Our vision is ”To be the preferred partner to small and mid-size biotech and pharma companies, making specialty medicines available to patients with high unmet medical need in Europe.”
The European market consists of nearly 40 countries with a broad range of supply chain demands, patient needs, healthcare traditions and medical standards, as well as more obvious differences in languages, cultures and payment systems. Accordingly, companies entering Europe are often faced with two difficult options: either charging more for their products, which might slow down or even remove the opportunity to receive reimbursement for the product, or not making the medication available at all in the specific country. Either decision will impact those in need of the medications – the patients, who risk being without the treatment that could give them a better life, and possibly even a chance of survival. Creating a cost-efficient platform for the provision of products intended for a limited number of patients is therefore important and can directly affect the availability of these niche medications to European patients.
Based on more than 25 years of experience, Sobi offers small and mid-sized pharmaceutical and biotechnology companies a cost-efficient and integrated platform for the commercialisation of their products in Europe, Middle East, North Africa and Russia. Sobi’s partnership offering is based on efficient distribution capacity and extensive market knowledge. The partnerships span over many years and include strategies for regulatory approval, pricing and reimbursement, as well as preparations for the launch of additional and/or subsequent marketing activities, tender management and logistics. The main objective is to help meet important medical needs in various therapeutic areas so that each patient receives optimal treatment.
During 2014, the partner platform has demonstrated that Sobi can also support the filing of products in the EU, a future valuable asset in building the late-stage pipeline portfolio.
The high level of activity in Sobi’s partner portfolio also continued during 2014.
In collaboration with US partner Exelixis, Inc., Sobi announced in March that Cometriq was authorised by the European Commission for the treatment of patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer.
In 2013, Sobi signed a ten-year partnership agreement with Auxilium Pharmaceuticals, Inc. for the development and commercialisation of Xiapex for the treatment of patients with Dupuytren’s contracture in 71 European, Asian and African countries, becoming Marketing Authorisation Holder in Europe in April 2014. In June, Sobi and Auxilium submitted an application to the EMA for an expansion of the indication for Xiapex to also include Peyronie’s disease, which is caused by collagen-rich patches of scar tissue that develop along the shaft of the penis under the skin. The Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion for the use of Xiapex in Peyronie´s disease in December 2014, and in January 2015, Xiapex was approved for the treatment of Peyronie’s disease in the EU.
In 2014, Sobi also entered into a new partnership with TiGenix NV for the commercialisation of ChondroCelect, a cell-based, first-in-class medicinal product for articular cartilage repair.
While the continued strong growth of Partner Products is partly the result of new agreements signed in 2013 and 2014, such as the Valeant portfolio and Xiapex, all parts of the product portfolio contributed to the positive trend. The portfolio comprised 44 different medicinal products from a total of 29 partners. For the full-year, total revenues for Partner Products amounted to SEK 682.2 M, with an annual growth rate of 25 per cent.
Indication: Dupuytren’s contracture is a condition where one or more fingers are bent forwards toward the palm and cannot be fully straightened. It is caused by a thickening of the tissues under the skin of the palm that form ‘cords’ pulling down on the fingers. Xiapex is intended for use in patients with cords in their palms that are sufficiently thick that they can be felt through the skin. As of January 2015, Xiapex is also approved for the treatment of Peyronie’s disease in the EU.
Product description: Xiapex (collagenase clostridium histolyticum), is a pharmacological treatment for Dupuytren’s contracture and may be an alternative to invasive and often complicated surgery for patients. Xiapex is administered by local injection directly into the Dupuytren’s cord.
Geographical market: Sobi holds the exclusive rights to commercialise Xiapex for the treatment of Dupuytren’s contracture and Peyronie’s disease in 71 Eurasian and African countries. Sobi is Marketing Authorisation Holder (MAH) for Xiapex in the 28 EU Member States, as well as Norway and Iceland.
Indication: Yondelis is used to treat patients with advanced soft tissue sarcoma, a type of cancer that develops in the soft, supporting tissues of the body. It is used when treatment with anthracyclines and ifosfamide (other anticancer medicines) is no longer effective, or in patients who cannot be administered these medicines.
Product description: Yondelis is a powder that is dissolved to make a solution for infusion (administered via a drip directly into the vein). It contains the active substance trabectedin.
Geographical market: Nordics, Central and Eastern Europe.