3SOF

Keep on watch.

• Coverage initiated on Durect by MDB Capital Group
Briefing.com (Wed, Aug 31) 
UPGRADES & DOWNGRADES HISTORY   
Date          Research Firm              Action            From           To
31-Aug-05  MDB Capital Group        Initiated                           Buy


****************************************************************

Profile Get Profile for: 

Durect Corp.
10240 Bubb Road
Cupertino, CA 95014
Phone: 408-777-1417
Fax: 408-777-3577
Web Site: http://www.durect.com

DETAILS   
Index Membership: N/A
Sector: Healthcare
Industry: Drug Manufacturers - Other
Full Time Employees: 132


BUSINESS SUMMARY   
DURECT Corporation develops pharmaceutical systems based on its proprietary drug delivery technology platforms. It has various product candidates under development in the areas of pain, and other chronic diseases and disorders. Its primary product candidates in development include SABER-Bupivacaine, TRANSDUR-Sufentanil, ORADUR- Oxycodone, DURIN-Leuprolide, and CHRONOGESIC. SABER-Bupivacaine, a post-operative pain relief depot product candidate, is a sustained release injectible using DURECT's SABER delivery system to deliver bupivacaine. TRANSDUR-Sufentanil, a transdermal sufentanil product candidate in phase II clinical studies, uses the TRANSDUR delivery system to deliver sufentanil, an opioid medication, to provide chronic pain relief for up to seven days. ORADUR- Oxycodone, an oral opioid product in phase III clinical studies, would be used to decrease the potential for oxycodone abuse. DURIN-Leuprolide is a product candidate using the DURIN implant system to deliver the peptide leuprolide to treat Alzheimer's disease. The CHRONOGESIC Pain Therapy System is an osmotic implant that would deliver sufentanil for an extended duration. CHRONOGESIC would be used to treat chronic pain and is based on the DUROS System, an osmotic pump. DURECT also engages in the research and development pharmaceutical systems in various therapeutic areas, including chronic pain, central nervous system disorders, and cardiovascular disease. In addition, the company manufactures and sells osmotic pumps used for animal research, and various biodegradable polymers for pharmaceutical and medical device clients for use as raw materials in their products. DURECT has strategic partnerships with Pain Therapeutics, Inc.; Voyager Pharmaceutical Corporation; Endo Pharmaceuticals, Inc.; Endo Pharmaceuticals, Inc.; and NeuroSystec Corporation. The company was co-founded by Felix Theeuwes, James E. Brown, and Thomas A. Schreck in 1998. DURECT is headquartered in Cupertino, California.

*************************************************************************

MACD looks good and there is a continuance in market accumulation. Insider and Institutional investors are buying...not selling!!! 
Support @ $6.28...6.18...5.84
Set a tight stop and roll the dice baby.

Technicals
Percentage Gainer

Last Price Quote is:
7.24%above 13-day EMA
15.25%above 50-day EMA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $333.20 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 10/24/2005
****Last Analyst Rating: Buy****

I'm a buyer.....

Moving to the upside......
+3.45%.......Volume.....728,804
Volume building

looks great Set    you are so the man.. I just have to keep on applauding, so many great picks! 

Thanks G,coming from you that means a great deal.
"You are Boss"!!!!!
Good trading my friend......

 
Recent buys
Insider action? increase in buy volume.

Press Release Source: DURECT Corporation


DURECT Corporation Announces Positive Phase III Clinical Results for Remoxy, a Novel Oral Pain Medication using the ORADUR(TM) Gel-Cap
Friday September 9, 7:30 am ET


CUPERTINO, Calif., Sept. 9 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX - News), an emerging specialty pharmaceutical company, announced today that Pain Therapeutics, Inc. has achieved positive Phase III clinical results for Remoxy(TM), a novel long-acting, abuse-deterrent oral formulation of oxycodone based on DURECT's ORADUR(TM) technology being developed under license from DURECT.


(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )

"These results represent a significant milestone for our ORADUR franchise and we are very pleased with the rapid progress by which this partnered program has advanced into late stage clinical development. Thus far, these clinical results reinforce our belief that products developed with our ORADUR sustained release oral gel-cap technology may offer a variety of benefits, including the potential to reduce abuse when compared to current long-acting dosage forms that are on the market today," stated James E. Brown, DVM, President and CEO of DURECT. "We continue working to expanding our relationships with a number of pharmaceutical companies to develop additional innovative sustained release oral gel-cap products that utilize select opioids and other potentially abused active agents."

Phase III Study Design and Results

The randomized, double-blinded study was designed to compare the safety and efficacy of Remoxy against placebo in osteoarthritic patients with moderate-to-severe chronic pain. Over 209 patients were enrolled in over 20 U.S. clinical sites. Patients were treated with Remoxy 20 mg or matching placebo twice daily over a 4-week study period. The results announced by Pain Therapeutics demonstrated a statistically significant percent decrease in pain scores for patients using Remoxy as compared to placebo, as measured by a standard Likert Pain Scale. Patients also reported a statistically significant difference in quality of life using Remoxy as compared to placebo, as measured by as measured by a standard SF-12 Health Survey and in patients' self- reported Quality of Analgesia. No drug-related safety issues were noted in the study, and as expected opioid-related adverse events (including nausea/vomiting, dizziness, pruritis (itching) and somnolence/sedation) and drop-out rates were higher in the Remoxy arm compared to placebo. Pain Therapeutics intends to initiate a second Phase III registration study by year-end 2005.

Remoxy draws upon the unique characteristics of the ORADUR sustained released oral gel-cap technology. Products based on the ORADUR technology can take the form of an easy to swallow gelatin capsule that uses a high-viscosity base component, SABER(TM) or sucrose acetate isobutyrate (SAIB), to provide controlled release of active ingredients for a period of from 12 to 24 hours of drug delivery. Oral dosage forms based on the ORADUR gel-cap may also have the added benefit of being less prone to abuse than other controlled release dosage forms on the market today. ORADUR-based products can be manufactured by a simple process using conventional methods making them readily scalable. These properties have the potential to make ORADUR-based products an

attractive option for pharmaceutical companies that seek to develop tamper and abuse resistant oral products.

About Remoxy

Remoxy is an oral, long-acting oxycodone capsule under development by Pain Therapeutics, Inc. that incorporates several abuse-deterrent properties and offers the convenience of twice-a-day dosing. Remoxy is formulated with DURECT Corporation's ORADUR technology under a joint development and license agreement. Oxycodone is also the active drug ingredient in OxyContin, a brand name narcotic painkiller with annual sales exceeding $1.9 billion. ORADUR is a patented technology based on sucrose acetate isobutyrate, a high-viscosity, biodegradable liquid matrix that forms the basis for a number of different injectible depot and oral gel-cap drug candidates, including Remoxy. Under the terms of the license agreement between Pain Therapeutics and DURECT, Pain Therapeutics has exclusive worldwide rights to develop and to commercialize Remoxy and certain other opioid drugs formulated with DURECT's ORADUR technology. DURECT is reimbursed for formulation and other work performed under its agreement with Pain Therapeutics, and will receive milestone payments based on the achievement of certain technical, clinical or regulatory milestones, in addition to receiving royalties on product sales.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies that treat chronic debilitating diseases and enable biotechnology products. These platform technologies include the SABER(TM) Delivery System (a patented and versatile depot injectable useful for protein and small molecule delivery), the ORADUR(TM) sustained release oral gel-cap technology (an oral sustained release technology with several potential abuse deterrent properties), the DURIN(TM) Biodegradable Implant (drug-loaded implant system), the TRANSDUR(TM) transdermal technology and the MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system). DURECT also collaborates with pharmaceutical companies to develop and commercialize proprietary and enhanced pharmaceutical products based on its technologies. DURECT has five disclosed on-going development programs of which four are in collaboration with pharmaceutical partners. Additional information about DURECT is available at http://www.durect.com.

NOTE: SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and MICRODUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT's products in development, anticipated product benefits and clinical trial plans are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's ability to complete the design, development, and manufacturing process development of the product candidate and obtain approvals from regulatory agencies to manufacture the product candidate, as well as Pain Therapeutics' ability to initiate, enroll and complete clinical trials and obtain product approvals from regulatory agencies to commercialize the product candidate, and marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Quarterly Report on Form 10-Q for the quarter ended June 30, 2005 filed with the SEC on August 4, 2005 under the heading "Factors that may affect future results."




--------------------------------------------------------------------------------
Source: DURECT Corporation

 
7:42AM Durect achieves positive Phase III clinical results for long-acting, abuse-deterrent oral formulation drug Remoxyl (DRRX) 6.76 :Results announced by Pain Therapeutics demonstrate statistically significant percent decrease in pain scores for patients using Remoxy as compared to placebo, as measured by a standard Likert Pain Scale.

 
AP
Pain Therapeutics' Remoxy Reduces Pain
Friday September 9, 10:08 am ET 
Pain Therapeutics' Remoxy Shown to Reduce Arthritis Pain in Late-Stage Clinical Trial


SOUTH SAN FRANCISCO, Calif. (AP) -- Biopharmaceutical company Pain Therapeutics Inc. said Friday that its Remoxy painkiller significantly reduced arthritis pain in patients enrolled in a late-stage clinical trial.


Pain Therapeutics shares surged 37 cents, or 5.7 percent, to $6.90 in morning trading on the Nasdaq. A year ago, the stock traded at a high of $8.39, but then dipped to a 52-week low of $4.78 in early April.

In a Phase III trial, the company found Remoxy relieved pain in osteoarthritic patients by a significant amount compared with patients given placebo. Side effects of the drug were typical of chronic opiate use: nausea, dizziness, itching and sedation. The company plans to begin an additional Phase III study by the end of the year before submitting a new drug application with the FDA.

Remoxy is intended to be an abuse-resistant version of Purdue Pharma LP's Oxycontin. The company's version of oxycodone, the active ingredient in Oxycontin, is a sticky, highly viscous mass that is difficult to snort or inject. Also, when placed in alcohol, Remoxy only releases a small amount of its oxycodone active ingredient.

The abuse-resistant formulation was developed using technology licensed from Cupertino, Calif.-based specialty drug maker Durect Corp. Durect saw the clinical trial results as a validation of its Oradur sustained release oral gel-cap technology. Shares of Durect were also up on the results, rising 28 cents, or 4.1 percent, to $7.04 in morning trading on the Nasdaq.

Possible new uptrend after falling to support around $5.15.
Nice bounce of the 200-dma.
Breaking out from its gradual rise off the bottom. MACD bottoming, stochastic rising out of oversold. Speculative bottom fishing, looking for a swing back up to $6.50-7.00 range.
Up nice in the afterhours.......After Hours (RT-ECN): 5.99  0.53 (9.71%)

Support @ $5.36...5.23...5.14
Resistance @ $5.47...5.77...6.08

Technicals
Last Price Quote is:
5.02%above 13-day EMA
-4.84%below 50-day EMA
RS Rating: 22 

Fundamentals
Key Data:
Market Cap (M): $271.21 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 02/09/2006
Last Analyst Rating: Equal-weight

Continuation.....   Nice week
Insider buying is not the sole reason for the price surge.
Short Covering is fueling the price.
DURECT is clearly undervalued at this price.
Very strong bounce off the 200-dma.

Support @ $5.77...5.43...5.14
Resistance @ $6.08...6.28...6.37

Technicals
Close Above the 50-day EMA
Percentage Gainer

Last Price Quote is:
9.72%above 13-day EMA
1.90%above 50-day EMA
RS Rating: 33 

Fundamentals
Key Data:
Market Cap (M): $271.21 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 02/09/2006
Last Analyst Rating: Equal-

moving.....

Volume: 823,723
Avg Vol (3m): 454,423

Technicals
Gap Up

Last Price Quote is:
8.68%above 13-day EMA
15.41%above 50-day EMA
RS Rating: 79 

Fundamentals
Key Data:
Market Cap (M): $311.18 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/09/2006
Last Analyst Rating: Sell

Could DRRX be setting itself up for a double bottom??

Press Release Source: DURECT Corporation


ORADUR(TM) Technology Milestone: New ORADUR-based Investigational Drug Candidate Commences Phase I Clinical Program
Wednesday August 2, 7:31 am ET


CUPERTINO, Calif., Aug. 2 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX - News) reported today the initiation of a Phase I clinical trial for a new ORADUR-based opioid drug candidate. This new drug candidate is the second ORADUR-based opioid drug to undergo clinical testing by King Pharmaceuticals, Inc., the company which will be commercializing the drug candidate, if approved, and Pain Therapeutics, Inc., DURECT's licensee of the rights to the drug candidate and other ORADUR-based products incorporating oxycodone and three other opioid compounds. The first drug candidate under development by Pain Therapeutics and King Pharmaceuticals, Remoxy (ORADUR-based oxycodone), is currently in Phase III clinical testing. According to Pain Therapeutics and King Pharmaceuticals, the investigational new drug (IND) application for this new drug candidate has been accepted by the U.S. Food and Drug Administration (FDA). The active pharmaceutical drug in the new ORADUR-based opioid drug candidate has not been disclosed.


(Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )

"We are very delighted with the advancement of our ORADUR technology platform and look forward to the continued progress of all of the products under the King Pharmaceuticals and Pain Therapeutics alliance," stated James E. Brown, DVM, President and Chief Executive Officer. "Furthermore, we look forward to developing additional innovative sustained release oral gel-cap products that utilize other opioids and other active agents prone to abuse."

About ORADUR

ORADUR sustained released oral gel-cap technology provides the unique characteristics of Remoxy and the other opioid drug candidates subject to the Pain Therapeutics and King Pharmaceuticals alliance. Products based on the ORADUR technology can take the form of an easy to swallow gelatin capsule that uses a high-viscosity base component, SABER(TM), to provide sustained release of active ingredients for a period of from 12 to 24 hours of drug delivery. Oral dosage forms based on the ORADUR gel-cap may also have the added benefit of being less prone to abuse than other controlled release dosage forms on the market today. ORADUR-based products can be manufactured by a simple process using conventional methods making them readily scalable. These properties have the potential to make ORADUR-based products an attractive option for pharmaceutical companies that seek to develop tamper and abuse resistant oral products.

About the Collaborations

On November 10, 2005, King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. announced that the companies have entered into a strategic alliance to develop and commercialize Remoxy, an oral, long-acting, abuse-resistant oxycodone capsule, and other ORADUR-based abuse-resistant products using three other opioid drugs. The products under this collaboration are formulated with DURECT Corporation's ORADUR technology under a development and license agreement between DURECT and Pain Therapeutics. Under the terms of the license agreement between Pain Therapeutics and DURECT, Pain Therapeutics has exclusive worldwide rights to develop and to commercialize Remoxy and other ORADUR-based products using oxycodone and three other opioid drugs. DURECT is reimbursed for formulation and other work performed under its agreement with Pain Therapeutics, and will receive milestone payments based on the achievement of certain technical, clinical or regulatory milestones, in addition to receiving royalties on end product sales. Pain Therapeutics has sublicensed the commercialization rights of Remoxy and other ORADUR-based opioid products to King Pharmaceuticals. Oxycodone is the active drug ingredient in Remoxy and in the branded product OxyContin®, a leading brand name opioid used in the treatment of moderate-to-severe pain.

About DURECT

DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies. The company is developing pharmaceutical systems to deliver the right drug to the right place in the right amount at the right time to treat chronic and episodic diseases and conditions.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT's and our collaborators' investigational products, development and clinical trial plans, commercial potential and possible economic returns are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's and that of its third-party collaborators' abilities to successfully design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Quarterly Report on Form 10-Q for the quarter ended March 31, 2006 filed with the SEC on May 10, 2006 under the heading "Risk Factors."

NOTE: SABER(TM) and ORADUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.

--------------------------------------------------------------------------------
Source: DURECT Corporation