BioWorld International Correspondent
LONDON - NeuTec Pharma plc launched a funding to raise £25 million (US$46 million) to finance commercialization of its lead product, Mycograb, 12 days after announcing positive results in a pivotal trial of the treatment for systemic candidiasis infections.
James Burnie, CEO, told BioWorld International, "There was a very good reaction from the market, so I think this will get away all right."
Shares in the Manchester-based company rose by 38 percent to £4.97 when the trial data were published. They closed at £5.32 Friday when the placing and open offer was announced. NeuTec joined London's Alternative Investment Market in February 2002, opening at £1.61.
NeuTec intends to file for approval in Europe within the next four to six months and, as Mycograb has orphan drug status, is expecting approval by mid-2005.
In the meantime, the company needs to expand production of the antibody and recruit a sales force. Pending consultation with the FDA, NeuTec also is planning to conduct U.S. trials and intends to test Mycograb in other indications.
Mycograb, which targets the heat-shock protein 90, has shown evidence of efficacy against cryptococcal infections that strike a high percentage of AIDS patients. It also is active against Aspergillus fumigatus, the commonest cause of invasive aspergillosis, an infection with a higher mortality rate than invasive candidiasis.
In addition, the company intends to expedite development of its second product, Aurograb, which is in Phase III work for methicillin-resistant Staphylococcus aureus infections.
Mycograb and Aurograb are recombinant antibodies based on antibodies derived from patients who recovered from serious infections.
NeuTec said there are 320,000 cases of systemic fungal infection per year worldwide, of which three-quarters are caused by Candida. The company will file for Mycograb in combination with the antibiotic amphotericin B for the treatment of immune-competent patients, but Burnie said Mycograb would be used to treat immune-incompetent patients, too.
"We are restricting the label to immune competent because in the end that was the people in the trial," he said. "But as a clinician myself, I think this is a regulatory fine point that will be ignored by doctors."
The placing of 5.3 million shares offered on the basis of two new shares for every existing nine shares is fully underwritten by Hoare Govett. Shareholders representing 25 percent of the shares are not taking up their entitlements.