Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

The last week or so has brought a variety of news in the Pharma world from good, bad to just plain old ugly. 

BMS's purchase of Medarex is an interesting one; time will tell what happens with the existing licensing deals and whether the pipeline, including ipilimumab pans out or not.  It certainly seems like shark infested waters at the moment, with an eat or be eaten strategy evolving in Pharma and Biotech.

The other week we posted a snapshort of denosumab, a RANK-L inhibitor being tested for the treatment of breast cancer patients with bone mestastases.  Yesterday, Amgen announced a deal with GSK to promote the monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand
and Mexico once the product is approved.  Amgen will
commercialize the drug for PMO and oncology in North America and for all oncology indications in Europe and specified
markets.  Seems like a good deal at first sight – Amgen get increased commercialisation in areas where they are weak and GSK get to add another source of revenue in regions where they are strong.

The news that Rigel's fostamatinib has failed to meet it's primary endpoint in a rheumatoid arthritis trial is disappointing.  The company announced:

"The TASKi3 Phase 2b clinical trial in rheumatoid
arthritis (RA) patients who had failed to respond to at least one
biologic treatment, the group treated with R788 (fostamatinib disodium)
did not report significantly higher ACR 20, ACR 50, ACR 70 and DAS28
response rates than the placebo group at three months, and therefore,
the trial failed to meet its efficacy endpoints."

The results for the placebo group were unusually high and so this cancelled out any possible chance of showing a statistical difference with the fostamatinib group.  Very unfortunate, but it happens.  It is possible that there was a carryover effect from the biologics taken as first-line therapy if the washout period was too short or the patients were poorly monitored, but who knows?  My guess is that we will see further trials in this area given the promising signs, perhaps a phase III trial or testing in other imunologic indications such as lupus and B-cell lymphomas.  It's unlikely to be the last of R788, but it is a major commercial setback for Rigel and significantly delays fostamatinib's time to market.

Medicines AgencyImage via Wikipedia

Meanwhile in Europe, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a negative opinion for the use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, advanced or metastatic non-small cell lung cancer (NSCLC).  The submission was based on the recent FLEX trial reported at ASCO last month.

Merck Serono is apparently considering an appeal, claiming that Erbitux is the first and only new targeted compound in clinical development in more than 10 years that increases overall survival in a NSCLC patient population including all histologies.  Clearly they would like the CHMP to reconsider its decision. 

The EMEA stated their reasons for rejecting the application as thus:

"The CHMP was concerned that the benefits of adding Erbitux to standard platinum-based
chemotherapy were modest in terms of survival times, and that the medicine did not have a convincing effect on how long patients lived without their cancer getting worse. Severe side effects were seen in some lung cancer patients who received Erbitux – these were similar to the side effects seen in patients treated with Erbitux for other types of cancer.

At that point in time, the CHMP was of the opinion that the benefits of Erbitux in the treatment of non-small cell lung cancer did not outweigh its risks. Hence, the CHMP recommended that the change  the marketing authorisation be refused."

If I recall from the FLEX data presented at ASCO last month, the overall survival was something like 11.3 vs. 10.1 months, a gain of about 1 month for a very significant cost, with not insignificant side effects, including a very nasty rash in some patients.  Put in this context, the CHMP clearly had doubts about the efficacy:side effect:cost benefit.  No doubt there will be a lot of noise around this decision over the next few weeks, but the decision is hardly surprising given the marginal improvement in lung cancer.

A wild month so far, for sure.  I wonder what next week will bring?

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3 Responses to “Around the horn in Pharma”

  1. MaverickNY

    Thank you for that link, Miguel, very helpful indeed. I’m not sure that Vectibix will overtake Erbitux on the basis of KRAS testing, but it will be interesting to see how Amgen and BMS/ImClone handle that side of the business going forward.

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