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Profile: DURECT Corp (DRRX.OQ)

DRRX.OQ on NASDAQ Stock Exchange Global Market

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Durect Corporation, incorporated on February 6, 1998, is a biopharmaceutical company with research and development programs. The Company's research and development programs fall into two categories: new chemical entities derived from its Epigenomic Regulator Program, in which the Company attempts to discover and develop molecules, which have not previously been approved and marketed as therapeutics, and Drug Delivery Programs, in which the Company applies its formulation expertise and technologies to active pharmaceutical ingredients whose safety and efficacy have previously been established but which the Company focuses to improve through a new formulation. The Company's products candidates include DUR-928, oral for metabolic/lipid disorders, and DUR-928, injectable for acute organ injuries. Its other product candidates include POSIMIR (controlled release injection of bupivacaine), REMOXY (oral controlled release oxycodone), ORADUR-ADHD, ELADUR (controlled release injection of bupivicane), Relday (risperidone), ORADUR-based opioid (hydromorphone) and SABER-based ophthalmic.

The Company's ALZET product line consists of miniature, implantable osmotic pumps and accessories used for experimental research in mice, rats and other laboratory animals. ALZET pumps continuously deliver drugs, hormones and other test agents at controlled rates from 1 day to 6 weeks without the need for external connections, frequent handling or repeated dosing. In laboratory research, these infusion pumps can be used for systemic administration when implanted under the skin or in the body. The Company designs, develops and manufactures a range of standard and custom biodegradable polymers based on lactide, glycolide and caprolactone under the LACTEL brand for pharmaceutical and medical device clients for use as raw materials in their products. These materials are manufactured and sold by it directly from its facility in Alabama, and are used by it and its third-party customers for a range of controlled-release and medical-device applications.

The Company also manufactures and sells osmotic pumps used in laboratory research and design; and develops and manufactures a range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device clients for use as raw materials in their products. Its product pipeline consists of over seven investigational drug candidates in clinical development, with one program the subject of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA). The Company has other programs underway in fields outside of pain management, including central nervous system disorders, acute organ injury, metabolic disorders, ophthalmic conditions, and other chronic diseases. Its bioerodible injectable depot systems include its SABER and CLOUD platform technologies.

POSIMIR (SABER-Bupivacaine)

The Company is developing POSIMIR, an extended-release formulation of bupivacaine, using its SABER delivery system for the treatment of post-surgical pain. Bupivacaine is an off-patent pharmaceutical agent. The physician would administer POSIMIR at the time of surgery to the surgical site. This formulation is designed to provide extended analgesia from a single dose. Its POSIMIR clinical development program has been devised to establish the safety and efficacy of POSIMIR for the treatment of post-surgical pain for over three days.

REMOXY (ORADUR-Oxycodone)

REMOXY is an oral, long-acting oxycodone gelatin capsule under development with Pain Therapeutics to which the Company has licensed development and commercialization rights under a development and license agreement, across the world.

ORADUR-ADHD Program

The Company is developing ORADUR-ADHD, based on its ORADUR Technology for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This drug candidate is focused on providing once-a-day dosing with added tamper resistant characteristics to address common methods of abuse and misuse of these types of drugs.

ELADUR (TRANSDUR-Bupivacaine)

The Company's transdermal bupivacaine patch (ELADUR) is under development. ELADUR is focused on providing continuous delivery of bupivacaine for over three days from a single application, as compared to a wearing time limited to over 10 hours with available lidocaine patches.

Relday

Relday is being developed to address unmet clinical needs in this large patient population. Relday is generally safe and well-tolerated, with results consistent with the profile of risperidone and the previous Phase I single-dose clinical trial.

Additional ORADUR-Opioid Products

The Company also worked with Pain Therapeutics on the development of over three additional ORADUR abuse-resistant opioid drug candidates, which would address the chronic pain market. Phase I clinical trials have been conducted for over two of these ORADUR-based products (hydrocodone and hydromorphone).

The Company competes with Alkermes, Pacira, Immune Pharmaceuticals, Innocoll, Nektar, Kimberly-Clark, Acorda Therapeutics, Flamel, Alexza, Mallinckrodt, Hospira, Pfizer, Cumberland Pharmaceuticals, Egalet, Acura, Elite Pharmaceuticals, Phosphagenics, Intellipharmaceutics, Collegium Pharmaceutical and Heron Therapeutics.

Company Address

DURECT Corp

10260 Bubb Rd
CUPERTINO   CA   95014-4166
P: +1408.7771417
F: +1408.7773577

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