PDL BioPharma, Inc. (NASDAQ:PDLI) Files An 8-K Other Events
Item 8.01 Other Events
its subsidiary, Noden Pharma DAC (Noden), received a Paragraph IV
Notice Letter advising that Anchen Pharmaceuticals, Inc. (Anchen)
submitted an Abbreviated New Drug Application (ANDA) to the
United States Food and Drug Administration (the FDA) seeking
authorization from the FDA to manufacture and market a generic
version of Tekturna>aliskiren hemifumarate tablets, 150 mg and
300 mg, in the United States.
8,617,595, which is listed in the Approved Drug Products with
Therapeutic Equivalence Evaluations (the Orange Book) for
Tekturna as expiring on February 19, 2026.
(Novartis) received Paragraph IV certifications from Par
Pharmaceuticals, Inc. (Par) for Tekturna HCT and Anchen on
December 31, 2013. Novartis did not file a responsive patent
infringement suit related to these certifications. However, to
Nodens knowledge, neither Par nor Anchen have in the meantime
commercialized generic aliskiren products.
rights related to Tekturna.
incorporated herein by reference.
and in the attached press release contain “forward-looking”
statements as defined in the Private Securities Litigation Reform
Act of 1995. These statements are based on management’s current
expectations or predictions of future conditions, events or results
based on various assumptions and management’s estimates of trends
and economic factors in the markets in which we are active, as well
as our business plans. Words such as “expects,” “anticipates,”
“intends,” “plans,” “believes,” “seeks,” “estimates,”
“projects,” “forecasts,” “may,” “should,” variations of
such words and similar expressions are intended to identify such
forward-looking statements. The forward-looking statements are
subject to risks and uncertainties, which may cause results to
differ materially from those set forth in the statements.
Forward-looking statements in this filing and in the attached press
release should be evaluated together with the many uncertainties
that affect the business of the Company and its markets,
particularly those discussed in the risk factors and cautionary
statements contained in the Company’s annual report filed with the
SEC on March 1, 2017, as well as subsequent filings. All
forward-looking statements are expressly qualified in their
entirety by such factors. The forward-looking statements are
representative only as of the date they are made, and the Company
assumes no responsibility to update any forward-looking statements,
whether as a result of new information, future events or otherwise.
|
Exhibit No.
|
|
Description
|
|
99.1
|
|
Press Release
|
About PDL BioPharma, Inc. (NASDAQ:PDLI)
PDL BioPharma, Inc., formerly Protein Design Labs, Inc., manages a portfolio of patents and royalty assets, consisting of its Queen et al. patents, license agreements with various biotechnology and pharmaceutical companies, and royalty and other assets acquired. The Company provides non-dilutive growth capital and financing solutions to late-stage public and private healthcare companies and offers immediate financial monetization of royalty streams to companies, academic institutions and inventors. It evaluates its investments based on the quality of the income generating assets and potential returns on investment. It is focused on intellectual property asset management, acquiring income generating assets and maximizing value for its stockholders, among others. It receives royalties on sales of over ten humanized antibody products, which include Avastin, Herceptin, Xolair, Kadcyla, Tysabri, Actemra, Gazyva and Entyvio all of which are approved for use. PDL BioPharma, Inc. (NASDAQ:PDLI) Recent Trading Information
PDL BioPharma, Inc. (NASDAQ:PDLI) closed its last trading session up +0.04 at 2.45 with 3,448,208 shares trading hands.
