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 14, 2017
Progenics Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
000-23143 |
13-3379479 | ||
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(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
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One World Trade Center, New York, New York |
10007 | |||
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(Address of principal executive offices) |
(Zip Code) | |||
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Registrant's telephone number, including area code (646) 975-2500 | ||||
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):
☐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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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. ☐
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Item 8.01. |
Other Events. |
On July 14, 2017, Progenics Pharmaceuticals, Inc. (“Progenics”) received notification of a Paragraph IV certification for certain patents for subcutaneous RELISTOR® (methylnaltrexone bromide), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification resulted from the filing by Par Sterile Products, LLC of an Abbreviated New Drug Application (ANDA) challenging such patents for subcutaneous RELISTOR (methylnaltrexone bromide).
Progenics and its licensee for RELISTOR, Salix Pharmaceuticals, Inc. (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) are assessing the notification and intend to vigorously enforce RELISTOR intellectual property rights.
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.
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PROGENICS PHARMACEUTICALS, INC. | ||
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By: |
/s/ Patrick Fabbio | |
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Patrick Fabbio | ||
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Senior Vice President and Chief Financial Officer | ||
Date: July 18, 2017