-- Currently enrolling patients in U.S. Phase II clinical trial for cocaine
addiction -- Expect to initiate U.S. Phase II clinical trial for methamphetamine
addiction in second quarter of 2008
CORAL GABLES, Fla., March 26 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a biopharmaceutical company that acquires, in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction, today reported financial results for the fourth quarter and year ended December 31, 2007.
Commenting on the year, Patrick J. McEnany, Chief Executive Officer of Catalyst Pharmaceutical Partners, noted, "Operationally, 2007 was an important year for Catalyst, during which time we achieved several key milestones. Most notably, we developed CPP-109, Catalyst's finished dosage form of vigabatrin, which is now being used in our first U.S. Phase II clinical trial. We also reported successful results of the use of vigabatrin to treat cocaine addiction, from a New York University, investigator-sponsored, double-blind, placebo-controlled Phase II trial in Mexico that was partially supported by Catalyst. That trial confirmed the positive results of the prior two Mexican human pilot studies."
Mr. McEnany continued, "In preparation for our clinical development efforts, we have also strengthened our management team with two key appointments. Steven R. Miller, Ph.D. joined the Company as Vice President of Pharmaceutical Development and Project Management and Patrick Kenny came on board as Director - Corporate Clinical Compliance."
"During 2007, we expanded our Scientific Advisory Board with two new members; Dr. Thomas Kosten, the Waggoner Professor of Psychiatry and Neuroscience at Baylor College of Medicine, and Dr. Richard Rawson of the University of California, Los Angeles' Department of Psychiatry. Drs. Kosten and Rawson are both key opinion leaders in the field of substance abuse and are contributing greatly to the achievement of Catalyst's goals."
"We are especially pleased that the positive results from our Mexico trial were discussed in Newsweek magazine's cover article on addiction in the March 3, 2008 issue. In the article, one of the foremost experts in the field of addiction noted that the results of this trial provide the best efficacy signal of any trial conducted so far for cocaine treatment and that treatment with vigabatrin seems especially promising, even for patients that are hardest to treat -- long-term cocaine addicts. We believe strongly in the viability of our technology and the promise that treatment with CPP-109 may bring to patients, the healthcare system and society at large."
For the year ended December 31, 2007, the Company's net loss was $4,139,493, or $0.33 per basic and diluted share, compared to a net loss of $2,729,454, or $0.36 per basic and diluted share, in the prior year. Results for 2007 and 2006 include non-cash charges relating to stock-based compensation of $556,343 and $1,220,739, respectively.
Research and development expenses for 2007 were $2,990,659, compared to $1,087,144 in 2006. This includes non-cash stock-based compensation for 2007 and 2006 of $365,107 and $344,649, respectively.
General and administrative expenses for 2007 were $2,036,470, compared to $1,815,183 in 2006. This includes non-cash stock-based compensation for 2007 and 2006 of $191,236 and $876,090, respectively.
For the fourth quarter of 2007, the Company's net loss was $944,938, or $0.08 per basic and diluted share, compared to a net loss of $741,241, or $0.07 per basic and diluted share, for the same period in 2006. Results for the fourth quarters of 2007 and 2006 include non-cash charges relating to stock-based compensation of $79,260 and $150,796, respectively.
As a development stage pharmaceutical company, Catalyst had no revenues during 2007 and 2006.
At December 31, 2007, the Company had cash and cash equivalents totaling $15.9 million and no long-term debt. The Company believes that its existing cash and cash equivalents will be sufficient to meet its projected operating requirements through the middle of 2009.
Company Development Update
In August 2007, Catalyst submitted to the U.S. Food & Drug Administration (FDA) the results of a bioequivalence study demonstrating that CPP-109 is bioavailable and bioequivalent to Sabril(R) Tablets, the version of vigabatrin marketed in Europe by Sanofi Aventis.
In December 2007, Catalyst announced positive initial top-line results from a Catalyst-supported, investigator-initiated, Phase II double-blind, placebo-controlled trial, in which vigabatrin met its primary efficacy endpoint of abstinence during the last weeks of treatment for cocaine addiction. Additional results of this trial will be reported when they become available. This 103-subject trial is the first randomized, double-blind, placebo-controlled clinical trial studying vigabatrin's effectiveness in treating cocaine addiction. These data show that a statistically significantly greater number of subjects treated with vigabatrin were able to abstain from cocaine usage during the last three weeks of the dosing period compared to those receiving placebo. Achievement of abstinence for an extended period during treatment is the critical first step for cocaine addicted patients to potentially achieve abstinence for much longer time periods. The data confirm the positive results seen in two previous open-label trials conducted in 2003 and 2004.
In January 2008, Catalyst announced that it has initiated enrollment of patients for its 180-patient, U.S. Phase II clinical trial evaluating the use of CPP-109 in treating patients with cocaine addiction. The Phase II trial is designed as a randomized, double-blind, placebo-controlled, intent-to-treat, multi-center trial to evaluate the safety and efficacy of CPP-109 as a treatment for cocaine addiction. Under the trial protocol, patients will be treated for a period of 12 weeks, with an additional 12 weeks of follow-up. The primary objective of the trial is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo-treated subjects are cocaine-free during their last two weeks of treatment (weeks 11 and 12). Additionally, Catalyst will be measuring a number of secondary endpoints based on reductions of cocaine use and craving. Catalyst expects to initiate a similar trial in patients with methamphetamine addiction in the second quarter of 2008.
The Company expects to receive initial top-line results from its Phase II clinical trial for cocaine addiction in the fourth quarter of 2008. Top-line results of the trial for methamphetamine addiction are expected in the third quarter of 2009.
About Catalyst Pharmaceutical Partners, Inc.
Catalyst Pharmaceutical Partners is a biopharmaceutical company focused on the development and commercialization of prescription drugs for the treatment of addiction. The Company has obtained from Brookhaven National Laboratory an exclusive worldwide license for nine patents and four patents pending in the United States relating to the right to use vigabatrin to treat a wide variety of substance addictions. Catalyst has also been granted rights to Brookhaven's vigabatrin-related foreign patents or patents pending in more than 30 countries. The Company's initial product candidate is CPP-109, which is the Company's finished dosage form of vigabatrin, also referred to in the literature as gamma-vinyl-GABA or GVG. CPP-109 has been granted "Fast Track" status by the FDA for the treatment of cocaine addiction. This indicates that the FDA has recognized that CPP-109 is intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrates the potential to address unmet medical needs. For more information about the Company, go to http://www.catalystpharma.com.
This press release contains forward-looking statements. Forward-looking
statements involve known and unknown risks and uncertainties which may
cause the Company's actual results in future periods to differ materially
from forecasted results. A number of factors, including those described in
the Annual Report on Form 10-K that the Company has filed with the U.S.
Securities and Exchange Commission ("SEC") reporting its financial position
and results of operations as of and for the year ended December 31, 2007,
could adversely affect the Company's ability to obtain these results.
Copies of the Company's filings with the SEC are available from the SEC or
may be obtained upon request from the Company. The Company does not
undertake any obligation to update the information contained herein, which
speaks only as of this date.
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS
Year Ended December 31,
Revenues $ - $ -
Operating costs and expenses:
Research and development 2,990,659 1,087,144
General and administrative 2,036,470 1,815,183
Total operating costs and expenses 5,027,129 2,902,327
Loss from operations (5,027,129) (2,902,327)
Interest income 887,636 172,873
Loss before income taxes (4,139,493) (2,729,454)
Provision for income taxes - -
Net loss $(4,139,493) $(2,729,454)
Net loss per share - basic and diluted $ (0.33) $ (0.36)
Weighted average shares outstanding
- basic and diluted 12,525,405 7,687,630
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
Cash and cash equivalents $15,943,896 $20,434,702
Interest receivable 63,709 85,787
Prepaid expenses 524,081 67,333
Total current assets 16,531,686 20,587,822
Property and equipment, net 127,788 20,157
Deposits 20,448 11,500
Total assets $16,679,922 $20,619,479
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $219,866 $448,072
Accrued expenses and other liabilities 83,419 324,774
Total current liabilities 303,285 772,846
Accrued expenses and other liabilities,
non current 53,880 -
Total liabilities 357,165 772,846
Total stockholders' equity 16,322,757 19,846,633
Total liabilities and stockholders' equity 16,679,922 20,619,479
|SOURCE Catalyst Pharmaceutical Partners|
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