UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News:
Orexo AB (publ.) (STO:ORX) announces that the United States District
Court for the District of Delaware ruled in Orexo’s favor in one of the
patent infringement litigations against Actavis Elizabeth LLC
(“Actavis”) regarding Zubsolv in the US. The other litigations regarding
infringement by Actavis on Orexo’s IP for Zubsolv continues.
Orexo commenced this patent infringement litigation in June 2014 in
response to Actavis’s Abbreviated New Drug Application (“ANDA”) seeking
approval to market and sell generic versions of Orexo’s patented Zubsolv
1.4/0.36 mg and 5.7/1.4 mg buprenorphine/naloxone products. The Orexo
patents in the litigation were US Patent No. 8,454,996 (expiring in
September 2019) and US Patent No. 8,940,330 (expiring in September 2032).
The Court held that Orexo’s ‘996 US patent is valid and infringed by
Actavis’s generic Zubsolv 1.4/0.36 mg and 5.7/1.4 mg
buprenorphine/naloxone products. The Court also held that Orexo’s ‘330
US patent is invalid. The decision prevents Actavis from commercializing
their products in the US before September 24, 2019. However, and
importantly, Actavis generic Zubsolv entry on the US market can be
postponed until late 2032 if the decision regarding validity of the ‘330
patent is reversed on appeal, or if a favorable decision is reached in
the separate litigation involving Orexo’s US Patent No. 9,259,421. Also,
another Zubsolv patent, US Patent No. 9,439,900, expiring in September
2032, was recently issued.
Orexo has throughout the patent litigation process maintained a strong
confidence in the strength of our intellectual property. This first
decision by the court enables Orexo to continue to execute on our
strategy for Zubsolv, and making this product the preferred treatment
for more patients. Orexo will continue to vigorously defend Zubsolv in
the other on-going litigation processes against Actavis and will
consider whether to appeal the portion of the decision relating to the
validity of the ‘330 patent.
“With the validation and proven infringement of the ‘996 patent we will
be able to continue our current strategy and leverage the opportunities
arising from patients gaining expanded access to treatment in the US
until at least late 2019. While I am disappointed with portions of the
court’s decision not to confirm the validity of the ‘330 patent, I
maintain confidence in the strength of our new ‘421 and ‘900 patents and
we are reviewing the possibilities to reverse the ‘330 decision through
appeal with our lawyers. A positive outcome in the litigation of the new
patents will sustain the exclusivity of Zubsolv until 2032.” says
Nikolaj Sørensen, CEO and President of Orexo AB.
CEO and President Nikolaj Sørensen and EVP and CFO Henrik Juuel will
hold a teleconference today, November 16, 2016, at 3.30pm CET.
All questions related to the teleconference had to be sent in advance to firstname.lastname@example.org
at latest 2.30pm CET.
To attend to the conference please just dial: (SE) +46 8 5059 63 06,
(UK) +44 20 31 394 830 or (US) +1 866 928 7517.
Orexo is a specialty pharmaceutical company commercializing its
proprietary product Zubsolv® for treatment of opioid dependence in the
US. Zubsolv is an advanced formulation of buprenorphine and naloxone
using Orexo’s unique knowledge and expertise in sublingual drug
delivery. R&D is focusing on reformulation of known substances to new
improved products that meet great unmet medical needs by using its
patented proprietary technologies. Orexo’s share is listed on Nasdaq
Stockholm Exchange Mid Cap (STO:ORX) and is available as ADRs on OTCQX
(ORXOY) in the US. Orexo’s global headquarters and R&D are based in
For more information about Orexo, please visit www.orexo.com
or follow us on Twitter or LinkedIn. For further information about
Zubsolv in the US, please visit www.zubsolv.com.
This information is information that Orexo AB (publ.) is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact persons set
out above, at 8.55am CET on November 16, 2016
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