News

Roche gets EU ok for Perjeta
Enlarge image

BusinessSwitzerlandEU

Roche gets EU ok for Perjeta

06.03.2013 - Swiss Roche has gotten EU approval for Perjeta (pertuzumab). The antibody boosts efficacy of Herceptin by blocking HER dimerisation.

The European Commission gave the green light for a combination therapy of pertuzumab, Herceptin (trastuzumab) and docetaxel in previously untreated adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer. The recommendation for market approval is based on Roche’s  Phase III CLEOPATRA study in which the combination therapy prolonged median progression-free survival for 6.1 months compared to Herceptin and chemotherapy alone. Furthermore, the treatment triggered a 34% reduction in the risk of death.

The improvement of Herceptin efficacy by Perjeta is due to a synergistic mode of action of the two antibody drugs. Herceptin blocks homodimerisation of HER2 when HER2 is overexpressed. The antibody prevents activation of HER2-dependent pathways by binding to the extracellular domain IV of the protein and thus blocks MAPK-dependent cell proliferation and PI3K-dependent inhibition of apoptosis. In contrast, Perjeta binds HER2 from the opposite side and prevents heterodimerisation with HER1 and HER3 proteins. Especially, inhibition of HER2/HER3 dimerisation seems important as HER3 supports PI3K-mediated cell proliferation following dimerisation with HER2.

“The EU approval of Perjeta is the result of years of research into the HER2 pathway and we are excited to offer a new treatment option for people with this aggressive disease,” said Roche’s CMO Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. The combination therapy provides a clever strategy for extension of Herceptin’s life cycle. However, Roche is already evaluating a combination therapy of its antibody-toxin warhead T-DM1 with Perjeta.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-01/roche-gets-eu-ok-for-perjeta.html

AntibodiesDenmarkNetherlands

22.05.2015 Dutch arGEN-X and Danish LEO Pharma are pairing up to develop antibody-based treatments for the chronic inflammation that causes many skin conditions.

M&ANetherlandsGermanyEU

12.05.2015 US pharma is coming to European biotech to fill their pipeline. Pfizer is paying €77.5m for an option on Dutch AM-Pharma, while Juno Therapeutics acquired German biotech Stage Cell Therapeutics for around €72m.

Rare diseasesItalyGermanyPoland

15.05.2015 Rome-based pharmaceutical group Sigma-Tau has sold its blood cancer drug programme Oncaspar to US company Baxter, who aims to spin out its biopharma business.



SurveyGermany

06.05.2015 More revenue, more staff, more funding: in the German biotech industry, all signs are pointing towards growth.

M&AUKSweden

18.05.2015 Double deal for allergy: UK’s speciality biopharma Circassia is boosting its asthma pipeline with the acquisition of Swedish asthma specialist Aerocrine as well as fellow British Prosonix.

FinancingUK

20.05.2015 The Scottish Government has announced it will double the amount of funds for rare diseases. The New Medicines Fund that was created last year for this purpose will be increased to £80m (€112m).

M&ASwitzerland

04.05.2015 Swiss crop chemical maker Syngenta AG is in talks with US company Monsanto to discuss a possible merger, insiders say.

BiofuelsEU

30.04.2015 The European Parliament has given the go-ahead on a new law limiting the use of harmful crop-based biofuel in the transport sector. The decision marks a breakthrough in the EU’s approach to biofuels.

FinancingSwitzerlandUK

29.04.2015 Biopharma start-up CRISPR Therapeutics has raised US$64m to hurry the new CRISPR/Cas9 technology to the clinic.

Events

All Events

Partner-Events

Frankfurt am Main (DE)

ACHEMA 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • BASILEA133.60 CHF4.70%
  • WILEX4.20 EUR3.45%
  • STRATEC BIOMEDICAL48.52 EUR3.23%

FLOP

  • MEDIGENE8.58 EUR-4.88%
  • PAION2.51 EUR-4.56%
  • CYTOS0.63 CHF-3.08%

TOP

  • 4SC4.65 EUR257.7%
  • SYNGENTA422.00 CHF28.3%
  • SARTORIUS169.65 EUR18.6%

FLOP

  • CYTOS0.63 CHF-37.6%
  • MEDIGENE8.58 EUR-33.2%
  • CO.DON2.89 EUR-8.3%

TOP

  • WILEX4.20 EUR418.5%
  • CYTOS0.63 CHF350.0%
  • 4SC4.65 EUR322.7%

FLOP

  • MOLOGEN4.92 EUR-54.4%
  • BIOFRONTERA2.30 EUR-24.1%
  • CO.DON2.89 EUR-21.3%

No liability assumed, Date: 23.05.2015