Sue Pearson Ph.D. Freelance Writer GEN

Will it be enough for the industry to succeed?

Poland has lagged behind some of the central and eastern European countries such as Hungary in developing its biotech industry. However, the Polish government has begun to recognize the potential of biotech as source of revenue as Poland’s population of 38 million people, as well as its good links with Germany and Russia, means that there is a large localized market for lower-cost biologics-based healthcare products. To begin to encourage the growth of this industry sector, the Polish government has in the past decade put in place several initiatives to help new biotechs. These include establishing Special Economic Zones, where technology companies receive up to 70% tax exemption for qualifying investment costs; building eight technology parks for biotechs; and setting up NewConnect, the alternative market of the Warsaw Stock Exchange.

These factors coupled with Poland’s entry to the European Union (EU) and its access to more funding and expertise has resulted in Poland now having around 70 biotech companies. The main clusters of these are in new science and technology parks at Warsaw, Krakow, Wroclaw, and Gdansk. The majority of these firms are small university start-ups but there are several biotechs worth noting including Polpharma Biologics, Mabion, Biovico, and Blirt.

Biosimilars or Biobetters?

Polpharma Biologics was set up at the Gdansk Science and Technology Park in the Pomeranian Special Economic Zone as a separate biotech division in 2011 by Poland’s most well-established pharmaceutical company, Polpharma. Polpharma, which has been in business since 1935, was privatized 13 years ago, and has divisions in Russia and Kazakhstan with 7,000 employees worldwide. The firm has just completed stage one of constructing Polpharma Biologics in February and now has a fully functioning R&D center in Gdansk, staffed by 25 scientists and growing to 80 staff by year-end, thus being the largest facility of its kind in Poland. At this center, scientists are developing biosimilar antibodies to treat autoimmune diseases, as well as cancers and other disorders.

Piotr Zien, Ph.D., head of science projects at Polpharma Biologics, states: “Biologics are new for Polpharma as the company has relied on producing small molecule-based generics in the past but, to capitalize on the government’s interest in having capacity to produce affordable biosimilars, Polpharma decided to set up a biologics division at Gdansk. Our first stage is R&D and then we intend to build a fully functional cGMP pilot plant because with the space we have; we have the opportunity to use all the cutting-edge technology and to build integrated R&D, analytical labs, and a pilot plant all in one place. This gives us the capability to develop and produce biosimilars for global markets, which are of the highest standards.”

Polpharma Biologics seem serious about their intention of producing Polish biosimilars and have invested heavily in state-of-the-art equipment for their R&D labs. Zien comments: “We have great multi-fermentors and a related analyzer, which is the first one installed in Poland to ensure we have the tools for fast cell-line selection and bioprocess development. Our analytical and purification labs also have the best available systems.” Zien adds: “We intend to build a pilot plant that will have two 1,000 liter capacity bioprocessing units so we can produce around 30 batches per year. We’re going to use all disposable technology and won’t be using stainless steel so that we can build it quickly; it will also be very flexible because speed is important when developing biological drugs. Our integrated R&D, analytical, and pilot plant with its customized equipment and large capacity will give us a superior position in the Polish market and a very strong position in Europe.”

Expression Experts

Another interesting biotech also based in Gdansk is Blirt, a more-established biotech start-up in Polish terms, being founded in 2008. The company began life as an R&D company working on development of novel drugs. After gaining experience and the right equipment, the firm began acting as a contract research organization mainly carrying out cell line development, protein and antibody production, as well as the associated analytics and bioanalytics.

Now the firm employs 40 people, including 14 Ph.D.-qualified scientists providing services and focusing on its internal oncology and antifungal drug discovery programs. Blirt has identified an innovative and potent oncology drug candidate acting on multidrug resistant (MDR) tumors and anti-fungal compounds, which the firm claims has significantly enhanced potential clinical utility over the parent molecules (Nystatin A1 and Amphotericin B), the golden standard treatments for these diseases. All compounds are at the preclinical stage of development and the company is now seeking licensors with the capability to advance the lead assets through research and development for a range of clinical indications.

Consistent with its strategy, Blirt is also developing skills to support biologics production, and the company has built a strong internal team in this area. Pawel Gruszczynski, Ph.D., business development manager at Blirt explains: “As a service provider in Europe, we have become known as contract researchers that are able to work with difficult to express proteins. In October 2012, our expertise was recognized when Blirt received a substantial grant from the Polish government to support this venture.”

The aim of the project is to develop an innovative platform for the production of novel biologic therapeutics based on antibody fragments. Blirt is using mammalian cells and single use fermentors (up to 50 L) for antibody production. Manufactured antibodies are then validated by surface plasmon resonance (SPR) technology to confirm interaction with specific antigens. The SPR equipment is used for standard affinity measurements and comparative analysis of biosimilars with the original marketed reference antibody. Blirt intends to introduce the SPR technology as a contract service for biosimilar development.

Gruszczynski firmly believes that the Polish biotech sector has a lot to offer, stating: “Outsourcing research activities to Poland allows our business partners to have their project completed within in a short time and at a reasonable, market-competitive price. Many of our scientists came from leading academic institutions in the U.S., U.K., Canada, and Switzerland. Their expertise has helped us to build collaborations with biotech, but also pharma companies. Our clients are mainly located in Germany, Austria, and Switzerland and they benefit from competitive pricing, as well as high-quality (ISO 9001 and GLP) services. We are continuing to expand our services throughout Europe, and look forward to starting work with U.S.-based companies.”

Rising Star

A rising star of the Polish biotech sector is Biovico, based near Gdansk at Gdynia. The company was founded in 2008 and mainly focuses on production of nutraceuticals and medical devices. The firm is run by Artur Wilandt, who by his own admission has learned his biotech entrepreneurship and networking skills by spending time training in Cambridge, U.K.

Wilandt states: “We produce many of the active ingredients in our nutraceuticals from fermentation. The products we have so far introduced into Poland include Lyprinol® to treat osteoarthritis and Alevox™ HA, an injectable supplement containing haluronic acid, which is injected into the knee to replace synovial fluid in the joint. Since we are on the Baltic Sea, we are now looking for marine extracts that have anti-inflammatory and immune modulation activity. In 2011, we were fortunate enough to be one of only 15 companies to have been awarded EU Framework 7 funding to do this as part of a consortium, coordinated by the University of Helsinki.”

Alevox HA from Biovico is an injectable supplement containing haluronic acid, which is injected into the knee to replace synovial fluid in the joint.

Krzysztof Lemke, Ph.D., head of research and development, continues: “Our strategy is to collaborate with Polish Universities to commercialize some of their great science.” One such product, which has come from a Polish University is a wet dressing called Alemat constructed from bionanocellulose derived from a fermentation using Gluconacetobacter xylinus. The CE-marked dressing is being trialed to treat leg ulcers and burns in Polish hospitals and is classed as a medical device. There are other hydrogel dressings on the market and Lemke explains why Alemat is different: “The structure of the cellulose in Alemat is very straight and clear. It is better than other hydrogel dressing as the cellulose can be used to produce a dressing of 20 cm by 20 cm so unlike other hydrogel dressings can be used to cover large areas of skin. Alemat also has a huge capacity to absorb liquids and provides a barrier to microbes to prevent infection. This is better for wound healing than dry bandages and is good for treating burns.”

Small-scale clinical trials in Poland have shown that burns dressed with Alemat heal in eight days and leg ulcers in 46 days, which Lemke claims is up to 40 percent quicker than those treated with other dressing types and he says patients report less pain during healing. The company is now looking for partners to develop and commercialize this product.

Alemat is a bionanocellulose-based wound dressing to treat burns and diabetic ulcers.

Future Challenges

Without any biological drugs in the clinical stages of development, Poland’s biopharma industry is still in its infancy. However, since Poland has talented yet underexploited scientists, some of the lowest labor costs in Europe and access to EU grant funding it is an attractive prospect for foreign biotech investors. This may help accelerate Polish biotech but a major issue holding back the sector in Poland is a lack of experienced and internationally focused management teams and investors to help commercialize and market the research appropriately. Additionally, according to Polpharma Biologics’ Dr. Zien, it is difficult to attract Polish scientists back to Poland after they have trained in Western Europe or the U.S. and admits that recruitment at Polpharma Biologics of scientists with biologics development expertise gained in foreign labs has been slower than expected. Perhaps the Polish government needs to put in place programs similar to its Homing Program aimed at repatriating academic scientists where those that have trained in pharma and biotechs abroad are enticed back to Poland with incentives as, without this pool of internationally focused expertise to man the pumps, Poland’s ambitions to build a successful biotech industry will falter.

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