PR Newswire
CUPERTINO, Calif., May 2, 2018
CUPERTINO, Calif., May 2, 2018 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended March 31, 2018 and provided a corporate update.
"We are very pleased with recent progress on our lead internal candidate DUR-928, with our first two Phase 2 trials in different indications now underway and a third Phase 2 trial in another indication expected to commence in the third quarter of this year," stated James E. Brown, D.V.M., President and CEO of DURECT. "On other fronts, we have economic stakes in two drug candidates that have approaching PDUFA dates. Indivior's NDA for RBP-7000, in development for schizophrenia, has a PDUFA target action date of July 28, 2018 and Pain Therapeutics' REMOXY ER has a PDUFA target action date of August 7, 2018."
Update on Selected Programs:
Epigenetic Regulator Program. DUR-928, the lead product candidate in our Epigenetic Regulator Program, is an endogenous, first-in-class small molecule, which may have broad applicability in several hepatic and renal diseases such as nonalcoholic steatohepatitis (NASH) and other disorders of the liver including primary sclerosing cholangitis (PSC), in acute organ injuries such as acute liver and kidney injury, and in inflammatory skin disorders such as psoriasis and atopic dermatitis.
Oral Administration
Injectable Administration
Topical Administration
Indivior Agreement and RBP-7000. In September 2017, we entered into a patent purchase agreement with an affiliate of Indivior PLC, whereby DURECT assigned certain of its U.S. patent rights to Indivior. This assignment may provide further intellectual property protection for RBP-7000, Indivior's investigational once-monthly injectable risperidone product for the treatment of schizophrenia. Indivior submitted an NDA for RBP-7000 to the FDA, which has been accepted for review. The PDUFA (Prescription Drug User Fee Act) target action date is July 28, 2018.
Under the terms of the agreement, Indivior has made an upfront non-refundable payment to DURECT of $12.5 million, with the potential for an additional $5 million payment based on NDA approval of RBP-7000, as well as quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the patent rights, including RBP-7000. The patent rights include granted patents extending through at least 2026.
REMOXY® ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR® technology, the investigational drug REMOXY ER is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse. In January 2018, Pain Therapeutics announced positive results from a human abuse potential study using nasal administration of REMOXY ER and stated that all studies necessary to resubmit the REMOXY ER NDA to the FDA had been completed. The REMOXY ER NDA was resubmitted to the NDA by Pain Therapeutics in February 2018 and this was followed by an announcement on March 1 that the FDA had determined that the NDA was sufficiently complete to permit a substantive review. A PDUFA target action date has been set for August 7, 2018. The FDA plans to hold an Advisory Committee Meeting to discuss the NDA for REMOXY ER, and the tentative date for this meeting is June 26, 2018.
POSIMIR® (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.
In October 2017, we reported that PERSIST, a Phase 3 clinical trial for POSIMIR did not meet its primary efficacy endpoint of reduction in pain on movement as compared to standard bupivacaine HCl over the first 48 hours after surgery. While the efficacy results trended in favor of POSIMIR versus the comparator, they did not achieve statistical significance. We are working together with Sandoz, our U.S. commercial licensee for POSIMIR, to consider potential next steps.
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2018 results and provide a corporate update will be broadcast live over the internet at 4:30 p.m. Eastern Time on May 2 and will be available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate in the live webcast, the call will be archived on DURECT's website under Audio Archive in the "Investor Relations" section.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR-928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury, hepatic and renal diseases such as nonalcoholic steatohepatitis (NASH) and PSC, and inflammatory skin conditions such as psoriasis and atopic dermatitis. DURECT's advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology, for which the FDA has set a PDUFA target action date of August 7, 2018. In addition, for the assignment of certain patent rights, DURECT may receive a milestone payment upon NDA approval and single digit sales-based earn-out payments from U.S. net sales of Indivior's RBP-7000 investigational drug for schizophrenia, for which Indivior has submitted an NDA and for which the FDA has set a PDUFA target action date of July 28, 2018. For more information, please visit www.durect.com.
NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928, REMOXY ER, POSIMIR and RBP-7000 are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding potential future payments from Indivior and Pain Therapeutics, clinical trial plans for DUR-928, including the Phase 2a trials in primary sclerosing cholangitis and alcoholic hepatitis, and the potential commencement of a clinical trial in psoriasis, the potential disclosure of Phase 2 data in 2018, the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat PSC, alcoholic hepatitis, other disorders of the liver, kidney diseases, acute organ injuries, psoriasis, atopic dermatitis or other inflammatory conditions, our plans for POSIMIR, and the potential regulatory approval of REMOXY ER and RBP-7000 (including the timing thereof) 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, the risks that future clinical trials of DUR-928 are not started when anticipated or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that FDA may not grant regulatory approval of RBP-7000 or REMOXY ER, the risks of obtaining marketplace acceptance of RBP-7000 or REMOXY ER, if approved, the risk that Sandoz may terminate our agreement with them and discontinue plans to commercialize POSIMIR, the risk that prior clinical trials (including prior Phase 1b trials of DUR-928) will not be confirmed in subsequent trials, the potential failure of clinical trials to meet their intended endpoints, the risk that Pain Therapeutics or Indivior will discontinue plans to commercialize REMOXY ER or RBP-7000, respectively, or be delayed in commercialization if such products receive FDA approval, the risk that additional time and resources that may be required for development, testing and regulatory approval of POSIMIR or DUR-928, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-K filed on March 8, 2018 under the heading "Risk Factors."
DURECT CORPORATION | ||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | ||||
(in thousands, except per share amounts) | ||||
(unaudited) | ||||
| | | | |
| | | | |
| | Three months ended | ||
| | March 31 | ||
| | 2018 | | 2017 |
| | | | |
Collaborative research and development and other revenue | $ 1,096 | | $ 434 | |
Product revenue, net | 2,392 | | 4,133 | |
| Total revenues | 3,488 | | 4,567 |
| | | | |
Operating expenses: | | | | |
| Cost of product revenues | 1,174 | | 1,543 |
| Research and development | 6,952 | | 7,548 |
| Selling, general and administrative | 3,194 | | 3,043 |
Total operating expenses | 11,320 | | 12,134 | |
| | | | |
Loss from operations | (7,832) | | (7,567) | |
| | | | |
Other income (expense): | | | | |
| Interest and other income | 158 | | 36 |
| Interest and other expense | (623) | | (583) |
Net other expense | (465) | | (547) | |
| | | | |
Net loss | $ (8,297) | | $ (8,114) | |
| | | | |
Net loss per share | | | | |
| Basic | $ (0.05) | | $ (0.06) |
| Diluted | $ (0.05) | | $ (0.06) |
| | | | |
Weighted-average shares used in computing net loss per share | | | | |
| Basic | 153,558 | | 141,815 |
| Diluted | 153,558 | | 141,815 |
| | | | |
Total comprehensive loss | $ (8,297) | | $ (8,116) | |
| | | | |
| | | |
DURECT CORPORATION | |||
CONDENSED BALANCE SHEETS | |||
(in thousands) | |||
| | | |
| As of | | As of |
| March 31, 2018 | | December 31, 2017(1) |
| (unaudited) | | |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ 39,325 | | $ 29,375 |
Short-term investments | 4,809 Werbung Mehr Nachrichten zur Durect Aktie kostenlos abonnieren
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