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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.

ResearchUKEU

23.07.2014 In the largest genomic study published on any psychiatric disorder so far, researchers have indentified 83 new locations in the human genome associated with the risk of developing schizophrenia.

BusinessUKIreland

21.07.2014 Abbvie’s tenacious pursuit of British rival Shire is finally paying off: The two companies have unveiled their transatlantic merger worth £32bn (€40bn).

ResearchEUSwitzerland

17.07.2014 A trans-border, cross-disciplinary project that aims to model the human brain in a computer has drawn heavy criticism from scientists pledging to boycott the project.

MergerUK

16.07.2014 After rejecting three merger propositions from US competitor Abbvie, Shire has now given up resistance to the deal and is recommending a new and improved offer worth £31.3bn.

AcquisitionUKDenmarkSpainGermanyFrance

15.07.2014 British specialty pharma company Prostrakan is handing over £230m for Archimedes Pharma Limited, a company that brings its lead product Pecfent and its proprietary drug delivery technology platform into the deal.

FundingEU

11.07.2014 Among the seven newly launched Joint Technology Initiatives (JTI) of Horizon2020 are two with deep roots in biotech: IMI is going into its second round while the newly established Bio-based Industries partnership invests in bioeconomy.

Stock marketNetherlandsUKBelgium

10.07.2014 Not one but two biopharma companies are seeking entry into the stock market: After Abzena raised €25m in an IPO earlier this week, Argen-x has followed suit and sold shares worth €40m.

M and AUKIreland

08.07.2014 Abbvie is determined to bring home British rare disease specialist Shire in a merger worth £30.1bn (€37.9bn). So far, Shire has rejected all offers from the US company.

M and ASwitzerland

04.07.2014 Genentech, a member of Swiss Roche Group, is set to acquire US-biotech Seragon Pharmaceuticals Inc. With the move, Genentech will obtain the rights to investigational breast cancer treatments.

MandAFranceGermany

03.07.2014 Nicox S.A. is stretching beyond the European market: The French eye health specialist is set to acquire Aciex Therapeutics Inc., a US-based pharma company with several ophthalmic therapeutics nearing market maturity.

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No liability assumed, Date: 23.07.2014