The Big Red Biotech Blog

A White House White Paper On Drug Approvals - Helpful?

It's Election time.  Time for another terrific "white paper" from a Blue Ribbon panel of experts outlining several recommendations as to how the federal Government (e.g. FDA and others) can speed drug approvals.

A White House White Paper On Drug Approvals // Pharmalot.

Like most such august panels, their recommendations in a robust 110 page report is long on advice and short on specifics. Some of these include:

• More funding for National Center for Advancing Translational Sciences (Francis should be happy)
• Create "broad-based" partnership to improve clinical trials and provide the FDA with more input on developing a pathway for "innovative medicines"
• Have the FDA do more to grant accelerated approval for drugs meeting the standard for addressing an "unmet need" for a serious life threatening condition
• Create a new pathwy for initial approval of drugs aimed at specific subgroups, dubbed Special Medical Use approvals
• Have the FDA run pilot studies to look at "adaptive approval mechanisms".  Congress should pony up $40 million annually to pay for this
• FDA should enact a "range of reforms', including the use of pre-market review leaders to oversee drug applications from investigative stages to final approval
• USDHHS should commission a study of economic incentives to promote innovation, i.e stimulate companies to chase drugs like treatments for Alzheimer's or antibiotics

So all we have to do is follow the advice -- blah blah blah blah -- and figure out how to put it into concrete actions. 

White paper + Blue Ribbon panel = Red Herring.  Will it get the Green light?

Posted by Bruce Lehr Sep 29th 2012.

 

Get Your Mind Right with Big Red

 

What We've Got Here is Failure to Communicate

Myriad is Baaaaaaaaaaaaaack!

I would ask you to read this very brief post in the Patent Doc blog. No doubt we can look forward to a thorough discussion and analysis of the points raised by the ACLU and PubPat in their petition for certiorari to the Supreme Court.  For now, just check out the questions raised in the brief:

1. Are human gene patentable?
2. Did the court of appeals err in upholding a method claim by Myriad that is irreconciable with this Court's ruling in Mayo v. Prometheus?
3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune v. Genentech, that petitioner's who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally and directly threatened with an infringement action?

Oh Boy! I can hardly wait for Kevin's discussion on this one.

Posted by Bruce Lehr Sep 25th 2012.

Times Tough or Rebounding for Biotechs?

I guess that depends if you read the Pharmalot version or the Fierce Biotech version of the recent study published by BDO.

Sooooooooo. Either we focus on Small biotech's decreased R&D spending, job cutting and dampening revenues, or on Big biotech's (> $50 M revenues) increase in R&D spending, hiring rebounds and rising revenues. 

Apparently, 90% of small biotechs reported losses in 2011 by an average of 12%, and decreased workforces by 3%. The industry as a whole though grew to $76 M from $62 M, and large biotech increased staff by 16%.

Twenty-four percent of Big guys raised equity capital while 64% of small biotech had to go that route as they had little cash from operations to rely upon. At years end, biotechs, on average, held 2.63 years worth of R&D spending in cash or liqud assets. And, a model employing virtual biotechs is gaining momentum.

Posted by Bruce Lehr Sep 25th 2012.

And The Outlook For Pharma Is… Improving?

Let me translate that headline for you.  It's based on Moody's Investor Services revising its outlook for the global pharma industry as "stable".  Since 2007, Moody's had given the industry a negative credit rating.

And The Outlook For Pharma Is… Improving? // Pharmalot.

Why the change?  Moody's believes the Industry is stable as it has hit rock bottom and will reach an earnings trough (caused by its latest patent cliff) in late 2012.  Then there's no where to go but up from here.  So after the industry has lost Lipitor and Plavix to generic competition -- what else can match that rapid free fall? 

Nothing. To paraphrase the Doors, "Pharma's been down so god damned long, that it looks like up to we."  Maybe its not time to crack out the bubbly though.

Posted by Bruce Lehr Sep 25th 2012

Newsflash! You Can Lose Money as VC Biotech Investor

Apparently, it has been recently discovered that investing as a VC player in biotech ventures can result in a LOSS OF CAPITAL.  Yes.  Let me repeat.  If you invest in a biotech VC fund (or company), you could lose it ALL. 

Shikhar Ghosh, a senior lecturer at Harvard Business school, made this startling discovery. In studying over 2000 companies that received venture funding between 2004 and 2010, he found that at least 75% did not return investor's capital.

Ok now.  What might this mean to you as an investor? Hmmm.  Maybe you shouldn't invest money in a VC deal if you can't afford to lose the capital. There I said it.  Now how is this different than your understanding about this type of investment say --- 5 minutes ago? See the WSJ story for the details.

Posted by Bruce Lehr Sep 23rd 2012.  

Timmerman Recommends These Biotech Tweeters

Luke Timmerman put together his definitive list of biotech movers and shakers that you should follow on Twitter (or at least a group of interesting Tweeters who offer insight in their areas of expertise). Luke should know, so check this esteemed "A list" out.

See Xconomy.

Posted by Bruce Lehr Sep 24th 2012.

 

10 Pharmas Form Non-profit to TransCelerate Their Profits

Or is it to just stem their R&D losses which have continued to climb? 

Regardless, 10 Big Pharma companies announced they formed a new non-profit organization in August to speed up the R&D of new drugs and save some money. These include the big names like:

• Abbott
• AstraZeneca
• Boehringer Ingelheim
• Bristol-Myers Squibb
• Eli Lilly
• GlaxoSmithKline
• Johnson & Johnson
• Pfizer
• Roche
• Sanofi

10 Pharmas Unite To Combat R&D Woes // Pharmalot.

The 10 companies state the new organization's goal is to boost the quality of clinical trials and speed up the typically slow pace of drug development.  New paradigms they believe will lead to substantial cost savings. Specifically, the group has agreed to focus on five initial projects:

• Development of a shared user interface for investigator site portals
• Mutual recognition of study site qualification and training
• Development of risk-based site monitoring and standards
• Development of clinical data standards
• Establishment of a comparator drug supply model

These pre-competitive type projects are expected to improve efficiency and reduce costs leading to better returns on R&D investments.

The FDA is on board with the idea.  Said Janet Woodcock, FDA's chief of drug regulation, "We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development. This collaborative approach, utilizing the collective experience and resources of 10 leading drug companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients." 

Here. here. See Fierce Biotech and PharmaTech Talk for more.

Posted by Bruce Lehr Sep 24th 2012.

Uh-oh! Indian Court Says Your Price is Too High to Novartis

Forget the resolution of the patent dispute.  Who cares if Novartis is able to get its patent for a new form of Gleevec (Glivec in India)?  The Indian Supreme Court today asked Novartis lawyers to tell their client to lower its prices.

One justice called the existing pricing of Glivec "shocking" and complained drug prices are already too high in India. 

Indian Court To Novartis: Lower Gleevec Price // Pharmalot.

Novartis says that it has one of the most active and largest donation programs for the poor amongst drug companies.  Their attorney said the company did not want to "profiteer without a conscience". 

The Supreme Court said their donation plan was a "complicated scheme for idenitifying those who are entitled to given free meds and those who can afford to pay 80 days of the annual cost of Glivec."  The Court said Novartis should earn goodwill by lowering its price.

Egads!  That doesn't bode well for Novartis' case does it?  What's more? It is another indication that big pharma won't necessarily be able to go to emerging markets to drive revenue gains. India, in particular, is being very aggressive in sending the message that high prices for cancer meds aren't going to be tolerated -- whether that translates as a direct request to lower price or a grant of a compulsory license to a local generic manufacturer (see Bayer Nexavar). 

Posted by Bruce Lehr Sep 12th 2012

Oh, Woe! Pharmerging Markets Won't Save Big Pharma Revenue

This just in from Forbes via PharmaGossip.  Big pharma has been counting on emerging markets to help it fill in revenue gaps from big selling products that have been steadily coming off patent.  Guess what?

The $47 Billion Hole in Pharma's Near-Term Future - Forbes .

According to the Forbes piece, citing Ernst & Young, big pharma's revenue estimates have been a tad overstated -- by a mere $47 B.  It seems emerging markets are competitive too and local competitors can sell generics at 50% or less the price.  Not to mention local governments are looking to save money and actually support sales fo generics.  Who'd thunk?

Oh well. Stuff happens.

Posted by Bruce Lehr Sep 4th 2012.