APP acquires manufacturing facility
American Pharmaceutical Partners (APP) has acquired a manufacturing facility and injectable oncology products from Bigmar, European-based operations, based in Lugano, Switzerland, for an undisclosed sum.
American Pharmaceutical Partners (APP) has acquired a manufacturing facility and injectable oncology products from Bigmar, European-based operations, based in Lugano, Switzerland, for an undisclosed sum.
Under the terms of the transaction, APP acquired from Bigmar a 25,000ft2 Isolator Technology manufacturing facility that over the years has produced certain oncology products, including daunorubicin, methotrexate and leucovorin calcium for APP's U.S. business, and together with the aforementioned, a total of eight USA approved Abbreviated New Drug Applications (ANDAs) for 15 product codes. APP also acquired a number of generic injectable oncology products currently marketed in Europe and South America, including Switzerland (five products and 17 product codes), Greece (four products and ten product codes), Italy (four products and eight product codes) and Brazil (eight products and 24 product codes).
In addition, APP obtained one ANDA and a number of Marketing Authorisation Applications pending with the FDA and European Agency for the Evaluation of Medicinal Products, respectively, as well as other products under development. Included in the transaction is a seasoned workforce to ensure a seamless transition.
'Through this transaction, APP gains entry into the European and South American markets, increases product manufacturing and lyophilisation capacity, expands the company's oncology product portfolio and adds a number of potential product candidates for both the European and U.S. markets,' said Dr Patrick Soon-Shiong, APP chairman, president and chief executive officer. 'This is the first step in our strategic initiative to leverage APP's broad product portfolio of injectable products and grow our business outside of North America.
'Initially, we will use the acquired facility to continue to supply certain oncology products for APP's US business and sell the existing product line in the E.U. market.
'Over time, we intend to increase the number of products manufactured at this facility, enhance the quality systems in this manufacturing facility and submit product applications for APP's products currently marketed in the US to the appropriate European regulatory agencies for marketing approval in the EU.'
Soon-Shiong went on to say that a key element of the transaction, which will be funded from cash on hand, was the acquisition of the manufacturing facility to provide additional capability to develop and manufacture injectable oncolytics. The facility is approved by both the FDA and European Union for manufacturing oncolytics and currently supplies markets in the US and Europe with some of the most often prescribed products in this therapeutic category.
The facility is one of only a few in Europe that manufactures generic sterile oncology products, and utilises a novel manufacturing technology (Isolator Technology), which is particularly suitable for safe and efficient manufacture of high quality oncolytics. The facility also contains packaging, labeling, warehousing and administrative areas.