Form 8-K AERIE PHARMACEUTICALS For: Sep 16
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 16, 2015
Aerie Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36152 | 20-3109565 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
2030 Main Street, Suite 1500
Irvine, California 92614
(Address of principal executive offices) (Zip code)
Registrant’s telephone number, including area code: (949) 526-8700
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01. | Regulation FD Disclosure. |
On September 16, 2015, Aerie Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the results from the Company’s second Phase 3 registration trial of RhopressaTM, (“Rocket 2”). A copy of the press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.
On or after September 16, 2015, representatives of the Company may present to various investors the information about the results of Rocket 2 described in the slides attached to this report as Exhibit 99.2 hereto, which is hereby incorporated by reference into this Item 7.01.
The information in this Item 7.01 (including Exhibits 99.1 and 99.2) is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 is not intended to, and does not, constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
The following exhibits relating to Item 7.01 shall be deemed to be furnished, and not filed:
| 99.1 | Press Release dated September 16, 2015. | |
| 99.2 | RhopressaTM Phase 3 “Rocket 2” Results dated September 16, 2015. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AERIE PHARMACEUTICALS, INC. | ||||||
| Date: September 16, 2015 |
By: | /s/ Richard J. Rubino | ||||
| Richard J. Rubino | ||||||
| Chief Financial Officer | ||||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press Release dated September 16, 2015. | |
| 99.2 | RhopressaTM Phase 3 “Rocket 2” Results dated September 16, 2015 | |
Exhibit 99.1
Aerie Pharmaceuticals Reports Positive RhopressaTM Phase 3 Efficacy Results
RhopressaTM Achieves Primary Clinical Endpoint in Rocket 2 Study
Conference Call and Webcast Today, September 16, at 5:00 p.m. ET
IRVINE, Calif., September 16, 2015 —(BUSINESS WIRE)— Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today reported the successful results of its second Phase 3 trial for RhopressaTM, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The trial achieved its primary efficacy endpoint demonstrating non-inferiority of RhopressaTM compared to timolol, the most widely used comparator. Management will host a conference call and provide accompanying slides to discuss these results at 5:00 p.m. ET today.
RhopressaTM Phase 3 Highlights for Rocket 2
| • | RhopressaTM, dosed both once-daily and twice-daily, achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol. The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25 mmHg (millimeters of mercury). |
| • | The Rocket 2 efficacy results for RhopressaTM demonstrated a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period. |
| • | The most common RhopressaTM adverse event was hyperemia, or eye redness, which was reported as increased in 35 percent of patients and was scored as mild for 83 percent of patients in the RhopressaTM once-daily arm of the trial. The adverse event profile for the RhopressaTM once-daily arm was consistent with the results of Rocket 1. |
| • | With these successful Rocket 2 results, and the successful performance of RhopressaTM in Rocket 1 at baseline IOPs below 25 mmHg, Aerie expects to file its NDA for RhopressaTM in mid-2016. |
As expected, RhopressaTM dosed twice-daily generated a higher incidence of adverse events and was slightly more efficacious than RhopressaTM dosed once-daily.
“We are very impressed by these RhopressaTM Phase 3 results from the Rocket 2 study. This product has demonstrated great promise with its novel mechanisms of action, including its ability to target the diseased tissue responsible for elevated IOP in glaucoma. The clear success demonstrated in this clinical trial, combined with the preclinical research to date on the disease-modification potential of RhopressaTM, represent key building blocks in driving Aerie toward becoming a major ophthalmic pharmaceutical company,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “We look forward to our Rocket 2 safety results expected at the end of 2015 or early 2016. Based on our previous discussions with the FDA, we expect to file our RhopressaTM NDA in mid-2016.”
Richard A. Lewis, M.D., Aerie’s newly appointed Chief Medical Officer who is a glaucoma specialist in Sacramento, California, past President of the American Society of Cataract and Refractive Surgeons (ASCRS) and past President of the American Glaucoma Society (AGS), added, “Clinicians have been
waiting for an IOP-lowering product that targets the diseased tissue. None of the treatments currently in the market have this unique function. The RhopressaTM efficacy data we see in these Rocket 2 results point to a potential breakthrough for our glaucoma patients.”
Triple-Action Rhopressa™
RhopressaTM is a novel triple-action eye drop that we believe, if approved, would become the only once-daily product available that specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical results have demonstrated that RhopressaTM also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, RhopressaTM provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, RhopressaTM is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have shown that RhopressaTM may have disease-modifying properties, including an anti-fibrotic effect on the trabecular meshwork and the potential to increase perfusion of the trabecular meshwork. Preclinical research is also currently underway to evaluate the potential neuroprotective benefits of RhopressaTM.
There are four Phase 3 registration trials for RhopressaTM. “Rocket 2,” the efficacy results of which are reported in this press release, is a 12-month safety trial with a 90-day interim efficacy readout. Safety data for the 12-month period of the Rocket 2 trial is expected late 2015 or early 2016. “Rocket 1,” the results of which were initially reported in April 2015, was a 90-day efficacy trial that did not achieve its primary endpoint, but did achieve its pre-specified secondary endpoint. “Rocket 3” is a 12-month safety-only study in Canada which is currently in progress. A fourth Phase 3 trial, named “Rocket 4,” is expected to commence in late September 2015. Based on the successful results of Rocket 2, Aerie expects to submit a New Drug Application filing for RhopressaTM in mid-2016.
Conference Call / Web Cast Information
Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss the RhopressaTM Phase 3 efficacy results from Rocket 2.
The live webcast and a replay may be accessed by visiting Aerie’s website at http://investors.aeriepharma.com. In addition, key data slides from the RhopressaTM Rocket 2 study will be discussed on the conference call and are posted to the website. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 1-888-734-0328 (U.S.) or 1-678-894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 42505859. Please dial in approximately 10 minutes prior to the call. Telephone replay will be available approximately two hours after the call. To access the replay, please call 1-855-859-2056 (U.S.) or 1-404-537-3406 (international). The conference ID number for the replay is 42505859. The telephone replay will be available until September 22, 2015.
About Aerie Pharmaceuticals, Inc.
Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie reported today the successful results of the Phase 3 registration trial in the United States named Rocket 2, where the primary efficacy endpoint was to demonstrate non-inferiority of IOP lowering for RhopressaTM compared to timolol. Aerie recently completed its first Phase 3 registration trial, named Rocket 1, the three-month efficacy results of which were initially reported in
April 2015, and expects to commence a fourth Phase 3 registration trial, named Rocket 4, in late September 2015. Aerie also completed in 2014 a Phase 2b clinical trial in which RoclatanTM met the primary efficacy endpoint, demonstrating the statistical superiority of RoclatanTM to each of its components, and plans to commence the first Phase 3 registration trial for RoclatanTM, named Mercury 1, in late September 2015. Aerie also recently announced research collaborations with GrayBug, Inc. and Ramot at Tel Aviv University as it further builds it pipeline for future growth.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the use of proceeds from our initial public offering and the issuance and sale of our senior secured convertible notes; our estimates regarding anticipated capital requirements and our needs for additional financing; the potential advantages of our product candidates; our plans to pursue development of our product candidates for additional indications and other therapeutic opportunities; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma; and our ability to protect our proprietary technology and enforce our intellectual property rights. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). In particular, the preclinical research discussed in this press release is preliminary and the outcome of such preclinical studies may not be predictive of the outcome of later clinical trials. Any future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research findings discussed in this press release. Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Contacts
Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
or
Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami Bavishi, 212-213-0006
or
Media
Justin Jackson, 212-213-0006
Source: Aerie Pharmaceuticals, Inc.
Exhibit 99.2
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Exhibit 99.2
RhopressaTM
Rocket 2 Phase 3 Topline Results
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Important Information
Any discussion of the potential use or expected success of our product candidates is subject to our product candidates being approved by regulatory authorities.
The information in this presentation is current only as of its date and may have changed or may change in the future. We undertake no obligation to update this information in light of new information, future events or otherwise. We are not making any representation or warranty that the information in this presentation is accurate or complete.
Certain statements in this presentation are “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “will,” “should,” “would,” “could,” “believe,” “expects,” “anticipates,” “plans,” “intends,” “estimates,” “targets,” “projects,” “potential” or similar expressions are intended to identify these forward-looking statements. These statements are based on the Company’s current plans and expectations. Known and unknown risks, uncertainties and other factors could cause actual results to differ materially from those contemplated by the statements. In evaluating these statements, you should specifically consider various factors that may cause our actual results to differ materially from any forward-looking statements. These risks and uncertainties are described more fully in the quarterly and annual reports that we file with the SEC, particularly in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Such forward-looking statements only speak as of the date they are made. We undertake no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events or otherwise, except as otherwise required by law.
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RhopressaTM Achieves Primary Clinical Endpoint
RhopressaTM QD and RhopressaTM BID met the criteria for non-
inferiority to Timolol BID for the primary efficacy analysis (baseline
IOP <25 mmHg)
RhopressaTM QD showed stable efficacy from Week 2 to Month 3
RhopressaTM QD adverse event profile in Rocket 2 similar to
Rocket 1
RhopressaTM BID slightly more effective than QD, but had higher
incidence of adverse events which led to greater early terminations
On target to file RhopressaTM NDA in mid-2016
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RhopressaTM
Rocket 2 Trial Design
Original primary endpoint:
Mean IOP for subjects with baseline IOP >20 mmHg and <27 mmHg N=756 randomized at 62 sites
Patients randomized 1:1:1
RhopressaTM 0.02% QD
RhopressaTM
Timolol 0.5%
0.02% BID
BID
Revised range for primary endpoint:
Mean IOP for subjects with baseline IOP > 20 mmHg and <25 mmHg N=403 subjects per protocol
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Study Endpoints
Efficacy
Primary efficacy endpoint was the mean IOP for subjects with baseline
IOP >20 mmHg and <25 mmHg in the study eye at nine time points:
08:00, 10:00, and 16:00 at Week 2, Week 6, and Month 3
Multiple secondary endpoints including baseline IOP <27 mmHg
Safety
Ocular and systemic safety measures at each visit through 12 months
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Baseline Demographics
Rhopressa TM QD Rhopressa TM BID Timolol BID
N = 251 N = 254 N = 251
Gender
Male 103 (41%) 89 (35%) 101 (40%)
Female 148 (59%) 165 (65%) 150 (60%)
Race, n (%)
White 178 (71%) 177 (70%) 166 (66%)
Black/African American 69 (28%) 69 (27%) 76 (30%)
Other 4 (1%) 8 (3%) 9 (4%)
Age (yrs)
< 65 111 (44%) 126 (50%) 131 (52%)
>65 140 (56%) 128 (50%) 120 (48%)
Iris Color, n (%)
Brown/Black 155 (62%) 169 (67%) 165 (66%)
Blue/Grey/Green 60 (24%) 57 (22%) 69 (28%)
Hazel 35 (14%) 28 (11%) 17 (7%)
Other 1 (0.4%) 0 (0%) 0 (0%)
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Early Termination Summary
Early termination rates comparable to Rocket 1
RhopressaTM QD: 18%
RhopressaTM BID: 40% (Rocket 2 only)
Timolol BID: 6%
Early termination rates for conjunctival hyperemia
RhopressaTM QD: 9%
RhopressaTM BID: 17%
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Primary Efficacy Endpoint
Maximum Baseline IOP <25 mmHg
mmHg +/- SEM
pre- 8AM 10AM 4PM
Study Qual 1 Baseline Week 2 Week 6 Month 3
25 24 23 22 21 20 19 18 17 16 15
AR-13324 0.02% q.d. (n=129)
AR-13324 0.02% b.i.d. (n=132)
Timolol 0.5% (n=142) IOP
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Primary Efficacy Endpoint
Maximum Baseline IOP <25 mmHg
Mean IOP
RhopressaTM qd N=129
RhopressaTM BID N=132
Timolol BID N=142
Baseline
8:00 AM 22.5 22.6 22.5
10:00 AM 21.3 21.3 21.3
4:00 PM 20.4 20.6 20.7
Day 15
8:00 AM 18.1 17.2 17.7
10:00 AM 16.7 16.4 16.9
4:00 PM 16.7 15.7 16.8
Day 43
8:00 AM 18.0 17.6 17.5
10:00 AM 17.0 16.3 16.6
4:00 PM 17.0 15.8 16.6
Day 90
8:00 AM 18.2 17.6 17.5
10:00 AM 17.0 16.9 16.9
4:00 PM 17.1 16.5 17.0
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Rocket 2 vs. Rocket 1 Efficacy
Similarities
RhopressaTM QD met non-inferiority at baseline IOPs <25 mmHg
RhopressaTM QD missed non-inferiority at baseline IOPs <27 mmHg
(secondary endpoint in Rocket 2)
RhopressaTM QD showed consistent IOP lowering across baseline IOPs
Timolol was slightly more efficacious in Rocket 2, but similarly showed loss
of efficacy at lower baseline IOPs
Differences
Early synergy with prior PGA use less obvious at Week 2 compared to
Rocket 1 and Phase 2 studies
Larger proportion of naïve patients in Rocket 2
50 of 62 study sites not involved in prior RhopressaTM studies
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Safety/Tolerability Overview of RhopressaTM
(Days 15-90)
There were no drug-related serious adverse events (SAEs)
The most common adverse event was conjunctival hyperemia
RhopressaTM QD: ~35% increased incidence of which 83% was mild,
16% moderate
RhopressaTM BID: ~50% increased incidence of which 66% was mild,
33% moderate
Other ocular AEs
AEs occurring in ~5-15% of subjects receiving RhopressaTM QD included:
conjunctival hemorrhage, corneal deposits, and blurry vision
AEs occurring in ~5-17% of subjects receiving RhopressaTM BID included:
conjunctival hemorrhage, blurry vision, corneal deposits, increased
lacrimation, reduced visual acuity, eye pruritus, and conjunctival edema
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RhopressaTM and RoclatanTM Next Steps
RhopressaTM
Rocket 2: First 100 patients on RhopressaTM 12-month safety results at
the end of 2015 or early 2016
On track to file our RhopressaTM NDA in mid-2016
Rocket 4: A fourth Phase 3 trial expected to commence by the end of
September 2015
RoclatanTM
Mercury 1: First Phase 3 12-month study expected to commence by the end of September 2015 Mercury 2: Phase 3 3-month study expected to commence in 2016 Mercury 3 (Europe): Efficacy study, comparing to a leading combo product marketed in Europe, expected to commence in H2 2016
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RhopressaTM Advantages
Proven once-daily IOP lowering Triple mechanism of action
Targets diseased trabecular meshwork in glaucoma Potential to preserve health of trabecular outflow pathway
Anti-fibrotic effect demonstrated preclinically in human trabecular meshwork cells
Increased perfusion demonstrated preclinically in human trabecular meshwork and episcleral tissues
Aerie will present additional details at Investor/Media Day at AAO, Nov 13
aerie pharamaceuticals, Inc.
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