Recently, GlaxoSmithKline (GSK) and Denmark-based Genmab AS received a conditional marketing authorization for Arzerra (ofatumumab) from the European Commission. The drug, a monoclonal antibody, is indicated for patients with chronic lymphocytic leukemia (CLL), a cancer of the blood and bone marrow. The approval triggered a DKK 87 million (approximately $16 million) milestone payment to Genmab.

The conditional approval does not surprise us since in Jan 2010 the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Arzerra.

Arzerra has been approved for cancer patients who were not responding to the currently available treatment options using fludarabine and alemtuzumab. A drug is granted conditional approval to cater to an unmet medical demand. Approval of this kind is renewed annually as the drug requires further studies to ensure its effectiveness.

Earlier, in October 2009, Arzerra received accelerated approval from the US Food and Drug Administration (FDA), following which Genmab became eligible to receive a milestone payment of DKK 116 million (approximately $23 million) from GlaxoSmithKline.

In a pivotal study, it was observed that 42% of patients with CLL who did not respond to fludarabine and alemtuzumab responded to the treatment with Arzerra. These patients had a median duration of response of 6.5 months.

Glaxo has made significant progress with its late-stage pipeline, the main focus areas being biopharmaceuticals, immuno-inflammation, infectious diseases, metabolic pathways, oncology, ophthalmology and respiratory. The company intends to stop pursuing research activity in certain areas including depression and pain and focus on higher growth areas such as neurodegenerative and neuro-inflammatory diseases like Alzheimer’s disease, multiple sclerosis and Parkinson’s disease.

Meanwhile, we believe biopharmaceuticals will play an important role in driving growth going forward. At the end of 2009, about 19% of Glaxo’s pipeline comprised biopharmaceuticals. The company is working on growing its biopharmaceutical pipeline through in-house discovery, the acquisition of Domantis and by in-licensing late-stage products. Glaxo has several clinical research programs underway including nine assets in late-stage development.

We have a “Neutral” recommendation for the stock.

Zacks Investment Research

1. (GSK) GlaxoSmithKline Drug Gets European Commission ApprovalGlaxoSmithKline Plc. (GSK) recently received good news in the form of European approval for its...
2. (GSK) GlaxoSmithKline’s Tykerb Received Accelerated Approval From The U.S. Food and Drug AdministrationGlaxoSmithKline (GSK) recently announced that it has received accelerated approval from the U.S. Food and...
3. (GSK) GlaxoSmithKline Earns Positive Opinion From Te European Medicines AgencyLast week, GlaxoSmithKline (GSK) and Denmark-based Genmab received good news with the European Medicines Agency’s...
4. (GSK) GlaxoSmithKline Exercises Drug OptionRecently, GlaxoSmithKline (GSK) exercised its option to obtain exclusive license regarding further development and commercialization...
5. (GSK) GlaxoSmithKline Earns FDA Approval for Arzerra, a Chronic Lymphocytic Leukemia DrugGlaxoSmithKline (GSK) and Denmark-based Genmab received some good news with the US Food and Drug...
6. (GSK) GlaxoSmithKline Earns FDA Approval for Advanced Renal Cell Carcinoma TreatmentYesterday, GlaxoSmithKline (GSK) received some good news with the US Food and Drug Administration’s (FDA)...

Search Posts by Tag: Glaxosmithkline plc | GSK | Drug Manufacturers - Major | Healthcare

RSS Feeds by Tag: Glaxosmithkline plc | GSK | Drug Manufacturers - Major | Healthcare |

Other Posts by: vitalstocks | RSS Feed for this author