At
“The second quarter marked significant progress on multiple fronts,” stated
Update of Selected Programs:
- POSIDUR (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. In
February 2014 , we received a Complete Response Letter from the FDA. Based on its review, theFDA determined that they could not approve the NDA in its present form, stating the NDA did not contain sufficient information to demonstrate that POSIDUR is safe when used in the manner described in the proposed label, and theFDA indicated that additional clinical safety studies would need to be conducted. Based on multiple interactions with theFDA , we announced inJune 2015 that we plan to conduct a new POSIDUR Phase 3 clinical trial consisting of approximately 300 patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery.DURECT anticipates beginning the trial in the fall of 2015 and expects that it will take approximately one year to complete enrollment. This clinical trial is designed to generate data necessary to support an NDA resubmission.
POSIDUR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to three days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIDUR, for which we hold worldwide rights, while at the same time we are evaluating whether to commercialize POSIDUR on our own in the U.S. in the event that we determine that is the preferred route of commercialization. - Epigenomic Regulator Program. DUR-928, the 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. Previously we communicated that the biological activity of DUR-928 has been demonstrated in 6 different animal disease models involving three animal species. Three of these models represent acute organ injury (endotoxin shock, kidney, and liver) and three represent chronic disorders of hepatic lipid accumulation and dysfunction (e.g., NAFLD and NASH). Today we are reporting that DUR-928 provided protection against ischemic damage to the brain in a rat stroke model. In this study, a number of measures (lesion volume, edema volume and T2 lesion as determined by MRI, plus body weight recovery and behavioral recovery) were taken at 1 day and at 7 days after induction of the stroke lesion. In this study, lesion volumes and brain edema were statistically significantly reduced compared to placebo at day 1, and T2 lesions (a measure of cell viability) were statistically significantly improved at day 1 and day 7. Other measurements showed a consistent trend in favor of DUR-928 in this model. The data from this stroke model provides further support to our other acute animal models and is suggestive of DUR-928’s potential use against ischemic damage and acute organ injuries. On
March 2, 2015 we announced that DUR-928 had successfully completed a single dose, oral administration Phase 1 clinical trial and onMay 18, 2015 we announced the successful completion of a multiple-ascending-dose, oral administration Phase 1 clinical trial. We are currently mapping out our strategy for taking the oral version of DUR-928 into patients. In addition, we are preparing for our Phase 1 clinical studies with an injectable formulation of DUR-928 in the second half of this year. - REMOXY (oxycodone) Extended-Release Capsules CII. Based on
DURECT’s ORADUR® technology, REMOXY is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse. InMay 2015 ,Pain Therapeutics stated that the transition of the program back from Pfizer was substantially complete, and that they expect to resubmit the NDA in the first quarter of 2016. The extended release oxycodone market is~$2.4 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. - Relday (Risperidone Program). Relday is a proprietary, long-acting, once-monthly subcutaneous injectable formulation of risperidone. To provide context, an existing long-acting injectable risperidone product that achieved
$1.2 billion in global net sales in 2014 requires drug reconstitution prior to use and twice-monthly, intramuscular injections.Zogenix (our licensee) has previously announced positive results from a single-dose Phase 1 clinical trial of Relday at the full dose range anticipated to be used in clinical practice.Zogenix commenced a multi-dose trial in the first quarter of 2015 and expects to have top-line data in the third quarter of 2015.Zogenix has also stated that it is targeting an end-of-Phase 2 meeting with theFDA by early 2016. - 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. - Feasibility Projects and Other Activities. During the second quarter of 2015, we continued work on several feasibility projects and have multiple discussions underway with other parties about new feasibility projects which are designed to demonstrate that our technologies can achieve the drug delivery objectives set forth by our collaborators and are worthy of further development. The Relday program and the Santen ophthalmic program are two such projects which have matured into development and license agreements.
- Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIDUR, 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 second quarter 2015 results will be broadcast live over the internet at
About
NOTE: POSIDUR™, SABER®, ORADUR®, and TRANSDUR® are trademarks of
DURECT Forward-Looking Statement
The statements in this press release regarding regulatory matters, including anticipated meetings and submissions for POSIDUR, REMOXY and Relday and potential
DURECT CORPORATION CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (in thousands, except per share amounts) (Unaudited) |
||||||||||
Three months ended |
Six months ended |
|||||||||
June 30 |
June 30 |
|||||||||
2015 |
2014 |
2015 |
2014 |
|||||||
Collaborative research and development and other revenue |
$ 1,778 |
$ 1,735 |
$ 3,516 |
$ 5,247 |
||||||
Product revenue, net |
2,663 |
2,846 |
5,698 |
5,627 |
||||||
Total revenues |
4,441 |
4,581 |
9,214 |
10,874 |
||||||
Operating expenses: |
||||||||||
Cost of product revenues |
1,022 |
1,091 |
2,028 |
2,154 |
||||||
Research and development |
5,638 |
6,088 |
11,005 |
11,557 |
||||||
Selling, general and administrative |
2,724 |
2,850 |
5,544 |
6,213 |
||||||
Total operating expenses |
9,384 |
10,029 |
18,577 |
19,924 |
||||||
Income (loss) from operations |
(4,943) |
(5,448) |
(9,363) |
(9,050) |
||||||
Other income (expense): |
||||||||||
Interest and other income (expenses) |
23 |
3 |
151 |
6 |
||||||
Interest expense |
(558) |
(33) |
(1,119) |
(34) |
||||||
Net other income (expense) |
(535) |
(30) |
(968) |
(28) |
||||||
Net loss |
$ (5,478) |
$ (5,478) |
$ (10,331) |
$ (9,078) |
||||||
Net loss per share |
||||||||||
Basic |
$ (0.05) |
$ (0.05) |
$ (0.09) |
$ (0.08) |
||||||
Diluted |
$ (0.05) |
$ (0.05) |
$ (0.09) |
$ (0.08) |
||||||
Weighted-average shares used in computing net loss per share |
||||||||||
Basic |
118,804 |
110,570 |
116,313 |
110,519 |
||||||
Diluted |
118,804 |
110,570 |
116,313 |
110,519 |
||||||
Total comprehensive loss |
$ (5,482) |
$ (5,481) |
$ (10,420) |
$ (9,077) |
DURECT CORPORATION CONDENSED BALANCE SHEETS (in thousands) |
||||
As of |
As of |
|||
June 30, 2015 |
December 31, 2014(1) |
|||
(unaudited) |
||||
ASSETS |
||||
Current assets: |
||||
Cash and cash equivalents |
$ 5,990 |
$ 2,680 |
||
Short-term investments |
31,606 |
30,016 |
||
Accounts receivable |
1,901 |
2,122 |
||
Inventories |
3,929 |
3,642 |
||
Prepaid expenses and other current assets |
1,170 |
1,034 |
||
Total current assets |
44,596 |
39,494 |
||
Property and equipment, net |
1,543 |
1,749 |
||
Goodwill |
6,399 |
6,399 |
||
Long-term investments |
– |
1,804 |
||
Long-term restricted Investments |
250 |
350 |
||
Other long-term assets |
288 |
288 |
||
Total assets |
$ 53,076 |
$ 50,084 |
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||
Current liabilities: |
||||
Accounts payable |
$ 654 |
$ 1,021 |
||
Accrued liabilities |
3,770 |
5,051 |
||
Contract research liability |
404 |
358 |
||
Deferred revenue, current portion |
776 |
538 |
||
Total current liabilities |
5,604 |
6,968 |
||
Deferred revenue, noncurrent portion |
2,473 |
2,742 |
||
Long-term debt, net |
19,862 |
19,824 |
||
Other long-term liabilities |
2,275 |
2,035 |
||
Stockholders’ equity |
22,862 |
18,515 |
||
Total liabilities and stockholders’ equity |
$ 53,076 |
$ 50,084 |
||
(1) Derived from audited financial statements. |
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/durect-corporation-announces-second-quarter-2015-financial-results-and-update-of-programs-300122640.html
SOURCE
Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936