Recs

5

Biotech Optimists Throw In the Towel

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

It's a grim fact of life for drug development: A drugmaker will sometimes get a complete response letter from the Food and Drug Administration, asking for more clinical trials. Without any other form of revenue, that drugmaker has no choice but to cut its workforce and hunker down for the long haul.

Yesterday, MannKind (Nasdaq: MNKD  ) said it was cutting 41% of its employees to lower expenses as it waits to complete two clinical trials the FDA is requiring prior to approval of its inhaled insulin product.

Earlier in the week, Orexigen Therapeutics (Nasdaq: OREX  ) announced that it was cutting 40% of its staff, after the FDA said it would have to run a cardiovascular study before approving its obesity drug.

Before that, the same fate befell Arena Pharmaceuticals (Nasdaq: ARNA  ) , A.P. Pharma, XenoPort (Nasdaq: XNPT  ) , and GTx (Nasdaq: GTXI  ) . Different names, different drugs, same story.

Investors should be cheering. Surviving to the finish line is goal No. 1.

Instead, they sent MannKind down 11% in after-hours trading. Continued selling led to a 25% collapse today. Orexigen was down 6% the day after its announcement.

I'm guessing that the price reaction stems from investors' sudden realization that they can't expect any quick fixes. Such remedies do exist; Forest Laboratories (NYSE: FRX  ) and Mylan (Nasdaq: MYL  ) once responded to the FDA and got an approval less than three weeks after an initial rejection. But MannKind and Orexigen didn't get one of those easy-fix rejections.

Of course, investors should have known that already. Alas, some biotech investors are eternal optimists. Do these share price plunges mean eternity is coming to an end?

Follow MannKind and Orexigen as they make additional attempts at gaining FDA approvals. Click on their names to add them to My Watchlist, which will help you keep track of all our Foolish analysis on the companies.

The Steve Jobs Betrayal
You may already know that in the final year of his life, Jobs revealed a stunning betrayal — and told his biographer, "I will spend my last dying breath... and every penny of Apple's $40 billion in the bank to right this wrong." What was it that made Jobs so irate — and why could it make a few in-the-know investors some major profits over the coming months and years?

Enter your email address below to find out what made Jobs so enraged!

Motley Fool Rule Breakers is always on the hunt for hot drug stocks and other cutting-edge picks. Click here to see all of our latest discoveries with a free 30-day trial subscription.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.


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 February 12, 2011, at 10:42 AM, Sum111 wrote:

    For those looking for quick returns Bio tech stocks are probably not for you. Pharma products take years to develop and do nothing but loose money until/if they come to market. But that being said they are the cutting edge technology in health care and as long as there are people with health needs, there will be Bio tech companies looking to improve/create drugs to meet those needs.

    I like Bio tech as they not only contribute to real quality of life for people, when successful their products tend to be very profitable. I have found though they require far more due diligence both before investing in them and a greater commitment to hold onto them once the decision is made to purchase them. In other words a greater tolerance for risk and patience as well as the commitment to research both the fundamentals of the company and its product is required.

  • Report this Comment On February 14, 2011, at 10:09 AM, Blindnomore wrote:

    Unfortuneately for anyone who decides to invest in biotechs there is a small (actually it's an all incompassing, pervasive) problem with the entire sector dealing with health. That problem is the FDA. That agency is totally and completely a bribe factory. It has almost zero worth for the country anymore. The entire agency is so large and so vast and such an encroachment on anything in the health industry, the costs associated with doing anything with the health industry are beyond out of control or anything resembling reasonable. The regulations they pass and enforce are more for the benefit of selected individuals and companies because of the amount of personal gain someone in the FDA will receive from those individuals and companies rather than what gain will befall the population of this country as well as the rest of the world. It is a huge government agency rife with corruption and greed on a scale that puts all of politics to shame. It is rather unrealistic to think that Forex Labs or Mylan were able to get quick fixes for their respective problems they had approving their drugs or devices. Those quick fixes do not occur ever unless there is a lot of grease thrown at the right wheel. No amount of public anger or display of such by any group has any effect. This was proven both with DNDN and with Arena's drug candidates. DNDN did so and got approval not due to any real or newly discovered information or due to information being distorted by reviewers but because the wheel was greased thata wanted it. Arna on the other hand has a greasy wheel that is biased against Arna and biased for one of its competitors. This leaves Arna and others with no real chance of surviving. Biotech and the health sector in general are a bad place to do DD. It is meaningless that gives no fair results.

  • Report this Comment On February 17, 2011, at 7:31 AM, TruffelPig wrote:

    FDA has, if anything, approved too many drugs. The problem of most drug companies is that their drugs are simply not good. This in particular includes Biotech start-ups. I observe that for years and one should only buy into companies that at least have a very very successful Phase II trial where the success reads like: "The FDA shifted all patients onto the new drug after n weeks because the FDA felt it was unethical to not supply the drug". There are companies like that out there. And then there are those "normal" companies with drugs that work but are not overwhelming - they will not make it in the extremely competitive drug industry.

Add your comment.

Compare Brokers

Fool Disclosure

DocumentId: 1440239, ~/Articles/ArticleHandler.aspx, 5/27/2012 11:06:23 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 1 day ago Sponsored by:
DOW 12,454.83 -74.92 -0.60%
S&P 500 1,317.82 -2.86 -0.22%
NASD 2,837.53 -1.85 -0.07%

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

5/25/2012 4:00 PM
MYL $21.63 Up +0.35 +1.64%
Mylan Inc. CAPS Rating: ****
OREX $3.33 Down -0.10 -2.92%
Orexigen Therapeut… CAPS Rating: *
XNPT $5.88 Down +0.00 +0.00%
XenoPort, Inc. CAPS Rating: **
MNKD $1.71 Up +0.01 +0.59%
MannKind Corp CAPS Rating: **
ARNA $6.00 Down -0.04 -0.66%
Arena Pharmaceutic… CAPS Rating: **
FRX $33.38 Up +0.05 +0.15%
Forest Laboratorie… CAPS Rating: ****
GTXI $3.07 Up +0.07 +2.33%
GTx, Inc. CAPS Rating: **

Advertisement