Imatinib from AqVida

Overview

AqVida has successfully developed and started the registration procedure into several European markets via DCP of a high-quality imatinib (INN) as a generic oncology therapeutic product, including a line extension of 200mg/strengths. According to AqVida’s best knowledge the capsule development does not infringe any existing patents after 06/2016.

Imatinib is used to treat a number of other malignancies, including chronic myelogenous leukemia and gastrointestinal stromal tumors.

AqVida can also supply imatinib mesylate as an active pharmaceutical ingredient (API).

Imatinib background

Imatinib is demonstrated to inhibit tyrosine kinase enzyme BCR-Abl from phosphorylating proteins to promote cancer growth through signaling cascade, thus causing tumor cell death through apoptosis.

BCR-Abl exclusively exists in cancer cells, allowing imatinib to form a targeted therapy that is cited as an oncology research paradigm.

The basic compound patent for imatinib expires in the Europe in June 2016.

AqVida’s origins were founded on fast-track development of highly complex and highly ethical products, mainly in the field of anti-cancer medicines.

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.

Dosing forms

Imatinib-AqVida capsules are now available, including a line extension of 200mg. AqVida offers Imatinib in 100 mg, 200 mg and 400 mg formats and can supports supply already today into markets where the patent does not apply.

Licensing

The Decentralized Registration Procedure (DCP; RMS/Germany) has been started (Day Zero: 08/2014) and includes several countries. A second wave DCP is scheduled still in 2014. AqVida is very confident that licensees are able to market the generic Glivec(R) (INN Imatinib) in 11/2015.

Resources

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Supplier Information
Supplier: AqVida GmbH
Address: Kaiser-Wilhelm-Str.89, 20355 Hamburg, Germany
Tel: +49 40 380 37190
Fax: +49 40 380 37192
Website: www.aqvida.com