Bli medlem
Bli medlem

Du är här

2016-11-16

Orexo: Favorable outcome from Zubsolv® patent infringement litigation against Actavis

Uppsala, Sweden, November 16, 2016 - Orexo AB (publ.) 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.
Teleconference
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 ir@orexo.com 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.

For more information please contact:

Orexo AB (publ.)
Nikolaj Sørensen, CEO and President Henrik Juuel, EVP and CFO
Tel: +46 (0)18 780 88 00 Tel: +46 (0)18 780 88 00
Email: ir@orexo.com Email: ir@orexo.com

About Orexo

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 Uppsala, Sweden.

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

-----------------------------------------------------------
http://news.cision.com/orexo/r/favorable-outcome-from-zubsolv--patent-in...
http://mb.cision.com/Main/694/2123791/590502.pdf

Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.