News

Roche’s T-DM1 over next hurdle
Enlarge image

Clinical TrialsEUSwitzerland

Roche’s T-DM1 over next hurdle

28.08.2012 - Swiss Roche AG reports its antibody-drug conjugate trastuzumab emtansine (T-DM1) improves overall breast cancer survival – and files MAAs.

After first promising news in spring Basel-headquartered F. Hoffmann-La Roche AG adds more substantiating Phase III data concerning the benefit of its antibody-drug conjugate (ADC) trastuzumab emtansine (T-DM1). On 27 August, the company and its licence partner ImmunoGen announced that the conjugate not only significantly improved progression-free survival (PFS) but also overall survival (OS) in patients with metastatic breast cancer. Patient data – which will be presented at an upcoming medical meeting – stems from the EMILIA Phase III trial. In EMILIA, the new drug was tested on 991 patients with HER2-positive non-resectable locally advanced or metastatic breast cancer who had previously unsuccessfully received trastuzumab (Herceptin) plus chemotherapy. Enrolled patients either fell into the T-DM1-only group or into the control, standard-of-care group receiving lapatinib (Tykerb) plus capecitabine (Xeloda). Roche also announced that it is about to submit the marketing application for T-DM1 to the European Medicines Agency (EMA).

 Genentech Inc., a Roche subsidiary situated in San Francisco (USA), is the developer of T-DM1. The company has already filed a marketing application for the drug to the Food and Drug Administration (FDA) in the US. The development was accomplished under an agreement with ImmunoGen, Inc. from Waltham (USA). The company from Massachusetts provides the linker chemistry and the compound drug’s cancer killing agent, which is targeted by the antibody (trastuzumab) to Her2neu tumour cell receptors. ImmunoGen calls its technology TAP, Targeted Antibody Payload. The cytotoxic agent is a derivative of maytansine that inhibits the assembly of microtubules. Maytansines are potent toxins that naturally occur in the shrubs and trees of the Genus Maytenus spp.

http://www.european-biotechnology-news.com/news/news/2012-03/roches-t-dm1-over-next-hurdle.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%
  • FORMYCON27.70 EUR316.5%
  • 4SC4.65 EUR315.2%

FLOP

  • MOLOGEN4.92 EUR-53.7%
  • BIOFRONTERA2.30 EUR-28.6%
  • PAION2.51 EUR-22.8%

No liability assumed, Date: 25.05.2015