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

Spectrum Pharmaceuticals is Making Headlines in Early 2011

Spectrum Pharmaceuticals Submits Supplemental New Drug Application (sNDA) For Ready-to-Use Formulation Of FUSILEV(R) In Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology

Article Date: 06 Jan 2011 - 1:00 PST
Spectrum Pharmaceuticals (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission is in support of FUSILEV's use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29 2011. FDA has up to 60 days to formally accept the submission.

"If approved, we believe a RTU formulation of FUSILEV, as the name implies, will be more convenient for the staff and easy to use. RTU formulation requires no reconstitution, and since it will also be of a higher strength than the currently available lyophilized formulation, the healthcare provider's time to administer FUSILEV to colorectal cancer patients will be considerably reduced," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.   Continued

Roche Touts Drug For ESMO

Roche Drug T-DM1 Outdoes Herceptin With Chemotherapy

By Rob Waters - Oct 8, 2010 3:02 PM ET Tweet (1)LinkedIn Share

Roche Holding AG said its two-drug treatment combining an anticancer agent with Herceptin, the company’s $5.27-billion breast cancer drug, was about as effective as, and caused fewer side effects than, Herceptin with chemotherapy.

The results, presented at the European Society for Medical Oncology meeting in Milan, were the first to measure the effectiveness of Roche’s experimental drug called trastuzumab- DM1 as an initial therapy in patients with a particular subtype of breast cancer. T-DM1 is a member of a new class of experimental drugs called antibody-drug conjugates that combine antibodies and anticancer drugs.

Roche Promotes Lung Cancer Therapies, ArQule

Roche drugs point to personalized lung cancer care

(Reuters) - Roche's experimental drug MetMab and its established product Tarceva showed impressive results in lung cancer trials on Saturday, highlighting how treating the disease is becoming much more focused.


Cancer experts meeting Milan said personalized treatment, first seen in breast cancer, was now emerging as a major theme in lung cancer. The shift could reduce the use of less targeted drugs, including Roche's own top-selling Avastin.

Roche and Immunogen Develop Highly Targeted Specific Cancer Drugs

Image via Wikipedia

Articles Today about Roche's partnership with ImmunoGen on TDM-1.  TDM-1 is a highly targeted cancer drug for Breast Cancer.

ImmunoGen-(IMGN)

Roche Holdings (RHHBY)

Drugs

ImmunoGen's TDM-1 Looks Strong at ESMO

BOSTON (TheStreet) -- The "armed antibody" drug TDM-1 under development by Roche and ImmunoGen(IMGN) posted a higher response rate and lower toxicity than the blockbuster breast cancer drug Herceptin, according to results from the first head-to-head study of the two drugs to be presented at a European cancer meeting Monday.


The data from the TDM-1 phase II study in front-line breast cancer patients are early and very preliminary, but also encouraging because they suggest TDM-1 may be the next-generation successor to Herceptin that Roche has been looking for.

ImmunoGen, as Roche's partner on TDM-1, stands to profit as well if the drug is approved and successful.

New Targets, Dual Agonists Increase Possibilities for Treating Diabetes

Image via Wikipedia Fritz French, Chief Executive Officer, Marcadia Biotech, Carmel, Ind.
Drug Discovery & Development - August 16, 2010

Diabetes is a common chronic disease affecting an estimated 285 million adults worldwide. This number will continue to grow as the population ages and becomes more obese—both risk factors for type 2 diabetes. The diabetes treatment market generated over $25 billion in 2009 and the number of patients is continuously rising.

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.

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