Stock investments ranging from Biotech, Pharmaceutical, and Medical Devices in the Healthcare Sector. Covering Clinical Trial recommendations and FDA Approvals.
News from the new Aids Vaccine. The study involved 16000 volunteers from Thailand shows promise with a 30% effective rate in preventing HIV. Sanofi-Aventis(SNY) and VaxGen(VXGN) were the stocks involved. Sanofi is approaching a 1 year high trading at 36.76 while VaxGen is experiencing a strong sell-off closing at 0.68 after reaching a high of 0.999 in OTC trading.
In 1995, Drs. Francis and Nowinski, a Seattle-based retrovirologist and entrepreneur, led the spin-off of the Genentech HIV vaccine effort, forming VaxGen to concentrate on further development of AIDSVAX.
The VaxGen team then developed the bivalent form of AIDSVAX to increase the vaccine's potential to protect against additional strains of HIV. Genentech, VaxGen's manufacturing and development partner for the vaccine, has manufactured large quantities of the bivalent AIDSVAX for the upcoming Phase III clinical trials.
"We are proud of the role Genentech played in the development of this vaccine. We congratulate VaxGen's team and support them as they continue this vital work," said William D. Young, Chief Operating Officer of Genentech and a member of VaxGen's board of directors.
VaxGen, based in South San Francisco, Calif., is a biotechnology company committed to making an HIV vaccine for worldwide use. Genentech, one of the world's leading pharmaceutical biotechnology companies, is also based in South San Francisco and is VaxGen's largest shareholder
This vaccine needs more devolopment, mostly with efficacy, but there are other stocks in search for a HIV vaccine.
Other companies searching for the HIV vaccine:
PRO542 Progenics Pharmaceuticals (PGNX) HIV
PRO 140 Progenics Pharmaceuticals (PGNX) HIV
HVTN 502 Merck (MRK)
HVTN 503 Merck (MRK)
Top Newswire Coverage from the HIV Vaccine Clinical Discovery.
Nearly 30 years after its discovery, AIDS still has no known cure. Researchers almost gave up hope of ever finding a vaccine. However, hopes were rekindled when a Phase III clinical trial involving more than 16,000 adult volunteers in Thailand demonstrated that an experimental HIV vaccine was safe and modestly effective, preventing HIV infection in 31.2 percent of cases.
That's a step in the right direction, but those are modest results; for any other disease, preventing infection in fewer than a third of the tested cases wouldn't arouse much hype or hope. But with the HIV virus, after 25 years of attempts and failures, some fairly recent, it's no wonder everybody is excited for this potential breakthrough.
The experimental vaccine is a combination of ALVAC, from Sanofi Pasteur, the vaccine division of Sanofi-Aventis (SNY), and AIDSVAX, originally developed by VaxGen (VXGN) and now held by the nonprofit Global Solutions for Infectious Diseases. Neither vaccine worked individually in previous trials, but the combination, called RV144, showed modest results. (Neither vaccine causes HIV, separately or together.) The trial was a collaborative effort among the U.S. Army, the Thai Ministry of Public Health, the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, Sanofi Pasteur, and GSID.
16,402 volunteers in Thailand participated in the trial, which opened in 2003. Half received the vaccine, and half placebos; all were counseled on HIV prevention. Of the 8,198 people injected with the placebo, 74 contracted HIV; of the 8,197 who got the vaccine, 51 got the virus -- a difference the collaborative effort calls statistically significant. More details will be given at the AIDS Vaccine Conference in Paris in October.
Researchers seemed surprised. "These results show that development of a safe and effective preventive HIV vaccine is possible," said Col. Nelson Michael, director of the U.S. Military HIV Research Program, in a statement. "While these results are very encouraging, we recognize that further study is required to build upon these findings."
The U.S. HIV/AIDS epidemic began in 1981, according to the NIAID; 565,927 people in the U.S. have died of AIDS. Globally, 33 million have lived with HIV/AIDS, and 2 million died of related illnesses in 2007.
But many challenges lie ahead. Different strains of HIV exist throughout the world; those common in Thailand unusual in the U.S., Africa, and elsewhere. Scientists will need to determine how long the protection lasts, whether booster shots will be needed, and so on. And some in the scientific community are skeptical; Jon Cohen at Science Insider explains that many AIDS vaccine researchers had predicted that the study would fail. They are now "dumbfounded -- and circumspect": concerned that the results came by chance.
This is the third big vaccine trial since 1983, when HIV was identified as the cause of AIDS, the AP reports. As recently as 2007, Merck & Co. (MRK) halted a study of its experimental vaccine after seeing that it actually increased the risk of infection. Before that, in 2003, AIDSVAX also failed in trials.
Vaccine makers might try to license the two-vaccine combo in Thailand. The U.S. Food and Drug Administration will need more studies before the vaccine can be considered for U.S. licensing, and its effectiveness will most likely need to be higher before it gets approval.
While Sanofi shares are down today, VXGN's are up over 10 percent.
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
This article was in NYT Sunday. Biologics Copyright Law coming under fire with Obama's administration. So whats the take???
Personally, I do enjoy having a job in the Biotech industry and would like to keep one in the future. With that being said, I do wish we had some type of healthcare coverage out there for people without jobs, those who can't afford it, and the elderly. But at what costs???
Already pharmaceutical companies are contemplating moving our jobs overseas and the fallout of the NC textile industry shows how quickly jobs that were once thriving in North Carolina and other parts of the country have gone elsewhere. If Obama's plan is inacted is there any assurance that our jobs won't go overseas. I see little congressional interest for this. I am worried with the State already in a deficit and close to bankrupcy how many more industry fallouts can we have in NC, tobacco, textiles, and future Biopharma industry. Or is Biopharma here to stay? We will have to see.
But how long should these companies retain copyright protection? 7-14 years is the current standard but with billions of dollars set in Research and Development of these medications is it fair to those researchers to shorten that.
Im torn because we have to fix the healthcare industry but at what price. I wish people who were sick had better options but at the same time we need jobs. This is a tough dilemna that ultimately congress will pass some law that absolutely does nothing to help the situation. It still comes down to lobbyist in Washington and those paying for the votes in Congress and the Senate. We all know that and the pharmaceutical industry is no different when it comes to special interest groups with the power and those who needs the medicine pretty much helpless in the cause.
Already the elderly are going to Canada and outside the US to get there drugs. But are generics really as safe as the real thing. I don't know but I have a feeling that there are some side effects and potency issues that are taking place that we don't know about. Lets face it people make mistakes. Biopharma is no different. But you really do see a difference in price of the generics. Why are the medicines people need so expensive and why can't the govenrnment do something that isn't going to cost us jobs that we ultimately lose someday.
So thats my take. Here's a great article on the whole news.
Also check out this good blog on generics at: http://genericdrugs.blogs.ie/
Setting a price on life Biotech drugs facing pressure from generics. Costly Drugs Known as Biologics Prompt Exclusivity Debate
A bitter congressional fight over the cost of super-expensive biotechnology drugs has come down to a single, hotly debated number: How many years should makers of those drugs be exempt from generic competition?
But what few people in Washington seem to recognize — or publicly acknowledge, anyway — is this magic number may ultimately not matter as much as the most vitriolic debaters insist.
At issue are such drugs as Cambridge-based Biogen Idec’s Avonex, for multiple sclerosis, which costs more than $20,000 a year; Genentech’s Avastin for cancer, which costs more than $50,000; and several Genzyme drugs for rare diseases that can cost $200,000 a year or more. Typically, such drugs are given by injection or intravenous infusions.
These drugs, known as biologics, are complex proteins made in vats of living cells. Because they are hard to copy exactly, they have not been subject to the generic competition that eventually knocks down the price of drugs such as Lipitor and Prozac. Pills such as Lipitor, known in the industry as small-molecule drugs, are made from simple chemicals whose recipes are easy to reproduce.
But now Congress, as a cost-cutting piece of the overall health care effort, is preparing legislation to enable the Food and Drug Administration to approve copycat versions of biologic drugs. That could save consumers, insurers and the government billions of dollars in the coming years.
The trick is to allow competition without undermining the financial incentives the pharmaceutical industry needs to undertake the risky job of developing the next drugs for cancer and other diseases. That is where the magic year number comes in. Trade groups for the big pharmaceutical and biotechnology companies say that to recoup their investments, they need an exclusivity period free of generic competition that would last 12 to 14 years from the time the FDA approves a drug for sale.
But consumer groups, insurers, employers and generic drug companies say anything more than five years — the exclusivity period now given to small-molecule drugs such as Lipitor — would eviscerate any potential savings from the new competition.
So far, the biotechnology industry appears to be winning. The Senate’s health committee, for example, has agreed to 12 years of exclusivity. In the House, a bill that provides at least 12 years of exclusivity has many more co-sponsors than one that would provide five years. The Obama administration has said seven years would be a “generous compromise.”
But in reality, neither the threat to innovation nor the potential savings from generic competition are as great as claimed.
For starters, whatever the exclusivity period, biologic drugs would also continue to be protected from copycats by patents. And in many cases, the patent protection would last longer than the exclusivity period, making the congressionally mandated exclusivity a moot point.
San Francisco-based Genentech’s Avastin, for instance, has patent protection until 2019 — 15 years after the drug’s 2004 approval by the FDA. The company’s breast cancer drug, Herceptin, has patents that extend 21 years from its 1998 approval.
Where the exclusivity period might matter most would be in the cases of drugs whose patents were nearing expiration by the time the developer succeeded in winning FDA approval. But that seldom happens.
“I can’t think of a biotech drug that’s been on the market that doesn’t have more than 7 to 14 years of patent protection,” said Eric Schmidt, biotechnology analyst at Cowen and Co.
Still, it is probably not true, as the other side claims, that the legislation would be virtually worthless if it granted a long exclusivity period. There are plenty of blockbuster biologics, like Amgen’s Epogen and Neupogen, that have been on the market more than 12 or 14 years and thus would get no extra protection from even an exclusivity period in the longer of the ranges now being discussed.
As for cost savings, the Congressional Budget Office has estimated that generic biologics might save the government only about $10 billion in the next 10 years. That is a relative drop in the bucket when it comes to paying for health care reform, which is expected to cost about $1 trillion over 10 years.
One reason for limited savings in the first decade is that it would probably take a few years for copycat biologics to reach the market after the law was enacted. Another factor is that biologics accounted for only 16 percent — about $46 billion — of total prescription drug spending last year, according to the market researchers IMS Health. And pharmaceuticals represent only about 10 percent of the nation’s overall health care spending.
The real savings might come more than 10 years out, as new biologic drugs appear and as biologics represent an increasingly greater part of overall spending on drugs. That ramp-up is already evident: Express Scripts, a pharmacy benefits manager, says its spending on biologics grew 10 percent last year, compared with 2.5 percent for other drugs.
But anyone expecting the price wars that ensue when generic pills come on the market — when prices often drop by more than 60 percent — might be disappointed by the way competition plays out.
Because it is harder and costlier to make biologic drugs than it is to copy pills, fewer generic competitors are likely to enter the fray. Many experts, including the Federal Trade Commission, expect price declines of more like 10 percent to 40 percent in biologics.
Even that would be a savings for the overall health care system. But for many individuals, a $35,000 copycat version of a $50,000 cancer drug would still be unaffordable.
Another factor is that generic biologics are likely to undergo greater regulatory scrutiny than generic pills require.
It is difficult or impossible to verify that a copy of a biologic is exactly the same as the original — which is why the drugs are often called “biosimilars” rather than generic biologics. Because even small changes might affect the drug’s safety or activity, it is likely that makers of biosimilars will have to conduct at least some clinical trials to win FDA approval of their drugs, which makers of generica small-molecule pills are not required to do. Such trials can cost a lot of money.
And because biosimilars will not be exact replicas of the drugs they mimic, the generic makers will probably need sales forces to persuade doctors to prescribe their drugs and pharmacists to dispense them. All of that costs money, too.
In Europe, which has already approved biosimilar versions of three biologic drugs, the market impact has been relatively small so far. In Germany, where biosimilars have made the biggest advances, the products have captured about 30 percent of the market for anemia drugs and prices have dropped only about 20 percent to 30 percent.
The likelihood that biosimilar competition might be somewhat muted means that sales and profits of the originals not necessarily dry up.
Kevin W. Sharer, Amgen’s chief executive, told investors in May that he hoped biotechnology companies would retain 30 percent to 50 percent of the cash flow from their drugs even after biosimilars reached the market. That, he said, “is a dramatically different outcome than we see in the small-molecule companies.” That is also one reason the Federal Trade Commission, in a report last month, said that no exclusivity period at all was needed. At the very least, because biologic drugs do not require appreciably more time or money to bring to market than small-molecule drugs, it is reasonable to ask why they should deserve longer protection from competition than the five years that small-molecule drugs now receive.
The reason, biotechnology executives say, has to do with patents, which may offer less protection for biologics than for small-molecule drugs. Because a biosimilar is not an exact knock-off of the original, a competitor might persuasively claim that it is not infringing the patents on the original drug.
So far biologic patents have held up well in court cases. Amgen, for example, has won legal victories preventing two separate competitors from introducing anemia drugs that were slightly different from its own Epogen.
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