CPEX Pharmaceuticals, Inc. (CPEX)

[surf1944]

7:04AM CPEX Pharmaceuticals announces preliminary results from its Phase 2a clinical trial of Nasulin (CPEX) 15.75 : Co reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the its nasal insulin product, Nasulin. The primary objective was to demonstrate that subjects receiving Nasulin would achieve a larger increase from baseline in the mean proportion of time spent with normal glucose levels (or in euglycemia) than those receiving placebo, as assessed by continuous glucose monitoring. Although subjects in the placebo group spent less time in euglycemia at the end of the study compared to subjects in the Nasulin group, the difference between the two groups was not statistically significant (p-value = 0.2). The secondary efficacy measurements of change from baseline in average glucose as measured by continuous glucose monitoring and the change from baseline in serum fructosamine were consistent with the primary endpoint analysis. No critical safety signals were detected with Nasulin in the study. The most common adverse events were those attributable to administration site reactions associated with the nasal route of delivery, the majority of which were mild.

[BioSpecialist]

CPEX hits new 52W High ....

[BioSpecialist]

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]

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]

Break Out is Coming Soon

Strong buy at this price ..

[BioSpecialist]

Market Cap 0f 23 M4 is a Joke !!!

Shares Out only 2,5 M

Fact Sheet:
http://www.cpexpharm.com/files/pdfs/fs/factsheet.pdf


Gabelli & Co. initiates coverage on CPEX Pharmaceuticals, Inc (Nasdaq: CPEX) with a Buy. Price target $17.


Zacks #1 Rank Additions for Thursday
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# CPEX Pharmaceuticals Inc (CPEX)

[BioSpecialist]

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]

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]

Big news coming soon ...

“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

[BioSpecialist]

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.”