AqVida bringing Sunitinib and Imatinib generics to market
Press Release | AqVida GmbH
MARCH 03, 2016
Hamburg, Germany: – Innovative North German oncology laboratory and generics developer AqVida has announced major steps forward in bringing the first of its new generation of developments, the pioneering oncology generics Sunitinib AqVida and Imatinib AqVida hard capsules to world markets.
Sunitinib is now in advanced development stages for a complete range of strengths (12.5 mg, 25 mg, 37.5 mg and 50 mg hard capsules), on course for filing for EU registration immediately after expiry of document protection period in Q3 / 2016.
Imatinib is even further ahead, with AqVida having successfully closed European registration phase at the end of 2015 for 100 mg and 400 mg dosage forms, along with an additional 200 mg capsule form for increased patient convenience. All three products are currently under decentralized authorization and registration procedures (DCP).
Speed to market
“We expect to obtain national marketing authorizations for Imatinib AqVida capsules after closure of the national phase within the coming weeks,” explained Dr. Stephan Zinzen, Head of Development.
AqVida has developed both Sunitinib and Imatinib capsules internally, identifying non-patent infringing formulas. This will enable instant product supply to off-patent countries worldwide, many years before patents expire in EU markets.
AqVida has also confirmed that Sunitinib and Imatinib active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) will all be manufactured in patent-free zones of the European Union, complying to EU and German quality standards, (maintaining complete European origin of all product components).
AqVida aims to capitalize on its distinctive ability to offer speed to market, with spare European licenses on offer for immediate transfer not only on its core portfolio of injectables. It can already offer German Marketing Authorization (MA) for its Imatinib capsules, along with marketing opportunities for Sunitinib capsules ready for patent expiry in 2021 in most European countries, with capability to supply markets where no patent applies.
Another ‘fast market’ generic in the portfolio is Azathioprine and of the core portfolio of parenteral Oncology Products, e.g. Docetaxel, Paclitaxel, Oxaliplatin, Irinotecan and 5-FU AqVida holds Marketing Authorizations(MA).
AqVida is specialized in developing, manufacturing and licensing oncology FDFs.
AqVida GmbH is a German pharmaceutical company specializing in the development registration and distribution of finished dosage forms mainly in the oncology sector. It has developed a portfolio of medicines for treating the most common types of cancer.
AqVida’s expertise in the development, registration and supply of generic oncology products and biosimilars has made the company a leading partner in the pharmaceutical industry.
AqVida works alongside some of the major companies in the market of oncology products. Together with its partners AqVida has achieved substantial development and growth with its oncology portfolio.
After having developed and launched several oncology parenteral forms such as e.g. Paclitaxel, Docetaxel and Oxaliplatin, AqVida and its partner company, Benavis, have started development work on the ‘tinib’ series of molecular targeted anti-cancer molecules. AqVida is also developing other molecular targeted anti-cancer molecules, such as Sunitinib.
AqVida recently celebrated its tenth birthday and has been growing rapidly in recent years, with new capacity shortly to come on stream from its advanced new robotic and zero-loss manufacturing site at Dassow, near Hamburg due for completion by end of 2016. This will increase the company’s capacity for outsourced development of new generics and biosimilars.
Jürgen Lehmberg, Commercial Director, AqVida GmbH
Wolfgang Heinze, CEO, AqVida GmbH
Tel: +49 40 380 37190
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