Interim Report 1 January – 30 September 2010
- Phase ll data with TB-402 in knee surgery show significantly better antithrombotic effect than enoxaparin, the current standard treatment.
- The cardiovascular project BI-204 and the cancer project TB-403 take next step in development process. Phase ll trials expected to start in early 2011
- In March BioInvent entered into a partnership with Human Genome Sciences to develop and commercialise therapeutic antibodies.
- Reorganisation gives greater focus on the company’s proprietary drug development. Adapted manufacturing capacity to in house needs, reduces fixed costs by around SEK 15 million on an annual basis.
- A directed new share issue that raised SEK 150 million for the company before transaction costs was implemented in February.
- Net revenues for January - September 2010: SEK 76.4 million (60.6).
- Loss after tax for January - September 2010 amounted to SEK -86.0 million (-130.8) and the loss after tax per share was SEK -1.42 (-2.35).
- Current investments together with cash and bank as of 30 September 2010: SEK 143.9 (113.8).
- Cash flow from current operations and investment activities for January – September 2010: SEK -84.5 million (-98.6).
BioInvent is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects mainly within the areas of thrombosis, cancer and atherosclerosis.
Comments by the CEO
BioInvent is currently running four clinical projects, all of which are highly innovative. Development of new innovative drugs that have the potential to meet significant medical need is an important part of the company's strategy. TB-402 for the prevention of blood clots is potentially a product that reduces the incidence of post-operative blood clots through a single injection, which represents a substantial advantage compared with current therapy, which requires daily dosing for up to five weeks after the surgical procedure. We reported Proof-of-Concept data earlier this year in a phase II study of knee surgery that supports this product profile. Backed by these data, we intend to work with our partner, ThromboGenics, to link a development partner to the programme to secure the resources needed to take the product candidate to market. The next stage of clinical development is being planned in parallel with this initiative.
The product candidate BI-204 is a new concept to initially prevent myocardial infarction in patients with coronary artery disease. Together with our partner, Genentech, we are preparing a phase II trial that will provide important information about the potential effects of the product candidate. As previously reported, we expect the study to start by the end of the year, or early first quarter next year.
Product candidate BI-505 represents a new approach to the treatment of multiple myeloma. The ongoing Phase I study has been expanded from two clinics in the United States to now include University Hospital in Lund as a recruiting centre.
Product candidate TB-403, which was licensed to Roche, potentially inhibits vascular growth in tumours without adverse effects of vascularisation in normal tissue. The concept represents a new way of cutting off oxygen and nutrient supply to the tumour. As a next step in the development, Roche plans for a phase Ib/II trial of TB-403 in combination with Avastin in patients with an aggressive form of brain tumour (Glioblastoma multiforme). The study will commence Q1 2011. The incidence of this disease, in the seven major pharmaceutical markets, is 25 000 - 30 000 individuals per year. The clinical need for new and effective treatment is considered as very large.
Overall, we can conclude that our projects are largely on track, which together with good cost control supports the picture of a company integrating forward in the value chain, while maintaining financial flexibility.
Lund, Svein Mathisen
Any questions regarding this report will be answered by:
BioInvent International AB (publ.)
Svein Mathisen, President & CEO, tel.+46 (0)46 286 85 67, mobile +46 (0)708 97 82 13
Cristina Glad, Executive Vice President, tel. +46 (0)46 286 85 51, mobile +46 (0)708 16 85 70.
Katja Toon, Anastasios Koutsos, tel. +44 (0)20 7866 7856,
Erik Clausen (US), tel: +1 415-230-5385,
The report is also available at www.bioinvent.com