Atrial fibrillation (AF) affects an estimated 1.5 million individuals in Japan, increasing their stroke risk and imposing considerable costs on the Japanese healthcare system. To reduce stroke incidence, guidelines recommend using anticoagulants in moderate-to-high risk non-valvular AF (NVAF) patients; however, many patients receive no treatment, aspirin only, or remain poorly-controlled on vitamin K antagonists (VKAs) due to high VKA discontinuation rates and non-adherence to guidelines. A prevalence-based Markov model was developed to estimate the clinical and budgetary impact of treating these patients with Xarelto(TM) (rivaroxaban, Bayer AG) in Japan.
Population, baseline risk of events, and associated management costs were estimated using data from Japanese publications where available. Treatment efficacy and safety were derived from published data and the J-ROCKET AF trial. Drug and physician visit costs were based on data from the Ministry of Health, Labour, and Welfare, the J-ROCKET AF trial, and Japanese clinical guidelines.
Our model demonstrates that increased use of rivaroxaban in inadequately-managed NVAF patients could avoid 456,081 non-fatal ischemic strokes (IS) and 76,975 cardiovascular deaths over 10 years in Japan. This clinical benefit offsets the increased incidence of myocardial infarctions and anticoagulant-related bleeding. Decreased event costs could lead to a ¥188.4 billion decrease in net spending over the analysis time horizon.
Introducing rivaroxaban may decrease the burden of NVAF in Japanese society. From a clinical perspective, the reduction in IS and embolic events outweighs the increased risk of anticoagulant-related bleeding; from an economic perspective, reduced event costs offset drug and physician visit costs, resulting in cost savings.

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On April 27, 2016 Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) reported its results for the first quarter 2016 (Press release, Swedish Orphan Biovitrum, APR 27, 2016, View Source;Media/News/RSS/?RSS=View Source [SID:1234511481]). Revenue for the quarter totalled SEK 1,273 M (865), an increase of 47 per cent compared to previous year. All parts of the business contributed to the result with Orfadin and Kineret delivering strong performance.

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Business Summary Q1 2016

Initiated commercial launch of Elocta in the first European countries; revenue in the quarter derived almost exclusively from Germany
European Commission approved transfer of marketing authorisation for Elocta to Sobi
Sobi and Biogen received recommendation from CHMP that marketing authorisation be granted for Alprolix for the treatment of haemophilia B
Received commercialisation rights to three products from PharmaSwiss
European patent granted for Orfadin oral suspension
Initiated clinical pipeline programmes for acute gout and Still’s disease, and a patent granted for a new formulation of Kineret
Financial Summary Q1 2016 (Q1 2015)

Total revenue was SEK 1,273 M (865), an increase of 47 per cent (48 per cent at CER)
Product revenue was SEK 1,108 M (632), an increase of 75 per cent (76 per cent at CER)
Revenues include a one-time credit from Biogen of SEK 322 M triggered by the first commercial sales of Elocta
Gross margin was 74 per cent (60)
EBITA was SEK 502 M (172)
Earning per share 1.13 SEK (0.28)
"2016 is off to a strong start with excellent financial results, new products added to our Partner Products portfolio, development of two new programmes for Kineret, the launch of Elocta in Europe, and positive opinions regarding Alprolix from the CHMP recommending that marketing authorisation be granted, and from the COMP recommending that the orphan designation be maintained," said Geoffrey McDonough, CEO and Pesident at Sobi. "In January we began the launch of Elocta in the first European countries, enabling people with haemophilia A in the region access to the first extended half-life factor treatment. Revenue from the quarter derives almost exclusively from Germany, the only market in the EU where pharmaceuticals are immediately reimbursed upon EU approval. We received positive reimbursement decisions late in the quarter in both the Netherlands and Ireland, and continue to advance discussions in Denmark, Sweden and the UK."

Financial Summary
Q1 Q1 Full year
Amounts in SEK M 2016 2015 Change 2015
Total revenues1 1,273 865 47% 3,228
Gross profit 944 519 82% 2,007
Gross margin 74% 60% 62%
EBITA 502 172 >100% 433
EBIT (Operating profit/loss) 410 102 >100% 146
Profit/loss for the period 301 75 >100% 68
1 Q1 2016 revenues include a one time credit of SEK 322 M relating to first commercial sales of Elocta.

Outlook 2016 unchanged
Sobi continues to expect total revenue for the full year to be in the range of SEK 4,800 to 5,000 M. Revenue will include one-time credits for Elocta of SEK 300 to 325 M and for Alprolix of SEK 300 to 325 M, which will not impact cash. Gross margin is expected be in the range of 68 to 70 per cent.

Sobi will continue to invest in the launches of Elocta and Alprolix, and will also take on incremental costs of SEK 250 – 300 M reflecting its 50 per cent share of Biogen’s ongoing development costs for the products. Sobi will assume these costs when it becomes marketing authorisation holder for Elocta, which occurred 24 March 2016; and for Alprolix expected in the second half of the year. These incremental costs are included in this outlook.

Sobi expects EBITA for the full year to be in the range of SEK 1,200 to 1,300 M.

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Sobi’s report for the first quarter 2016 can be found on View Source;Media/Reports/.

Purpose: Aim of the present study was to investigate the sensitivity of high resolution ultrasound (HRU), standard contrast-enhanced ultrasound (CEUS) and CEUS using a novel vascular endothelial growth factor receptor 2 (VEGFR2)-targeted contrast agent for the detection of hepatic metastases in a mouse model of colorectal cancer using clinical standard technology. Materials and Methods: The human colon cancer cell line HT29, transfected with luciferase cDNA for in vivo bioluminescence monitoring, was injected intrasplenically into CB17.SCID mice. Mice were monitored weekly by bioluminescence and after 2 and 4.5 weeks by HRU and CEUS. Contrast media (untargeted BR1, targeted BR55) was applied and digital cine loops from the arterial phase (15 - 45 sec), portal venous phase (50 - 120 s) and late phases (3 - 5 min, 1hour) of the whole liver were analyzed. Data were correlated with postmortem histopathology. Results: Without contrast enhancement, lesions > 4 mm were reliably detected. After use of untargeted CEUS, lesions > 2 mm were reliably detected and enhanced rim vascularization and late-phase wash-out was shown. With BR55, lesions > 0.8 mm were reliably detected with excellent documentation of vascularization. A persistent contrast enhancement was seen > 30 min after injection. Contrast-enhancement patterns with BR55 significantly correlated with CD31 (R2 = 0.74) and VEGFR2-immunohistochemistry (R2 = 0.66). Conclusion: Detection of metastases by HRU and CEUS was earlier and more accurate than monitoring via bioluminescence. In vivo monitoring of hepatic micrometastases can thus be performed without prior modification of cancer cells using standard technology.
© Georg Thieme Verlag KG Stuttgart · New York.

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On April 27, 2016 Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) reported its 2015 Annual Report, themed "A new chapter of our story" (Press release, Swedish Orphan Biovitrum, APR 27, 2016, View Source;Media/News/RSS/?RSS=View Source [SID:1234511482]). The integrated report summarises the business as well as financial highlights for 2015, and gives a deeper insight into the company’s strategic agenda and its patient-centric innovation model.

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The 2015 Annual Report is available both in print and as an interactive online version, in responsive design to enable viewing on all mobile devices. New features in the online version include pdf and excel downloads of the report and the financial results as well as video comments from CEO Geoffrey McDonough and stakeholders.

CEO and President Geoffrey McDonough wrote in his letter to the shareholders, "We believe that the culture of pioneering in the service of patients with rare diseases requires a small, agile, and human scale organisation that can stay responsive to the changing landscape of patient needs, science and society. We began our transition five years ago and over this period Sobi’s market capitalisation has increased more than sevenfold."

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To read the digital version of the report please follow this link.
To read or download the annual report in Swedish, please follow this link.
To read or download the annual report in English, please follow this link.
To order a printed copy, please send an email to [email protected].

Elotuzumab is a first in class humanized IgG1 monoclonal antibody for the treatment of multiple myeloma (MM). Elotuzumab targets the glycoprotein signaling lymphocyte activation molecule family 7 (SLAMF7, also described as CS1 or CRACC) which is expressed on the surface of myeloma cells and a subset of immune cells, including natural killer cells. A soluble version of SLAMF7 (sSLAMF7) has also been reported in MM patients but has not been evaluated as a potential biomarker following therapeutic intervention. In order to measure serum levels of sSLAMF7, two immunoassays were developed to monitor changes in circulating sSLAMF7 before and after elotuzumab treatment. Free (drug-unbound) and total (drug-bound and unbound) electrochemiluminescence (ECL) ELISA assays were developed and validated following a fit for purpose (FFP) methodology. Both assays met analytical acceptance criteria for precision, drug interference, dilution linearity, spike recovery, parallelism, and stability. Both exhibited the range and sensitivity necessary to measure clinical samples with an LLOQ of 51.2 pg/mL and ULOQs of 160 (free) and 800 ng/mL (total). Previously described assays were unable to detect sSLAMF7 in healthy individuals. However, due to the increased sensitivity of these new assays, low but measurable sSLAMF7 levels were detected in all normal healthy sera evaluated and were significantly elevated in MM patients. Cohort statistics revealed a significant increase of circulating sSLAMF7 in MM patients versus normal controls and both significant decreases in free and increases in total levels of protein post-elotuzumab treatment.

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