At
“The highlight of the quarter was undoubtedly the resubmission of the REMOXY® NDA, followed by its acceptance for review by the
Update of Selected Programs:·
- Epigenomic Regulator Program. DUR-928, our Epigenomic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury.
During the first quarter, we began our first patient trial utilizing DUR-928. This study is an open-label single-ascending-dose safety and pharmacokinetic Phase 1b trial of DUR-928 in NASH patients and matched control subjects. This study will be conducted in successive cohorts evaluating single-dose levels of oral DUR-928. After a PK/safety review at each dose, the study can proceed to the next higher dose. The study is being conducted in
Australia , and we anticipate that we will start obtaining results from this trial in the second quarter of 2016. This study is designed to enable and inform a subsequent multi-dose study in NASH or other patients with other liver function impairment.In addition, our protocol has been approved by the institutional review board for a second study in patients with DUR-928, also being conducted in
Australia . This Phase 1b trial of DUR-928 is an open-label single-ascending-dose safety and pharmacokinetic study in patients with impaired kidney function and matched control subjects. This study will be conducted in successive cohorts evaluating single-dose levels of DUR-928 administered by injection. After a PK/safety review at each dose, the study can proceed to the next higher dose. We anticipate that this study will be completed in 2016, and that this study will enable and inform subsequent trials for patients with either acute kidney injury or other kidney function impairment. - REMOXY (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, REMOXY is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse.
Pain Therapeutics (our licensee) resubmitted the NDA on schedule inMarch 2016 . InApril 2016 ,Pain Therapeutics announced that theFDA had determined that the NDA was sufficiently complete to permit a substantive review and thatSeptember 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA). The extended release oxycodone market is greater than$2 billion in the U.S. alone, and we are eligible for a potential royalty on REMOXY between 6.0% to 11.5% of net sales depending on sales volumes. - POSIMIR (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. In
November 2015 , we began enrolling patients for PERSIST, a new POSIMIR Phase 3 clinical trial, consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. In a previous clinical trial of 50 patients undergoing laparoscopic cholecystectomy, POSIMIR was compared with the active control bupivacaine hydrochloride, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024), using the same statistical methodology specified for the current trial. We began recruiting patients for this trial with an intent to compare POSIMIR to placebo. Based on recommendations from theFDA received subsequent to the start of the trial, inApril 2016 we decided to amend the PERSIST trial including by incorporating standard bupivacaine HCl as an active control. This change will add to the time and cost to complete the PERSIST trial, but we believe that a positive outcome from this trial design would result in a stronger NDA filing and potentially commercial advantages. This clinical trial is designed to generate data necessary to support an NDA resubmission.POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide 3 days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights. We are also continuing to evaluate the requirements for commercializing POSIMIR on our own in the U.S., in the event that we determine that to be the preferred route of commercialization.
- Relday (Risperidone Program). Relday is a proprietary, long-acting, once-monthly subcutaneous injectable formulation of risperidone for the treatment of schizophrenia. In
September 2015 ,Zogenix (our licensee) announced that they had completed a multi-dose Phase 1b trial with results consistent with the profile of risperidone and a previous Phase 1 single-dose clinical trial.Zogenix has stated that it is seeking a development and commercialization partner for Relday and that Relday is well-positioned to begin a Phase 3 program once a partner is secured. - ORADUR-ADHD Program. In 2013, we selected a formulation for the lead program in our ORADUR-ADHD (Attention Deficit Hyperactivity Disorder) program, ORADUR-Methylphenidate. This formulation was chosen based on its potential for rapid onset of action, long duration with once-a-day dosing and target pharmacokinetic profile as demonstrated in a Phase 1 trial. In addition, this product candidate utilizes a small capsule size relative to the leading existing long acting products on the market and incorporates our ORADUR anti-tampering technology.
Orient Pharma , our licensee in defined Asian and South Pacific countries, has initiated a Phase 3 study inTaiwan and anticipates completing it in 2016. We retain rights to all other markets in the world, notably including the U.S.,Europe andJapan , and are engaged in licensing discussions with other companies. - Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIMIR, DUR-928, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2016 results will be broadcast live over the internet at
About
NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of
DURECT Forward-Looking Statement
The statements in this press release regarding regulatory matters, including the PDUFA date for REMOXY and potential
DURECT CORPORATION |
|||||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS |
|||||||
(in thousands, except per share amounts) |
|||||||
(unaudited) |
|||||||
Three months ended |
|||||||
March 31 |
|||||||
2016 |
2015 |
||||||
Collaborative research and development and other revenue |
$ 419 |
$ 1,738 |
|||||
Product revenue, net |
3,189 |
3,035 |
|||||
Total revenues |
3,608 |
4,773 |
|||||
Operating expenses: |
|||||||
Cost of product revenues |
1,242 |
1,006 |
|||||
Research and development |
6,625 |
5,367 |
|||||
Selling, general and administrative |
3,062 |
2,820 |
|||||
Total operating expenses |
10,929 |
9,193 |
|||||
Loss from operations |
(7,321) |
(4,420) |
|||||
Other income (expense): |
|||||||
Interest and other income |
27 |
128 |
|||||
Interest expense |
(558) |
(561) |
|||||
Net other income (expense) |
(531) |
(433) |
|||||
Net loss |
$ (7,852) |
$ (4,853) |
|||||
Net loss per share |
|||||||
Basic |
$ (0.06) |
$ (0.04) |
|||||
Diluted |
$ (0.06) |
$ (0.04) |
|||||
Weighted-average shares used in computing net loss per share |
|||||||
Basic |
122,149 |
113,793 |
|||||
Diluted |
122,149 |
113,793 |
|||||
Total comprehensive loss |
$ (7,835) |
$ (4,938) |
|||||
DURECT CORPORATION |
||||
CONDENSED BALANCE SHEETS |
||||
(in thousands) |
||||
As of |
As of |
|||
March 31, 2016 |
December 31, 2015(1) |
|||
(unaudited) |
||||
ASSETS |
||||
Current assets: |
||||
Cash and cash equivalents |
$ 3,853 |
$ 3,583 |
||
Short-term investments |
20,181 |
25,457 |
||
Short-term restricted Investments |
100 |
– |
||
Accounts receivable |
1,722 |
2,222 |
||
Inventories |
4,007 |
3,917 |
||
Prepaid expenses and other current assets |
3,074 |
3,142 |
||
Total current assets |
32,937 |
38,321 |
||
Property and equipment, net |
1,477 |
1,566 |
||
Goodwill |
6,399 |
6,399 |
||
Long-term restricted Investments |
150 |
250 |
||
Other long-term assets |
236 |
236 |
||
Total assets |
$ 41,199 |
$ 46,772 |
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||
Current liabilities: |
||||
Accounts payable |
$ 994 |
$ 1,286 |
||
Accrued liabilities |
4,552 |
4,970 |
||
Contract research liability |
454 |
575 |
||
Deferred revenue, current portion |
464 |
616 |
||
Current portion of Long-term debt, net |
1,826 |
– |
||
Total current liabilities |
8,290 |
7,447 |
||
Deferred revenue, noncurrent portion |
2,206 |
2,269 |
||
Long-term debt, net |
17,892 |
19,684 |
||
Other long-term liabilities |
2,585 |
2,489 |
||
Stockholders’ equity |
10,226 |
14,883 |
||
Total liabilities and stockholders’ equity |
$ 41,199 |
$ 46,772 |
||
(1) Derived from audited financial statements. |
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/durect-corporation-announces-first-quarter-2016-financial-results-and-update-of-programs-300263777.html
SOURCE
Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936