Orexo AB

[BioSpecialist]

listen to the presentation and review the slides

15 Feb 2008
http://www.financialhearings.com/hearing/financia1.nsf/(recordednew)/36A4ADC8FEA67F01C12573D2002C386A?OpenDocument

[BioSpecialist]

listen to the presentation and review the slides

15 Feb 2008
http://media.fronto.com/streaming/fh/default.aspx?id=%7B06ff2d14-8518-4f65-9cdf-53525033dd5e%7D

[BioSpecialist]

Orexo discloses new mechanism for asthma and COPD treatment

The discovery of the eoxins and their characteristics has paved the way for a new class of pharmaceuticals for treatment of asthma and COPD. One of the world’s most-cited scientific journals, Proceedings of the National Academy of Sciences of the United States (PNAS), is now publishing Orexo´s research on the initial discovery and biological functions of eoxins. The publication describes the scientific rationale behind Orexo´s drug development program on eoxin inhibitors.

Eoxins constitute a new group of inflammatory mediators, which adds to understanding the mechanisms for airway inflammation. Eoxins are pro-duced from the endogenous fatty acid arachidonic acid, via the initial action of the enzyme 15-lipoxygenase. Inflammatory cells in the res-piratory tract are the main producers of eoxins, and the production is initiated by well known inflammatory mediators released in connection with allergy and asthma. These data, together with the powerful pro-inflammatory effects demonstrated for the eoxins, indicate an important role for eoxins in the inflammation seen in connection with asthma and COPD, chronic obstructive pulmonary disease.

The research article in Proceedings of the National Academy of Sciences of the United States (PNAS) Early Edition, published on the 9th of January 2008, is the first in a series of publications on eoxin research. It scientifically establishes how the eoxins are synthesized, their molecular structure and their biological effects.

"The publishing of our eoxin research is an important acknowledgement of the discovery of eoxins and their role for respiratory diseases. Orexo´s eoxin inhibitor program (OX-2477) is aiming for an oral, non-steroidal anti-inflammatory drug, with potential to replace or reduce the need for inhaled corticosteroids in asthma and COPD. We will now initiate discussions regarding strategic research partnerships in this area and thus strengthen the future growth possibilities for Orexo", says Charlotte Edenius, Vice President Research & Preclinical Development and Chief Scientific Officer at Orexo.

A first candidate drug is currently undergoing pre-clinical safety studies to enable commencement of clinical phase I studies during 2008.

Orexo´s eoxin research project has until recently been developed by Biolipox, which was acquired by Orexo in 2007. Biolipox was founded based on the discovery of the eoxins by professors Hans-Erik Claesson and Magnus Björkholm from the Karolinska Institutet. Through the acquisition of Biolipox, Orexo is a global leader in arachidonic acid research with close links with the Karolinska Institutet and other academic institutions.

[BioSpecialist]

up to 45,90 sek // target 140 -160 sek

http://www.avanza.se/aza/press/aktie.jsp?orderbookId=28567

[BioSpecialist]

Endo Pharmaceuticals has informed the stock market that it expects to file NDA in the first half of 2008.


Orexo: Orexo's Partner Endo Announces Positive Results from Interim Analysis of Rapinyl (TM) Phase III Clinical Trial
Monday December 17, 7:47 am ET


STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News:
Orexo´s (STO:ORX) licensing partner for Rapinyl ™ in North America announced today positive results from the previously announced, planned interim statistical analysis of a Phase III, placebo-controlled, double-blind trial of its development product, Rapinyl ™. The data from the analysis of 61 patients demonstrated that Rapinyl ™ met its primary endpoint, the Sum of Pain Intensity Difference from baseline to 30 minutes (SPID 0-30), and the results were highly statistically significant (p=0.0004). In addition, all the secondary endpoints were met. Statistically significant separation from placebo on mean pain intensity difference was seen as early as 10 minutes.


On the basis of these results and in accordance with the predetermined criteria of the interim analysis, Endo is terminating enrollment in the double-blind crossover portion of this clinical study. Enrollment is continuing in the safety portion of this trial and a second Phase III trial to meet the requirements for additional safety data. Rapinyl ™ is an oral, fast-dissolving tablet of fentanyl intended for the treatment of breakthrough cancer pain. Rapinyl ™ is in registration phase in Europe with Orexo's partner ProStrakan. Kyowa Hakko, a licensee in Japan, is preparing for a phase III study.

“We are extremely pleased by the outcome of this analysis, which we believe demonstrates that Rapinyl ™ can be an effective treatment for breakthrough pain in cancer patients,” said David A. Lee, M.D., Ph.D., Chief Scientific Officer. “We remain confident that Rapinyl´s quick dissolution and rapid absorption profile make it a potentially attractive treatment for breakthrough cancer pain.”

Endo will conduct a thorough analysis of the data to determine the next course of action, including the possibility of filing a New Drug Application (NDA) based on these results.

Endo further noted that although this planned interim analysis was only intended to determine efficacy and not tolerability, those adverse events that were reported were consistent with what is usually observed with other opioids.

“The results from Endo Pharmaceuticals support that Rapinyl ™ can be an effective treatment for breakthrough pain in cancer patients,” said Torbjorn Bjerke, M.D., President and CEO. “It is also a confirmation of our sublingual tablet form and how well it works when immediate onset of effect is desirable”.


About Orexo

Orexo is a pharmaceutical company which focuses on identifying suboptimal therapeutic characteristics of existing products and developing more efficient and effective delivery methods for them. By combining approved active substances with Orexo´s drug delivery technologies it is possible to significantly enhance their therapeutic value, such as providing quicker onset of action or ease of administration. This business model is aimed at bringing products to market faster with lower development risk and costs.

Orexo, which has its global headquarters and development laboratories in Sweden, currently operates across the world through development, licensing and distribution agreements in all major markets.

Orexo has a balanced portfolio with two products on the market, three in registration and/or late stage clinical phase, one in clinical phase I, one in formulation phase and two in early development phase.

Orexo is listed on the Nordic List at the OMX Nordic Exchange Stockholm, Mid Cap (ticker: ORX).

[BioSpecialist]

Oddo Asset Management bought 1 million shares

http://www.avanza.se/aza/press/news.jsp?n=817137

OREXO:ODDO HAR KÖPT 1 MLN AKTIER, HEALTCAP MINSKAT T 31% (NY) (Direkt)
2008-01-21 14:29

STOCKHOLM (Direkt) Oddo Asset Management gick under
hösten in i Orexo genom att köpa drygt 1 miljon aktier,
motsvarande 4,8 procent av kapital och röstetal.

Det framgår av SIS Ägarservice senaste uppdatering
som sträcker sig fram till årsskiftet.

Bakom innehavet via Oddo Asset Management står Crédit
Agricole, med cirka 590.000 aktier, samt Auriga Ventures med
drygt 440.000 aktier, säger en talesman för Orexo till
Nyhetsbyrån Direkt . De två firmorna blev ägare i Orexo i
samband med bolagets förvärv av Biolipox.

Vidare framgår att Healthcap, som är största ägare i
Orexo, numera äger 31 procent. Minskningen från cirka 36
procent är en utspädningseffekt, också det i samband med
Orexos förvärv av Biolipox./MH