CUPERTINO, Calif., Aug. 8, 2017 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced financial results for
the three months ended June 30, 2017
and provided a corporate update.
- Executed a U.S. commercialization agreement with Sandoz for
POSIMIR®, including a $20
million upfront payment, as well as milestone payments and
double digit royalties.
- Total revenues were $4.3 million
and net loss was $9.9 million for the
three months ended June 30, 2017 as
compared to total revenues of $3.2
million and net loss of $9.0
million for the three months ended June 30, 2016.
- At June 30, 2017, cash and
investments were $33.6 million,
compared to cash and investments of $25.2
million at December 31, 2016.
Cash and investments increased during the quarter primarily as a
result of the upfront payment received from Sandoz in connection
with our POSIMIR agreement. Debt at June 30,
2017 was $19.9 million.
"Highlights of the second quarter included reaching agreement
with Sandoz to commercialize POSIMIR in the United States and completing ahead of
schedule the enrollment of PERSIST, the POSIMIR pivotal Phase 3
clinical trial in post-operative pain," stated James E. Brown, D.V.M., President and CEO of
DURECT. "We completed drug-drug interaction studies with
DUR-928, the lead molecule in our Epigenetic Regulator Program, and
found no evidence of likely drug interactions. We also
completed a second Phase 1b study in which we observed that DUR-928
was well tolerated in moderate to severe kidney function impaired
patients and that the pharmacokinetics were comparable among the
patients and matched control subjects. In addition, we were
pleased that Orient Pharma, our licensee in certain Asian and South
Pacific countries, has achieved positive top-line results from a
Phase 3 clinical study of ORADUR-Methylphenidate ER conducted in
Taiwan."
Update on Selected Programs:
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 May 2017, we signed a
development and commercialization agreement with Sandoz AG covering
the United States. Under the terms
of the agreement, Sandoz has made an upfront payment to DURECT of
$20 million, with the potential for
up to an additional $43 million in
development and regulatory milestones, up to an additional
$230 million in sales-based
milestones, as well as a tiered double digit royalty on product
sales in the United States. DURECT
will remain responsible for the completion of the PERSIST Phase 3
clinical trial for POSIMIR as well as FDA interactions through
approval.
- In June 2017, we completed
enrolling 296 patients in Part 2 of PERSIST, a POSIMIR Phase 3
clinical trial consisting of patients undergoing laparoscopic
cholecystectomy (gallbladder removal) surgery. We expect to
complete patient follow-up visits in the third quarter and to
announce top-line results from PERSIST in the fourth quarter of
this year.
Epigenetic Regulator Program. DUR-928, the lead product
candidate in our Epigenetic Regulator Program, is an endogenous,
small molecule, new chemical entity (NCE), which may have broad
applicability in several metabolic diseases such as nonalcoholic
steatohepatitis (NASH) and other disorders of the liver, in acute
organ injuries such as acute kidney injury, and in
autoimmune/inflammatory skin disorders such as psoriasis.
Oral Administration
- We recently conducted in vivo drug-drug interaction
(DDI) studies with both orally administered and IV injected
DUR-928. The results demonstrate that DUR-928 did not have effects
on the safety and pharmacokinetics (PK) of midazolam, a drug used
for detecting drug-drug interactions via the enzyme CYP3A4. This
enzyme is commonly associated with causing many clinically relevant
drug-drug interactions. These data will be included in upcoming
INDs submitted to the FDA.
- We are actively working towards initiating a Phase 2 trial in
primary sclerosing cholangitis (PSC), with orally administered
DUR-928. PSC is a chronic liver disease characterized by a
progression of cholestasis (decrease in bile flow) with
inflammation and fibrosis of bile ducts. We recently applied for
and have received orphan drug designation for PSC with
DUR-928.
Injectable Administration
- We recently completed a Phase 1b study in Australia with DUR-928. This was an
open-label, single-ascending-dose study investigating safety and PK
in patients with impaired kidney function (stage 3 and 4 chronic
kidney disease) and matched control subjects.
- This study was conducted in successive cohorts evaluating
single-dose levels (first a low dose and then a high dose which was
four times larger than the low dose cohort) of DUR-928 administered
by intramuscular injection. The low dose cohort enrolled 6 kidney
function impaired patients and 3 matched control subjects, and the
high dose cohort enrolled 5 kidney function impaired patients and 3
matched control subjects.
- In this trial, DUR-928 was well tolerated among all subjects
and the PK parameters between the kidney function impaired patients
and the matched control subjects were comparable.
- We are working closely with expert advisors to design Phase 2
trials in one or more indications with an injectable formulation of
DUR-928.
Topical Administration
- As previously disclosed, we completed an exploratory Phase 1b
trial in psoriasis patients (n = 9 evaluable patients) utilizing
intralesional micro injections of DUR-928; promising activity was
observed which we believe warrants further investigation.
- In the first half of 2017, we developed several topical
formulations of DUR-928 that we expect to utilize in a future
topical application psoriasis trial. We believe that there is a
large unmet medical need for new topical drugs for inflammatory
skin diseases such as psoriasis and atopic dermatitis.
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 March 2017, Pain
Therapeutics announced that it plans to resubmit the REMOXY ER NDA
after completing two additional studies regarding REMOXY ER based
on guidance obtained in a recent meeting with the
FDA. The two studies are a clinical abuse potential
study via the intranasal route of abuse and a non-clinical abuse
potential study using household solvents. Pain
Therapeutics stated that it expects to complete these studies by
year end 2017, after which it intends to have a pre-NDA meeting
with the FDA followed by resubmission of the REMOXY NDA.
ORADUR-ADHD Program. ORADUR-Methylphenidate ER is
an investigational drug that has the potential for rapid onset of
action and long duration with once-a-day dosing, 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 reported that a Phase 3 study
conducted in Taiwan has achieved
positive results. We retain rights to all other markets in
the world, notably including the U.S., Europe and Japan. We intend to reach out
with these Phase 3 data to potential development and
commercialization partners for major markets not licensed to Orient
Pharma.
Earnings Conference Call
A live audio webcast
of a conference call to discuss second quarter 2017 results and
provide a corporate update will be broadcast live over the internet
at 4:30 p.m. Eastern Time on
August 8 and is available by
accessing DURECT's homepage at www.durect.com and clicking
"Investor Relations." If you are unable to participate during 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 1 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, chronic metabolic diseases such as
primary sclerosing cholangitis (PSC), nonalcoholic fatty liver
disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other
liver diseases with both broad and orphan populations, and
inflammatory skin conditions such as psoriasis. DURECT's
advanced oral, injectable, and transdermal 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 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.
POSIMIR, DUR-928, REMOXY ER and ORADUR-Methylphenidate ER 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 the potential
benefits and uses of our drug candidates, including the potential
use of DUR-928 to treat PSC, other disorders of the liver,
kidney diseases, acute organ injuries, or psoriasis or other
inflammatory conditions, the potential use of POSIMIR to treat
pain, the potential abuse deterrent properties of REMOXY ER and the
potential use of ORADUR-Methylphenidate ER to treat ADHD, our
clinical trial plans for DUR-928 and potential reporting of Phase 3
results for POSIMIR, potential regulatory approvals of POSIMIR and
REMOXY ER, potential markets for our product candidates, potential
payments under the Sandoz agreement, Pain Therapeutics' plans for
REMOXY ER and our plans to seek a licensee for
ORADUR-Methylphenidate ER 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 do not demonstrate the
safety or efficacy of DUR-928 in a statistically significant
manner, that the PERSIST clinical trial of POSIMIR will take longer
to analyze and report than anticipated or result in data that will
not support a successful NDA resubmission or product approval, that
Pain Therapeutics may not be able to adequately address all of
FDA's concerns regarding the REMOXY ER NDA or that there could be a
delay in addressing such concerns, the potential that FDA may not
grant regulatory approval of POSIMIR or REMOXY ER, the risks of
obtaining marketplace acceptance of POSIMIR or REMOXY ER, if
approved, the risk that Sandoz will not achieve milestones
triggering payments, the risk that prior clinical trials (including
prior trials of POSIMIR in laparoscopic cholecystectomy patients
and 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 Orient
Pharma will discontinue development of REMOXY ER or
ORADUR-Methylphenidate ER, respectively, or be delayed in
development or regulatory submissions, the risk that additional
time and resources that may be required for development, testing
and regulatory approval of 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-Q filed on May 10,
2017 under the heading "Risk Factors."
DURECT
CORPORATION
|
CONDENSED
STATEMENTS OF COMPREHENSIVE LOSS
|
(in thousands,
except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
|
June
30
|
|
June
30
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
1,268
|
|
$
371
|
|
$
1,702
|
|
$
790
|
Product revenue,
net
|
3,051
|
|
2,786
|
|
7,184
|
|
5,975
|
Total
revenues
|
4,319
|
|
3,157
|
|
8,886
|
|
6,765
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product revenues
|
924
|
|
913
|
|
2,467
|
|
2,155
|
Research and development
|
9,079
|
|
7,852
|
|
16,627
|
|
14,477
|
Selling, general and administrative
|
3,681
|
|
2,888
|
|
6,724
|
|
5,950
|
Total operating
expenses
|
13,684
|
|
11,653
|
|
25,818
|
|
22,582
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(9,365)
|
|
(8,496)
|
|
(16,932)
|
|
(15,817)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest and other income
|
39
|
|
40
|
|
75
|
|
67
|
Interest and other expense
|
(601)
|
|
(558)
|
|
(1,184)
|
|
(1,116)
|
Net other income
(expense)
|
(562)
|
|
(518)
|
|
(1,109)
|
|
(1,049)
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ (9,927)
|
|
$ (9,014)
|
|
$ (18,041)
|
|
$ (16,866)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
Basic
|
|
$
(0.07)
|
|
$
(0.07)
|
|
$
(0.13)
|
|
$
(0.13)
|
Diluted
|
|
$
(0.07)
|
|
$
(0.07)
|
|
$
(0.13)
|
|
$
(0.13)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share
|
|
|
|
|
|
|
|
Basic
|
|
142,532
|
|
132,812
|
|
142,176
|
|
127,480
|
Diluted
|
|
142,532
|
|
132,812
|
|
142,176
|
|
127,480
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
$ (9,925)
|
|
$ (9,007)
|
|
$ (18,041)
|
|
$ (16,842)
|
DURECT
CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
|
As of
June 30,
2017
|
|
As of
December 31,
2016(1)
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$ 30,405
|
|
$ 5,404
|
Short-term investments
|
|
3,055
|
|
19,600
|
Accounts receivable
|
|
1,385
|
|
1,154
|
Inventories
|
|
3,714
|
|
3,782
|
Prepaid expenses and other current assets
|
|
3,454
|
|
2,486
|
Total current
assets
|
|
42,013
|
|
32,426
|
|
|
|
|
|
Property and
equipment, net
|
|
1,089
|
|
1,297
|
Goodwill
|
|
6,399
|
|
6,399
|
Long-term restricted
Investments
|
|
150
|
|
150
|
Other long-term
assets
|
|
282
|
|
236
|
Total
assets
|
|
$ 49,933
|
|
$ 40,508
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$ 1,783
|
|
$ 2,086
|
Accrued liabilities
|
|
4,103
|
|
5,060
|
Contract research liability
|
|
2,131
|
|
783
|
Deferred revenue, current portion
|
|
16,207
|
|
968
|
Term loan, current portion, net
|
|
3,273
|
|
19,853
|
Total current
liabilities
|
|
27,497
|
|
28,750
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
5,617
|
|
1,879
|
Term loan, noncurrent
portion, net
|
|
16,611
|
|
-
|
Other long-term
liabilities
|
|
2,046
|
|
1,541
|
|
|
|
|
|
Stockholders' equity
(deficit)
|
|
(1,838)
|
|
8,338
|
Total liabilities and
stockholders' equity (deficit)
|
|
$ 49,933
|
|
$ 40,508
|
|
(1) Derived
from audited financial statements.
|
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SOURCE DURECT Corporation