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): November 7, 2016
COHERUS BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
| Delaware (State or other jurisdiction of incorporation) |
001-36721 (Commission File Number) |
27-3615821 (IRS Employer Identification Number) |
333 Twin Dolphin Drive, Suite 600
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 November 7, 2016, Coherus BioSciences, Inc. issued a press release regarding the non-institution of an Inter Partes Review of AbbVie Inc.’s U.S. Patent 9,114,166, which generally concerns an isotonic formulation of TNF-a IgG1 antibody at a protein concentration of 50 mg/ml and pH of 4.0 to 8.0. The full text of the press release is furnished as Exhibit 99.1 to this Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press release dated November 7, 2016. | |
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.
| COHERUS BIOSCIENCES, INC. | ||||||
| Date: November 7, 2016 | By: |
/s/ Jean-Frédéric Viret | ||||
| Name: | Jean-Frédéric Viret | |||||
| Title: | Chief Financial Officer | |||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press release dated November 7, 2016. | |
Exhibit 99.1
Coherus BioSciences Receives Decision Denying Institution of the ‘166 IPR
Related to AbbVie’s HUMIRA® Formulation
Management to host a call to discuss the decision
REDWOOD CITY, Calif., November 7, 2016 -- Coherus BioSciences, Inc. (Nasdaq: CHRS), today announced that it has received a decision from the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office denying institution of Coherus’ petition for Inter Partes Review (IPR) of AbbVie’s U.S. Patent 9,114,166 (the “’166 Patent”) related to AbbVie’s HUMIRA (adalimumab) formulation.
“While we are disappointed by this outcome it is important to note that our longstanding strategy has been to develop and preserve multiple options pursuant to adalimumab formulation intellectual property. There are additional scientific and legal approaches available to address the various formulation intellectual property challenges, and all of the arguments raised in our IPR petition remain available in a District Court proceeding,” said Denny Lanfear, President and Chief Executive Officer of Coherus. “Coherus remains committed to launching our HUMIRA biosimilar once approved.”
Coherus’ management team will host a conference call on Monday, November 7, 2016 at 2:30 pm ET.
Conference Call Information
Dial-in: (844) 452-6826 (domestic) or (765) 507-2587 (international)
Conference ID: 13640467
Please join the conference call at least 10 minutes early to register.
A replay of this conference call will be posted to the company’s website http://investors.coherus.com and will be available until November 30, 2016.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus’ plans, potential opportunities including market opportunities, expectations, goals, objectives, strategies, product pipeline, clinical studies, product development, and the potential benefits of its products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ ability to advance its intellectual strategy for CHS-1420 and to initiate CHS-1420
commercialization and any future District Court proceeding. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the Securities and Exchange Commission and its future periodic reports to be filed with the Securities and Exchange Commission.
HUMIRA® is a registered trademark of AbbVie Biotechnology Ltd.
Contact:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527