Press release

Financial Statement 1 January - 31 December 2010

· Start of phase II studies with the cardiovascular candidate BI-204  approved by the US  Food and Drug Administration (FDA). The first patient is expected to be dosed soon.

  · Phase ll data with TB-402 in knee surgery show significantly better antithrombotic effect  than enoxaparin, the current standard treatment.

  · The cancer project TB-403 moves to the next step in the development process with the  start of two new clinical studies in the first quarter this year.

  · In March 2010 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 2010.

  · Net revenues for January - December 2010: SEK 82.9 million (80.7).

  · Loss for January - December 2010 amounted to SEK -128.4 million (-176.7) and the loss per share was SEK -2.12 (-3.17).

  · Current investments together with cash and bank as of 31 December 2010: SEK 106.1 (84.0).

  · Cash flow from current operations and investment activities for January - December 2010: SEK -122.3 million (-128.4).

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, atherosclerosis and inflammation.

 

Comments by the CEO
An important milestone was reached in 2010 when BioInvent presented strong data for the clinical phase II study of TB-402 for the prevention of blood clots following knee surgery. Meanwhile the company has been working hard with its partners to optimise the conditions for successful development in the clinical programmes for the three other drug candidates. With most of the pieces in place, we are expecting the next one to two years to bring new data from several studies; data that will be crucial for future commercial success.

In the ongoing clinical study of BI-505 in multiple myeloma the dosing of patients in cohort seven, of nine planned cohorts, has recently started. We are expecting to be able to publish the results from the study in the second half of the year. The study's primary objective is to examine the product candidate's safety profile. Studying biomarkers for multiple myeloma can also provide important information on whether the patient will respond to treatment or not.

Although new treatment methods have been introduced over the past few years, there is still a great medical need in the multiple myeloma market. For BioInvent, the nature of this market makes the indication attractive with the ambition of integrating forward in the value chain. Results from the ongoing BI-505 study will determine the future strategy for the drug candidate. Clinical results indicating that the product candidate has advantages compared to other treatments will provide a strong incentive for us taking the product candidate forward ourselves.

In November 2010 the US Food and Drug Administration (FDA) approved BioInvent's plan for the first phase II study for the BI-204 drug candidate. The study will examine whether BI-204 can reduce inflammation in the vessel walls of cardiovascular patients more than existing treatments are able to do. This inflammation is believed to be a significant cause of plaque in the vessel walls growing and rupturing. We expect to dose the first patients soon and to report on the study in the first half of 2012. The goal is to develop a drug that prevents new cardiovascular events in patients with acute coronary artery disease. Showing a reduction in inflammation in patients' blood vessels is an important milestone towards our goal. It would also confirm in trials on humans the activity that extensive pre-clinical data for BI-204 has already demonstrated.

After reporting clinical data mid 2010 for our anticoagulant TB-402 showing a statistically significant improvement in the antithrombotic effect on patients undergoing knee surgery compared with the current standard treatment with enoxaparin, the subsequent regulatory and clinical development plan has now been set in place. We aim for marketing approval for TB-402 for use in both knee and hip surgery. A phase IIb study on patients undergoing hip surgery is therefore the next step in the development. This patient group currently receives prophylactic treatment for up to five weeks with daily doses of existing drugs. If we can show in this patient group that a single dose of TB-402 could provide the necessary protection against venous thromboembolism, it would mean a great improvement of this prophylactic treatment.

Our partner Roche plans to start two studies with TB-403 in the first quarter of this year. One study will be carried out on patients with an aggressive form of brain tumour (Glioblastoma multiforme), while the other is for patients with severe liver cancer (Hepatocellular cancer). Both indications represent great medical needs with the possibility of relatively short development timelines to market.

Svein Mathisen

 

Contact
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.

College Hill
Melanie Toyne Sewell, Anastasios Koutsos, tel. +44 (0)20 7866 7856, [email protected] ([email protected]) 
Rebecca Skye Dietrich, tel: +1 857 241-0795, [email protected] ([email protected])

The report is also available at www.bioinvent.com (http://www.bioinvent.com/)