Biotech @ TheStreet

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

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.

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 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>.

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

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.

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.

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.

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!