Latest Intelligence on Biotech in United States

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Type Product title / description Pub Price
CommentWire
CommentWire

UCB: Cimzia's indication expansion hindered by FDA

Although the FDA's complete response letter for Cimzia in rheumatoid arthritis will delay its US approval, Datamonitor believes UCB has the experience to handle the setback and the drug may still reach the market by the second half of 2009. Ultimately however, the delay will not be a major impediment as extensive uptake is not expected at launch due to poor differentiation in a mature drug class.

Published By Datamonitor
07 Jan 2009
Expert View
Expert View

Genentech/Merck Serono: is this the end of the line for Raptiva?

Raptiva's safety profile continues to face US and EU regulatory agency scrutiny, which Datamonitor believes will have significant ramifications for the drug's use in psoriasis and any future employment in transplantation. With fresh concern over the safety of Genentech's drug, alternative therapies are likely to impact upon Raptiva's commercial potential.

Published By Datamonitor
23 Feb 2009
CommentWire
CommentWire

Genentech/Roche: Avastin adds fifth indication to label

Following positive results from two Phase II trials, Genentech/Roche's Avastin has obtained accelerated FDA approval for glioblastoma patients who have progressed after previous treatment. While the commercial potential in this indication is small, it creates an opportunity for Avastin to become an established treatment in this type of brain cancer.

Published By Datamonitor
06 May 2009
CommentWire
CommentWire

Seattle Genetics/Millennium: promising immunotherapy for relapsed/refractory Hodgkin's lymphoma

Seattle Genetics and Millennium: the Takeda Oncology Company have announced encouraging results from a Phase II trial of brentuximab vedotin in relapsed or refractory Hodgkin's lymphoma. Full results of the trial are yet to be published, but the candidate looks set to become the first immunotherapy approved for the disease.

Published By Datamonitor
29 Sep 2010
CommentWire
CommentWire

Celgene: increased 2010 revenue forecast highlights company's ambition

Celgene has posted an increase in its Q3 and year-to-date sales compared to 2009 figures, which has led the company to raise its own 2010 total revenue forecasts from $3.45 billion to $3.6 billion. The company is expected to grow further out to 2015, as its looks to expand its global market share and product portfolio.

Published By Datamonitor
02 Nov 2010
Expert View
Expert View

Roche/Genentech: Avastin to lose metastatic breast cancer indication and associated sales in the US

The FDA has recommended that metastatic breast cancer be removed from Avastin's label after reviewing survival data from Phase III clinical trials. Roche/Genentech has requested a public hearing about the decision, as the removal of breast cancer from the label will impact the drug's US sales. Furthermore, the decision indicates a new level of expectation for Avastin in terms of clinical outcomes.

Published By Datamonitor
17 Dec 2010
Expert View
Expert View

Roche/Genentech/Biogen Idec: US approval will boost Rituxan dominance

The FDA has approved Rituxan for first-line maintenance treatment of patients with advanced follicular lymphoma that responded to initial treatment with Rituxan plus chemotherapy. Sales are expected to increase across the seven major markets following the FDA's decision and, as a result, Rituxan looks set to dominate in this indication.

Published By Datamonitor
02 Feb 2011
CommentWire
CommentWire

Sanofi-Aventis/Regeneron: negative trial data may signal the end for aflibercept in lung cancer

New data indicate that the addition of aflibercept to docetaxel as a second-line treatment for patients with non-small cell lung cancer failed to improve overall survival in a Phase III trial. On the basis of these results and given the competitive landscape of the non-small cell lung cancer market, it is unlikely that Sanofi-Aventis and Regeneron will pursue an approval for this indication.

Published By Datamonitor
15 Mar 2011
CommentWire
CommentWire

Takeda/Seattle Genetics: hopes of pipeline drug boost collaboration agreement

Encouraged by a partnership that has to date been successful, Millennium has invested further into Seattle Genetics' antibody-drug conjugate technology. As the wait for the first commercially successful antibody-drug conjugate therapeutic continues, pharmaceutical players are actively populating their pipelines with this innovative monoclonal antibody class.

Published By Datamonitor
17 Mar 2011
CommentWire
CommentWire

Cephalon: acquisition strategy continues with the purchase of Gemin X Pharmaceuticals

As Cephalon faces declining sales across its key central nervous system franchise due to generic sales erosion, the company continues to pursue a strategy of acquisition in order to further diversify its product portfolio. The Gemin X agreement could provide potential long-term growth for Cephalon's expanding oncology interest.

Published By Datamonitor
23 Mar 2011

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