0001400482-16-000130.txt : 20160317 0001400482-16-000130.hdr.sgml : 20160317 20160316210702 ACCESSION NUMBER: 0001400482-16-000130 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160316 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160317 DATE AS OF CHANGE: 20160316 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ACUCELA INC. CENTRAL INDEX KEY: 0001400482 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 020592619 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-55133 FILM NUMBER: 161511079 BUSINESS ADDRESS: STREET 1: 1301 SECOND AVE. STREET 2: SUITE 4200 CITY: SEATTLE STATE: WA ZIP: 98101 BUSINESS PHONE: 206-805-8300 MAIL ADDRESS: STREET 1: 1301 SECOND AVE. STREET 2: SUITE 4200 CITY: SEATTLE STATE: WA ZIP: 98101 FORMER COMPANY: FORMER CONFORMED NAME: Acucela Inc DATE OF NAME CHANGE: 20070523 8-K 1 acucela-20160317xform8xk.htm 8-K 8-K




UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): March 16, 2016


ACUCELA INC.
(Exact name of registrant as specified in its charter)


 Washington
(State or other jurisdiction
of incorporation)
000-5513
(Commission
File Number)
02-0592619
(IRS Employer
Identification No.)

1301 Second Avenue, Suite 4200
Seattle, Washington 98101
(Address of principal executive offices, including zip code)

(206) 805-8300
(Registrant’s telephone number, including area code)
(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 (see General Instruction A.2. below):

o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))









Item 1.01 Entry into a Material Definitive Agreement.

On March 16, 2016, Acucela Inc. (the “Company”) entered into an option and license agreement with YouHealth Eyetech, Inc. (“YouHealth”), a U.S. based company. YouHealth’s parent company, Guangzhou Kang Rui Biological Pharmaceutical Technology Co., Ltd., is a party to the agreement as a guarantor of YouHealth’s performance of its obligations. Pursuant to the terms of the agreement, YouHealth granted the Company an exclusive option to obtain an exclusive, royalty-bearing license, with the right to sublicense, to certain YouHealth technology to develop and commercialize products containing lanosterol for the treatment of ophthalmological diseases (“Products”) in any part of the world excluding the People’s Republic of China, Taiwan and Hong Kong (collectively, the “YouHealth Territory”). The Company may exercise the option at any time before June 30, 2019 (the “Option Period”) by providing written notice to YouHealth and a payment of $10 million. During the Option Period, the Company granted to YouHealth an exclusive, royalty-free, fully-paid license, without the right to sublicense, to certain of the Company’s technology to develop Products in the YouHealth Territory. If the Company exercises the option, the license granted by the Company to YouHealth will then permit sublicenses and commercialization of Products by YouHealth in the YouHealth Territory.

Pursuant to the terms of the agreement, the Company is obligated to pay an upfront fee of $5 million to YouHealth. During the Option Period, YouHealth is eligible to receive up to an additional $5 million upon the achievement of certain near-term development and regulatory milestones. Upon the Company’s exercise of the option, YouHealth would be eligible to receive up to $300 million upon the Company’s achievement of certain regulatory milestones, such as initiation of Phase 3 clinical trials and approvals of new drug applications by applicable regulatory authorities, across multiple indications, and up to $90 million upon the Company’s achievement of certain post-approval sales-based milestones. In addition to these potential one-time payments, YouHealth is eligible to receive a mid single-digit percentage of annual net sales, which percentage will increase to a higher mid single-digit if certain annual net sales figures are exceeded. Royalties will be payable on a product-by-product and country-by-country basis until the later of 10 years from the date of first commercial sale in a particular country and the expiration of the last-to-expire valid claim of certain YouHealth patents covering the products. The royalty percentage is subject to a 50% reduction in the event no valid patent claim covers the Product and the royalty will terminate at any time generic competition occurs before the completion of the royalty term.

Each party will be solely responsible for the development, manufacture and commercialization of Products in its respective territory, compliance with applicable regulatory requirements and related expenses. The Company also agreed to use diligent efforts to achieve certain diligence milestones applicable to an existing license between YouHealth and the Regents of the University of California, which license comprises part of the technology licensed to the Company by YouHealth.

Unless terminated by the parties, the Company’s agreement with YouHealth expires on June 30, 2019 if the Company has not exercised its option, or on the expiration of the last-to-expire royalty term for any commercialized Product. Either party may terminate the agreement upon the other party’s material breach, after provision of written notice and an opportunity to cure such breach. The Company has the right to terminate the agreement for any reason at any time upon 60 days prior written notice to YouHealth. If the Company declines to exercise the option by the end of the Option Period, YouHealth will have a right of first negotiation to obtain an exclusive, worldwide license, with right to sublicense, under certain of the Company’s patents to develop and commercialize Products for the treatment of ophthalmological diseases.

The foregoing description of the option and license agreement is only a summary of its material terms and does not purport to be complete.

A copy of the option and license agreement with YouHealth will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. A press release issued by the Company on March 16, 2016 regarding the execution of the option and license agreement is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.
(d) Exhibits

Exhibit Number        Description
99.1            Press release dated March 16, 2016.







SIGNATURE

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.

ACUCELA INC.
 
 
Date: March 16, 2016
 
 
 
 
 
By:
/s/ John E. Gebhart
 
 
John E. Gebhart
 
 
Chief Financial Officer













EXHIBIT INDEX

Exhibit Number        Description
99.1            Press release dated March 16, 2016.


EX-99.1 2 exhibit991pressrelease-cha.htm EXHIBIT 99.1 Exhibit
                                Press Release


Acucela Secures Option to Exclusively License Novel Cataract Treatment
Potential non-surgical pharmacologic treatment for cataracts
SEATTLE (March 16, 2016) — Acucela Inc. (Tokyo: 4589) (“Acucela”), a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, and YouHealth Eyetech, Inc. (“YouHealth”), announced today an agreement involving an exclusive option from YouHealth on lanosterol technology licensed from the Regents of the University of California, San Diego for the non-surgical pharmacologic treatment of cataracts.
Cataracts are responsible for 51% of all blindness1 as well as 24 million surgical procedures worldwide in 20152. Cataracts are a pervasive condition characterized by optical opacities that develop as a result of protein aggregation in the crystalline lens of the eye, generally due to the natural aging process. Currently, there is no non-surgical treatment available for cataracts. A non-invasive therapy that improves lens clarity and vision at the early stage of cataract development and may reverse lens opacification at later stages would be considered a significant medical breakthrough.
This therapy, if approved, would be the first of its kind for the pharmacologic treatment of cataracts. Acucela plans to initially evaluate lanosterol as a treatment for mild cataracts with an option to fully develop and commercialize the compound globally with the exception of Greater China including China, Taiwan and Hong Kong. The use of lanosterol in other ophthalmic conditions such as presbyopia may be investigated by Acucela in the future. YouHealth’s parent company, Guangzhou Kang Rui Biological Pharmaceutical Technology Co., Ltd. (“Kang Rui”) will be responsible for lanosterol’s clinical development and commercialization in Greater China including China, Taiwan and Hong Kong.
Lanosterol, a naturally occurring compound found in the human body, has shown promise for this condition in several preclinical studies. It has been identified as a key molecule in the prevention of lens protein aggregation and lens opacification. A scientific collaboration between Dr. Kang Zhang MD, PhD, Dept. of Ophthalmology, University of California, San Diego and scientists associated with Kang Rui identified two genetic mutations that impair key catalytic functions responsible for maintaining the normal crystalline structure of the lens. They then identified and published the therapeutic effect of lanosterol in in-vitro, cell-transfection and in-vivo experiments3.
“The potential for the lanosterol technology to provide an entirely new treatment paradigm for early stage cataracts raises hope for millions who now can only wait for their cataracts to worsen to the point where surgery is warranted. We welcome the opportunity to work with YouHealth to make this therapy a reality,” stated Dr. Ryo Kubota, MD, PhD, and Chairman, President and CEO of Acucela.
“We are excited to work with Acucela to advance this novel technology into development for the treatment of cataract,” said Rui Hou, CEO of Kang Rui.
1Visiongain, Ophthalmic Drugs Market Forecast, 2015-2025; World Health Organization
2 Market Scope, The Global IOL Market 2015
3 Nature 523 (2015) 607-614

About Acucela Inc.
Acucela Inc. (http://www.acucela.com/ or http://www.acucela.jp) is a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases affecting millions of people worldwide. Acucela’s lead investigational drug candidate, emixustat hydrochloride, is currently in clinical development in collaboration with Otsuka Pharmaceutical Co., Ltd. for geographic atrophy associated with dry age-related macular degeneration based on Acucela’s proprietary visual cycle modulation technology.
About Guangzhou Kang Rui Biological Pharmaceutical Technology Co., Ltd. and YouHealth Eyetech, Inc.
Guangzhou Kang Rui Biological Pharmaceutical Technology Co., Ltd., the parent company of YouHealth Eyetech, Inc., is a leading R&D company specialized in novel ophthalmic drug and treatment developments in China. It has several first in class drugs under development for cataract, age-related macular degeneration, corneal diseases, glaucoma and dry eye.




Cautionary Statements
Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include statements regarding our expectations regarding corporate development activities and the ultimate success of the enterprise; our development plans and ability to successfully commercialize our product candidates; the timing of and results from our and our collaborators’ ongoing clinical trials and pre-clinical development activities; the potential efficacy, future development plans and commercial potential of our and our collaborators’ product candidates and the progress and potential of ongoing development programs. These statements are based on current assumptions that involve risks, uncertainties and other factors that could cause the actual results, events or developments to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: our investigational product candidates may not demonstrate the expected safety and efficacy; our pre-clinical development efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; the success of our investigational product candidate, emixustat hydrochloride, depends heavily on the willingness of our collaboration partner to continue to co-develop our investigational product candidate; our clinical trials could be delayed; new developments in the intensely competitive ophthalmic pharmaceutical market may require changes in our clinical trial plans or limit the potential benefits of our investigational product candidates; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. For a detailed discussion of the foregoing risks and other risk factors, please refer to our filings with the Securities and Exchange Commission, which are available on the Company’s investor relations website (http://ir.acucela.com/) and on the SEC’s website (http://www.sec.gov).
“Acucela” and the Acucela logo are registered trademarks or trademarks of Acucela Inc. in various jurisdictions.
Media Contact :
Michael Hasegawa
Senior Director, Corporate Communications
Phone: +81.3.5789.5872


Email: mhasegawa@acucela.com




GRAPHIC 3 pressreleasecharger20_image1.gif begin 644 pressreleasecharger20_image1.gif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