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Public Device & Biopharma Ophthalmology Company Showcase - pSivida

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Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.

Presenter:
Nancy Lurker, President & CEO


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For more ophthalmology innovation
Visit us at www.ois.net

Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.

Presenter:
Nancy Lurker, President & CEO


Powered by:
Healthegy

For more ophthalmology innovation
Visit us at www.ois.net

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Public Device & Biopharma Ophthalmology Company Showcase - pSivida

  1. 1. OPHTHALMOLOGY INNOVATION SUMMIT@AAO OCTOBER 13, 2016 NASDAQ: PSDV NANCY LURKER, PRESIDENT & CEO 
  2. 2. SAFE HARBOR STATEMENT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to obtain needed capital; our ability to achieve profitable operations; potential declines in Retisert royalties; fluctuations in our operating results; further impairment of our intangible assets; our ability to obtain marketing approvals for and successfully commercialize Medidur for posterior segment uveitis; performance by CROs, vendors and investigators; timing of filing marketing approval applications for Medidur; acceptability of data to be filed in support of Medidur marketing applications; maintenance of orphan designation for Medidur, potential off-label sales of ILUVIEN for posterior segment uveitis; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; Alimera’s ability to continue as a going concern; the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; outcome of dispute with Alimera on commercialization expenses; any exercise by Pfizer of its option with respect to the latanoprost product; our ability to develop Tethadur to successfully deliver large biologic molecules and develop products using it; efficacy and future development of severe OA implant by us; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements; termination or breach of current license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; effects of potential U.K. exit from the EU; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. You should read and interpret any forward-looking statements in light of these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward- looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized. 2
  3. 3. DELIVERING INNOVATION TO THE EYE Focused on preventing blindness through proprietary sustained release drug technologies 3
  4. 4. OUR HISTORY More than 20 years of focus on eye diseases Developed 3 FDA approved sustained release products used for the posterior segment of the eye Licensed ophthalmology products to Bausch & Lomb & Alimera Medidur™ program for posterior uveitis approaching commercialization Dario Paggiarino, M.D. appointed Chief Medical Officer on August 1, 2016 Nancy Lurker appointed President & CEO on September 15, 2016 4
  5. 5. NANCY LURKER: 25-YEAR CAREER OF MAXIMIZING PHARMACEUTICAL ASSETS Multiple key launches including Plavix®, Detrol® and Detrol LA®, Ambien®, Reclast® and Exforge® Strong track record of working with R&D to transition products from the clinic to commercialization Expertise in launch risk mitigation US and International markets Led public and private companies 5
  6. 6. KEY PSIVIDA ATTRIBUTES Proved sustained release injectable drug technology for small molecules Developed three approved branded eye products Fourth eye product in the pipeline with commercial launch potential within 18 months/ EU; 24 months/US Solid balance sheet Strong scientific team 6
  7. 7. ILUVIEN™ FOR DIABETIC MACULAR EDEMA (DME): PARTNERED WITH ALIMERA Approvals  Approved for DME in US, 17 EUs Payments  PSDV received over $55m to date Revenues to PSDV  20% of any product profit Lasts for 3 Years ILUVIEN™ Licensed Product 7
  8. 8. DURASERT™: APPROVED TECHNOLOGY FOR OCULAR DELIVERY Long Duration  Up to 3 years from single injection minimizes frequent monthly ocular injections; now focusing on 6-month regimen Proprietary Sustained Polymer Technology  Tailored to be bioerodible or non-erodible Broadly Applicable  Can deliver many types of small molecule drugs Strong Patent Estate  Issued patents covering technology and inserter extend beyond 2027 Lasts for 3 Years DURASERT™ Approved Technology 8
  9. 9. TWO HIGHLY ATTRACTIVE PROGRAMS:  POSTERIOR SEGMENT UVEITIS  WET AMD 9
  10. 10. UVEITIS IS THE THIRD LEADING CAUSE OF PREVENTABLE BLINDNESS IN THE DEVELOPED WORLD Source: The Ocular Immunology and Uveitis Foundation 10
  11. 11. UVEITIS IS INFLAMMATION OF THE UVEAL TRACT (IRIS, CILIARY BODY, CHOROID) OR ADJACENT STRUCTURES Posterior Segment Anterior Segment 11
  12. 12. MEDIDUR PHASE III PRODUCT FOR POSTERIOR SEGMENT UVEITIS US PREVALENCE 175,000 CASES POTENTIAL TO EXCEED $100M* ANNUAL REVENUE 5 YEARS AFTER LAUNCH * Internal Market Research 12
  13. 13. MEDIDUR™ PHASE III TREATMENT FOR POSTERIOR SEGMENT UVEITIS SAME DURASERT™ MICRO-INSERT AS FDA APPROVED ILUVIEN™ SAME DRUG AS RETISERT™ AND ILUVIEN™ DELIVERS FLUOCINOLONE ACETONIDE (CORTICOSTEROID) 13
  14. 14. MEDIDUR™ CLINICAL PROGRAM Study 001 Phase III clinical trial: 129 patients Primary end-point: Prevention of recurrence Result: p < 0.000000001 FIRST PHASE III TRIAL: PREVENTION OF RECURRENCE COMPLETE INSERTER TRIAL: EASE OF ADMINISTRATION COMPLETE Study 006 Phase III clinical trial: 26 patients Primary end-point: Ease of administration Result: Positive usability Study 005 Phase III clinical trial: 150 patients Primary end-point: Prevention of recurrence Enrollment status: Complete by 4Q2016 SECOND PHASE III TRIAL: PREVENTION OF RECURRENCE ONGOING 14
  15. 15. EFFICACY END-POINT: UVEITIS RECURRENCE RATES AT 6 AND 12 MONTHS 6 MONTHS RECURRENCE 18.4% Medidur™ eyes vs 78.6% sham Medidur™ eyes 3.9X more likely to be recurrence free Primary end-point achieved p < 0.000000001 12 MONTHS RECURRENCE 27.6% Medidur™ eyes vs 85.7% sham Medidur™ eyes 5.1X more likely to be recurrence free Evidence of durable response 15
  16. 16. VISUAL ACUITY GAIN (VS DAY 1) VISION GAIN @ 12 MONTHS (≥15 LETTERS) 22.9% Medidur™ treated eyes gained 11.9% sham eyes gained VISION GAIN @ 6 MONTHS (≥15 LETTERS) 22.9% Medidur™ treated eyes gained 7.3% sham eyes gained Medidur™ had positive effect on vision gain 16
  17. 17. SYSTEMIC MEDICATION SPARING @ 6 MONTHS 18.2% Medidur™: 8/44 still on system medication 52.4% Sham: 11/21 still on systemic medication SYSTEMIC MEDICATION SPARING @ 12 MONTHS 18.2% Medidur™ still on system medication 52.4% sham patients still on systemic medication SYSTEMIC MEDICATION SPARING AT 6 AND 12 MONTHS Medidur™ had significant systemic sparing medication effect *At baseline 50.3% of patients were on systemic meds (steroids, immuno-modulators, biologics) 17
  18. 18. SAFETY ENDPOINT: IOP ELEVATION IOP 6 MONTH MEDIDUR 6 MONTH SHAM 6 MONTH DELTA AS OF JULY 1, 2016 MEDIDUR AS OF JULY 1, 2016 SHAM AS OF JULY 1, 2016 DELTA > 21 mm 27.6% 16.7% 10.9% 34.5% 26.2% 8.3% > 25 mm 16.1% 4.8% 11.3% 21.8% 16.7% 5.1% > 30 mm 10.3% 0% 10.3% 17.2% 11.9% 5.3% Surgery 2.4% 0% 2.4% 4.6% 4.8% -0.2% Difference between Medidur™ and sham decreases with time *Inter-Ocular Pressure 18
  19. 19. AS OF JULY 1, 2016 45% of phakic Medidur™ eyes had CS 9.5% of phakic control eyes had CS SAFETY ENDPOINT: CATARACT SURGERY At baseline 51% of eyes had already had cataract surgery (CS) BY 6 MONTHS 9.5% of phakic* Medidur™ eyes had CS 4.8% of phakic control eyes had CS *Phakic = normal lens 19
  20. 20. EU MAA FILING UPDATE Study 006 Inserter clinical trial: 26 patients Preparing filing package for MAA filing in Q1 ʼ17 Study 001 Phase III clinical trial: 129 patients Primary end-point: Prevention of Recurrence 20
  21. 21. FDA FILING UPDATE Study 001 Phase III clinical trial: 129 patients Primary end-point: Prevention of Recurrence Study 005 Phase III clinical trial: 150 patientsPreparing filing package for NDA filing in 2H 2017 Study 006 Inserter clinical trial: 26 patients 21
  22. 22. WET AGE-RELATED MACULAR DEGENERATION (AMD) IS A CHRONIC EYE DISEASE THAT CAUSES PROGRESSIVE VISION LOSS 22
  23. 23. CAUSED BY ABNORMAL BLOOD VESSELS THAT LEAK FLUID OR BLOOD INTO THE MACULA (CENTRAL VISION) 23
  24. 24. WET-AMD PROGRAM: DURASERT™ WITH TKI US PREVALENCE ~1.2M PATIENTS 200,000 NEW DX PER YEAR 2015 GLOBAL MARKET SIZE $5.3B* * Internal Market Research 24
  25. 25. WET-AMD PROGRAM: DURASERT™ WITH TKI CURRENT TREATMENT (ANTI-VEGF) REQUIRES INTRAVITREAL INJECTIONS EVERY 4 WEEKS OR MORE LONG TERM STUDIES SHOW PROGRESSIVE VISION LOSS DESPITE CONTINUED ANTI-VEGF THERAPY 25
  26. 26. DURASERT™ WITH TKI FOR WET-AMD Tyrosine kinase inhibitors (TKIs) are antiangiogenic small molecules known to inhibit both VEGF and PDGF, two factors involved in wet AMD TKIs dual pharmacological action and sustained delivery could result in:  Improved vision and  Reduced frequency of intravitreal injections TKI on market is effective in two non-clinical models of wet AMD with Durasert™ IND-enabling studies with bioerodible Durasert™ underway now 26
  27. 27. FINANCIAL HIGHLIGHTS CASH: $29M AT JUNE 30 2016 NO DEBT 34M SHARES 0.6M WARRANTS 5.1M OPTIONS 27
  28. 28. ESTABLISH CLEAR OPERATING PLAN FOR CURRENT FISCAL YEAR END OF YEAR OBJECTIVES ESTABLISH THREE YEAR STRATEGIC PLAN STAY ON TRACK FOR US/EU REGULATORY FILINGS EXPAND AND ACCELERATE WORK ON COLLABORATIONS TO MAXIMIZE SUSTAINED RELEASE TECHNOLOGY 28
  29. 29. DELIVERING INNOVATION TO THE EYE 29
  30. 30. 30

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