News

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

http://www.european-biotechnology-news.com/news/news/2013-01/roche-gets-eu-ok-for-perjeta.html

LicensingSwitzerland

30.08.2016 Swiss biopharma company Ferring has acquired the exclusive development and commercialisation rights to Seikagaku’s Phase III chemonucleolytic leg pain treatment for €85m.

Clinical TrialsFrance

26.08.2016 Adocia said it would discontinue its diabetic foot ulcer programme after its lead product BioChaperone PDGF disappointed in Phase III. The French company will turn the focus on its earlier-stage products.

M&AUKSweden

24.08.2016 Pharma major Pfizer is putting the cherry on top of its multi-billion-dollar takeover of Medivation with the acquisition of AstraZeneca’s antibiotics for a cool US$1.5bn. With the divestment, AZ aims to further sharpen its focus.

FinancingUK

23.08.2016 Cambridge University-allied investor Cambridge Innovation Capital has raised £75m (€87m) to reinvest in technology and healthcare companies. Among the backers were Woodford Investment and Winton Ventures.

R&DDenmark

19.08.2016 Together with partner Johnson & Johnson, Danish biotech Genmab is now one step closer to FDA approval with its combination treatment for multiple myeloma after its submission of a supplemental Biologics License Application. In July, Genmab was granted a Breakthrough Therapy Designation (BTD) for its blood cancer therapy.

ResearchUKEU

17.08.2016 Philip Hammond, the UK’S chancellor has announced the government will guarantee funding for EU-backed "structural and investment fund" projects whose timelines extend beyond the UK’s departure from the EU, provided the projects are signed prior to this year's Autumn Statement on the UK budget. The decision ensures continued funding for farmers, companies and institutions involved in the EU’s Horizon 2020 project. The move could cost the UK government up to £6bn (€6.9bn).

Stock marketsGermany

15.08.2016 Back in April, the American FDA gave the green light for the colorectal cancer-screening test Epi procolon. Now Berlin-based diagnostics specialist Epigenomics is considering a secondary listing in the US. A draft of the required registration document was confidentially submitted to the US Securities and Exchange Commission (SEC).

LicensingDenmark

11.08.2016 Danish Genmab AS has granted Gilead Sciences license to use its DuoBody technology platform to develop bispecific antibodies for the treatment of HIV. The deal is worth up to €252m.

Clinical developmentHungaryIreland

09.08.2016 Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.

ImmunotherapySpain

08.08.2016 Araclon Biotech’s Alzheimer’s vaccine ABvac40 is going forward into Phase II after showing a good safety profile in Phase I. The promising trial results were presented at the Alzheimer’s Association International Conference.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Partner-Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • NEUROVIVE PHARMACEUTICAL AB (S)6.15 SEK8.85%
  • HYBRIGENICS (F)0.94 EUR8.05%
  • IXICO (UK)31.50 GBP5.00%

FLOP

  • ARGEN-X (B)13.70 EUR-3.52%
  • VECTURA (UK)132.10 GBP-3.17%
  • SAREUM HOLDINGS (UK)0.72 GBP-2.70%

TOP

  • NORDIC NANOVECTOR (N)33.60 NOK37.1%
  • KARO BIO (S)43.00 SEK30.3%
  • NEUROVIVE PHARMACEUTICAL AB (S)6.15 SEK28.1%

FLOP

  • BIONOR PHARMA (N)0.42 NOK-26.3%
  • E-THERAPEUTICS (UK)11.50 GBP-14.1%
  • GW PHARMACEUTICALS (UK)519.00 GBP-12.8%

TOP

  • NICOX (F)10.31 EUR431.4%
  • SAREUM HOLDINGS (UK)0.72 GBP227.3%
  • GENMAB (DK)1095.00 DKK83.3%

FLOP

  • BB BIOTECH (D)44.55 EUR-82.8%
  • EVOCUTIS (UK)0.04 GBP-77.8%
  • CIRCASSIA LIMITED (L)96.20 GBP-71.9%

No liability assumed, Date: 30.08.2016