Biovitrum Initiates Clinical Phase II Study of Glaucoma Treatment

The biopharma company Biovitrum, listed on the Stockholm Stock Exchange since September 15, 2006, has initiated a clinical Phase II study with the candidate drug BVT.28949, a 5-HT2A antagonist for the treatment glaucoma. The results are expected to be available midyear of 2007.
The first clinical safety study included 64 healthy volunteers and was entered in September 2005. This study has been compiled and evaluated and convincing positive results support continued clinical trials.

The present Phase II study includes 150 patients with an elevated intraocular pressure (a hallmark of glaucoma) and the study is estimated to be completed during spring 2007 with results available in the middle of the year. The Phase II study is placebo-controlled (results are compared to patients treated with a preparation without real pharmacological effect), and is carried out at several clinics in both Sweden and Ukraine.

- It is with great satisfaction we see this project develop further in clinical phase. Our commitment to the area of serotonergic mechanisms has once more proven to be successful. We hope that our efforts shall lead to an efficient and safe medicine that improves the situation for many who suffer from glaucoma, says Anders Ullman, Senior Vice President R&D at Biovitrum.

Glaucoma is a disease characterized by damage to the optic nerve and it is in most cases accompanied by an increased pressure within the eye. The disease leads to gradually impaired vision and is the most common cause of blindness in the industrialized world. It is estimated that nearly 70 million people worldwide suffer from glaucoma. Current treatments aim to reduce intraocular pressure either by reducing the production or by increasing the outflow of aqueous humor. The total market value for this type of medicines amounts to approximately $3.9 billion.

The current hypothesis is that BVT.28949 reduces intraocular pressure by stimulating the outflow of aqueous humor through a mechanism different from that of presently available products, which means that BVT.28949 could function as a monotherapy or as a combination alternative with existing products. The glaucoma project builds on considerable knowledge and experience of serotonergic mechanisms and how these are used to create safe and effective pharmaceutical substances.

Biovitrum has presently two projects in clinical Phase II,three projects in Phase I, and another six projects in late preclinical phase within the prioritized areas of metabolic disease, pain and blood and eye disorders.

Facts to the editor


Biovitrum
Biovitrum is one of the largest biopharma companies in Europe. With operations in Sweden and in the UK Biovitrum conducts research and develops pharmaceuticals for unmet medical needs both for common diseases and conditions that affect smaller patient populations. Biovitrum has a broad and balanced R&D portfolio with several projects in clinical and preclinical phases for the treatment of obesity, diabetes, inflammation and eye and blood diseases as well as a number of well defined niche indications. Biovitrum develops and produces protein-based drugs on a contractual basis and markets a range of specialist pharmaceuticals primarily in the Nordic countries. Biovitrum has approximately revenues of USD 119 million and 550 employees. Biovitrum is listed on the Stockholm Stock Exchange since September 15, 2006. For more information see www.biovitrum.com/.


The serotonergic technology platform and BVT.28949
While several effective treatments exist for decreasing intraocular pressure, they do not successfully control glaucoma in a significant number of patients. According to Biovitrum’s opinion there is a need for glaucoma treatments acting through novel mechanisms, with the potential to be used as a second-line monotherapy or in combination with current therapies.

BVT.28949 is a selective 5-HT2A antagonist (serotonin receptor 2A antagonist), suitable for topical administration in the form of eye drops. 5-HT2A-receptors control the outflow of aqueous humor from the eye globe. BVT.28949 lowers the intraocular pressure by increasing the outflow of aqueous humor and Biovitrums current hypothesis is that BVT.28949 acts through stimulation of outflow via the trabecular meshwork, unlike prostaglandins (e.g. Xalatan®) which reduce intraocular pressure through another outflow mechanism.
Other projects within Biovitrum that are based on the serotonergic technology platform target other diseases such as obesity. Already today there are several medicines with serotonergic mechanisms of action on the market. As an example, earlier this year Biovitrum acquired the Nordic rights to the drug Aloxi®, a second generation serotonin receptor (5.HT3) antagonist, for treatment of nausea and vomiting in cancer patients.

Contact Information

Anna Karin Källén

Vice President, Communications & IR

Biovitrum AB

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