SwedenSweden

Orexo spins OX219 up to speed

01.10.2011

Uppsala – Backed by strong clinical research, the development of Orexo AB’s drug candidate OX219 for treatment of opioid dependence is gathering momentum. A clinical Phase I study was carried out to decide the commercial formulation and dose for the active ingredients buprenorphine and naloxone. While buphrenorphine is known to be effective against withdrawal symptoms and blocks the “high” effects of other opioids, naloxone counteracts the “high” effect that may arise following the intravenous injection of a dissolved tablet.
After FDA consultations, Orexo has decided to apply for a final drug development and registration path according to the 505(b)(2) application process. This enables regulatory clearance based on documentation from an already approved drug, in this case Suboxone®. That would allow Orexo to obtain approval without costly clinical efficacy and safety studies, and thus lead to a much faster route to market. The Swedish drugmaker will use its proprietary sublingual technology to dispense OX219. Orexo says that means previously acquired technology worth some SEK38m will be written off in Q3/2011, but that this decision will have no impact on the company’s liquid assets.
Clinical development of OX219 is being pursued in the US, which is the main market for current market leader Suboxone. The global market for products for the treatment of opiate dependence is currently estimated at US$1.4bn. OX219 is one of the three development programmes that Orexo intends to take all the way to market launch on its own. All of them are based on previously-known substances that Orexo has reformulated using the sublingual route of administration.

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17.11.2011

Exton/Helsingborg – A Swedish specialist for improving glucocorticoid replacement therapy has attracted transatlantic attention. DuoCort Pharma AB, based in Helsingborg, was bought by ViroPharma Incorporated, an US-based...

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Uppsala/Basel – Swedish life science initiative Uppsala BIO is set to team up with drugmaker Hoffman-La Roche AG. For the next three years, the cluster will become the ninth member – and the first from Europe – of the Swiss...

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20.08.2011

Petach Tikva/Lund – Active Biotech AB suffered a severe setback in the development of its oral multiple sclerosis drug laquinimod. Together with ally Teva (Israel), the Swedish drugmaker announced that the substance failed in...

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08.08.2011

Lund - Researchers from Lund University may have found a viable alternative to animal testing. In an article in the open access journal BMC Genomics (August 2011) they demonstrated that the response of laboratory grown human...

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04.08.2011

Uppsala - After good interim results Oasmia wastes no time and starts the approval process for its ovarian cancer drug Paclical. The interim analysis, based on data from approximately 400 patients, showed the expected efficacy of...

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02.08.2011

Petach Tikva/Lund - Active Biotech's experimental multiple sclerosis drug laquinimod failed in a phase III-trial. This is a major setback for the Swedish drug maker and its ally Teva Pharmaceutical Industries from Israel. Both...

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Huddinge, Sweden - Medivir cashes in on Medivir. For EUR 31m the Swedishspecialty pharma company sold all North American remaining rights forXerese, a drug against cold sores (herpes labialis), to Swedish Meda. InFebruary 2010,...

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15.06.2011

Uppsala/Tokyo – Orexo AB’s cancer pain treatment Abstral has reached the Canadian drug market. The Swedish drugmaker confirmed yesterday that Paladin Labs Inc have launched marketing of the sublingual formulation of fentanyl in...

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12.06.2011

Stockholm – Swedish investor Karolinska Development AB outperformed its own expectations in its Initial Public Offering on the Nasdaq OMX Stockholm. The company sold 15.2 million shares at SEK40 during the offering, raising a...

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