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): July 22, 2016
Inotek Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
| DELAWARE |
001-36829 |
04-3475813 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
| 91 Hartwell Avenue Lexington, MA |
02421 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code (781) 676-2100
Not Applicable
(Former name or former address, if changed since last report)
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:
| ¨ | 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 8.01 | Other Events. |
On July 22, 2016, Inotek Pharmaceuticals Corporation (the “Company”) issued a press release announcing that the United States Patent and Trademark Office issued a composition of matter patent for the combination of the Company’s lead product candidate, trabodenoson, with a prostaglandin analog for the treatment of intraocular pressure in patients with glaucoma. A copy of the press release is filed as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 8.01.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated July 22, 2016 | |
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.
| Date: July 22, 2016 | INOTEK PHARMACEUTICALS CORPORATION | |||||
| By: | /s/ Dale Ritter | |||||
| Dale Ritter | ||||||
| Vice President—Finance | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated July 22, 2016 | |
Exhibit 99.1
Inotek Pharmaceuticals Expands Intellectual Property Portfolio with Combination Patent
- Covers Combination of Trabodenoson and a Prostaglandin for Reducing Intraocular Pressure in Glaucoma -
LEXINGTON, Mass – July 22, 2016 – Inotek Pharmaceuticals Corporation (NASDAQ: ITEK), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases, today announced that the United States Patent and Trademark Office issued a composition of matter patent for the combination of the Company’s lead product candidate, trabodenoson, with a prostaglandin analog for the treatment of intraocular pressure (IOP) in patients with glaucoma. US Patent number 9,370,530 (’530 patent) further strengthens the Company’s patent estate for trabodenoson and adds composition of matter intellectual property protection for the combination or kit treatment option until 2031. Trabodenoson, the Company’s lead clinical product candidate, is a first-in-class, selective adenosine mimetic targeting the A1 receptor and has been observed in Phase 2 clinical trials to reduce IOP, an important risk factor for glaucoma. Prostaglandin analogs are currently the most commonly used drug class for this disease.
Earlier this month, Inotek announced the initiation of their Phase 2 dose-ranging trial of a fixed-dose combination (FDC) of trabodenoson and latanoprost, the most commonly used prostaglandin analog prescribed for glaucoma. Glaucoma is one of the leading causes of blindness, and occurs when there is damage to the optic nerve, often as a result of elevated eye pressure. While the goal of glaucoma treatment is to preserve vision, lowering IOP has been shown to prevent progressive vision loss. There are currently no FDC products for glaucoma treatment that include a prostaglandin analog that are approved in the United States, even though about half of glaucoma patients that start treatment with a prostaglandin require a second, adjunctive therapy to increase IOP lowering. Inotek believes an FDC of trabodenoson with latanoprost has the potential to produce efficacy greater than either drug alone in a convenient one-drop, once daily treatment option for patients with glaucoma.
“The issuance of the combination patent covering the use of trabodenoson with a prostaglandin analog is an important addition to Inotek’s growing intellectual property portfolio. This protects use of the combination of trabodenoson with any prostaglandin analog in a single, convenient daily eye drop,” commented David P. Southwell, President and Chief Executive Officer of Inotek. “We look forward to reporting data from our recently initiated Phase 2 FDC trial of trabodenoson and the most commonly used prostaglandin, latanoprost, in the second half of 2017.”
The ’530 patent broadly covers the use of trabodenoson and a prostaglandin analog as a combination, kit or method of use for reducing IOP. Inotek’s patent estate also includes composition of matter patents covering the trabodenoson compound through 2026 in the United States and through 2025 abroad, the crystalline formulation of trabodenoson used in
eye drops through 2033 in the United States and patents relating to the use of trabodenoson for reducing IOP, which expire in 2031 in the United States, and, if issued abroad, will expire in 2030.
About Inotek Pharmaceuticals Corporation
Inotek Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases. The Company’s lead product candidate in glaucoma, trabodenoson, is a first-in-class, selective adenosine mimetic currently in Phase 3 development. Trabodenoson was developed in Inotek’s laboratories and is designed to restore the eye’s natural pressure control mechanism by targeting the adenosine A1 subreceptor. Additionally, the Company is evaluating the potential for selective adenosine mimetics to address optic neuropathies and other degenerative retinal diseases. For more information, please visit www.inotekpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions. These forward-looking statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Inotek Pharmaceuticals
Inotek Contact:
Claudine Prowse, Ph.D., 781-552-4305
Vice President, Strategy and Investor Relations Officer
cprowse@inotekpharma.com