By Cormac Sheridan

BioWorld International Correspondent

Swiss firms Berna Biotech Ltd. and Bachem Ltd. are investing CHF20 million to fund a joint venture for developing therapeutic and prophylactic peptide vaccines. The new company, which is due to commence operations at the start of next year, will inherit existing preclinical projects from Berna Biotech in the areas of melanoma, malaria, hepatitis C and Alzheimer¿s disease. Each partner is taking a 50 percent stake in the new entity.

¿The idea is that we open the company for the next funding round in year two or three, depending on results,¿ Kuno Sommer, CEO of Berne-based Berna Biotech, told BioWorld International. Its business plan calls for two candidate products to reach the human proof-of-concept stage within two years and for two additional candidates to enter animal proof-of-concept studies within the same time frame.

The new company has not yet chosen a name, but its senior management team has been selected. It will be led by CEO Peter Klein, currently head of registration and patents at Berna Biotech. Rinaldo Zurbriggen, head of virology research at Berna Biotech, will be its chief scientific officer.

The company has an exclusive license for applying Berna Biotech¿s proprietary virosome-based vaccine delivery technology to peptides. Bubendorf-based Bachem is supplying its expertise in peptide manufacturing.

According to Zurbriggen, vaccines delivered via virosomes ¿ reconstituted viral envelopes ¿ display superior performance to those combined with aluminum-based adjuvants. Berna Biotech employs mimetic technology to model 3-dimensional epitopes on antigens of interest, which are tethered to a proprietary template. These are incorporated into virosomes containing influenza virus membrane proteins that enable them to bind to immunocompetent cells via the sialic acid receptor.

Antigen presentation takes place on the surface of the cell following receptor-mediated endocytosis of the particle, eliciting a more specific antibody response than aluminum-conjugated vaccines, Zurbriggen said. The epitopes also are protected from peptidase degradation by the lipid bilayer of the virosome.

¿If they are not lipophilic, we make them lipophilic,¿ he said. They also are able to evoke a cytotoxic T-lymphocyte response by activating CD4 helper cells. This project represents Berna Biotech¿s first joint venture, although similar initiatives for other projects are under discussion, Sommer said. The company has five Phase III trials under way and a preclinical pipeline of a dozen projects. The company, formerly called the Swiss Serum & Vaccine Institute Berne, has a 100-year heritage in vaccines. It restructured under new management in 1999, and it netted CHF146.9 million from an IPO on the Zurich-based SWX market in July.

Sommer said that the global vaccines market is worth around US$6 billion annually and is experiencing double-digit growth. It is dominated by pharma companies American Home Products Corp., the Aventis Pasteur arm of Aventis SA, GlaxoSmithKline plc, and Merck & Co. Inc., each of which has annual vaccine sales of over US$1 billion.

¿The other US$2 billion of this world market is spread out,¿ he said. Sommer positions Berna Biotech as one of a number of mid-tier players, along with PowderJect Pharmaceuticals plc, of Oxford, UK; Acambis plc, of Cambridge, UK; the vaccines business of Chiron Corp., of Emeryville, Calif.; and Rhein Biotech NV, of Maastricht, the Netherlands.

¿It has to consolidate,¿ he said. ¿We will be part of it.¿ Berna Biotech¿s current vaccines business is worth CHF100 million. The company needs to scale to around five times that figure, Sommer said. ¿That gives you enough muscle to develop your own pipeline to really push forward.¿

No Comments