News

Two are better than one
Enlarge image

RegulatoryEUDenmarkSwitzerland

Two are better than one

12.06.2012 - FDA approves Roche's antibody pertuzumab (Perjeta). Given together with trastuzumab (Herceptin) it will help breast cancer patients.

Basel/Glostrup/Bethesda – The US Food and Drug Administration (FDA) has approved Roche's drug Perjeta (pertuzumab) as combination therapy of people with metastatic HER2-positive breast cancer who have not received HER2 therapy or chemotherapy before. When administered together with Herceptin (trastuzumab) and in combination with standard docetaxel chemotherapy, Perjeta showed an increase in progression-free survival time of 6.1 months. Data stems from a Phase III study, the treatment of the control group was Herceptin and docetaxel chemotherapy alone.

Both the HER2 signaling inhibitor Herceptin and the HER2 dimerisation blocker Perjeta are humanised monoclonal antibodies. And both target the HER2 receptor, a protein found highly enriched on the outside of cells in a kind of breast cancer aptly named HER2-positive metastatic breast cancer. However, both drugs act in a complementary fashion, meaning that they target different parts of the HER2 receptor.  Currently, Genentech, the manufacturer of Perjeta, is not able to meet demand. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said why the approval was given in spite of the shortage: "There's a need for the treatment of metastatic breast cancer and we do not want to delay the drug's availability to patients pending resolution of the production issues relating to further supply." 

In March, Roche filed an EU market authorisation application for the subcutaneous administration of Herceptin which is less invasive and takes less time.

On 12 June, cancer diagnostics company Dako Denmark A/S announced that the FDA has granted market authroisation for its HercepTestand HER2 FISH pharmDxKit as companion diagnostics for pertuzumab.

http://www.european-biotechnology-news.com/news/news/2012-02/two-are-better-than-one-for-roche-and-for-patients.html

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.

FinancingGermany

10.03.2015 The Gates Foundation has dipped into its purse to bring infectious diseases vaccines to the poorest countries. German vaccine specialist CureVac is set to receive US$52m for their mRNA platform technology.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • MEDIGENE12.51 EUR18.92%
  • CO.DON2.88 EUR9.09%
  • FORMYCON26.77 EUR8.91%

FLOP

  • 4SC1.16 EUR-7.20%
  • MOLOGEN5.69 EUR-2.07%
  • CYTOS1.43 CHF-1.38%

TOP

  • CYTOS1.43 CHF320.6%
  • MEDIGENE12.51 EUR194.4%
  • FORMYCON26.77 EUR60.3%

FLOP

  • MORPHOSYS60.10 EUR-19.6%
  • BASILEA108.20 CHF-11.5%
  • WILEX3.10 EUR-9.6%

TOP

  • SANTHERA96.50 CHF2312.5%
  • FORMYCON26.77 EUR271.8%
  • WILEX3.10 EUR198.1%

FLOP

  • CYTOS1.43 CHF-52.5%
  • MOLOGEN5.69 EUR-49.4%
  • PAION2.53 EUR-24.0%

No liability assumed, Date: 30.03.2015