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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12.03.2012

Gothenburg – Researchers at the Sahlgrenska Academy have discovered a previously unknown mechanism which helps intestinal bacteria to affect the formation of blood vessels. In a study of mice, the team led by Fredrik Bäckhed...

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08.03.2012

Swiss Nestlé S.A. has extended its collaboration agreement with BioGaia AB. The world’s largest nutrition company is paying up to €50.8m for a perpetual licence to use BioGaia’s patented Lacto­bacillus reuteri in infant nutrition...

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08.03.2012

Stockholm – Swedish drug delivery specialist Orexo AB has announced the intention to cut its headcount by 30% in order to reduce the company's burn rate. The personnel reduction by 35 people is expected to lower the costs by a...

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07.03.2012

After a long period of negotiations, Sweden’s Orexo AB and Belgium’s Janssen Pharmaceutica have terminated their joint research programmes. “Unfortunately, we lack the funds to continue on our own to develop the OX-CLI and OX-ESI...

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06.03.2012

Uppsala/Moscow – Vaccine adjuvant specialist Isconova AB is set to begin receiving royalties and product revenues from Russian partner VetBioChem. The veterinary medicine company has launched two new rabies vaccines for dogs and...

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23.02.2012

Stockholm - Probiotics can help prevent diseases, Swedish researchers have found out. The results are in sharp contrast with all health claim judgements involving probiotics published by the EU's food watchdog EFSA up to now. The...

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16.02.2012

Huddinge – Full stop for one of Sweden's most promising biotech companies. Karo Bio has terminated the trial of its late-stage cholesterol drug eprotirome and won't proceed with its plans to spin off its preclinical operations....

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19.12.2011

Helsingborg/Exton – Swedish drug developer DuoCort Pharma AB has been purchased by US-based biopharmaceuticals maker ViroPharma Inc. ViroPharma paid around €25m up front, but DuoCort’s former owners could end up receiving €97m...

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15.12.2011

Stockholm/Cologne – Researchers at the Swedish Karolinska Institute and the University of Cologne have identified a new protein-based defense mechanism against cancer (Struct. & Molec. Biology, doi: 10.1038/10.1038/nsmb.2188)....

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15.12.2011

Craigavon/Uppsala – Irish Almac Discovery, a member of the Almac Group, will begin cooperating with Uppsala-based Beactica AB to develop new cancer drug candidates. In late November, the companies announced that Beactica’s Sprint...

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