Biotech @ TheStreet

An audio file of the MAP Pharma conference call held March 27.

Wed, 04 Apr 2012 15:25:57 -0400

An audio file of the MAP Pharma conference call held March 27.

Today's $BIIB story from BioPharm Insight

Thu, 08 Mar 2012 14:02:18 -0500

Biogen’s BG-12 on watch for malignancy data from extension trial – source BioPharm Insight

Biogen Idec’s (NASDAQ:BIIB) BG-12 extension trial has cases of malignancies in the ongoing extension trial, a study that includes patients from both the Phase III CONFIRM and DEFINE trials, according to a person familiar with the situation. Since all patients in the extension trial are treated with active therapy, it will be difficult to assess the rate of malignancies relative to a background rate as per a placebo arm and will be difficult to draw causality, the person familiar noted.

When asked whether there have been cases of malignancies in the extension study, a Biogen spokesperson said the company has not released any data publicly on the extension study. He declined to comment on whether the company plans to release any interim data from the extension study before the estimated completion date in 2016.

Hypothetically, if the long-term data shows that patients in the extension study get different types of cancer, similar to Merck Serono’scladribine, that would be less problematic, the person familiar said. If, however, patients in the extension trial have the same type of cancer, as seen in pre-clinical data, then it would draw more attention from the neurology community, he noted.

This still does not change the fact that BG-12 is perceived to be much safer than Novartis’ Gilenya, based on the current data so far, the person familiar said.

Biogen has completed regulatory filings for approval in both the US and EU for BG-12 as a treatment for relapsing remitting multiple sclerosis (RRMS).

A second source noted via email that he cannot talk about what issues may be associated with BG-12 until Biogen “comes clean” with the research data at the upcoming American Academy of Neurology meeting. His personal opinion is that “the press releases have some information missing, as would be expected, and how the drug is publicly perceived will likely hinge on this data,” he said. “Biogen-Idec is keeping a very tight lid on information,” he said in the email.

The person familiar said the presentation at AAN is unlikely to reveal issues. Biogen is not going to release information regarding malignancies at AAN because it is in the extension trial, according to the person familiar.

The extension trial was initially a two-year trial, but is now a five-year trial, said a Biogen spokesperson The study is an additional Phase III study that evaluates the long-term safety profile of BG-12 over a five-year period, including approximately 1,700 patients. The estimated primary completion date for the extension study is June 2016, according to clinicaltrials.gov.

The Phase III DEFINE and CONFIRM studies have not shown a signal of malignancies with BG-12 that is higher than the background rate, a Biogen spokesperson said.

Data from the extension trial has been submitted as part of the FDA package, the spokesperson said. All completed and ongoing studies have been included in the FDA submission, the Biogen spokesperson said.

The company has not been notified if there will be an FDA advisory committee, the spokesperson noted. “We do keep the FDA posted on any safety events that happen in our trial, that’s normal practice as well,” the spokesperson said.

There were no malignancies in the CONFIRM study. In the DEFINE trial , there were two malignancies in the twice-daily drug group, two cases in the thrice-daily drug group and also two cases in the placebo arm, the spokesperson said. In DEFINE, there were two cases in each group, therefore there was no increased risk in the active arm and the rates were consistent with background rate, the spokesperson said. The rate of malignancies was less than 1% in the DEFINE trial, he said.

Biogen will be presenting more detailed safety and tolerability data from the CONFIRM study at AAN, a Biogen spokesperson said via email. The study will be presented on 26 April (2 pm) during Session S41: Multiple Sclerosis: Clinical Trials: Safety. The study is entitled “Safety and Tolerability of BG-12 in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Analyses From the CONFIRM Study [S41.005].

CONFIRM was a multicenter, randomized, placebo-controlled, reference comparator study that evaluated the efficacy and safety of BG-12 over two years in spell out RRMS patients. The study enrolled a total of 1,417 patients, and both dose regimens of BG-12 — 240 mg twice daily (BID) and three times daily (TID) versus placebo — showed favorable safety and tolerability profiles.

According to the AAN study abstract, overall, the incidence of adverse events (87%-94%), serious adverse events (16%-22%), including serious infections (1%-2%), and discontinuations due to AEs (10%-12%) were similar across all study groups, including placebo. The incidence of hepatic and renal events was also comparable among all study groups. The most common AEs in the BG-12 groups were flushing and gastrointestinal events. There were no malignancies in the BG-12 groups.

The company’s current language is correct, as CONFIRM and DEFINE are safe and reported no malignancies higher than the background rate, the person familiar said. There were no malignancies in the CONFIRM trial, he noted. The FDA might ask for the extension trial data, but since BG-12’s safety profile is so good from DEFINE and CONFIRM, the drug is most likely going to be approved.

Biogen has a current market cap of USD 29.96bn.

by Kimberly Ha in New York

These slides are from Insmed’s March 2011 investor...

Fri, 20 Jan 2012 09:55:32 -0500

These slides are from Insmed’s March 2011 investor presentation.

Lazard on AMRN - Jan. 19, 2012

Thu, 19 Jan 2012 10:07:00 -0500

Amarin Corporation PLC (AMRN - $8.39) William Tanner, PhD / 212-632-1512
AMRN: Simplifying the patent review process
could accelerate visibility on market exclusivity;
BUY
BUY - Price Target $26
􀂄 Based on clinical data, we believe AMR101 could be an important and
differentiated product for treating hypertriglyceridemia. Absent the ability to
predict when BD activities will occur, we view emergence of clarity that patent
protection will be afforded AMR101 as a key near-term stock driver.
􀂄 Making it easier for the PTO. We spoke with management yesterday (including the
General Counsel) to discuss the new tack for pursuing patents for AMR101. Though
not independently verifiable, the company believes the U.S. PTO examiner has had
difficulty focusing on important aspects of the ‘889 patent application that may have
led to the less than desirable decisions by them.
􀂄 Focus now on the 4g dose. Filings recently posted on the PTO web site were the result
of a meeting that occurred at the end of Nov. 2011. In the response to the non-final
office action date of Nov. 4, the ‘889 pending claims are now focused only on the 4g
dose. Previously, claims had been sought for both the 4g and the 2g doses. Especially
as it relates to differentiation from Lovaza, management believes the clinical responses
are superior for the 4g dose than the 2g dose meaning that patentability of the former is
probably most important.
􀂄 Duration of market exclusivity likely main variable for NPV calculation in
investor models. Given the relative temporal proximity to the MARINE PDUFA date
(July 26), we would not be surprised if BD activities subsided somewhat until the FDA
decision is known. Because AMRN shares trade below what we believe is the shortest
reasonable period of market exclusivity (5 yrs), meaningful progress with patent
prosecution could have a significant impact on the share price, in our opinion. Based
on management comments, a reply from the PTO to the recent filing could occur in six
weeks or thereabouts.

Amarin

Fri, 04 Nov 2011 10:43:34 -0400

I deleted my previous post which copied in its entirety the research note from Monness Crespi Hardt analyst Avik Roy. He asked I take it down because his research is proprietary for clients of his firm.

The “non-final rejection” letter from U.S. patent examiners to Amarin regarding AMR101 can be found here:

http://t.co/mxTuBIxV

IMS bulletin on Incivek Scripts

Wed, 12 Oct 2011 19:56:01 -0400

IMS issued the following bulletin Wednesday night concerning Vertex Pharma’s Incivek scripts:

Summary:
A significant portion of Incivek mail data was not reported to IMS beginning with data week ending 9/23/11 through data week ending 9/30/11. This interruption should be resolved for the week ending 10/7/11.
Issue:
A significant portion of Incivek mail data was not reported to IMS beginning with data week ending 9/23/11 through data week ending 9/30/11.
In accordance with our standard operating procedures, replacement data was implemented in our sales and prescription services for data weeks ending 9/23/11 through data week 9/30/11. Replacement data is based on a historical week for the product/supplier and Incivek is a recently launched product; therefore, this replacement data may have impacted reported sales and prescription data during this time period.
IMS has been informed that reporting will be restored moving forward effective with data week ending 10/7/11 (visible in NPA Weeklyon 10/17/11<x-apple-data-detectors://12>). We also expect to receive the historical data for the weeks not reported.
Impact:
An initial NPA impact analysis of TRx data for the affected weeks is targeted for10/14/11<x-apple-data-detectors://13>.
Once the historical weeks of data have been received, we will conduct further impact analysis for the weeks ending 9/23/11 through 9/30/11 and the September 2011 data month for both NPA and NSP.
Next Steps and Recommendations:
We are assessing the need to restate the historical weeks and will provide an updateon 10/14/11<x-apple-data-detectors://15>.

BPAX CEO Wants to Sell Co...

Mon, 11 Jul 2011 13:24:17 -0400

And the sun sets in the west….

Here’s today’s Bloomberg story on BioSante, which says nothing new.

BioSante’s Female Sex Drug Spurs Deal-Making Talks, CEO Says
2011-07-11 17:08:42.437 GMT

By Catherine Larkin
     July 11 (Bloomberg) — BioSante Pharmaceuticals Inc. is in
talks to partner on its sex gel to raise female libido or sell
the company, according to Chief Executive Officer Stephen Simes.
     Scientists have tried to chemically treat female sexual
dysfunction since Pfizer Inc.’s Viagra, with $1.9 billion in
2010 sales, was introduced 13 years ago for erectile dysfunction
in men. After failed attempts by Pfizer, Boehringer Ingelheim
GmbH and Procter & Gamble Co., BioSante, based in Lincolnshire,
Illinois, is next in line seeking to capitalize on the idea.
     The market for a female sex drug may mirror sales for male
products at about $4 billion a year, said Jason Butler, an
analyst at JMP Securities in New York. Simes, in an interview,
said he aims to seek U.S. regulatory next year for his LibiGel
testosterone gel, in anticipation of U.S. sales in 2013. In the
meantime, there have been talks about possible deals with
“many, many companies,” he said.
     “BioSante was an underdog,” said Elemer Piros, an analyst
at Rodman & Renshaw in New York, in a July 8 phone interview.
“Nobody really wanted to touch BioSante when they had a three-,
four-, five-year window ahead of them. The company is just being
recognized, just starting to appear on people’s radar screens.”
     The company’s shares have more than doubled this year to
$3.60 at the end of trading on July 8. Four analysts surveyed by
Bloomberg estimate they’ll reach $5.50 within a year.
     BioSante may fetch an acquisition price as high as $1
billion as early as the first quarter of next year if two
studies of 500 women each find the drug increases desire and
sexual experiences, Piros said. The data is due to be reported
by the end of the year, the company said.

                      $540 Million in Sales

     Chris Holterhoff, an analyst at Oppenheimer & Co. in New
York, estimates 2015 sales of $540 million for LibiGel, with use
by 6 percent of potential patients. Possible use of the drug
beyond its officially approved designation for postmenopausal
women may double that revenue, Piros said.
     A “very conservative” estimate may be a licensing deal
for $100 million plus future royalties, or an acquisition in the
range of $300 million to $500 million, Simes said. He
acknowledged a higher price may be possible with “a significant
premium” over the company’s market cap of about $337 million.
     “What we think is the gating factor to partner interest
and to approval is very strong safety data,” Holterhoff said in
a July 8 telephone interview.

                          Safety Study

     LibiGel also is being tested for cardiovascular safety and
a potential risk of breast cancer in a study of more than 3,600
women. Researchers monitoring that study have not found an
imbalance in risks that would require the study to be stopped
early, which Piros said is “good enough proximal information”
to suggest the drug is safe.
     “We believe the value of LibiGel will increase as new
efficacy and safety data become available and these data will be
available beginning in the coming months,” Simes said today.
     The safety data will be available in the third quarter of
next year, according to the company.
     “There’s a broad range of potential partners and acquirers
for this product,” JMP’s Butler said in a July 8 telephone
interview. “You can look at any of the mid-to-large specialty
pharmaceutical companies as well as any of the global pharmas.”
     Pfizer, based in New York, and Eli Lilly & Co., of
Indianapolis, would make good partners because they have
successfully marketed sex medicines for men, Butler said.
Oppenheimer’s Holterhoff also identified Endo Pharmaceuticals or
Warner Chilcott Plc.

                          Pfizer Plans

     Raul Damas, a Pfizer spokesman, said in an e-mailed
response that the world’s largest drugmaker has “no current
plans to develop medicines for female sexual dysfunction.”
     Kevin Wiggins, a spokesman for Chadds Ford, Pennsylvania-
based Endo, said the company doesn’t comment on market
speculation. Lilly spokesman Mark Taylor said the company
doesn’t comment on possible business development activity.
Voice-mail and e-mail messages weren’t immediately returned by
Emily Hill, a spokeswoman for Dublin-based Warner Chilcott.
     Testosterone, while often characterized as a male hormone,
also plays a role in women’s libido. The amount of testosterone
produced naturally by a woman’s body decreases with age,
especially after menopause. The goal of therapy is to increase
hormone levels to the normal range of a premenopausal woman.
There were 4 million prescriptions for male testosterone gels
written to women in 2009, representing about 30 percent of the
females who report sexual problems to their doctors, Simes said.
     LibiGel is applied to the upper arm once daily in pea-sized
amounts, unlike male testosterone gels that are often slathered
across the upper body.
     BioSante licensed the drug in 2000 and had planned for the
drug to reach the market years ago before the FDA asked for more
safety data in the wake of the 2004 withdrawal of Merck & Co.’s
Vioxx painkiller over heart risks.
     So far the delays haven’t spooked investors, Simes said.

                        ‘No Competition’

     “People are impressed with the market opportunity and at
least today there is no competition,” he said. “We didn’t
expect it to take this long to get this product for women. It’s
taken a lot more time and a lot more money.”
      Pfizer stopped developing Viagra for women in 2004 because
studies didn’t show a benefit. Later that year, Cincinnati-based
P&G withdrew its application to sell a female testosterone patch
after the FDA asked for more safety information. Closely held
Boehringer, of Ingelheim, Germany, abandoned its flibanserin
pill last year after failing to convince the FDA that it was
safe and effective in women.

For Related News and Information:
Today’s most popular health-care stories: MNI HEA <GO>
Russell 3000 Health-Care Index: RGUSH <INDEX> MRR 10 <GO>
Bloomberg Industries pharmaceuticals analysis: BI PRHM <GO>
BioSante’s relative value: BPAX US <EQUITY> RV <GO>
FDA review of new medicines: TNI FDA NP BN <GO>
Bloomberg Drug Database: BDRG <GO>

—With assistance from Naomi Kresge in Berlin. Editors: Bruce
Rule, Andrew Pollack

PTIE, Remoxy and bad math

Thu, 23 Jun 2011 09:23:42 -0400

From my digital archives, June 2004:

Fuzzy Math at Pain Therapeutics

By Adam Feuerstein

TheStreet.com Senior Writer

Quick, someone get the folks at Pain Therapeutics (PTIE:Nasdaq) a new calculator.

The company needs one (or maybe some math lessons) because a press release Tuesday detailing study results for its experimental painkiller Remoxy is rife with mathematical errors. The mistakes don’t necessarily change the conclusions of the study, but it certainly makes you wonder if anyone’s paying attention to the details. The study results, as I wrote in a column yesterday, showed that Pain Therapeutics’ painkiller Remoxy is less abusable than OxyContin. With about $2 billion in sales last year, OxyContin is a much used, but also much abused, powerful narcotic sold by Purdue Pharma. Remoxy is made by encapsulating the active painkilling ingredient oxycodone in a proprietary gel-like substance. Pain Therapeutics says this formulation stops drug addicts from chewing Remoxy or dissolving it in alcohol in order to break through the time-release mechanism and catch a quick high, like they do with OxyContin.

A Look at the Numbers

But just how much more “abuse-resistant” is the experimental Remoxy compared to OxyContin? According to Pain Therapeutics, “In a head-to-head clinical comparison of the two drugs, OxyContin released over 200% more drug than Remoxy in an abuse study in high-proof alcohol and over 170% more drug in a chewing study in the first hour of the studies (when abusers presumably expect to get high.)” Sounds impressive. It’s too bad Pain Therapeutics got the numbers wrong. When the data made public by the company Tuesday are calculated correctly, OxyContin released 132% more drug than Remoxy in the alcohol study, and just 74% more in the chewing study. Additional calculations in two charts included in the company’s press release were also wrong. I’m no math whiz, so I double-checked my number-crunching with Elemer Piros, biotech analyst at Rodman & Renshaw. He concurred that Pain Therapeutics’ calculations are wrong. And he’s bullish on the company, with a market outperform rating. Piro’s firm has done banking for Pain Therapeutics.

More Testing Needed

Despite the statistical screw-up, the message of this study still stands. Remoxy appears to be more resistant to tampering and abuse than OxyContin, although the study is so small that drawing any definitive conclusions is a stretch and a lot more testing will be required. But still, the real numbers are less impressive than the erroneous figures Pain Therapeutics included in its press release and discussed on a conference call. I called the company and explained the miscalculations to Christi Waarich, head of investor relations. She told me that CEO Remi Barbier would call to explain. So far, he hasn’t, and the company has yet to cop to its mistake or issue a correction. Maybe I’m being nitpicky, making a big deal about a misstep in two, tiny 10-patient studies. Fair enough. But when it comes to drug development, details are important. And it worries me — and should worry investors, too — that a drug company presumably stocked with a fair number of M.D.’s and Ph.D.’s on its payroll didn’t catch an elementary-school-level math mistake.

Pain Therapeutics fell 69 cents, or 7.5%, to close at $8.41 in Tuesday trading.

Radient Pharma, Onko-Sure & Super Religare Labs

Wed, 15 Jun 2011 06:55:10 -0400

Super Religare Labs of India might offer 33,000 lab tests per day, but one of those tests is not Radient’s Onko-Sure. I suppose Umesh Bhatia and his team might still be in “launch prep mode.” If you’re wondering why Radient hasn’t announced this “new major partnership,” read the email thread below:

From: SRL Customer Care [connect@srl.in]
Sent: Wednesday, June 15, 2011 3:48 AM
To: Adam Feuerstein
Subject: RE: Notification about General Enquiry

Dear Sir

Please be informed that currently we are not offering the test Onko- Sure.

Thanks & Regards,

Somesh Mishra

Customer Care Group
Super Religare Laboratories Limited
Email: connect@srl.in
Web: www.srl.in

From: Adam Feuerstein [mailto:Adam.Feuerstein@thestreet.com]
Sent: Tuesday, June 14, 2011 5:42 PM
To: SRL Customer Care
Subject: RE: Notification about General Enquiry

The test is named is Onko-Sure. It is used to monitor colon cancer and also as a pan-cancer screen. Is this a test that is offered by SRL?

Thank you.

Adam Feuerstein

Adam Feuerstein
Sr. Columnist
TheStreet

From: connect [connect@srl.in]
Sent: Tuesday, June 14, 2011 7:39 AM
To: Adam Feuerstein
Subject: RE: Notification about General Enquiry

Dear Sir,

Please provide the name of test.

Thanks & Regards

Amit Mishra
Customer care Group
Super Religare Laboratories Ltd.

Web-www.srl.in

From: adam.feuerstein@thestreet.com [mailto:adam.feuerstein@thestreet.com]
Sent: Tuesday, June 14, 2011 4:53 PM
To: customercare@srl.in
Subject: Notification about General Enquiry

Hello,
Notification about General Enquiry
This mail is to notify that you have received an Enquiry. Kindly do the needful.

Patients name:

adam feuerstein

Accession number:

City:

Email:

adam.feuerstein@thestreet.com

Comments:

Do you offer the Onko-Sure test for cancer? Please respond. Thank you.

This email was sent from Super Religare Laboratories Ltd. This email (and any attachments or hyperlinks within it) may contain information that is confidential, legally privileged or otherwise protected from disclosure. If you are not the intended recipient of this email, you are not entitled to use, disclose,distribute, copy, print, disseminate or rely on this email in any way. If you have received this email in error, please notify the sender immediately by telephone or email and destroy it, and all copies of it. The sender confirms that Super Religare Laboratories Ltd. shall not be responsible if this email message is used for any indecent, unsolicited or illegal purposes, which are in violation of any existing laws and the sender shall at all times indemnify Super Religare Laboratories Ltd. of any civil and or criminal liabilities or consequences there. While Super Religare Laboratories Ltd. has taken reasonable steps to ensure that this emai l and any attachments thereto are free from computer viruses and the like, It does not undertake any responsibility for loss or corruption of recipients data during transmission. Before opening any email the recipient should ensure that data is free from any viruses.

Hate email

Fri, 25 Mar 2011 12:43:55 -0400

I received the email below this morning. It’s ugly and hateful. It will offend you. I apologize for that. But this email and the racist and anti-semitic sentiments it conveys are real. I wish I could tell you that email like this is a rarity. Unfortunately, it’s not. I get stuff like sent to me all the time.

From: XXXXXXXXXX@XXXXXX.com [XXXXXXXXXXX@XXXXXXX.com]
Sent: Friday, March 25, 2011 7:41 AM
To: Adam Feuerstein
Subject: Article Comments

From: Tim <XXXXXXXXX@XXXXXXX.com>
Story Headline:
Story URL: http://www.thestreet.com/_email/story//1/.html

Message:
Hey how about coming over tonight after work so I can fuck your jew mouth with my jew dick
you stupid jew nigger.

How do i cope with email like this? With laughter. For example, “Tim” seems fairly confused. He has a “jew dick” so I guess that makes him Jewish, but yet he’s expressing real hatred towards Jews. He’s anti-semitic and racist (“jew nigger” shows some originality) but he’s not homophobic because he wants me to go to his house and engage in an act of oral sodomy. Is Tim a gay, Jewish anti-semitic racist? Interesting combination!

Answers for Garza

Sat, 12 Mar 2011 19:58:46 -0500

My answers to the questions posed by BioMedReports’ M.E. Garza regarding my coverage of Radient Pharmaceuticals:

Is it true that the Mayo clinic asked you to change the title of your report against Radient earlier in the week? If not, then what led you to change the original title?

A Mayo Clinic spokesperson requested we amend the headline of my original Radient-Mayo story to reflect Mayo’s sale of blood samples to Radient. My editor and I agreed, so the original headline, “Mayo Clinic Denies Link to Radient Pharma” was changed to “Mayo Clinic Denies Test Link to Radient Pharma.”

No other changes were made to the story.

How many times did you talk to Kathy Anderson the spokesperson at Mayo Clinic? Were the exchanges you had with her pleasant or did they ever become confrontational?

I spoke with Kathy Anderson twice — once before the story ran and once after. [The latter call was when she requested the change in the headline.] We also communicated via email. I thought our phone conversations were pleasant. Anderson did a great job answering promptly my questions and providing the information I requested. She’s was (and still is) a total pro. I wish more public affairs people were as competent as she is.

Were you aware that the Mayo Clinic did have a collaboration agreement with Radient prior to your phone calls to the Mayo clinic?

Based on my reporting to that point, I was aware that Mayo Clinic sold blood samples to Radient for use in a clinical trial of Onko-Sure. I was also aware that Radient had claimed to be conducting the clinical trial in partnership with Mayo, based on the company’s press releases and public statements. I contacted both Radient and Mayo to confirm and get more details and information. That’s called reporting.

Do you have any proof that the India orders are not real or is that simply your belief?

Radient has issued press releases and its CEO has made statements quoted by BioMedReports claiming that the company is involved in a cancer-screening project in India which includes the sale of Onko-Sure. I have tried to verify these statements independently without success. Again, this is called reporting.

Do you have any proof that the company is not working with the Indian officials to expand their programs there or is that simply your belief?

As reported in my story, a spokesperson for the India Ministry of Health and Family Welfare could find no records of Gaur Diagno, the Indian company which Radient claims is running the Onko-Sure program. I have also had no luck corroborating Radient’s statements about Jaiva Technologies, the parent company of Gaur Diagno.

I asked Radient’s CEO to explain or elaborate on his statement made to BioMedReports claiming that Radient was in negotiations with the Rajiv Gandhi government to expand the Onko-Sure program in India. As I reported, Gandhi has been dead for 20 years and eight prime ministers have led India since he left office. To date, Radient’s CEO has not commented or provided any clarification of his remarks.

I’m continuing to report this story, so stay tuned for further updates.

Did any officials AMEX, the SEC or FINRA contact you about the report yet?

No.

Are you in touch with or have any collaboration with the single law firm who is seeking damages from Radient?

No.

Were you really banned by Stock Twits due to your many negative tweets about the company? Will they allow you to keep posting there?

No. Yes.

Have your editors/employers or others asked you to write the five most recent articles about the company? Do they take any exception to anything you have written?

No. No.

Can you comment further as to why you believe that the company is not real or misleading investors?

No. My comments and reporting on Radient can be found in the stories I’ve already published. Any further comment will come in future stories and columns, if/when I choose to publish.

Can you comment about the $250 million lawsuit which has been filed against for slander/libel?

You must be referring to the lawsuit filed against TheStreet and me by Generex almost one year ago. Sorry, our lawyers don’t allow me to comment. I will say that anyone can file a lawsuit; winning a lawsuit is an entirely different matter.

BioMedReports' Garza Asks Questions

Sat, 12 Mar 2011 18:58:37 -0500

M.E. “Dusty” Garza of BioMedReports.com sent me an email Saturday asking questions about my coverage of Radient Pharmaceuticals. I’m not the story here, Radient is the story, but Garza apparently thinks otherwise.

Here’s Garza’s email to me, in full:

On the record questions garza@biomedreports.com Sent: Saturday, March 12, 2011 3:36 PM To: Adam Feuerstein Adam,

Is it true that the Mayo clinic asked you to change the title of your report against Radient earlier in the week? If not, then what led you to change the original title?

How many times did you talk to Kathy Anderson the spokesperson at Mayo Clinic? Were the exchanges you had with her pleasant or did they ever become confrontational?

Were you aware that the Mayo Clinic did have a collaboration agreement with Radient prior to your phone calls to the Mayo clinic?

Do you have any proof that the India orders are not real or is that simply your belief?

Do you have any proof that the company is not working with the Indian officials to expand their programs there or is that simply your belief?

Did any officials AMEX, the SEC or FINRA contact you about the report yet?

Are you in touch with or have any collaboration with the single law firm who is seeking damages from Radient?

Were you really banned by Stock Twits due to your many negative tweets about the company? Will they allow you to keep posting there?

Have your editors/employers or others asked you to write the five most recent articles about the company? Do they take any exception to anything you have written?

Can you comment further as to why you believe that the company is not real or misleading investors?

Can you comment about the $250 million lawsuit which has been filed against for slander/libel?

We are preparing a special report having questioned sources from the entities mentioned above and since you have been so relentless in your quest to “warn” investors about the company, we are herby giving you the opportunity to respond to these questions on the record before any further news developments.

Regards,

M.E. Garza
BioMedReports.Com

P.S.
What is the name/contact information of your editor/supervisor at thestreet.com?

BofAs Rachel McMinn on EASL abstracts

Mon, 07 Mar 2011 14:15:45 -0500

I consider BofA biotech analyst Rachel McMinn to be the Street’s axe when it comes to Hep C stocks. Research abstracts for this spring’s European Hep C research meeting were posted online this morning, so here’s McMinn’s take from her note to clients:

Combo data the biggest area of focus

Abstracts for the European Association for the Study of the Liver (EASL) became
available this morning, with impact on our coverage stocks (VRTX, VRUS, GILD,
ACHN, IDIX). We believe the most important investor focus will be on combination
therapy results; we view the VRUS and VRTX data as positive relative to
expectations. The GILD data solidifies our concerns that GILD’s initial combo
approach is unlikely to be competitive, but second combo approaches could be
more fruitful.

VRUS nuc/nuc combo: unprecedented results, nuc class ?s

VRUS’ combo data offers the most tantalizing results at this year’s meeting, and
further supports the company’s strategy of combining its two nucleoside inhibitors
(‘7977/‘938) in an all-oral regimen. While the data are very limited (14 days total),
the dual nuc combo had an unprecedented 15/16 (94%) of patients reaching
undetectable (UND) viral levels compared to 50% with monotherapy from its
potent nuc PSI-938. However, data from VRUS/Roche’s lead nuc RG7128 cast at
least some shadow on the class for now, showing high relapse rates (24%) in the
best-performing patients. Still, the overall profile for VRUS’ unpartnered nucs is
more robust than RG7128, making it difficult to extrapolate.

VRTX’s QUAD: initial data show 12/24 duration possible

VRTX’s QUAD data (‘222/telaprevir/PEG/RBV) showed 57% of patients UND at
week 2 (> our 30-50% projected range), suggesting there is a
potential opportunity for VRTX to shift therapy duration to 12/24 weeks with
QUAD from 24/48 weeks with triple therapy and extend telaprevir franchise
sales. Overall tolerability appears good and, while there was one case of acute
renal failure, it appears to be unrelated to therapy. 12-week data at the meeting
will provide important insight into viability of the regimen.

BMY’s QUAD: impressive efficacy, tolerability a question

BMY’s QUAD pilot data (‘032/’052/PEG/RBV) in null responders showed a 100%
SVR12 (cure) rate, an impressive step up from 30% seen with VRTX’s triple
therapy, with a caveat of a small number of patients in the study. That said,
tolerability could be problematic, with 6/21 (29%) patients with liver enzyme
elevations >3x ULN, which we believe has been linked to BMY’s protease inhibitor
based on our prior research.

GILD: ditch tegobuvir and substitute NS5a

Data from GILD’s lead non-nuc tegobuvir showed no benefit on SVR when added
to standard of care, which makes us incrementally more bearish on GILD’s Phase
2b strategy of using tegobuvir as a base for QUAD therapy — we remain
unconvinced this QUAD regimen will be better than VRTX’s triple therapy.
However, proof of principle data for GILD’s novel NS5a inhibitor (GS-5885) shows
potent activity (-3.1 to -3.3 log at 3 days) and good genotype activity (GT1a/b),
and we like GILD’s plan to combine this product with its protease inhibitors as a
second QUAD approach.

NVS validates novel HCV class

Phase 2b data for NVS’ cyclophillin inhibitor alisporivir (Debio-025) showed a
76% SVR rate, an improvement over 55% control with the placebo adjusted
response of 21% being slightly below the 25-31% seen with protease inhibitors.
Limited safety details in the abstract suggest the drug is well tolerated, although
4% of patients experienced bilirubin elevations >5x ULN. While alisporivir might
not be differentiated enough by itself, we expect NVS to pursue combination
strategies with other antivirals, putting it on the map as a potential serious M&A
and/or BD player in HCV.

Next generation protease inhibitors

Boehringer Ingelheim’s (BI) protease inhibitor ‘335 does not appear meaningfully
differentiated from VRTX’s telaprevir, except more convenient dosing (once daily),
with SVR rates of 73-83% in treatment naive patients and 20-55% in treatment
failures (null/partial responder). Phase 2b data for Tibotec/Medivir’s TMC435 in
treatment failures is consistent with prior disclosure.

BIO CEO & Investor Conference

Sun, 13 Feb 2011 07:45:00 -0500

I’ll be attending and live-blogging the BIO CEO & Investor Conference on Mon. Feb. 14 and Tues. Feb. 15. For those interested in following the real-time coverage, here’s my tentative schedule for both days. All times are ET.

Monday

9 am: Exact Sciences

9:30 am: Cerus

10 am: Genta

10:30 am Medivation

11 am: Resverlogix

1:30 pm: Chelsea Therapeutics

2 pm: Northwest Biotherapeutics

2:30 pm Sangamo Biosciences

3 pm: Cleveland Biolabs

3:30 pm Athersys

4 pm Oncolytics Biotech

4:30 pm OncoGenex Pharma

Tuesday

8 am Spherix

8:30 am SuperGen

9 am Clinical Data

9:30 am Alimera or Xoma (Can’t decide)

10 am Aastrom Biosciences

10:30 AVI Biopharma

11 am Novavax (maybe MannKind)

11:30 am Neoprobe

1 pm StemCells

1:30 pm YM Bioscience

2 pm Advanced Cell Technology

2:30 pm Cell Therapeutics

3 pm Icagen

3:30 pm Telik

ARNA Sell-Side Reports

Mon, 25 Oct 2010 07:44:37 -0400

Oppenheimer

On 10/23, ARNA announced the FDA issued a complete response letter (CRL) for
lorcaserin, citing several reasons for delaying the drug’s approval. The CRL focused
on lorcaserin’s potential cancer risk and modest clinical efficacy, requesting
additional preclinical data and ph.III BLOOM-DM results, minimally. We believe
there is meaningful risk the FDA will eventually request additional clinical trials in
order to address concerns regarding lorcaserin’s benefit/risk profile. Following an
unfavorable FDA panel outcome in September, the CRL comes as no surprise, and
we expect modest additional downside in ARNA. However, we believe ARNA faces
considerable challenges, given likely prolonged lorcaserin timelines and minimal
near-term pipeline news. As such, we expect shares to continue to trade near
current cash of $1.50/share.

— The FDA requested additional preclinical data regarding cancer risk in
rats. The agency asked for additional evidence supporting that the cancer risk is
irrelevant to lorcaserin’s use in humans. We believe reassessment of existing
data is unlikely to yield definitive answers, and additional preclinical studies will
likely be needed to further address the FDA’s questions.

— The FDA views lorcaserin weight loss as “marginal.” The FDA requested
results from the ph.III BLOOM-DM trial in obese diabetics, which should be
available by YE10. However, in the unlikely event the results from BLOOM-DM
are more compelling than results from BLOOM/BLOSSOM, we question
whether the FDA would change its overall view on lorcaserin’s efficacy.

— The path forward for lorcaserin looks difficult. Based on the AdCom
outcome and the CRL, we currently expect a multi-year approval delay.
However, we expect ARNA will get more clarity on the drug’s regulatory
pathway following a Type A FDA meeting, which should occur in Nov.

— ARNA’s cash position is a concern. With the recent $50M Eisai upfront
payment, we estimate ARNA has cash through ‘11, on the company’s current
spend trajectory. However, we believe ARNA may need to ramp spending
beyond development offsets from Eisai to meet FDA demands for additional
clinical/preclinical data for lorcaserin.

Barclays:

We reiterate our 3-Underweight rating on ARNA following its receipt of a complete
response letter (CRL) from the FDA for lorcaserin. With prior EMDAC panel vote 9:5
against approval and with the FDA highlighting diagnostic uncertainty in classifying
mammary masses in rats, unresolved dose response for mammary adenoCA with
lorcaserin, unidentified safety margin for lorcaserin emergent astrocytoma, marginal
weight loss in non-diabetic patients and absence of data in diabetics, we believe that
ARNA has a very high hurdle to adequately meet FDA requests for additional data.

ARNA announced late yesterday that it had received a complete response letter from
the FDA indicating that the agency couldn’t approve the lorcaserin NDA in its current
form. In outlining non-clinical and clinical reasons for its decision, the FDA requested
detailed accounting of all slides prepared from female rats that contributed to tumor
incidence data in each update to the FDA, consultation with the FDA on an independent
pathology group to re-adjudicate all mammary and lung tissue from female rats,
demonstration that increase in adenoCA in rats given lorcaserin is reasonably irrelevant
to human risk, clarification of astrocytoma exposure margins for lorcaserin and
BLOOM-DM data in diabetics expected in the next few weeks.

Review of FDA briefing documents indicates questions on tumor classifications
between week 96 and week 104 assessments, a potential focus of the FDA in its CRL,
and in addition highlights FDA disagreement that pre-clinical data were sufficient to
establish a prolactin thesis underling mammary tumors and to establish a safety margin
for brain cancers. With focus on BLOOM-DM data diabetics appear tougher to treat and
we remain doubtful that data will impact perceived benefit risk.

JPMorgan

Early Saturday morning the FDA issued an expected complete response letter (CRL)
for ARNA’s obesity drug Lorqess (lorcaserin). To us, the path forward looks like a
difficult one. The company must disprove a preclinical cancer signal (never easy to
do) AND hope that the pending BLOOM-DM data are more impressive than prior
results (also a high hurdle considering that obese diabetics are notoriously more
difficult to treat than otherwise healthy obese patients). We consequently see the odds
of a quick resubmission and ultimate approval as very low. With no quick fix, our
thesis is unchanged, and we would continue to avoid ARNA shares.

• Onerous CRL makes for a grim lorcaserin outlook. To ARNA’s credit, the press
release outlined the CRL in relatively greater detail than we’re accustomed to
seeing. Nevertheless, the outlook isn’t bright in our view. Most notably, the letter
confirms that the FDA’s key concerns revolve around pre-clinical signals that
lorcaserin treatment could be associated with breast/brain cancer as well as the
product’s “marginal” efficacy. We believe these hurdles will be tough to clear.

• Best case scenario looks least likely to play out. It’s noteworthy that the FDA did
not require any new clinical studies, yet. As such, IF the company (and independent
experts) are able to refute the pre-clinical cancer signals, and IF the BLOOM-DM
data come back better than expected to help alleviate the concern of “marginal”
efficacy, then perhaps the company could re-file in 1H11.

• We believe it’s more likely that lorcaserin faces a long and bumpy road. We
expect Arena will be required to generate a substantial amount of additional
preclinical and clinical data for lorcaserin before it’s re-considered for approval. The
ongoing debate over the clinical relevance of the tumor findings in rats is a real
concern to us as it can be difficult to disprove a cancer signal. Perhaps even more
ominous is the FDA’s clear lack of comfort with lorcaserin’s “marginal” efficacy.
To this point, we do not expect results from the BLOOM-DM trial (top-line data
expected in the next few weeks) to bail ARNA out as obese diabetic patients are
notoriously more difficult to treat than otherwise healthy obese patients.

• ARNA may trade near cash. Unless the pending BLOOM-DM results surprise to
the upside, we expect ARNA shares to continue to slide toward cash levels
(~$1.14/sh). There are other pipeline programs, but they are early stage and have yet
to generate any compelling data. As such, we would continue to avoid ARNA.

Concept Capital on $JAZZ

Wed, 18 Aug 2010 13:23:35 -0400

Here’s the text of Concept Capital’s note issued today regarding $JAZZ and Friday’s FDA advisory panel:

Jazz Pharmaceuticals Rekinla: Risk Management At The Heart Of FDA Analysis, Not Approvability

· FDA’s Arthritis Drugs Advisory Committee and Drug Safety & Risk Management Advisory Committee will review Jazz PharmaceuticalsRekinla (sodium oxybate) for a supplemental indication for treatment of fibromyalgia. Sodium oxybate is currently approved for the reduction of daytime sleepiness and cataplexy in patients with narcolepsy under the trade name Xyrem.

· Due to the particular focus of the advisory committee meeting on concerns related to the two REMS programs, FDA’s questions to the committee (to view the questions, click here), and the presence of key drug safety members on the panel, we believe the most likely outcome is a vote against approval at the meeting. However, the path to FDA approval appears clear for Rekinla: Jazz must address FDA’s concerns related to the two REMS programs and the possibility for misuse. Therefore, a negative vote coming out of committee could be confusing considering the overall prospects for approvability are more positive.

· If the sponsor is able to make a forceful presentation at the meeting that 1) the success of the Xyrem REMS in limiting abuse will be replicated in a much broader population; and 2) the potential for medication errors is significantly less than the agency believes, the drug could receive a favorable recommendation for approval.

Based on our reading of the FDA briefing documents, we believe the approvability of the new indication is not in question; overall, FDA appears to believe the drug is effective and has a risk profile in fibromyalgia similar to the already approved indication. The key focus of the agency and the advisory committee will be risk management and the sponsor’s ability to control the drug to limit abuse (Xyrem is classified as a Schedule III controlled substance, meaning that it has moderate dependence liability) and prevent medication errors in a much broader population. To viewthe FDA briefing documents, click here.

Approximately half of FDA’s briefing documents focus on Jazz’s Risk Evaluation and Mitigation Strategies (REMS) program for Xyrem, called the Xyrem Success Program, and the proposed REMS for Rekinla. The two REMS are very similar.

The Xyrem REMS is one of the most restricted distribution programs approved by FDA. Under the Xyrem REMS, the drug is restricted to be distributed through a central pharmacy. The central pharmacy requirements include: verification that the physician is eligible to prescribe the drug, verification of all patient registry information, filling of the initial prescription only after the prescriber and the patient have received and read the educational materials, and the first prescription be limited to a one month’s supply, no greater than 5 refills and no more than a 3 month supply with each shipment. In addition, patients and physicians must be registered to a secure database and shipment of the drug must be arranged and verified. The primary difference between the Xyrem REMS and the proposed Rekinla REMS is that the drug would be available through 15 specialty pharmacies, presumably to meet a larger patient population, instead of one central pharmacy.

The effectiveness of the Xyrem restricted distribution plan in the approved indication does not appear to be a major approvability issue considering it has been in place for almost eight years (Xyrem was approved in 2002). FDA’s primary concern is that there will be two REMS programs for the same drug with two proprietary trade names in two different indications.

Specifically, FDA reviewers worry that patients diagnosed with fibromyalgia and narcolepsy may be mistakenly given a double dose of sodium oxybate and prescribed both Rekinla and Xyrem by prescribers that fail to recognize that both products contain the same active compound. Jazz argues that the two patient populations do not overlap, an argument that FDA staff disagree with.

$CPIX hit w/ 3 downgrades

Tue, 17 Aug 2010 07:42:00 -0400

Cumberland Pharmaceuticals was slapped with three downgrades this morning. This is not a stock I follow but I know it’s popular with the bio-runup trading crowd. For those interested, here are some excerpts from the analyst downgrades:

Jefferies Hold from buy, price target $5.50 from $13:

Management staying the course. CPIX plans to stick with its
Caldolor strategy of focusing exclusively on formulary wins, now
deferring the initiation of pull-through selling into early 2011. This is
a slower transition than most had expected and indicates sales
could be very small for the remainder of 2010. In the meantime,
with minimal apparent urgency, mgt plans to shift its priorities
toward preparation for the next stage of the launch. The prolonged
delay in competition is a blessing, but so far the advantage gained
with potential prescribing physicians is quite narrow.
• Problem: Doctors unaware of Caldolor. We have spoken to a
number of doctors, and few are aware of Caldolor. They have not
been called upon by a sales rep and are thus not educated about
the drug nor its benefits. While mgt’s focus on formulary
acceptance could explain this, we struggle with two questions: 1)
why wouldn’t some of the early adopters (the 100 hospitals that
added Caldolor to formulary in the first 4 months) be using more at
this point, and 2) why do the two stages of the strategy have to be
sequential, especially with most of the IPO proceeds sitting idle on
the balance sheet. We believe the company is missing the
opportunity to produce and benefit from one of the loudest
proponents of the drug…the prescribing doctor. If more doctors
were aware of the drug, we believe it would not only drive sales, but
also help gain formulary approval in neighboring hospitals.

Acetadote risk is real. Acetadote is currently protected from generic competition by 7-year orphan exclusivity;however, this ends on Jan 23, 2011. The product does not have an orange book listed patent so a competitor wouldnot be required to notify Cumberland prior to FDA approval of a generic. Cumberland has filed an sNDA for an
expanded indication (non-acetaminophen related liver insults) but this would not normally add any additional exclusivity to the original indication. The new indication could receive 3-years of Hatch-Waxman exclusivity (7-years for a second orphan indication) but that exclusivity would not prevent a generic from being approved for the original indication. Cumberland management has indicated the potential to wrap the product in its entirety into extended exclusivity based on discussions with the FDA. Commentary from management at a recent conference indicated the new indication may
have orphan status and that in exchange for a shorter period of exclusivity, the franchise would be protected from generic competition. While we are not party to those conversations, it is not common for the Agency to deviate from its regulations.

Well Fargo downgrades to market perform, lowers estimates

Summary: Downgrade to Market Perform as pushout of Caldolor revenue
ramp will likely restrain near-term share price performance. 2Q EPS of $0.01
missed consensus of $0.03. Revenue guidance of $42-$43MM implies minimal
revenue contribution from Caldolor in 2010. Lowering 2010E and 2011E EPS to
$0.02 (from $0.42) and $1.35 (from $1.62), respectively. Reducing valuation
range to $6-$8 (6-7x 2011E EPS of $1.35, r=25%, 1 yr) from $16-$18.
• Downgrade to Market Perform. Though we believe Caldolor could become a
competitive product, mgmt’s focus on hospital formulary acceptance is likely to
restrain near-term growth. The strategy may pay off eventually, but given the
slow Caldolor ramp to date and below-consensus guidance, CPIX shares are
unlikely to outperform until evidence of Caldolor pull-through emerges.
• 2Q 2010 Key Takeaways: 1) 2010 revenue guidance of $42-$43MM vs.
consensus of $52.9MM suggests minimal Caldolor revenue contribution in 2H;
2) 200,000 shares repurchased in 2Q; 3) Caldolor formulary acceptances now
230; 4) Acetadote sNDA submitted in US for non-acetaminophen liver failure
(March); 5) CPIX signed CAH as exclusive distributor of its products.
• Mgmt provided 2010 revenue guidance of $42-$43MM, suggesting
minimal contribution from Caldolor. With Acetadote and Kristalose
tracking to $40MM annually, guidance suggests minimal demand pull-through
for Caldolor in 2010. Mgmt maintains its strategy of attaining formulary
acceptance for Caldolor in 500 institutions before shifting to drive demand pullthrough,
which is unlikely to occur until late 2010.

Duncan-Williams downgrade to hold from buy. Price target $6 from $8.50

We revise our investment thesis: (1) We lack conviction about the strength of data submitted to support the Acetadote sNDA and are concerned that a delay in patent approval for the new formulation could create an opportunity for generic entry in 2011-2012. However, we do not yet assume the brand goes generic in 2011. (2) We have lowered our estimates on Caldolor to ~$70 million at peak given even greater than expected delay in pull-through, and imminent competitive entry; (3) We still like the company’s healthy balance sheet; and (4) we believe that Cumberland could identify other attractive hospital opportunities to grow its top line.

Jazz Pharma: FDA Panel Prep

Tue, 03 Aug 2010 07:35:17 -0400

My thoughts (and a prediction) for the JAZZ FDA panel on Aug. 20

$ACOR: Ampyra launch strong

Tue, 03 Aug 2010 07:09:56 -0400

Acorda Therapeutics reported Q2 Ampyra sales of $29.7 million, well ahead of the consensus estimate of about about $16 million.

$DNDN report Q2 results tomorow. I expect all the big TV/cable networks to break in live with a...

Mon, 02 Aug 2010 13:26:38 -0400

$DNDN report Q2 results tomorow. I expect all the big TV/cable networks to break in live with a special report.