CUPERTINO, Calif., May 10, 2017 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced financial results for
the three months ended March 31, 2017
and provided a corporate update.
- Total revenues were $4.6 million
and net loss was $8.1 million for the
three months ended March 31, 2017 as
compared to total revenues of $3.6
million and net loss of $7.8
million for the three months ended March 31, 2016.
- Subsequent to the end of the first quarter, we signed an
agreement with Sandoz AG pursuant to which we anticipate receiving
a $20 million upfront license
payment.
- At March 31, 2017, cash and
investments were $16.8 million,
compared to cash and investments of $25.2
million at December 31,
2016. Including the upfront license fee from Sandoz less a fee
owed to an advisory firm, our pro forma cash and investments at
March 31, 2017 would have been
approximately $36.1 million. Debt at
March 31, 2017 was $19.9 million.
"We are very pleased to have a company with the market presence
and resources of Sandoz to commercialize POSIMIR® in
the United States," stated
James E. Brown, D.V.M., President
and CEO of DURECT. "Recent enrollment rates for PERSIST, the
POSIMIR pivotal Phase 3 clinical trial in post-operative pain, are
ahead of schedule and support completion of dosing in the second
quarter of 2017, which would position us to announce top-line
results in the fourth quarter of this year. We were also pleased to
present at a major scientific meeting the results from our Phase 1b
NASH study in which we observed promising decreases in certain cell
death markers, an improvement of a key biomarker of liver function,
and decreases in certain biomarkers associated with inflammation,
in each case from a single oral dose of DUR-928, the lead molecule
in our Epigenetic Regulator Program."
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 intended 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 will make 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 ongoing PERSIST Phase 3
clinical trial for POSIMIR as well as FDA interactions through
approval. Closing of the transaction is anticipated to occur in the
second quarter of 2017 and is contingent solely on the expiration
or termination of the applicable waiting period under the
Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.
- We expect to finish dosing patients in PERSIST, a POSIMIR Phase
3 clinical trial consisting of patients undergoing laparoscopic
cholecystectomy (gallbladder removal) surgery, in the second
quarter of 2017 and to have top-line results in the fourth quarter
of this year.
- In a previous clinical trial of 50 patients in the same
surgical model (laparoscopic cholecystectomy), POSIMIR was compared
with the active control bupivacaine HCl, 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) and for the first 2 days after surgery (p=0.0198), using
the same statistical methodology specified for the current
trial. There can be no assurance that the PERSIST trial will
replicate these results.
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
- Our first patient trial utilizing DUR-928 was an open-label,
single-ascending-dose safety and pharmacokinetic (PK) Phase 1b
trial in liver function impaired (NASH) patients and matched
control subjects. This study was conducted in Australia, evaluating single-dose levels
(first a low dose and then a high dose) of orally administered
DUR-928 in successive cohorts. Twenty subjects with
NASH and 12 matched control subjects received DUR-928.
- A poster reporting results from this study was presented at the
International Liver Congress™ 2017 organized by the
European Association for the Study of the Liver (EASL) in
Amsterdam on April 22, 2017.
- Although this study was not designed to assess efficacy, we
observed a dose dependent reduction of certain biomarkers after a
single oral dose of DUR-928. There can be no assurance
these results will be confirmed in larger controlled studies.
-
- The mean decrease of full-length CK-18 (a generalized cell
death marker) at 12 hours after dosing was 33% in the NASH patients
in the low dose cohort and 41% in the high dose cohort.
- The mean decrease of cleaved CK-18 (a cell apoptosis marker) at
12 hours was 37% in the NASH patients in the low dose cohort and
47% in the high dose cohort.
- The mean decrease in total bilirubin (a liver function marker)
at 12 hours in the NASH patients was 27% in the low dose cohort and
31% in the high dose cohort.
- High sensitivity C-Reactive Protein (hsCRP), a marker of
inflammation, trended higher at 12 hours in the NASH patients by 3%
on average in the low dose cohort but trended lower by 12% on
average in the high dose cohort.
- IL-18, an inflammatory mediator implicated in both liver and
kidney diseases, trended lower at 12 hours by 5% on average in both
the low dose cohort and in the high dose cohort.
- A poster describing results from two STAM™ NASH
mouse model studies was presented at the AASLD Emerging Trends
Conference 2017: Emerging Trends in Non-alcoholic Fatty Liver
Disease in Washington, DC on
March 17, 2017.
- We are actively working towards 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. It is an orphan medical
condition for which there is no established medical
treatment.
Injectable Administration
- Our second Phase 1b study with DUR-928, also being conducted in
Australia, is an open-label,
single-ascending-dose safety and pharmacokinetic study in patients
with impaired kidney function (stage 3 and 4 chronic kidney
disease) and matched control subjects.
- This study is being conducted in successive cohorts evaluating
single-dose levels (first a low dose and then a high dose) of
DUR-928 administered by intramuscular injection. The low dose
cohort consisted of 6 kidney function impaired patients and 3
matched control subjects.
- Data from the low dose cohort showed the PK parameters between
the kidney function impaired patients and the matched control
subjects were comparable. After a PK/safety review of this
cohort, patients are now being enrolled in the high dose cohort,
utilizing a dose four times larger than the low dose
cohort. We expect to complete this study shortly.
- 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
intradermal micro injections of DUR-928; promising activity was
observed which we believe warrant further investigation.
- In the first quarter of 2017, we developed several topical
formulations of DUR-928 that we are evaluating for a topical
application microplaque psoriasis trial. We believe that there
is a large unmet medical need for new topical drugs for
inflammatory skin diseases such as psoriasis or atopic dermatitis
for use prior to systemic biologic treatments which often have
significant associated side effects.
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 September 2016, Pain
Therapeutics (our licensee) received a Complete Response Letter
from the FDA for REMOXY ER. Based on its review, the FDA has
determined that the NDA cannot be approved in its present form and
specifies additional actions and data that are needed for drug
approval.
- 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 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 completed dosing a Phase 3 study in
Taiwan and anticipates obtaining
top-line results from that study in the second quarter of 2017. We
retain rights to all other markets in the world, notably including
the U.S., Europe and Japan.
Earnings Conference Call
A live audio webcast
of a conference call to discuss first quarter 2017 results and
provide a corporate update will be broadcast live over the internet
at 4:30 p.m. Eastern Time on
May 10 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
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 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 NASH, other disorders of the liver,
kidney diseases 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-ADHD to treat ADHD, clinical trial plans for DUR-928,
POSIMIR and our other product candidates (including timing and
potential results), potential reporting of Phase 3 results for
POSIMIR and ORADUR-methylphenidate, potential regulatory approvals
of POSIMIR and REMOXY ER, potential markets for our product
candidates, potential closing of the agreement with Sandoz for
POSIMIR and potential payments under that agreement, and Pain
Therapeutics' plans for REMOXY 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 conduct 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 of delays in the commencement, enrollment or completion of
other clinical trials, 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, respectively, or be delayed in development
or regulatory submissions, the risk that the Sandoz agreement for
POSIMIR will not close or that future milestones under that
agreement will not be achieved, the risk of adverse decisions by
regulatory agencies or delays and additional costs due to
requirements imposed by regulatory agencies, 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-K filed on March 29, 2017
under the heading "Risk Factors."
DURECT
CORPORATION
|
|
CONDENSED
STATEMENTS OF COMPREHENSIVE LOSS
|
(in thousands,
except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
|
|
|
|
March
31
|
|
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
434
|
|
$
419
|
|
|
Product revenue,
net
|
4,133
|
|
3,189
|
|
|
|
Total
revenues
|
4,567
|
|
3,608
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Cost of product
revenues
|
1,543
|
|
1,242
|
|
|
|
Research and
development
|
7,548
|
|
6,625
|
|
|
|
Selling, general and
administrative
|
3,043
|
|
3,062
|
|
|
Total operating
expenses
|
12,134
|
|
10,929
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(7,567)
|
|
(7,321)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
Interest and other
income
|
36
|
|
27
|
|
|
|
Interest and other
expense
|
(583)
|
|
(558)
|
|
|
Net other income
(expense)
|
(547)
|
|
(531)
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ (8,114)
|
|
$ (7,852)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
Basic
|
|
$
(0.06)
|
|
$
(0.06)
|
|
|
|
Diluted
|
|
$
(0.06)
|
|
$
(0.06)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share
|
|
|
|
|
|
|
Basic
|
|
141,815
|
|
122,149
|
|
|
|
Diluted
|
|
141,815
|
|
122,149
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
$ (8,116)
|
|
$ (7,835)
|
|
|
DURECT
CORPORATION
|
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
|
|
|
As of
|
|
As of
|
|
|
March 31,
2017
|
|
December 31,
2016(1)
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
4,272
|
|
$
5,404
|
Short-term investments
|
|
12,406
|
|
19,600
|
Accounts receivable
|
|
2,076
|
|
1,154
|
Inventories
|
|
3,462
|
|
3,782
|
Prepaid expenses and other current assets
|
|
2,905
|
|
2,486
|
Total current
assets
|
|
25,121
|
|
32,426
|
|
|
|
|
|
Property and
equipment, net
|
|
1,191
|
|
1,297
|
Goodwill
|
|
6,399
|
|
6,399
|
Long-term restricted
Investments
|
|
150
|
|
150
|
Other long-term
assets
|
|
236
|
|
236
|
Total
assets
|
|
$
33,097
|
|
$
40,508
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$
1,138
|
|
$
2,086
|
Accrued liabilities
|
|
3,289
|
|
5,060
|
Contract research liability
|
|
787
|
|
783
|
Deferred revenue, current portion
|
|
1,016
|
|
968
|
Term loan, current portion, net
|
|
1,272
|
|
19,853
|
Total current
liabilities
|
|
7,502
|
|
28,750
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
1,822
|
|
1,879
|
Term loan, noncurrent
portion, net
|
|
18,597
|
|
-
|
Other long-term
liabilities
|
|
1,929
|
|
1,541
|
|
|
|
|
|
Stockholders'
equity
|
|
3,247
|
|
8,338
|
Total liabilities and
stockholders' equity
|
|
$
33,097
|
|
$
40,508
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
|
|
|
|
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SOURCE DURECT Corporation