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How to join the lawsuit? Does anybody know if warrant investors need to proactively join the suit in order to participate in the payout or are we, by default, part of the suing party? If we need to proactively join is there a process? Thanks
Initial Pretrial Conference scheduled for 1/27/16 at 9:30 (11/12/15).
No Additional parties may be joined after 3/09/16.
No amendment to the pleadings will be permitted after 3/09/16.
Except for good cause shown, all discovery shall be commenced in time to be completed by 5/11/16
Dispositive motions are to be served by 6/08/16. Answering papers are to be served within 14 days. Reply papers are to be served within seven (7) days. In the event a dispositive motion is made, the date for submitting the Joint Pretrial Order shall be changed from that shown herein to three (3) weeks from the decision on the motion. The final pretrial conference shall be adjourned to a date four (4) weeks from the decision on the motion.
A final pretrial conference will be held on 6/22/16 at 9:45.
The Joint Pretrial Order shall be filed no later than 6/15/16. The requirements for the pretrial order and other pretrial submissions shall be governed by the Court's Individual Rules of Practice.
A Subsequent Case Management Conference will be held on 4/13/16 at 9:45.
Source: PACER [Docket 7]
$GCVRZ recent news/filings
bearish
## source: finance.yahoo.com
Fri, 06 Nov 2015 17:37:24 GMT ~ European shares end higher after strong U.S. jobs data
[Reuters - UK Focus] - European stock markets ended higher on Friday after stronger than expected U.S. jobs data boosted the dollar, lifting export-oriented stocks like autos, although Cartier brand-owner Richemont plunged after ...
read full: http://uk.finance.yahoo.com/news/european-shares-end-higher-strong-173724527.html
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Fri, 06 Nov 2015 17:01:00 GMT ~ Europe close: Equities advance despite disappointing data as US jobs report provides boost
read full: http://uk.finance.yahoo.com/news/europe-close-equities-advance-despite-165700423.html
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Fri, 06 Nov 2015 07:43:00 GMT ~ Friday newspaper round-up: Volkswagen, Sanofi, Toyota, Eurostar
read full: http://uk.finance.yahoo.com/news/friday-newspaper-round-volkswagen-sanofi-072100423.html
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Fri, 06 Nov 2015 00:15:00 GMT ~ Europe midday: Equities push lower as investors await non-farm payrolls
read full: http://uk.finance.yahoo.com/news/europe-midday-equities-push-lower-001500572.html
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Sun, 01 Nov 2015 07:00:01 GMT ~ Drugged up: GSK, Roche and Sanofi to set out their stalls
read full: http://uk.finance.yahoo.com/news/drugged-gsk-roche-sanofi-set-070001015.html
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$GCVRZ charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$GCVRZ company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/GCVRZ/company-info
Ticker: $GCVRZ
OTC Market Place: Not Available
CIK code: 0001121404
Company name: Sanofi
Company website: http://en.sanofi.com
Incorporated In: France
$GCVRZ share structure
## source: otcmarkets.com
Market Value: $161,780,485 a/o Nov 10, 2015
Shares Outstanding: 1,311,025,000 a/o Dec 31, 2010
Float: Not Available
Authorized Shares: Not Available
Par Value: No Par Value
$GCVRZ extra dd links
Company name: Sanofi
Company website: http://en.sanofi.com
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=GCVRZ+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=GCVRZ+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=GCVRZ+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/GCVRZ/news - http://finance.yahoo.com/q/h?s=GCVRZ+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/GCVRZ/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/GCVRZ/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=GCVRZ+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/GCVRZ
DTCC (dtcc.com): http://search2.dtcc.com/?q=Sanofi&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Sanofi
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Sanofi&x=0&y=0
WHOIS (domaintools.com): http://whois.domaintools.com/http://en.sanofi.com
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://en.sanofi.com#
Corporate website internet archive (archive.org): http://web.archive.org/web/*/http://en.sanofi.com
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/GCVRZ
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001121404&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/GCVRZ/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/GCVRZ/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=GCVRZ&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=GCVRZ
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/GCVRZ/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=GCVRZ+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=GCVRZ+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=GCVRZ
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=GCVRZ
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=GCVRZ+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/GCVRZ/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=GCVRZ+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/GCVRZ.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=GCVRZ
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/GCVRZ/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/GCVRZ/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/GCVRZ
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/GCVRZ
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/GCVRZ:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=GCVRZ
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=GCVRZ
$GCVRZ DD Notes ~ http://www.ddnotesmaker.com/GCVRZ
Agreed. Seeing as a competitive product sold 1.4B its first year on the market!!!
No predictions, but I'd assume the negligence upon first FDA submission and terrible management of the marketing of Lemtrada should equate to the $1 FDA and #1 sales milestone at the minimum.
going to go out on a limb here and say that 'I think' this suit 'may' have merit(?)
might actually add some as lotto tickets
American Stock Transfer & Trust Company LLC is seeking the following relief:
On Count I, a judgment that Sanofi breached its agreement with the Trustee with respect to the Approval Milestone and the Trustee, on behalf of the express trust for the benefit of the Holders, is entitled to an award of money damages in an amount to be determined at trial, but not less than $236,421,000;
B. On Count II, a judgment that Sanofi breached its agreement with the Trustee with respect to the Product Sales Milestones and the Trustee, on behalf of the express trust for the benefit of the Holders, is entitled to an award of money damages in an amount to be determined at trial;
C. On Count III, a judgment that Sanofi violated the covenant of good faith and fair dealing implied in its CVR Agreement with the Trustee and, therefore, the Trustee, on behalf of the express trust for the benefit of the Holders, is entitled to an injunction prohibiting Sanofi from exercising the Failure Purchase option and money damages in an amount to be determined at trial; and
D. Any such other and further relief as the Court may deem just, equitable, and proper.
Sanofi delayed drug to avoid $708 mln in payments, lawsuit claims (11/09/15)
By Brendan Pierson
A new lawsuit accuses Sanofi SA of stalling development of its multiple sclerosis drug Lemtrada to avoid paying out at least $708 million to rights holders under its 2011 agreement to acquire Genzyme Corp.
The lawsuit, filed on Monday in Manhattan federal court by American Stock Transfer & Trust Co LLC, a trustee for the rights holders, seeks at least $236.1 million in damages.
Genzyme was in the process of developing Lemtrada when Sanofi bought it. Under the merger agreement, Sanofi issued Genzyme shareholders tradable certificates entitling them to payments if Lemtrada won approval from the U.S. Food and Drug Administration by March 31, 2014, and further payments if it met certain sales benchmarks after that.
Sanofi promised it would make "diligent efforts" to meet those goals, according to the complaint. Instead, the trustee alleges, it deliberately took a "slow path" to bring Lemtrada to market.
The lawsuit claims Sanofi deliberately ignored the FDA's concerns about the designs of its clinical trials, leading the agency to deny the company's first application for approval.
The trustee further claims that even after Lemtrada was finally approved in November 2014, Sanofi skimped on marketing it, while actively promoting a different multiple sclerosis drug, Aubagio. As a result, the lawsuit says, Lemtrada has failed to meet any of the sales benchmarks.
The drug is expected to lose patent protection in September 2017, according to the lawsuit, further limiting its prospects.
Sanofi said in a statement that it was aware of the lawsuit but did not comment on pending litigation.
The case is American Stock Transfer & Trust Company LLC v. Sanofi, U.S. District Court, Southern District of New York, No. 1:15-cv-08725. (Reporting by Brendan Pierson in New York; Editing by Matthew Lewis)
http://www.reuters.com/article/2015/11/09/sanofi-genzyme-lawsuit-idUSL1N13433H20151109?type=companyNews
American Stock Transfer & Trust Company LLC, as Trustee, v. Sanofi, U.S. District Court Southern District of New York (Foley Square), Civil Case No. 15-8725
Thanks for sharing. How do you see this playing out??
E.I.
Any updates/thoughts since Q3 revenues are out????
Thanks.
"Sanofi’s MS franchise which consists of both Aubagio and Lemtrada registered sales of €468 million in the first half of 2015, reflecting an increase of 118.3% year over year. On the second quarter call, Sanofi had said that the MS franchise is on track to cross more than $1 billion in annualized sales in 2015." - See more at: http://www.zacks.com/stock/news/192908/sanofi-unveils-new-positive-data-on-lemtrada-and-aubagio#sthash.4LzyKm8U.dpuf
I'll throw some caution in here: "they just have to compensate the CVR holders with the volume weighted average price over the last 45 days"
that vol weighted avg could be .01 fwiw
October has 'potential' catalysts, if they fail to ignite i'll happily take on some more risk during tax-loss selling
g/l!
Worst case scenario?
The Future Of GCVRZ (8/11/15)
http://seekingalpha.com/article/3427536-the-future-of-gcvrz
Sanofi Lemtrada Sales Disappoint: CVR Milestones Will Not Be Achieved (7/31/15)
http://seekingalpha.com/article/3381805-sanofi-lemtrada-sales-disappoint-cvr-milestones-will-not-be-achieved
Two Posts on GCVRZ from YM Board:
[both seem worth knowing about, I haven't verified these as of yet]
OFF LABEL USE MARKETING
by ghin10 • 8 hours ago
The Federal District Court for the Southern District of New York ruled that FDA could not enforce its off-label marketing ban against Amarin Pharma Inc.'s fish oil drug, Vascepa, as long as the drug company gave doctors and others truthful accounts of medical studies of the drug's off label uses. See Saturday/Sunday (8/8, 8/9/2015 ) edition of WSJ, B1. Will be interesting to see if Genzyme uses this to promote Lemtrada for off label purposes with appropriate and full disclosure. Not saying it is a game changer, but could be an important marketing boost for US sales.
northforkinvestor • Aug 17, 2015 4:07 PM
not necessarily: on or after 4/1/17 SNY can optionally purchase and cancel all outstanding CVRs at the average trading price of the CVRs if the VWOP CVR trading price is less than $.50 and Lemtrada sales in the prior 4 qtr period were less than $1 bb in the aggregate.
completely disagree. When you chart this out and see how only the US sales are really driving any real growth and even then with a full quarter the odds of this getting it are in this range. The sales price is appropriate imo.
We've also been getting hurt by the European sales due to the strengthing of the dollar.
Milestones based on USA dollars, sales are mostly in Europe.
10M shares today! Good news, bad news, buy-back, institutional buying, dumping?!?!?
All positive and good news!!!!
http://www.streetinsider.com/dr/news.php?id=10483725
When should we expect updated Global revenue numbers, reimbursement and predictives?!?
Much appreciated. Maybe at the minimum a $2 payout is achievable. Thoughts?!?
My guess is a reaction to the NEJM article/letter on DMF and PML that there may be longer term use risk and seeing patient lymphocyte counts may not be enough to reduce risk. A lot of analysts defend BIIB and it was even up a little on the day.
Its the Contigent Value Right for Lemtrade sales. It was part of the SNY acquisition of Genzyme you can see the terms here:
http://www.sec.gov/Archives/edgar/data/732485/000095012311017162/b85162exv99waw43.htm
I cannot find any profile on this stock. Is it related to:
"Sanofi (NYSE: SNYOpens Flyout Module that includes Quote information for linked symbol), rated Market Perform: "Alirocumab offers flexibility advantage; Aubagio sales could be sustained into next decade; Lemtrada infusion centers increasing in number; novel IO strategy in the works; Dengue Vaccine well positioned versus competition."?
Good volume and bump today. I haven't been able to locate anything new. Any news? Someone knows something.....
Agreed.
And then Q2. Followed by Q3. We need one year's worth of sales data by region.
Q1 will be a lot more revealing imo
Lemtrada Update (2/05/15)
Fourth quarter and full-year sales of Lemtrada® were €16 million and €34 million, respectively. Fourth-quarter sales of the product were €12 million in Western Europe. In November, the U.S. Food and Drug Administration (FDA) approved Lemtrada® for the treatment of patients with relapsing forms of multiple sclerosis. In the U.S., fourth-quarter sales of Lemtrada® were €2 million.
http://en.sanofi.com/Images/38294_20150205_Results_en.pdf
Chris DeMuth, Jr. Positions For 2015: Banking M&A, Milestone Payments, Litigation Results (12/22/14)
http://seekingalpha.com/article/2773105-chris-demuth-jr-positions-for-2015-banking-m-and-a-milestone-payments-litigation-results
MS drug has the potential to change lives (12/15/14)
FORT WORTH — Sundie Ellis, 40, is busy again, working full time for the first time in years.
"Before Lemtrada, I worked about three or four hours a day," she said. "Now I work a full day — plus I help out around the house, which is not something I could do."
Multiple sclerosis triggered serious nerve pain, exhausting fatigue, and mental confusion in Ellis for 11 years. She took 15 medications daily just to function.
In desperation, she traveled to Germany in April to receive infusions of a drug called Lemtrada for five consecutive days. The once-a-year therapy has the potential to help alleviate MS symptoms.
In some cases, lost function has been restored.
Lemtrada was not approved by the Food and Drug Administration for use in the United States when Ellis made her transatlantic journey.
It wasn't the potential for serious side effects — including kidney failure and thyroid cancer — that led to the FDA decision. Rather, Lemtrada had not been tested in double-blind, placebo-controlled studies, like most other drugs.
Lemtrada did have years of testing, however, and had been approved for use in 40 other countries. Many MS patients were willing to travel overseas and pay for the drug out of pocket, at a cost of more than $100,000.
Ellis said not long after the therapy, she stopped needing most of the medications she had been taking.
"And any time you get rid of one medicine, you get rid of the side effects that come with it," she said. "So it was kind of lifting of symptoms, and the day was better."
In November, the FDA approved Lemtrada for use in the U.S.
"Its biggest effect is to give people hope," Ellis said.
Now, she says she has hope and energy to live life again. When she needs another infusion next year, she'll only have to travel down the street — not to Germany — to get it.
http://www.wfaa.com/story/news/health/2014/12/15/lemtrada-approved-for-treatment-of-multiple-sclerosis-in-us/20451859/
[MEI brought this story to my attention]
Solid!!!!
Any idea of the number of MDs with the coveted REMS Cert? Length of REMS Cert process? Projections of certified providers???
First MS Patients in the U.S. Receive Genzyme’s Lemtrada Following FDA Approval (12/03/14)
- Lemtrada now available in the U.S. two weeks post approval -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company, today announced that the first U.S. patients have initiated treatment with Lemtrada® (alemtuzumab) in the commercial setting following its November 14th FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
“As an investigator in the Phase III clinical development program with firsthand experience, I have been awaiting the ability to prescribe Lemtrada to patients in my practice who could potentially benefit from this treatment,” said Christopher LaGanke, M.D., founder of North Central Neurology Associates in Cullman, Ala. “Following REMS training and certification, I am excited that I was able to become the first physician to initiate patient treatment in the United States.”
Lemtrada has a unique dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
The FDA approval of Lemtrada was based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif® (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).
In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up.
“Since approval, we have been singularly focused on providing access as quickly as possible for those patients awaiting Lemtrada by ensuring drug availability, completing required REMS training and certifications, and establishing appropriate patient support,” said Bill Sibold, Head of Genzyme’s Multiple Sclerosis business.
The Lemtrada label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions and also noting Lemtrada may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders.
The most common side effects of Lemtrada are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. Other serious side effects associated with Lemtrada include autoimmune thyroid disease, autoimmune cytopenias, infections and pneumonitis.
Lemtrada is only available through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy). This program has been developed to ensure that access to Lemtrada in the U.S. is only through certified prescribers, healthcare facilities and pharmacies and to also ensure that patients are enrolled in the REMS program. The program is intended to help educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after the last infusion. The REMS is based on a developmental risk management program that was successfully implemented in the Phase 2 and Phase 3 trials and allowed for early detection and management of some of the serious risks associated with Lemtrada.
As part of its continued commitment to MS patients, Genzyme’s MS One to One® program will provide information about multiple sclerosis, Lemtrada and other relevant resources. MS One to One is available and staffed by dedicated MS nurses and highly trained representatives who can provide support for individuals living with MS, their health care providers, family and loved ones. For more information about these support services, call the MS One to One line at 1-855-MSOne2One (1-855-676-6326) Monday through Friday, from 8:30am – 8:00pm ET. Information and support are also available at www.MSOnetoOne.com
First approved in September 2013 in the European Union, Lemtrada is approved in more than 40 countries. Additional marketing applications for Lemtrada are under review by regulatory agencies around the world.
Multiple sclerosis is estimated to affect more than 2.3 million people globally. There are approximately 400,000 people living with MS in the United States.
Important Safety Information About Lemtrada for U.S. Patients
Serious and life-threatening autoimmune conditions such as immune thrombocytopenia (ITP) and anti-glomerular basement membrane disease can occur in patients receiving Lemtrada. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals in patients who receive Lemtrada. Lemtrada is associated with serious and life-threatening infusion reactions. Lemtrada can only be administered in certified healthcare settings that have on-site access to equipment and personnel trained to manage anaphylaxis and serious infusion reactions. Lemtrada may be associated with an increased risk of malignancy, including thyroid cancer, melanoma and lymphoproliferative disorders. The Lemtrada REMS Program, a comprehensive risk management program with frequent monitoring, is being implemented to help mitigate these serious risks.
The Lemtrada label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions and also noting Lemtrada may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. Lemtrada is contraindicated in patients with Human Immunodeficiency Virus (HIV) infection.
U.S. Indication and Usage
Lemtrada is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
Please visit www.lemtrada.com for full U.S. Prescribing Information for Lemtrada, including boxed warning and contraindications.
About Lemtrada® (alemtuzumab)
Alemtuzumab is a monoclonal antibody that targets CD52, a protein abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab depletes circulating T and B lymphocytes after each treatment course. Lymphocyte counts then increase over time with a reconstitution of the lymphocyte population that varies for the different lymphocyte subtypes.
In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rate (0.18 for Lemtrada and 0.39 for interferon beta-1a (p<0.0001) a 55 percent relative reduction. The difference observed in proportion of patients with disability progression at year two did not reach statistical significance (8 percent for Lemtrada and 11 percent for interferon beta 1-a (p=0.22)), a relative risk reduction of 30 percent. The percent of patients remaining relapse-free at year two for Lemtrada was 78 percent vs. 59 percent for interferon beta-1a (p<0.0001). The percent change in T2 lesion volume from baseline did not reach statistical significance (-9.3 for Lemtrada and -6.5 for interferon beta 1-a, p=0.31).
In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates (0.26 for Lemtrada and 0.52 for interferon beta 1-a, p<0.0001, a 49 percent relative reduction). The proportion of patients with confirmed six-month disability progression was significantly lower for Lemtrada (13 percent for Lemtrada vs. 21 percent for interferon beta 1-a, p=0.0084), a 42 percent relative risk reduction. The percent of patients remaining relapse-free at year two for Lemtrada was 65 percent vs. 47 percent for interferon beta-1a (p<0.0001). The percent change in T2 lesion volume from baseline did not reach statistical significance (-1.3 for Lemtrada and -1.2 for interferon beta 1-a, p=0.14).
Genzyme holds the worldwide rights to alemtuzumab and has responsibility for its development and commercialization in multiple sclerosis. Bayer Healthcare receives contingent payments based on global sales revenue.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Genzyme®, Lemtrada® and MS One to One® are registered trademarks of Genzyme Corporation. Rebif® is a registered trademark of EMD Serono, Inc. All rights reserved.
http://www.businesswire.com/news/home/20141203005183/en/MS-Patients-U.S.-Receive-Genzyme%E2%80%99s-Lemtrada-FDA#.VH8Yuol0yUk
I suspect best entry point will be around calendar year end. Tax loss selling. Look for high volume associated with decline in PPS. I remain long a bit over 20K sh. If you see high volume with PPS decline on last trading day of the calendar year and some recover on low volume on the first trading day of the new calendar year (2015), this is also a good entry point. January effect. Otherwise, this is a LT hold. Best to all.
Best Idea For 2014: Sanofi Rights Post-FDA Approval (11/26/14)
http://seekingalpha.com/article/2712625-best-idea-for-2014-sanofi-rights-post-fda-approval
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The CVR contains 5 discrete milestones related to the development and commercialization of Lemtrada: |
1) | Approval Milestone: CVR holders are entitled to receive $1 per CVR after U.S. FDA approval of Lemtrada for treatment of multiple sclerosis, if the approval occurs on or before March 31, 2014. |
2) | Product Sales Milestone #1: CVR holders are entitled to receive $2 per CVR in the event net sales for Lemtrada total $400 million or more on a global basis during specified periods following product launch. |
3) | Product Sales Milestone #2: CVR holders are entitled to receive $3 per CVR in the event global net sales for Lemtrada total $1.8 billion during any 4 consecutive calendar quarters. Any quarters used in the achievement of this sales milestone cannot be used again for the achievement of any subsequent milestones. In addition, if this Product Sales Milestone #2 is achieved despite U.S. FDA approval of Lemtrada for treatment of multiple sclerosis not having occurred on or before March 31, 2014 (and so the Approval Milestone Payment was not made), CVR holders will be entitled to receive an additional $1 per CVR for Product Sales Milestone #2. |
4) | Product Sales Milestone #3: CVR holders are entitled to receive $4 per CVR in the event global net sales for Lemtrada total $2.3 billion during any 4 consecutive calendar quarters. Any quarters used in the achievement of this sales milestone cannot be used again for the achievement of any subsequent milestones. |
5) | Product Sales Milestone #4: CVR holders are entitled to receive $3 per CVR in the event global net sales for Lemtrada total $2.8 billion during any 4 consecutive calendar quarters. |
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