LANTHEUS HOLDINGS,INC. (NASDAQ:LNTH) Files An 8-K Entry into a Material Definitive Agreement
Item1.01
| Entry into a Material Definitive Agreement. |
On April25, 2017, Lantheus Medical Imaging, Inc. (LMI), the
operating subsidiary of Lantheus Holdings, Inc. (the Company),
entered into an exclusive Collaboration and License Agreement
(the License Agreement) with GE Healthcare Limited (GEHC) for the
continued Phase III development and worldwide commercialization
of flurpiridaz F 18, an investigational positron emission
tomography myocardial perfusion imaging agent that may improve
the diagnosis of coronary artery disease.
Separately, LMI entered into an Amended and Restated Supply
Agreement with GEHC, effective as of April25, 2017 (the Supply
Agreement), to which LMI will supply GEHC with TechneLite
(Technetium Tc99m Generators), Xenon-133 (Xenon Xe 133 Gas) and
Gallium-67 (Gallium Citrate Ga 67 Injection) through December31,
2020.
License Agreement
Under the License Agreement, GEHC will complete the worldwide
development of flurpiridaz F 18, pursue worldwide regulatory
approvals and, if successful, lead a worldwide launch and
commercialization of the agent, with LMI collaborating on both
development and commercialization through a joint steering
committee. LMI will maintain the option to co-promote the agent
in the U.S. GEHCs development plan will initially focus on
obtaining regulatory approval for flurpiridaz F 18 in the U.S.,
Japan, Europe and Canada.
In connection with the transaction, GEHC will make a USD 5million
upfront cash payment to LMI.
In addition, if flurpiridaz F 18 receives regulatory approvals
and is commercially successful, LMI will receive:
|
up to USD 60million in regulatory and sales milestones payments |
| tiered double-digit royalties on U.S. sales |
| mid-single-digit royalties on sales outside of the U.S. |
LMI and the Company intend to use the proceeds of the upfront
cash payment for general corporate purposes.
The License Agreement generally runs through December31, 2036 and
may be terminated (in whole or on a country-by-country basis, as
specified in the License Agreement) by GEHC at will, by either
party for the other partys material breach or insolvency, by LMI
for the cessation of development or commercialization activities
or patent challenges brought by GEHC.
LMI retains rights to develop and commercialize flurpiridaz F 18
outside of cardiac imaging indications, subject to GEHCs purchase
option and rights of first offer.
The License Agreement contains customary covenants,
representations and warranties, indemnities and limitations of
liability.
Supply Agreement
The Supply Agreement specifies pricing levels and requires GEHC
to purchase minimum percentage volumes of each of the specified
products from LMI during the term of the agreement. The Supply
Agreement will expire on December31, 2020 and may be terminated
upon the occurrence of specified events, including a material
breach by the other party and certain force majeure events.
| Item8.01 | Other Events |
A copy of the joint press release of the Company and GEHC, dated
April25, 2017, announcing the signing of a definitive
collaboration and license agreement for worldwide development and
commercialization of flurpiridaz F 18 is attached hereto as
Exhibit 99.1 and is incorporated herein by reference.
| Item9.01 | Financial Statements and Exhibits |
(d) Exhibits
|
Exhibit No. |
Description |
|
| 99.1 |
Joint press release of Lantheus Holdings, Inc. and GE Healthcare Limited, dated April 25, 2017, entitled Lantheus and GE Healthcare Announce the Signing of a Definitive License Agreement for Worldwide Development and Commercialization of Flurpiridaz F 18 |
About LANTHEUS HOLDINGS, INC. (NASDAQ:LNTH)
Lantheus Holdings, Inc. is engaged in the development, manufacture and commercialization of diagnostic medical imaging agents and products that assist clinicians in the diagnosis and treatment of cardiovascular and other diseases. Its imaging agents and products are used across a range of imaging modalities, including echocardiography and nuclear imaging. It operates in two segments: U.S. Segment and International Segment. The U.S. Segment produces and markets its medical imaging agents and products throughout the United States. In the United States, it sells its products to radiopharmacies, integrated delivery networks, hospitals, clinics and group practices. The International Segment operations consist of production and distribution activities in Puerto Rico and direct distribution activities in Canada. Its portfolio of nine commercial products is diversified across a range of imaging modalities. Its products include an ultrasound contrast agent and medical radiopharmaceuticals. LANTHEUS HOLDINGS, INC. (NASDAQ:LNTH) Recent Trading Information
LANTHEUS HOLDINGS, INC. (NASDAQ:LNTH) closed its last trading session up +0.20 at 11.80 with 164,348 shares trading hands.
