Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘BMS’

Exelixis and BMS part ways over XL184

It came as no big surprise this morning to hear that Exelixis and BMS have announced they are terminating their agreement over XL184.  The compound is being tested in medullary thyroid cancer, glioblastoma multiforme (GBM) and non-small cell lung cancer (NSCLC).  This is a small molecule that inhibits several targets, namely MET, RET and VEGFR2.

According to Exelixis, the CEO stated in their press release:

"We certainly understand BMS' need to make pipeline and prioritization decisions."

It looks as if they couldn't agree on the priorities for the clinical development, which would be a little odd given the $240M invested in XL184 and XL281 in 2008, with the same indications planned.

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Two new cancer drugs approved – cabazitaxel and nilotinib

Yesterday brought two new approvals in a day from the FDA in completely different cancer types.

In the morning, sanofi-aventis' cabazitaxel (Jevtana) was approved in castrate-resistant prostate cancer after failure of docetaxel (Taxotere) several months ahead of schedule.  This approval comes hot on the heels of Dendreon's sipuleucel-T (Provenge) in asymtomatic metastatic prostate cancer last month.

What this means is that once androgen ablation therapies stop working, there are three new treatment options for men with prostate cancer, none of which compete with each other, with the possible exception of the chemotherapies, since docetaxel is often given in second-line in men who previously responded well and have had a treatment break.  It will be interesting to see if this approach continues or if oncologists will prefer cabazitaxel in those with a good performance status.

#AUA2010: new perspectives and learnings in prostate cancer

It's been an interesting time here in San Francisco at the American Urology Association (AUA) meeting. Mostly, I've attended prostate cancer sessions to get both a breadth and depth perception of what's going on this cancer type.  

My focus is very much therapeutic development, so here are three key trends that I've noticed at the 2010 AUA meeting:

  1. PSA is not a brilliant biomarker, but it's all we have for now.
  2. Androgen ablation is not permanent.
  3. Immunotherapy is a hot new topic.

What alternatives are there to PSA?

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ASCO 2010 Preview #1

It's only 3 weeks to go to the Annual ASCO meeting in Chicago so I thought it would be a good time to kick off the annual preview of key data.  One of the things that sets the tone of the meeting is which abstracts are in the plenary session.  Sometimes I don't attend the session if it looks arcane, but this year looks really interesting and worthwhile attending.

The selected abstracts comprise the following:

#LBA1: Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or Fallopian tube cancer (FTC): A Gynecologic Oncology Group study.

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BioSante announce positive data from GVAX leukemia vaccine in CML

This morning the newswires (HT Mike Huckman) are full of the BioSante (formerly Cell Genesys) news on their leukemia vaccine, GVAX, which is being tested to see whether it is a viable approach for eradication of minimal residual disease. Accordingly, BioSante announced:

"Positive results of a human clinical study that show that its GVAX Leukemia vaccine may be able to reduce or eliminate the last remaining cancer cells in some chronic myeloid leukemia (CML) patients taking the drug Gleevec (imatinib mesylate). All patients enrolled in the trial used Gleevec for at least one year and still had cancer cells present. The study was conducted by researchers at the Johns Hopkins Kimmel Cancer Center in Baltimore, Maryland, led by Hyam Levitsky, M.D., professor of oncology, medicine and urology at the Cancer Center. The research was funded by the National Institutes of Health."

Abbott makes some waves in Pharma

While listening to last week's presentation by BMS on their pipeline, one slide in particular caught my attention:

 Abbott makes some waves in Pharma
Source: BMS

Now, it wasn't the fact that BMS were second in their table of Total Shareholder Return (TSR) that was interesting to me, but that Abbott were first, and by a long way, according to the chart above.  Of course, shareholder return is only one measure of performance and says nothing at all about putting customers and patients first, but that is another story/blog.

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Ipilimumab from BMS looks like an interesting new melanoma drug

It's been a frantic week on the work front and today was no different, but I wanted to highlight a really interesting slide from the BMS pipeline presentation yesterday afternoon.

Here's one of the slides Elliot Sigal, President of R&D, showed from one of the ipilimumab trials.  More data may be available at ASCO if the submitted abstract is accepted, but for now, even though it's only an n of 1, a picture tells a thousand words:

 Ipilimumab from BMS looks like an interesting new melanoma drug
Source: BMS

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Why do some Pharma companies do well in oncology and other's don't?

A chance email yesterday from Matthew Herper of Forbes Health got me thinking.  He was interested in whether a company, who have been successful in other therapeutic areas, could do well in cancer.

A question like that can quietly sit in the back of your mind for days percolating and brewing until you sit down and really think about it.

I've had some great opportunities to work in several different therapy areas including cardiovascular, dermatology, immunology, CNS, hematology and oncology.  The last two have much in common, the others less so.  But what makes them different, what factors are important to take into consideration and how do make it work?

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Update on malignant melanoma therapies

After yesterday's post about the NY Times article on Roche/Plexxikon's PLX4032, a few people wrote and asked about other therapies in development for the treatment of malignant melanoma.

Melanoma is the deadliest form of skin cancer and occurs in about 69,000 patients in the United States each year, resulting in approximately 9,000 deaths.  Sadly, the number of melanoma cases worldwide is increasing faster than any other cancer.

One of the most promising agents in development is Pfizer's tremelimumab (CP-675,206), a humanised IgG2 monoclonal antibody targeting Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), a natural brake on the immune system that has been implicated in melanoma.  The basic idea is that tremelimumab inhibits CTLA4, thereby stimulating or enhancing the body's immune response to tumours and fight the cancer.

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Chronic Leukemia is a hot topic right now!

Last night and this morning brought some topical news on the leukemia front.

Just before 5pm EST yesterday, the FDA announced they had approved Roche/Genentech's rituximab (Rituxan) in chronic lymphocytic leukemia (CLL).  Rituxan is already approved for non-Hodgkins Lymphoma (NHL) and rapidly the standard of care when combined with CHOP chemotherapy in this disease.  CLL is the most common adult leukemia and tends to affect older patients.

According to the Roche press release this morning, the FDA approval was for:

"Rituximab plus fludarabine and cyclophosphamide (FC) chemotherapy for people with either previously untreated (first-line) or previously treated (relapsed or refractory) CD20-positive chronic lymphocytic leukemia (CLL)."

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