Orexo has developed four products. From idea to market. Our aim and ambition is to create value through development and commercialization of new drugs offering superior medical benefit addressing unmet medical needs. Orexo’s development efforts follow a three-pronged approach:
- Orexo has three internal development projects underway that are aimed at broadening our commercial platform and offering a comprehensive range of treatment options to opioid dependent patients. Once on the market, these products will be highly synergistic with Zubsolv® and Orexo’s existing commercial footprint, unlocking commercial synergies and profit growth such as OX382. The most advanced of these projects is an innovative swallowable formulation of buprenorphine, which represents a first-to-market opportunity for Orexo and will have clear benefits over today’s treatment options.
- For development assets that do not have a direct fit with our current commercial platform in the United States, such as Zubsolv outside the US, OX-CLI, OX-MPI and OX51, Orexo’s strategy is to work with partners who have more insight into the respective disease space or geographies and more capacity to drive the development forward.
- Some of our development platforms can be used for a broad spectrum of possible pharmaceutical compounds. Orexo is constantly testing APIs for application in one of our platforms even if those fall outside our direct commercial focus segments. In such cases, Orexo will perform the early stages of development and then find partners for these assets.
Zubsolv® Europe – opioid dependence
In Q3 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Zubsolv for use in the treatment of opioid dependence. The European Commission is now reviewing the CHMP opinion and a final decision is expected in Q4 2017.
Orexo has jointly worked with Mundipharma and its network of independent associated companies, who have acquired all rights to Zubsolv outside the United States, to complete the submission that was filed with the European Medicines Agency (EMA) in October 2016. The submission was based on data from a bioequivalence study, previous pharmacokinetic studies, and Orexo’s extensive clinical program that includes data on more than 1,000 opioid dependent patients.
Depending on local reimbursement, a launch of Zubsolv in Europe is anticipated to be initiated in H1 2018. Orexo will receive a milestone payment pending achievement of an EU marketing authorization and commercialization of Zubsolv and are also entitled to receive up to low double-digit royalties on future net sales. Furthermore, Orexo will supply the product to Mundipharma and will be rewarded for future savings in the cost of goods.
With an estimated 1.3 million high-risk opioid users, opioid dependence is a serious health concern in Europe where heroin accounts for a majority of the opioid misuse. While opioid dependence in Europe has not reached the epidemic proportions seen in the United States, there are several alarming trends. The number of overdose-related deaths has increased for the third consecutive year and synthetic opioids are a growing health threat. Consequently, there are signs of expansion of the opioid market in Europe according to UNODC.
OX382 – oral formulation of buprenorphine
Orexo is developing a swallowable formulation of buprenorphine (OX382). The aim is to be first-to-market in this new product class and to offer clear benefits over today’s treatment options for certain patient categories and treatment settings.
For most treatments without need for immediate absorption of the active ingredient, a swallowable formulation is preferred and generally recognized as the standard formulation. Buprenorphine has poor and unreliable absorption in the gastrointestinal (GI) tract which has so far been the major hurdle to develop a swallowable formulation. Orexo has developed, and filed a patent application for an innovative technology that could address these hurdles and deliver buprenorphine in a controlled and reliable manor in the GI tract.
This new formulation is expected to have several convincing advantages over currently available buprenorphine formulations. Swallowable pharmaceuticals are generally preferred by patients over sublingual or buccal products as they do not have issues with bad taste or local irritation in the mouth. In addition, OX382 would offer specific benefits wherever patients receive their opioid dependence treatment under supervision of a health care professional or a pharmacist. Unlike today, there will be no need to wait for a sublingual or buccal formulation to dissolve in the mouth, allowing for much more efficient processes in the respective clinics. Supervised (opioid dependence) treatment is common in the US, e.g., for patients who receive treatment in methadone clinics, and is particularly common in Europe where about half of opioid dependent patients receive treatment in a monitored setting.
The new unique product could be used in both opioid dependence and pain treatment. The development program is approaching the first clinical study in humans (Phase I), which is expected to be completed in H1, 2018. With a positive result of the phase I study Orexo will outline the development plan and priority of potential indications, which will enable more firm guidance on the commercial potential and development risks.
OX-CLI – asthma and COPD
OX-CLI is a Leukotriene (LT) C4 Synthase inhibitor program. The OX-CLI compounds, based on a new chemical entity (NCE), could enable the development of a completely novel personalized treatment for respiratory disorders such as asthma and COPD.
OX-CLI is developed by Orexo´s partner AstraZeneca. In Q2 2017 the project advanced into clinical phase 1 studies which triggered a milestone payment of USD 2.5 million. AstraZeneca will continue the drug development without any further involvement of Orexo.
Future milestone payments can be expected if OX-CLI meets defined development and commercial objectives. In addition to the milestones, Orexo will receive a tiered single digit royalty on future net-revenue associated with sales of products based on the OX-CLI program.
OX-MPI – inflammation
The lead candidate drug in the OX-MPI program, BI1029539, has been identified as a highly selective anti-inflammatory compound targeting microsomal prostaglandin E synthase (mPGES-1).
The OX-MPI program was acquired by Gesynta Pharma AB on September 29 2017. Gesynta Pharma AB is a recently formed research company located in Stockholm, Sweden, and among the founders are highly reputed executives from the biotech industry and experienced researchers at the Karolinska Institute within the field of arachidonic acid pathways and inflammatory diseases. At the time of the acquisition the project was in the preclinical phase and Gesynta Pharma AB will progress the candidate drug into proof-of-concept clinical trials.
Under the terms of the agreement Orexo will receive a tiered double-digit share of the future revenues that Gesynta Pharma AB generates from the OX-MPI project.
OX51 – acute pain episodes
OX51 is a new sublingual tablet formulation containing alfentanil. The project has been developed to meet the rapidly growing demand for effective pain relief during short surgical and diagnostic procedures.
A placebo-controlled dose-finding study in patients undergoing prostate biopsy was completed in 2013. The results supported a continuation of the development of OX51 to the next phase in development towards a new product.
To be able to take the project into phase III discussions with potential partners are ongoing. The discussion has taken longer than anticipated and some critical areas remain to be agreed to finalize the negotiations of a co-development program.
New formulation technologies
Orexo is currently developing its second-generation sublingual formulation technology. The aim is to perfect the sublingual delivery of drugs, thereby unlocking new active ingredients that can currently not be administered sublingually. The project is in the exploratory phase, and several active ingredients have been identified as promising candidates for this new technology.
In addition, Orexo has two non-disclosed projects, both of which will also fall into the addiction category and with the ambition to provide clear clinical differentiation versus currently available treatment alternatives. Orexo will disclose more details once the final feasibility tests are completed and have shown positive results.