BioSpecialist
14 years ago
Bullish Chart !!!!!!!!!
Get on board before the stock gets discovered .Please do your own DD !!! GLTA
New Partner Deal soon = 40-50$ Tgt within 6 Months !!!!
Cpex Pharma (CPEX)
Market Cap : 27,5 Mio$
Cash : 14,8 Mio$
Price : 10,70 $
Shares Out : 2,53 M
Pipeline
http://www.cpexpharm.com/pipeline.htm
Third-Quarter Highlights
For the third quarter of 2009 compared to the third quarter of 2008;
* Revenues increased 26% to $5.0 million from $3.9 million.
* Operating expenses increased 17% to $5.8 million from $5.0 million.
* Net loss was $872,000, or $0.34 per share, compared to $1.0 million, or $0.43 per share.
The growth in revenues for the third quarter of 2009 was due to increased royalties on sales of Testim®. This growth is due to a reported 17% increase in prescriptions for Testim during the third quarter of 2009 compared to the same period in 2008. Operating expenses in the third quarter of 2009 increased $853,000, primarily due to clinical trial expenses associated with CPEX’s ongoing NasulinTM clinical program and legal costs associated with its on-going litigation with Upsher-Smith Laboratories regarding Testim. These increases were partially offset by a decrease in share-based compensation expense. Operating expenses for the three months ended September 30, 2008 include a $1.2 million non-cash charge resulting from the modification of equity awards associated with the spin-off from Bentley.
Business Update
Ongoing Clinical Trials: CPEX’s intranasal insulin product candidate for the treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes, Nasulin, is continuing clinical trials evaluating the safety and efficacy profile of the product. CPEX has completed screening activities in a Phase 2a study designed to assess the efficacy and safety of Nasulin versus placebo over a 6-week treatment period. This study is being conducted at multiple centers in the U.S. Prior trials in patients with Type 1 or 2 diabetes, as well as in healthy volunteers, have indicated that Nasulin appears to have an ultra-rapid time/action profile which has the potential to mimic more closely the body’s natural insulin response to meals.
Partnering Update: Following the completion of an End-of-Phase-2 meeting earlier this year, Serenity Pharmaceuticals, CPEX’s licensing and development partner, recently began recruiting patients in multiple Phase 3 clinical trials with their undisclosed urology drug delivered using CPEX’s intranasal technology for the treatment of nocturia. These randomized, double blind, placebo controlled studies are being conducted at multiple sites in the United States.
New Patents Issued: On October 27, 2009 the United States Patent and Trademark Office issued six additional patents that expand the scope and claims of CPEX’s original patent covering Testim®, 1% testosterone gel. Testim® is marketed by Auxilium under license from CPEX. The new patents will expire in April 2023 and are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration.
Management Comments
“We are pleased about the recent completion of screening activities in our current Phase 2a study and the continued progress of our Nasulin clinical program. We look forward to presenting data from our earlier trials at the Ninth Annual Diabetes Technology Meeting taking place this week in San Francisco” stated John A. Sedor, CPEX President and Chief Executive Officer. “We are also encouraged by Serenity’s advancement of their compound for the treatment of nocturia into Phase 3 studies. This drug addresses a large urology indication with few treatment options. This is an exciting opportunity for CPEX and Serenity and we look forward to updating you on the future of this program .
BioSpecialist
14 years ago
CPEX is on the move
still very cheap ............
Cpex Pharma (CPEX)
Market Cap : 24,5 Mio$
Cash : 14,8 Mio$
Price : 9,50 $
Shares Out : 2,53 M
Pipeline
http://www.cpexpharm.com/pipeline.htm
Third-Quarter Highlights
For the third quarter of 2009 compared to the third quarter of 2008;
* Revenues increased 26% to $5.0 million from $3.9 million.
* Operating expenses increased 17% to $5.8 million from $5.0 million.
* Net loss was $872,000, or $0.34 per share, compared to $1.0 million, or $0.43 per share.
The growth in revenues for the third quarter of 2009 was due to increased royalties on sales of Testim®. This growth is due to a reported 17% increase in prescriptions for Testim during the third quarter of 2009 compared to the same period in 2008. Operating expenses in the third quarter of 2009 increased $853,000, primarily due to clinical trial expenses associated with CPEX’s ongoing NasulinTM clinical program and legal costs associated with its on-going litigation with Upsher-Smith Laboratories regarding Testim. These increases were partially offset by a decrease in share-based compensation expense. Operating expenses for the three months ended September 30, 2008 include a $1.2 million non-cash charge resulting from the modification of equity awards associated with the spin-off from Bentley.
Business Update
Ongoing Clinical Trials: CPEX’s intranasal insulin product candidate for the treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes, Nasulin, is continuing clinical trials evaluating the safety and efficacy profile of the product. CPEX has completed screening activities in a Phase 2a study designed to assess the efficacy and safety of Nasulin versus placebo over a 6-week treatment period. This study is being conducted at multiple centers in the U.S. Prior trials in patients with Type 1 or 2 diabetes, as well as in healthy volunteers, have indicated that Nasulin appears to have an ultra-rapid time/action profile which has the potential to mimic more closely the body’s natural insulin response to meals.
Partnering Update: Following the completion of an End-of-Phase-2 meeting earlier this year, Serenity Pharmaceuticals, CPEX’s licensing and development partner, recently began recruiting patients in multiple Phase 3 clinical trials with their undisclosed urology drug delivered using CPEX’s intranasal technology for the treatment of nocturia. These randomized, double blind, placebo controlled studies are being conducted at multiple sites in the United States.
New Patents Issued: On October 27, 2009 the United States Patent and Trademark Office issued six additional patents that expand the scope and claims of CPEX’s original patent covering Testim®, 1% testosterone gel. Testim® is marketed by Auxilium under license from CPEX. The new patents will expire in April 2023 and are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration.
Management Comments
“We are pleased about the recent completion of screening activities in our current Phase 2a study and the continued progress of our Nasulin clinical program. We look forward to presenting data from our earlier trials at the Ninth Annual Diabetes Technology Meeting taking place this week in San Francisco” stated John A. Sedor, CPEX President and Chief Executive Officer. “We are also encouraged by Serenity’s advancement of their compound for the treatment of nocturia into Phase 3 studies. This drug addresses a large urology indication with few treatment options. This is an exciting opportunity for CPEX and Serenity and we look forward to updating you on the future of this program.”
BioSpecialist
14 years ago
UNDER RADAR...
http://www.cpexpharm.com/files/pdfs/fs/factsheet.pdf
Cpex Pharma (CPEX)
Market Cap : 23 Mio$
Cash : 14,8 Mio$
Price : 9,16 $
Shares Out : 2,53 M
Pipeline
http://www.cpexpharm.com/pipeline.htm
Insider activity
http://finance.yahoo.com/q/it?s=CPEX
Third-Quarter Highlights
For the third quarter of 2009 compared to the third quarter of 2008;
* Revenues increased 26% to $5.0 million from $3.9 million.
* Operating expenses increased 17% to $5.8 million from $5.0 million.
* Net loss was $872,000, or $0.34 per share, compared to $1.0 million, or $0.43 per share.
The growth in revenues for the third quarter of 2009 was due to increased royalties on sales of Testim®. This growth is due to a reported 17% increase in prescriptions for Testim during the third quarter of 2009 compared to the same period in 2008. Operating expenses in the third quarter of 2009 increased $853,000, primarily due to clinical trial expenses associated with CPEX’s ongoing NasulinTM clinical program and legal costs associated with its on-going litigation with Upsher-Smith Laboratories regarding Testim. These increases were partially offset by a decrease in share-based compensation expense. Operating expenses for the three months ended September 30, 2008 include a $1.2 million non-cash charge resulting from the modification of equity awards associated with the spin-off from Bentley.
Business Update
Ongoing Clinical Trials: CPEX’s intranasal insulin product candidate for the treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes, Nasulin, is continuing clinical trials evaluating the safety and efficacy profile of the product. CPEX has completed screening activities in a Phase 2a study designed to assess the efficacy and safety of Nasulin versus placebo over a 6-week treatment period. This study is being conducted at multiple centers in the U.S. Prior trials in patients with Type 1 or 2 diabetes, as well as in healthy volunteers, have indicated that Nasulin appears to have an ultra-rapid time/action profile which has the potential to mimic more closely the body’s natural insulin response to meals.
Partnering Update: Following the completion of an End-of-Phase-2 meeting earlier this year, Serenity Pharmaceuticals, CPEX’s licensing and development partner, recently began recruiting patients in multiple Phase 3 clinical trials with their undisclosed urology drug delivered using CPEX’s intranasal technology for the treatment of nocturia. These randomized, double blind, placebo controlled studies are being conducted at multiple sites in the United States.
New Patents Issued: On October 27, 2009 the United States Patent and Trademark Office issued six additional patents that expand the scope and claims of CPEX’s original patent covering Testim®, 1% testosterone gel. Testim® is marketed by Auxilium under license from CPEX. The new patents will expire in April 2023 and are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration.
Management Comments
“We are pleased about the recent completion of screening activities in our current Phase 2a study and the continued progress of our Nasulin clinical program. We look forward to presenting data from our earlier trials at the Ninth Annual Diabetes Technology Meeting taking place this week in San Francisco” stated John A. Sedor, CPEX President and Chief Executive Officer. “We are also encouraged by Serenity’s advancement of their compound for the treatment of nocturia into Phase 3 studies. This drug addresses a large urology indication with few treatment options. This is an exciting opportunity for CPEX and Serenity and we look forward to updating you on the future of this program.”
BioSpecialist
14 years ago
A real BIG Opportunity !!!
CPEX's Nasulin Insulin Therapy Featured in an Oral Presentation and Four Abstracts at the Ninth Annual Diabetes Technology Meeting
* Press Release
* Source: CPEX Pharmaceuticals, Inc.
* On 9:51 am EST, Thursday November 5, 2009
EXETER, N.H.--(BUSINESS WIRE)--CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX - News) today announced that its intranasal insulin product candidate, NasulinTM, will be featured in an oral presentation and four abstracts at the Ninth Annual Diabetes Technology Meeting, November 5-7, 2009 at the Hyatt Regency Airport in San Francisco, California. Dr. Lance Berman, Senior Vice President and Chief Medical Officer, is scheduled to deliver an oral presentation entitled “The Technology and Clinical Aspects of Nasal Insulin Therapy” at 9:30 a.m. PST on Saturday, November 7. Further details on the abstracts are provided below.
A Randomized 6-Way Crossover Study of NasulinTM, Saline and Lispro in Subjects with Type 2 Diabetes to Determine Optimum Dose Timing
A similar glucose-lowering effect may be achieved by administering Nasulin either just before or at the end of the meal offering more flexibility of dosing than with injectable insulins.
Two Randomized Crossover Glucose Clamp Studies of NasulinTM and Lispro
In both Type1 diabetic patients and healthy volunteers, peak glucose metabolism rates occurred earlier with ultra-rapid acting Nasulin than with rapid acting lispro. The pharmacodynamic profile indicates Nasulin has optimum activity when glucose levels rise during a meal with less potential for hypoglycemia in the hours after the meal has ended.
Dose-Exposure for Single and Dual Nostril Administration of Nasal Insulin (NasulinTM)
The findings from this study demonstrated significantly enhanced insulin absorption when a 50 IU dose is administered as 2 sprays of 25 IU given in the same nostril rather than one spray in each nostril. In addition, the study also demonstrated that nasal administration of up to 200 microliters per nostril was well tolerated allowing the administration of doses up to 100 IU. Together these findings provide an improved dosing methodology and a higher maximum dose for evaluation in future clinical trials.
Dose-Exposure for Two Dose Strengths of Nasal Insulin (NasulinTM)
These data demonstrated that the original Nasulin concentration (1.0%) and the new concentration (0.7%) revealed proportional dose-dependent increases in insulin exposures.
Dr. Berman commented, “The data from these studies provide important information on Nasulin’s ability to rapidly lower glucose following a meal. With the completion of each study, we gain additional insight into the potential benefits Nasulin could offer to patients with diabetes. The most exciting aspect of these results is the second dose concentration, which will provide subjects in future clinical trials with a wider dose range to individually titrate their insulin needs to maximize glucose reduction without increasing the risk of hypoglycemia. These potential advantages of Nasulin’s ultra-rapid time-action profile may provide treating physicians and their patients safer alternatives for controlling their diabetes.”
BioSpecialist
14 years ago
Cheapest Bio-Stock on Nasdaq ....
This stock is under Radar .Do your own Research .
Cpex Pharma (CPEX)
Market Cap : 23,4 Mio$
Cash : 14,8 Mio$
Price : 9,27 $
Shares Out : 2,53 M
Pipeline
http://www.cpexpharm.com/pipeline.htm
Insider activity
http://finance.yahoo.com/q/it?s=CPEX
Third-Quarter Highlights
For the third quarter of 2009 compared to the third quarter of 2008;
* Revenues increased 26% to $5.0 million from $3.9 million.
* Operating expenses increased 17% to $5.8 million from $5.0 million.
* Net loss was $872,000, or $0.34 per share, compared to $1.0 million, or $0.43 per share.
The growth in revenues for the third quarter of 2009 was due to increased royalties on sales of Testim®. This growth is due to a reported 17% increase in prescriptions for Testim during the third quarter of 2009 compared to the same period in 2008. Operating expenses in the third quarter of 2009 increased $853,000, primarily due to clinical trial expenses associated with CPEX’s ongoing NasulinTM clinical program and legal costs associated with its on-going litigation with Upsher-Smith Laboratories regarding Testim. These increases were partially offset by a decrease in share-based compensation expense. Operating expenses for the three months ended September 30, 2008 include a $1.2 million non-cash charge resulting from the modification of equity awards associated with the spin-off from Bentley.
Business Update
Ongoing Clinical Trials: CPEX’s intranasal insulin product candidate for the treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes, Nasulin, is continuing clinical trials evaluating the safety and efficacy profile of the product. CPEX has completed screening activities in a Phase 2a study designed to assess the efficacy and safety of Nasulin versus placebo over a 6-week treatment period. This study is being conducted at multiple centers in the U.S. Prior trials in patients with Type 1 or 2 diabetes, as well as in healthy volunteers, have indicated that Nasulin appears to have an ultra-rapid time/action profile which has the potential to mimic more closely the body’s natural insulin response to meals.
Partnering Update: Following the completion of an End-of-Phase-2 meeting earlier this year, Serenity Pharmaceuticals, CPEX’s licensing and development partner, recently began recruiting patients in multiple Phase 3 clinical trials with their undisclosed urology drug delivered using CPEX’s intranasal technology for the treatment of nocturia. These randomized, double blind, placebo controlled studies are being conducted at multiple sites in the United States.
New Patents Issued: On October 27, 2009 the United States Patent and Trademark Office issued six additional patents that expand the scope and claims of CPEX’s original patent covering Testim®, 1% testosterone gel. Testim® is marketed by Auxilium under license from CPEX. The new patents will expire in April 2023 and are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration.
Management Comments
“We are pleased about the recent completion of screening activities in our current Phase 2a study and the continued progress of our Nasulin clinical program. We look forward to presenting data from our earlier trials at the Ninth Annual Diabetes Technology Meeting taking place this week in San Francisco” stated John A. Sedor, CPEX President and Chief Executive Officer. “We are also encouraged by Serenity’s advancement of their compound for the treatment of nocturia into Phase 3 studies. This drug addresses a large urology indication with few treatment options. This is an exciting opportunity for CPEX and Serenity and we look forward to updating you on the future of this program.”
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surf1944
14 years ago
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