Pfizer's Other Big News

Pfizer (PFE) palbociclib may soon join drugs from Novartis (NVS) and AstraZeneca (AZN) in treating breast cancer.

May 19, 2014 at 1:05PM

Pfizer (NYSE:PFE) has confirmed plans to file its promising breast cancer drug palbociclib for FDA approval in the third quarter. If approved, Pfizer could enjoy significant revenue, given it will be dosed alongside Novartis' (NYSE:NVS) Femara, a breast cancer treatment for post-menopausal women, with nearly $400 million in annual sales.

However, the market for palbociclib could eventually be much bigger. Studies are also being conducted evaluating palbociclib alongside AstraZeneca's (NYSE:AZN) Faslodex, which generates roughly $700 million in annual sales, and instead of Roche's Xeloda, which had sales of more than $1.5 billion last year.

PFE Chart

PFE data by YCharts

Palbociclib put up impressive mid-stage trial results in patients with ER+ and HER2- advanced breast cancer. That subset makes up roughly 60% of advanced breast cancer patients.

Patients with metastatic breast cancer receiving palbociclib and Femara didn't see their disease progress for 20.2 months, versus 10.2 months for Femara alone. Overall survival, while not statistically signfiicant, also improved to 37.5 months from 33.3 months for those taking only Femara.

Since palbociclib has FDA breakthrough status, those results appear good enough that Pfizer thinks it has a good chance of winning FDA approval without phase 3 trial data in hand.

Competing for share
Increasingly, drug developers are conducting studies that would complement, rather than replace, current treatment. That offers the potential to enhance survival and significantly expand the market for breast cancer treatment, as longer-living patients progress from therapy to therapy.

Pfizer isn't alone in believing that there's a substantial opportunity to develop adjunct treatments. Novartis is also developing a drug for ER+, HER2 negative patients. Novartis LEE0011, which targets the CDK 4/6 enzyme, a key to cell proliferatin, entered phase 3 breast cancer trials in December

Additionally, Eli Lilly (NYSE:LLY) is also working on a CDK4/6 drug, LY2835219. Lilly has ongoing trials studying its use in mantle cell lymphoma, lung, breast, and skin cancer. In April, Lilly reported that 47 heavily pre-treated metastatic breast cancer patients participated in a phase 1 trial of LY2835219, and that the disease progressed in just 11 patients at 24 weeks.

Building an oncology franchise
If approved, palbociclib would join two Pfizer drugs already successfully competing for oncology market share. Xalkori, a drug approved as a treatment for ALK positive non-small-cell lung cancer generated sales of $88 million in the first quarter, up 69% from a year ago. Inlyta, a kidney cancer drug, also had sales of $88 million last quarter, up 46% from last year. Pfizer may also see its oncology presence jump markedly if it succeeds in winning over AstraZeneca shareholders.

AstraZeneca has rebuffed Pfizer's overtures so far, notably shutting down an offer earlier today. But that hasn't halted Pfizer's interest, which is driven, in part, by AstraZeneca's promising oncology drugs. Drugs in AstraZeneca's pipeline target ovarian cancer and non-small-cell lung cancer, and oncology drugs already on the market produced more than $700 million in revenue for AstraZeneca in the first quarter.

Fool-worthy final thoughts
The World Health Organization reports that there were 1.7 million cases of breast cancer diagnosed in 2012 globally, and that breast cancer incidence has climbed 20% since 2008. That suggests the market for breast cancer treatment may--unfortunately--continue to grow. According to the National Cancer Institute, spending on breast cancer could total as much as $25 billion in 2020, up from $16 billion in 2010.

The significant unmet need and patient population growth suggest that palbociclib could eventually generate significant sales for Pfizer. Currently, industry analysts predict palbociclib's annual sales could range between $1 billion and $6 billion a year.

Top dividend stocks for the next decade
The smartest investors know that dividend stocks simply crush their non-dividend paying counterparts over the long term. That's beyond dispute. They also know that a well-constructed dividend portfolio creates wealth steadily, while still allowing you to sleep like a baby. Knowing how valuable such a portfolio might be, our top analysts put together a report on a group of high-yielding stocks that should be in any income investor's portfolio. To see our free report on these stocks, just click here now.

Todd Campbell has no position in any stocks mentioned. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may or may not have positions in the companies mentioned. Todd owns Gundalow Advisors, LLC. Gundalow's clients do not have positions in the companies mentioned.The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not 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.

4 in 5 Americans Are Ignoring Buffett's Warning

Don't be one of them.

Jun 12, 2015 at 5:01PM

Admitting fear is difficult.

So you can imagine how shocked I was to find out Warren Buffett recently told a select number of investors about the cutting-edge technology that's keeping him awake at night.

This past May, The Motley Fool sent 8 of its best stock analysts to Omaha, Nebraska to attend the Berkshire Hathaway annual shareholder meeting. CEO Warren Buffett and Vice Chairman Charlie Munger fielded questions for nearly 6 hours.
The catch was: Attendees weren't allowed to record any of it. No audio. No video. 

Our team of analysts wrote down every single word Buffett and Munger uttered. Over 16,000 words. But only two words stood out to me as I read the detailed transcript of the event: "Real threat."

That's how Buffett responded when asked about this emerging market that is already expected to be worth more than $2 trillion in the U.S. alone. Google has already put some of its best engineers behind the technology powering this trend. 

The amazing thing is, while Buffett may be nervous, the rest of us can invest in this new industry BEFORE the old money realizes what hit them.

KPMG advises we're "on the cusp of revolutionary change" coming much "sooner than you think."

Even one legendary MIT professor had to recant his position that the technology was "beyond the capability of computer science." (He recently confessed to The Wall Street Journal that he's now a believer and amazed "how quickly this technology caught on.")

Yet according to one J.D. Power and Associates survey, only 1 in 5 Americans are even interested in this technology, much less ready to invest in it. Needless to say, you haven't missed your window of opportunity. 

Think about how many amazing technologies you've watched soar to new heights while you kick yourself thinking, "I knew about that technology before everyone was talking about it, but I just sat on my hands." 

Don't let that happen again. This time, it should be your family telling you, "I can't believe you knew about and invested in that technology so early on."

That's why I hope you take just a few minutes to access the exclusive research our team of analysts has put together on this industry and the one stock positioned to capitalize on this major shift.

Click here to learn about this incredible technology before Buffett stops being scared and starts buying!

David Hanson owns shares of Berkshire Hathaway and American Express. The Motley Fool recommends and owns shares of Berkshire Hathaway, Google, and Coca-Cola.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.

©1995-2014 The Motley Fool. All rights reserved. | Privacy/Legal Information