Seeking Alpha: Is Roche At Risk Of Losing Its Way?

By just about any reasonable standard, Roche (OTCQX:RHHBY) is an exceptional pharmaceutical and diagnostics company. Through internal efforts and acquisitions large and small (particularly Genentech), Roche has become one of the largest players in oncology, with particular strength in biologics. That strength has in turn led to double-digit free cash flow growth over the past decade and solid recent share price performance.

As a shareholder, though, I'm starting to get a little concerned by some of the changes at and around Roche. I might be making mountains out of mole hills, but I also remember what a mentor told me when I joined the buy-side in my mid-20's, "Your job now is to be a professional worrier; it's the things you don't worry about and check out that will bite you in the ". With that in mind, while I see a lot of positives at Roche that merit ongoing ownership, the direction of the firm does leave me more willing to consider selling the shares.

Continue reading here:
Is Roche At Risk Of Losing Its Way?

Seeking Alpha: With An Iffy Non-Oncology Pipeline, Roche Pays Up For InterMune

Roche (OTCQX:RHHBY) does a lot of things well. It is one of the largest players in oncology and markets three of the top ten best-selling drugs in the world. It also has a strong diagnostics business and a deep immuno-oncology platform. What Roche has not done so well, though, is develop new drugs outside of oncology, with notable recent failures in cardiology, diabetes, and CNS disease. Given those failures, and perhaps seeing an opportunity to leverage existing efforts in pulmonary/respiratory disease, Roche has stepped up with an expensive bid for InterMune (NASDAQ:ITMN).

Read more here:
With An Iffy Non-Oncology Pipeline, Roche Pays Up For InterMune

Seeking Alpha: Roche May Be Hoping That Anadys Is Cheap Insurance

There is no question that hepatitis C treatments are garnering a great deal of attention from investors in biotech and pharmaceuticals these days. Investors seemingly can't wait to hear the latest clinical data from Pharmasset (VRUS) or the latest prescription data on Vertex's (VRTX) Incivek. So leave it to Roche (RHHBY.PK) then to draw everybody's attention back to a small hepatitis C drug developer that has been largely forgotten by many investors.

A Surprising Deal
Analysts and investors have been waiting for quite a while to see Anadys Pharmaceuticals (ANDS) either find a partner for setrobuvir and ANA773 or find a buyer for the entire company. As often seems to be case, few had Roche on the list of most likely partners, but it is Roche that has stepped up to buy the entire company.

Please read the full story at the link below:
Roche May Be Hoping That Anadys Is Cheap Insurance

InterMune - The Black Knight of Biotech?

Fans of Monty Python no doubt recall the exchange between King Arthur and the Black Knight early in the movie, where the Black Knight refused to back down and concede defeat no matter what damage King Arthur managed to inflict. While the FDA inflicted far more than a flesh wound on InterMune's (Nasdaq:ITMN) stock price when the agency went against its own panel's recommendation and rejected the application to market pirfenidone (Esbriet) for idiopathic pulmonary fibrosis (IBF), the company may yet win this battle. 

Europe Comes To The Defense ... Maybe
InterMune's shares soared last week on the news that the Committee for Medicinal Products for Human Use (known by the very unfortunate acronym of CHMP) recommended approval of Esbriet within the European Union. Similar to the how the U.S. system works, the CHMP serves as a buffer between the company's application and final approval, and provides recommendations to the European Medicines Agency (like panels do for the FDA).

Like in the U.S., though, a favorable opinion/recommendation does not guarantee final approval, nor the possibility of restrictive labeling. Nevertheless, it is notable that this process moved along quite quickly - CHMP could have come back to the company with a further list of questions/issues, but instead decided it had enough information to issue its recommendation. At this point, then, a final decision will come within 60 calendar days. (For more, see Measuring The Medicine Makers.)


Please follow the link for the full piece:
http://stocks.investopedia.com/stock-analysis/2010/InterMune--The-Black-Knight-Of-Biotech-ITMN-PFE-GSK-GILD-GENZ-RHHBY1220.aspx

Bristol-Myers Pays A Premium For Its Partner

Bristol-Myers Squibb (NYSE:BMY) may have the unfortunate distinction of being among the most highly-concentrated pharmaceutical companies in the U.S. (For a quick refresher on this, check out Top-Heavy Pharmaceuticals), but management is certainly looking to do something about that. After Monday's close, Bristol-Myers announced a friendly buyout of its partner ZymoGenetics (Nasdaq:ZGEN) in a deal that gives shareholders of this small biotech $9.75 a share in cash, or an 84% premium to the prior closing price.

What is Bristol-Myers Buying?
ZymoGenetics actually has quite a lot going on, but Bristol-Myers is almost certainly buying the company in order to have 100% ownership of its PEG-Interferon lambda drug. This promising hepatitis C therapy is in Phase 2 testing, but could be a blockbuster ($1 billion or more in sales) in less than five years' time. Moreover, this drug could fit in nicely with Bristol-Myers' other clinical HCV candidates, and lead to a potential combination therapy. Just as Gilead (Nasdaq:GILD) has significantly changed the HIV treatment landscape with its combination therapies, Bristol-Myers could possibly do something similar in hepatitis C. 


To read the full piece, please go to:
http://stocks.investopedia.com/stock-analysis/2010/Bristol-Myers-Pays-A-Premium-For-Its-Partner-BMY-ZGEN-GILD-MRK-ITMN0910.aspx

A Big Deal For Biotechs - ASCO

One of the major biotech events of the year is fast approaching. The annual meeting of the American Society of Clinical Oncology (ASCO) will take place in Chicago from June 4 to June 8, 2010. This event is like Woodstock for biotechnology - if Woodstock were clean, air-conditioned and had plenty of restrooms. If you invest in biotechs or pharmaceuticals that want to play in the huge and well-reimbursed world of oncology, this is one of the major events of the year. 

Ahead of the meeting, ASCO releases a list of abstracts that scientists and companies will present. In some cases, these abstracts give away at least most of the story (efficacy, safety, etc.), while other abstracts are embargoed until the meeting itself. In any case, investors can still look forward to follow-up data (abstracts are submitted well ahead of the meeting) and oftentimes the amount of attention garnered by a presentation reflects overall interest in the compound.

Here we present some of the companies presenting abstracts at ASCO. 

For the full article, please continue on: 
http://stocks.investopedia.com/stock-analysis/2010/A-Big-Deal-For-Biotechs---ASCO-AMGN-PFE-CLDX-PCYC-ITMN0526.aspx


 

Will Adaptive Design Change the BioPharma World?

I wrote the following for Investopedia, and it was published today. 
I'm actually pretty interested in seeing what, if any, reaction I get to this. I really do believe this is one of the bigger ideas that could emerge in biopharma over the next few years, but it is an idea that you scarcely hear about outside of occasional panels and forums at industry conferences and meetings. 

I hope you find it interesting. 

Every so often a good idea comes out way ahead of its time. Fuel cells actually predate the gasoline engine, the Apple (Nasdaq:AAPL) Newton is the almost-forgotten iPad/iPhone predecessor, and Nikola Tesla sketched out plans for concepts like wireless energy transfer and airplanes that could take off vertically in the 1920s.  

Adaptive clinical trial design may ultimately belong on this list as well. Although the idea of changing pharmaceutical drug trials in response to data generated within the trial has been around for at least 10 years, the idea may finally be on the cusp of being realized. Should this concept become more commonplace, it could be a major step forward for biotechnology and pharmaceutical companies.

Read the full column at: 
http://stocks.investopedia.com/stock-analysis/2010/Will-Adaptive-Design-Change-The-BioPharma-World-AMGN-GILD-ITMN-EXEL-LLY-PFE-PRXL0513.aspx  

FDA Makes InterMune Sick (ITMN, GSK, AZN, GILD, VRTX, ACHN, VRUS)

I originally wrote this piece right after InterMune announced its FDA setback, but there was a bit of a logjam in the editing process. In any case, there are still some valuable points here. 

Failure is an inherent risk in the boom-and-bust world of biotech, and InterMune (Nasdaq: ITMN) shareholders saw that risk play out on Wednesday morning. The FDA effectively rejected the company's application for marketing approval of Esbriet (pirfenidone) in the treatment of idiopathic pulmonary fibrosis. 

Clearly the damage has already been done, but what InterMune investors must decide now is whether there is enough promise in the drug and the company to hang on in the hopes of a rebound. 

For the rest of the article, please click on the following link:
http://stocks.investopedia.com/stock-analysis/2010/FDA-Makes-InterMune-Sick-ITMN-GSK-AZN-GILD-VRTX-ACHN-VRUS0510.aspx