OxyPharma

[Stockholm, Sweden, November 30, 2009.] Swedish drug development company OxyPharma today announced the preliminary results of its phase II clinical trial of Rabeximod, an orally administered disease-modifying anti-rheumatic drug (DMARD) for treatment of moderate or severe active rheumatoid arthritis. The study demonstrated clear therapeutic effects of Rabeximod in patients with rheumatoid arthritis, resulting in a significant effect on key biological and disease variables after 16 weeks.

The study was designed to reveal an effect of Rabeximod at 12 weeks (primary endpoint), based on the assumption of a similar onset of action as other disease-modifying anti-rheumatic drugs. Treatment with Rabeximod was given during 12 weeks to 224 patients with moderate or severe active rheumatoid arthritis that were not fully responsive to prior treatment with methotrexate, with clinical follow-up visits through week 16. Patients, all on a stable dose of methotrexate, were randomized to one of three dosing regimens of Rabeximod (6.25 mg, 15 mg, or 37.5 mg once daily) or placebo. Principal Investigator was Professor Lars Klareskog, Head of Rheumatology Unit at Karolinska University Hospital, Stockholm, Sweden.

Rabeximod showed a delayed onset of action, which resulted in a significant therapeutic effect of the dosing regimen seen at 16 weeks rather than at the 12 week endpoint. At 16 weeks, the 15 mg Rabeximod dose group exhibited statistically significant (p<0.05) effects for seven of the key secondary endpoints of treatment: ACR20, DAS28 response rate, pain, subject global assessment, physician global assessment, number of swollen joints and number of tender joints. At 12 weeks, none of the treatment groups demonstrated a significant effect on the ACR20 response rate, which was the primary endpoint of the study.

The study also demonstrated a good safety profile of Rabeximod. The incidence of adverse events in the Rabeximod 6.25 mg, 15 mg and placebo groups were similar. Skin disorders were the most frequently reported adverse event, with the highest incidence in the 37.5 mg Rabeximod group, all rated mild to moderate in severity. No adverse synergistic effect was seen with methotrexate.

Based on the efficacy and safety results, 15 mg Rabeximod administered once daily appears to be the most optimal dose. These results indicate that the treatment duration of 12 weeks in the study was too short to reach an optimal clinical effect of Rabeximod in combination with methotrexate. The full potential of Rabeximod in the treatment of patients with rheumatoid arthritis will be revealed in studies designed with a longer duration of treatment.

“This is the first clinical trial evaluating the effect of Rabeximod for the treatment of moderate or severe rheumatoid arthritis”, said Ulf Björklund, CEO, OxyPharma. “The study suggests that Rabeximod causes a beneficial modification of disease activity with a delayed onset of its therapeutic benefits. The results thus indicate that a three month treatment period was not sufficient to observe the full therapeutic effect of the drug. This outcome is what can be expected with a disease-modifying anti-rheumatic drug where the effect appears slowly and lasts longer, especially since the compound has a long half-life. As the main variables are statistically significant at week 16, OxyPharma is confident that studies with longer treatment duration will prove oral Rabeximod to be an effective, convenient and safe drug for commercialization”.

“The management and the board of OxyPharma consider the results very encouraging for further development of Rabeximod. We have therefore decided to invite pharmaceutical companies for partnering discussions. OxyPharma is in the process of appointing an advisor to assist in this process”, said Mr. Björklund.

Rabeximod is an orally available small molecule that is first-in-class and classified as a disease-modifying anti-rheumatic drug. Its mechanism of action is an interaction with the inflammatory tissue type A cells, often described as macrophages. In vitro data on human peripheral blood cells show that Rabeximod suppresses the differentiation of monocytes into pro-inflammatory macrophages but not anti-inflammatory macrophages. The inflammatory macrophage is the central orchestrator of the inflammatory response leading to tissue destruction and clinical symptoms. Thus, the macrophages is a key cell in immune presentation of antigens and plays a role in both the initiating phase of the inflammation as well as in perpetuating the inflammatory process.

OxyPharma is a Swedish drug development company developing new drugs primarily for the treatment of Rheumatoid Arthritis (RA) and Multiple Sclerosis (MS). The development programs are carried out in collaboration with the Karolinska Institute in Stockholm, Sweden and contract research organizations (CRO’s) in England, Sweden and Israel.

OxyPharma was founded in 2002 and is based in Stockholm, Sweden. The company’s largest shareholder is innovator and entrepreneur Leif Lundblad (mainly through his investment company LLD Nybohov Invest). Ulf Björklund is OxyPharma’s CEO.

Ulf Björklund

CEO, OxyPharma AB

Peter Karaszi

Press Officer, OxyPharma AB

OxyPharma is a member of SwedenBIO. For more information about Swedish biotech, please visit www.swedenbio.com

[Stockholm, Sweden, September 27, 2005.] Swedish drug development company OxyPharma will participate in the US-bound Swedish Biotech Mission, organized by Invest in Sweden Agency (ISA). Existing and potential partners, members of the press and potential investors are welcome to meet OxyPharma in Raleigh, N.C., San Diego, CA., and San Francisco, CA., October 21st- 26th.

OxyPharma’s is one of approx. 20 Swedish companies participating in a series of Bio-Business events in Raleigh, N.C., San Diego, CA., and San Francisco, CA., organized by ISA, Invest in Sweden Agency. The events will include morning seminars, lunch buffets and B2B meetings in each location.

OxyPharma is a Swedish drug development company focusing on RA and MS drugs. The latest developments in OxyPharma include the recently announced successful completion of preclinical safety evaluation and toxicity studies on the company’s patented RA candidate drug Rob 803 (announced in late August 2005). Earlier this year (in April), OxyPharma selected Rob 895 as its candidate drug for the treatment of multiple sclerosis (MS).

The aim of the Swedish Biotech Mission is to introduce US biotech, pharmaceutical and venture capital companies to what may be Europe’s best kept biotech secret – Sweden is ranked among the top four biotech nations in Europe, with around 200 very active companies and world-class academic research institutions such as the Karolinska Institute (home of the Nobel Prize in Medicine and Physiology).
Members of the press are cordially invited to meet OxyPharma’s CEO Ulf Björklund in any of the locations: Raleigh, N.C., Oct 20-21, San Diego, CA., Oct 22-24, and/or San Francisco, CA., Oct 25-26. Please contact Mr. Björklund directly to set up meetings (phone number +46 8 726 17 02 or +46 70 667 04 40, email adress ulf.bjorklund@oxypharma.com).

[ Stockholm , Sweden , August 26, 2005.] Swedish drug development company OxyPharma has successfully completed its preclinical safety and toxicity program for the company's drug for the treatment of Rheumatoid Arthritis (RA). OxyPharma now plans to take the RA drug into phase I clinical studies.

OxyPharma, the Swedish drug development company focusing on RA and MS drugs, has successfully completed its preclinical safety evaluation studies on the company's patented RA candidate drug Rob 803. The safety and toxicity studies were designed and carried out in accordance with international requirements for the safety evaluation of human pharmaceuticals as stipulated by e.g. the US Food and Drug Administration (FDA), European Medicines Agency (EMEA), and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

OxyPharma now plans to take Rob 803 into phase I clinical studies, possibly as soon as October 2005. Phase IIa clinical studies of the compound may start in mid 2006.

Rob 803 has been developed from OxyPharma's patented lead compound B-220, from which OxyPharma has developed several analogue substances, including Rob 895 which was recently selected as a candidate drug for the treatment of multiple sclerosis (MS).

“ The positive preclinical results are a milestone for us and pave the way for first-time-in-human clinical studies to be commenced as soon as possible. I am obviously very happy with the development so far and optimistic for the future”, said Ulf Björklund, CEO, OxyPharma.

At present, there are no effective, safe and easily administrated drugs for the treatment of RA, a disease that affect millions of people worldwide. However, preclinical studies and the recently completed safety program indicate that OxyPharma's substance can be effective, easy to administrate (orally) and may be produced at low cost compared with current products. The value of the RA market is estimated at more than USD 3bn annually, and is growing rapidly.

2005-04-05
Swedish drug development company OxyPharma has selected a candidate drug (CD) for the treatment of multiple sclerosis (MS) from its autoimmune diseases drug discovery program. The selected compound, Rob 895, is now ready to go into a full-scale pre-clinical program.

Rob 895 has been developed from OxyPharma’s patented lead compound B-220, from which OxyPharma has developed several analogue substances, which in animal studies have shown very promising results for the treatment of both MS and rheumatoid arthritis (RA). Based on the successful completion of the pre-clinical program for Rob 895, OxyPharma intends to submit a regulatory filing for the initiation of first-time-in-human clinical studies.

The selected compound (Rob 895) is the second drug candidate arising from OxyPharma’s drug discovery program. Last year, OxyPharma selected Rob 803 as its candidate drug for the treatment of RA. OxyPharma is currently conducting toxicological studies of Rob 803 and intends to start Phase IIa clinical studies of the compound in early 2006. Additional research has demonstrated Rob 895 to be a more attractive drug candidate than the lead compound for pharmaceutical development due to properties that include improved potency, tolerability, pharmacokinetics and pharmaceutics.

MS is a chronic, inflammatory condition to the nervous system afflicting approximately 2.5 million people worldwide. Most patients diagnosed with MS are between the ages of 30 and 50, and the disease has a medium duration of more than 30 years. The value of the MS market was USD 3.5bn in 2003, and is growing rapidly.
At present, there are no effective, safe and easily administrated drugs for the treatment of neither MS nor RA. Animal studies indicate that OxyPharma’s small molecule substances can be effective, easy to administrate orally and may be produced at low cost compared to present alternatives for the treatment of both diseases.

2004-11-24
Swedish Drug Development Company OxyPharma Files Patent Application for Substances for the Treatment of Rheumatoid Arthritis and Multiple Sclerosis

- New Investors Invited to Participate in Financing Round -

Swedish drug development company OxyPharma has filed a patent application for the substance Rob 803 including other related substances. Rob 803 and analogues have in animal tests shown very promising results for the treatment of Rheumatoid Arthritis (RA) and Multiple Sclerosis (MS). In addition, OxyPharma plans a financing round aimed at new investors in order to continue developing drugs for the treatment of RA and MS.

OxyPharma has filed a patent application in Europe covering substances, synthesis as well as indications – including both RA and MS – for its substance Rob 803 and associated analogue substances under development. In the US, a provisional patent application has been filed.

Rob 803 has been developed from OxyPharma’s patented lead compound B-220, from which OxyPharma has developed several analogue substances, which in animal studies have shown very promising results for the treatment of RA and MS.

OxyPharma has for the treatment of RA selected Rob 803 as its candidate drug (CD), and for which OxyPharma is currently conducting toxicological studies. OxyPharma intends to start Phase IIa clinical studies of Rob 803 in early 2006. OxyPharma intends to select a candidate drug for MS in February 2005.

At present, there are no effective, safe and easily administrated drugs for the treatment of RA and MS, diseases that affect millions of people worldwide. However, animal studies indicate that OxyPharma’s substances can be effective, easy to administrate (orally) and may be produced at low cost compared with current products. The value of the RA and MS markets are each estimated at more than USD 3bn annually, and are growing rapidly.

Financing Round of SEK 80-130m Planned
OxyPharma announces the plans to attract new investors by issuing new shares. The objective is to secure the midterm need for operative capital to further develop the RA and MS drugs (e.g. by clinical studies). The financing round will consist of newly emitted shares valued at between SEK 80m and SEK 130m (approx. EUR 9m – EUR 15m) that are offered to primarily European investors. OxyPharma’s main owner Leif Lundblad has expressed his willingness to participate in the financing round on the same terms as the new investors.

OxyPharma’s majority owner is Leif Lundblad, innovator and entrepreneur. Leif Lundblad has founded several companies and has more than 300 patents to his name. He founded Inter Innovation, a company developing technologies for cash handling in e.g. ATM’s. Inter Innovation was subsequently listed on the Stockholm Stock Exchange and had annual revenues of more than SEK 1.2bn and 2000 employees when it was acquired by the British company De La Rue. Leif Lundblad sits on several boards, including the Swedish Industrial Development Fund.

2004-10-01
Peter Karaszi Joins OxyPharma as PR Consultant

Peter Karaszi is OxyPharma's new Press Officer. He will handle all media contacts together with the company's CEO Ulf Björklund. Peter Karaszi has a decade-long experience in Public Relations, e.g. as Public Relations Manager for international corporations and as an independent PR Consultant. He has written several books on PR and media contacts.