Stem cell theory challenged

New alternative to controversial technology offered

An alternative to controversial stem cell therapy could be provided by patented technology that extracts mature white blood cells from veins and turns them into cells with programmable properties comparable to those of stem cells. The technology was developed by Blasticon (Germany).

"We work with mononuclear cells that can be extracted from blood," says Fred Fändrich, director of the clinic for general surgery and thoracic surgery at the University Clinic of Schleswig-Holstein (Germany) and founder of the company. "In the second step we 'reprogramme' these programmable cells into the desired target cells; for example, liver or muscle cells or cells in pancreatic islets of Langerhans." The therapeutic possibilities lie in replacing defective or missing cells (regenerative medicine) or producing cells that regulate the immune system. This technology would represent a significant advancement in the treatment of autoimmune diseases or in transplant medicine.

The German company's announcement of its technology comes at an appropriate time — in mid-March, the German Bundestag (Lower House) will vote on an amendment to the German Stem Cell Act. The opposing poles in the debate could not be further apart: its proponents are calling for the complete liberalization of stem cell research, while critics are in favour of a general ban on the use of human stem cells.

http://www.blasticon.de/

Genmab acquires new facility

An agreement reached between Genmab and PDL BioPharma means that Genmab will acquire PDL's antibody manufacturing facility in Minnesota (USA) for $240 million (€154 million). "During the past few years, Genmab has been preparing for the market launch of our late-stage antibodies and we continue to build a broad pipeline of antibody products, which currently includes 10 products in clinical development. Consequently, the need to secure significant manufacturing capacity has become an increasing priority," says Lisa N. Drakeman, chief executive officer of Genmab. The company plans to retain approximately 170 employees currently working at the manufacturing facility and does not foresee reducing either the PDL BioPharma or Genmab headcount following the acquisition.

"We are pleased to enter into this agreement, which we believe is the optimal transaction to fully realize the value of our biologics manufacturing facility."

The transaction has been approved by the boards of directors of both companies and is expected to close later this year, subject to customary closing conditions.

http://www.genmab.com/

http://www.pdl.com/

New biosimilar gets EU recommendation

The first biosimilar version of G-CSF has received a positive opinion from the EU. The European Commission is now expected to grant marketing authorization for the product, which will be marketed in the EU by Teva under the brand name TevaGrastim. G-CSF, mainly indicated for the treatment of chemotherapy-induced neutropenia, was developed by Teva in collaboration with a partner. The innovator product, Neupogen Filgrastim, had annual sales of approximately $300 million (€192.4 million) in the EU for the 12 months ending September 2007, based on IMS sales data.

Amir Elstein, executive vice president of global resources for Teva, says: "We are very pleased by the opinion. Our successful development of this product reflects our commitment to bringing high-quality and affordable biopharmaceutical products to patients and payers. Our strong biogeneric pipeline reflects our determination to capture the considerable long-term prospects we believe the biogeneric market will offer."

http://www.tevapharm.com/