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

M&AIreland

31.03.2015 In its aim to expand its drug portfolio in orphan disease products, Horizon Pharma has acquired US company Hyperion Therapeutics for US$1.1bn in cash. The takeover entitles the UK biopharma to all of Hyperion’s common stock.

BusinessGermany

31.03.2015 Merck Serono has forged a US$941m (€876m) deal with US Intrexon for the development and commercialisation of CAR-T therapies. The new CAR-T projects are set to strengthen their R&D technology portfolio in immuno-oncology.

Stock MarketsFranceEU

27.03.2015 Europe is once more proving that it can be a good bet for biotech companies going public. A newly established EU-wide lobbying initiative could help the IPO boom on its way.

FinancingPoland

24.03.2015 Poland has announced the closing of a new venture capital fund at US$42m (€32m). The fund, which is the first of its kind in Poland, is dedicated to the Life Sciences with a strong connection to Central and Eastern Europe.

BioeconomyFranceSwedenGermanyNetherlandsFinland

23.03.2015 A BASF-led consortium aims to decrease bio-based production costs using industrial biotechnology. The Horizon2020 funded consortium is the sixth project of the SPIRE Public Private Partnership and has a budget of €14m.

Stock MarketsFranceSwedenUKNorwayIreland

20.03.2015 There are no signs of inertia creeping into the European biotech industry this spring. A total of eight IPOs are set to go public by the end of the year’s first quarter.

FinancingUKEU

17.03.2015 Pharma giants GlaxoSmithKline (GSK) and Johnson & Johnson (J&J) will be key collaborators in a new global fund for dementia research to address the rising threat posed by dementia and Alzheimer’s disease.

FinancingFranceDenmarkSwedenGermany

19.03.2015 French venture capital firm Seventure Partners has raised a further €25m for its microbiome-focused Health for Life Capital Fund. It now stands at €100m.

EventsFranceEUSwitzerlandUKGermany

12.03.2015 With around 1,400 companies and 2,400 participants, the springtime counterpart of BIO-Europe enjoyed a successful premiere in France this year. The overall mood of the European biotech industry was positive, and the French hosts in particular reported new initiatives.

M&ABelgium

11.03.2015 Belgian cell-based therapeutics developer and CMO MaSTherCell SA has been acquired by US biotech Orgenesis Inc. for €23m.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • FORMYCON27.83 EUR3.30%
  • EVONIK34.17 EUR2.92%
  • VITA 345.91 EUR1.55%

FLOP

  • EPIGENOMICS5.59 EUR-5.73%
  • WILEX2.86 EUR-4.98%
  • BB BIOTECH271.10 EUR-4.88%

TOP

  • CYTOS1.43 CHF297.2%
  • MEDIGENE12.33 EUR184.8%
  • FORMYCON27.83 EUR71.5%

FLOP

  • MORPHOSYS57.18 EUR-21.9%
  • WILEX2.86 EUR-9.2%
  • BASILEA110.70 CHF-7.8%

TOP

  • SANTHERA93.75 CHF2186.6%
  • FORMYCON27.83 EUR283.9%
  • WILEX2.86 EUR144.4%

FLOP

  • CYTOS1.43 CHF-53.1%
  • MOLOGEN5.41 EUR-52.9%
  • PAION2.35 EUR-36.0%

No liability assumed, Date: 01.04.2015