This Week in Biotech

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

Editor's note: A previous version of this article incorrectly stated that the FDA has never approved an inhalable insulin therapy. The Fool regrets the error.

With the SPDR S&P Biotech Index up 32% year to date, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.

As you might imagine, Christmas week wasn't filled with an overabundance of rulings and data, but there were still quite a few big events that investors should have taken note of. Here are four that crossed my radar, in case you missed them.

The biggest news this week was an approval in Japan for next-generation blood-thinning drug Eliquis in Japan. The drug, developed by Bristol-Myers Squibb (NYSE: BMY  ) and Pfizer (NYSE: PFE  ) , has now been approved in Canada, the European Union, and Japan over just the past few weeks, but is awaiting a decision from the Food and Drug Administration, which sent the company a rejection letter earlier this year demanding more clinical data. Both companies have resubmitted their new drug application, with a PDUFA date of March 17. Although it isn't approved in the United States yet, I've proclaimed Eliquis to be a life-changing drug and figure it could be the blockbuster that both Bristol and Pfizer have been seeking since Plavix and Lipitor went off patent.

Roche (NASDAQOTH: RHHBY  ) also received a nice bit of good news this week, when the FDA expanded the indication for oseltamivir, better known as Tamiflu, to children as young as 2 weeks old and up to 12 months old as a new symptom flu treatment. The FDA was very clear that Tamiflu is not a flu preventative agent for this age group and fully encouraged everyone older than 6 months of age to get an annual influenza shot, but this added indication could help boost Tamiflu's sales, which have struggled recently. 

In less dramatic but nonetheless important news, AMAG Pharmaceuticals (NASDAQ: AMAG  ) filed for a supplemental new drug application for its iron-deficiency anemia, or IDA, drug, Feraheme. AMAG hopes to expand Feraheme's indication from just chronic kidney disease, or CKD, to all iron-deficient anemias. CKD affects approximately 1.6 million people in the U.S., with an additional 2.4 million affected by a non-CKD form of IDA. Given that sales of Feraheme have stalled, this additional indication could more than double sales. In advance of its supplemental NDA, AMAG has run two late-stage trials encompassing more than 1,400 patients and should receive a decision sometime next year. 

Finally, MannKind's (NASDAQ: MNKD  ) massively dilutive offering, which I alluded to back in early October, finally came to fruition, with a twist. MannKind's outstanding share count did increase by 200 million to 550 million; however, 40 million shares were sold to the Mann Group, which is controlled by MannKind's CEO, Alfred Mann. In short, MannKind's CEO purchased $107 million more worth of MannKind's stock. If that's not an indication of commitment by a CEO, I'm not sure what is. Investors will definitely be glad to see this development, as history isn't on their side. MannKind's lead drug, an inhalable insulin to treat type 1 and type 2 diabetes, known as Afreeza, is going up against figures that show the FDA has approved inhalable insulin therapies only in rare cases. Needless to say, 2013 should be a make-or-break year for MannKind.

Is 2013 the year MannKind turns it around?
Still down around 90% from its highs less than a decade ago, there's been no giant leap for MannKind shareholders. The debate rages over whether the company's revolutionary inhalable insulin, slated to go in front of the FDA next year, will be a complete flop or a massive blockbuster success. In this brand-new premium report on MannKind, we outline every key topic investors have to know with this risky stock. It also comes with a full year of analyst updates to keep you covered as key news develops, so don't miss out -- simply click here now to claim your copy today.

Read/Post Comments (2) | Recommend This Article (2)

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 December 29, 2012, at 1:28 PM, DarthTrader92660 wrote:

    Your comment "the FDA has never approved an inhalable form of insulin therapy." is factually incorrect. Pfizer's Exubera was FDA approved several years ago.

  • Report this Comment On December 29, 2012, at 6:47 PM, manipulatethis wrote:


    DarthTrader is spot on. Obviously you haven't done your research and yet again shows that many writers on herehave no clue as to what they write about at times.

    If you had done your research on MNKD, you would have seen that the FDA was on the verge of approving Afrezza before a low life by the name of Martin Shrekli manipulated the FDA to halt their pending approval. I wonder why no one looked into how one guy could do such a thing.

    Regardless of all that, the data of various clinical trials has shown AFrezza to work well and be well tolerated for an inhalable.

    It's just a shame that so called financial journalists can't get the basics right. Also shows the editors of this site also are pretty lousy.

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: 2172538, ~/Articles/ArticleHandler.aspx, 10/25/2016 4:45:22 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 7 hours ago Sponsored by:
DOW 18,223.03 77.32 0.43%
S&P 500 2,151.33 10.17 0.47%
NASD 5,309.83 52.43 1.00%

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

10/24/2016 4:00 PM
AMAG $26.30 Up +0.30 +1.15%
AMAG Pharmaceutica… CAPS Rating: *****
BMY $49.23 Down -0.79 -1.58%
Bristol-Myers Squi… CAPS Rating: ****
MNKD $0.55 Down -0.04 -7.22%
MannKind CAPS Rating: *
PFE $32.13 Down -0.05 -0.16%
Pfizer CAPS Rating: ****