BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) Files An 8-K Entry into a Material Definitive Agreement
Item1.01
| Entry Into a Material Definitive Agreement. |
On April12, 2017, BioMarin Pharmaceutical Inc., a Delaware
corporation (the Company), entered into a Settlement and License
Agreement (the Settlement Agreement) with Merck Cie (Merck) and
Par Pharmaceutical, Inc. (Par) related to the ongoing patent
infringement litigation (the Litigation) that the Company and
Merck filed against Par in the U.S. District Court for the
District of New Jersey (the District Court). As previously
disclosed, in the Litigation, the Company and Merck allege that
certain patents of the Company and Merck covering Kuvan
(sapropterin dihydrochloride) 100 mg oral tablets and powder for
oral solution in 100 mg packets (the Kuvan Patents) are or will
be infringed by the generic versions of Kuvan covered by the
abbreviated new drug applications (ANDAs) filed by Par.
Under the Settlement Agreement, the Company and Merck have agreed
to file a stipulation of dismissal of the Litigation with the
District Court, Par has agreed to release the Company and Merck
from all claims that Par has, may have had, might have asserted,
may now have or assert, or may hereafter have or assert that are
reasonably related to the Litigation, and the Company and Merck
have agreed to release Par from all claims that the Company or
Merck have, may have had, might have asserted, may now have or
assert, or may hereafter have or assert that are reasonably
related to the Litigation.
to the Settlement Agreement, the Company and Merck have granted
Par a fully paid up, royalty-free, non-exclusive license under
the Kuvan Patents to make, have made, use, import, distribute,
have distributed, sell and offer for sale a generic version of
Kuvan in 100 mg oral tablet and powder for oral solution in 100
mg and 500 mg packet formulations in the United States and its
territories, including the Commonwealth of Puerto Rico, upon the
earlier of (i)April1, 2021, if Par is not entitled to the 180-day
first-filer exclusivity period described in 21 U.S.C.
355(j)(5)(B)(iv) with respect to a generic equivalent of Kuvan
(the Exclusivity Period), or (ii)October1, 2020, if Par is
entitled to the Exclusivity Period, or earlier under certain
circumstances (the Generic Entry Date). Such circumstances
include a final decision that the then-asserted and adjudicated
claims of the Kuvan Patents are invalid, unenforceable or not
infringed by a generic equivalent, or events related to the
market entry of other generic versions of Kuvan. The Settlement
Agreement will remain in effect until the expiration of the last
to expire of the Kuvan Patents. The Settlement Agreement with Par
does not resolve pending patent litigation brought by the Company
against other parties who have submitted ANDAs to the U.S. Food
and Drug Administration seeking marketing approval for generic
versions of Kuvan.
In accordance with legal requirements, the parties have agreed to
submit the Settlement Agreement to the U.S. Federal Trade
Commission Bureau of Competition (FTC) and the Antitrust Division
of the U.S. Department of Justice (DOJ) for review.
The foregoing description of the Settlement Agreement does not
purport to be complete and is qualified in its entirety by
reference to the complete text of the Settlement Agreement, which
will be filed as an exhibit to the Companys Quarterly Report on
Form 10-Q for the quarter ending June30, 2017.
| Item8.01 | Other Events. |
On April13, 2017, the Company issued a press release to which it
announced that it had entered into the Settlement Agreement. A
copy of the press release is furnished as Exhibit 99.1 hereto.
| Item9.01 | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibit relating to Item1.01 shall be deemed to be
furnished, and not filed:
|
ExhibitNo. |
Description |
|
| 99.1 | Press release dated April 13, 2017 |
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Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking
statements, including, but not limited to, statements about:
possible launch dates for generic versions of Kuvan in both the
United States and the European Union, and ongoing litigation
related to generic versions of Kuvan. These forward-looking
statements are predictions and involve risks and uncertainties.
Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, but are
not limited to, risks and uncertainties related to: the review of
the settlement agreement with Par Pharmaceutical by the FTC and
the DOJ; the outcome of current litigation with Dr.Reddys
Laboratories, possible future ANDA filings related to Kuvan
tablets or Kuvan powder for oral solution; and those factors
detailed in BioMarins filings with the Securities and Exchange
Commission, including, without limitation, the factors contained
under the caption Risk Factors and elsewhere in the Companys
Securities and Exchange Commission (SEC) filings and reports
(Commission File No.001-26727), including the Annual Report on
Form 10-K for the year ended December31, 2016, filed with the SEC
on February27, 2017, and future filings and reports by the
Company. The Company undertakes no duty or obligation to update
any forward-looking statements contained in this Current Report
on Form 8-K as a result of new information, future events or
changes in its expectations.
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About BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)
BioMarin Pharmaceutical Inc. (BioMarin) develops and commercializes pharmaceuticals for various diseases and medical conditions. The Company’s product portfolio consists of approximately five approved products, and multiple clinical and pre-clinical product candidates. Its approved products include Vimizim (elosulfase alpha), Naglazyme (galsulfase), Kuvan (sapropterin dihydrochloride), Aldurazyme (laronidase) and Firdapse (amifampridine phosphate). Its products in clinical development include Kyndrisa, Pegvaliase, Reveglucosidase alfa, Vosoritide (formerly BMN 111), Cerliponase alfa, BMN 044, BMN 045, BMN 053 and BMN 270. Vimizim is an enzyme replacement therapy for the treatment of mucopolysaccharidosis type IV (MPS IV A). Naglazyme is a recombinant form of N-acetylgalactosamine 4-sulfatase (arylsulfatase B) indicated for patients with mucopolysaccharidosis VI (MPS VI). Kuvan is a synthetic oral form of 6R-BH4 indicated for patients with phenylketonuria (PKU). BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) Recent Trading Information
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) closed its last trading session 00.00 at 88.38 with 741,799 shares trading hands.