Recent News Concerning HPV in Men, HPV is now linked to causing Throat Cancer

Throat Cancer Linked to HPV
By LAURA LANDRO

A sharp rise in a type of throat cancer among men is increasingly being linked to HPV, the sexually transmitted human papillomavirus that can cause cervical cancer in women.

A new study from the National Cancer Institute warns that if recent trends continue, the number of HPV-positive oral cancers among men could rise by nearly 30% by 2020. At that rate, it could surpass that of cervical cancers among women, which are expected to decline as a result of better screening.

The study is to be presented this week at the annual American Society of Clinical Oncology meeting.

Between 1988 and 2004, the researchers found, the incidence of HPV-positive oropharynx cancers—those that affect the back of the tongue and tonsil area—increased by 225%. Anil Chaturvedi, a National Cancer Institute investigator who led the research, estimates there were approximately 6,700 cases of HPV-positive oropharynx cancers in 2010, up from 4,000 to 4,500 in 2004, and cases are projected to increase 27% to 8,500 in 2020. 

Find out more about HPV  Currently, Merck markets the vaccine Gardisil

Key US Q3 Earnings Announcements

JNJ 3Q Earnings The pace of big name earnings announcements peaks next week with leaders in most sectors present. If markets can avoid a bout of profit taking from fears about US banking and housing, other major announcements could be significant for fueling or dousing the ongoing rally. Here’s a list of highlights from next week’s earnings calendar.

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•Monday: IBM (IBM), Apple (AAPL), Citigroup (C), Halliburton (HAL)

•Tuesday: Bank of America (BAC), Goldman Sachs (GS), Johnson& Johnson (JNJ), Coca-Cola (KO), Yahoo (YHOO)

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:

Comprehensive List of Drugs Approved During the Summer 2010

I found this nice list of 2010 drug approvals on The Health Wisdom Blog.  This probably is the most informative posting on Drug Approvals from 2010.


Glaxo (GSK), Merck (MRK), Novartis (NVS), Sanofi-Aventis (SNY), and Amgen (AMGN)  were again at the top on these approvals.

New Drugs Approved Summer 2010

New drugs not only offer hope, but possibly a better quality of life, for those awaiting new treatments. However, new drug approvals can also spark controversy. The FDA approved 17 new drugs this summer (June-August 2010). Many offer new promise, and one in particular promises a great deal of future debate.

Comprehensive List of Drug Approvals From 2009

Image by boodoo via Flickr I found a nice list of all the drugs approved in 2009 and their respectable companies.

Those of note were Glaxo SmithKline (GSK) with HPV vaccine, H1N1, seasonal flu vaccine, renal carcinoma, and lymphocyte leukemia.

Novartis (NVS) for H1N1, seasonal flu vaccine, MS, malaria, and schizophrenia.

Schering-Plough, now Merck (MRK) , for schizophrenia. Schering was bought out for their extensive drug pipeline of numerous upcoming drugs.

Sanofi-Aventis (SNY) had an antiarrhythmic drug, along with another flu vaccine for elderly patients. Sanofi is getting snuffed out with the Genzyme takeover bid but the bidding could still continue.

Others included Takeda Pharmaceuticals (TKPHF), Cypress Biosciences/Forest Labs, Allos Therapeutics, Lilly/Daiichi Sankyo, Gloucester Pharmaceuticals, and Theravance.

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.

Top BioPharma Pipeline Plays August 2010

Image via CrunchBase Stocks currently on my Watchlist for top BioPharma plays in the near future.

1. Valeant Pharmaceuticals (NYSE:VRX)

Biotechnology Research Report on Valeant's Potiga

On August 11, 2010, we expect the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee to review the marketing application of Valeant Pharmaceuticals International’s (VRX) Potiga (formerly known as Retigabine), designed for the treatment of partial-onset seizures in epilepsy patients who have become refractory (failing to show response to prior therapy) to anti-epilepsy drugs (AEDs).

Glaxo's cancer vaccine inches toward approval--Merck's Cervarix vs GSK Gardasil.

By MATTHEW PERRONE - AP Business Writer
Published: Fri, Sep. 04, 2009

WASHINGTON -- Federal regulators said Friday that a GlaxoSmithKline vaccine prevents the leading cause of cervical cancer in women, bringing the company one step closer to competing with Merck's blockbuster Gardasil, which has controlled the U.S. market for three years. GlaxoSmithKline(GSK) Google Finance

In documents posted online, the Food and Drug Administration said Cervarix - Glaxo's vaccine against human papilloma virus or HPV - successfully blocked the two leading strains of the virus nearly 93 percent of the time.

But even as the British drugmaker moves closer to competing in the U.S., Merck is poised to begin marketing Gardasil to boys and men. In a separate review, the FDA said that vaccine prevented genital warts in males 90 percent of the time.

The agency will ask a panel of vaccine experts next week to weigh in on both vaccines. The FDA is not required to follow the group's advice, though it usually does.

While Merck has suggested the approval for boys could double the potential market for Gardasil, Leerink Swann analyst Seamus Fernandez said the benefit likely will be minimal.

Genital warts caused by HPV usually clear up by themselves, and the cancers caused by the virus are extremely rare in men.

"If it's not preventing something serious like cervical cancer and there are questions about safety, I think parents' acceptance of the vaccine in young boys might be less urgent than for their girls," said Fernandez.

Glaxo has won a number of government contracts for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data about the vaccine. Earlier studies of Cervarix showed a higher number of muscular and neurological problems among patients who used the vaccine compared with an alternate treatment.

The FDA said Friday that outside experts have now determined Cervarix did not cause those problems.

"The conclusion in the case of each of these efforts was that the data are not sufficient to establish a link," the agency said in its review.

FDA reviewers also noted a slightly higher rate of miscarriages in women taking Cervarix, but said "the data do not establish a causal relationship."

Glaxo wants its vaccine approved for girls and women ages 10 to 25. The FDA is expected to make a decision on the vaccine later this year, but analysts say London-based Glaxo may still have trouble making inroads into the U.S. market.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck's vaccine also defends against two other HPV types that cause 90 percent of genital warts, something Cervarix does not target.

The most common side effects with both vaccines were pain and swelling at the injection site.

Gardasil became an early success story for Merck after its 2006 launch, achieving sales that are rare for a vaccine. The company has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year.

But sales have been slowing amid questions about the longevity of the vaccine's effect and its price tag of nearly $400. In the most recent quarter, Gardasil sales fell to $268 million, down 18 percent from the prior year period.

A government-funded study last year found that the HPV vaccine is cost-effective for young teens, but not for women in their 20s. And labeling for the vaccine notes that the "duration of protection of Gardasil has not been established." Company trials have only tracked immunity out to five years after receiving the three-injection regimen.

Whitehouse, N.J.-based Merck will make the case on Sept. 9 for approving the vaccine for boys and men ages 9 to 26.

Related articles by Zemanta

• Gardasil Vaccine Associated With 28 Deaths In 2008 According To Judicial Watch Report (drug-injury.com)
• HPV vaccine Cervarix approved by WHO (cbc.ca)
• Human papillomavirus (HPV) vaccination (alanhealthupdate.blogspot.com)
• Study Suggests HPV Vaccine Is Safe, but Doctors Still Wary (time.com)

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