Stock investments ranging from Biotech, Pharmaceutical, and Medical Devices in the Healthcare Sector. Covering Clinical Trial recommendations and FDA Approvals.
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.
Image via WikipediaTHOUSAND OAKS, Calif., June 27, 2011 /PRNewswire/ --
Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or delay the spread of cancer to the bone.
The sBLA submission is based on a pivotal Phase 3 Study ('147) evaluating XGEVA versus placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrate that XGEVA significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone.
Bone metastasis-free survival is a composite measure of the development of bone metastases or death.
"The successful outcome of this study provides clinical evidence supporting the view that tumors activate the RANK Ligand pathway to penetrate bone," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "XGEVA has the potential to become a significant advance for patients with castrate-resistant prostate cancer who currently have no treatment options to help prevent the spread of cancer to their bones."
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.
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.
Cytokinetics (CYTK) is a clinical trial drugmaker that has been making some ground-breaking news this past week. They have numerous clinical trials taking place right now ranging from oncology (breast cancer and non-Hodgkin's lymphoma) to high risk heart failure. Their stock has risen in the past week from 3.50 to a high of 5.00 Monday afternoon 092209. Today the stock is trading at 4.67. Currently, they are recruiting patients for 3 Clinical Trials for their pipeline medications. Here is their ClinicalTrials.gov link: Cytokinetics Trials
Cytokinetics recently announced favorable Phase II data from last week for its Heart Failure medication. Here is the presss release from their website.
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.
This was shockingly huge news yesterday as Medarex went from 8 to 16 points in a matter of an instant. Do regular people say points or dollars. Nonetheless. This was front page of CBS MarketWatch last night.
July 22, 2009, 7:54 p.m. EST Bristol-Myers to buy Medarex for $16 a share cash Deal values Medarex at almost double its Wednesday close
This happened last night during aftermarket hours but it happened so fast I don't know how anyone who hadn't purchased it that afternoon could have gotten in on that one. It is exciting to see these kinds of things and you wish you could have some forewarning and there probably was but I just hadn't heard about it. Anyways, MED fizzled out at 15.87 and well they're getting bought for 16 so unless you are buying Bristol Stock, or you wish to, good luck with that one. Anyways, they do have a few good things in the pipeline and that is good for Bristol. There have been so many mergers that I guess I need to get more research on the merger deals. Unfortunately most of that info comes real close to insider trading and you know how Wall St frowns on all of that. Thanks Martha Stewart!!!
So Lets Talk Mergers Why Don't We.
Oh there's the whole Merck-Schering deal. Roche-Genentech, oh that one was bruttle wasn't it. Wyeth and Pfizer Ahhh wasn't that so nice and sweet, for Pfizer maybe but I think it was dumb. Most of these are. Just the big fish feeding on down the food chain and getting rid of hardworking people in the Biopharma industry. All in the name of a buck. Hey I need money too but it gets a little old after working in the industry for awhile, constantly getting bought out and name changes and new corporate bull.
That brings me to my little company's ordeal that I used to work for. Covance to Akzo Nobel to Organon Biosciences to umm what the hell, to Schering Plough To Merck. I mean how many times does one place have to change the sign out front. Seriously can't be a good environment when all that is happening. But many stay with mergers, many leave, many quit, and many are fired or laid off or whatever to generate more profits for the big fish. I also went through this when Bayer sold their plant to some Venture capitalist firm and called it Talecris. But just recently Talecris was getting bought by an Australian firm and that deal was blocked by the SEC earlier this year. So who knows anymore. There is little stability in the biotech industry when it comes to small companies. Eventually no matter how promising they all sell out and spend the rest of their days on the coast of France while the rest of the workers are generally screwed.
Aghhhh, biotech and its turnover can get rough when companies are constantly buying and selling each other out. Its bruttle out there sometimes and you have to decide what you really want out of life and how much do you like the flourescent lighting in the labs. Anyways, got a little off topic here.
Point was, I will work on more merger deals here as they can make or break your portolio sometimes.
This was from BioHealth Investor. Maybe my future rival but I hope maybe we could team up someday as I own invest-biohealth.com. I am still working on that website along with biopharmainvestor.com too.
Bristol picks up multiple potential gems with a Medarex deal (BMY, MEDX, ABT, JNJ, AMGN, WYE) July 23, 2009
Bristol Myers Inc. (NYSE: BMY) plans to spend $2.4 billion to buy partner Medarex Inc. (Nasdaq: MEDX), and it’s getting more than just the cancer monoclonal antibody that developed together.
There are other potential gems in the Medarex pipeline.
The monoclonal antibody ipilimumab is by far the main reason that Bristol pulled the trigger. It is currently in Phase III trials for both metastatic melanoma and hormone-refractory prostate cancer.
Last month, the U.K.’s Independent reported that patients that took a single does of ipilimumab in a trial obliterated the prostate cancer. The paper called the research a “shock breakthrough”. Researchers took the unusual step of releasing case details ahead of the drug trial in which the patients took part, mostly because the recovery of those patients was so surprising. One metastatic patient apparently had a tumor the size of a golf ball. It shrank enough to be surgically removed and the patient made a full recovery.
There could be no bigger potential cancer market for a monoclonal antibody than prostate cancer. It is the largest potential cancer market with 192,280 cases diagnosed each year, according to the National Cancer Institute — more new cases than even breast cancer.
With ipilimumab, Bristol has picked up a candidate that has the potential to become a drug in not only advanced prostate cancer, but also non small-cell lung cancer and melanoma.
The other potential products in the Medarex pipeline that show promise include MDX-1106, a fully human IgG4 antibody in patients with refractory solid tumors including non-small cell lung cancer, colon cancer, melanoma, or prostate cancer. It’s in early stage trials, but so far has shown anti-tumor activity. In the future, it may be something that Bristol tests as a combination therapy along with ipilimumab.
One additional big candidate that Bristol would own if the deal gets shareholder approval would be MDX-1100, which recently went through a Phase II study in rheumatoid arthritis. The drug met its primary endpoint; full data is expected later this year.
While rheumatoid arthritis is a crowded market with market leader Humira from Abbott Laboratories Inc. (NYSE: ABT) Johnson & Johnson’s (NYSE: JNJ) Remicade and Amgen Inc. (NYSE: AMGN) and Wyeth’s (NYSE: WYE) Enbrel, there is promise with any new arthritis drug that shows safety and efficacy. The CDC projects that the number of people age 65 or older who have arthritis or chronic joint symptoms will nearly double from 21.4 million in 2001 to 41.4 million in 2030, as more people are living longer.
Shareholders may balk at the high price Bristol plans to pay for Medarex. But there are likely to be few questions about the strength of the Medarex pipeline, or that Bristol Myers is the natural acquirer given the strength of their partnership. — Mike Tarsala
If you're out there Biohealth investor, I like your site and would like to introduce myself as biopharma investor. Anyways.
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