Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



Investors Should Brace for a Busy Week From the Biotech Sector

Don't let it get away!

Keep track of the stocks that matter to you.

Help yourself with the Fool's FREE and easy new watchlist service today.

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 (UNKNOWN: THRX.DL  ) and GlaxoSmithKline (NYSE: GSK  ) 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 (NASDAQOTH: RHHBY  ) 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 (NASDAQ: SGEN  ) 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.

As we ponder the upcoming results of these three FDA meetings, let it serve as a constant reminder that your financial health is just as important as your personal health. The Motley Fool's special free report "3 Stocks That Will Help You Retire Rich" names specific investment opportunities that could help you build long-term wealth and help you retire well. The Fool also outlines critical wealth-building strategies that every investor should know. Click here to keep reading.

Read/Post Comments (1) | Recommend This Article (1)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On September 08, 2013, at 1:00 AM, Sassmore wrote:

    The mention in this article about the sale of a stake in Theravance to Elan is, frankly, dead wrong. Keep up on your facts if you would like to be a respected site for investors, please.

Add your comment.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2626931, ~/Articles/ArticleHandler.aspx, 9/28/2016 9:54:17 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated Moments ago Sponsored by:
DOW 18,270.90 42.60 0.23%
S&P 500 2,162.60 2.67 0.12%
NASD 5,311.32 5.61 0.11%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

9/28/2016 9:39 AM
GSK $43.68 Up +0.36 +0.83%
GlaxoSmithKline CAPS Rating: ***
RHHBY $31.45 Up +0.06 +0.19%
Roche Holding Ltd.… CAPS Rating: *****
SGEN $56.45 Down -0.13 -0.22%
Seattle Genetics CAPS Rating: ****
THRX.DL $0.00 Down +0.00 +0.00%
Theravance CAPS Rating: **