It's that time of year again...Valentine's Day! In honor of that, Seeking Alpha put together some nice data on 6 companies that work in the cardiac device market and in the website's opinion are making the right decisions. The basic take home message: Abbott and Edwards Life Sciences look like the strongest buys of the six.
Check it out for yourself!
Cadence Pharmaceuticals will have to wait just a big longer before it's IV acetaminophen his the market. The NDA was sent back to the company after "deficiencies" were noted by the FDA at the company's drug manufacturing facility. I think this is just a minor bump in the road, and that the drug itself represents an unmet need in the market for treating not just pain, but also fever in patients who can't take pills. Look for Cadence to resubmit as soon as the problems are ironed out and an approval to follow thereafter....
Here's the Cadence press release, courtesy of Fierce Biotech
Roche has announced some very promising results of late stage trials for its new Type 2 Diabetes drug taspoglutide, which could translate into a potential blockbuster if the drug makes it to market. This drug would be the first weekly GLP-1 analogue treatment available and would be a new treatment option for diabetics who could potentially control blood sugar levels with a once weekly treatment of this new medication. Watch this one closely as new effective diabetic treatments always generate a lot of press...
Business Week reports on the Roche's results at this link
Finally Cephalon reported last week that it had a substantial increase in 4th quarter profits...pretty impressive considering the state of the bioech market. You can chalk that up to increased sales for almost every marketed drug and with Nuvigil jumping fully on board in 2010, this trend may continue.
Read more at this AP article via Yahoo! Finance
Have a heart, it's V-Day!
14 February 2010 |
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E
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Time's Up!
10 February 2010 |
Posted by
E
Everyone's talking about the upcoming patent cliff next year...well the downward slope towards the edge starts this year:
See this nifty little article by Fierce Pharma on the patent expirations for 2010
While that patent cliff is enough to turn investors white, Elan reported that it expects to have an operating profit in 2010. This would be the first time in over 10 years that the company has turned a profit, but it says a lot that 2010 would be year for that amidst all the financial uncertainty out there. What's the reason for this turnaround? Tysabri seems to be the culprit, and you can expect sales to rise as this drug shrugs off PML concerns in favor of its effectiveness....
Reuters reports here on the profit projection
Finally while many companies like GSK and Sanofi are cutting R&D budgets, Crucell said it is expanding operations in R&D to keep pace with rivals and expand its robust pipeline. 2009 was a big year by itself for the European biotech, but you can expect 2010 to be even stronger with this increased investment in research. This company looks like a good play considering the state of the industry around it...
Reuters discusses Crucell here
Tysabri Back in the News
08 February 2010 |
Posted by
E
The FDA is hitting Biogen's Tysabri with another warning for its label as new data shows that patients receiving infusions of the powerful MS drug are more likely to develop the potentially lethal brain infection PML as they receive more infusions. The information suggests that the number of infusions received is directly proportional to the risk of contracting PML, but it's hard to say whether or not this will affect use of the drug. It's a known fact that many people think Tysabri is the most effective MS treatment and patients are willing to take the 1 in 1000 risk of developing PML in exchange for a better quality of life. Biogen's stock may suffer initially, but not for long as the overall outlook of Tysabri looks good.
Read the FDA advisory here
Next health care reform may be stalling, but there are some rumblings in the Senate of an interesting plan to help promote biotechs to continue developing expensive ground breaking products. A senator from New Jersey is proposing a biotech tax credit that would help cut R&D costs by up to 50% if a project is deemed to meet a yet unmet medical need or has the potential to cut healthcare costs. This is a very interesting proposition, and not surprisingly it has been greeted warmly by the biotech industry. During a time where biotechs are struggling for cash and investors have tight wallets, such legislation could be a boon for the industry. Keep an eye out as this moves along through the Senate....
Read more at NJ.com
Optimer has created a new antibiotic for the common bacteria C.diff that seems to be at least as effective as a commonly used treatment for the potentially lethal infection. What does this mean for Optimer? Buyout talks of course. Because the drug has shown promise in another pivotal trial, suitors could come out of the woodwork to get a piece of this drug that has potential to really get a solid foothold in the antibiotic market.
Xconomy offers insight here
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The Day After...
03 February 2010 |
Posted by
E
Ironwood's IPO did not turn out exactly as planned when the company did not quite reach the price per share amount for which it was hoping. This could could put the brakes on any pending IPOs in the biotech world as they wait and see what happens to Ironwood. Best care scenario is that investors were just tentative and did not jump in on stock at the first call, but will come around in a few weeks. Worst case scenario is that investors are still scarred by the financial happenings over the past year and won't budge. Either way, Ironwood will have to wait and see what goes down.
Read more here in Xconomy
Next, the Canadian company Labopharm scored a FDA approval today for its once daily version of trazodone. The approval is good for the manufacturer, but I wonder just how big the market is going to be for this drug. Trazodone is not a new medication, and in the anti-depressant world it faces stiff competition from other, newer meds. Nevertheless, somebody will use it as sales are projected in the $30-$40 million range.
Read more here fromhttp://www.reuters.com/article/idUSN0313639620100203
It's not secret that a battle is brewing over legislation on how to protect the intellectual property of biologics. Well, Teva is moving forward with a biosimilar for a populat Amgen drug, Neupogen, and it hopes to get FDA approval to produce and market the product. How will Teva go about this with no real biosimilar regulations in place? The answer is that Teva is treating its drug as a entirely new product with a new BLA...interesting idea. If the FDA looks favorably on this new biologic, expect Teva to pull in some serious cash.
Fierce Biotech reports on the situation here
Last, but not least: Seeking Alpha published a nice blog on the differences between Eli Lilly's new R&D program and GSK's program. Both have their advantages, but I'll let you decide which one you like better!
Seeking Alpha Blog
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another IPO...
01 February 2010 |
Posted by
E
After some time of speculation, Ironwood announced that it will go forward with a big time IPO this week that will hopefully finance the company's push towards finalizing development and commercialization of its lead drug linaclotide. Analysts seem to think the drug is a can't miss prospect, but with the mercurial nature of the stock market and investors lately, the IPO is not a sure thing. Along with Otsuka's planned IPO, I like this one...not a huge risk because the company has already started to prove its worth in R&D.
Read more here
And as many of you know, GSK announced today that it is going to cut about 4000 jobs in research and development, right on the heels of Astra Zeneca's statement that they were cutting 8000 workers. Similar to AZ, GSK will be doing the majority of the job cuts in the US and Europe while it works to expand its presence in developing markets. However GSK will still have a focus on developing new products in house...it seems just not with the same fervor as before. This clearly isn't good news for those GSK employees in the US, but is a clear indication of the changing markets of pharma and biotech.
The Times reports here
And finally for some lighter reading:
Here's a nice piece by Fierce Biotech on the top 10 deals in 2009 and one from BNet on upcoming FDA decisions and happenings in the biotech world
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pharma stock
