SECAUCUS, N.J. and SOUTH SAN FRANCISCO, Calif., Nov. 8 /PRNewswire-FirstCall/ -- AlgoRx Pharmaceuticals, Inc. and Corgentech Inc. today announced positive data from the second of two Phase 3 trials of ALGRX 3268 -- a fast-acting local anesthetic administered into the skin by powder injection and aimed at reducing pain associated with venipunctures and intravenous line placements. The primary endpoint of the 535-pediatric patient trial was achieved showing that treatment with ALGRX 3268 demonstrated statistically significantly less pain (p=0.002) compared with the placebo group. ALGRX 3268 was well tolerated and demonstrated no significant safety issues.
This Phase 3 trial (004) was conducted at nine centers in the United States in patients 3 to 18 years of age. A total of 535 patients were administered a placebo (266 patients) or the local anesthetic, ALGRX 3268 (269 patients) one to three minutes before having their procedures which required either venipuncture or intravenous line placement. The primary endpoint was pain upon needle insertion utilizing the FACES pain scale.
The first Phase 3 trial (003) of ALGRX 3268 with an identical clinical trial protocol was conducted in 574 patients, and data from this pivotal trial were reported in October 2005. The primary endpoint of the pediatric trial was achieved showing that treatment with ALGRX 3268 demonstrated statistically significantly less pain (p=0.007) compared with the placebo group. ALGRX 3268 was well tolerated and demonstrated no significant safety issues.
"We are very pleased with the data announced today and believe that the results from these two Phase 3 clinical trials demonstrate that ALGRX 3268 could be beneficial to patients by reducing local pain with a much faster onset of action than the drugs that are currently on the market," stated Ronald M. Burch, M.D., Ph.D., chief executive officer of AlgoRx. "The data from these two trials will be included in a new drug application (NDA) for ALGRX 3268, which we expect to file with the FDA during 2006."
"With the positive Phase 3 dataset for ALGRX 3268 across more than 1,000 patients, we are focused on filing our NDA in an effort to achieve product approval in 2007," said John P. McLaughlin, chief executive officer of Corgentech. "We look forward to closing our proposed merger of Corgentech and AlgoRx in mid December. Three positive clinical data announcements have been made since the merger transaction was announced, and each of these affirms the benefits of this merger for our stockholders. We will file an amendment to our S-4 shortly updating it with our most recent financial information and other matters and expect the S-4 to then become effective."
About ALGRX 3268 and the Market Opportunity for a Fast-Acting Local Anesthetic
ALGRX 3268 represents a near-term product opportunity for which an NDA is expected to be filed in 2006. The product is aimed at reducing the pain associated with venipunctures and intravenous line placements. ALGRX 3268 is based on a needleless injection system called Powderject(R), which accelerates lidocaine particles, in powder form, into the epidermis in order to anesthetize nerves. The product, which may be especially useful in pediatric populations and emergency room settings, is easy to use and anesthetizes quickly -- generally in one minute -- offering an important advantage over currently available therapies.
Local anesthetics for venipunctures and intravenous line placements is an underserved market. Currently, in the largest children's hospitals and academic institutions in the United States, approximately 18 million venipunctures and intravenous line placements occur each year. Of these, topical local anesthetics are used in only approximately 2.1 million of these procedures given that the currently marketed products require from 10 to 60 minutes to offer benefit, compared with ALGRX 3268 which anesthetizes nerves within approximately one minute. With its fast onset-of-action, additional opportunities exist for ALGRX 3268 in the adult emergency room setting, hemodialysis and blood donation centers as well as physicians' offices and clinical laboratories.
AlgoRx is a private, emerging pharmaceutical company focused on developing and commercializing a diversified portfolio of pharmaceutical product candidates to address pain, a large and under-served market. AlgoRx's portfolio of pain management drug candidates includes ALGRX 3268, which is in Phase 3 clinical trials, ALGRX 4975, which is in Phase 2 clinical trials, and ALGRX 1207, which is soon to enter the clinic. AlgoRx is based in Secaucus, NJ. For more information on the company and its technologies, please visit www.algorx.com.
Corgentech is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for significant unmet medical needs. Corgentech is based in South San Francisco, CA. For more information on the company and its technologies, please visit www.corgentech.com.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, ALGRX 3268 clinical results forecasts of product development, FDA filings, benefits of the proposed merger, and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether the companies can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Corgentech's Form 10-K/A for the year ended December 31, 2004 and most recently filed Form 10-Q.
NOTE: Corgentech and AlgoRx undertake no obligation and do not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Additional Information and Where to Find It
Corgentech Inc. has filed a registration statement on Form S-4, and Corgentech and AlgoRx Pharmaceuticals, Inc. have filed a related joint proxy statement/prospectus, in connection with the merger transaction involving Corgentech and AlgoRx. Investors and security holders are urged to read the registration statement on Form S-4 and the related joint proxy statement/prospectus because they contain important information about the merger transaction. Investors and security holders may obtain free copies of these documents and other documents filed with the SEC at the SEC's web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by contacting Corgentech Investor Relations at the email address: email@example.com.
Corgentech, AlgoRx and their directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Corgentech and AlgoRx in connection with the merger transaction. Information regarding the special interests of these directors and executive officers in the merger transaction is included in the joint proxy statement/prospectus of AlgoRx and Corgentech described above. Additional information regarding the directors and executive officers of Corgentech is also included in Corgentech's proxy statement for its 2005 Annual Meeting of Stockholders, which was filed with the SEC on April 27, 2005. This document is available free of charge at the SEC's web site at www.sec.gov and from Investor Relations at Corgentech as described above.