Counting my change
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Now your talking...Let the games begin!!
The IBOX looks great!
I totally agree. BIEL is setting themselves up perfectly.Step by step.You have to believe in their products. I cannot find in any store or the internet anything that comes close to BIEL's product line. All I can find is medicated patches and lotions. I can't even find bad reviews of BIELS products anywhere.
it is totally logical Fast Track status is enormous.I suggest you read up more on the FDA fast track designation.
are you a comedian? Genta' fast track is huge!
Spot on CCCP...Genta on fire!!
New Life in Genta!
Genta Poised For A Rebound Year Based On Latest Company Developments
TORONTO, ONTARIO--(Marketwire - April 8, 2010) - TheMarketFinancial.com, the news portal which covers the latest Wall Street developments while delivering financial and investment intelligence to a community of highly informed investors, has issued a special independent research coverage on Genta Incorporated (OTC:GETA).
The latest development for Genta came with their flagship product, Tesetaxel, being granted Fast Track designation by the FDA for advanced gastric cancer, a more profound medical term for stomach cancer. This news comes in light of some very important turn of events for the gastric cancer drug market, as it is projected to double to nearly $1.5 billion in 2018.
According to a recent report published on News-Medical.net, "Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and health care issues, finds that the gastric cancer drug market — driven by the launch of several targeted agents over the next few years — will more than double from approximately $700 million in 2008 to nearly $1.5 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan."
Many investors don't understand the importance of a Fast Track designation, and its purpose in aligning the drug towards commercial success. Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
A drug that receives Fast Track designation is eligible for some or all of the following:
* More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
* More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
* Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
* Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and
* Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
To read the company profile published by TheMarketFinancial, visit this link: http://www.themarketfinancial.com/new-year-new-genta-new-found-glory-otcgeta/2020
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Transdel Pharmaceuticals Closes $1 Million Debt Financing
- Company Provides Update on Recent Accomplishments -
prnewswire
Press Release Source: Transdel Pharmaceuticals, Inc. On Thursday April 8, 2010, 7:58 am
LA JOLLA, Calif., April 8 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board:TDLP.ob - News), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced that it has completed a private debt financing of $1 million.
The Company issued a senior convertible promissory note with an annual interest rate of 7.5 percent to an existing shareholder. The note has a two-year term. The Company has a right to prepay the note at any time upon providing written notice to the holder. At any time prior to the Company's repayment of the note, the holder may convert all or any part of the outstanding principal and accrued interest on the note into shares of the Company's common stock at a conversion rate of $1.00 per share.
"We are pleased by the continued support from our shareholders. This financing provides us with additional resources to continue planning the second Phase 3 clinical study for our lead topical pain drug, Ketotransdel® as well as continue our ongoing partner discussions for Ketotransdel® with U.S. and foreign based companies," said John Lomoro, Acting Chief Executive Officer and Chief Financial Officer. "During 2010, we plan to raise additional funding through either partnership arrangements or further equity or debt financings to complete the Phase 3 clinical program for Ketotransdel®."
Separately, Transdel highlighted its accomplishments during 2009, underscored by the completion of the first Phase 3 clinical study for Ketotransdel®. Significant achievements that occurred recently or during 2009 include:
Ketotransdel®
* In October 2009, the Company announced top-line results from the Phase 3 clinical study of Ketotransdel®, a topical cream based non-steroidal anti-inflammatory drug for acute pain. The 364 patient study demonstrated statistical significance in its primary endpoint in the per protocol analysis and was favorable for Ketotransdel® in the Intent-To Treat (ITT) Analysis. Ketotransdel® also demonstrated an excellent safety and tolerability profile.
* In January 2010, the Company reported the results of its further in-depth analyses of the ITT data from the Ketotransdel® Phase 3 study. For the modified ITT analysis, the Company identified 35 patients who did not meet study entry criteria at the time of randomization. Excluding the data from these patients who should not have been randomized into the study based on information that was not known at the time of enrollment, the study demonstrated statistical significance (p<0.038) on the primary efficacy endpoint. This analysis was confirmed by a third-party statistical expert.
Anti-Cellulite Cosmeceutical Product
* In June 2009, the Company announced that it had entered into a licensing agreement providing JH Direct, LLC with the exclusive worldwide rights to the Company's anti-cellulite cosmeceutical product which utilizes the Transdel™ patented transdermal delivery system technology. The Company anticipates that JH Direct will launch the anti-cellulite product through a direct response television campaign during the second half of 2010.
Management
* The Company added two experienced pharmaceutical executives to the management team with the appointment of Joachim P.H. Schupp, M.D. as Chief Medical Officer and Terry Nida as Chief Business Officer. In addition, John Lomoro, the Company's Chief Financial Officer, is serving as Acting Chief Executive Officer as the Board of Directors undertakes a search for a permanent Chief Executive Officer. This expanded management team more fully positions the Company as it focuses on commercial opportunities for its proprietary product candidates and novel Transdel™ drug delivery system.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTC Bulletin Board:TDLP.ob - News) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel™ cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead pain product, has completed a Phase 3 clinical trial and utilizes the Transdel™ technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel™ platform technology to expand and create a portfolio of topical products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. For more information, please visit http://www.transdelpharma.com.
Safe Harbor Statement
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the Company's interpretation of the results of its Phase 3 clinical trial for Ketotransdel®; the Company's ability to obtain regulatory approval to market Ketotransdel; and the Company's ability to complete additional development activities for products utilizing its proprietary transdermal delivery platform. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the outcome of the final analyses of the data from the Phase 3 clinical trial may vary from the Company's initial conclusions; the FDA may not agree with the Company's interpretation of such results or may challenge the adequacy of the Company's clinical trial design or the execution of the clinical trial; the FDA may continue to require the Company to complete additional clinical trials for Ketotransdel® before the Company can submit a 505(b)(2) NDA application; the results of any future clinical trials may not be favorable and the Company may never receive regulatory approval for Ketotransdel®; and the Company's current need to raise additional funding to complete its product development plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Labopharm completes licensing and distribution agreement with Nippon Shinyaku for once-daily tramadol in Japan
prnewswire
Press Release Source: Labopharm Inc. On Thursday April 8, 2010, 7:00 am
LAVAL, QC, April 8 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced its wholly owned subsidiary, Labopharm Europe Limited, has completed a licensing and distribution agreement for once-daily tramadol with Nippon Shinyaku Co., Ltd. of Japan.
Labopharm will receive an up-front payment upon signature of the agreement and is eligible to receive additional payments related to the achievement of certain regulatory and commercialization milestones.
Under the terms of the agreement, Nippon Shinyaku has the exclusive right to market and sell Labopharm's once-daily tramadol product in Japan. Labopharm will supply Nippon Shinyaku with unpackaged tablets and will receive a fixed transfer price, as well as a royalty on net sales of the product. Regulatory approval in Japan may require additional clinical trials and Nippon Shinyaku will assume all costs related to the clinical and regulatory approval process.
About Nippon Shinyaku Co., Ltd.
Nippon Shinyaku aims to be trusted and respected by the society as an indispensable entity with significance of existence in the healthcare industry. Based on the management philosophy of "Contribution to the human health and the comfortable life" and the mission to continuously create high quality and unique pharmaceuticals which can be good news for patients, Nippon Shinyaku aims to meet the needs of medical practice promptly and adequately. Founded in 1919 and headquartered in Kyoto, Nippon Shinyaku Co., Ltd. has more than 1,750 employees and had sales of 63.1 billion yen (approximately US$701 million) in 2008. Nippon Shinyaku is a publicly traded company listed on both the Tokyo and Osaka Stock Exchanges. For more information, please visit http://www.nippon-shinyaku.co.jp/english/.
About Labopharm Inc.
Headquartered in Laval, Canada with US offices in Princeton, New Jersey, Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is now available in 19 countries around the world, including the U.S., Canada, major European markets and Australia. Its second product, OLEPTRO(TM), a novel formulation of trazodone for the treatment of major depressive disorder in adults, has received regulatory approval in the U.S. and is under regulatory review in Canada. Labopharm has initiated the European regulatory approval process for its third product, a twice-daily formulation of tramadol-acetaminophen. The Company also has a pipeline of follow-on products in both pre-clinical and clinical development.
This press release contains forward-looking statements, including, statements concerning the market opportunity for once-daily tramadol in Japan, statements concerning potential payments related to the commercialization of once-daily tramadol in Japan and statements concerning the Company's portfolio of products, which reflects the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Except as required by law, the Company undertakes no obligation and does not intend to update these forward-looking statements.
DDSS News - Labopharm completes licensing and distribution agreement with Nippon Shinyaku for once-daily tramadol in Japan
prnewswire
Press Release Source: Labopharm Inc. On Thursday April 8, 2010, 7:00 am
LAVAL, QC, April 8 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced its wholly owned subsidiary, Labopharm Europe Limited, has completed a licensing and distribution agreement for once-daily tramadol with Nippon Shinyaku Co., Ltd. of Japan.
Labopharm will receive an up-front payment upon signature of the agreement and is eligible to receive additional payments related to the achievement of certain regulatory and commercialization milestones.
Under the terms of the agreement, Nippon Shinyaku has the exclusive right to market and sell Labopharm's once-daily tramadol product in Japan. Labopharm will supply Nippon Shinyaku with unpackaged tablets and will receive a fixed transfer price, as well as a royalty on net sales of the product. Regulatory approval in Japan may require additional clinical trials and Nippon Shinyaku will assume all costs related to the clinical and regulatory approval process.
About Nippon Shinyaku Co., Ltd.
Nippon Shinyaku aims to be trusted and respected by the society as an indispensable entity with significance of existence in the healthcare industry. Based on the management philosophy of "Contribution to the human health and the comfortable life" and the mission to continuously create high quality and unique pharmaceuticals which can be good news for patients, Nippon Shinyaku aims to meet the needs of medical practice promptly and adequately. Founded in 1919 and headquartered in Kyoto, Nippon Shinyaku Co., Ltd. has more than 1,750 employees and had sales of 63.1 billion yen (approximately US$701 million) in 2008. Nippon Shinyaku is a publicly traded company listed on both the Tokyo and Osaka Stock Exchanges. For more information, please visit http://www.nippon-shinyaku.co.jp/english/.
About Labopharm Inc.
Headquartered in Laval, Canada with US offices in Princeton, New Jersey, Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is now available in 19 countries around the world, including the U.S., Canada, major European markets and Australia. Its second product, OLEPTRO(TM), a novel formulation of trazodone for the treatment of major depressive disorder in adults, has received regulatory approval in the U.S. and is under regulatory review in Canada. Labopharm has initiated the European regulatory approval process for its third product, a twice-daily formulation of tramadol-acetaminophen. The Company also has a pipeline of follow-on products in both pre-clinical and clinical development.
This press release contains forward-looking statements, including, statements concerning the market opportunity for once-daily tramadol in Japan, statements concerning potential payments related to the commercialization of once-daily tramadol in Japan and statements concerning the Company's portfolio of products, which reflects the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Except as required by law, the Company undertakes no obligation and does not intend to update these forward-looking statements.
Genta's Tesetaxel Granted Fast Track Designation by FDA for Advanced Gastric Cancer
Last update: 4/6/2010 8:05:02 AM
BERKELEY HEIGHTS, N.J., Apr 06, 2010 (BUSINESS WIRE) -- Genta Incorporated (OTCBB: GETA.OB) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for "Fast Track" designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.
Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The designation typically enables a Company to submit a New Drug Application (NDA) on a "rolling" basis with ongoing FDA review during the submission process. NDAs with Fast Track designation are also usually granted priority review by FDA at the time of submission.
Based on promising results in a Phase 2a trial, Genta is conducting a confirmatory Phase 2b trial of tesetaxel as 2nd-line treatment in patients with advanced gastric cancer who have failed a single 1st-line regimen. As defined, the 1st-line regimen must comprise a platinum-containing compound (cisplatin, carboplatin, or oxaliplatin) and a fluoropyrimidine (5-fluorouracil, capecitabine, or S-1). The Fast Track designation targets
the patient population that is enrolling in the Phase 2b trial.
Genta has formulated a trial design and clinical protocol for a randomized, double-blind, placebo-controlled Phase 3 trial of tesetaxel in this patient population. In developing the trial, the Company completed a dose-ranging and pharmacokinetic study of tesetaxel plus capecitabine (Xeloda(R); Hoffmann LaRoche, Inc.). Results from that study showed that full doses of each of these orally administered drugs could be administered together without causing overlapping side-effects.
Genta plans to submit its proposed Phase 3 trial to FDA in the 2nd-quarter in order to secure a Special Protocol Assessment (SPA). The Company looks forward to meeting with the FDA to discuss the trial design.
About Tesetaxel
Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine. However, these agents are associated with serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
Tesetaxel is a novel taxane that is administered by mouth as a capsule. The drug was developed with a goal of maintaining the high antitumor activity while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is combined with other anticancer drugs (such as "all oral" chemotherapy programs). Tesetaxel has demonstrated high activity against cell lines that are resistant to paclitaxel and docetaxel.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with conventional taxanes. Moreover, unlike other oral taxanes that have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity.
Tesetaxel in Advanced Gastric Cancer
In the completed Phase 2a study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m(2) once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or capecitabine. All but 2 of these patients had also received a third chemotherapy drug along with this regimen. Final intent-to-treat analysis, including all patients enrolled in the study, showed that 5 patients achieved a partial response, 2 patients achieved a partial response unconfirmed by CT scan, and 14 patients achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense(R) is being developed as an agent that may enhance the effectiveness of anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from the recently completed randomized Phase 3 study of Genasense(R) in patients with advanced melanoma (the AGENDA trial). The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta has initiated a broad clinical program to evaluate the safety and efficacy of tesetaxel in patients with solid tumors. In the U.S., Genta is exclusively marketing Ganite(R) (gallium nitrate injection), which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite(R) that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: .
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words "potentially", "anticipate", "could", "calls for", and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
-- the Company's ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
-- the safety and efficacy of the Company's products or product candidates;
-- the commencement and completion of any clinical trials;
-- the Company's assessment of its clinical trials;
-- the Company's ability to develop, manufacture, license, or sell its products or product candidates;
-- the Company's ability to enter into and successfully execute any license and collaborative agreements;
-- the adequacy of the Company's capital resources and cash flow projections, or the Company's ability to obtain sufficient financing to maintain the Company's planned operations;
-- the adequacy of the Company's patents and proprietary rights;
-- the impact of litigation that has been brought against the Company; and
-- the other risks described under Certain Risks and Uncertainties Related to the Company's Business, as contained in the Company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2009 and its most recent quarterly report on Form 10-Q.
SOURCE: Genta Incorporated
Genta Investor Relations 908-286-3980 info@genta.com
Copyright Business Wire 2010
Terms & Conditions. Powered and implemented by Interactive Data Managed Solutions.
News provided by Dow Jones NewswiresSM, PR News Wire™ and Business Wire™. Dow Jones Newswires is a service mark of Dow Jones & Company. PR News Wire is a Trademark of PR Newswire Association, Inc. Business Wire is a registered trademark and service mark of Business Wire.
Ameritrade is not responsible for the quality and suitability of third party financial or investment information or services. Please consult other sources of information and consider your individual financial position and goals before making an investment decision. Ameritrade, Division of Ameritrade, Inc., member NASD/SIPC. Ameritrade and Ameritrade logos are trademarks or registered trademarks of Ameritrade IP Company, Inc. 2002 Ameritrade IP Company, Inc. All rights reserved. Used with permission.
Genta's Tesetaxel Granted Fast Track Designation by FDA for Advanced Gastric Cancer
Last update: 4/6/2010 8:05:02 AM
BERKELEY HEIGHTS, N.J., Apr 06, 2010 (BUSINESS WIRE) -- Genta Incorporated (OTCBB: GETA.OB) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for "Fast Track" designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.
Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The designation typically enables a Company to submit a New Drug Application (NDA) on a "rolling" basis with ongoing FDA review during the submission process. NDAs with Fast Track designation are also usually granted priority review by FDA at the time of submission.
Based on promising results in a Phase 2a trial, Genta is conducting a confirmatory Phase 2b trial of tesetaxel as 2nd-line treatment in patients with advanced gastric cancer who have failed a single 1st-line regimen. As defined, the 1st-line regimen must comprise a platinum-containing compound (cisplatin, carboplatin, or oxaliplatin) and a fluoropyrimidine (5-fluorouracil, capecitabine, or S-1). The Fast Track designation targets
the patient population that is enrolling in the Phase 2b trial.
Genta has formulated a trial design and clinical protocol for a randomized, double-blind, placebo-controlled Phase 3 trial of tesetaxel in this patient population. In developing the trial, the Company completed a dose-ranging and pharmacokinetic study of tesetaxel plus capecitabine (Xeloda(R); Hoffmann LaRoche, Inc.). Results from that study showed that full doses of each of these orally administered drugs could be administered together without causing overlapping side-effects.
Genta plans to submit its proposed Phase 3 trial to FDA in the 2nd-quarter in order to secure a Special Protocol Assessment (SPA). The Company looks forward to meeting with the FDA to discuss the trial design.
About Tesetaxel
Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine. However, these agents are associated with serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
Tesetaxel is a novel taxane that is administered by mouth as a capsule. The drug was developed with a goal of maintaining the high antitumor activity while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is combined with other anticancer drugs (such as "all oral" chemotherapy programs). Tesetaxel has demonstrated high activity against cell lines that are resistant to paclitaxel and docetaxel.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with conventional taxanes. Moreover, unlike other oral taxanes that have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity.
Tesetaxel in Advanced Gastric Cancer
In the completed Phase 2a study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m(2) once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or capecitabine. All but 2 of these patients had also received a third chemotherapy drug along with this regimen. Final intent-to-treat analysis, including all patients enrolled in the study, showed that 5 patients achieved a partial response, 2 patients achieved a partial response unconfirmed by CT scan, and 14 patients achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense(R) is being developed as an agent that may enhance the effectiveness of anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from the recently completed randomized Phase 3 study of Genasense(R) in patients with advanced melanoma (the AGENDA trial). The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta has initiated a broad clinical program to evaluate the safety and efficacy of tesetaxel in patients with solid tumors. In the U.S., Genta is exclusively marketing Ganite(R) (gallium nitrate injection), which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite(R) that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: .
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words "potentially", "anticipate", "could", "calls for", and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
-- the Company's ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
-- the safety and efficacy of the Company's products or product candidates;
-- the commencement and completion of any clinical trials;
-- the Company's assessment of its clinical trials;
-- the Company's ability to develop, manufacture, license, or sell its products or product candidates;
-- the Company's ability to enter into and successfully execute any license and collaborative agreements;
-- the adequacy of the Company's capital resources and cash flow projections, or the Company's ability to obtain sufficient financing to maintain the Company's planned operations;
-- the adequacy of the Company's patents and proprietary rights;
-- the impact of litigation that has been brought against the Company; and
-- the other risks described under Certain Risks and Uncertainties Related to the Company's Business, as contained in the Company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2009 and its most recent quarterly report on Form 10-Q.
SOURCE: Genta Incorporated
Genta Investor Relations 908-286-3980 info@genta.com
Copyright Business Wire 2010
Terms & Conditions. Powered and implemented by Interactive Data Managed Solutions.
News provided by Dow Jones NewswiresSM, PR News Wire™ and Business Wire™. Dow Jones Newswires is a service mark of Dow Jones & Company. PR News Wire is a Trademark of PR Newswire Association, Inc. Business Wire is a registered trademark and service mark of Business Wire.
Ameritrade is not responsible for the quality and suitability of third party financial or investment information or services. Please consult other sources of information and consider your individual financial position and goals before making an investment decision. Ameritrade, Division of Ameritrade, Inc., member NASD/SIPC. Ameritrade and Ameritrade logos are trademarks or registered trademarks of Ameritrade IP Company, Inc. 2002 Ameritrade IP Company, Inc. All rights reserved. Used with permission.
More to come. This stock is flying under radar!! I have tried the product and it is amazing...nothing like it.
Spectrum Pharmaceuticals Announces Fourth Quarter and Fiscal Year 2009 Corporate Update
* Form 10-K For Fiscal Year Ended December 31, 2009 Submitted to the SEC on April 2, 2010
* FY09 Revenues Approximately $38.0M
* ZEVALIN® FY09 and Q4 Revenues Approximately $15.7M and $5.1M, respectively
* Strong Cash Position With Approximately $125M In Cash and Investments as of December 31, 2009
* Major Development Programs on Track
* Delay In Filing of Form 10-K Related To Accounting Restatement To Reclassify Common Stock Warrants From Equity To Liability
o $19.8M Income In FY09 and $6.6M Common Stock Warrant Liability At December 31, 2009, Result From Accounting Entries, With No Cash Impact
o No Impact On Financial Statement Amounts Previously Reported For Assets, Revenues, Operating Costs And Expenses, Or Net Cash Flows
o No Effect On Performance Of Core Business Operations
businesswire
Press Release Source: Spectrum Pharmaceuticals, Inc. On Monday April 5, 2010, 6:00 am EDT
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI - News), a commercial-stage biotechnology company with a primary focus in oncology, today reported financial results for the fourth quarter and fiscal year ended December 31, 2009.
Company Operations and Performance
“The year 2009 was filled with notable accomplishments for Spectrum that have laid the groundwork for continued and significant growth in 2010 and beyond,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “The stabilization of the ZEVALIN® brand in 2009 and the signing of two partnerships for the Asian territories for apaziquone (EOquin®) provided us with the resources to acquire Belinostat, a novel HDAC inhibitor in pivotal trials for peripheral T-Cell lymphoma (PTCL). As of today, we have two FDA-approved and marketed anti-cancer drugs ZEVALIN and FUSILEV, that in 2009 generated approximately $28.2M in product revenue. In addition, we have two novel anti-cancer drugs in late stage pivotal trials being conducted under a Special Protocol Assessment (SPA) from the FDA. These are Belinostat for PTCL and apaziquone for bladder cancer. In 2009 we completed enrollment of over 1,600 patients in clinical trials with apaziquone. We currently expect to file the New Drug Applications for Belinostat and apaziquone in 2011 and 2012, respectively. We have been successful in growing Spectrum through strict fiscal discipline, portfolio management, and an opportunistic approach to drug acquisitions.”
Fourth Quarter Results1 Ended December 31, 2009
Consolidated revenue of $8.6 million was comprised of product sales of $5.2 million – $5.1 million from ZEVALIN, an increase of 8.5% over third quarter 2009, and $0.1 million from FUSILEV – $1.5 million attributable to the milestone payment upon full enrollment of the apaziquone Phase 3 trials, and $1.9 million attributable to the amortization of the Allergan licensing fee. This compares to $8.0 million in revenue in the same period in 2008. The Company recorded a net profit of $10.2 million, or $0.21 (basic earnings) and $0.20 (diluted earnings) per share, compared to a net loss of $8.9 million, or ($0.28) basic and diluted loss per share, in the fourth quarter of 2008, after reporting $19.8 million of income resulting from the reclassification of common stock warrants from equity to liability. Total research and development expenses were $3.5 million, as compared to $7.6 million in the same period of 2008, a $4.1 million, or 54% decrease, mainly due to sharing by our partner, Allergan, Inc., of apaziquone-related development costs, and a reduction in development costs related to other pipeline products. Selling, general and administrative expenses were $11.1 million compared to the $6.2 million in the same period in 2008. The $4.9 million increase was attributable to the direct cost of commercialization activities related to ZEVALIN and FUSILEV and related payroll costs.
Fiscal Year End Results1 Ended December 31, 2009
Consolidated revenue of $38.0 million was comprised of product sales of $28.2 million – of which $15.7 million derived from ZEVALIN and $12.5 million from FUSILEV – $1.5 million attributable to the milestone payment upon full enrollment of the apaziquone Phase 3 trials, and $8.3 million attributable to the amortization of the Allergan licensing fee. This consolidated revenue compares to $28.7 million for the same period in 2008, which was comprised of approximately $7.7 million and $0.3 million derived from FUSILEV and ZEVALIN sales. After the recording of $8.1 million income resulting from the reclassification of common stock warrant from equity to liability, the Company recorded a net loss of $19.0 million, or ($0.48) basic and diluted loss per share, compared to a net loss of $14.2 million, or ($0.45) basic and diluted loss per share, in the same period of 2008. Research and development expenses were $21.1 million, as compared to $26.7 million in the same period of 2008, a $5.6 million, or 21% decrease, mainly due to sharing by our partner, Allergan Inc., of apaziquone-related development costs, and a reduction in development costs related to other pipeline products. Selling, general and administrative expenses were $33.6 million, compared to the $15.2 million in the same period in 2008, attributable to the direct cost of commercialization activities related to ZEVALIN and FUSILEV and related payroll costs.
Net cash used in operations in the fiscal year ended December 31, 2009 was $17.6 million compared to approximately $8.0 million during 2008, stated after revenues of approximately $20.7 million from the sale of interests in certain non-core assets. The 2009 operating cash outflows are reflective of higher selling, general, and administrative expenses due, in a large part, to the marketing efforts associated with ZEVALIN, substantially mitigated by revenues from ZEVALIN and FUSILEV and the participation by Allergan Inc. in apaziquone-related development expenses.
As of December 31, 2009, the Company had cash and total investments of approximately $125 million, compared to approximately $78 million as of December 31, 2008. Currently there are approximately 49 million shares of common stock outstanding.
Restatement of Financial Statements
As more fully described in the Company’s Annual Report on Form 10K for the fiscal year ended December 31, 2009, the common stock warrants issued in connection with registered common stock offerings during 2005 and 2009, were previously classified as equity. In connection with the audit for the fiscal year 2009, the Company, in consultation with its independent registered public accounting firm, Ernst & Young LLP, reassessed the “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock”, a highly complex area of accounting under US Generally Accepted Accounting Principles. In view of an interpretation that these common stock warrants could, under highly remote theoretical circumstances require net-cash-settlement, the Company’s audit committee determined that recordation of common stock warrants as liabilities was required under US GAAP. Accordingly, the Company made accounting adjustments restating previously issued consolidated financial statements, including the quarterly condensed consolidated financial statements for the periods ended March 31, 2008 through September 30, 2009.
“The restatement does not have any impact on the financial statement amounts previously reported for the Company’s cash balances, assets, revenues, operating costs and expenses, or reported net cash flows for any of the restated years, or any quarterly period in those years,” said Shyam Kumaria, Vice President of Finance.
In our Form 10-K for the fiscal year ended December 31, 2009, we have reflected the necessary adjustments to previously filed financial statements. We have not amended such previously filed Annual Reports on Form 10-K for the fiscal years ended December 31, 2005, 2006, 2007 and 2008, or the Quarterly Reports on Form 10-Q for the periods ended September 30, 2005 through September 30, 2009, which previously issued statements should thus no longer be relied upon. For further information regarding the restatement, please read our Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
Upcoming Company Milestones
ZEVALIN
* Continue to grow the ZEVALIN brand, currently approved for:
o Treatment of patients with previously untreated follicular non-Hodgkin’s lymphoma, who achieve a partial or complete response to first-line chemotherapy; and
o Treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.
* Pursue removal of the bioscan requirement prior to ZEVALIN administration;
* Pursue consistent reimbursement for ZEVALIN in the community setting.
FUSILEV
* Submit requested FUSILEV data in colorectal cancer to the FDA in the second half of 2010.
Belinostat
* Peripheral T-Cell Lymphoma
o File NDA in 2011, with a potential approval in late 2011 or early 2012.
* Carcinoma of Unknown Primary
o Target complete enrollment by year-end in the ongoing Phase 2 trial that is being conducted and 100% funded by TopoTarget.
* Other tumor types
o Explore additional trials in additional indications.
Apaziquone (EOquin)
* Phase 3 data expected in first quarter 2012; and
* Initiate a multiple-instillation trial in non-muscle invasive bladder cancer by year-end 2010.
Conference Call
Tuesday, April 6, 2010 @ 11:30a.m. Eastern/8:30a.m. Pacific
Domestic: 877-837-3910 passcode 57165403
International: 973-796-5077 passcode 57165403
Webcast and replays: www.sppirx.com
Audio replays will be available through April 17, 2010.
Domestic: (800) 642-1687, passcode 57165403
International: (706) 645-9291, passcode 57165403
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) is indicated for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.
ZEVALIN is a CD20-directed radiotherapeutic antibody administered as part of the ZEVALIN therapeutic regimen. The ZEVALIN therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Full prescribing information can be found at www.ZEVALIN.com.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in 50-mg vials of freeze-dried powder. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation containing only the pharmacologically active isomer of leucovorin.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to building an efficient in-house clinical research organization with regulatory and data management capabilities, the Company has established a commercial infrastructure for its drug portfolio. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs in late stage development, apaziquone and belinostat, along with a diverse pipeline. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to the restatement of our consolidated financial statements, our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, continued and significant growth in 2010 and beyond, that we expect to file the New Drug Applications for Belinostat and Apaziquone as early as 2011 and 2012, respectively, the safety and efficacy of ZEVALIN and FUSILEV, continue to grow the ZEVALIN brand, pursue removal of the bioscan requirement prior to ZEVALIN administration, pursue consistent reimbursement for ZEVALIN in the community setting, submit requested FUSILEV data in colorectal cancer to the FDA by the end of the third quarter 2010; in ongoing belinostat PTCL pivotal trial; file an NDA in 2011, with a potential approval in late 2011 or early 2012, target complete enrollment for Belinostat by year-end in the ongoing Phase 2 CUP trial, explore additional trials in additional indications for Belinostat, that Apaziquone Phase 3 data is expected in first quarter 2012; initiate a multiple-instillation trial in non-muscle invasive bladder cancer by year-end 2010 for Apaziquone and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum, EOquin® is a registered trademark of Allergan Inc., TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
1 All numbers are approximates
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
(In thousands, except share and per share data)
Summary Condensed Consolidated Statement of Operations
Quarter Ended December 31,
(Unaudited)
Year Ended December 31,
Restated Restated
2009 2008 2009 2008
Total revenues $ 8,620 $ 8,049 $ 38,025 $ 28,725
Operating expenses:
Cost of product sales (excludes amortization of purchased intangibles shown below) 2,446 1,193 8,148 1,193
Selling, general and administrative 11,069 6,209 33,607 15,156
Research and development 3,525 7,594 21,058 26,683
Amortization of purchased intangibles 870 158 3,720 158
Acquired in-process research and development - 4,700 - 4,700
Total operating expenses
17,910 19,854 66,533 47,890
Loss from operations (9,290 ) (11,805 ) (28,508 ) (19,165 )
Change in fair value of common stock warrant liability 19,834 (210 ) 8,075 1,271
Other income, net 61 609 662 1,165
Pre-tax net income (loss) 10,605 (11,406 ) (19,771 ) (16,729 )
Income tax expense (421 ) (5 ) (421 ) (5 )
Net loss of attributable to non-controlling interest - 2,538 1,146 2,538
Net income (loss) - attributable to Spectrum Pharmaceuticals, Inc. stockholders $ 10,184 $ (8,873 ) $ (19,046 ) $ (14,196 )
Net loss per share - attributable to Spectrum Pharmaceuticals, Inc. stockholders
Basic $ 0.21 $ (0.28 ) $ (0.48 ) $ (0.45 )
Diluted $ 0.20 $ (0.28 ) $ (0.48 ) $ (0.45 )
Basic weighted average common shares outstanding 48,425,486 31,928,778 39,273,905 31,551,152
Diluted weighted average common shares outstanding 49,704,126 31,928,778 39,273,905 31,551,152
Summary Condensed Consolidated Balance Sheets
December 31,
2009 2008
Restated
ASSETS
Current Assets:
Cash, cash equivalents and marketable securities $ 113,341 $ 75,938
Accounts receivable, net 8,658 9,776
Inventories 3,230 1,841
Prepaid expenses and other current assets 1,028 693
Total Current Assets 126,257 88,248
Bank certificates of deposit & treasuries 11,438 2,148
Property and equipment, net 1,928 1,782
Zevalin related intangible assets, net 33,325 37,042
Other assets 185 289
Total assets $ 173,133 $ 129,509
LIABILITIES AND EQUITY
Total current liabilities (excluding common stock warrant liability) $ 32,864 $ 32,806
Common stock warrant liability 6,635 765
Total current liabilities 39,499 33,571
Total noncurrent liabilities and deferred revenues 25,310 42,822
Total liabilities 64,809 76,393
Total equity (including non-controlling interest) 108,324 53,116
Total liabilities and equity $ 173,133 $ 129,509
Contact:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
Four Best Values in Biotech
Morgan Joseph likes Amgen, Spectrum Pharma, Isis and Genzyme.
Morgan Joseph
STOCK SELECTION WILL BE the key to outperformance, in our opinion, because the valuation of the biotechnology sector, across the board, is currently neither compelling nor expensive. We favor stocks with cheaper valuations and strong pipelines. Among our Buy-rated stocks, we think the best four stocks to buy now are Amgen (ticker: AMGN), Spectrum Pharmaceuticals (SPPI), Isis Pharmaceuticals (ISIS) and Genzyme (GENZ).
We are adding Genzyme to our trading list, while Amgen, Isis and Spectrum remain on the list.
Neoprobe to Present at Future Leaders in Biotech Conference
businesswire
Press Release Source: Neoprobe Corporation On Thursday April 1, 2010, 1:09 pm
DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that its President and CEO, David Bupp, will present at the upcoming Future Leaders in the Biotech Industry conference on April 8, 2010, at 4:30 p.m. The conference is being held at the Millennium Broadway Hotel in New York City.
Hosted by BioCentury and Thomson Reuters, Future Leaders in the Biotech Industry showcases companies best positioned to provide market leadership in the biotech industry. Mr. Bupp will provide a corporate overview, including an update and discussion of the clinical and regulatory status of Neoprobe’s two drug development products, Lymphoseek® and RIGScan™ CR.
A live audio webcast of this presentation and copy of the presentation slides will be available at:
http://www.corporateir.net/ireye/confLobby.zhtml?ticker=NEOP&item_id=2957639
A replay of the presentation will also be available at the same site following the live webcast.
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Contact:
Neoprobe Corporation
Brent Larson, 614-822-2330
Vice President / CFO
or
The Shoreham Group
Tim Ryan, 212-242-7777
Neoprobe to Present at Future Leaders in Biotech Conference
businesswire
Press Release Source: Neoprobe Corporation On Thursday April 1, 2010, 1:09 pm
DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that its President and CEO, David Bupp, will present at the upcoming Future Leaders in the Biotech Industry conference on April 8, 2010, at 4:30 p.m. The conference is being held at the Millennium Broadway Hotel in New York City.
Hosted by BioCentury and Thomson Reuters, Future Leaders in the Biotech Industry showcases companies best positioned to provide market leadership in the biotech industry. Mr. Bupp will provide a corporate overview, including an update and discussion of the clinical and regulatory status of Neoprobe’s two drug development products, Lymphoseek® and RIGScan™ CR.
A live audio webcast of this presentation and copy of the presentation slides will be available at:
http://www.corporateir.net/ireye/confLobby.zhtml?ticker=NEOP&item_id=2957639
A replay of the presentation will also be available at the same site following the live webcast.
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Contact:
Neoprobe Corporation
Brent Larson, 614-822-2330
Vice President / CFO
or
The Shoreham Group
Tim Ryan, 212-242-7777
Neoprobe to Present at Future Leaders in Biotech Conference
businesswire
Press Release Source: Neoprobe Corporation On Thursday April 1, 2010, 1:09 pm
DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that its President and CEO, David Bupp, will present at the upcoming Future Leaders in the Biotech Industry conference on April 8, 2010, at 4:30 p.m. The conference is being held at the Millennium Broadway Hotel in New York City.
Hosted by BioCentury and Thomson Reuters, Future Leaders in the Biotech Industry showcases companies best positioned to provide market leadership in the biotech industry. Mr. Bupp will provide a corporate overview, including an update and discussion of the clinical and regulatory status of Neoprobe’s two drug development products, Lymphoseek® and RIGScan™ CR.
A live audio webcast of this presentation and copy of the presentation slides will be available at:
http://www.corporateir.net/ireye/confLobby.zhtml?ticker=NEOP&item_id=2957639
A replay of the presentation will also be available at the same site following the live webcast.
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Contact:
Neoprobe Corporation
Brent Larson, 614-822-2330
Vice President / CFO
or
The Shoreham Group
Tim Ryan, 212-242-7777
BIEL up 20% on strong news!
BioElectronics Becomes Fully Reporting - Completes 2009 Audit, Files Form 10K with Securities and Exchange Commission
businesswire
Press Release Source: BioElectronics Corp. On Thursday April 1, 2010, 8:00 am EDT
FREDERICK, Md.--(BUSINESS WIRE)--BioElectronics Corp. (PINKSHEETS: BIEL - News), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced the completion of its full year audit and the filing of Form 10K with the Securities and Exchange Commission. BioElectronics is now a fully reporting company.
“We have now completed our audits through full year 2009. The process of providing full transparency is very important to us and we expect to remain fully compliant and reporting moving forward,” commented Andrew Whelan, CEO of BioElectronics Corp. “The recent developments at the Company are very exciting as our international distribution continues to grow and as we continue to work through the clearance process with the U.S. FDA. We are especially excited about the strength of our balance sheet, which shows strong financial ratios and a significant level of debt repayment throughout 2009. We believe BioElectronics is now very well positioned to move into the revenue growth phase we envision for the rest of this year and into next.”
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch® Therapy, RecoveryRx(TM) Devices, HealFast(TM) Therapy (www.healfasttherapy.com) and the Allay(TM) family of inexpensive, disposable drug-free anti-inflammatory devices. For more information please see http://www.BioElectronicsCorp.com.
Contact:
BioElectronics Corp.
Joe Noel, 925-922-2560
BIEL 10k looks great.Also, current on Pinks. Everything coming together!
Nature's Peak Announces It Will Attend the 2010 Kehe Holiday Show -- 'Your Path to Market During the Holidays' on June 13 - 15
Nature's Peak will attend the 2010 Kehe Holiday Show with its Master Broker through Kehe's Tree of Life subsidiary
prnewswire
Press Release Source: Everock/Nature's Peak On Wednesday March 31, 2010, 8:00 am
SANTA CRUZ, Calif., March 31 /PRNewswire-FirstCall/ -- Nature's Peak / Everock, Inc. (Pink Sheets:EVRN.pk - News) announced today that together with its Master Broker, Source One Sales and Marketing, it will attend the 2010 Kehe Holiday Show, June 13 – 15th at the McCormick Place Lakeside Center in Chicago Illinois.
Paul Wilkinson, CEO of Nature's Peak / Everock, said, "We are very pleased to have this opportunity to be at the show and to share a booth with Source One, our Master Broker and through Kehe's Tree of Life subsidiary."
Tree of Life is now part of Kehe Distributors. The company now provides Natural & Organic, Specialty & Gourmet, and International & Multicultural products to more than 33,000 natural food stores, grocery stores, and other specialty product retailers throughout North America.
"The 2010 Kehe Holiday Show provides us with an excellent opportunity to showcase our VeggieDips and VeggieSpreads at one of the largest and well attended shows in the industry. In attendance will be hundreds of Kehe and Tree of Life retailers from across the country ready to book our products during what will be the most anticipated and attended show of the year!"
Wilkinson continued, "The Kehe Holiday Show is known for exciting new items, hot holiday-season promotions, and a chance to sell on the show floor."
"We will offer seasonal promotions and items that provide consumer value and the retailer with more value options within the specialty and natural products world. In addition, we will be providing red-hot holiday promotions and compelling 'show floor only deals,'" said Wilkinson.
About Everock / Nature's Peak:
Nature's Peak produces a line of all-natural gourmet vegetable dips and sandwich spreads marketed under the Nature's Peak brand.
Both VeggieDip and VeggieSpread are 100% all-natural, vegetarian, Kosher and gluten-free, and contain no preservatives, artificial ingredients, trans-fats, or sugars. There are six flavors in each product line, including novel delicious flavor combinations.
Nature's Peak products are marketed through its Master Broker to natural food stores, specialty groceries as well as regional and national grocery chains. Our products will also be available to restaurants, delis and other food service providers across America.
Visit our website at www.NaturesPeak.com to learn more about our products and to discover new and delicious recipe ideas.
Forward Looking Statements:
This press release contains certain "forward-looking" statements, as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. Statements, which are not historical facts, are forward-looking statements. The Company, through its management, makes forward-looking public statements concerning its expected future operations, performance and other developments. Such forward-looking statements are necessarily estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statements. These statements are identified as any statement that does not relate strictly to historical or current facts. They use words such as "anticipates," "intends," "plans," "expects," "will," and other words and phrases of similar meaning. In all cases, a broad variety of assumptions can affect the realization of the expectations or forecasts in those statements. It is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, the Company's ability to develop operations, the Company's ability to consummate and complete an acquisition, the Company's access to future capital, the successful integration of acquired companies, government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, competition, sales and other factors that may be identified from time to time in the Company's public announcements. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially.
This press release is provided for information purposes only and is not intended to constitute an offer to sell or a solicitation of an offer to buy securities.
Advanced Due Diligence for NEOP Investors
http://advancedduediligence.blogspot.com/
Advanced Due Diligence for NEOP Investors
http://advancedduediligence.blogspot.com/
I agree.
NEOP up 16% on strong news!!
NEOP up 16% on strong news !!
Neoprobe Releases Annual Letter to Shareholders
businesswire
Press Release Source: Neoprobe Corporation On Tuesday March 30, 2010, 12:15 pm
DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment product, today released the text of its annual Letter to Stockholders from Neoprobe Chairman, Carl J. Aschinger, Jr., and President and CEO, David C. Bupp.
The letter highlights Neoprobe’s business and financial activities in 2009 and early 2010 and outlines planned business initiatives for the remainder of 2010. The text of the stockholder letter follows.
Dear Neoprobe Stockholder,
We are pleased to report that 2009 was a period of outstanding clinical and commercial advancements for Neoprobe Corporation and our products. The beginning of 2010 has seen a continuation of the progress achieved last year with the successful completion of the Phase 3 clinical evaluation of Lymphoseek® in patients with breast cancer or melanoma (NEO3-05). We have completed our meeting with FDA to review the results of the NEO3-05 Phase 3 clinical study and we are preparing for the submission of the New Drug Application (NDA) for Lymphoseek with FDA later this year. The Lymphoseek NDA, if successful, will represent the first radiolabeled product cleared for marketing with an intraoperative indication for the identification of lymphatic tissue. Our evaluation of the final results of the Phase 3 clinical study confirmed that the primary endpoint of the study was achieved. In addition, no serious drug-related safety events were reported in the clinical trial or any of our prior clinical evaluations of Lymphoseek. Our achievements in 2009 and to-date in 2010 make us very optimistic about Neoprobe’s future as a diversified medical products company. We continue to execute a strategic business model built around a growing medical device platform while we develop a portfolio of recurring revenue drug and biologic products either in or poised to commence Phase 3 clinical evaluations, including Lymphoseek and RIGScan™ CR.
Our meeting with FDA in March 2010 confirmed that the NDA for Lymphoseek will be predicated on the efficacy data from NEO3-05. In addition, the NDA will be supported by safety data from the Phase 1 and Phase 2 clinical studies that have been completed and safety data from NEO3-05 and the patients enrolled to-date in a second Phase 3 clinical study being conducted in patients with head and neck squamous cell carcinoma (NEO3-06). No efficacy data has been requested by FDA for the NDA from NEO3-06. We intend to expand enrollment in NEO3-06 to support the registration for marketing of Lymphoseek in the European Union and for potential post-marketing claims for Lymphoseek in the United States. This modification to our original registration plan emerged in our recent meeting discussions with FDA. We have requested a subsequent series of pre-NDA meetings with FDA and expect to hold these meetings later in the second quarter.
In the first quarter of this year, the quality systems of all of Neoprobe’s significant contract suppliers were inspected by FDA. The inspections included the suppliers for Lymphoseek. The quality systems of all of the facilities were found to be robust and we believe the inspection findings will be beneficial to any inspections that might occur during the Lymphoseek NDA review process.
During 2009 and early 2010, we enhanced our internal staffing to meet the needs of our clinical and development programs. We have augmented our internal staff with personnel with backgrounds in drug manufacturing, regulatory affairs, quality assurance and clinical management. A key staff addition was Dr. Frederick O. Cope, who joined the Neoprobe team as Vice President, Pharmaceutical Research and Clinical Development. Dr. Cope brought a wealth of experience in clinical management and medical product development to Neoprobe, including six years of overseeing the oncology collaborative research programs at The Ohio State University medical research facilities. We have added a total of ten full and part-time personnel to the Neoprobe team in the past twelve months, primarily in the drug development, quality assurance and regulatory areas. The Neoprobe team and our research collaborators are dedicated to developing and providing innovative products that meet the medical needs of healthcare providers and the oncology patients they help to diagnose and treat.
In 2009, the gross profit from our medical device business improved to $6.4 million an increase of 35%. The operating profit generated by our medical device business supported our drug development initiatives in addition to covering our public company corporate overhead costs. The increase in gross profit helped to decrease our loss from operations despite activities in 2009 to support two Phase 3 clinical trials as well as NDA preparation activities. Our net loss attributable to common shareholders for the year was $39.8 million and included $38.1 million in non-cash expenses, primarily due to the accounting treatment resulting from eliminating derivative instrument features embedded in some of our debt and related investment instruments. We ended 2009 with $5.6 million in cash to support our 2010 operations and initiatives.
The core of our medical device business, the Neoprobe gamma radiation detection systems, generated increasing revenue in 2009. The Neoprobe devices continue to be recognized as the premium gamma detection systems and the market leader among gamma radiation detection devices. In 2009, gamma detection device revenues increased by $2.0 million or 27% versus the then-record 2008 revenues. The gross margin on the gamma detection products improved to 67%. The revenue and margin growth of the gamma detection products continued to be led by our wireless probes based on Bluetooth® technology. Growth was further stimulated with the introduction of a high energy probe and updated operating software for the gamma detection systems. All of our gamma detection probes are compatible with the neo2000® and neoprobe® GDS consoles produced during the last five years.
2009 was the first year of an extended marketing and distribution agreement for our gamma detection equipment between Neoprobe and our primary medical device marketing partner, Ethicon Endo-Surgery, Inc. (Ethicon), a Johnson & Johnson company. The new marketing agreement commenced in January 2009 and runs through December 2013. The enhanced financial terms of the new agreement allowed Neoprobe to receive an increased portion of the revenue derived by Ethicon from the sale of the gamma detection device products to end customers and contributed to Neoprobe’s device gross margin increasing to 67%. Since we announced the marketing agreement extension, a number of product development initiatives have been introduced to the surgical community including a new control console, a wireless version of our laparoscopic probe and a high energy detection probe that could be used by physicians in conjunction with PET imaging targeting agents. The new probes received very favorable feedback at the 2009 Society of Surgical Oncology meeting. We continue to look at initiatives that will provide complementary products to our gamma detection device portfolio and that will enhance the margin contribution of the product line.
Consistent with our guidance for 2009, Neoprobe pursued nominal business activities related to its blood flow measurement devices. In the 3rd quarter of 2009 we announced that we discontinued commercial activities related to the blood flow measurement device business and incurred a non-cash impairment charge of $1.7 million for the net assets related to the blood flow measurement device business. We have initiated activities to sell the assets of the blood flow measurement device business.
In 2009, overall corporate research and development expenses totaled $5.0 million, an increase of 16% compared to the prior year. The primary reason for the increase was the development activities associated with the Lymphoseek commercialization program. In 2009, we completed a Phase 3 clinical evaluation of Lymphoseek in patients with breast cancer or melanoma and initiated enrollment in a second Phase 3 clinical study in patients with head and neck squamous cell carcinoma. With the successful completion of the breast or melanoma Phase 3 study of Lymphoseek, we completed additional development activities for Lymphoseek including the completion of drug manufacturing and drug testing validation protocols associated with supporting the NDA for Lymphoseek and initiatives associated with the initiation of clinical development and marketing registration of the product in Europe.
During 2009 and to date in 2010, a number of development, commercial and research milestones were achieved for our drug, biologic and medical device product initiatives:
* Completion of NEO3-05 clinical evaluation of Lymphoseek in patients with breast cancer or melanoma;
* Assessment of final clinical data that the NEO3-05 clinical study achieved its primary efficacy endpoint and achieved positive results related to the secondary endpoints;
* Completion of a successful meeting for NEO3-05 with FDA to review Phase 3 results and discussion of development plans to support a NDA submission for Lymphoseek as a lymphatic tissue tracing agent;
* Submission of a Phase 3 clinical protocol for RIGScan CR, NEO2-17 for treatment of colorectal cancer to FDA under the provisions of a Special Protocol Assessment (SPA);
* Validation of the first lot of commercial drug product of Lymphoseek that will be used for the commercial launch of the product in the United States upon NDA clearance;
* Introduction of the wireless laparoscopic and high energy probes for our gamma detection device systems that were developed in cooperation with Ethicon; and
* Development of a clinical strategy for the patient specific activated cellular therapy technology of our majority owned subsidiary Cira Bio including assessment of chronic fatigue syndrome CFS patients.
In June 2008, we announced initiation of enrollment in a Phase 3 clinical assessment of Lymphoseek to demonstrate the ability of Lymphoseek to accurately identify lymph nodes draining from the primary tumor in patients with either breast cancer or melanoma. The Phase 3 study, NEO3-05, compared the ability of Lymphoseek and the commonly used vital blue dyes to identify lymph nodes in intraoperative lymphatic mapping procedures. NEO3-05 evaluated 156 protocol compliant patients who provided 251 vital blue dye positive nodes of which 239 contained Lymphoseek. The statistical analysis determined that the p-value for the primary objective of the study was 0.009, which exceeded the commonly used regulatory standard of a p-value of 0.05 or better. In addition to the 251 lymph nodes identified with the vital blue dye, Lymphoseek identified 86 lymph nodes that were missed by the dyes. Relative to the secondary endpoint of looking at the pathology status of the lymph nodes, 17% of the nodes identified by Lymphoseek but not by the blue dye were found to contain tumor. There were no safety issues attributed to Lymphoseek reported in the study.
With the successful completion of the NEO3-05 clinical study, Neoprobe began discussions with FDA to schedule a meeting and to determine the criteria for a NDA submission. In addition, the first of the Phase 3 clinical data was reported at international medical conferences beginning with the data from the breast patients enrolled in NEO3-05 at the San Antonio Breast Cancer Symposium in December 2009. Additional clinical data including the results of the melanoma patients treated in NEO3-05 was presented at the Society of Surgical Oncology in March 2010. A manuscript for submission to one of the major peer reviewed medical journals has been prepared.
While the concept of the lymph node staging of cancer patients with radiolabeled colloids and vital blue dye products has become widely adopted for breast cancer and melanoma patients, no radiolabeled products have been approved as biological marker-based lymph node targeting agents. Under the scientific advice process, Neoprobe reviewed a Phase 3 clinical study design with the centralized European medical products regulatory review body the EMEA to support the registration of the drug in Europe. The Phase 3 clinical trial would be conducted in patients with head and neck squamous cell carcinoma. In third quarter of 2008, we received the EMEA’s agreement to the clinical trial design. With the receipt of the EMEA concurrence, we approached FDA with the design of a Phase 3 clinical trial (NEO3-06). The NEO3-06 trial is to be conducted at cancer centers in the United States and Europe and based upon the recent discussions with FDA on the NDA for Lymphoseek we expect that it will involve approximately 300 patients. We began first patient enrollment in the trial at clinical sites in the United States last year and are awaiting clearance from the first investigational sites in Europe to commence patient enrollment in the clinical trial in Europe this year. We intend to use the results from NEO3-06 to amend marketing claims for Lymphoseek in the United States and to support the marketing clearance for the product in Europe.
Our development activities have not been confined to our medical devices and Lymphoseek. In the course of our discussions with the EMEA on Lymphoseek, we opened a dialogue on the RIGS® technology. Our initial approach was favorably received and we determined that the EMEA would be receptive to a modified review of a development plan and clinical approach for the RIGS biologic product for the treatment of colorectal cancer. The product review was presented under the scientific advice procedure that had worked well for Lymphoseek. In October of 2008, we received a favorable response to the scientific advice assessment. The response included the potential for RIGScan CR to be considered for the Conditional Marketing Authorization program adopted by the EMEA in December 2007. During 2009 we discussed with our clinical and statistical advisors means of harmonizing the Phase 3 study design and product development plan with FDA. To that end, we developed a prospective Phase 3 clinical trial (NEO2-17) that would be conducted in patients diagnosed with cancer of the colon or rectum. The proposed study had a primary clinical endpoint of improvement in overall survival and a series of diagnostic and prognostic secondary endpoints. As designed the trial would evaluate approximately 300 patients randomized to unequal control and RIGS treatment arms. The NEO2-17 protocol and supporting materials were submitted to FDA in late 2009 under an Investigational New Drug amendment with a request for a pre-Phase 3 meeting and a review by FDA in the provisions of a SPA. In anticipation of a response from FDA to our SPA request in the 3rd quarter of 2009, we commenced development activities for the biologic component of RIGS with Laureate Pharmaceuticals.
What do we see in the coming months for Neoprobe Corporation in 2010?
* Publication of the complete data from the Lymphoseek Phase 3 clinical study (NEO3-05) conducted in patients with breast cancer or melanoma in a major peer-reviewed medical journal;
* Submission of the NDA for Lymphoseek as a lymphatic tissue tracing agent;
* Initiation of the European phase of the Lymphoseek Phase 3 clinical study (NEO3-06) in patients diagnosed with head and neck squamous cell carcinoma;
* Finalization of the Phase 3 clinical trial design for RIGScan CR with FDA through the SPA procedures and moving forward with development partnership initiatives;
* Acceptance of the RIGS drug manufacturing plan under an IND amendment; and
* Maintain a leadership position for our gamma detection device business by evaluating potential new or enhanced product offerings.
In conclusion, we are very optimistic about the commercial prospects for Neoprobe Corporation. We face challenges with the current economic and regulatory environment, but we achieved a great deal in 2009 and we believe 2010 will be an exciting year for the commercial prospects of Neoprobe. Our employees are focused on improving our products toward providing more effective cancer patient care and improving patient outcome. We appreciate your continued assistance and support in making Neoprobe a successful biomedical company.
Sincerely,
Carl J. Aschinger, Jr. David C. Bupp
Chairman of the Board
President and CEO
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Neoprobe Corporation
Brent Larson, 614-822-2330
Vice President / CFO
or
The Shoreham Group
Tim Ryan, 212-242-7777
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Neoprobe Releases Annual Letter to Shareholders
businesswire
Press Release Source: Neoprobe Corporation On Tuesday March 30, 2010, 12:15 pm
DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment product, today released the text of its annual Letter to Stockholders from Neoprobe Chairman, Carl J. Aschinger, Jr., and President and CEO, David C. Bupp.
The letter highlights Neoprobe’s business and financial activities in 2009 and early 2010 and outlines planned business initiatives for the remainder of 2010. The text of the stockholder letter follows.
Dear Neoprobe Stockholder,
We are pleased to report that 2009 was a period of outstanding clinical and commercial advancements for Neoprobe Corporation and our products. The beginning of 2010 has seen a continuation of the progress achieved last year with the successful completion of the Phase 3 clinical evaluation of Lymphoseek® in patients with breast cancer or melanoma (NEO3-05). We have completed our meeting with FDA to review the results of the NEO3-05 Phase 3 clinical study and we are preparing for the submission of the New Drug Application (NDA) for Lymphoseek with FDA later this year. The Lymphoseek NDA, if successful, will represent the first radiolabeled product cleared for marketing with an intraoperative indication for the identification of lymphatic tissue. Our evaluation of the final results of the Phase 3 clinical study confirmed that the primary endpoint of the study was achieved. In addition, no serious drug-related safety events were reported in the clinical trial or any of our prior clinical evaluations of Lymphoseek. Our achievements in 2009 and to-date in 2010 make us very optimistic about Neoprobe’s future as a diversified medical products company. We continue to execute a strategic business model built around a growing medical device platform while we develop a portfolio of recurring revenue drug and biologic products either in or poised to commence Phase 3 clinical evaluations, including Lymphoseek and RIGScan™ CR.
Our meeting with FDA in March 2010 confirmed that the NDA for Lymphoseek will be predicated on the efficacy data from NEO3-05. In addition, the NDA will be supported by safety data from the Phase 1 and Phase 2 clinical studies that have been completed and safety data from NEO3-05 and the patients enrolled to-date in a second Phase 3 clinical study being conducted in patients with head and neck squamous cell carcinoma (NEO3-06). No efficacy data has been requested by FDA for the NDA from NEO3-06. We intend to expand enrollment in NEO3-06 to support the registration for marketing of Lymphoseek in the European Union and for potential post-marketing claims for Lymphoseek in the United States. This modification to our original registration plan emerged in our recent meeting discussions with FDA. We have requested a subsequent series of pre-NDA meetings with FDA and expect to hold these meetings later in the second quarter.
In the first quarter of this year, the quality systems of all of Neoprobe’s significant contract suppliers were inspected by FDA. The inspections included the suppliers for Lymphoseek. The quality systems of all of the facilities were found to be robust and we believe the inspection findings will be beneficial to any inspections that might occur during the Lymphoseek NDA review process.
During 2009 and early 2010, we enhanced our internal staffing to meet the needs of our clinical and development programs. We have augmented our internal staff with personnel with backgrounds in drug manufacturing, regulatory affairs, quality assurance and clinical management. A key staff addition was Dr. Frederick O. Cope, who joined the Neoprobe team as Vice President, Pharmaceutical Research and Clinical Development. Dr. Cope brought a wealth of experience in clinical management and medical product development to Neoprobe, including six years of overseeing the oncology collaborative research programs at The Ohio State University medical research facilities. We have added a total of ten full and part-time personnel to the Neoprobe team in the past twelve months, primarily in the drug development, quality assurance and regulatory areas. The Neoprobe team and our research collaborators are dedicated to developing and providing innovative products that meet the medical needs of healthcare providers and the oncology patients they help to diagnose and treat.
In 2009, the gross profit from our medical device business improved to $6.4 million an increase of 35%. The operating profit generated by our medical device business supported our drug development initiatives in addition to covering our public company corporate overhead costs. The increase in gross profit helped to decrease our loss from operations despite activities in 2009 to support two Phase 3 clinical trials as well as NDA preparation activities. Our net loss attributable to common shareholders for the year was $39.8 million and included $38.1 million in non-cash expenses, primarily due to the accounting treatment resulting from eliminating derivative instrument features embedded in some of our debt and related investment instruments. We ended 2009 with $5.6 million in cash to support our 2010 operations and initiatives.
The core of our medical device business, the Neoprobe gamma radiation detection systems, generated increasing revenue in 2009. The Neoprobe devices continue to be recognized as the premium gamma detection systems and the market leader among gamma radiation detection devices. In 2009, gamma detection device revenues increased by $2.0 million or 27% versus the then-record 2008 revenues. The gross margin on the gamma detection products improved to 67%. The revenue and margin growth of the gamma detection products continued to be led by our wireless probes based on Bluetooth® technology. Growth was further stimulated with the introduction of a high energy probe and updated operating software for the gamma detection systems. All of our gamma detection probes are compatible with the neo2000® and neoprobe® GDS consoles produced during the last five years.
2009 was the first year of an extended marketing and distribution agreement for our gamma detection equipment between Neoprobe and our primary medical device marketing partner, Ethicon Endo-Surgery, Inc. (Ethicon), a Johnson & Johnson company. The new marketing agreement commenced in January 2009 and runs through December 2013. The enhanced financial terms of the new agreement allowed Neoprobe to receive an increased portion of the revenue derived by Ethicon from the sale of the gamma detection device products to end customers and contributed to Neoprobe’s device gross margin increasing to 67%. Since we announced the marketing agreement extension, a number of product development initiatives have been introduced to the surgical community including a new control console, a wireless version of our laparoscopic probe and a high energy detection probe that could be used by physicians in conjunction with PET imaging targeting agents. The new probes received very favorable feedback at the 2009 Society of Surgical Oncology meeting. We continue to look at initiatives that will provide complementary products to our gamma detection device portfolio and that will enhance the margin contribution of the product line.
Consistent with our guidance for 2009, Neoprobe pursued nominal business activities related to its blood flow measurement devices. In the 3rd quarter of 2009 we announced that we discontinued commercial activities related to the blood flow measurement device business and incurred a non-cash impairment charge of $1.7 million for the net assets related to the blood flow measurement device business. We have initiated activities to sell the assets of the blood flow measurement device business.
In 2009, overall corporate research and development expenses totaled $5.0 million, an increase of 16% compared to the prior year. The primary reason for the increase was the development activities associated with the Lymphoseek commercialization program. In 2009, we completed a Phase 3 clinical evaluation of Lymphoseek in patients with breast cancer or melanoma and initiated enrollment in a second Phase 3 clinical study in patients with head and neck squamous cell carcinoma. With the successful completion of the breast or melanoma Phase 3 study of Lymphoseek, we completed additional development activities for Lymphoseek including the completion of drug manufacturing and drug testing validation protocols associated with supporting the NDA for Lymphoseek and initiatives associated with the initiation of clinical development and marketing registration of the product in Europe.
During 2009 and to date in 2010, a number of development, commercial and research milestones were achieved for our drug, biologic and medical device product initiatives:
* Completion of NEO3-05 clinical evaluation of Lymphoseek in patients with breast cancer or melanoma;
* Assessment of final clinical data that the NEO3-05 clinical study achieved its primary efficacy endpoint and achieved positive results related to the secondary endpoints;
* Completion of a successful meeting for NEO3-05 with FDA to review Phase 3 results and discussion of development plans to support a NDA submission for Lymphoseek as a lymphatic tissue tracing agent;
* Submission of a Phase 3 clinical protocol for RIGScan CR, NEO2-17 for treatment of colorectal cancer to FDA under the provisions of a Special Protocol Assessment (SPA);
* Validation of the first lot of commercial drug product of Lymphoseek that will be used for the commercial launch of the product in the United States upon NDA clearance;
* Introduction of the wireless laparoscopic and high energy probes for our gamma detection device systems that were developed in cooperation with Ethicon; and
* Development of a clinical strategy for the patient specific activated cellular therapy technology of our majority owned subsidiary Cira Bio including assessment of chronic fatigue syndrome CFS patients.
In June 2008, we announced initiation of enrollment in a Phase 3 clinical assessment of Lymphoseek to demonstrate the ability of Lymphoseek to accurately identify lymph nodes draining from the primary tumor in patients with either breast cancer or melanoma. The Phase 3 study, NEO3-05, compared the ability of Lymphoseek and the commonly used vital blue dyes to identify lymph nodes in intraoperative lymphatic mapping procedures. NEO3-05 evaluated 156 protocol compliant patients who provided 251 vital blue dye positive nodes of which 239 contained Lymphoseek. The statistical analysis determined that the p-value for the primary objective of the study was 0.009, which exceeded the commonly used regulatory standard of a p-value of 0.05 or better. In addition to the 251 lymph nodes identified with the vital blue dye, Lymphoseek identified 86 lymph nodes that were missed by the dyes. Relative to the secondary endpoint of looking at the pathology status of the lymph nodes, 17% of the nodes identified by Lymphoseek but not by the blue dye were found to contain tumor. There were no safety issues attributed to Lymphoseek reported in the study.
With the successful completion of the NEO3-05 clinical study, Neoprobe began discussions with FDA to schedule a meeting and to determine the criteria for a NDA submission. In addition, the first of the Phase 3 clinical data was reported at international medical conferences beginning with the data from the breast patients enrolled in NEO3-05 at the San Antonio Breast Cancer Symposium in December 2009. Additional clinical data including the results of the melanoma patients treated in NEO3-05 was presented at the Society of Surgical Oncology in March 2010. A manuscript for submission to one of the major peer reviewed medical journals has been prepared.
While the concept of the lymph node staging of cancer patients with radiolabeled colloids and vital blue dye products has become widely adopted for breast cancer and melanoma patients, no radiolabeled products have been approved as biological marker-based lymph node targeting agents. Under the scientific advice process, Neoprobe reviewed a Phase 3 clinical study design with the centralized European medical products regulatory review body the EMEA to support the registration of the drug in Europe. The Phase 3 clinical trial would be conducted in patients with head and neck squamous cell carcinoma. In third quarter of 2008, we received the EMEA’s agreement to the clinical trial design. With the receipt of the EMEA concurrence, we approached FDA with the design of a Phase 3 clinical trial (NEO3-06). The NEO3-06 trial is to be conducted at cancer centers in the United States and Europe and based upon the recent discussions with FDA on the NDA for Lymphoseek we expect that it will involve approximately 300 patients. We began first patient enrollment in the trial at clinical sites in the United States last year and are awaiting clearance from the first investigational sites in Europe to commence patient enrollment in the clinical trial in Europe this year. We intend to use the results from NEO3-06 to amend marketing claims for Lymphoseek in the United States and to support the marketing clearance for the product in Europe.
Our development activities have not been confined to our medical devices and Lymphoseek. In the course of our discussions with the EMEA on Lymphoseek, we opened a dialogue on the RIGS® technology. Our initial approach was favorably received and we determined that the EMEA would be receptive to a modified review of a development plan and clinical approach for the RIGS biologic product for the treatment of colorectal cancer. The product review was presented under the scientific advice procedure that had worked well for Lymphoseek. In October of 2008, we received a favorable response to the scientific advice assessment. The response included the potential for RIGScan CR to be considered for the Conditional Marketing Authorization program adopted by the EMEA in December 2007. During 2009 we discussed with our clinical and statistical advisors means of harmonizing the Phase 3 study design and product development plan with FDA. To that end, we developed a prospective Phase 3 clinical trial (NEO2-17) that would be conducted in patients diagnosed with cancer of the colon or rectum. The proposed study had a primary clinical endpoint of improvement in overall survival and a series of diagnostic and prognostic secondary endpoints. As designed the trial would evaluate approximately 300 patients randomized to unequal control and RIGS treatment arms. The NEO2-17 protocol and supporting materials were submitted to FDA in late 2009 under an Investigational New Drug amendment with a request for a pre-Phase 3 meeting and a review by FDA in the provisions of a SPA. In anticipation of a response from FDA to our SPA request in the 3rd quarter of 2009, we commenced development activities for the biologic component of RIGS with Laureate Pharmaceuticals.
What do we see in the coming months for Neoprobe Corporation in 2010?
* Publication of the complete data from the Lymphoseek Phase 3 clinical study (NEO3-05) conducted in patients with breast cancer or melanoma in a major peer-reviewed medical journal;
* Submission of the NDA for Lymphoseek as a lymphatic tissue tracing agent;
* Initiation of the European phase of the Lymphoseek Phase 3 clinical study (NEO3-06) in patients diagnosed with head and neck squamous cell carcinoma;
* Finalization of the Phase 3 clinical trial design for RIGScan CR with FDA through the SPA procedures and moving forward with development partnership initiatives;
* Acceptance of the RIGS drug manufacturing plan under an IND amendment; and
* Maintain a leadership position for our gamma detection device business by evaluating potential new or enhanced product offerings.
In conclusion, we are very optimistic about the commercial prospects for Neoprobe Corporation. We face challenges with the current economic and regulatory environment, but we achieved a great deal in 2009 and we believe 2010 will be an exciting year for the commercial prospects of Neoprobe. Our employees are focused on improving our products toward providing more effective cancer patient care and improving patient outcome. We appreciate your continued assistance and support in making Neoprobe a successful biomedical company.
Sincerely,
Carl J. Aschinger, Jr. David C. Bupp
Chairman of the Board
President and CEO
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Neoprobe Corporation
Brent Larson, 614-822-2330
Vice President / CFO
or
The Shoreham Group
Tim Ryan, 212-242-7777
Buzz up! 0
Send
Share
Print
Neoprobe Releases Annual Letter to Shareholders
businesswire
Press Release Source: Neoprobe Corporation On Tuesday March 30, 2010, 12:15 pm
DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment product, today released the text of its annual Letter to Stockholders from Neoprobe Chairman, Carl J. Aschinger, Jr., and President and CEO, David C. Bupp.
The letter highlights Neoprobe’s business and financial activities in 2009 and early 2010 and outlines planned business initiatives for the remainder of 2010. The text of the stockholder letter follows.
Dear Neoprobe Stockholder,
We are pleased to report that 2009 was a period of outstanding clinical and commercial advancements for Neoprobe Corporation and our products. The beginning of 2010 has seen a continuation of the progress achieved last year with the successful completion of the Phase 3 clinical evaluation of Lymphoseek® in patients with breast cancer or melanoma (NEO3-05). We have completed our meeting with FDA to review the results of the NEO3-05 Phase 3 clinical study and we are preparing for the submission of the New Drug Application (NDA) for Lymphoseek with FDA later this year. The Lymphoseek NDA, if successful, will represent the first radiolabeled product cleared for marketing with an intraoperative indication for the identification of lymphatic tissue. Our evaluation of the final results of the Phase 3 clinical study confirmed that the primary endpoint of the study was achieved. In addition, no serious drug-related safety events were reported in the clinical trial or any of our prior clinical evaluations of Lymphoseek. Our achievements in 2009 and to-date in 2010 make us very optimistic about Neoprobe’s future as a diversified medical products company. We continue to execute a strategic business model built around a growing medical device platform while we develop a portfolio of recurring revenue drug and biologic products either in or poised to commence Phase 3 clinical evaluations, including Lymphoseek and RIGScan™ CR.
Our meeting with FDA in March 2010 confirmed that the NDA for Lymphoseek will be predicated on the efficacy data from NEO3-05. In addition, the NDA will be supported by safety data from the Phase 1 and Phase 2 clinical studies that have been completed and safety data from NEO3-05 and the patients enrolled to-date in a second Phase 3 clinical study being conducted in patients with head and neck squamous cell carcinoma (NEO3-06). No efficacy data has been requested by FDA for the NDA from NEO3-06. We intend to expand enrollment in NEO3-06 to support the registration for marketing of Lymphoseek in the European Union and for potential post-marketing claims for Lymphoseek in the United States. This modification to our original registration plan emerged in our recent meeting discussions with FDA. We have requested a subsequent series of pre-NDA meetings with FDA and expect to hold these meetings later in the second quarter.
In the first quarter of this year, the quality systems of all of Neoprobe’s significant contract suppliers were inspected by FDA. The inspections included the suppliers for Lymphoseek. The quality systems of all of the facilities were found to be robust and we believe the inspection findings will be beneficial to any inspections that might occur during the Lymphoseek NDA review process.
During 2009 and early 2010, we enhanced our internal staffing to meet the needs of our clinical and development programs. We have augmented our internal staff with personnel with backgrounds in drug manufacturing, regulatory affairs, quality assurance and clinical management. A key staff addition was Dr. Frederick O. Cope, who joined the Neoprobe team as Vice President, Pharmaceutical Research and Clinical Development. Dr. Cope brought a wealth of experience in clinical management and medical product development to Neoprobe, including six years of overseeing the oncology collaborative research programs at The Ohio State University medical research facilities. We have added a total of ten full and part-time personnel to the Neoprobe team in the past twelve months, primarily in the drug development, quality assurance and regulatory areas. The Neoprobe team and our research collaborators are dedicated to developing and providing innovative products that meet the medical needs of healthcare providers and the oncology patients they help to diagnose and treat.
In 2009, the gross profit from our medical device business improved to $6.4 million an increase of 35%. The operating profit generated by our medical device business supported our drug development initiatives in addition to covering our public company corporate overhead costs. The increase in gross profit helped to decrease our loss from operations despite activities in 2009 to support two Phase 3 clinical trials as well as NDA preparation activities. Our net loss attributable to common shareholders for the year was $39.8 million and included $38.1 million in non-cash expenses, primarily due to the accounting treatment resulting from eliminating derivative instrument features embedded in some of our debt and related investment instruments. We ended 2009 with $5.6 million in cash to support our 2010 operations and initiatives.
The core of our medical device business, the Neoprobe gamma radiation detection systems, generated increasing revenue in 2009. The Neoprobe devices continue to be recognized as the premium gamma detection systems and the market leader among gamma radiation detection devices. In 2009, gamma detection device revenues increased by $2.0 million or 27% versus the then-record 2008 revenues. The gross margin on the gamma detection products improved to 67%. The revenue and margin growth of the gamma detection products continued to be led by our wireless probes based on Bluetooth® technology. Growth was further stimulated with the introduction of a high energy probe and updated operating software for the gamma detection systems. All of our gamma detection probes are compatible with the neo2000® and neoprobe® GDS consoles produced during the last five years.
2009 was the first year of an extended marketing and distribution agreement for our gamma detection equipment between Neoprobe and our primary medical device marketing partner, Ethicon Endo-Surgery, Inc. (Ethicon), a Johnson & Johnson company. The new marketing agreement commenced in January 2009 and runs through December 2013. The enhanced financial terms of the new agreement allowed Neoprobe to receive an increased portion of the revenue derived by Ethicon from the sale of the gamma detection device products to end customers and contributed to Neoprobe’s device gross margin increasing to 67%. Since we announced the marketing agreement extension, a number of product development initiatives have been introduced to the surgical community including a new control console, a wireless version of our laparoscopic probe and a high energy detection probe that could be used by physicians in conjunction with PET imaging targeting agents. The new probes received very favorable feedback at the 2009 Society of Surgical Oncology meeting. We continue to look at initiatives that will provide complementary products to our gamma detection device portfolio and that will enhance the margin contribution of the product line.
Consistent with our guidance for 2009, Neoprobe pursued nominal business activities related to its blood flow measurement devices. In the 3rd quarter of 2009 we announced that we discontinued commercial activities related to the blood flow measurement device business and incurred a non-cash impairment charge of $1.7 million for the net assets related to the blood flow measurement device business. We have initiated activities to sell the assets of the blood flow measurement device business.
In 2009, overall corporate research and development expenses totaled $5.0 million, an increase of 16% compared to the prior year. The primary reason for the increase was the development activities associated with the Lymphoseek commercialization program. In 2009, we completed a Phase 3 clinical evaluation of Lymphoseek in patients with breast cancer or melanoma and initiated enrollment in a second Phase 3 clinical study in patients with head and neck squamous cell carcinoma. With the successful completion of the breast or melanoma Phase 3 study of Lymphoseek, we completed additional development activities for Lymphoseek including the completion of drug manufacturing and drug testing validation protocols associated with supporting the NDA for Lymphoseek and initiatives associated with the initiation of clinical development and marketing registration of the product in Europe.
During 2009 and to date in 2010, a number of development, commercial and research milestones were achieved for our drug, biologic and medical device product initiatives:
* Completion of NEO3-05 clinical evaluation of Lymphoseek in patients with breast cancer or melanoma;
* Assessment of final clinical data that the NEO3-05 clinical study achieved its primary efficacy endpoint and achieved positive results related to the secondary endpoints;
* Completion of a successful meeting for NEO3-05 with FDA to review Phase 3 results and discussion of development plans to support a NDA submission for Lymphoseek as a lymphatic tissue tracing agent;
* Submission of a Phase 3 clinical protocol for RIGScan CR, NEO2-17 for treatment of colorectal cancer to FDA under the provisions of a Special Protocol Assessment (SPA);
* Validation of the first lot of commercial drug product of Lymphoseek that will be used for the commercial launch of the product in the United States upon NDA clearance;
* Introduction of the wireless laparoscopic and high energy probes for our gamma detection device systems that were developed in cooperation with Ethicon; and
* Development of a clinical strategy for the patient specific activated cellular therapy technology of our majority owned subsidiary Cira Bio including assessment of chronic fatigue syndrome CFS patients.
In June 2008, we announced initiation of enrollment in a Phase 3 clinical assessment of Lymphoseek to demonstrate the ability of Lymphoseek to accurately identify lymph nodes draining from the primary tumor in patients with either breast cancer or melanoma. The Phase 3 study, NEO3-05, compared the ability of Lymphoseek and the commonly used vital blue dyes to identify lymph nodes in intraoperative lymphatic mapping procedures. NEO3-05 evaluated 156 protocol compliant patients who provided 251 vital blue dye positive nodes of which 239 contained Lymphoseek. The statistical analysis determined that the p-value for the primary objective of the study was 0.009, which exceeded the commonly used regulatory standard of a p-value of 0.05 or better. In addition to the 251 lymph nodes identified with the vital blue dye, Lymphoseek identified 86 lymph nodes that were missed by the dyes. Relative to the secondary endpoint of looking at the pathology status of the lymph nodes, 17% of the nodes identified by Lymphoseek but not by the blue dye were found to contain tumor. There were no safety issues attributed to Lymphoseek reported in the study.
With the successful completion of the NEO3-05 clinical study, Neoprobe began discussions with FDA to schedule a meeting and to determine the criteria for a NDA submission. In addition, the first of the Phase 3 clinical data was reported at international medical conferences beginning with the data from the breast patients enrolled in NEO3-05 at the San Antonio Breast Cancer Symposium in December 2009. Additional clinical data including the results of the melanoma patients treated in NEO3-05 was presented at the Society of Surgical Oncology in March 2010. A manuscript for submission to one of the major peer reviewed medical journals has been prepared.
While the concept of the lymph node staging of cancer patients with radiolabeled colloids and vital blue dye products has become widely adopted for breast cancer and melanoma patients, no radiolabeled products have been approved as biological marker-based lymph node targeting agents. Under the scientific advice process, Neoprobe reviewed a Phase 3 clinical study design with the centralized European medical products regulatory review body the EMEA to support the registration of the drug in Europe. The Phase 3 clinical trial would be conducted in patients with head and neck squamous cell carcinoma. In third quarter of 2008, we received the EMEA’s agreement to the clinical trial design. With the receipt of the EMEA concurrence, we approached FDA with the design of a Phase 3 clinical trial (NEO3-06). The NEO3-06 trial is to be conducted at cancer centers in the United States and Europe and based upon the recent discussions with FDA on the NDA for Lymphoseek we expect that it will involve approximately 300 patients. We began first patient enrollment in the trial at clinical sites in the United States last year and are awaiting clearance from the first investigational sites in Europe to commence patient enrollment in the clinical trial in Europe this year. We intend to use the results from NEO3-06 to amend marketing claims for Lymphoseek in the United States and to support the marketing clearance for the product in Europe.
Our development activities have not been confined to our medical devices and Lymphoseek. In the course of our discussions with the EMEA on Lymphoseek, we opened a dialogue on the RIGS® technology. Our initial approach was favorably received and we determined that the EMEA would be receptive to a modified review of a development plan and clinical approach for the RIGS biologic product for the treatment of colorectal cancer. The product review was presented under the scientific advice procedure that had worked well for Lymphoseek. In October of 2008, we received a favorable response to the scientific advice assessment. The response included the potential for RIGScan CR to be considered for the Conditional Marketing Authorization program adopted by the EMEA in December 2007. During 2009 we discussed with our clinical and statistical advisors means of harmonizing the Phase 3 study design and product development plan with FDA. To that end, we developed a prospective Phase 3 clinical trial (NEO2-17) that would be conducted in patients diagnosed with cancer of the colon or rectum. The proposed study had a primary clinical endpoint of improvement in overall survival and a series of diagnostic and prognostic secondary endpoints. As designed the trial would evaluate approximately 300 patients randomized to unequal control and RIGS treatment arms. The NEO2-17 protocol and supporting materials were submitted to FDA in late 2009 under an Investigational New Drug amendment with a request for a pre-Phase 3 meeting and a review by FDA in the provisions of a SPA. In anticipation of a response from FDA to our SPA request in the 3rd quarter of 2009, we commenced development activities for the biologic component of RIGS with Laureate Pharmaceuticals.
What do we see in the coming months for Neoprobe Corporation in 2010?
* Publication of the complete data from the Lymphoseek Phase 3 clinical study (NEO3-05) conducted in patients with breast cancer or melanoma in a major peer-reviewed medical journal;
* Submission of the NDA for Lymphoseek as a lymphatic tissue tracing agent;
* Initiation of the European phase of the Lymphoseek Phase 3 clinical study (NEO3-06) in patients diagnosed with head and neck squamous cell carcinoma;
* Finalization of the Phase 3 clinical trial design for RIGScan CR with FDA through the SPA procedures and moving forward with development partnership initiatives;
* Acceptance of the RIGS drug manufacturing plan under an IND amendment; and
* Maintain a leadership position for our gamma detection device business by evaluating potential new or enhanced product offerings.
In conclusion, we are very optimistic about the commercial prospects for Neoprobe Corporation. We face challenges with the current economic and regulatory environment, but we achieved a great deal in 2009 and we believe 2010 will be an exciting year for the commercial prospects of Neoprobe. Our employees are focused on improving our products toward providing more effective cancer patient care and improving patient outcome. We appreciate your continued assistance and support in making Neoprobe a successful biomedical company.
Sincerely,
Carl J. Aschinger, Jr. David C. Bupp
Chairman of the Board
President and CEO
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Neoprobe Corporation
Brent Larson, 614-822-2330
Vice President / CFO
or
The Shoreham Group
Tim Ryan, 212-242-7777
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Momoffour...I agree,this board is intended to give opinions good or bad on good dd.glad your here!
PAPPENNIES, YOU ARE SPOT ON! WELCOME TO THE BOARD
EVRN management has no intention of hurting the PPS by reckless diluting.Remember,all of Robert and Paul's shares are restricted.They have the same hope as we do of healthy increase of the PPS.Controlled dilution is normal in a growing company.
up 34% what a great day!!
HEB up 7.5%
Alert - HEB on sudden strong volume
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Genta Incorporated to Host Conference Call to Discuss Fourth Quarter 2009 Highlights and Financial Results
businesswire
Press Release Source: Genta Incorporated On Wednesday March 24, 2010, 8:05 am EDT
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GNTA - News) announced today that the Company will release its financial results for the fourth quarter and for the year ending December 31, 2009 on Monday, March 29, 2010. Genta management will host a conference call and live audio webcast that morning to discuss the financial results at 8:00 am EDT.
Participants can access the live call by dialing (877) 634-8606 (U.S. and Canada) or (973) 200-3973 (International). The access code for the live call is Genta Incorporated. The call will also be webcast live at http://www.genta.com/investorrelation/events.html.
For investors unable to participate in the live call, a replay will be available approximately two hours after the completion of the call, and will be archived for 30 days. Access numbers for this replay are: (800) 642-1687 (U.S. and Canada) and (706) 645-9291 (International); conference ID number is: 64262291.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from the recently completed randomized Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA trial). The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta has initiated a broad clinical program to evaluate the safety and efficacy of tesetaxel in patients with solid tumors. In the U.S., Genta is exclusively marketing Ganite® (gallium nitrate injection), which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite® that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
* the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
* the safety and efficacy of the Company’s products or product candidates;
* the commencement and completion of any clinical trials;
* the Company’s assessment of its clinical trials;
* the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
* the Company’s ability to enter into and successfully execute any license and collaborative agreements;
* the adequacy of the Company’s capital resources and cash flow projections, or the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations;
* the adequacy of the Company’s patents and proprietary rights;
* the impact of litigation that has been brought against the Company; and
* the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2008 and its most recent quarterly report on Form 10-Q.
Contact:
Genta Investor Relations
908-286-3980
info@genta.com