dependent increases versus placebo in plasma- renin activity levels, as well as reductions in systolic and diastolic blood pressure. These findings are in addition to previously reported top line results from the MAD trial that showed all doses of PS433540 up to 1,000 mg daily for 4 weeks to be safe and well-tolerated.
This MAD study was designed to evaluate the 14-day safety and tolerability of 50, 100, 250, 500 and 1,000 mg doses of PS433540 in healthy volunteers. Study investigators witnessed a dose dependent increase in plasma-renin activity levels for PS433540, which was more pronounced at Day 15 than at Day 1. This observed increase in plasma-renin activity is indicative of PS433540's ability to block the angiotensin receptor, which is involved in blood pressure control. Furthermore, associated with the increase in plasma-renin activity levels was a decrease in both diastolic and systolic blood pressure for PS433540 of up to 15 mmHg. The company believes that these preliminary results may support the potential use of PS433540 as a new therapeutic option for certain patients affected by hypertension and related disorders.
-- Pharmacopeia announced that it licensed a Phase 1 selective androgen receptor modulator (SARM) program from Bristol-Myers Squibb Company (BMS), including lead and back-up compounds. Pharmacopeia plans to develop the lead compound from this program, PS178990, as a potential novel treatment for muscle wasting associated with end-stage renal disease, cancer- and AIDS- related cachexia and recovery from severe burns and traumatic surgery. The SARM program has a broad portfolio of pending composition of matter patent applications that, if granted, would provide intellectual property coverage to the SARM program through at least 2023. PS178990 has been well characterized both in preclinical studies and in a Phase 1 single ascending dose study. The company plans to conduct several Phase 1 studies in 2008, including the initiation of a multiple ascending dose study of PS178990, to obtain additional safety and tolerability data before entering Phase 2.
In consideration for the SARM program license, Pharmacopeia will apply a portion of its existing medicinal chemistry resources to an unrelated BMS discovery program for up to three years. In addition, the company would pay BMS milestone payments at submission and on approval of a therapeutic product for marketing and a stepped royalty on net sales of therapeutic products, if any, resulting from the SARM program.
-- Pharmacopeia announced that it identified two new lead compounds for advancement in its alliance with GlaxoSmithKline (GSK), through its collaboration with the Center of Excellence for External Drug Discovery. As a result of the identification of these new lead compounds, Pharmacopeia received milestone payments totaling $1 million from GSK. The first of the lead compounds is the initial lead in a program addressing respiratory disease. The other newly identified lead compound is the second from a program in inflammatory pain.
Subsequent to the end of the year:
-- Pharmacopeia announced the completion of recruitment in the company's multi-center Phase 2a clinical study of PS433540. The objective of the Phase 2a randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of 200 and 500 mg of PS433540 in subjects with Stage I and Stage II hypertension. The company expects to announce results from this Phase 2a study in the second quarter of 2008.
-- Pharmacopeia announced the nomination of a development compound from its internal CCR1 discovery program. The compound, known as PS031291, is a potent and highly selective antagonist at the CCR1 chemokine receptor, which has been implicated as playing a significant role in multiple inflammatory and autoimmune disease processes. Pharmacopeia believes PS031291 may possess significant potential in the oral treatment of multiple myeloma and various inflammatory diseases including rheumatoid arthritis.
"During 2007, Pharmacopeia's therapeutic pipeline grew and matured more than at any time in the past. Phase 2a DARA results that are expected in the second quarter have the potential to add important value to the program," stated Les Browne, Ph.D., Pharmacopeia's President and Chief Executive Officer. "Also during 2007, our alliances with GlaxoSmithKline, Schering-Plough and Bristol-Myers Squibb each achieved significant milestones. In 2008, we anticipate that successes with internal programs and external alliances will continue to build our therapeutics portfolio."
FOURTH QUARTER & YEAR END 2007 FINANCIAL RESULTS
At December 31, 2007, Pharmacopeia had cash, cash equivalents and marketable securities of $71.3 million, exceeding the company's year-end guidance of between $65 million and $70 million. Net cash used in operating activities for the year ended December 31, 2007 was $11.1 million, which included the receipt of an aggregate $20.0 million in up-front payments in connection with Pharmacopeia's alliances with Wyeth and Organon and $5.0 million in additional research funding in connection with Pharmacopeia's alliance with GSK. Absent the receipt of $25.0 million from these collaborators, Pharmacopeia's net cash used in operating activities in 2007 would have been approximately $36.1 million.
Pharmacopeia reported a net loss of $19.3 million, or ($0.65) per share, for the quarter ended December 31, 2007. The company recorded a net loss of $8.2 million, or ($0.41) per share, for the same quarter in 2006. For the year ended December 31, 2007, Pharmacopeia recorded a net loss of $47.9 million, or ($1.79) per share. Pharmacopeia recorded a net loss of $27.8 million, or ($1.69) per share for the 2006 year.
http://biz.yahoo.com/prnews/080228/neth083.html?.v=39
surf1944
17 years ago
Pharmacopeia Acquires Selective Androgen Receptor Modulator ('SARM') Program from Bristol-Myers Squibb
PRINCETON, N.J., Oct. 15 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP), an innovator in the discovery and development of novel small molecule therapeutics, today announced that it has licensed from Bristol-Myers Squibb (NYSE: BMY) a selective androgen receptor modulator (SARM) program, including a lead compound in Phase 1 clinical development and back-up compounds. PS178990 is a non-steroidal selective androgen receptor modulator, or SARM, which was designed to provide the benefits of testosterone without its unwanted side effects on prostate. The program has completed a Phase 1 single ascending dose study.
SARM agonists are a potential novel treatment for muscle wasting associated with a number of serious chronic and acute medical conditions such as surgical and severe burn recovery, end-stage renal disease and cancer- and AIDS-related cachexia. The shortage of existing treatments results in extended hospital stays and recovery time as well as diminished quality of life.
'I am very pleased to have broadened our portfolio under mutually attractive terms by adding PS178990, which is the seventh clinical development-stage compound being advanced by Pharmacopeia or its collaborators,' stated Les Browne, Ph.D., President and Chief Executive Officer of Pharmacopeia. 'Furthermore, this program offers Pharmacopeia another opportunity to build the business by adding a Phase 1 development- stage product candidate with the potential to treat a wide range of underserved conditions.'
In consideration for the SARM program license, Pharmacopeia will apply a portion of its medicinal chemistry resources to an unrelated Bristol-Myers Squibb discovery program for up to three years and pay Bristol-Myers Squibb milestone payments associated with submission and approval of a therapeutic product for marketing and a stepped royalty on net sales of therapeutic SARM products, if any, resulting from the SARM development program.
Pharmacopeia will hold a conference call today, October 15, beginning at 8:30 a.m. Eastern Time to discuss this addition to its clinical portfolio. Forward-looking and material information may be discussed on this conference call.
Date: October 15, 2007
Time: 8:30 a.m. EDT
Domestic Callers: (877) 879-6174
International Callers: (719) 325-4810
Confirmation Code: 3655914
Name of Conference: Pharmacopeia
Webcast information can be accessed by visiting www.pharmacopeia.com
A replay of the conference call can be accessed by dialing toll-free (888) 203-1112 in the U.S., or (719) 457-0820 outside the U.S. The access code for the replay is 3655914. A replay of the webcast will also be accessible on Pharmacopeia's website on the 'Investors' page at http://www.pharmacopeia.com. The replays will be available for two weeks.
ABOUT PHARMACOPEIA
Pharmacopeia is a clinical development stage biopharmaceutical company dedicated to discovering and developing novel small molecule therapeutics to address significant medical needs. The company has a broad portfolio of clinical and preclinical candidates under development internally or with partners including seven clinical compounds in Phase 2 or Phase 1 development addressing hypertension, diabetic nephropathy, muscle wasting, inflammation and respiratory disease. The company is leveraging its fully integrated drug discovery platform to sustain the growth of its development pipeline. Pharmacopeia has established strategic alliances with major pharmaceutical and biotechnology companies, including Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Organon, Schering-Plough, and Wyeth Pharmaceuticals. For more information please visit the company's website at http://www.pharmacopeia.com.
Contact:
Brian M. Posner
Executive Vice President and Chief
Financial Officer
(609) 452-3643
ir_pr@pcop.com
This press release, and oral statements made with respect to information contained in this press release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, goal, contingency or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward- looking statements include, but are not limited to, statements about the successful implementation of Pharmacopeia's strategic plans, Pharmacopeia's plans to develop PS178990, a product candidate from its SARM program, Pharmacopeia's plans to develop PS433540, a product candidate from its DARA program, Pharmacopeia's Phase 1 clinical studies with respect to PS178990, Pharmacopeia's Phase 1 and Phase 2 clinical studies with respect to PS433540, including timing and expected outcomes of such studies, Pharmacopeia's estimates of the market opportunities for its product candidates, including PS178990 and PS433540, Pharmacopeia's ability to successfully perform under its collaborations with Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Organon and Wyeth, Pharmacopeia's ability to build its pipeline of novel drug candidates through its own internally-funded drug discovery programs, third party collaborations and in-licensing, Pharmacopeia's ability to raise additional capital, Pharmacopeia's expectations concerning the development priorities of its collaborators, their ability to successfully develop compounds and its receipt of milestones and royalties from the collaborations, Pharmacopeia's anticipated operating results, financial condition, liquidity and capital resources, Pharmacopeia's expectations concerning the legal protections afforded by U.S. and international patent law, Pharmacopeia's ability to pursue the development of new compounds and other business matters without infringing the patent rights of others, additional competition, and changes in economic conditions.
Further information about these and other relevant risks and uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov and from Pharmacopeia at http://www.pharmacopeia.com. All forward-looking statements in this press release and oral statements made with respect to information contained in this press release are qualified entirely by the cautionary statements included in this press release and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by such forward-looking statements. These forward-looking statements speak only as of the date of this press release. Pharmacopeia undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.
SOURCE Pharmacopeia
Source: PR Newswire (October 15, 2007 - 6:15 AM EST)
News by QuoteMedia
www.quotemedia.com
surf1944
17 years ago
Phase 2 Clinical Studies Initiated for a Novel Therapeutic Candidate Identified Through Pharmacopeia Collaboration
Phase 2 Clinical Trial Initiated for a p38 Kinase Inhibitor Identified through Collaboration with Bristol-Myers Squibb for the Treatment of Psoriasis
PRINCETON, N.J., Sept. 18 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP), an innovator in the discovery and development of novel small molecule therapeutics, today announced that Bristol-Myers Squibb Company (NYSE: BMY) has initiated a Phase 2 clinical trial with a p38 kinase inhibitor (BMS-582949) that resulted from a collaborative research program between Pharmacopeia and Bristol-Myers Squibb. BMS-582949 is being evaluated for the oral treatment of moderate to severe psoriasis. The multi-centered randomized, double-blind, placebo-controlled trial, will examine safety and efficacy of the compound at three different doses. Approximately 100 patients are expected to be enrolled in the study.
'It is generally accepted that p38 kinase inhibitors could be effective in a range of inflammatory diseases including psoriasis, rheumatoid arthritis, and inflammatory bowel disease,' said Les Browne, Ph.D., President and Chief Executive Officer of Pharmacopeia. 'Psoriasis is an important indication to evaluate in order to rapidly achieve proof of concept for this compound. We are very pleased to see BMS-582949 advance and complement the other clinical development programs with which we are associated, especially our own Phase 2 DARA program.'
Bristol-Myers Squibb is also currently conducting a Phase 1 trial in Canada with a second p38 kinase inhibitor resulting from the collaborative research program.
Under the terms of the companies' ongoing collaboration, Pharmacopeia will receive milestone payments for the p38 compounds in the program to the extent the program progresses through clinical development, and royalty payments for any product from the program that reaches the marketplace. Bristol-Myers Squibb is solely responsible for further development and commercialization of the therapeutic candidate.
ABOUT PHARMACOPEIA
Pharmacopeia is committed to discovering and developing novel therapeutics to address significant medical needs. The Company has a broad portfolio advancing toward clinical validation, both independently and with partners. Pharmacopeia's most advanced internal program is a dual-acting angiotensin and endothelin receptor antagonist (DARA) for hypertension and diabetic kidney disease for which a Phase 2 clinical trial is underway. Other internal proprietary programs address primarily immunoregulation. Pharmacopeia's collaborative efforts have resulted in a portfolio that includes two partnered programs that have advanced into Phase 2 clinical trials targeting chronic obstructive pulmonary disease (COPD) and psoriasis and two partnered programs in Phase 1 clinical trials targeting oncology and inflammatory disease. Four additional partnered compounds are in preclinical development. Pharmacopeia's current strategic alliances are with Cephalon, GlaxoSmithKline, Organon and Wyeth.
This press release, and oral statements made with respect to information contained in this press release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, goal, contingency or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward- looking statements include, but are not limited to, statements about the successful implementation of Pharmacopeia's strategic plans, Pharmacopeia's plans to develop PS433540, a product candidate from its DARA program, Pharmacopeia's Phase 1 and Phase 2 clinical studies with respect to PS433540, including timing and expected outcomes of such studies, Pharmacopeia's estimates of the market opportunities for its product candidates, including PS433540, Pharmacopeia's ability to successfully perform under its collaborations with Cephalon, GlaxoSmithKline, Organon and Wyeth, Pharmacopeia's ability to build its pipeline of novel drug candidates through its own internally-funded drug discovery programs, third party collaborations and in-licensing, Pharmacopeia's ability to raise additional capital, Pharmacopeia's expectations concerning the development priorities of its collaborators, their ability to successfully develop compounds and its receipt of milestones and royalties from the collaborations, Pharmacopeia's anticipated operating results, financial condition, liquidity and capital resources, Pharmacopeia's expectations concerning the legal protections afforded by U.S. and international patent law, Pharmacopeia's ability to pursue the development of new compounds and other business matters without infringing the patent rights of others, additional competition, and changes in economic conditions.
Further information about these and other relevant risks and uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov and from Pharmacopeia at http://www.pharmacopeia.com. All forward-looking statements in this press release and oral statements made with respect to information contained in this press release are qualified entirely by the cautionary statements included in this press release and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by such forward-looking statements. These forward-looking statements speak only as of the date of this press release. Pharmacopeia undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.
Contact:
Amy P. Sharpless
Investor Relations Coordinator
Pharmacopeia
(609) 452-3643
SOURCE Pharmacopeia
Source: PR Newswire (September 18, 2007 - 6:30 AM EST)
News by QuoteMedia
www.quotemedia.com
surf1944
17 years ago
Pharmacopeia Announces Second Quarter 2007 Financial Results
Quarter Highlights Include Progress in DARA Clinical Program, Achievement of Collaborative Milestones and Completion of Successful Financing
Plans for Earlier Initiation of a Phase 2a Hypertension Trial for DARA Program
PRINCETON, N.J., Aug. 2 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP) today announced results for the quarter and six months ended June 30, 2007, and highlighted several important developments in its therapeutic programs and corporate milestones achieved since the beginning of the quarter.
During the second quarter of 2007:
-- Pharmacopeia announced positive results from the first study in the
Company's Phase 1 clinical trial for PS433540, a product candidate from
its DARA program. Data from the single ascending dose (SAD) study
indicated that PS433540 was well tolerated at all six single-doses
administered from 25 mg to 1,000 mg. In addition, study results showed
that the product candidate possesses dose-related exposure upon oral
dosing and a half-life that is consistent with once-daily oral
administration.
-- Pharmacopeia reported that a compound identified through its
collaboration with Schering-Plough had been selected by Schering-Plough
for preclinical development. This selection triggered a $1 million
milestone payment to Pharmacopeia. Schering-Plough is currently
developing seven candidates that resulted from the collaboration with
Pharmacopeia, with one candidate in a Phase 2 clinical trial for
chronic obstructive pulmonary disease (COPD); three candidates in Phase
1 clinical trials for oncology, metabolic disease and inflammatory
disease; and three candidates in preclinical development. Schering-
Plough is solely responsible for further development and
commercialization of these candidates. However, Pharmacopeia is
eligible to receive additional milestone payments if these programs
advance further in clinical trials, and will also receive royalties on
sales of any resulting therapeutic products incorporating compounds
derived from these programs.
-- Pharmacopeia received the second of three potential $5 million payments
as part of the Company's product development and commercialization
alliance with GlaxoSmithKline (GSK). This payment was triggered by
Pharmacopeia's completion of certain early discovery activities
established under its agreement with GSK. At present, multiple
Pharmacopeia - GSK programs are underway, all of which will be
conducted as internal programs by Pharmacopeia unless GSK exercises its
development option. In July of this year, Pharmacopeia announced that a
lead compound was identified for advancement, six months ahead of the
original schedule. Compounds from the program have potential utility in
inflammatory pain and have now entered the lead optimization phase at
Pharmacopeia. As a result of this progress, Pharmacopeia received a
$500,000 milestone payment from GSK in the third quarter.
-- Pharmacopeia closed an underwritten public offering that raised
aggregate proceeds of approximately $40.3 million in May 2007. Net
proceeds to Pharmacopeia after transaction costs were approximately
$37.1 million. Through the offering, Pharmacopeia sold approximately
8.1 million shares of newly issued common stock, including the over-
allotment which was exercised in full by the underwriters. Pharmacopeia
intends to use the proceeds from the offering for expenditures related
to clinical trials for its PS433540 product candidate, for further
development of its internal program portfolio and for general corporate
purposes.
'Pharmacopeia had a strong second quarter, making significant progress with multiple therapeutic programs and completing a successful underwritten public offering,' stated Les Browne, Ph.D., Pharmacopeia's President and Chief Executive Officer. 'One of the highlights of our quarter was the positive results from the initial study of our Phase 1 clinical trial for PS433540, and we look forward to the continued development of this product candidate as well as progress on our other internal programs. We are also very pleased with the recent success of our collaborations with both Schering-Plough and GlaxoSmithKline. We expect to have more to report from our alliances in the coming months.'
PS433540 CLINICAL PROGRAM
Pharmacopeia today also provided an update to the timeline for its clinical program for PS433540. The Phase 1 multiple ascending dose (MAD) study, designed to evaluate 14 days of treatment in healthy volunteers, commenced in April 2007. This study was designed to sequentially evaluate the 50, 100, 250 and 500 mg doses of PS433540, and is currently continuing with the 500 mg panel. The Company expects to report results of the MAD study in the third quarter of this year. In addition, separate Phase 1 food effect and comparative bioavailability studies have been completed. The food effect study showed no clinically relevant difference in the pharmacokinetic profile of PS433540 when taken with or without food. The comparative bioavailability study showed that the bioavailability of PS433540 dosed as a capsule, which has been developed for use in Phase 2 clinical studies, is similar to that of a suspension, used in Phase 1. The Phase 1 angiotensin II challenge study was initiated in July 2007. Pharmacopeia expects results of the angiotensin II challenge study to be reported late in the third quarter or early in the fourth quarter of this year. The endothelin challenge study is expected to start during the second half of this year.
As a result of the positive preclinical and clinical data generated to date, and upon consultation with its Clinical Advisory Board, the Company has decided to move up initiation of a Phase 2a hypertension clinical trial for PS433540. This trial is now planned to commence in the second half of 2007. The Company anticipates that the study will be completed and results reported in the first half rather than in the second half of 2008. The study is designed to validate the concept that PS433540 lowers blood pressure in hypertensives and to help establish the framework to initiate a second Phase 2 hypertension study in the first half of 2008. The objective of the Phase 2a study will be to establish initial tolerability and 24-hour efficacy of PS433540 in hypertensive subjects. The study is expected to enroll approximately 140 subjects and will be placebo controlled, using 2 dose levels of PS433540.
SECOND QUARTER, 2007 FINANCIAL RESULTS
At June 30, 2007, Pharmacopeia had cash, cash equivalents and marketable securities of $92.7 million. This balance includes net proceeds of approximately $37.1 million from the underwritten public offering that closed in May 2007. Pharmacopeia expects to end the year with $65.0 million to $70.0 million in cash and short-term investments.
Pharmacopeia's net revenue was $5.0 million for the quarter ended June 30, 2007, compared to $3.3 million for the quarter ended June 30, 2006. For the six months ended June 30, 2007, net revenue was $11.3 million, compared to $7.4 million for the same period in 2006. The increase in net revenue during the three- and six- month periods was largely due to an increase in milestone revenue, as well as revenue recorded from Pharmacopeia's alliances with Cephalon, GSK and Wyeth. This increase was partially offset by a decrease in research revenue recorded from the Company's collaboration with Schering- Plough.
Collaborative research and development expense increased 91% to $5.7 million in the three months ended June 30, 2007 compared to $3.0 million in the three months ended June 30, 2006. For the six months ended June 30, 2007, collaborative research and development expense increased 73% to $10.9 million compared to $6.3 million for the same period in 2006. These increases are primarily attributable to increased resources allocated to our recent alliances with Cephalon, GSK and Wyeth.
The Company incurred proprietary research and development expense of $5.0 million in the quarter ended June 30, 2007, compared to $5.5 million in the same period in 2006, a decrease of 8%. This decrease relates to resources expended on the Company's JAK3 program, the expense for which has been primarily classified as collaborative research and development expense since the Company partnered the program with Wyeth in December 2006. This decrease was offset by increased costs relating to the Company's Phase 1 clinical program for PS433540. For the six months ended June 30, 2007, proprietary research and development expense increased to $12.5 million, compared to $11.8 million for the same period in 2006, an increase of 6%. The increase during the six months ended June 30, 2007 was primarily due to costs associated with the Phase 1 clinical program the Company initiated with respect to PS433540.
General and administrative expense was $2.8 million for the quarter ended June 30, 2007, compared to $2.4 million for the same period in 2006, an increase of 14%. General and administrative expense was $5.5 million for the six months ended June 30, 2007, compared to $4.9 million for the same period in 2006, an increase of 12%. These increases were largely due to higher consulting and share-based compensation costs for the respective periods.
Pharmacopeia reported a net loss of $6.9 million, or ($0.26) per basic and diluted share, for the quarter ended June 30, 2007. The Company recorded a net loss of $7.2 million, or ($0.47) per basic and diluted share, for the same quarter in 2006. For the six months ended June 30, 2007, Pharmacopeia recorded a net loss of $16.9 million, or ($0.63) per share. Pharmacopeia recorded a net loss of $14.9 million, or ($0.98) per basic and diluted share for the 2006 six-month period.
Further details regarding Pharmacopeia's second quarter 2007 results will be presented in a conference call today, August 2, 2007, at 5:00 p.m. Eastern Time. Dr. Leslie J. Browne, President and Chief Executive Officer, Mr. Brian M. Posner, Executive Vice President and Chief Financial Officer, and Dr. Rene Belder, Vice President, Clinical and Regulatory Affairs, will host the call. Forward-looking and material information may be discussed on this conference call.
Date: August 2, 2007
Time: 5:00 p.m. EDT
Domestic Callers: (800) 310-6649
International Callers: (719) 457-2693
Confirmation Code: 7923994
Name of Conference: Pharmacopeia's Second Quarter 2007 Financial Results
Webcast information can be accessed by visiting
http://www.pharmacopeia.com
A replay of the conference call can be accessed by dialing toll-free (888) 203-1112 in the U.S., or (719) 457-0820 outside the U.S. The access code for the replay is 7923994. A replay of the webcast will also be accessible on Pharmacopeia's website on the 'Investors' page at http://www.pharmacopeia.com. The replays will be available for two weeks.
ABOUT PHARMACOPEIA
Pharmacopeia is committed to discovering and developing novel therapeutics to address significant medical needs. The Company has a broad portfolio advancing toward clinical validation, both independently and with partners. Pharmacopeia's most advanced internal program is a dual-acting angiotensin and endothelin receptor antagonist (DARA) for hypertension and diabetic kidney disease for which Phase 1 clinical trials are underway. Other internal proprietary programs address primarily immunoregulation. Pharmacopeia's collaborative efforts have resulted in a portfolio that includes one partnered program currently in Phase 2 clinical trials targeting chronic obstructive pulmonary disease (COPD) and four partnered programs in Phase 1 clinical trials targeting rheumatoid arthritis, oncology, metabolic and inflammatory diseases. Four additional partnered compounds are in preclinical development. Pharmacopeia's current strategic alliances are with Cephalon, GlaxoSmithKline, Organon and Wyeth.
Contact:
Brian M. Posner
Executive Vice President and Chief Financial Officer
Pharmacopeia
(609) 452-3643
This press release, and oral statements made with respect to information contained in this press release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, goal, contingency or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward- looking statements include, but are not limited to, statements about the successful implementation of Pharmacopeia's strategic plans, Pharmacopeia's plans to develop PS433540, a product candidate from its DARA program, Pharmacopeia's Phase 1 clinical studies and proposed Phase 2 clinical studies with respect to PS433540, including timing and expected outcomes of such studies, Pharmacopeia's estimates of the market opportunities for its product candidates, including PS433540, Pharmacopeia's ability to successfully perform under its collaborations with Cephalon, GlaxoSmithKline, Organon and Wyeth, Pharmacopeia's ability to build its pipeline of novel drug candidates through its own internally-funded drug discovery programs, third party collaborations and in-licensing, Pharmacopeia's ability to raise additional capital, Pharmacopeia's expectations concerning the development priorities of its collaborators, their ability to successfully develop compounds and its receipt of milestones and royalties from the collaborations, Pharmacopeia's anticipated operating results, financial condition, liquidity and capital resources, Pharmacopeia's expectations concerning the legal protections afforded by U.S. and international patent law, Pharmacopeia's ability to pursue the development of new compounds and other business matters without infringing the patent rights of others, additional competition, and changes in economic conditions.
Further information about these and other relevant risks and uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov and from Pharmacopeia at http://www.pharmacopeia.com. All forward-looking statements in this press release and oral statements made with respect to information contained in this press release are qualified entirely by the cautionary statements included in this press release and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by such forward-looking statements. These forward-looking statements speak only as of the date of this press release. Pharmacopeia undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.
Tables to follow
PHARMACOPEIA, INC.
SELECTED FINANCIAL DATA
(Dollars in thousands, except share data)
Consolidated Statements of Operations
For the Three Months For the Six Months
Ended June 30, Ended June 30,
2007 2006 2007 2006
(unaudited) (unaudited)
Revenue
Net revenue $4,957 $3,292 $11,306 $7,408
Operating Expenses
Collaborative research and
development expense 5,685 2,979 10,922 6,312
Proprietary research and
development expense 5,033 5,468 12,451 11,760
General and administrative
expense 2,771 2,424 5,459 4,871
Total operating expenses 13,489 10,871 28,832 22,943
Operating loss (8,532) (7,579) (17,526) (15,535)
Interest and other income 942 333 1,638 614
Interest and other expense (5) - (5) -
Change in warrant liability 638 - (1,068) -
Restructuring credits - 88 - 88
Loss before income taxes (6,957) (7,158) (16,961) (14,833)
(Benefit from) provision for
income taxes (52) 20 (52) 28
Net loss $(6,905) $(7,178) $(16,909) $(14,861)
Net loss per share:
- Basic and diluted $(0.26) $(0.47) $(0.63) $(0.98)
Weighted average number
of common stock shares
outstanding:
- Basic and diluted 26,336,997 15,263,977 26,716,303 15,237,364
PHARMACOPEIA, INC.
SELECTED FINANCIAL DATA
(Dollars in thousands)
Consolidated Balance Sheets
June 30, December 31,
2007 2006
(unaudited)
Cash, cash equivalents and marketable
securities $92,686 $46,140
Accounts receivable, net - 5,006
Other assets, net 15,599 14,981
Total assets $108,285 $66,127
Current liabilities $27,375 $18,750
Long-term liabilities 28,402 16,946
Total stockholders' equity 52,508 30,431
Total liabilities and stockholders'
equity $108,285 $66,127
SOURCE Pharmacopeia
Source: PR Newswire (August 2, 2007 - 3:00 PM EST)
News by QuoteMedia
www.quotemedia.com
surf1944
17 years ago
Pharmacopeia to Receive $5 Million Payment from GlaxoSmithKline
Payment Triggered by Pharmacopeia's Achievement of Collaboration Criteria
PHILADELPHIA and PRINCETON, N.J., June 13 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK), a global pharmaceutical company, and Pharmacopeia (Nasdaq: PCOP), an innovator in the discovery and development of novel small molecule therapeutics, announced today that Pharmacopeia will receive a payment of $5 million from GSK. This is the second $5 million payment to be received by Pharmacopeia in connection with the product development and commercialization agreement entered into by the two companies in March 2006.
This payment is triggered by Pharmacopeia's completion of certain early discovery activities established under its agreement with GSK. Pharmacopeia is entitled to a third $5 million payment upon the completion of additional early discovery activities. Pharmacopeia is also entitled to success-based milestone payments totaling up to $83 million per program for any drug development program pursued through the multi-program alliance and up to double-digit royalties on the sales of any products commercialized by GSK from the alliance. Should GSK decline its option to complete pivotal trials of programs resulting from the alliance, Pharmacopeia may independently pursue development of these programs, subject to its obligations to GSK under the agreement.
Hugh Cowley, Senior Vice President of GSK and head of the Center of Excellence for External Drug Discovery (CEEDD) at GSK noted, 'The alliance between the CEEDD and Pharmacopeia is off to a tremendous start, and the CEEDD is very pleased with the progress to date on the several programs underway. We expect the alliance to contribute to GSK's development pipeline in the future, validating the collaboration model we sought to establish under the CEEDD umbrella at GSK.'
'The alliance with GSK has proven to be very valuable to Pharmacopeia,' said Les Browne, Ph.D., President and Chief Executive Officer of Pharmacopeia. 'Allying our scientific expertise and platform with the insights we obtain from the CEEDD scientists provides an excellent opportunity to develop novel therapeutics and approaches that we believe may one day address some of the most significant unmet medical needs.'
About The CEEDD
GlaxoSmithKline is enhancing the way it discovers and develops drugs by creating a small dedicated team who will feed the GSK pipeline solely through the efforts of its external alliances. The CEEDD (Center of Excellence for External Drug Discovery) was formed as further validation of GSK's strategy to create small, independent and accountable R&D teams (Centers of Excellence for Drug Discovery or CEDDs). In essence, the CEEDD will 'virtualize' a portion of the GSK pipeline; namely, from Target to Clinical PoC, by forming multiple risk-sharing/reward-sharing alliances. Capitalizing on the speed and efficiency of its collaborators will allow GSK to deliver pharmaceuticals products faster to patients.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
About Pharmacopeia
Pharmacopeia is committed to discovering and developing novel therapeutics to address significant medical needs. The Company has a broad portfolio advancing toward clinical validation, both independently and with partners. Pharmacopeia's most advanced internal program is a dual-acting angiotensin and endothelin receptor antagonist (DARA) for hypertension and diabetic kidney disease for which Phase 1 clinical trials are underway. Other internal proprietary programs address primarily immunoregulation. Pharmacopeia's collaborative efforts have resulted in a portfolio that includes one partnered program currently in Phase 2 clinical trials targeting chronic obstructive pulmonary disease (COPD) and four partnered programs in Phase 1 clinical trials targeting rheumatoid arthritis, oncology, metabolic and inflammatory diseases. Four additional partnered compounds are in preclinical development. Pharmacopeia's current strategic alliances are with Cephalon, GlaxoSmithKline, Organon and Wyeth.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2004.
This press release, and oral statements made with respect to information contained in this press release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, goal, contingency or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward- looking statements include, but are not limited to, statements about the successful implementation of Pharmacopeia's strategic plans, Pharmacopeia's plans to develop PS433540, a product candidate from its DARA program, Pharmacopeia's Phase 1 clinical studies and proposed Phase 2 clinical studies with respect to PS433540, including timing and expected outcomes of such studies, Pharmacopeia's estimates of the market opportunities for its product candidates, including PS433540, Pharmacopeia's ability to successfully perform under its collaborations with Cephalon, GlaxoSmithKline, Organon and Wyeth, Pharmacopeia's ability to build its pipeline of novel drug candidates through its own internally-funded drug discovery programs, third party collaborations and in-licensing, Pharmacopeia's ability to raise additional capital, Pharmacopeia's expectations concerning the development priorities of its collaborators, their ability to successfully develop compounds and its receipt of milestones and royalties from the collaborations, Pharmacopeia's anticipated operating results, financial condition, liquidity and capital resources, Pharmacopeia's expectations concerning the legal protections afforded by U.S. and international patent law, Pharmacopeia's ability to pursue the development of new compounds and other business matters without infringing the patent rights of others, additional competition, and changes in economic conditions.
Further information about these and other relevant risks and uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov and from Pharmacopeia at http://www.pharmacopeia.com. All forward-looking statements in this press release and oral statements made with respect to information contained in this press release are qualified entirely by the cautionary statements included in this press release and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by such forward-looking statements. These forward-looking statements speak only as of the date of this press release. Pharmacopeia undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.
Pharmacopeia Contact:
Simon M. Tomlinson
Senior Vice President, Business Development
609-452-3643
GlaxoSmithKline Contact:
Rick Koenig
610-270-5546
SOURCE Pharmacopeia
Source: PR Newswire (June 13, 2007 - 7:30 AM EDT)
energymanNJ
18 years ago
PCOP -- Pharmacopeia Drug Discovery, Inc.
Com (1 Cent)
http://www.pinksheets.com/quote/print_filings.jsp?url=%2Fredirect.asp%3Ffilename%3D0001104659%252D07...
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
--------------------------------------------------------------------------------
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
--------------------------------------------------------------------------------
Pharmacopeia Drug Discovery, Inc.
(Exact name of registrant as specified in its charter)
Delaware
51-0418085
(State or other jurisdiction
of incorporation or organization)
(I.R.S. Employer
Identification No.)
--------------------------------------------------------------------------------
P.O. Box 5350
Princeton, New Jersey 08543-5350
(609) 452-3600
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
--------------------------------------------------------------------------------
Stephen C. Costalas, Esq.
Executive Vice President, General Counsel and Secretary
Pharmacopeia Drug Discovery, Inc.
P.O. Box 5350
Princeton, New Jersey 08543-5350
(609) 452-3600
(Name, address including zip code, and telephone number, including area code, of agent for service)
--------------------------------------------------------------------------------
With a copy to:
Ella DeTrizio, Esq.
Dechert LLP
P.O. Box 5218
Princeton, New Jersey 08543-5218
(609) 620-3211
--------------------------------------------------------------------------------
Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this Registration Statement.
If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. o
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. x
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. o
CALCULATION OF REGISTRATION FEE
Title of Each Class of
Securities to be Registered
Amount to be
Registered
Proposed Maximum
Offering Price
Per Security(1)
Proposed Maximum
Aggregate Offering
Price (2)
Amount of
Registration Fee
Common Stock, $.01 par value per share
(3)
(3)
(3)
(3)
Preferred Stock, $.01 par value per share
(3)
(3)
(3)
(3)
Debt Securities
(3)
(3)
(3)
(3)
Warrants
(3)
(3)
(3)
(3)
Units
(3)
(3)
(3)
(3)
$45,000,000
100%
$45,000,000
$4,815
--------------------------------------------------------------------------------
(1) This registration statement includes $45,000,000 of securities which may be issued by the registrant from time to time in indeterminate amounts and at indeterminate times. Securities registered hereunder may be sold separately, together or as units with other securities registered hereunder. The securities registered hereunder also include such indeterminate number of shares of common stock and preferred stock, warrants or units of registrant.
(2) Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rule 457(o) of the Securities Act of 1933, as amended (the “Securities Act”).
(3) Not required to be included in accordance with General Instruction II.D. of Form S-3 under the Securities Act.
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment that specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until this Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
--------------------------------------------------------------------------------
The information in this prospectus is not complete and may be changed. We may not sell these securities until the Securities and Exchange Commission declares our registration statement effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
Subject to completion, dated February 16, 2007
$45,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
We may offer and sell, from time to time in one or more offerings, any combination of common stock, preferred stock, warrants, debt securities or units having an aggregate initial offering price not exceeding $45,000,000. When we decide to sell a particular class or series of securities, we will provide specific terms of the offered securities in a prospectus supplement.
We will provide specific terms of the offerings of our securities in supplements to this prospectus. The prospectus supplement may also add, update or change information in this prospectus. You should read this prospectus and any prospectus supplement, as well as the documents incorporated by reference or deemed to be incorporated by reference into this prospectus, carefully before you invest.
This prospectus may not be used to offer or sell our securities unless accompanied by a prospectus supplement.
Our common stock is traded on the Nasdaq Global Market under the symbol “PCOP.” Each prospectus supplement will contain information, where applicable, as to any listing on the Nasdaq Global Market or any other securities exchange covered by the prospectus supplement.
The mailing address of our principal executive offices is P.O. Box 5350, Princeton, NJ 08543-5350, and our telephone number is (609) 452-3600.
Investing in our securities involves various risks. See the section entitled “Risk Factors” on page 3 for more information on these risks. Additional risks associated with an investment with us as well as with our securities will be described in the related prospectus supplements.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities, or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this Prospectus is , 2007.