This week is going to be a busy one in the Icarus office with several client strategy reports to finish and many Pharma companies reporting 3Q earnings and plans for making year end targets.

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Meanwhile, on the Biotech front, Genentech and Amgen are reviewing their letters from the FDA on rituximab in moderate to severe rheumatoid arthritis (RA) who no longer respond to methotrexate (and other DMARDs) and denosumab for the treatment and prevention of postmenopausal osteoporosis, respectively.

Neither letters are a big surprise.  The FDA has declined to support the approval of rituximab in rheumatoid arthritis owing to the incidence of a rare, but fatal adverse event, known as progessive multifocal leukeoencephalopathy (PML).  According to Genentech:

"PML is a usually fatal brain disease caused by the reactivation of a common virus called the JC virus. Although the incidence of PML in RA patients treated with Rituxan is rare (as of today, three reports out of approximately 100,000 patients), there are no known reliable PML treatments."

Amgen have an entirely different kettle of fish on their hands, however.  The FDA were expected to get back to the company this month and last week there were rumours circulating about potential delays in the approval due to the FDA's backlog and other reasons.  However, they have indeed sent a complete response letter, requesting further information be provided, including:

"The Complete Response Letter related to the Prolia applications requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. This letter does not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication.

The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. The FDA acknowledged receipt of Amgen's previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia."

Amgen had clearly anticipated the need for a REMS in pre-submitting some materials, so this application will likely lead to full approval in the near future.  Whether the company has the sales muscle to compete in a highly competitive mass market segment with primary care doctors instead of specialists such as medical oncologists is a whole different ball game though.

At the other end of the spectrum, GSK have received approval to market their HPV vaccine for prevention of cervical cancer, Cervarix, a competitor to Merck's Gardasil, which ironically, just received approval for the treatment of genital warts in boys, a new indication in addition to the one already held for the prevention of cervical cancer in girls.  The Merck vaccine inhibits several additional HPV types compared to the GSK one, but whether this is significant or not is unclear.  Either way, physicians and patients now have a choice and this can only be a good thing, although there will likely not be any difference in the manufacturer's prices of the two vaccines.


Amgen announced that they have also received a complete response letter for the BLA for Prolia in the treatment and prevention of bone loss due to
hormone ablation therapy (HALT) in breast and prostate cancer patients.  In a press release, the company stated:

"The Complete Response Letter on the Prolia HALT applications requested
additional information regarding the safety of Prolia in patients with
breast cancer receiving aromatase inhibitor therapy and patients with
prostate cancer receiving androgen deprivation therapy. Specifically,
the FDA has requested results from additional adequate and
well-controlled clinical trials demonstrating that Prolia has no
detrimental effects on either time-to-disease progression or overall

This second letter requesting data from additional clinical trials will likely significantly delay approval for the cancer indication.

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