News

Roche gets EU ok for Perjeta
Enlarge image

BusinessSwitzerlandEU

Roche gets EU ok for Perjeta

06.03.2013 - Swiss Roche has gotten EU approval for Perjeta (pertuzumab). The antibody boosts efficacy of Herceptin by blocking HER dimerisation.

The European Commission gave the green light for a combination therapy of pertuzumab, Herceptin (trastuzumab) and docetaxel in previously untreated adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer. The recommendation for market approval is based on Roche’s  Phase III CLEOPATRA study in which the combination therapy prolonged median progression-free survival for 6.1 months compared to Herceptin and chemotherapy alone. Furthermore, the treatment triggered a 34% reduction in the risk of death.

The improvement of Herceptin efficacy by Perjeta is due to a synergistic mode of action of the two antibody drugs. Herceptin blocks homodimerisation of HER2 when HER2 is overexpressed. The antibody prevents activation of HER2-dependent pathways by binding to the extracellular domain IV of the protein and thus blocks MAPK-dependent cell proliferation and PI3K-dependent inhibition of apoptosis. In contrast, Perjeta binds HER2 from the opposite side and prevents heterodimerisation with HER1 and HER3 proteins. Especially, inhibition of HER2/HER3 dimerisation seems important as HER3 supports PI3K-mediated cell proliferation following dimerisation with HER2.

“The EU approval of Perjeta is the result of years of research into the HER2 pathway and we are excited to offer a new treatment option for people with this aggressive disease,” said Roche’s CMO Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. The combination therapy provides a clever strategy for extension of Herceptin’s life cycle. However, Roche is already evaluating a combination therapy of its antibody-toxin warhead T-DM1 with Perjeta.

© eurobiotechnews.eu/tg

FundingEU

25.07.2014 The European Commission aims to support innovation in Europe and announced a "Fast Track to Innovation" pilot as well as five innovation prices under Horizon 2020.

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.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • BIOINVENT INTERNATIONAL AB (S)3.10 SEK9.15%
  • Allergy Therapeutics (UK)19.12 GBP6.94%
  • PHARMING (NL)0.48 EUR6.67%

FLOP

  • ANTISOMA (UK)1.32 GBP-14.84%
  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.29%
  • CHRONTECH PHARMA (S)0.07 SEK-12.50%

TOP

  • WILEX (D)3.15 EUR331.5%
  • SANTHERA (CH)68.55 CHF99.3%
  • ADDEX (CH)4.08 CHF85.5%

FLOP

  • MERCK KGAA (D)65.43 EUR-48.6%
  • HYBRIGENICS (F)1.83 EUR-29.1%
  • PROSENSA (NL)9.48 USD-26.2%

TOP

  • SANTHERA (CH)68.55 CHF3489.0%
  • GW PHARMACEUTICALS (UK)427.00 GBP780.4%
  • PAION (D)2.79 EUR304.3%

FLOP

  • CYTOS (CH)0.26 CHF-92.4%
  • EVOCUTIS (UK)0.21 GBP-92.0%
  • PROSENSA (NL)9.48 USD-68.2%

No liability assumed, Date: 24.07.2014