http://thehcc.

tv

November 15th – November 21st

In the general news, the General Motors IPO, the largest ever, took place raising
more than $20 B. In politics, another White House member left: David Axelrod. Rep.
Charlie Rangel was censured and Rep. Pelosi was re-elected as the leader of the
Democrats. Overseas, the Irish insolvency problem and need for a British bailout was in
the news along with the inane buzz of Prince William’s engagement.
In healthcare business, AMGN plans to acquire Actelion (ATLN). BSX plans to
acquire private Sadra Medical for its TAVI, and BAX plans to buy private Archemix.
On the data front, Merck posted good data on anecetrapib: a drug that raises
HDL. A similar drug by Pfizer was abandoned due to safety. HeartWare (HTWR)
posted good pivotal BTT data on its LVAD to compete with THOR. The JNJ/Bayer
ROCKET-AF data on Xarelto (rivaroxaban) met the primary endpoint, but failed to
meet superiority over warfarin placing it at a disadvantage in marketing to Pradaxa.
Exelixis (EXEL) shares jumped on XL184 cancer data. PFE drug axitinib met its
endpoint in renal cell cancer. Lastly, the PFE/BMY anticoagulation drug trial of
apixaban for ACS was stopped due to excessive bleeding.
From the FDA and other HHS, the FDA Benlysta (by HGSI) AdCom was rough
going with many questions about the BLISS-52 trial and the relevance of non-US
patients, low efficacy in blacks, and safety. At the end of the day, the panel voted to
approve. Over at CMS, the MedCAC panel for DNDN’s Provenge resulted in what
seemed to be adequate support for reimbursement by
Medicare. In drug approvals, AMGN’s denosumab was Picture of the Week
approved for the skeletal metastasis of cancer indication, or “Ohhh, my lucky charms, in the form of bad
SRE, and branded now as Xgeva (yet another Pharma name debt, could destroy the EU”

destined for multiple pronunciations like Chantix). Another

AdCom approved MRK’s HPV vaccine Gardasil for anal cancer.
In new approvals, MELA stock jumped 100% on approval
of its melanoma detection device. Eisai’s breast CA drug Halaven
(eribulin) was approved. Shire’s Vyvanse was approved for
ADHD. Lastly, Xanodyne agreed to withdraw Darvon
(propoxyphene) from the U.S. market after trials required by
REMS reinforced safety concerns.

1
The FDA’s new standards for diabetes drug safety
November 19, 2010

The FDA issued proposed guidelines for new Type 2 diabetes drug clinical trials adding
cardiovascular safety endpoints in addition to glycemic control efficacy outcome
measures. Since then, the Avandia saga and other surprise rejections of new diabetes
drugs have pharmaceutical companies reevaluating whether it makes financial sense to
develop new diabetes drugs. In Part 3, The Healthcare
Channel interviewed the decision maker for these
issues: CDER Director Janet Woodcock.

In the final of the four parts, Dr. Woodcock discusses

her views on how the FDA should address the growing
problem of advisory committee intimidation by
investors and activists.

Login to view the story, or register here

The unique new form of bleeding caused by centrifugal LVADs

November 14, 2010

Partial data will be presented today at the AHA meeting on the HeartWare centrifugal
LVAD. The company opted to not publish the full safety details. Not well appreciated is
a unique form of coagulopathy caused by these centrifugal pumps that lead to GI
bleeding and stroke.

The two leading experts on these devices, Bud Frazier of Texas and Mark Slaughter of
Louisville, discuss this problem. More important, the problem can be managed with
proper training.

Login to view the video or register here.

2
PFO closure and stroke
NMT Medical reported today at the AHA meeting disappointing results from the StarFlex
Closure 1 study. The device that closes PFO's in the heart did not reduce the rate of
embolic stroke. The study has been plagued with problems for years and it should not be
concluded that closing the PFO does not prevent stroke. St Jude recently acquired AGA
medical which has a similar device. In addition to preventing stroke, closing the PFO
might also reduce migraine headaches.

In Part 3 of the Weekly Summary show, William O’Neill, Executive Dean for Clinical
Affairs and cardiologist, University of Miami Health System, leads the discussion about
the FDA approval for Medtronic to begin clinical trials of its CoreValve TAVI. The AGA
medical products to close PFO and left atrial appendage are also overviewed.

Login to view the story, or register here

Exclusive: Director of CDER, Janet Woodcock, on new drug safety

strategies
November 17, 2010

The Healthcare Channel interviewed Dr. Janet Woodcock, long-time Director of CDER,
the FDA center responsible for approving drugs and monitoring for safety. In Part 1, she
reviews her responsibilities as Director over a period of time spanning both Republican
and Democratic administrations. The recent ACA healthcare reform law and the 2007
FDAAA have radically changed how the FDA is handling safety of drugs.

Login to view the story, or register here

3
Exclusive: The FDA’s concern over using non-North American clinical
data to approve drugs
November 17, 2010

The WSJ today highlights the deliberations yesterday by advisory committee doctors
over the relevance and reliability of the BLISS-52 trial data that was derived from
overseas, non-North American demographics. This trial was one of the pivotal trials
submitted to obtain approval for the lupus drug Benlysta (made by Human Genome
Sciences, ticker HGSI). Assuming those data are of high integrity, the relevance of data
from patients different from the U.S., and countries with delivery of care different from
the U.S., is controversial.

The HCC has previously interviewed the Regional Inspector for the OIG, Joyce
Greenleaf, who authored a report on this growing problem of outsourcing clinical trials.
In addition to the Benlysta BLISS-52 trial, other high-profile trials that gathered most of
the data from overseas include JUPITER for Crestor (AstraZeneca), PLATO for
ticagrelor (also AstraZeneca), and the CRYSTAL for Erbitux (Eli Lilly), and many
others. In all of those examples, the data supporting efficacy in the North American
patients were minimal to non-existent.

The ticagrelor PLATO trial, still pending a decision by the FDA, was not statistically
significant in American or Canadians. The CRYSTAL trial, conducted by Merck KGa
after the first American trial failed sending Martha Stewart and Sam Waksman to jail for
insider trading, was the only major trial to show efficacy for Erbitux. Subsequent Phase 3
trials for Erbitux have failed. For Benlysta to treat lupus, the first American trial called
BLISS-76 lost significance with time so the company essentially repeated the trial
overseas as BLISS-52.

The Healthcare Channel interviewed the senior policymaker for drug decisions at the
FDA, Dr. Janet Woodcock, Director of CDER. She discusses these matters and what the
FDA is planning to do about them.

Login to view the story, or register here

4
Will ROCKET-AF be Bayer/JNJ’s ENHANCE scandal?
November 12, 2010

For the full story, Login and view the Investor Flash text section, or Register here

Update: More problems from Puerto Rico

J&J, Glaxo Actions in Puerto Rico Spark FDA Oversight Inquiry in Congress

By Catherine Larkin - Nov 8, 2010 4:04 PM ET Mon Nov 08 21:04:11 GMT 2010

Johnson & Johnson’s and GlaxoSmithKline Plc’s drug-safety missteps sparked a Congressional
investigation of U.S. regulators overseeing manufacturing in Puerto Rico.

Representatives Darrell Issa and Edolphus Towns sent a letter today to Food and Drug
Administration Commissioner Margaret Hamburg, asking for inspection records and warning
letters from the past decade, “to better understand whether FDA Puerto Rico is fulfilling its
regulatory responsibility.” Issa, a California Republican, and Towns, a New York Democrat, lead
the House Committee on Oversight and Government Reform.

The lawmakers said they have questions on actions by FDA employees in Puerto Rico during
J&J’s “phantom recall” of Motrin in 2008, when contractors tried to retrieve quantities of 88,000
packages of faulty drugs sent to stores without notifying the FDA. On Oct. 26, Glaxo agreed to
pay $750 million to settle a government false-claims lawsuit over the sale of defective drugs
made at a plant in Puerto Rico.

“It appears that FDA’s Puerto Rico district office may be having difficulty exercising oversight on
the numerous pharmaceutical manufacturing facilities on the island,” Issa and Towns wrote. “We
question whether the Puerto Rico district office is adequately staffed to fulfill the agency’s
mission of securing the nation’s pharmaceutical supply.”

Drug-manufacturing facilities in Puerto Rico failed inspections 64 percent of the time in 446
visits from regulators from 1999 to 2010, according to data compiled by Bloomberg. The
facilities have failed at more than a 70 percent rate since 2007, including a 76 percent rate in 29
inspections this year.

J&J, of New Brunswick, New Jersey, is the world’s largest maker of health-care products.
London-based Glaxo is the U.K.’s biggest drugmaker. Dick Thompson, a spokesman for the
FDA, didn’t immediately respond to a message seeking comment.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

5
About The Healthcare Channel

The Healthcare Channel (The HCC) is the first digital video channel dedicated to
professionals in healthcare such as policymakers in Washington, journalists, healthcare
executives, scientists, doctors, and institutional investors.

The HCC is a video portal for all forms of business and research information including
interviews, coverage of medical meetings, panels of experts, etc.

Our viewers already have news services such as Bloomberg and Reuters, so we focus on
forward-looking analysis. We try to find underappreciated topics that will matter the most
to clinical medicine and the healthcare industry. Our content is brief and high-yield.

The HCC is not a boutique research shop, broker dealer, or banking outfit. Our business
model is subscription based content, advertising, and syndication. Our content can be
viewed on NPR, Reuters, The Wall Street Journal, ABC News and other national
platforms.

Our unique position allows us more freedom from bias than the current sources of
investing news and analysis. We have no investment banking or sell side research biases.
We have no hidden stock theses or investment agendas. We may have simultaneously
playing different stories that are both positive and negative to the same company.

Our video style is intentionally not flashy, in keeping with the “white paper” topics
discussed. The web site is design to be as clean and simple as possible.

CONTACTS

Twitter @thehcc
General: info@thehcc.tv
Subscription sales: sales@thehcc.tv
Ad Sales: sales@thehcc.tv
http://thehcc.tv/
Copyrights and Limitations on Use

All content in this Site, including site layout, design, images, programs, text and other information
(collectively, the "Content") is the property of CortexTV, LLC and The Healthcare Channel and its
affiliated companies or licensors and is protected by copyright and other intellectual property laws.

You may not copy, display, distribute, modify, publish, reproduce, store, transmit, create derivative works
from, or sell or license all or any part of the Content, products or services obtained from this Site in any
medium to anyone, except as otherwise expressly permitted under applicable law or as described in these
Terms and Conditions or relevant license or subscriber agreement.

6
You may print or download Content from the Site for your own personal, non-commercial use, provided
that you keep intact all copyright and other proprietary notices. You may not engage in systematic retrieval
of Content from the Site to create or compile, directly or indirectly, a collection, compilation, database or
directory without prior written permission from CortexTV, LLC.

You agree that you will not use any robots, spiders, crawlers or other automated downloading programs or
devices to: (i) continuously and automatically search or index any Content, unless authorized by us; (ii)
harvest personal information from the Site for purposes of sending unsolicited or unauthorized material; or
(iii) cause disruption to the working of the Site. If this Site contains robot exclusion files or robot exclusion
headers, you agree to honor them. Any questions about whether a particular use is authorized and any
requests for permission to publish, reproduce, distribute, display or make derivative works from any
Content should be directed to CORTEXTV,. For research, please email CORTEXTV, LLC..

You may not use the services on the Site to publish or distribute any information (including software or
other content) which is illegal, which violates or infringes upon the rights of any other person, which is
abusive, hateful, profane, pornographic, threatening or vulgar, which contains errors, viruses or other
harmful components, or which is otherwise actionable at law. CORTEXTV, LLC may at any time exercise
editorial control over the content of any information or material that is submitted or distributed through its
facilities and/or services.

You may not, without the approval of CORTEXTV, LLC, use the Site to publish or distribute any
advertising, promotional material, or solicitation to other users of the Site to use any goods or services. For
example (but without limitation), you may not use the Site to conduct any business, to solicit the
performance of any activity that is prohibited by law, or to solicit other users to become subscribers of
other information services. Similarly, you may not use the Site to download and redistribute public
information or shareware for personal gain or use the facilities and/or services to distribute multiple copies
of public domain information or shareware.

Trademarks

CORTEXTV, LLC ; "The healthcare Channel"; "Investor Flash" are registered trademarks of CORTEXTV,
LLC. All other trademarks appearing on this Site are the property of their respective owners.

Links to Other Sites

The Site may contain hyperlinks to other sites or resources that are provided solely for your convenience.
CORTEXTV, LLC is not responsible for the availability of external sites or resources linked to the Site, and
does not endorse and is not responsible or liable for any content, advertising, products or other materials on
or available from such sites or resources. Transactions that occur between you and any third party are
strictly between you and the third party and are not the responsibility of CORTEXTV, LLC. Because
CORTEXTV, LLC is not responsible for the availability or accuracy of these outside resources or their
contents, you should review the terms and conditions and privacy policies of these linked sites, as their
policies may differ from ours.

Disclaimer of Warranties and Liability

Neither CORTEXTV, LLC, its affiliates, nor any third-party content providers or licensors makes any
warranty whatsoever, including without limitation, that the operation of the Site will be uninterrupted or
error-free; that defects will be corrected; that this Site, including the server that makes it available, is free of
viruses or other harmful components; as to the results that may be obtained from use of the Content or other
materials on the Site; or as to the accuracy, completeness, reliability, availability, suitability, quality, non-
infringement or operation of any Content, product or service provided on or accessible from the Site.

7
THIS SITE AND ALL CONTENT, PRODUCTS AND SERVICES INCLUDED IN OR ACCESSIBLE
FROM THIS SITE ARE PROVIDED "AS IS" AND WITHOUT WARRANTIES OR
REPRESENTATIONS OF ANY KIND (EXPRESS, IMPLIED AND STATUTORY, INCLUDING BUT
NOT LIMITED TO THE WARRANTIES OF TITLE AND NONINFRINGEMENT AND THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE), ALL OF
WHICH CORTEXTV, LLC DISCLAIMS TO THE FULLEST EXTENT PERMITTED BY LAW. YOUR
USE OF THE SITE IS AT YOUR SOLE RISK.

To the extent permissible under applicable laws, no responsibility is assumed for any injury and/or damage
to persons, animals or property as a matter of products liability, negligence or otherwise, or from any use or
operation of any ideas, instructions, methods, products or procedures contained in the Site. If the Content
contained on this site contains medical or health sciences information, it is intended for professional use
within the medical field. No suggested test or procedure should be carried out unless, in the reader's
judgment, its risk is justified. Because of rapid advances in the medical sciences, we recommend that the
independent verification of diagnoses and drug dosages should be made. Discussions, views, and
recommendations as to medical procedures, products, choice of drugs, and drug dosages are the
responsibility of the authors.

NEITHER CORTEXTV, LLC NOR ANY OF ITS AFFILIATES OR LICENSORS SHALL BE LIABLE
TO YOU OR ANYONE ELSE FOR ANY LOSS OR INJURY, CAUSED IN WHOLE OR PART BY ITS
NEGLIGENCE OR CONTINGENCIES BEYOND ITS CONTROL IN PROCURING, COMPILING,
INTERPRETING, REPORTING OR DELIVERING INFORMATION THROUGH THE SITE. IN NO
EVENT WILL CORTEXTV, LLC, ITS AFFILIATES OR LICENSORS BE LIABLE TO YOU OR
ANYONE ELSE FOR ANY DECISION MADE OR ACTION TAKEN BY YOU IN RELIANCE ON
SUCH INFORMATION. CORTEXTV, LLC AND ITS AFFILIATES AND LICENSORS SHALL NOT BE
LIABLE TO YOU OR ANYONE ELSE FOR ANY DAMAGES (INCLUDING, WITHOUT
LIMITATION, CONSEQUENTIAL, SPECIAL, INCIDENTAL, INDIRECT, OR SIMILAR DAMAGES)
EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

CORTEXTV, LLC neither endorses nor takes responsibility for any products, goods or services offered by
outside vendors through our services or advertised on our system.

Systems Reliability

CORTEXTV, LLC aims to keep the Site available twenty-four (24) hours a day, seven (7) days a week and
to maintain saved information. However, due to technical failures, acts of God or routine maintenance,
availability may be limited and/or information may be lost. CORTEXTV, LLC shall not be liable for lost
information or non-availability of the services.

Indemnification

You hereby agree to indemnify, defend and hold CORTEXTV, LLC, its directors, officers, shareholders,
parents, subsidiaries, affiliates, agents and licensors harmless from and against any and all liability, losses,
damages and costs, including, without limitation, reasonable attorneys' fees, arising from your use of the
Site or Content.

Export Control

You acknowledge that U.S. export control laws and regulations apply to this site, including the Export
Administration Regulations of the U.S. Department of Commerce, which prohibit the export or re-export of
products and technology to certain countries and persons. You agree to comply strictly with all U.S. export
laws, regulations and orders, and assume sole responsibility for obtaining any required licenses to export or
re-export products or technology.

8
Governing Law and Venue

These terms and conditions shall be governed by and construed in accordance with the laws of the State of
New York, without regard to its conflicts of law principles. You hereby submit to and agree that the sole
jurisdiction and venue for any actions that may arise under or in relation to the subject matter hereof shall
be the courts located in the State of New York.

CortexTV, LLC and The Healthcare Channel

Disclaimer for Analysis, Video Content, and email messages

This document is for informational purposes only. This is not to be construed as an offer of the solicitation
of an offer to buy or sell any securities or other instruments mentioned herein or to participate in any
particular trading strategy in any jurisdiction in which such an offer or solicitation would violate applicable
laws or regulations. The information contained herein is based on sources believed to be reliable; however,
we do not represent that this information is accurate, current, or complete and it should not be relied upon
as such. Opinions, estimates, and projections in this report may represent the individual author's personal
opinions, and should not be construed as the opinions or investment strategy of CortexTV, LLC or its
affiliated companies, shareholders, directors, officers and/or employees. Opinions expressed are current
opinions as of the date appearing on this material only, and we do not undertake to advise of changes in
these opinions or information.

Any information or data provided in this message has been obtained from sources we believe to be reliable,
but we do not guarantee its accuracy or completeness. Such information reflects current market conditions,
is subject to change without notice and should not be relied upon for tax purposes. CortexTV, LLC, its
affiliated companies, and/or officers, directors or employees, may at times have a position in any security
described above. CortexTV, LLC and The Healthcare Channel are not broker dealers or equity research
shops.

CortexTV, LLC reserves the right to monitor and review the content of all e-mail communications sent
and/or received by its employees. This information is intended to be confidential and solely for the use of
CortexTV, LLC and those persons or entities to whom it is directed. If you received this message in error,
please contact CortexTV, LLC immediately at info@cortextv.com.

9
10