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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.

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&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&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.

M&AFranceGermany

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.

FinanceBelgium

01.07.2014 Belgian antibody specialist Ablynx has raised €41.7m through a private placement of new shares and plans on boosting their range of nanobodies in development.

BioeconomyBelgiumUK

30.06.2014 Building on a £1.2m financing round, Celtic Renewables partners with a Belgian pilot plant to bring its bio-fuel made from whisky production residue to an industrial scale.

ConventionEUUK

25.06.2014 Sun, celebrities and a scandal - the world’s largest biotech convention is getting off to an explosive start in San Diego, California.

InvestmentGermanyNetherlands

24.06.2014 Bayer Healthcare is getting back into gene therapy with a US$252m deal aimed at the development of a haemophilia A treatment.

InvestmentNetherlands

20.06.2014 Tomtom founder Pieter Geelen invests in Dutch biotech Ocello, the company behind a 3D mapping technology used for predicting drug behaviour in patients.

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No liability assumed, Date: 13.07.2014