AqVida Oncology Portfolio

products-servicesAqVida GmbH
December 1st 2014

Overview

AqVida GmbH was founded in 2005 with an original mission to improve the lives of cancer patients by focusing on the development, manufacturing and licensing of onco-generics. The company specializes in supplying high quality and lower cost replacements for oncology medicines as they come off patent.

The company offers a core portfolio of off-the-shelf onco-generic products, supplied via license partners to different market segments. This portfolio covers all the main bases in oncology and allows clients to supplement existing offerings or to generate a comprehensive oncological portfolio from scratch within a very short start up time.

AqVida is also dedicated to an ongoing program of R&D to provide additional product developments, including highly specific niche molecules, to serve the needs of its partners worldwide.

Oncology expertize

Oncology has traditionally been one of the most challenging and rewarding pharmaceutical segments, and has become one of the largest segments economically.

AqVida has an impressive track record in oncology, having obtained some 150 approvals for its products in several countries over the past five years. Well-established manufacturing and supply-chain have been established as part of AqVida’s leading presence in the high-quality German oncology market. This enabled AqVida to become a partner for several German companies in the oncology field and to secure a good market share for its core products.

The key to AqVida’s success in oncology medicines is to maximize flexibility and responsiveness to client demand. AqVida maintains constant stock inventory of all its main products in Germany so that it can provide a highly responsive supply service to license partners, without having to insist on purchase of full commercial batches.
AqVida can supply split batches and can also cover unexpected peaks in demand at short notice.

Existing Product Portfolio

AqVida can offer supply and licensing opportunities on the following products:

Solids

Product Alternative Names Application Dosage forms
Azathioprine Azasan®, Imuran®, etc. Immunosuppressant, Film-tablets: 25mg, 50mg
Imatinib Gleevec®, Glivec®, tyrosine-kinase inhibitor Capsules: 100mg, 200mg, 400mg (line extension with 200mg strengths)

 

Injectable

Product Alternative Names Application Dosage forms
Docetaxel Taxotere® Chemotherapy (breast, prostate, non-small cell lung cancer, stomach and head and neck cancer) Solution for infusion / 20mg/ml [20mg, 80mg, 140mg, 160mg]
Epirubicin Pharmorubicin® Chemotherapy (various) Solution for infusion / 2mg/ml [10mg, 20mg, 50mg, 100mg, 200mg]
Gemcitabine Gemzar® Chemotherapy (bladder, pancreas, non-small cell lung cancer, ovarian and breast cancer.) Lyophilisate for solution for infusion: 200mg, 1g, 2g
Irinotecan Campto® Chemotherapy (colon/rectal) Solution for infusion: 20mg/ml [40mg, 100mg, 300mg, 500mg]
Oxaliplatin Eloxatin® Chemotherapy (colorectal and oesophagus) Solution for infusion / 5mg/ml [50mg, 100mg, 150mg, 200mg]
Paclitaxell Taxol® Chemotherapy (ovarian, breast and non-small cell lung cancer.) Solution for infusion / 6mg/ml [30mg, 100mg, 300mg]

 

Products under development

AqVida’s R&D pipeline also lists e.g. the following products under development or as available dossiers, ready for submission. Further development projects can be shared after signing a CDA.

Solids

Product Alternative Names Application Dosage forms
Sunitinib Sutent®, SU11248 Multi-targeted receptor tyrosine kinase (RTK) inhibitor Capsule [12.5mg, 25mg, 50mg]
Pemetrexed Alimta® Chemotherapy (non-small cell lung cancer and pleural mesothelioma) Lyophilisate for solution for infusion: 100mg, 500mg, 1g]

 

Licensing

AqVida focuses on its core competences of development, manufacturing and licensing rather than compete for end-user sales against its European license partners. Outside Europe, AqVida can negotiate territorial exclusivity.

Quick Access

For companies that need to build an oncology from a low or zero base, AqVida can offer quick access via a Mutual Recognition Procedure (MRP) that should deliver products ready to market in 6-12 months provided no national registration procedure is required.

AqVida can provide access to European marketing approvals (MAs) within a couple of months, either via duplication of existing MA and or starting a specific MRP.

Facilities and standards

AqVida’s quality management system conforms to all German and EU legal requirements for the pharmaceutical industry and is GMP certified by the German Health Authorities.

AqVida’s manufacturing licence applies to the EU-batch control analysis and the EU-batch release of pharmaceutical products.

The in-house AqVida laboratory provides all infrastructure needed for the highly qualified R&D team to conduct analytics and quality control according to strict quality management processes. Laboratory activities include analytical method development and validation, batch control analytics as well as stability testing. All processes comply with European GMP.

The AqVida Regulatory Affairs team supervises compilation of high-quality registration dossiers, based on years of experience and up-to-date knowledge.

To ensure successful registration procedure Regulatory Affairs accompanies the pharmaceutical product development from scratch and coordinates the complete registration procedure from submission to approval matching the required national, European or international standards.

The company’s robust supplier qualification system assures the provision of EU-GMP compliant medicinal products.

AqVida’s new German cGMP manufacturing site now under construction will further improve quality and cost competitiveness when operative.

Resources

Click on AqVida Oncology Portfolio for more information.
Click on AqVida to contact the company directly.


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