Successful BE study paves way for AqVida to launch first generic Sunitinib capsules
Press Release | AqVida GmbH
MAY 23, 2016
Hamburg, Germany: – Innovative North German oncology laboratory and generics developer AqVida has moved a significant step closer to a pioneering launch of generic Sunitinib with a successful bioequivalence (BE) study.
The BE study, supervised by an independent German CRO, compared AqVida’s generic Sunitinib 50 mg capsules with the original branded Sutent® 50 mg capsules. The study returned excellent results, proving identical quality as the originator product, with a ratio for the test/reference AUC(0-72h) of 101% and a ratio for the test/reference cmax of 99 %.
AqVida now will submit one of the first generic application for marketing authorization for Sunitinib, an important oncology drug. This first wave registration procedure will be selected carefully for several European countries during Q3 of 2016, along with MA applications in non-EU countries. AqVida has started to negotiate with potential license and distribution partners who are interested to launch a generic version of Sutent® after patent expiry.
Commenting on the BE study outcome, AqVida commented: “We have a unique advantage in commercializing our Sunitinib capsules into countries in which no patents for Sunitinib are valid.”
Patent free manufacture
This is due on part to AqVida’s earlier decision to partner and cooperate with a strong and reliable manufacture of Sunitinib’s APIs and backward integrated FDFs (finished dosage forms) located in a patent-free zone. , allowing the company to support fast market commercial production in territories where no patent applies.
“As soon as the DEP (Data Exclusive Period) expires, we will submit Sunitinib as one of the first generic manufacturers,” said AqVida.
The company is inviting approaches from partner companies interested in licensing Sunitinib as a generic version of Sutent®.
AqVida obtained the approval of Imatinib, a generic version of Glivec® and is preparing the product launch as soon as the patent has been expired. Besides 100mg and 400mg, Aqvida’s licensing partners will launch the 200mg for increased patient compliance. AqVida is also well advanced to develop another tyrosine-kinase inhibitor and will announce this product candidate shortly.
AqVida GmbH is a German pharmaceutical company specializing in the fast-track 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. The Hamburg-based company also has offices in Oberhaching, Bavaria and in Hangzhou, China.
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.
Products are sold under the AqVida brand or those of its partners’ in the EU and other markets.
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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