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

GenericsEUUKHungaryGermanyItalyGreeceAustriaLuxembourgFranceSpain

26.02.2015 It is the first biosimilar monoclonal antibody in many European markets: Mundipharma and Hospira are launching Celltrion’s Remicade generic.

M&AUK

23.02.2015 British drug developer Heptares has been acquired by Japanese biopharma play Sosei for US$400m (€352m).

bioethanolGermanyUKBelgiumFrance

19.02.2015 The price of oil has been sliding for months, and the European bioethanol market is taking it hard. CropEnergies AG has now stopped production at its British unit Ensus UK.

BusinessFranceGermany

17.02.2015 After Christopher Viehbacher’s unceremonious ousting last year, Sanofi has been on the look out for a new CEO. Now, sources say Bayer’s Olivier Brandicourt is set to fill the position.

BusinessUKSwitzerland

12.02.2015 Glaxosmithkline is intent on bolstering its vaccine portfolio further and has bought all shares of Swiss development partner Glycovaxyn.

InvestmentsUKEU

10.02.2015 Interest in biotechnology is on the rise among British investors. Not just one, but two major financiers are planning investment funds in the field.

IVFUKEU

04.02.2015 In a historic move, the UK is set to become the first country to allow the creation of babies with the genetic material of three people – a mother, a father and a female mitochondrial donor.

Events

All Events

Partner-Events

Planegg/Martinsried

1st Munich Biotech Pitch

Berlin (DE)

Proteomic Forum 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • EVOLVA1.67 CHF7.74%
  • VITA 345.75 EUR6.48%
  • PAION2.15 EUR4.37%

FLOP

  • WILEX3.16 EUR-7.87%
  • MAGFORCE5.65 EUR-1.74%
  • FORMYCON16.51 EUR-1.14%

TOP

  • WILEX3.16 EUR58.0%
  • THERAMETRICS0.07 CHF16.7%
  • BASILEA121.50 CHF16.6%

FLOP

  • SANTHERA96.00 CHF-16.8%
  • 4SC0.79 EUR-13.2%
  • MOLOGEN5.40 EUR-10.9%

TOP

  • SANTHERA96.00 CHF2426.3%
  • WILEX3.16 EUR435.6%
  • FORMYCON16.51 EUR104.3%

FLOP

  • CYTOS0.34 CHF-88.5%
  • MOLOGEN5.40 EUR-55.6%
  • BIOFRONTERA1.90 EUR-51.8%

No liability assumed, Date: 02.03.2015