The Motley Fool: Is Pfizer Putting the Car-T Before the Horse?

Immuno-onocology is grabbing a large share of the headlines in oncology drug development these days and generating significant buzz for Big Pharma companies including Merck and Bristol-Myers Squibb (NYSE: BMY  ) . While Pfizer (NYSE: PFE  ) has not been seen as a leader in IO drug development, the company does have antibodies in development targeting IO targets like 4-1BB, OX-40, and PD-1. Now the company has added more shots on goal to its IO platform, striking a collaboration agreement with French biotech Cellectis to develop chimeric antigen receptor T-cell therapies, an unproven but high-potential emerging therapeutic class.

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Is Pfizer Putting the Car-T Before the Horse?

The Motley Fool: Cancer Vaccines: Doomed to Fail?

Some ideas sound good in theory but just never manage to work out in real-world experience, and cancer vaccines are on their way to that destination. Following the failures of Vical and Merck KGaA with their respective cancer vaccines, GlaxoSmithKline (NYSE: GSK  ) has announced the second pivotal trial failure for its MAGE-A3 cancer vaccine. Glaxo will continue to try to identify patient sub-populations in both melanoma and lung cancer that could/do respond to a clinically significant degree, but the odds are good that this high-risk/high-reward program is on its last legs.

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Cancer Vaccines: Doomed to Fail?

Investopedia: Little Left To Dendreon But The Hope Trade

Biotech investors are a stubborn and hopeful lot, and many of them will never give up the ship. While confidence and patience are admirable traits up to a point, it sometimes feels like some biotech investors would spin the sun going dark as a positive, as it means no more skin cancer. In the case of Dendreon (Nasdaq:DNDN), it's only the true believers and traders who have any confidence that this company has much of a future. With another very disappointing quarter in the books, I think the only real debate left to have is whether the company can survive.

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Investopedia: Is "Less Bad" As Good As It Gets For Dendreon?

Investors who continue to stick by Dendreon (Nasdaq:DNDN), and its struggling prostate cancer therapy, Provenge, finally got a glimmer of good news after third quarter results. While Wall Street seemed to be pleased that this quarterly result was closer to "on target" (after a string of bad quarterly reports), Dendreon still has a lot of work ahead of it to turn this story around. I know Dendreon still has a loyal core of supporters, but it's difficult to argue for buying this stock when so many other drug companies offer better prospects for long-term gains.

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Seeking Alpha: Is There Room For One More Advanced Melanoma Treatment?

Investors should know in about three to six months if Vical's (VICL) Allovectin has the clinical credentials to get FDA approval for treating advanced melanoma. As another cancer immunotherapy company, Dendreon (DNDN), has ably demonstrated though, approval from the FDA is no guarantee of attaining commercially viable market share or retaining investor enthusiasm. So with all of the attention that Roche (RHHBY.OB) and Bristol-Myers (BMY) have gotten for their melanoma drugs Zelboraf and Yervoy, is there enough opportunity left in advanced melanoma for Vical?

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Is There Room For One More Advanced Melanoma Treatment?

Investopedia: The Week Ahead In Healthcare

As is generally the case for many areas of the stock market, summer marks a pronounced slowdown in newsflow and stock action for the healthcare sector. Although these periods can be frustrating for investors and traders who crave action, the sluggish pace of trading can afford others an opportunity to get caught up on due diligence and begin establishing positions.

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http://stocks.investopedia.com/stock-analysis/2012/The-Week-Ahead-In-Healthcare-DNDN-MDVN-JNJ-XBI0808.aspx

Seeking Alpha: DONE-Dreon?

With yet another disappointment in the bag, maybe the Dendreon (DNDN) bulls can take a break with the "success is just around the corner" stories. Every controversial story has its supporters, but supporting Dendreon has come at a high cost as the price has continued to break down on successive disappointments with the cancer vaccine Provenge.

I hope that with second quarter results in hand and a significant restructuring on the way, the argument will at last shift from whether Provenge is a great drug (it's not) to whether it's a salvageable business (it might be).

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DONE-Dreon?

Seeking Alpha: For Dendreon There's A Little Light, But A Lot Of Tunnel

Volatile biotech Dendreon (DNDN) has been a painful lesson for some investors that there's a big difference between good technology and a good stock. The company deserves, and gets, plenty of credit for developing the first-ever cancer vaccine, but serious questions about efficacy, cost-benefit, competition and intrinsic profitability have lingered from the moment of approval Now that repeated sales disappoints have knocked the stock down significantly over the past year, the stock may at last be priced with more rational expectations in mind.

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For Dendreon There's A Little Light, But A Lot Of Tunnel

Seeking Alpha: Better Days Ahead For GlaxoSmithKline

Britain's GlaxoSmithKline (GSK) is relatively unusual among drug companies today. Not all that much revenue is left vulnerable to patent expirations, the company has a deep pipeline balanced between potential home runs and solid singles and doubles, and only one drug accounts for more than 10% of pharmaceutical sales. While the Street has already rewarded Glaxo with a healthy valuation, there is still a great deal of debate as to the potential of key pipeline candidates and shareholders could yet see upside here if a few key drugs exceed expectations.

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Better Days Ahead For GlaxoSmithKline

Seeking Alpha: Celldex Therapeutics - A Potential Triple With Data On The Way

Investors are not exactly suffering for a lack of choice in oncology-related drug and biotech plays. From giants like Roche (Nasdaq: RHHBY.PK) to pure-plays like Celgene (Nasdaq: CELG) and emerging names like Medivation (Nasdaq: MDVN) or Seattle Genetics (Nasdaq: SGEN), investors could spend all day reading up on companies focused on developing drugs for the multi-billion-dollar oncology market.

Amidst all that interest, Celldex Therapeutics (Nasdaq: CLDX) has to some degree fallen into the cracks and gone unheralded. With a Phase 3 drug for brain cancer, a potential Phase 3 candidate in breast cancer, and a relatively deep pipeline, it would seem that Celldex deserves more than a sub-$100 million enterprise value. Surely there are risks and tribulations ahead, but risk-tolerant investors may want to consider these shares before trial data and partnerships move the stock from these levels.

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Celldex Therapeutics: A Potential Triple With Data On The Way

Seeking Alpha: Accuray Has to Turn Short-Term Pain Into Long-Term Gain

If the first six months are any indication, Accuray's (ARAY) acquisition of TomoTherapy hasn't really pleased anybody. Investors have seen steady erosion in their position value, while clinicians seem unimpressed or even confused about the purported benefits of this tie-up. All of that said, these are early days. Accuray already seems to be effecting a turnaround in the Tomo service operations and given the overall med-tech weakness in 2011, it may well be too soon to declare this merger and this company a failure.

Bad News First – A Tough Market Getting Tougher
Accuray is a small fish in a tough pond. Radiation therapy systems are large, expensive commitments for hospitals to make and that makes it all the more difficult for a small would-be player like Accuray to unseat established giants like Varian (VAR). Moreover, difficult financial markets have not helped hospital capital budgets and reimbursement pressures continue to constrain the radiation market.

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Accuray Has To Turn Short-Term Pain Into Long-Term Gain

Investopedia: The Top Biotech Performers of 2011

This has really been a year of the "haves" versus the "have nots" in biotechnology. Although a few dedicated biotech ETFs have done rather well and there have been some huge individual outperforming stocks, the sector as a whole has not necessarily been all that strong. Still, for those companies that could deliver encouraging data, particularly in the fields of hepatitis and cancer, the market was more than willing to reward the stocks with a higher valuation.


Hepatitis C - The Story of 2011
If any one theme should leap out at biotech investors in 2011, it is the explosion of interest in companies targeting hepatitis C. It is not as though hepatitis C is a new disease, but a host of companies have finally developed compounds that look to offer major improvements in disease management and quality of life for the millions of people with this condition.

Two of the top three performing biotechs with current market capitalizations above $250 million are hepatitis C plays. Pharmasset (Nasdaq:VRUS) has delivered the sort of year that biotech investors dream about for 2011, with the stock up nearly 500% in the last year. The stock was already doing incredibly well on the basis of very strong clinical data in PSI-7977 trials - data that basically showed 100% response in early administration of the drug. This stock found another level, though, when Gilead Sciences (Nasdaq:GILD) stepped up and offered to pay a considerable premium to acquire the company.


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Investopedia: Dendreon's Chinese Water Torture

Sometimes a notable scientific and technological achievement nevertheless fails as a commercially viable product. With another disappointing quarter in the books and little evident momentum, all but the staunchest Dendreon (Nasdaq:DNDN) bulls have to be entertaining some nagging doubts that the cancer vaccine Provenge is ultimately never going to be the blockbuster that they hoped. Certainly it's not yet over for Provenge, but doctor enthusiasm is decidedly muted and there is a growing roster of promising alternatives for prostate cancer.

Q3 Results - As Expected on Sales, But Poor Margins  
With Wall Street, it's always one thing or another. Dendreon actually met its (lowered) revenue guidance, but with an unexpected boost of about $3 million in royalty revenue from Merck (NYSE:MRK) for the hepatitis drug Victrelis. Provenge sales were up about 28% on a gross basis and 30% on a net basis, and up a bit less than 6% sequentially for the last month of the quarter.

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http://stocks.investopedia.com/stock-analysis/2011/Dendreons-Chinese-Water-Torture-DNDN-MRK-PFE-JNJ-SNY-MDVN-EXEL-TRMS1103.aspx

Seeking Alpha: Exelixis' Curious And Risky Strategy

The FDA was not created to fulfill the role of parent or God, but by and large it is nevertheless a good idea to do as the agency suggests. That makes the decision of small oncology biotech Exelixis (EXEL) to proceed with a clinical trial design that the FDA does not agree with a curious one. While Exelixis may indeed succeed in this approach and bring cabozantinib to the market fairly quickly, it is a risky strategy that bring a lot of volatility to these shares.

No SPA
Clinical trial design and FDA policies are admittedly confusing to the uninitiated, so here is the simple version of what is going on with Exelixis. The company had hoped to get the FDA to sign off on a Special Protocol Assessment (SPA) for its Phase 3 study of cabozantinib in very sick advanced prostate cancer patients, but the FDA has elected not to do so.

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Exelixis' Curious And Risky Strategy

Investopedia: Boogeymen That Keep CEOs Awake At Night

Tis the season when kids, and more than a few adults, sacrifice sound sleep in the name of thrills and chills from horror movies. But it's not just Halloween flicks that can lead to sleepless nights. In fact, there are several issues that can keep concerned CEOs from getting all of their beauty sleep. 

Did You Remember to Lock the Doors and Windows?   
There is almost no limit to the number of potentially damaging leaks that spring up in any business. Social media can prove an irresistible opportunity for an executive or employee to offend or embarrass, and disgruntled employees and corporate spies are always looking to hand over your crown jewels to a rival. From harassment and discrimination suits to patent infringement and outright theft, a CEO can never rest easy that what is going on in-house is both proper and likely to stay in-house.

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http://stocks.investopedia.com/stock-analysis/2011/Boogeymen-That-Keep-CEOs-Awake-At-Night-KO-BP-JNJ-DNDN-AAPL-MSFT-RIMM1027.aspx

Seeking Alpha: Bad Management Ails Johnson & Johnson; New Drugs May Offer A Boost

This has been rough stretch for one of the bluest of the blue chip stocks – health care giant Johnson & Johnson (JNJ). A generally rotten U.S. healthcare market has certainly hampered results, but management has fired a few rounds into its own feet with extreme product quality issues in the consumer care business (leading to numerous recalls) and unimpressive capital allocation and R&D decisions in the device business. All of that said, though, today's poor performance may be prologue to a better day for patient investors.

Low-Quality Third Quarter
There were only a very few bright spots in this quarter, though reported results did not deviate much from analyst forecasts. Revenue looked alright at 7%, but organic constant currency growth was under 3%, and JNJ has become dependent on foreign markets for its growth (international growth clocked in at over 8% this quarter).


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Bad Management Ails Johnson & Johnson; New Drugs May Offer A Boost

Investopedia: Seattle Genetics - And Now The Hard Bit

This has been a tough year for biotechs. Compounding a lull in clinical news, the FDA continues to play a "catch me if you can" game of changing standards for approval. On top of that, pharmaceutical companies like Pfizer (NYSE:PFE) and Merck (NYSE:MRK) have shown relatively little interest in making major acquisitions without approved products in hand. In addition, independents like Dendreon (Nasdaq:DNDN) have shown that FDA approval is only one battle in the larger war.



With all of that in mind, then, how excited should investors be over word last last week that the FDA has approved Seattle Genetics' (Nasdaq:SGEN) Adcetris? Clearly this is good news (far better than a rejection, at least), and the FDA was rather lenient with the labeling. Still, investors should be cautious as post-approval can be a challenging time to own biotechnology stocks.

The FDA Roars, but Ultimately Says Yes
The FDA gave a thorough work-over to Seattle Genetics during the company's panel meeting, seeming to make it abundantly clear that the agency had issues with the company's application to sell Adcetris for relapsed/refractory Hodgkin's lymphoma, let alone another indication for anaplastic large cell lymphoma.

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Investopedia: Dendreon's Bull Story In Intensive Care

For Dendreon (Nasdaq:DNDN) bulls, the sky was going to be the limit. Provenge, a high-priced cancer vaccine shown to be effective in serious prostate cancer cases, was going to be a multi-billion dollar blockbuster, and Dendreon was going to ride it on the way to becoming the next Amgen (Nasdaq:AMGN), Biogen Idec (Nasdaq:BIIB), Centocor or Genentech.

And then came the second quarter results.


A Startling Turn of Events
Dendreon skeptics were certainly out there before August 3. The incredible rise in Dendreon's stock price on the back of a very expensive drug, which offered limited additional survival benefit and was the first ever of its kind, had shorts licking their chops. Even the analyst community (which is often quite bullish and positive as a general rule) had it skeptics. Analysts like Lucy Lu at Citigroup and Lee Lalowski at Credit Suisse, for instance, publicly wondered whether expectations were too high given the cost of Provenge and issues of doctor comfort with the therapy.

 

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http://stocks.investopedia.com/stock-analysis/2011/Dendreons-Bull-Story-In-Intensive-Care-DNDN-JNJ-SGEN-HGSI-AMGN-BIIB0809.aspx

Seeking Alpha: Do Dendreon's Problems Matter To Your Biotech Portfolio?

There was no shortage of skeptics about the true market potential of Dendreon's (DNDN) Provenge cancer vaccine, but there were few credible prognosticators who predicted the magnitude of the disappointment in Provenge sales. What has been most interesting about the reaction to this shortfall, though, is how it blitzed the entire biotech sector. While the data gets sketchier the further back one goes, the post-Dendreon reaction Thursday (a bad day for the market overall), may have resulted in the worst single day in the history of the sector.

The question for investors, though, is whether or not the problems at Dendreon really have anything to do with their particular holdings. Though many investors may have sold their biotech stocks after the Dendreon news thinking that it's just too hard to figure out the eventual winners and losers (after all, FDA approval is supposed to the key to the vault), the reality is that nothing at all has really changed for the large majority of companies developing new drugs for diseases like hepatitis C, diabetes, or cancer.

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Do Dendreon's Problems Matter to Your Biotech Portfolio?

Investopedia: Vical Gets Some Validation

Investors in small-cap vaccine biotech Vical (Nasdaq:VICL) received some good news late on Thursday, as the company announced a licensing deal with a major Japanese pharmaceutical company. While this is a solid deal that will bring some more cash into the business, the real question for investors these days is whether Vical's candidate for metastatic melanoma can ultimately obtain FDA approval and then stand with the likes of Bristol-Myers' (NYSE:BMY) Yervoy in the market.

Astellas Steps Up  
While Vical's Allovectin-7 therapy for melanoma gets a lot of the press, Thursday's deal concerns the company's experimental TransVax product for cytomegalovirus (CMV) in transplant patients. Astellas Pharma (OTCBB:ALPMY.PK) has acquired worldwide rights to TransVax and will assume responsibility for its clinical development. In exchange, Vical gets a staggered up-front payment of $35 million in total, future potential milestones, royalty payments (if the drug makes it to market) and the option to co-promote the drug in the United States.

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