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): August 28, 2017
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) |
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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events
On August 28, 2017, Coherus BioSciences, Inc. issued a press release reporting that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a clinical pharmacokinetic bioequivalence study that compared CHS-1420 to Humira manufactured in Europe in healthy subjects. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press release dated August 28, 2017. | |
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: August 29, 2017 | COHERUS BIOSCIENCES, INC. | |||||
| By: | /s/ Jean-Frédéric Viret | |||||
| Name: | Jean-Frédéric Viret | |||||
| Title: | Chief Financial Officer | |||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press release dated August 28, 2017. | |
Exhibit 99.1
Coherus BioSciences Announces Positive Topline Results for Clinical
Pharmacokinetic Bioequivalence Study
for CHS-1420 (Humira® Biosimilar Candidate)
versus European Marketed Humira in Healthy Subjects
REDWOOD CITY, Calif., August 28, 2017 – Coherus BioSciences, Inc. (NASDAQ: CHRS), today reported topline results from the first of three ongoing pharmacokinetic bioequivalence (“PK/BE”) studies comparing CHS-1420, a proposed adalimumab (“Humira”) biosimilar candidate versus European marketed Humira. The study met the criteria for clinical PK/BE on all prospectively defined endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC-0-last), and area under the time-concentration curve from first time point extrapolated to infinity (AUC-0-inf). The 90% confidence intervals of the geometric mean ratios for all PK endpoints fell well within the bioequivalence boundaries of 80% to 125%. Both agents were well tolerated and there were no clinical meaningful differential adverse events observed between the two agents in this study.
This study was a randomized, single-blind, single-dose, parallel-group study in 216 healthy subjects designed to assess the PK/BE of CHS-1420 to that of European marketed Humira by comparing relative bioavailability after sub-cutaneous administration of a single 40 mg dose. The safety and tolerability of CHS-1420 was also evaluated.
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, sales & marketing 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-1420 (adalimumab biosimilar) and CHS-0214 (etanercept 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, expectations, goals, objectives, milestones, product pipeline, clinical studies, product development, release of data 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 our ability to replicate these data in the other two ongoing studies. 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’ its Quarterly Report on Form 10-Q for the period ended June 30, 2017, filed with the Securities and Exchange Commission on August 7, 2017 and its future periodic reports to be filed with the Securities and Exchange Commission.
Contact:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com