The company Vektor-Pharma plans to develop and manufacture medicated adhesive patches and therapeutic films. Pharmacists and mechanical engineers have entered into a kind of symbiotic relationship and are currently working on the establishment of a successful business. Interdisciplinary synergy is key to developing such transdermal therapeutic systems (TTS) more quickly, effectively and cheaply than any one discipline would be able to do on its own. The company founders are convinced that the TTS can compete with solid forms of drug dosage such as tablets, capsules and pills. However, although TTS do not work for all drugs, they do work for many highly effective pharmaceuticals.
There is huge demand for services and products of the kind offered by Vektor-Pharma. The market for transdermal therapeutic systems is growing up to 15 per cent faster than the traditional pharmaceutical market. At present, 25 pharmaceutical substances are suitable for use in TTS, and the suitability of several more is being tested. Experts believe that the potential is much higher.
With the exception of cases where pharmaceutical companies provide the manufacturing technology themselves, the global TTS market is divided amongst around ten companies. Europe, and Germany in particular, are regarded as the technology and market leaders in this field, which started to systematically develop more than 30 years ago. Potential clients are all the pharmaceutical companies that plan to administer their drugs using innovative TTS.
Although TTS at first appear to consist of nothing more than a carrier foil, the basic component plus pharmaceutical substance and protective sheet, the modern two-phase systems are the result of complex pharmaceutical manufacturing techniques. The drug contained in the “reservoirs” is sealed between an external matrix; a solubility equilibrium exists between the inner and outer phase. The drug is retained in the patch and is only released when the adhesive sticks to the skin. The patch ensures uninterrupted delivery from the inside of the drug delivery system to its outer matrix.
TTS ensure a constant, uninterrupted release of the drug into the blood. Multimorbid geriatric patients who frequently need to take a large number of different medications benefit from such patches. “The form of dosage can be tailored exactly to the requirements of individual patients,” said Thomas Beckert, Managing Director of Vektor-Pharma, explaining the benefit of TTS for the treatment of age-related diseases such as Parkinson’s and Alzheimer’s and for the treatment of pain. TTS are also beneficial from a pharmacological point of view as they prevent what is generally known as “first-pass effect” of orally administered drugs, i.e. the phenomenon that the “first pass” through the liver greatly reduces the bioavailability of drugs, so that only a limited amount of the drug is passed on to the rest of the system. The “first-pass effect” is often also associated with adverse drug effects.
When pharmacists and mechanical engineers, such as is the case at Vektor-Pharma, pool their skills into a single business model, this results in a competitive pharmaceutical manufacturing technology. “Production cost is our trump card, along with the flexibility and small size of the patches,” said one of the four company founders whose synergistic know-how was brought into machines that have thus far been more efficient than those used by the company’s competitors, the majority of which are based in Germany and Europe.
The machines used for the manufacture of transdermal systems usually fill several rooms; they consist of at least two units between ten and fourteen metres long. “Our unit is twelve metres long,” one of the company founders told us, also pointing out that their TTS manufacturing unit can even be relocated to a regional pharmaceutical client. However, only clients – usually companies that produce generics – are allowed to see Vektor-Pharma’s miniaturized and optimized manufacturing technology. The start-up company will now have to file patents. Although this is a costly process, Vektor-Pharma does not have much choice if it wants to protect its technology and maintain its developmental lead.
It is not just coincidence that a company like Vektor-Pharma has established itself in Upper Swabia, a region in the German state of Baden-Württemberg that is home to a large number of internationally highly successful pharmaceutical and mechanical engineering companies. Nevertheless, the foundation of Vektor-Pharma resembles a “picture book story that could not have been written any better by business developers”: two pharmacists and two mechanical engineers discovered that they had common interests and skills, identified the economic value added and established a company that is financed with own resources – something that is quite typical for companies in the Upper Swabian area (ed. note: Swabians are generally said to be clever, frugal, entrepreneurial and hard-working).
The four founders are: Dr. Thomas Beckert, 45, who has been managing director of the company, which now has nine employees, since 2009. Beckert, a pharmacist, has held leading positions in the pharmaceutical industry, where he attained a great deal of expertise in TTS and controlled drug delivery systems. He brought into the new company a particular form of capital, i.e. a dense contact network of people and companies around the world.
Then there is Roland Weber, an industrial mechanic with additional qualifications in mechanical engineering. Weber used to work for a big regional SME where he obtained detailed insights into the development and manufacture of small batch series. Manuel Bea, a mechanical engineer, is in charge of the start-up’s pharmaceutical development activities. Dr. Stefan Müller brings his huge experience in the pharmaceutical industry into the company and is in charge of Vektor-Pharma’s analytics.
In the start-up phase, the Uttenweiler-based company benefitted greatly from the fact that it had two highly qualified persons (QP; ed. note: EU regulations specify that no batch of medicinal product be released prior to certification by a QP. He/she needs to certify that the batch is in accordance with the relevant requirements) on board: Beckert and Müller are in charge of the drugs produced, from production to testing and approval. With this experience, which is quite rare, the company was able to rapidly win orders from regional companies and thus lay the financial basis for further development. In addition, doing business with regional customers has already led to reports about the company’s achievements in pharmaceutical journals. Vektor-Pharma is working with partners in the pharmaceutical industry on “two larger projects” which are the financial cushion that will enable the company to extend its own competences. “Our objective is to enter production and we are already moving towards this,” said Beckert.
The start-up company is already registered as developing company as stipulated under the German Pharmaceutical Law. The next step is to obtain product approval, and then obtain the authorisation to carry out pharmaceutical analyses and finally the authorisation for producing TTS. The company founders anticipate that their company will have around 50 employees in the medium term and will focus on the pharmaceutical development and production of small batches.