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EX-99.1 - EXHIBIT 99.1 - Coherus BioSciences, Inc.d893562dex991.htm

 

 

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): March 16, 2015

 

 

COHERUS BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36721   27-3615821

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

201 Redwood Shores Parkway, Suite 200

Redwood City, CA 94065

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 649-3530

 

 

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 March 16, 2015 Coherus BioSciences, Inc. (the “Company”) received written feedback from the Food and Drug Administration (FDA) on its biologic enabling license (BLA) clinical development program for CHS-1701, its pegfilgrastim biosimilar candidate. Pursuant to the FDA feedback, the Company initiated a pivotal pharmacodynamics and pharmacokinetics study on the CHS-1701 development plan. An additional immunogenicity study is planned in healthy volunteers pursuant to this BLA and is projected to be concluded in 2015 to support submission of the 351(k) (biosimilar) license application for CHS-1701 in Q4 2015 or Q1 2016.

The foregoing is only a summary of the material terms of the written feedback from the FDA and does not purport to be a complete description of such feedback.

A copy of the press release announcing the finalization of the CHS-1701 BLA enabling clinical program is attached hereto as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
No.

  

Description

99.1    Press Release dated March 17, 2015


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: March 19, 2015 COHERUS BIOSCIENCES, INC.
By:

/s/ Jean-Frédéric Viret

Name: Jean-Frédéric Viret
Title: Chief Financial Officer


EXHIBIT INDEX

 

Exhibit
No.

  

Description

99.1    Press Release dated March 17, 2015