Cancer Clinical Trials and Treatments Late Stage Developments

Image via WikipediaFrom FierceBiotech

For the cancer drug research enthusiast, this report might read in places like a special oncology edition of a gun magazine. Indeed, there are plenty of weapons against cancer to read about here. Several of the drugs listed here represent the advancement of relatively new methods of attacking cancer, including "armed antibodies" and cancer-killing viruses.

 In addition, decades of basic research into the molecular drivers of cancer growth are bearing fruit for drug developers. Not only are these companies making progress in clinical trials, they have landed buyout deals and lucrative partnerships. It's also clear that relatively small companies like Aveo Pharmaceuticals and Curis are making inroads along side the big boys like Pfizer and Roche.

There are 10 late-stage drugs listed in this report, but this editor hesitates to call them the "Top 10" only because there are so many variables to consider to rank them in such a way objectively. Yet these 10 drugs have certainly been generating news and, in most cases, lots of interest among investors and the medical community. All of the drugs have reached pivotal trials for at least one type of cancer.
Here's the list in alphabetical order by each drug's most commonly used moniker, whether that is its alphanumeric code name or generic name. As always, please let us know whether you think there are cancer drugs in pivotal trials that you think should have been on this list or ones on this list that shouldn't be.

1. Carfilzomib - multiple myeloma
2. Crizotinib (PF-02341066) - lung cancer
3. GDC-0449 (vismodegib) - basal cell carcinoma
4. OncoVex - advanced melanoma
5. PLX4032 (RG7204) - melanoma
6. Ponatinib - leukemia
7. SGN-35 (brentuximab vedotin) - Hodgkin's lymphoma, anaplastic large cell lymphomas
8. Tivozanib (AV-951) - advanced renal cell carcinoma
9. T-DM1 (Trastuzumab-DM1) - breast cancer
10. XL184 (cabozantinib) -  prostate cancer

Pfizer's To Present Lung Cancer Data July 3-7

Image via CrunchBase Pfizer Inc. will present early and mid-stage data from its lung cancer portfolio, including PF-00299804 (PF-299) an investigational, oral, pan-HER inhibitor;¹ and crizotinib, an investigational, oral, first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK,² at the International Association for the Study of Lung Cancer’s (IASLC) 14^th World Conference on Lung Cancer (WCLC), July 3-7 in Amsterdam, The Netherlands.

“While lung cancer remains a difficult-to-treat disease, we’re learning more about how therapies like crizotinib and PF-299 may be able to specifically target ALK or the HER pathway, respectively, and how this may lead to more rationally selected and personalized therapy,” said Maurizio Voi, MD, Thoracic Tumor Strategy Lead, Pfizer Oncology. “Data being presented show survival outcomes for PF-299 and crizotinib, as well as quality-of-life or patient-reported outcomes after treatment for patients with non small cell lung cancer, which represent important considerations in determining the best treatment option for these patients.”

First Presentation of PF-299 Preliminary Overall Survival Data

Continued....

Big Pharma Earnings Preview: US Drug Makers May Report Lower 3Q Profits

Stocks Mentioned in this article: 
Johnson and Johnson (JNJ)
Eli Lilly and Co.  (LLY)
Merck  (MRK)
Pfizer  (PFE)


EARNINGS PREVIEW: US Drug Makers May Report Lower 3Q Profit

By Nathan Becker, Of DOW JONES NEWSWIRES

TAKING THE PULSE: Analysts expect most major U.S. drug makers to post third- quarter earnings slightly lower than those a year earlier, as sales of several big-name drugs have declined recently after some consumers cut back on health- care costs. Health-care reform and European national health programs imposing price cuts on drugs also offer added pressure for companies. Results in recent quarters have been skewed by big acquisitions, either boosting companies' revenue or sagging their bottom lines because of charges. Several of the industry bigwigs have also been subject to downbeat credit-ratings news because of recent problems with supply and pipeline issues, as well as upcoming patent expiry.

COMPANIES TO WATCH:

Big Gains For Pain Therapy Stocks Today: KG, PTIE, WPI, ENDP

So Pfizer is increasing their portfolio with King Pharmaceuticals, a maker of veterinary meds and pain therapies.  In addition to this news, another company came into the spotlight for pain management therapies.  This company is Pain Therapeutics (PTIE).  Pain Therapeutics is in clinical trials now in collaboration with King Pharmaceuticals so look for Pfizer to kick in some clinical trial expertise with Pain Therapeutics (PTIE).  Additional companies involved in pain therapies is Endo Pharmaceuticals.  I highly suggest buying Endo as a buy right now.  Since June 2010 Endo's stock has risen form 20.22 to its current trading at 34.99.  I suggest a limit order to buy at some discount.  Another Pain therapies stock is Watson Pharmaceuticals, a generic drug maker. 

My opinion on this is that Pain Therapeutics could be slightly overvalued on the hyped news, and although it may seem attractive to buy right now, I suggest waiting for the pullback as it will be years before these clinical trials are actually approved by the FDA.  Also, I am a little cautious placing a buy on Pfizer right now as they will be losing patents on Lipitor next year and other brand name drugs will become available as generics.  I might actually place Pfizer's stock right now on hold or sell, as earnings could be lower than expected.  Just because everyone is doing it does not make it a buy in my opinion. I actually do not necessarily see King Pharmaceuticals as such a hot buy with only 4.85% profit margin and 18M in profits on 380M in revenue.  But given that layoff will presume who knows. 

Stick to your guns and remain a cautious investor and good things will come.  I apply Warren Buffett's principles to the BioPharma Stock World and like purchasing stocks at a discount.  You should be searching for the next Pfizer and not chasing after something that is overly hyped.  Just my opinion.

Stocks mentioned in this article

Pfizer--(PFE)
King Pharmaceuticals --(KG)
Endo Pharmaceuticals --(ENDP)
Pain Therapeutics --(PTIE)  Up 18.56% today on the news
Watson Pharmaceuticals--(WPI)

Savient Pharma Soars on FDA Approval For Gout Treatment



Gout Uric Acid Crystals



From the Wall Street Journal and Reuters: Savient Pharmaceuticals

Wikinvest: (SVNT) Google Finance (SVNT)

Savient shares rally as FDA approves gout drug
Sept 15
Wed Sep 15, 2010 9:15am EDT

The approval is also expected to trigger a renewed interest in the company that has been looking for a strategic deal, and some analysts expect a deal within three to four months.

Pharma's R&D Focus Shifting to Stem Cells

Another good article on Pharmaceutical companies unleashing the power of Stem Cells and increasing their research as a new wave of the future. I will comment further but it was a good read on things to come.

Pharma's R&D Focus Shifting to Stem Cells
Susan Aldridge, Ph.D.

Investors' Interest in These Cells Increases as Scientists Continue to Unleash Their Potential


Stem cells could replace and potentially improve upon at least some in vivo models in drug discovery and development. That was a key message from the “World Stem Cells and Regenerative Medicine Congress” held recently in London.

“There is a major focus now on stem cells in pharma R&D with the major investors showing an interest,” according to Ian Cotgreave, Ph.D., director of molecular toxicology and safety assessment at AstraZeneca. He noted that pharma’s current focus is on cardiomyocytes and hepatocytes, as well as on differentiation protocols and understanding phenotypic progression.

Pfizer Hit With Record fine, but unlikely to end bogus drug marketing

Image by Arturo de Albornoz via Flickr

Have your heard the Lipitor generic debate commercial on the Radio these days. This is what they are talking about here!!! To hell with the fines they are still generating cash. Patent ends next year though. Lot of pressure on Pfizer to perform.
This is a list I have compiled of Lipitor Marketing Reports by Pfizer.

Top 10 Drug Sales Charts and Forecasts 2014 & Generic Drug Superstars

Recently a top 10 drug list was forecast for the year 2014. 5 years down the road. So lets take a look at them. The list was provided by Evaluate Pharma and its a great tool for forecasting stock futures. The list is not perfect. The ones at the top tend to stay there for a reason. Nonetheless, I like the forecast. It's heavy on the Biotech sector and most on the 2014 forecast list are Cancer Therapeutics. Biotech is set to go from 28% of sales today to close to 50% in 2014. Seven of the top 10 drugs in 2014 are forecast to be biotech in origin. This is especially important with pharmaceuticals as biologics are hard to make into generics.

Patent law changes could occur and drug makers are forced to come up with new ways to generate profit. So it's really important to forecast when patents expire and also include generic makers into this list. Teva, Watson(WPI), Mylan(MYL), , K-V, Hi-Tech(HITK), Caraco(CPD), and Sandoz are some of the major generic makers today. Projected sales for the year 2012 are around $30 Billion. My only problem with generic makers, recently has been their quality contol issues. Both Mylan and Caraco have had major setbacks with the FDA this year. If they can control this they should be fine. Often quality control issues and deviations can really hurt companies and must be addressed quickly and ethically.

Major hits to big pharma include the following.

1. Fentanyl--Mylan
Launched: January 2005
2008 sales: $900 million
Branded equivalent: Duragesic, by Janssen (JNJ), 2008 sales of $1.1 billion

2. Amlodipine besylate and benazepril hydrochloride---Teva
Launched: July 2007
2008 sales: $779 million
Branded equivalent: Norvasc, by Pfizer (PFE, Fortune 500), 2008 sales of $2.2 billion

3. Metoprolol succinate---K-V
Launched: May 2008
2008 sales: $675 million
Branded equivalent: Toprol, by AstraZeneca (AZN), 2008 sales $807 million

4. Lamotrigine---Teva
Launched: February 2005
2008 sales: $671 million
Branded equivalent: Lamictal, by GlaxoSmithKline (GSK), 2008 sales $1.6 billion

6. Omeprazole---Watson
Launched: July 2008
2008 sales: $609.8 million
Branded equivalent: Prilosec, by AstraZeneca, 2008 sales $1.1 billion

7. Azithromycin---Teva, & Sandoz
Launched: November 2005
2008 sales: $599 million
Branded equivalent: Zithromax, by Pfizer, 2008 sales $429 million

8. Budeprion---Anchen, IMPAX Laboratories, & Teva (Joint Effort although new lawsuit pending)
Launched: December 2006
2008 sales: $521 million
Branded equivalent: Wellbutrin, by Biovail (BVF), 2008 sales $579 million


With that said of generics, Big Pharma will find ways to address and consolidate their earnings, including buying up generic makers. The next wave of mergers could be in the generic industry. We will have to see. But biologics are where the future lies. Biologics are tough to reproduce and Big Pharma is finding ways to improve their current patents and processes.

One example that I have seen is Talecris' viral inactivated therapeutics of some of thier processes to insure safety of their product and essentially marketability. If Big Pharma can make ways to improve their medication then they can keep making a profit. Look for Talecris' IPO in the near future. Their products are derived from Human Blood Plasma. The various proteins extracted from plasma can be used to treat a variety of diseases including immune deficiencies, genetic emphysema, and hemophilia. This viral inactivation process is key to their marketability and profits. Check out their pipeline at the following link: http://www.talecris.com/talecris-research-development-pipeline.htm


Now its charts charts and more charts. But the charts should help you in your forecasting for your own stocks. I like Roche,Novartis and Pfizer. I also think that Merck will be a huge player in the future with the acquisition of Schering-Plough and Schering's recent acquisition of Organon Biosciences. Schering has added a nice pipeline with their acquisition and now Merck will reap the benefits of this. Do not forget to look at the top 10 R&D chart. It's key to understanding and forecasting. Blockbusters can be made overnight through good R&D.

The Roche-Genentech takeover will be huge as Biologics will become the drugs of the future. Genomic science is key to understanding and creating new drugs and Genentech is king in the Genomic world. The only shocker that could top Roche would be a Merger between Pfizer and Novartis. Or really Novartis and anybody in the top 10. Pigs will fly and OJ will go to jail. Oh wait OJ is already in jail. Lets just wait and see.

NOTE: Click on the Chart If It Is Hard To See.
Here are the top 10 products by sales for 2008


And now here are the top 10 products forecast for 2014


Top Drugs and their estimated expiration date through 2012


Top 15 Companies estimated from 2007 for 2014


Top 10 Oncology Sales from 2007 forecast for 2014

Top 10 Research and Development by Therapeutic Area