Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc. (Form: 8-K, Received: 07/24/2017 06:48:23)

 

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 24, 2017

 

 

Amphastar Pharmaceuticals, Inc.

(Exact name of Registrant as specified in its charter)

 

 

 

 

 

 

 

 

 

 

 

 

 

Delaware

 

001-36509

 

33-0702205

(State or other jurisdiction of

incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

11570 6th Street
Rancho Cucamonga, California 91730

(Address of principal executive offices, including zip code)

 

(909) 980-9484

(Registrant’s telephone number, including area code)

 

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))

 

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 July 24, 2017,   Amphastar Pharmaceuticals, Inc. (“Amphastar”) announced in a press release that a federal jury delivered a unanimous verdict in favor of the Company in a lawsuit brought by Momenta Pharmaceuticals, Inc. and Sandoz Inc. in the U.S. Court for the District of Massachusetts.

 

A copy of the press release is being filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

 

ITEM 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

 

 

 

Exhibit No.

  

Description

 

 

  99.1

  

Press Release of Amphastar Pharmaceuticals, Inc. dated July 24, 2017

 


 

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.

 

 

 

 

 

 

AMPHASTAR PHARMACEUTICALS, INC.

Date: July 24, 2017

 

 

By:

/S/WILLIAM J. PETERS

 

 

William J. Peters

 

Chief Financial Officer and Senior Vice President

 

 

 

 


 

Exhibit Index

 

 

 

 

Exhibit No.

  

Description

 

 

  99.1

  

Press Release of Amphastar Pharmaceuticals, Inc. dated July 24, 2017

 

 


 

Exhibit 99.1

Amphastar Announces Jury Verdict in Patent Litigation against Momenta Pharmaceuticals, Inc. and Sandoz Inc.

RANCHO CUCAMONGA, CA – July 24, 2017 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that a federal jury delivered a unanimous verdict in favor of Amphastar in a lawsuit brought by Momenta Pharmaceuticals, Inc. and Sandoz Inc. (the “Plaintiffs”) in the U.S. Court for the District of Massachusetts. The jury found the claims of Momenta’s U.S. Patent No. 7,575,886 (the “Patent”) to be invalid for lack of enablement and lack of adequate written description.  The jury further found that the Plaintiffs had waived their ability to enforce the Patent because of Plaintiffs’ conduct before the U.S. Pharmacopeia (“USP”), and that the Plaintiffs were estopped from enforcing the Patent because of this conduct.

Amphastar's CEO, Dr. Jack Zhang, stated: "We have always believed that the facts and the law do not support the Plaintiffs’ baseless allegations and we are very pleased that justice has prevailed.  We remain proud of our technology for product development and will continue to execute on our mission of developing and manufacturing life-saving drugs for the benefit of patients .”  

Company Information

Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable and inhalation products. In 2014, the Company also commenced sales of insulin active pharmaceutical ingredient products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information is available at the Company’s website at www.amphastar.com.

Forward Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding litigation matters, collection of the bond posted by the Plaintiffs and other matters related to its current products, pipeline of product candidates and other future events. These statements are not historical facts but rather are based on Amphastar’s current expectations, estimates, and projections regarding Amphastar’s business, operations, and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s

 


 

 

control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission. Amphastar undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available.

  CT?ID=BWNEWS&STY=20110324005500R1&SID=CMTX2&DISTRO=NX

Contact Information:

Amphastar Pharmaceuticals, Inc.

Bill Peters

Chief Financial Officer

(909) 980-9484