A roundup of some of the top news coming out of the Central and Eastern European (CEE) region’s pharma industry, including Poland’s first draft of a national critical medicines list; Polpharma’s acquistion of the dermatological firm Ziołolek; Sopharma’s sale of its logistics unit, Farmalogistika; Horus Pharma’s significant stake in Romania’s Inocare, and the EU’s approval of a EUR 52 million aid package for Lek Pharma.

 

Poland develops its first national critical medicines list, boosting pharma resilience (Euractiv)

The Polish Ministry of Health has taken a significant step to enhance the country’s pharmaceutical security by drafting the first-ever National Critical Medicines List. This initiative addresses the pressing need to strengthen Poland’s medical supply chain while also meeting the expectations of the domestic pharmaceutical market.

According to the Ministry, the inclusion of a particular API in the list underscores its importance in treating serious illnesses. However, the Ministry emphasised that being listed does not necessarily indicate an imminent risk of shortage in the Polish market.

 

SyVento Biotech Opens New mRNA Manufacturing Facility in Poland (Contract Pharma)

SyVento Biotech has opened its new mRNA manufacturing facility, a FlexFactory delivered by Cytiva, spanning over 7,000 m2, including lab and production areas, offices, and shared spaces. This development represents a milestone for SyVento Biotech, enabling the CDMO to accelerate and enhance its service offerings.

It also establishes SyVento Biotech as a pioneer in the Polish market as it is the first mRNA FlexFactory in the country and the first in Europe equipped with the Historian automation system.

 

Polpharma acquires Ziołolek (Company Website)

Polpharma, a leader in the Polish pharmaceutical market, has become the majority shareholder of Ziołolek, a Poznan-based manufacturer of dermatological products, medical devices and OTC medicines, including the well-known Linomag brand of cream and ointment.

Polpharma, with almost 90 years of history, is one of the largest manufacturers of medicines in Central and Eastern Europe. With the acquisition of Ziołolek, Polpharma plans to expand its product range with unique products, mainly in the dermatological category, which have not previously been produced at its facilities, including the Linomag brand.

 

Bulgaria’s Sopharma to sell Farmalogistika unit for 2.2 mln euro (SeeNews)

Bulgarian pharmaceuticals producer Sopharma said its board approved the sale of its logistics unit Farmalogistika to local printing company Sofprint Group for some 4.39 million levs ($2.33 million/2.24 million euro).

The deal is part of Sopharma’s strategy to optimise its operations and focus on health-related activities, the company said in a stock exchange filing on Thursday.

 

Bulgarian public healthcare increasingly dependent on private funding (Euractiv)

Bulgaria’s pharmaceutical industry has called for an urgent increase in public spending for medicines after the budget ran out, forcing the state to become increasingly dependent on private funding.

The pharmaceutical industry currently covers the budget deficit for medicines in Bulgaria without affecting patients. A mechanism for predictability and sustainability in the budget of the state Healthcare Fund requires pharmaceutical companies to return part of their revenues to the state in the form of rebates. The costs to private companies is increasing.

 

French Eye Care Lab Horus Pharma Acquires Stake in Inocare Pharm (Romania Journal)

Horus Pharma, the leading independent French ophthalmology laboratory, founded in 2003, announces that it is taking a significant stake in the Romanian ophthalmology company Inocare Pharm, based in Bucharest.

“Romania is an ideal regional base to meet the demand for high-quality ophthalmic solutions and services in the Balkans and the Commonwealth of Independent States,” the French company said.

 

SCHOTT Pharma Opens New Production Facility for Prefillable Glass Syringes in Hungary (Contract Pharma)

Supported by a EUR 9 million ($9.7 billion) investment from the local government, SCHOTT Pharma is expanding its global capacities for strategically important high-value solutions that address key pharma trends. At the same time, the company is strengthening its competitiveness in Europe and the supply security for major pharmaceutical companies and contract manufacturing organizations.

To supply the fast and dynamically growing market, SCHOTT Pharma plans to further invest a multi-million Euro amount in Hungary in prefillable syringes in the near future.

 

FDA Accepts Richter’s Marketing Authorization for Denosumab Biosimilars (Hungary Today)

The U.S. Food and Drug Administration (FDA) has accepted the application submitted by Gedeon Richter and Hikma for the approval of denosumab biosimilars (affordable versions of osteoporosis drugs, mimicking its safety and efficacy), Richter announced on the Budapest Stock Exchange’s website on Thursday.

The announcement highlighted that Hikma, a UK-based global company, entered into an exclusive sales and licensing agreement with Richter in December 2021. Under the terms of the agreement, Richter is responsible for developing the biosimilars and supplying the finished products for the U.S. market. Hikma, in turn, is responsible for handling the FDA registration process and holds exclusive rights to market the products in the U.S. once approved.

EU Approves €52M Aid for Slovenian Lek Pharma (Mirage News)

The Commission has approved, under EU State aid rules, a Slovenian measure of around €52 million to support Lek Pharmaceuticals (‘Lek’) in the construction of a new high-tech plant to produce biological drug substances in Lendava. The measure will contribute to the EU’s strategic objectives relating to job creation and regional development, as well as to ensuring affordable medicines in line with the Pharmaceutical Strategy for Europe.

Slovenia notified the Commission of its plan to support Lek, part of the Sandoz group, in the construction of a new biological drug substances production plant at its existing site in Lendava, Pomurje.

 

Celltechna opens $54m gene therapy center in Lithuania (BioProcess International)

Contract development and manufacturing organization (CDMO) Celltechna, a part of the Northway Group, has broken ground on a gene therapy center in Vilnius, Lithuania. The €50 million ($54 million) facility is designed to support future expansion, enabling the addition of two research and development centers and six production buildings.  

Announced in November 2023, the facility supports viral vector and plasmid cGMP manufacturing, cell banking and full characterization, and analytical and quality testing, including viral clearance studies. The facility will employ more than 100 people.