At
“We initiated our multiple-ascending-dose, oral administration Phase 1 study with DUR-928 in March and expect to have results in the second quarter of 2015,” 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 has determined that they cannot approve the NDA in its present form, stating the NDA does 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. We had a face-to-face meeting with theFDA inSeptember 2014 to discuss what needs to be done to address the issues cited in the Complete Response Letter. As a result of this meeting and based on subsequent communications with theFDA , we have submitted to theFDA a protocol synopsis for a soft tissue Phase 3 clinical trial designed to generate the efficacy and safety data required by theFDA for product approval. We anticipate receivingFDA feedback to that protocol synopsis in the near term.
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. Simultaneous with these activities, we are preparing to be in a position to commercialize POSIDUR ourselves in the U.S. in the event that we determine that is the preferred route of commercialization.
- 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. Development and commercialization rights had been held by Pfizer until October of 2014, when Pfizer notified our licensee,Pain Therapeutics , that it was returning those rights. We understand that the studies required to resubmit the NDA were completed in 2014, although we have not seen the results.Pain Therapeutics has stated that it is focused on an orderly transition of the program back from Pfizer, which they expect to be substantially complete in the second quarter of 2015, finalizing a strategy around the prospect of resubmitting the NDA, and seeking a new commercial partner. The extended release oxycodone market is~$2.5 billion in the U.S. alone, and we are eligible for a potential royalty on REMOXY of between 6.0% to 11.5% of net sales depending on sales volumes.
- Epigenomic Regulator Program. On
March 2, 2015 we announced our Epigenomic Regulator Program and the successful completion of a single dose, oral administration Phase 1 clinical trial with the program’s lead product candidate DUR-928. DUR-928 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. OnMarch 30, 2015 we announced the initiation of a multiple-ascending-dose, oral administration Phase 1 clinical trial with DUR-928. We expect to have results from this study in the second quarter of 2015.
- 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. We understand that
Orient Pharma , our licensee in defined Asian and South Pacific countries, anticipates initiating a Phase 3 study inTaiwan in mid-2015 and 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 first 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 first 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 meetings, discussions and submissions for POSIDUR, REMOXY and Relday and potential
DURECT CORPORATION |
|||||||
CONDENSED STATEMENTS OF COMPREHENSIVE (LOSS) |
|||||||
(in thousands, except per share amounts) |
|||||||
(unaudited) |
|||||||
Three months ended |
|||||||
March 31 |
|||||||
2015 |
2014 |
||||||
Collaborative research and development and other revenue |
$ 1,738 |
$ 3,512 |
|||||
Product revenue, net |
3,035 |
2,781 |
|||||
Total revenues |
4,773 |
6,293 |
|||||
Operating expenses: |
|||||||
Cost of product revenues |
1,006 |
1,063 |
|||||
Research and development |
5,367 |
5,469 |
|||||
Selling, general and administrative |
2,820 |
3,363 |
|||||
Total operating expenses |
9,193 |
9,895 |
|||||
Income (loss) from operations |
(4,420) |
(3,602) |
|||||
Other income (expense): |
|||||||
Interest and other income (expenses) |
128 |
3 |
|||||
Interest expense |
(561) |
(1) |
|||||
Net other income (expense) |
(433) |
2 |
|||||
Net loss |
$ (4,853) |
$ (3,600) |
|||||
Net loss per share |
|||||||
Basic |
$ (0.04) |
$ (0.03) |
|||||
Diluted |
$ (0.04) |
$ (0.03) |
|||||
Weighted-average shares used in computing net loss per share |
|||||||
Basic |
113,793 |
110,468 |
|||||
Diluted |
113,793 |
110,468 |
|||||
Total comprehensive loss |
$ (4,938) |
$ (3,596) |
DURECT CORPORATION |
||||
CONDENSED BALANCE SHEETS |
||||
(in thousands) |
||||
As of |
As of |
|||
March 31, 2015 |
December 31, 2014(1) |
|||
(unaudited) |
||||
ASSETS |
||||
Current assets: |
||||
Cash and cash equivalents |
$ 1,989 |
$ 2,680 |
||
Short-term investments |
27,026 |
30,016 |
||
Accounts receivable |
2,243 |
2,122 |
||
Inventories |
3,806 |
3,642 |
||
Prepaid expenses and other current assets |
1,402 |
1,034 |
||
Total current assets |
36,466 |
39,494 |
||
Property and equipment, net |
1,615 |
1,749 |
||
Goodwill |
6,399 |
6,399 |
||
Long-term investments |
500 |
1,804 |
||
Long-term restricted Investments |
250 |
350 |
||
Other long-term assets |
288 |
288 |
||
Total assets |
$ 45,518 |
$ 50,084 |
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||
Current liabilities: |
||||
Accounts payable |
$ 890 |
$ 1,021 |
||
Accrued liabilities |
3,186 |
5,051 |
||
Contract research liability |
307 |
358 |
||
Deferred revenue, current portion |
1,048 |
538 |
||
Current portion of long-term debt, net |
1,826 |
– |
||
Total current liabilities |
7,257 |
6,968 |
||
Deferred revenue, noncurrent portion |
2,608 |
2,742 |
||
Long-term debt, net |
18,017 |
19,824 |
||
Other long-term liabilities |
2,161 |
2,035 |
||
Stockholders’ equity |
15,475 |
18,515 |
||
Total liabilities and stockholders’ equity |
$ 45,518 |
$ 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-first-quarter-2015-financial-results-and-update-of-programs-300075310.html
SOURCE
Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936