eSubmitter | The Continuum of Risk
eSubmitter | The Continuum of Risk | fda form 3743

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eSubmitter | The Continuum of Risk - fda form 3743
eSubmitter | The Continuum of Risk – fda form 3743 | fda form 3743

CUPERTINO, Calif., Nov. 1, 2017 /PRNewswire/ — DURECT Corporation (DRRX) today appear banking after-effects for the three months concluded September 30, 2017 and provided a accumulated update.  

“The top-line after-effects from the Phase 3 analytic balloon of POSIMIR did not accommodated expectations, trending in favor of POSIMIR but not extensive statistically significance.  We will be alive to accept the balloon after-effects added absolutely in the advancing weeks,” declared James E. Brown, D.V.M., President and CEO of DURECT.  “On added fronts, absolute highlights of the third division included extensive an acceding with Indivior which resulted in a allusive upfront acquittal to DURECT as able-bodied the abeyant for added payments based on the advance of RBP-7000, a biologic applicant for schizophrenia for which Indivior has submitted an NDA to the FDA.  We are additionally authoritative cogent advance appear initiating assorted Phase 2 studies with DUR-928.”  

Update on Selected Programs and Transactions:

POSIMIR (SABER®-Bupivacaine) Post-Operative Affliction Abatement Depot.  POSIMIR is our investigational post-operative affliction abatement annex that utilizes our patented SABER technology and is advised to bear bupivacaine to accommodate up to 3 canicule of affliction abatement afterwards surgery.    

In October 2017, we appear that PERSIST, a Phase 3 analytic balloon for POSIMIR did not accommodated its primary adeptness endpoint of abridgement in affliction on movement over the aboriginal 48 hours afterwards anaplasty as compared to accepted bupivacaine HCl.   While after-effects trended in favor of POSIMIR against the comparator, they did not accomplish statistical significance. We and Sandoz, our licensee for commercialization rights for POSIMIR in the United States, will be alive to accept the balloon after-effects added absolutely in the advancing weeks.     

Epigenetic Regulator Program.  DUR-928, the advance artefact applicant in our Epigenetic Regulator Program, is an endogenous, baby molecule, new actinic article (NCE), which may accept ample account in several metaic diseases such as nonalcoholic steatohepatitis (NASH) and added disorders of the liver, in astute agency injuries such as astute alarmist and/or branch injury, and in autoimmune/inflammatory bark disorders such as crawling and atopic dermatitis.

Oral Administration

Injectable Administration

Topical Administration

Indivior Agreement.  In September 2017, we entered into a apparent acquirement acceding with an associate of Indivior PLC, whereby DURECT assigned assertive of its U.S. apparent rights to Indivior. This appointment may accommodate added bookish acreage aegis for RBP-7000, Indivior’s investigational once-monthly injectable risperidone artefact for the analysis of schizophrenia.  Indivior submitted a New Biologic Application (NDA) for RBP-7000 to the U.S. Food and Biologic Administration (FDA) on September 28, 2017. 

Under the acceding of the agreement, Indivior has fabricated an upfront non-refundable acquittal to DURECT of $12.5 million, with the abeyant for an added $5 actor based on NDA approval of RBP-7000, as able-bodied as annual earn-out payments that are based on a distinct chiffre allotment of U.S. net sales for assertive articles covered by the apparent rights, including RBP-7000. The apparent rights accommodate accepted patents extending through at atomic 2026.

REMOXY® ER (oxycodone) Extended-Release Capsules CII.  Based on our ORADUR technology, the investigational drug REMOXY ER is a different long-acting conception of oxycodone advised to abash accepted methods of analytical associated with opioid abusage and abuse.  In March 2017, Affliction Analysis appear that it affairs to resubmit the REMOXY ER NDA afterwards commutual two added studies apropos REMOXY ER based on advice acquired in a affair with the FDA.  The two studies are a analytic corruption abeyant abstraction via the intranasal avenue of corruption and a non-clinical corruption abeyant abstraction application domiciliary solvents.  Pain Analysis declared that it expects to complete these studies by year end 2017.   In October 2017, Affliction Analysis appear that there is a pre-NDA advice affair with the FDA planned for November 14, 2017 and Affliction Analysis is planning an NDA resubmission in the aboriginal division of 2018.

Story Continues

ORADUR-ADHD Program.  ORADUR-Methylphenidate ER is an investigational biologic that has the abeyant for accelerated access of activity and continued continuance with once-a-day dosing, utilizes a baby abridged admeasurement about to the arch absolute long-acting articles on the bazaar and incorporates our ORADUR anti-tampering technology.  Orient Pharma, our licensee in authentic Asian and South Pacific countries, has appear that a Phase 3 abstraction conducted in Taiwan has accomplished absolute results.  We absorb rights to all added markets in the world, conspicuously including the U.S., Europe and Japan.  We accept started a activity of contacting abeyant development and commercialization ally for above markets not accountant to Orient Pharma.

Upcoming broker conference.  DURECT will be presenting at the Stifel 2017 Healthcare Appointment at 11:45 am Eastern time on November 15.  The appointment is actuality captivated at the Lotte New York Palace Hotel.  A alive audio webcast of the presentation will be accessible by accessing http://wsw.com/webcast/stifel10/drrx .  A alive audio webcast of these presentations will additionally be accessible by accessing DURECT’s homepage at www.durect.com  and beat “Investor Relations.”  If you are clumsy to participate during the alive webcast, the alarm will be archived on DURECT’s website beneath Audio Archive in the “Investor Relations” section.

Earnings Appointment CallA alive audio webcast of a appointment alarm to altercate third division 2017 after-effects and accommodate a accumulated amend will be advertisement alive over the internet at 4:30 p.m. Eastern Time on November 1 and is accessible by accessing DURECT’s homepage at www.durect.com and beat “Investor Relations.” If you are clumsy to participate during the alive webcast, the alarm will be archived on DURECT’s website beneath Audio Archive in the “Investor Relations” section.

About DURECT Corporation

DURECT is a biopharmaceutical aggregation developing analysis based on its Epigenetic Regulator Program and proprietary biologic commitment platforms.  DUR‑928, a new actinic article in Phase 1 development, is the advance applicant in DURECT’s Epigenetic Regulator Program.  An endogenous, orally bioavailable baby molecule, DUR-928 has been apparent in preclinical studies to comedy an important authoritative role in lipid homeostasis, inflammation, and corpuscle survival.  Human applications may accommodate astute agency injury, abiding metaic diseases such as nonalcoholic blubbery alarmist ache (NAFLD), nonalcoholic steatohepatitis (NASH) and added alarmist diseases with both ample and drop populations, and anarchic bark altitude such as psoriasis.  DURECT’s avant-garde articulate and injectable commitment technologies are advised to accredit new break and added attributes for small-molecule and biologic drugs. One artefact applicant in this class is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic advised to accommodate up to 3 canicule of connected affliction abatement afterwards surgery.  Another artefact applicant is REMOXY® ER (oxycodone), an investigational affliction ascendancy biologic based on DURECT’s ORADUR® technology.  In addition, for the appointment of assertive apparent rights, DURECT may accept a anniversary acquittal aloft NDA approval and distinct chiffre sales-based earn-out payments from U.S. net sales of Indivior’s RBP-7000 investigational biologic for schizophrenia, for which Indivior submitted an NDA on September 28, 2017.  For added information, amuse appointment www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Added referenced trademarks accord to their corresponding owners.  POSIMIR, DUR-928, RBP-7000, REMOXY ER and ORADUR-Methylphenidate ER are biologic candidates beneath development and accept not been accustomed for commercialization by the U.S. Food and Biologic Administration or added bloom authorities.

DURECT Forward-Looking Statement

The statements in this columnist absolution apropos abeyant approaching payments from Indivior, analytic balloon affairs for DUR-928, including the abeyant admission of analytic trials in primary sclerosing cholangitis, abstinent and astringent astute alarmist activity impairment, and psoriasis, the abeyant allowances and uses of our biologic candidates, including the abeyant use of DUR-928 to amusement PSC, added disorders of the liver,  kidney diseases, astute agency injuries, or crawling or added anarchic conditions, the abeyant use of POSIMIR to amusement pain, the abeyant corruption bridle backdrop of REMOXY ER, the abeyant use of RBP-7000 to amusement schizophrenia, and the abeyant use of ORADUR-Methylphenidate ER to amusement ADHD, abeyant markets for our artefact candidates, Indivior’s affairs for RBP-7000, Affliction Therapeutics’ affairs for REMOXY ER and our affairs to seek a licensee for ORADUR-Methylphenidate ER are advanced statements involving risks and uncertainties that can account absolute after-effects to alter materially from those in such advanced statements. Abeyant risks and uncertainties include, but are not bound to, the risks that approaching analytic trials of DUR-928 are not started back advancing or do not authenticate the assurance or adeptness of DUR-928 in a statistically cogent manner, that Affliction Analysis may not be able to abundantly abode all of FDA’s apropos apropos the REMOXY ER NDA or that there could be a adjournment in acclamation such concerns, the abeyant that FDA may not admission authoritative approval of POSIMIR, or REMOXY ER, the risks of accepting exchange accepting of POSIMIR, RBP-7000 or REMOXY ER, if approved, the accident that Sandoz may aish our acceding with them and abandon affairs to commercialize POSIMIR, the accident that above-mentioned analytic trials (including above-mentioned Phase 1b trials of DUR-928) will not be accepted in consecutive trials, the abeyant abortion of analytic trials to accommodated their advised endpoints, the accident that Affliction Therapeutics, Indivior or Orient Pharma will abandon development of REMOXY ER, RBP-7000 or ORADUR-Methylphenidate ER, respectively, or be delayed in development or authoritative submissions, the accident that added time and assets that may be appropriate for development, testing and authoritative approval of POSIMIR or DUR-928, abeyant adverse furnishings arising from the testing or use of our biologic candidates, our abeyant abortion to advance our collaborative agreements with third parties or able new collaborations and risks accompanying to our adeptness to access basic to armamentarium operations and expenses. Added advice apropos these and added risks is included in DURECT’s Form 10-Q filed on August 9, 2017 beneath the branch “Risk Factors.”

DURECT CORPORATION

CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in thousands, except per allotment amounts)

(unaudited)

Three months ended

Nine months ended

 September 30 

 September 30 

2017

2016

2017

2016

Collaborative analysis and development and added revenue

$  5,602

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Abbott Vascular Shu Chi Hsu, Ph.D. Project Manager, Regulatory .. | fda form 3743

$     352

$   7,304

$   1,142

Product revenue, net

2,644

3,391

9,828

9,366

Revenue from auction of bookish acreage rights

12,500

12,500

Total revenues

20,746

3,743

29,632

10,508

Operating expenses:

Cost of artefact revenues 

3,105

2,180

5,572

4,335

Research and development

8,378

6,805

25,005

21,282

Selling, accepted and administrative 

3,138

3,043

9,862

8,993

Total operating expenses

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Form FDA 11 – Supplementary Information Certificate to Foreign .. | fda form 3743

14,621

12,028

40,439

34,610

Income (Loss) from operations

6,125

(8,285)

(10,807)

(24,102)

Other assets (expense):

Interest and added income

605

45

680

112

Interest and added expense

(619)

(592)

(1,803)

(1,708)

Net added expense

(14)

(547)

(1,123)

(1,596)

Net assets (loss)

$  6,111

$ (8,832)

$(11,930)

$(25,698)

Net assets (loss) per share

Basic 

$    0.04

$   (0.06)

$    (0.08)

Untitled - fda form 3743
Untitled – fda form 3743 | fda form 3743

$    (0.20)

Diluted

$    0.04

$   (0.06)

$    (0.08)

$    (0.20)

Weighted-average shares acclimated in accretion net assets (loss) per share

Basic 

147,213

137,933

143,873

130,990

Diluted

151,885

137,933

143,873

130,990

Total absolute assets (loss)

$  6,114

$ (8,836)

$(11,927)

$(25,678)

 

DURECT CORPORATION

CONDENSED BALANCE SHEETS

(in thousands)

As of

As of

September 30, 2017

December 31, 2016(1)

(unaudited)

ASSETS

Current assets:

    Banknote and banknote equivalents

$                35,287

1111Orig11s11 - fda form 3743
1111Orig11s11 – fda form 3743 | fda form 3743

$                     5,404

    Short-term investments

6,379

19,600

    Accounts receivable

2,180

1,154

    Inventories, net

3,155

3,782

    Prepaid costs and added accepted assets

2,877

2,486

Total accepted assets

49,878

32,426

Property and equipment, net

1,045

1,297

Goodwill

6,399

6,399

Long-term belted Investments

150

150

Other abiding assets

282

236

Total assets

$                57,754

$                   40,508

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

    Accounts payable

$                  2,058

1111Orig11s11 - fda form 3743
1111Orig11s11 – fda form 3743 | fda form 3743

$                     2,086

    Accrued liabilities

5,718

5,060

    Contract analysis liability

728

783

    Deferred revenue, accepted portion

16,002

968

    Term loan, accepted portion, net

5,276

19,853

Total accepted liabilities

29,782

28,750

Deferred revenue, noncurrent portion

1,140

1,879

Term loan, noncurrent portion, net

14,623

Other abiding liabilities

2,170

1,541

Stockholders’ equity

10,039

8,338

Total liabilities and stockholders’ equity 

$                57,754

$                   40,508

(1)  Derived from audited banking statements.

 

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