Ethical reward for AqVida’s Imatinib following Indian CRO scandals
Press Release | AqVida GmbH
JANUARY 12, 2015
Hamburg, Germany: – Innovative German oncology laboratory AqVida got reconfirmed its code of conduct to partner with reliable CROs and looks forward to get Imatinib approved in Europe.
Worldwide doubts concerning the reliability of many low-cost clinical trials following the mass recall of studies carried out in India. Earlier this month, regulators in France, Germany, Belgium and Luxembourg suspended marketing approval of more than 80 dugs due to concerns over the quality of data from clinical trials conducted by India’s GVK Biosciences. Germany’s BfArM regulatory agency also called for the reliability of more than 80 development programs to be reviewed; Europe-wide it reaches 1’600.
The quality of Indian pharmaceutical research first came under fire earlier this year, with alleged problems ranging from data manipulation to sanitation.
BE quality confirmed
AqVida’s bioequivalence study was carried out end of 2013 and proved that the bioavailability of the generic product matches the originator. Rather than outsource overseas, AqVida chose CCDRD, an experienced German CRO, to carry out the BE study.
Dr. Stephan Zinzen, Head of Development of AqVida, explained that the decision was driven by AqVida’s policy of rejecting any action that might sacrifice or compromise on quality.
“Even though it was considered to choose a non-European CRO due to commercial reason, the Board of AqVida, considered Consumer Health to be an integral part of our Company Policy.
Ethics vs. cost
“At the time we started the Imatinib development, we faced intense challenges to keep costs under control, with a bioequivalence study with a German CRO costing up to twice as much as a study conducted with a CRO partner from abroad,” said Dr. Zinzen.
“AqVida follow a code of conduct that means we put ethics before anything else. The health of patients will always come before the profitability of the company. Although we are a relatively young company, we could have chosen a low cost development route and charge a significantly lower price. But in an industry where we are dealing with seriously ill patients we have to get it right the first time round. We foresaw these risks in the market and chose to stick to our ethical values,” he added.
Imatinib DCP on schedule
“Today we are very pleased that we did not compromise on quality and can feel very confident that we have having increased our reputation of a reliable pharmaceutical company, with the focus on developing reliable oncology drugs that are ethically sound,” declared Dr. Zinzen.
“Now we can expect to finalize our running DCP long before the patent expiry and ahead of any competitors who find the quality of their clinical studies called into serious question.
Imatinib is demonstrated to inhibit tyrosine kinase enzyme BCR-Abl from phosphorylating proteins and thus promoting tumor growth through signaling cascade. Imatinib can thus cause tumor cell death through apoptosis.
Originally marketed as Gleevec® or Glivec®, the basic compound patents for imatinib will expire in Europe End 2016.
AqVida has developed Imatinib in-house, using a non-patent infringing formula and has developed quality imatinib (INN) as a high-quality generic oncology therapeutic product.
Imatinib AqVida is licensed out not only in the dosage forms of 100 mg and 400 mg but also as a line extension in 200 mg capsule format for added patient convenience.
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. 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.
AqVida’s was founded in 205, based on expertise in 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.
Products are sold under the AqVida brand or those of its partners’ in the EU and other markets.
Jürgen Lehmberg, Commercial Director, AqVida GmbH
Wolfgang Heinze, CEO, AqVida GmbH
Tel: +49 40 380 37190
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