With more than 26 years’ experience in the field of orthopaedics, dermatology and personalised medicine, the Heidelberg-based biotechnology company Biopharm GmbH is firmly established in the regenerative medicine market. Based on its proprietary growth factor technology platform, Biopharm develops innovative methods for the treatment of bone and cartilage damage and improvement of the wound healing process.
In the biotechnology industry, a quarter of a century is an eternity; only a handful of innovative German biotech companies have lasted for so long. Heidelberg-based Biopharm GmbH is one such company. Established in 1986, the company is still run on the same basis, while other companies that belong to the first biotech generation in Germany – if they have survived at all - have changed ownership, company structure or objectives. The founder of Biopharm GmbH, Michael Paulista, is a member of the company’s management board and is still actively involved in shaping his company; ongoing business activities are being managed by his business partner Dr. Florian Wagner, who has been the company’s CEO since 2010.
A research-based biopharmaceutical company can only achieve continuity and economic success by remaining at the forefront of technological development and active in a market segment with long-term medical requirements. Since it was established in 1986, Biopharm has focused on the field of human growth factors for use in regenerative medicine, a field that has expanded enormously since the discovery of a large number of regulatory proteins that control cell and tissue differentiation (cytokines in the broadest sense) in the 1980s and remains as relevant as ever. Biopharm specifically focuses on one of these regulatory proteins, the so-called “growth/differentiation factor 5” (GDF-5), which belongs to the family of “bone morphogenetic proteins” (BMP) within the “transforming growth factor beta” superfamily.
In 1992, Biopharm was granted a worldwide patent for recombinant human GDF-5 (rhGDF-5). Based on this multifunctional protein, the company established its “Growth Factor Technology Platform” and developed new patent-protected growth factors for numerous applications in the field of regenerative medicine. In addition to developing drugs for application in the fields of dermatology (e.g. regenerative wound healing) and orthopaedics (e.g. osteoporosis), which Biopharm does on its own and in cooperation with partners, the company has also licensed out the technology platform for applications in the field of dental and maxillofacial surgery and for the treatment of degenerated intervertebral discs.
From a very early stage in company development, Biopharm has financed its proprietary research and development projects through the provision of services, contract research and the development of biogeneric drugs and tests for important therapeutic indications. In 2011, the analytical services business division was integrated into a new company, which operates under the name “SYMBIOSIS – The Analytical Company” and is based in the city of Eppelheim close to Heidelberg (see BIOPRO article entitled “SYMBIOSIS – The Analytical Company”).
According to the World Health Organisation, the gradual deterioration of bone microarchitecture, associated with greater bone weakness and the risk of bone fractures and malformations, is one of the ten most common diseases in the world. Its prevalence increases as populations age. The cost for society, mainly arising from the treatment of osteoporotic vertebral and spinal column damage, is enormous. Osteoporosis therapy involves kyphoplasty, a medical spinal procedure where plastics (polymethyl methacrylate, PMMA) or hydroxyapatite (a kind of calcium phosphate) are injected into the affected vertebrae where they polymerise into cement.
Biopharm has developed a new growth factor that has been shown to have greater potential in the regeneration of tissue in bone fractures than other known growth factors. The growth factor BB-1 is a disulphide-linked beta-chain homodimer. In an ongoing project, Biopharm is combining innovative bioresorbable bone cement on the basis of calcium phosphate with the growth factor BB-1 for direct application to vertebrae damaged by osteoporosis. The new approach has promising advantages over currently used methods: the growth factor promotes the reorganisation and stabilisation of the weakened bone structure as the biological cement is resorbed.
In cooperation with the University and University Hospital of Jena, Biopharm is currently developing a highly pressure-resistant calcium phosphate cement for the therapy of fractured vertebrae in osteoporosis sufferers. This research and development project is funded by the German Federal Ministry of Education and Research under its “KMU-innovativ” funding programme for a period of three years.
Biopharm GmbH’s technology platform is also used for treating skin wounds that result, for example, from burns or diabetes-related ulcers. Animal experiments have shown that active GDF-5 is able to accelerate the healing process. The skin epithelium regenerates more quickly and is also better structured and associated with less inflammation. In 2011, Biopharm signed an exclusive research cooperation agreement with the Weinheim-based company Freudenberg with the aim of jointly developing a wound dressing technology involving GDF-5. The Freudenberg Group is a worldwide family enterprise with an annual turnover of 5.5 billion euros and a workforce of 34,000 people (2010). The company’s “Freudenberg Nonwovens” business division is developing “ScaffoleneTm+growth factor”, a bioresorbable fleece that enables local release of the growth factor by way of slow diffusion.
The company is also developing bone cement containing growth factor BB-1. A system for the repair of cartilage tissue is in the planning stage and consists of selected polymers that promote the differentiation of cartilage cells. The polymer matrix comprises a made-to-measure growth factor that is being developed using the company’s proprietary “Growth Factor Technology Platform”. The regeneration of cartilage is an attractive field of business, potentially targeting the huge market connected with the treatment of joint and vertebrae damage.