I have observed that BCG improves plaque psoriasis. I will gladly demonstrate same for you on You Tube.
Shoot me. Life is short and I urge you to consider all the alternatives. See below, something that I am sure sure the drug company researchers did not disclose to participants and/or prospective participants. Life is a casino. Place your bets as you wish not as they wish.
Just because you are sick and desperate does not mean that you lack the capacity or inclination to ask questions or see that regeneron et al disclose to you the risks, benefits and alternatives to what they seek to sell to you at great expense !
http://www.regeneron.com/regn688
BCG came from France. France is good
Pharmaceutical Company comes from France. The devil loves only money?
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FORM 4
[ ]
Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue.
See
Instruction 1(b).
|
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549 |
OMB APPROVAL
OMB Number: 3235-0287 Estimated average burden hours per response... 0.5 |
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| 1. Name and Address of Reporting Person * Sanofi | 2. Issuer Name and Ticker or Trading Symbol REGENERON PHARMACEUTICALS INC [ REGN ] |
5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)
_____ Director
__
X
__ 10% Owner
_____ Officer (give title below) _____ Other (specify below) |
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3. Date of Earliest Transaction
(MM/DD/YYYY)
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4. If Amendment, Date Original Filed
(MM/DD/YYYY)
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6. Individual or Joint/Group Filing
(Check Applicable Line)
_
X
_ Form filed by One Reporting Person
___ Form filed by More than One Reporting Person |
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Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned |
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1.Title of Security
(Instr. 3) |
2. Trans. Date | 2A. Deemed Execution Date, if any |
3. Trans. Code
(Instr. 8) |
4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) |
5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) |
6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) | 7. Nature of Indirect Beneficial Ownership (Instr. 4) | |||
| Code | V | Amount | (A) or (D) | Price | ||||||
| Common Stock | 7/15/2014 | P | 1865 (1) (2) | A | $310.1843 (1) (3) | 22077606 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 4144 (1) (2) | A | $311.0431 (1) (5) | 22081750 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 9669 (1) (2) | A | $312.2346 (1) (6) | 22091419 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 27048 (1) (2) | A | $313.0640 (1) (7) | 22118467 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 24749 (1) (2) | A | $314.1123 (1) (8) | 22143216 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 12830 (1) (2) | A | $314.9629 (1) (9) | 22156046 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 12683 (1) (2) | A | $316.0220 (1) (10) | 22168729 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 18772 (1) (2) | A | $317.1444 (1) (11) | 22187501 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 8131 (1) (2) | A | $318.1141 (1) (12) | 22195632 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 8409 (1) (2) | A | $319.0803 (1) (13) | 22204041 | I | See note (4) | ||
| Common Stock | 7/15/2014 | P | 800 (1) (2) | A | $319.6944 (1) (14) | 22204841 | I | See note (4) | ||
|
Table II - Derivative Securities Beneficially Owned ( e.g. , puts, calls, warrants, options, convertible securities) |
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1. Title of Derivate Security
(Instr. 3) |
2. Conversion or Exercise Price of Derivative Security | 3. Trans. Date | 3A. Deemed Execution Date, if any |
4. Trans. Code
(Instr. 8) |
5. Number of Derivative Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) |
6. Date Exercisable and Expiration Date |
7. Title and Amount of Securities Underlying Derivative Security
(Instr. 3 and 4) |
8. Price of Derivative Security
(Instr. 5) |
9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) | 10. Ownership Form of Derivative Security: Direct (D) or Indirect (I) (Instr. 4) | 11. Nature of Indirect Beneficial Ownership (Instr. 4) | ||||
| Code | V | (A) | (D) | Date Exercisable | Expiration Date | Title | Amount or Number of Shares | ||||||||
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Reporting Owners
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| Reporting Owner Name / Address |
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| Director | 10% Owner | Officer | Other | ||
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Sanofi
54, RUE LA BOETIE PARIS, I0 75008 |
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X |
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Signatures
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| /s/ John Felitti, Associate Vice President, Corporate Law, Financial & Securities Law | 7/17/2014 | |
| ** Signature of Reporting Person | Date | |
| Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly. | |
| * | If the form is filed by more than one reporting person, see Instruction 4(b)(v). |
| ** | Intentional misstatements or omissions of facts constitute Federal Criminal Violations. See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a). |
| Note: | File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure. |
| Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB control number. | |
Dupilumab/REGN668
(IL-4R Antibody)
An antibody to the receptors for
interleukin-4 and interleukin-13 that is being evaluated in atopic
dermatitis and eosinophilic asthma in collaboration with Sanofi.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
(IL-4R Antibody)
Pipeline
Clinical Leadership
Inflammation
ARCALYST® (rilonacept)
Sarilumab/REGN88 (IL-6R Antibody)
Dupilumab/REGN668 (IL-4R Antibody)
Cardiovascular and Metabolism
Oncology
Ophthalmology
Clinical Trials
Pain
An antibody to the receptors for interleukin-4 and interleukin-13 that is being evaluated in atopic dermatitis and eosinophilic asthma in collaboration with Sanofi.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
- See more at: http://www.regeneron.com/regn688#sthash.qD9sjgpx.dpufDupilumab/REGN668
(IL-4R Antibody)
Pipeline
Clinical Leadership
Inflammation
ARCALYST® (rilonacept)
Sarilumab/REGN88 (IL-6R Antibody)
Dupilumab/REGN668 (IL-4R Antibody)
Cardiovascular and Metabolism
Oncology
Ophthalmology
Clinical Trials
Pain
An antibody to the receptors for interleukin-4 and interleukin-13 that is being evaluated in atopic dermatitis and eosinophilic asthma in collaboration with Sanofi.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
- See more at: http://www.regeneron.com/regn688#sthash.qD9sjgpx.dpuf
Dupilumab/REGN668
(IL-4R Antibody)
An antibody to the receptors for
interleukin-4 and interleukin-13 that is being evaluated in atopic
dermatitis and eosinophilic asthma in collaboration with Sanofi.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
Dupilumab/REGN668
(IL-4R Antibody)
An antibody to the receptors for
interleukin-4 and interleukin-13 that is being evaluated in atopic
dermatitis and eosinophilic asthma in collaboration with Sanofi.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
>>> Rigshospitalet <news@meltwaterpress.com> 9/3/2012 9:27 AM >>>
 Press release |
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3rd of September 2012 |
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Tuberculosis vaccine - a new remedy for allergies and asthma in children? M Can a vaccine against tuberculosis help combat asthma and eczema in Danish children early in life? This will now be examined in a comprehensive Danish research study. From September 2012, thousands of Danish pregnant women will receive an invitation to allow their newborns to take part in a sensational trial. The tuberculosis vaccine was removed from the vaccine program in Denmark during the 1980s, however new research indicates that the vaccine can improve the health of children. Research carried out in developing countries shows that the health of infants who have been given the tuberculosis vaccine (BCG/Calmette) at birth is improved and the babies have a better survival rate than those who have not been given the vaccine. The vaccine also seems to have a preventive effect against asthma and atopic dermatitis. Results are so striking that they cannot be explained by the fact that the children did not catch tuberculosis. Therefore, researchers assess the vaccine to have a general positive effect on the immune system, which means that children are less sick, and have less atopic dermatitis, asthma and allergies. Whether this positive effect also can benefit Danish children will now be examined in a large Danish research project headed by Lone Graff Stensballe, Paediatrician from the Department of Paediatrics and Adolescent Medicine at Rigshospitalet. The research project will run for three years, starting in September 2012, where 4,300 infants and their parents will be followed through interviews, examinations, and, for 300 of the children, blood tests as well. The project will comprise five PhD courses and a research collaboration with obstetricians, paediatricians, midwives, nurses and laboratory technicians from the three hospitals taking part in the project. “We are very excited about this unique opportunity to improve the health of Danish children early in life,” says Lone Graff Stensballe. “Unfortunately, we have seen large increases in admissions, consumption of medicines, asthma, eczema and allergies among Danish children. We hope to curb these increases with the new research project.” The research project will be carried out at Rigshospitalet in collaboration with Hvidovre Hospital, Kolding Sygehus Lillebælt and the new Centre for Vitamins and Vaccines at SSI (Statens Serum Institut). For further information and interviews, please contact: Lone Graff Stensballe Head of Research Paediatrician, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Denmark Telephone: +45 6022 8092 E-mail: lone.graff.stensballe@rh.regionh.dk |
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Afmelding: Ønsker du ikke længere at få tilsendt e-mails fra Rigshospitalet via Meltwater Press, venligst klik: [her]. Afmelding kan tage op til 2 arbejdsdage.
Hvis du ønsker at kontakte Meltwater Press, kan du kontakte Meltwater Press på:
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N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.
Dupilumab treatment in adults with moderate-to-severe atopic dermatitis.
Beck LA1, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suárez-Fariñas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR.
Abstract
BACKGROUND:
Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13, has shown efficacy in patients with asthma and elevated eosinophil levels. The blockade by dupilumab of these key drivers of type 2 helper T-cell (Th2)-mediated inflammation could help in the treatment of related diseases, including atopic dermatitis.METHODS:
We performed randomized, double-blind, placebo-controlled trials involving adults who had moderate-to-severe atopic dermatitis despite treatment with topical glucocorticoids and calcineurin inhibitors. Dupilumab was evaluated as monotherapy in two 4-week trials and in one 12-week trial and in combination with topical glucocorticoids in another 4-week study. End points included the Eczema Area and Severity Index (EASI) score, the investigator's global assessment score, pruritus, safety assessments, serum biomarker levels, and disease transcriptome.RESULTS:
In the 4-week monotherapy studies, dupilumab resulted in rapid and dose-dependent improvements in clinical indexes, biomarker levels, and the transcriptome. The results of the 12-week study of dupilumab monotherapy reproduced and extended the 4-week findings: 85% of patients in the dupilumab group, as compared with 35% of those in the placebo group, had a 50% reduction in the EASI score (EASI-50, with higher scores in the EASI indicating greater severity of eczema) (P<0.001); 40% of patients in the dupilumab group, as compared with 7% in the placebo group, had a score of 0 to 1 (indicating clearing or near-clearing of skin lesions) on the investigator's global assessment (P<0.001); and pruritus scores decreased (indicating a reduction in itch) by 55.7% in the dupilumab group versus 15.1% in the placebo group (P<0.001). In the combination study, 100% of the patients in the dupilumab group, as compared with 50% of those who received topical glucocorticoids with placebo injection, met the criterion for EASI-50 (P=0.002), despite the fact that patients who received dupilumab plus glucocorticoids used less than half the amount of topical glucocorticoids used by those who received placebo plus the topical medication (P=0.16). Adverse events, such as skin infection, occurred more frequently with placebo; nasopharyngitis and headache were the most frequent adverse events with dupilumab.CONCLUSIONS:
Patients treated with dupilumab had marked and rapid improvement in all the evaluated measures of atopic dermatitis disease activity. Side-effect profiles were not dose-limiting. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov numbers, NCT01259323, NCT01385657, NCT01639040, and NCT01548404.).Lisa A. Beck, M.D.
Contact Information
University of Rochester Medical CenterSchool of Medicine and Dentistry
601 Elmwood Ave, Box 697
Rochester, NY 14642
Fax: (585) 461-3509
Administrative: (585) 275-3871
Lab: (585) 276-3209
lisa_beck@urmc.rochester.edu
New
drugs that block highly specific parts of the immune system are showing
remarkable promise in treating two maddening skin diseases, eczema and
psoriasis, according to papers published Wednesday in a leading medical
journal.
In
four small studies, an experimental drug being developed by Sanofi and
Regeneron Pharmaceuticals brought about a marked and rapid improvement
in symptoms of eczema, including the telltale incessant itching, the
researchers reported. Separately, the companies announced results of
still another trial Wednesday that showed similar success, although
those results have not been reviewed by outside experts.
While
larger studies are still needed, experts said the results were
important because there are no approved treatments that work well in
patients with moderate or severe eczema, also called atopic dermatitis.
“What
is exciting is there is now the hope of a therapy that so far looks
very efficacious and so far looks quite safe, very safe in fact,” said
Dr. Lisa A. Beck, a professor of dermatology at the University of
Rochester Medical Center.
Dr. Beck, who is a paid consultant to the two companies, was the lead author of the paper on the drug, dupilumab, that was published in the New England Journal of Medicine.
For
psoriasis, a drug being developed by Novartis proved to be highly
effective in late-stage clinical trials in clearing the skin of the
characteristic patchy red plaques, according to another paper also
published in the medical journal.
Many
effective therapies are already on the market for psoriasis, however,
and Dr. Mark Lebwohl, chairman of dermatology at Mount Sinai Hospital in
New York and an author of the paper, said the Novartis drug,
secukinumab, might be better than the other drugs, but “only a little
better.”
Atopic
dermatitis affects perhaps as much as 20 percent of the population,
about a fifth of whom have moderate to severe cases of the disease,
according to Dr. Beck’s paper. Regeneron estimates about one million
adults in the United States may be in that category.
While topical treatments are available, they do not work well for more severe cases, doctors say.
Those
patients can use systemic steroids or other immune suppressants like
cyclosporine. But they are not officially approved for the condition and
although they work well, they can have severe side effects that limit
how long they can be used. Among other things, immune suppression
increases susceptibility to infections, and people with atopic
dermatitis already suffer from recurrent skin infections.
Some
experts said that while dupilumab might not be more effective than
general immune suppressants, it has a more specific mode of action,
inhibiting only two immune system proteins — interleukin-4 and
interleukin-13 — that contribute to the disease. That could make it
safer.
“This
is a fantastic advance for millions of people,” said Dr. Richard Gallo,
chief of the division of dermatology at the University of California,
San Diego, who was not involved in the studies reported in the new
paper.
In
one of the trials, that lasted 12 weeks and involved 109 adults with
moderate or severe atopic dermatitis, 85 percent of those who got weekly
injections of dupilumab had a 50 percent reduction in a score measuring
disease severity, compared with 35 percent who received weekly
injections of a placebo.
About
40 percent of those who used the drug had a complete or near-complete
clearance of skin lesions compared with only 7 percent of those in the
placebo group. The drug also did better than a placebo in reducing
itching.
The
people who got the drug had fewer skin infections than those in the
control group. The main side effects of the drug were headaches and cold
symptoms like runny noses.
Kathleen
Cronin, a mechanical engineer from Rochester, said that two years ago
her eczema had become so severe that she had red skin all over her body,
open wounds that would not heal, bacterial infections and fatigue.
“It’s just pulling you to scratch until you have an open wound and the
blood is flowing,” she said.
After
Ms. Cronin, 52, entered the trial for dupilumab, her condition got even
worse. But she now thinks she was getting the placebo. Three weeks ago
she began taking the actual drug in an extension of the trial.
“I’ve
had three shots now and it’s been literally a miracle,” she said. Her
skin is no longer red and she doesn’t itch, allowing her to sleep
better.
In
their separate announcement Wednesday, Sanofi and Regeneron said they
had completed a larger Phase 2 study involving 380 patients, with the
drug showing similar effectiveness as in the smaller study. The
companies will now begin Phase 3 testing aimed at obtaining approval for
the drug for use by adults. Eventually they hope to test it for
children as well. Dupilumab has also shown some promise in treating
asthma.
Dupilumab
could be the first biologic — a drug produced in living cells — to
reach the market for atopic dermatitis. But other companies like Johnson
& Johnson and Chugai Pharmaceutical are testing biologics that work
through different mechanisms, according to the National Eczema Association.
By
contrast, several biologics are already available to treat psoriasis,
including Amgen’s Enbrel, AbbVie’s Humira and Johnson & Johnson’s
Remicade and Stelara.
The
two clinical trials for psoriasis sponsored by Novartis involved more
than 2,000 patients. One measure of success was how many patients
achieved a 75 percent reduction in disease severity after 12 weeks.
From 67 to 82 percent of patients who took Novartis’s secukinumab
achieved that goal, far better than the 5 percent who received a
placebo and the 44 percent for those who used Enbrel. More than half the
patients who got secukinumab had completely or nearly completely clear
skin after 12 weeks. Secukinumab inhibits an immune system protein
called interleukin-17A.
“This
is a very small part of the immune system that is hit and it appears
from the results that it is the part of the immune system you have to
hit to get rid of psoriasis,” said Dr. Lebwohl, who has been a paid
consultant to Novartis.
Novartis
has already applied for regulatory approval. Eli Lilly and the team of
Amgen and AstraZeneca are in late-stage testing of their own drugs that
work by blocking the action of interleukin-17A.
Office: (585) 275-1039
Dupilumab/REGN668
(IL-4R Antibody)
An antibody to the receptors for
interleukin-4 and interleukin-13 that is being evaluated in atopic
dermatitis and eosinophilic asthma in collaboration with Sanofi.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
Dupilumab/REGN668
(IL-4R Antibody)
An antibody to the receptors for
interleukin-4 and interleukin-13 that is being evaluated in atopic
dermatitis and eosinophilic asthma in collaboration with Sanofi.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
Development Phase: Phase 2 in eosinophilic asthma and Phase 2 in atopic dermatitis.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.
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