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Investors Should Brace for a Busy Week From the Biotech Sector

By Sean Williams - Sep 7, 2013 at 4:30PM

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With three Food and Drug Administration announcements on the docket this week, biotech savvy investors had better be paying attention.

Editor's note: A previous version of this article incorrectly stated that Elan owned a stake in Theravance's COPD royalties. The Fool regrets the error.

With second-quarter earnings season now in the books and about a month to go before third-quarter earnings kicks off, biotech savvy investors are in for a treat this week with three separate events from the Food and Drug Administration likely to garner a lot of attention.

Anoro ellipta
On Tuesday, Theravance (NASDAQ: THRX) and GlaxoSmithKline (GSK 0.84%) are scheduled to meet with the FDA panel with regard to their chronic obstructive pulmonary disease inhaler anoro ellipta. If the briefing documents released Friday are any indication of how the meeting will go, shareholders in both companies should be fairly excited with the FDA finding only benign problems with the drug and noting it was quite effective in both doses.

If recommended positively by the FDA's panel and approved by its PDUFA date in mid-December, anoro ellipta would become the second long-acting COPD inhaler developed by the collaboration of Theravance and GlaxoSmithKline to make it to market in less than a year -- the other being Breo Ellipta. It would also firmly solidify Glaxo and Theravance as the premier COPD drugmakers.

On Thursday, Roche (RHHBY 2.34%) shareholders can look forward to an FDA panel meeting of their own. Already approved to treat metastatic HER2-positive breast cancer in combination with Herceptin and docetaxel for patients that haven't received any prior chemotherapy, Roche is hoping to add an additional indication (known as a supplemental biologics license application, or sBLA) for Perjeta to be used as a neoadjuvant treatment (i.e., before surgery) in for patients with early stage HER2-positive breast cancer.

In the company's Neosphere study which involved 417 people who had recently been diagnosed with early stage HER2-positive breast cancer, the combination of Perjeta, Herceptin, and docetaxel induced a pathological complete response (pCR) in 45.8% of patients which was 58% higher than the next closest therapy option of the combination of Herceptin and docetaxel which delivered a pCR of 29%. In its Tryphaena study, the combination of drugs proved favorable in turning in no more serious adverse events than the current standard of treatment.

Since Perjeta was already approved by the FDA as a late-stage treatment for HER2-positive breast cancer in June 2012, and its safety and efficacy data in the aforementioned trials handily met its goals, I don't see why Perjeta shouldn't get a round of positive opinions from the FDA's panel this week.

Finally, Seattle Genetics (SGEN -2.24%) is expected to receive word from the FDA on the approval or rejection of its sBLA for Adcetris on or before Sept. 14.

Adcetris, Seattle Genetics' only FDA-approved drug, gained its approval in August 2011 as a treatment for Hodgkin's lymphoma and systemic anaplastic large cell lymphoma (ALCL). When it was approved, ALCL patients had a particularly strong response in trials, with 88% experiencing a complete or partial response that lasted, on average, 12.6 months.

Adcetris' new proposed indication would allow it to be used in cases of retreatment and in extended duration trials beyond 16 cycles for Hodgkin's lymphoma and ALCL patients. Of the 23 patients retreated with Adcetris in trials, 70% achieved an objective response, of which nine had a complete remission. With regard to utilizing Adcetris as an extended treatment, the 17 patient study in which patients were treated for an average duration of 17.3 months demonstrated an even higher objective response rate of 88% with 76% showing a complete remission.

As in the prior two cases, the data seems to overwhelmingly favor a positive outlook from the FDA – in this case an approval. With overall revenue growth for Seattle Genetics having slowed to 15%, this could be just the type of boost needed to support its rallying share price.

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.

The Motley Fool recommends Seattle Genetics. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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