Share prices of the Pharming Group NV fell 25.6% after a committee of the European Medicines Agency (EMEA) reissued a negative opinion of its lead drug candidate, Rhucin, a treatment for hereditary angioedema (HAE).
Shares of ReNeuron Group Plc fell 2.25 pence or 16.4% to 11.50 pence on London’s Alternative Investment Market (AIM) following the company’s disclosure that the US Food and Drug Administration (FDA) has once again delayed its Phase 1 clinical study of its stem-cell therapy for patients with stroke, ReN001.
The European Medicines Agency expects to see an increase in marketing-authorisation applications in 2008 after strong growth in 2007.
Intercytex Group Plc, the London-listed developer of regenerative medicines to restore skin and hair, reported relatively modest income for 2007 that was based entirely on milestone fees. However, it said it would start marketing its first commercial product in 2008, using its own sales force.
MediGene AG said its revenue should increase significantly in 2008 while its loss should narrow.
Oxford BioMedica Plc narrowed its loss and increased its cash position in 2007 while progressing its cancer products through the clinic.
ProStrakan Group Plc expects to break even in 2009 on the back of continued revenue growth for its four marketed products and the expected US launch in the second half of 2008 of Sancuso, a treatment to prevent the side effects of chemotherapy.
Innate Pharma SA, which develops drugs that target the innate immune system, reported that its revenues rose 68.6% to €14.3 million in 2007 from €8.5 million a year earlier while its net loss for 2007 widened to €8.9 million from €6 million.
Wyeth Europa Ltd has withdrawn its marketing authorisation application for Pristiqs (desvenlafaxine) from the European Medicines Agency (EMEA) in order to conduct additional clinical studies that will address the agency’s questions about the benefit/risk profile of the product.
Alizyme Plc said that it has raised approximately £10 million before expenses following the placement of 20 million new ordinary shares with institutions.