The rasping chill of the agent of change

The biotech business is a new opportunity for many generic players. Regulations are still in their embryonic stage in Europe. But increasing numbers of European governments are starting to realise the massive benefits of a buoyant biotech sector. Polpharma, like many other generic players, is now preparing itself to enter this dynamic, thriving area, and at some speed.

It’s certainly got the experience behind it to be a formidable operator. Polpharma’s roots go back to 1935. After a long period of state ownership it was privatised in 2000. Polpharma is now the number one generic player in Poland, with a local market share exceeding 13 percent and a burgeoning over the counter – and highly successful – business too.

One big change in the biotech industry is directly related to geographical growth patterns, which has led to emergence of new big pharma markets like China, Russia, Brazil, etc. – the so-called BRIC market. “Such emerging markets are experiencing higher growth rates,” says Krzysztof Jakubiak “and building a critical size there is becoming more competitive. On one hand it is very beneficial to be located in such markets, on the other hand we would need to face increased competition.”
 
Still, competition from low∞cost countries like India and China is not yet as visible in Europe as in USA. “We are constantly investing in production and commercial effectiveness to maintain our competitive advantages,” says Krzysztof Jakubiak. “We are also constantly looking at India and China for the opportunity to move part of the value chain to these countries too.”

Biotech is also an industry that has come of age. It’s an industry well and truly alive in universities, research institutions and other research institutions.

But, crucially, twinned to this is an increasingly entrepreneurial , business∞ savvy culture, helping start∞ups and biotech SMEs quickly get their products to market.

Polpharma in brief:
• Polpharma products are present in approximately 50 countries worldwide. 19 percent of the company’s turnover comes from its international operations.
• Polpharma has its main sales structures in Russia and representative offices in Lithuania, Ukraine, Kazakhstan, Belarus, Vietnam, Azerbaijan and Uzbekistan.
• Approximately 60 percent of the international sales of drugs are generated on the Russian market. Active pharmaceutical ingredients (API) are primarily exported to North America and the European Union.

Well integrated
Polpharma Group now boasts fully integrated production of finished dosage forms (FDF) and active pharmaceutical ingredients (API), as well as R&D activities and commercial operations. Total employment in Polpharma and associated companies numbers well above four thousand people. An impressive achievement since going into private ownership just a decade ago.
 
It also has an excellent regional presence in the CEE region through a network of commercial offices in all major markets in the region. “We are taking part in industry integration processes, developing strategic alliances with companies in Poland, Russia and Spain,” says Polpharma’s Krzysztof Jakubiak. “Through acquisitions in selected countries we want to accelerate our growth and our expansion in the region.”

He adds that the company is leveraging fragmentation of the market, working in different partnerships to expand their product portfolio, “and to commercialise our product in markets where we do not have our own presence.”

US opportunities and more
The new President Obama-led healthcare reform changes also create new possibilities of increasing Polpharma’s API sales to the US market. Its API production plant meets the strict FDA requirements and current Good Manufacturing Practice (cGMP) guidelines.

There are also other opportunities: the strategy for growth is targeting main goals such as organic growth in Poland and CEE markets with possible acquisitions in the most attractive markets to achieve a leading position in the region, says Krzysztof Jakubiak.  “We are also expanding our product portfolio which we commercialise directly in CEE and through out-licensing in the rest of Europe.”

All these developments means that Polpharma is not a company – like many biotech or small pharma operators – dependent on keeping going from one finance round to the next.

And although the Continent’s range of biotech players are small, a growing entrepreneurial culture and Brussels backing for this industry is also helping industry players like Polpharma to dig deep roots in increasingly nutritious soil.

In next-door Germany, bio-tech regions are common, meanwhile universities across Europe and government-funded research institutions also continue to support companies like Polpharma. A cultural sea change is under way, and Polpharma is at the heart of this change.  

R&D – the road ahead
Any R&D department has to be well organised and well funded if it is to be commercially effective. That’s definitely the case with Polpharma. Its R&D base consists of 300-plus specialists, able to deliver 30-40 projects per year. Its integrated regulatory structure is skilfully adept at managing the registration processes worldwide – a complex and fast-moving environment.

Its R&D scope covers API development, generics and generics+, special technologies – liquids, semi liquids, soft gelatin caps, FDF dossiers as well as out-licensing capabilities. “Beside internal developments, our R&D has a strong network of partners for different types of co∞developments and partnerships  such as opportunities in specialty generics and new drug delivery systems,” says Krzysztof Jakubiak.

“We want to expand our geographical presence in CEE and achieve a leading position on key markets in the region,” says Krzysztof Jakubiak. “We want to further expand our portfolio of generic products to cover all critical molecules and we want to have a foothold in a biotech business.”

Polpharma’s values are your values
Polpharma cares about patients’ well-being and promotes the principles of preventive health measures. It also assist physicians in fulfilling their vocation by supporting them in expanding their medical knowledge. It’s driven by fairness and professional ethics, respect for the needs of their employees, business partners, local communities and social organisations.

It’s also a company that observes the highest standards of due diligence and professionalism. Of course, it also fully supports the development of Polish science and numerous social undertakings. The meaning of its everyday activity is best described by the motto “People helping People”.

Technology and safety focus
Polpharma, as you would expect, utilises up-to-date modern technology, ensuring the safety of products, employees, and the environment. Manufacturing processes comply with all the environmental protection requirements of the European Union. The company has the following certificates: ISO 14001 (environment), OHSAS 18001 and PN-N-18001 (safety and hygiene at work). Polpharma’s annual capacity is approximately 200 million drug packages.

Operating from one of the largest and most modern drug manufacturing plants in Europe – Starogard Gdanski – the company manufactures solid drug forms, such as tablets, film-coated tablets, effervescent tablets, sugar coated tablets and capsules (the annual manufacturing capacity of solid forms is six billion units). A fully hermetic manufacturing process allows for protection from any possible contamination and protects employees from contact with chemicals.