Background
NeuTec Pharma ltd is a biopharmaceutical company which specialises in the development of genetically recombinant antibodies, or "grabs", for the treatment of life-threatening infections.
The company’s principal focus to date has been on progressing Mycograb® and Aurograb®, its two lead products, to market approval through clinical trials. As is normal in the development of a biological agent, there have been a number of technological hurdles to overcome.
Over the last eight years NeuTec has made significant progress in developing its products and research programmes and has recorded a number of key achievements including:
- the large scale cGMP production of Mycograb® and Aurograb®
- the granting of Orphan Drug Status for Mycograb® in Europe by the EMEA
- the granting of Orphan Drug Status for Mycograb® by the US Food and Drugs Administration ("FDA") in 2002
- the submission of an Investigational New Drug ("IND") application with the US Food and Drugs Administration ("FDA") in February 2003
- completion of, and reporting upon the results from, the successful confirmatory study on Mycograb® in invasive candidiasis in July 2004
- initiation of a compassionate use programme for Mycograb® in January 2005
- validated application made to the EMEA for market authorisation in the treatment of invasive candidiasis in March 2005
- 1st patient entered in a multi-centre phase Ib study to evaluate Mycograb® administered in metastatic breast cancer patients in September 2005
- successful application to the FDA for an IND to carry out phase III trial using Mycograb® as adjunctive therapy for cryptococcal meningitis in patients with AIDS
- the completion of a Phase II clinical trial on Aurograb® in June 2003. The study demonstrated a profile that suggests likely activity against MRSA
- commencement of a pan European phase III clinical trial on Aurograb® in May 2004
- the development of the FABTEC© platform technology for the identification of new therapeutic antibody fragments
- 18 families of patents have been filed and over 70 patents have been granted worldwide protecting the intellectual property created by the company's research and development programmes
- the identification of further potential products from its research programme for future development
In February 2002 the company’s equity was admitted on the Alternative Investment Market (“AIM”) of the London Stock Exchange. In July 2006 the company was acquired by Novartis Pharma AG.
Research and development
NeuTec identifies the key antigens and associated antibodies by characterising the antibody responses produced by patients who recover from an infection and then comparing them with those in patients who die from the infection. "Grabs" against these patented antigens are derived, using the Company's FabTec© platform technology, from patients who have recently recovered from the relevant infection and are therefore actively producing high levels of protective antibodies. As a result, these "grabs" are of high specificity, affinity and potency against the microbial target.