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



Puma Biotechnology Inc's Overnight Triple is Just the Beginning

Look at that cat go.

Puma Biotechnology (NYSE: PBYI  ) more than tripled in afterhours after announcing that its phase 3 trial testing neratinib in breast cancer patients was successful.

The trial enrolled patients with early breast tumors having a mutation that causes overexpression of HER2. The typical course of treatment involves surgery and then taking Roche's  (NASDAQOTH: RHHBY  )  Herceptin for a year to ensure that any remaining cancer cells are killed. After that, patients in the trial got either neratinib or placebo for a year.

After two years from the end of the Herceptin treatment, patients that took neratinib had a 33% improvement in disease-free survival compared to placebo. Treatment with neratinib also helped patients avoid ductal carcinoma in situ, a non-invasive early stage of breast cancer. There was a 37% improvement in disease-free survival including ductal carcinoma in situ for patients taking neratinib compared to placebo .

Puma plans to file for approval with the Food and Drug Administration in the first half of 2015.

I'll gladly cover your trial today for lower royalty payments tomorrow
In addition to the positive clinical trial data, Puma announced a revision to its licensing deal with Pfizer (NYSE: PFE  ) , which could give it better economics on neratinib .

When Puma Biotechnology licensed neratinib from Pfizer, the biotech inherited some clinical trials that were still ongoing. The agreement had Puma paying for the trials until a cap was reached, after which Pfizer took over payments.

In an effort to clean up its books, Pfizer asked Puma to pick up the tab on the remaining trials and agreed to adjust the royalty payments Puma owes Pfizer. Puma estimates it'll cost $30 million to finish up the legacy trials, and Pfizer agreed to change the royalty from a sliding scale of 10% to 20% depending on sales to a fixed rate in the low-teens to mid-teens.

We don't know the full details of the original deal, but at the high end of the sliding scare, Puma is saving at least 5%, which at that savings, Puma can make back the $30 million after $600 million in sales. Considering that Roche's Herceptin is a multibillion dollar drug, it certainly looks like Puma got the better end of the deal.

More data to come
The safety database for the trial released today hasn't been validated yet, but in previous trials, about 30% of patients had bad gastrointestinal issues, mainly diarrhea. The side effect probably isn't enough to keep the drug off the market, but it could limit sales if patients can't tolerate the drug.

Puma is testing taking neratinib with Imodium, to prevent the side effect. Since Imodium is available as a generic drug -- over the counter, no less -- doctors should be comfortable prescribing the drug combination if the data supports it.

And the drug could be used in settings other than as a post-surgery adjuvant. Puma is testing neratinib in the neoadjuvant setting prior to surgery either in combination with Herceptin or without it. And has another trial testing neratinib head-to-head against Herceptin in patients with tumors that have metastasized to other parts of the body. Both those trials are finishing up and should read out data this quarter. If they're positive, the potential sales would go up substantially and could start cutting into Roche's sales of Herceptin.

After the post-data jump, Puma Biotechnology has a market cap a little above $5 billion, which doesn't seem out of line given the potential for multibillion dollars in sales. Heck, we might even see Pfizer acquire the company to get the full economics of neratinib.

Leaked: This coming blockbuster will make every biotech jealous
The best biotech investors consistently reap gigantic profits by recognizing true potential earlier and more accurately than anyone else. Let me cut right to the chase. There is a product in development that will revolutionize not just how we treat a common chronic illness, but potentially the entire health industry. Analysts are already licking their chops at the sales potential. In order to outsmart Wall Street and realize multi-bagger returns you will need The Motley Fool's new free report on the dream-team responsible for this game-changing blockbuster. CLICK HERE NOW.

Read/Post Comments (1) | Recommend This Article (9)

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 July 23, 2014, at 2:56 PM, ronniesen wrote:

    Since Puma has already leaped, what other biotechs are pursuing the same class of drugs as neratinib and are now more likely to show efficacy in their trials?

Add your comment.

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: 3039860, ~/Articles/ArticleHandler.aspx, 9/4/2015 2:50:49 PM

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...

Brian Orelli

Dr. Orelli is a Senior Biotech Specialist. He has written about biotech, pharmaceutical, and medical device companies for The Motley Fool since 2007.

Today's Market

updated Moments ago Sponsored by:
DOW 16,039.34 -335.42 -2.05%
S&P 500 1,913.02 -38.11 -1.95%
NASD 4,660.56 -72.94 -1.54%

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

9/4/2015 2:34 PM
PBYI $89.74 Down -0.79 -0.87%
Puma Biotechnology… CAPS Rating: *
PFE $31.18 Down -0.72 -2.24%
Pfizer CAPS Rating: ****
RHHBY $33.06 Down -0.34 -1.02%
Roche Holding Ltd.… CAPS Rating: *****