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1-Methyl-N-[(1S)-2-(methyl-(phenylmethyl)amino)-2-oxo-1-phenylethyl]-5-[[oxo-[2-[4-(trifluoromethyl)phenyl]phenyl]methyl]amino]-2-indolecarboxamide
C40-H33-F3-N4-O3
674
Antiobesity agent
N-{(1S)-2-[Benzyl(methyl)amino]-2-oxo-1-phenylethyl}-1-methyl-5-[4′-(trifluoromethyl)biphenyl-2-carboxamido]-1H-indol-2-carboxamide (WHO)
1H-Indole-2-carboxamide, 1-methyl-N-[(1S)-2-[methyl(phenylmethyl)amino]-2-oxo-1-phenylethyl]-5-[[[4′-(trifluoromethyl)[1,1′-biphenyl]-2-yl]carbonyl]amino]- (USAN)
1-Methyl-5-[(4′-trifluormethylbiphenyl-2-carbonyl)amino]-1H-indol-2-carbonsäure-[(S)-(benzylmethylcarbamoyl)phenylmethyl]amid (IUPAC)
5-[4′-(Trifluoromethylbiphenyl-2-carbonyl)amino]-1H-indole-2-carboxylic acid benzylmethyl carbamoylamide
| Identifiers | |
|---|---|
| CAS number | 481658-94-0 |
| ATCvet code | QA08AB91 |
Dirlotapide is a drug used to treat obesity in dogs. It is manufactured by Pfizer and marketed as Slentrol.
It works as a selective microsomal triglyceride transfer protein (MTTP) inhibitor. This blocks the assembly and release of lipoproteins into the bloodstream, thereby reducing fat absorption. It also elicits a satiety signal from lipid-filled cells lining the intestine.
It is supplied as an oral solution. It is not intended for use in humans, cats, or parrots.
On January 5 2007, the U.S. Food and Drug Administration (FDA) approved Slentrol, the first time the FDA has approved a drug for obese dogs.[1]
Dirlotapide is used to manage obesity in dogs and helps by reducing appetite. It should be used as part of an overall weight control program that also includes proper diet and exercise, under the supervision of a veterinarian. Side effects may include vomiting, diarrhea, lethargy, drooling, or uncoordination. Allergic reaction to the medication may include, facial swelling, hives, scratching, sudden onset of diarrhea, vomiting, shock, seizures, pale gums, cold limbs, or coma. Contact your veterinarian if you observe any of these signs. The dose of dirlotapide will need to be recalculated each month, based on your dog’s weight.
Canine patient information sheet http://www.drsfostersmith.com/Rx_Info_Sheets/rx_dirlotapide.pdf
EMEDASTINE DIFUMARATE
Emedastine difumarate (Emadine) is a second generation antihistamine used in eye drops to treat allergic conjunctivitis. Its mechanism of action is a H1 receptor antagonist.
| Active Ingredient | Form | Dosage | Drug Type | Application | Product | |
|---|---|---|---|---|---|---|
| EMEDASTINE DIFUMARATE | SOLUTION/DROPS; OPHTHALMIC | 0.05% | RX | 020706 | 001 |
There are 1 patent(s) protecting ALCON’s EMADINE.
The last patent expires on 2013-12-08.
| Patent | Expiration | |
|---|---|---|
| US5441958 | Ophthalmic compositions comprising emedastine and methods for their use
Topical ophthalmic compositions comprising 1-(2-ethoxyethyl)-2-(4-methyl-1-homopiperazinyl)-benzimidazole and its ophthalmically acceptable acid addition salts have been found to be useful in treating allergic conjunctivitis and related ailments.
|
2013-12-8 |
Exclusivity is marketing rights granted by the FDA to the ALCON.
EMADINE ® (emedastine difumarate ophthalmic solution) 0.05% is a sterile ophthalmic solution containing emedastine, a relatively selective, H1-receptorantagonist for topical administration to the eyes. Emedastine difumarate is a white, crystalline, water-soluble fine powder with a molecular weight of 534.57. The chemical structure is presented below:
Structural Formula:
 |
Chemical Name:
lH-Benzimidazole, 1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl), (E)-2-butenedioate (1:2)
Each mL of EMADINE contains: Active: 0.884 mg emedastine difumarate equivalent to 0.5 mg emedastine. Preservative: benzalkonium chloride0.01%. Inactives: tromethamine; sodium chloride; hydroxypropyl methylcellulose; hydrochloric acid/sodium hydroxide (adjust pH); and purified water. It has a pH of approximately 7.4 and an osmolality of approximately 300 mOsm/kg.
l-(2- ethoxyethyl)-2-(4-methyl-l-homopiperazinyl)-benzimidazole, otherwise known asemedastine, and its ophthalmically acceptable acid addition salts and methods for their use.
Allergic conjunctivitis is frequently characterized by ocular pruritus
(itching), erythema (inflammatory redness), edema and tearing. This condition is one of the most frequently treated by ophthalmologists, optometrists and allergists. To date, treatment has been primarily through the use of topically applied histamine t antagonists in combination with α-agonists. See, for example, the following articles:
1. Miller, J. and E.H. Wolf, “Antazoline phosphate and naphazoline hydrochloride, singly and in combination for the treatment of allergic conjunctivitis – a controlled, double-blind clinical trial.” Ann. Allergy, 35:81-86 (1975). 2. Vandewalker, M.L. et al., “Efficacy of Vasocon-A and its components with conjunctival provocation testing (CPT).” j± Allergy Clin. Immunol., 83:302 (1989). 3. Abelson, M.B. et al., “Effects of topically applied ocular decongestant and antihistamine.” Am. I. Ophthalmol., 90:254- 257 (1980).
Recent studies indicate that the antihistamine levocabastine exhibits clinical activity in patients with allergic conjunctivitis without the addition of a vasoconstrictor. See, Dechant, K.L. and K.L. Goa, “Levocabastine. A review of its pharmacological properties and therapeutic potential as a topical antihistamine in allergic rhinitis and conjunctivitis/’ Drugs, 41:202-224 (1991). In addition, it has recently been demonstrated that Hα antagonists are effective in relieving conjunctival injection (hyperemia) and erythema, as well as pruritus. See, Berdy, G.J. et al., “Allergic conjunctivitis: A survey of new antihistamines.” T. Ocular Pharmacol.. 7:313-324 (1991).
Although there are many different antihistamines available for systemic treatment of allergies and related ailments, many such antihistamines are not suitable for topical ophthalmic use because of limited ocular bioavailability. For example, terfenadine (Seldane®, made by Marion Merrell Dow), astemizole (Hismanal®, made by Janssen Pharmaceutica) and loratadine (Claritin®, made by Schering) all have good systemic activity; however, terfenadine has little or no local ocular activity, and astemizole and loratadine each have greatly reduced local ocular activity (as compared to its systemic activity).
This week, Bristol-Myers Squibb Company announced new data on the investigational anti-IL-6 antibody clazakizumab in adult patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate will be highlighted at the 2013 annual meeting of the American College of Rheumatology (ACR), taking place from October 25-30 in San Diego, Calif.
This asset was developed by Alder Biopharmaceuticals, and partnered with Bristol-Myers Squibb in 2009 in a deal worth $85 million up front and an additional $764 million in potential milestone payments. The therapeutic was developed using Alder’s yeast-based production technology, Mab Xpress, which enables the production of high quantities of antibodies.
Alder’s technology allows this class of therapeutics to enter disease areas that have previously been inaccessible for antibodies, such as migraine and cardiovascular disease. Alder is advancing an antibody therapeutic developed using this technology, ALD403, which targets the calcitonin gene-related peptide (CGRP) and holds promise for treating…
View original post 41 more words
With 11 treatments in Phase I trials, 8 in Phase II, and 13 in Phase III, Bayer has a strong pipeline.
By far the most interest currently, given that the latest reports came out October 21st, is riociguat (BAY 63-2521),
which has had good news from its ongoing Phase III clinical trials of the treatment for pulmonary arterial hypertension, also known as PAH. PAH is a progressive condition that overburdens the heart.
Trials indicate subjects had improved heart function and could better tolerate physical exercise. Patients on riociguat improved their walking distance by 36 meters on average, while those on placebo showed no improvement.
Professor Hossein Ardeschir Ghofrani of University Hospital Giessen, the principal investigator, was quite pleased with the results and explained the value of the measurement. “The six-minute walk distance test is a well-validated clinical measure in patients with PAH, and therefore, the results of the PATENT-1 trial are encouraging. . .These data from the PATENT study suggest that riociguat may be a potential treatment option both for patients who have never been treated for PAH as well as for those who have received prior treatment.”
Hossein A. Ghofrani
Associate Professor of Internal Medicine,
MD (University of Giessen) 1995 Research interests: pulmonary hypertension, ischaemia-reperfusion, experimental therapeutics, clinical trials
http://www.uni-giessen.de/cms/fbz/fb11/forschung/graduierte/mbml/faculty
Although Bayer put forth no sales estimate for the treatment, analysts predicted 2017 sales from riociguat of $480 million
BAYER PIPELINE AS ON OCT 25 2013
phase 1
| Project | Indication |
|---|---|
| CDK-Inhibitor (BAY 1000394) | Cancer |
| Mesothelin-ADC (BAY 94-9343) | Cancer |
| PSMA Bi TE Antibody (BAY 2010112) | Cancer |
| PI3K-Inhibitor (BAY 1082439) | Cancer |
| FGFR2 Antibody (BAY 1179470) | Cancer |
| HIF-PH (BAY 85-3934) | Anemia |
| Partial Adenosine A1 Agonist(BAY 1067197) | Heart Failure |
| Vasopressin Receptor Antagonist(BAY 86-8050) | Heart Failure |
| sGC Stimulator (BAY 1021189) | Heart Failure |
| S-PRAnt (BAY 1002670) | Symptomatic uterine fibroids |
| BAY 1026153 | Endometriosis |
phase2
| Project | Indication |
|---|---|
| PI3K-Inhibitor (BAY 80-6946) | Cancer |
| Regorafenib | Cancer |
| Refametinib (MEK-Inhibitor) | Cancer |
| Radium-223-Dichloride | Cancer |
| Sorafenib | Additional Indications |
| MR-Antagonist (BAY 94-8862) | Congestive Heart Failure (CHF) |
| MR-Antagonist (BAY 94-8862) | Diabetic Nephopathy |
| Riociguat (sGC Stimulator) | Pulmonary Hypertension |
| Neutrophil Elastase Inhibitor(BAY 85-8501) | Bronchiectasis |
phase 3
| Project | Indication |
|---|---|
| Sorafenib | Breast Cancer |
| Sorafenib | Adjuvant HCC |
| Sorafenib | Adjuvant RCC |
| Regorafenib | HCC 2nd line |
| Rivaroxaban | Major Adverse Cardiac Events |
| Rivaroxaban | CHF and CAD |
| peg rFVIII(BAY 94-9027) | Hemophilia |
| Aflibercept | Myopic choroidal neovascularization (mCNV) |
| Aflibercept | Diabetic Macular Edema (DME) |
| LCS 16 | Contraception |
| Vaginorm | Vulvovaginal atrophy (VVA) |
| Sodium Deoxycholate | Submental fat removal |
| Cipro DPI | Lung infection |
| Tedizolid | Skin and Lung Infections |
| Amikacin Inhale | Gram-negative pneumonia |
Sorafenib tosylate
https://newdrugapprovals.wordpress.com/2013/07/16/nexavar-sorafenib/
TEDIZOLID PHOSPHATE
Leverkusen, October 8, 2013 – Following the recent commercial introduction of five new drugs to address the medical needs of patients with various diseases, Bayer is now accelerating the development of further five promising drug candidates which are currently undergoing phase I and II clinical studies. The company today announced that it plans to progress these five new highly innovative drug candidates in the areas of oncology, cardiology, and women’s health into phase III clinical studies by 2015.
“Our Pharma research and development has done a tremendous job of bringing five new products to the market offering physicians and patients new treatment alternatives for serious diseases”, said Bayer CEO Dr. Marijn Dekkers. “Following our mission statement ‘Science For A Better Life’, the five chosen further drug candidates all have the potential to impact the way diseases are treated for the benefit of patients.”
Bayer CEO Dr. Marijn Dekkers
“Our research and development activities are strongly focused on areas where treatment options are not available today or where true breakthrough innovations are missing”, said Prof. Andreas Busch, member of the Bayer HealthCare Executive Committee and Head of Global Drug Discovery at Bayer HealthCare. “Our drug development pipeline holds a number of promising candidates which we want to bring to patients who need them urgently”, said Kemal Malik, member of the Bayer HealthCare Executive Committee, Chief Medical Officer and Head of Pharmaceutical Development at Bayer HealthCare. “Furthermore we are continuing to expand the range of indications for all our recently launched products Xarelto, Stivarga, Xofigo, Riociguat as well as Eylea and further refine the profile of these drugs in specific patient populations.”
Cl 223Ra Cl
Xofigo
https://newdrugapprovals.wordpress.com/2013/09/21/xofigo-injection-recommended-for-approval-in-eu/
The five mid-stage candidates have been selected for accelerated development based on positive “proof-of-concept” data from early clinical studies. Three of them are development compounds in the area of cardiology or the cardio-renal syndrome: Finerenone (BAY 94-8862) is a next generation oral, non-steroidal Mineralocorticoid Receptor antagonist which blocks the deleterious effects of aldosterone. Currently available steroidal MR antagonists have proven to be effective in reducing cardiovascular mortality in patients with heart failure but have significant side effects that limit their utilization. Finerenone is currently in clinical Phase IIb development for the treatment of worsening chronic heart failure, as well as diabetic nephropathy.
Finerenone (BAY 94-8862)
The second drug candidate in the area of cardiology is an oral soluble guanylate cyclase (sGC) stimulator (BAY 1021189). The start of a Phase IIb study in patients with worsening chronic heart failure is expected later this year.
For the cardio-renal syndrome, a Phase IIb program with the investigational new drug Molidustat (BAY 85-3934) is under initiation in patients with anemia associated with chronic kidney disease and/or end-stage renal disease. Molidustat is a novel inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) which stimulates erythropoietin (EPO) production and the formation of red blood cells. Phase I data have shown that inhibition of HIF-PH by Molidustat results in an increase in endogenous production of EPO.
Molidustat (BAY 85-3934)
In oncology, Copanlisib (BAY 80-6946), a novel, oral phosphatidylinositol-3 kinases (PI3K) inhibitor, was selected for accelerated development. Copanlisib demonstrated a broad anti-tumor spectrum in preclinical tumor models and promising early clinical signals in a Phase I study in patients with follicular lymphoma. A Phase II study in patients with Non-Hodgkin’s lymphoma is currently ongoing.
Bayer has also made good progress in the development of new treatment options for patients with gynecological diseases: sPRM (BAY 1002670) is a novel oral progesterone receptor modulator that holds the promises of long-term treatment of patients with symptomatic uterine fibroids. Based on promising early clinical data the initiation of a Phase III study is planned for mid-2014.
Initiation of further studies with recently launched products
Bayer has successfully launched five new pharmaceutical products, namely Xarelto™, Stivarga™, Xofigo™, Eylea™, and Riociguat, which has very recently been approved in Canada under the trade name Adempas™.
Regorafenib, stivarga
Bayer’s Eylea (aflibercept),
https://newdrugapprovals.wordpress.com/2013/06/01/lucentis-rival-one-step-away-from-nhs-approval/
Xarelto has been approved globally for five indications across seven distinct areas of use, allowing doctors to treat patients in a greater variety of venous and arterial thromboembolic conditions than any other novel oral anticoagulant. The company continues to study the use of Xarelto for the treatment of further cardiovascular diseases. Ongoing clinical Phase III studies include COMPASS and COMMANDER-HF. The COMPASS study will assess the potential use of Xarelto in combination with aspirin, or as a single treatment to prevent major adverse cardiac events (MACE) in nearly 20,000 patients with atherosclerosis related to coronary or peripheral artery disease. The COMMANDER-HF study will evaluate the potential added benefit of Xarelto in combination with single or dual-antiplatelet therapy to help reduce the risk of death, heart attack and stroke in approximately 5,000 patients with chronic heart failure and coronary artery disease, following hospitalization for exacerbation of their heart failure.
In order to answer medically relevant questions for specific patient populations Bayer has initiated a range of additional Xarelto studies in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent placement (PIONEER-AF-PCI), cardioversion (X-VERT) or an AF ablation procedure (VENTURE-AF).
As an extension to the Xarelto clinical trial programme, a number of real-world studies are designed to observe and further evaluate Xarelto in everyday clinical practice. These include the XAMOS study of more than 17,000 orthopaedic surgery patients, which confirmed the clinical value of oral, once-daily Xarelto in routine clinical practice in adults following orthopaedic surgery of the hip or knee. XANTUS is designed to collate data on real-world protection with Xarelto in over 6,000 adult patients in Europe with non-valvular AF at risk of stroke while XANAP is designed to collate data on real-world protection with Xarelto in over 5,000 adult patients in Europe and Asia with non-valvular AF at risk of stroke. XALIA will generate information from over 4,800 patients treated for an acute DVT with either Xarelto or standard of care.
In the area of oncology, Stivarga has been approved in 42 countries for use against metastatic colorectal cancer that is refractory to standard therapies, and additionally for gastrointestinal stromal tumor (GIST) in the US and Japan. Bayer is now planning to assess Stivarga in earlier stages of colorectal cancer as well as other cancer types. A Phase III trial in patients with colorectal cancer after resection of liver metastases is currently under initiation. Based on early clinical data Bayer has also initiated a Phase III study in liver cancer in patients who have progressed on sorafenib treatment.
Furthermore, the anti-cancer drug Xofigo (radium 223 dichloride) is a first-in-class alpha-pharmaceutical which is designed for use in prostate cancer patients with ‘bone metastases’ (secondary cancers in the bone) to treat the cancer in the bone and to help extend their lives. Xofigo is approved in the US for the treatment of patients with advanced castrate-resistant prostate cancer with symptomatic bone metastases. In addition, the European CHMP recently gave a positive opinion for radium 223 dichloride for the same use. The decision of the European Commission on the approval is expected in the fourth quarter of 2013.
Based on the excellent Phase III results for Xofigo in patients with castration resistant prostate cancer and symptomatic bone metastases Bayer is looking to expand the use of Xofigo to earlier stages of the disease, and plans to initiate a Phase III study in combination with the novel anti-hormonal agent abiraterone. In addition, early stage signal-generating studies in other cancer forms where bone metastases are important causes of morbidity and mortality are planned.
In the area of pulmonary hypertension Adempas (Riociguat) is the first member of a novel class of compounds – so-called ‘soluble guanylate cyclase (sGC) stimulators’ – being investigated as a new and specific approach to treating different types of pulmonary hypertension (PH). Adempas has the potential to overcome a number of limitations of currently approved treatments for pulmonary arterial hypertension (PAH) and addresses the unmet medical need in patients with chronic thromboembolic pulmonary hypertension (CTEPH). It was approved for the treatment of CTEPH in Canada in September 2013, making it the world’s first drug approved in this deadly disease.
Riociguat has already shown promise as a potential treatment option beyond these two PH indications. An early clinical study was conducted in PH-ILD (interstitial lung disease), a disease characterized by lung tissue scarring (fibrosis) or lung inflammation which can lead to pulmonary hypertension, and, based on positive data, the decision was taken to initiate Phase IIb studies in PH-IIP (idiopathic pulmonary fibrosis), a subgroup of PH-ILD. Moreover, scientific evidence was demonstrated in preclinical models that the activity may even go beyond vascular relaxation. To prove the hypothesis Bayer is initiating clinical studies in the indication of systemic sclerosis (SSc), an orphan chronic autoimmune disease of the connective tissue affecting several organs and associated with high morbidity and mortality. If successful, Riociguat has the potential to become the first approved treatment for this devastating disease.
In the area of ophthalmology, Eylea (aflibercept solution for injection) is already approved in Europe and several additional countries for the treatment of neovascular (wet) age-related macular degeneration and for macular edema following central retinal vein occlusion. In September, Bayer HealthCare and Regeneron Pharmaceuticals presented data of the two phase III clinical trials VIVID-DME and VISTA-DME of VEGF Trap-Eye for the treatment of diabetic macular edema (DME) at the annual meeting of the Retina Society in Los Angeles and at the EURetina Congress in Hamburg, Germany. Both trials achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity from baseline compared to laser photocoagulation at 52 weeks. Bayer plans to submit an application for marketing approval for the treatment of DME in Europe in 2013.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 54,900 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
DULAGLUTIDE
PRONUNCIATION doo” la gloo’ tide
THERAPEUTIC CLAIM Treatment of type II diabetes
CHEMICAL NAMES
1. 7-37-Glucagon-like peptide I [8-glycine,22-glutamic acid,36-glycine] (synthetic
human) fusion protein with peptide (synthetic 16-amino acid linker) fusion protein with immunoglobulin G4 (synthetic human Fc fragment), dimer
2. [Gly8,Glu22,Gly36]human glucagon-like peptide 1-(7-37)-peptidyltetraglycyl-Lseryltetraglycyl-L-seryltetraglycyl-L-seryl-L-alanyldes-Lys229-[Pro10,Ala16,Ala17]human immunoglobulin heavy constant γ4 chain H-CH2-CH3 fragment, (55-55′:58-58′)-bisdisulfide dimer
STRUCTURAL FORMULA
Monomer
HGEGTFTSDV SSYLEEQAAK EFIAWLVKGG GGGGGSGGGG SGGGGSAESK 50
YGPPCPPCPA PEAAGGPSVF LFPPKPKDTL MISRTPEVTC VVVDVSQEDP 100
EVQFNWYVDG VEVHNAKTKP REEQFNSTYR VVSVLTVLHQ DWLNGKEYKC 150
KVSNKGLPSS IEKTISKAKG QPREPQVYTL PPSQEEMTKN QVSLTCLVKG 200
FYPSDIAVEW ESNGQPENNY KTTPPVLDSD GSFFLYSRLT VDKSRWQEGN 250
VFSCSVMHEA LHNHYTQKSL SLSLG 275
Disulfide bridges location
55-55′ 58-58′ 90-150 90′-150′ 196-254 196′-254′
MOLECULAR FORMULA C2646H4044N704O836S18
MOLECULAR WEIGHT 59.67 kDa
MANUFACTURER Eli Lilly and Company
CODE DESIGNATION LY2189265
CAS REGISTRY NUMBER 923950-08-7
http://www.ama-assn.org/resources/doc/usan/dulaglutide.pdf
LY2189265 (dulaglutide), a glucagon-like peptide-1 analog, is a biologic entity being studied as a once-weekly treatment for type 2 diabetes.
Dulaglatuide works by stimulating cells to release insulin only when blood sugar levels are high.
Gwen Krivi, Ph.D., vice president, product development, Lilly Diabetes, said of the drug, “We believe dulaglutide, if approved, can bring significant benefits to people with type 2 diabetes.”
In fact, it might help to control both diabetics’ blood sugar and their high blood pressure.
Eli Lilly CEO John Lechleiter believes the drug has the potential to be a blockbuster. Lilly could be ready to seek approval by 2013.
For more information on dulaglutide clinical studies, click here.
Data Preseted at 49th EASD Annual Meeting Show Treatment with Lilly’s Investigational Dulaglutide Resulted in Improved Patient-Reported Health Outcomes – September 26, 2013
Lilly Announces Positive Results of Phase III Trials of Dulaglutide in Type 2 Diabetes – April 16, 2013
Lilly Diabetes Announces Positive Results of Phase III Trials of Dulaglutide in Type 2 Diabetes – October 22, 2012
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http://www.ama-assn.org/resources/doc/usan/ixekizumab.pdf
USAN IXEKIZUMAB
PRONUNCIATION ix” e kiz’ ue mab
THERAPEUTIC CLAIM Treatment of autoimmune diseases
CHEMICAL NAMES
1. Immunoglobulin G4, anti-(human interleukin 17A) (human monoclonal LY2439821γ4-chain), disulfide with human monoclonal LY2439821 κ-chain, dimer
2. Immunoglobulin G4, anti-(human interleukin-17A (IL-17, cytotoxic
T-lymphocyte-associated antigen 8)); humanized mouse monoclonal LY2439821 des-Lys446-[Pro227]γ4 heavy chain {H10S>P,CH3107K>-} (133-219′)-disulfide with humanized mouse monoclonal LY2439821 κ light chain, dimer (225-225”:228-228”)-bisdisulfide
MOLECULAR FORMULA C6492H10012N1728O2028S46
MOLECULAR WEIGHT 146.2 kDa
SPONSOR Eli Lilly and Co.
CODE DESIGNATION LY2439821
CAS REGISTRY NUMBER 1143503-69-8
Ixekizumab is a humanized monoclonal antibody used in the treatment of autoimmune diseases.[1]
Ixekizumab was developed by Eli Lilly and Co.
more info
Inflammation represents a key event of many diseases, such as psoriasis, inflammatory bowel diseases, rheumatoid arthritis, asthma, multiple sclerosis,
atherosclerosis, cystic fibrosis, and sepsis. Inflammatory cells, such as neutrophils, eosinophils, basophils, mast cells, macrophages, endothelial cells, and platelets, respond to inflammatory stimuli and foreign substances by producing bioactive mediators. These mediators act as autocrines and paracrines by interacting with many cell types to promote the inflammatory response. There are many mediators that can promote inflammation, such as cytokines and their receptors, adhesion molecules and their receptors, antigens involved in lymphocyte activation, and IgE and its receptors. [0004] Cytokines, for example, are soluble proteins that allow for communication between cells and the external environment. The term cytokines includes a wide range of proteins, such as lymphokines, monokines, interleukins, colony stimulating factors, interferons, tumor necrosis factors, and chemokines. Cytokines serve many functions, including controlling cell growth, migration, development, and differentiation, and mediating and regulating immunity, inflammation, and hematopoiesis. Even within a given function, cytokines can have diverse roles. For example, in the context of mediating and regulating inflammation, some cytokines inhibit the inflammatory response (anti-inflammatory cytokines), others promote the inflammatory response (pro-inflammatory cytokines). And certain cytokines fall into both categories, i.e., can inhibit or promote inflammation, depending on the situation. The targeting of proinflammatory cytokines to suppress their natural function, such as with antibodies, is a well-established strategy for treating various inflammatory diseases.
Many inflammatory diseases are treated by targeting proinflammatory cytokines with antibodies. Most (if not all) of the anti-proinflammatory cytokine antibodies currently on the market, and those currently in clinical trials, are of the IgG class. See, for example, Nature Reviews, vol. 10, pp. 301-316 (2010); Nature Medicine, vol. 18, pp. 736-749 (2012); Nature Biotechnology, vol. 30, pp. 475-477 (2012); Anti-Inflammatory & Anti- Allergy Agents in Medicinal Chemistry, vol. 8, pp. 51-71 (2009);
FlOOO.com/Reports/Biology/content/1/70, F 1000 Biology Reports, 1 :70 (2009); mAbs 4: 1, pp. 1-3 (2012); mAbs 3: 1, pp. 76-99 (2011); clinicaltrials.gov (generally), and
clinicaltrialsregister.eu/ (generally). These IgG antibodies are administered systemically and thus are often associated with unwanted side effects, which can include one or more of, for example, infusion reactions and immunogenicity, hypersensitivity reactions,
immunosuppression and infections, heart problems, liver problems, and others. Additionally the suppression of the target cytokines at non-diseased parts of the body can lead to unwanted effects.
In an attempt to reduce side effects associated with systemic treatment and to eliminate the inconvenience and expense of infusions, an article proposed an oral anti-TNF therapy that could be useful in treating Crohn’ s disease. Worledge et al. “Oral Administration of Avian Tumor Necrosis Factor Antibodies Effectively Treats Experimental Colitis in Rats.” Digestive Diseases and Sciences 45(12); 2298-2305 (December 2000). This article describes immunizing hens with recombinant human TNF and an adjuvant, fractionating polyclonal yolk antibody (IgY, which in chickens is the functional equivalent to IgG), and administering the unformulated polyclonal IgY (diluted in a carbonate buffer to minimize IgY acid hydrolysis in the stomach) to rats in an experimental rodent model of colitis. The rats were treated with 600mg/kg/day of the polyclonal IgY. The uses of animal antibodies and polyclonal antibodies, however, are undesirable.
In a similar attempt to avoid adverse events associated with systemic administration, another group, Avaxia Biologies Inc., describes a topical (e.g., oral or rectal) animal-dervied polyclonal anti-TNF composition that could be useful in treating
inflammation of the digestive tract, such as inflammatory bowel disease. WO2011047328. The application generally states that preferably the polyclonal antibody composition is prepared by immunizing an animal with a target antigen, and the preferably the polyclonal antibody composition is derived from milk or colostrum with bovine colostrums being preferred (e.g., p. 14). The application also generally states that the animal derived polyclonal antibodies could be specific for (among other targets) other inflammatory cytokines (e.g., pp. 6-7). This application describes working examples in which cows were immunized with murine TNF and the colostrum was collected post-parturition to generate bovine polyclonal anti-TNF antibodies (designated as AVX-470). The uses of animal-derived antibodies and polyclonal antibodies, however, are undesirable.
IgA molecular forms have been proposed as treatments for various diseases, most notably as treatments for pollen allergies, as treatments against pathogens, and as treatments for cancer.
For example, one article describes anti-AmbCtl (a ragweed pollen antigen) humanized monomelic IgA and dimeric IgA antibodies made in murine cells (NSO and Sp2/0 cells). The dimeric IgA contains a mouse J-chain. The article proposes that the antibodies may be applied to a mucosal surface or the lower airway to inhibit entry of allergenic molecules across the mucosal epithelium and therefore to prevent the development of allergic response. Sun et al. “Human IgA Monoclonal Antibodies Specific for a Major Ragweed Pollen Antigen.” Nature Biotechnology 13, 779-786 (1995).
Several other articles propose the use of IgA antibodies as a defense against pathogens.
Two articles proposed the use of an anti-streptococcal antigen I II secretory IgA-G hybrid antibody. Ma et al. “Generation and Assembly of Secretory Antibodies in Plants.” Science 268(5211), 716-719 (May 1995); Ma et al. “Characterization of a
Recombinant Plant Monoclonal Secretory Antibody and Preventive Immunotherapy in Humans.” Nature Medicine 4(5); 601-606 (May 1998). The hybrid antibody contains murine monoclonal kappa light chain, hybrid Ig A-G heavy chain, murine J- Chain, and rabbit secretory component. The antibody was made by successive sexual crossing between four transgenic N. tabacum plants and filial recombinants to form plant cells that expressed all four protein chains simultaneously. The parent antibody (the source of the antigen binding regions, is identified as the IgG antibody Guy’s 13. The group proposes that although slgA may provide an advantage over IgG in the mucosal environment, such is not always the case (1998 Ma at p. 604, right column).
A related article identifies the anti-streptococcal antigen I/II secretory IgA-G hybrid antibody, which was derived from Guy’s 13 IgA, as CaroRx. Wycoff. “Secretory IgA Antibodies from Plants.” Current Pharmaceutical Design 10(00); 1-9 (2004). Planet Biotechnology Inc. This related article states that the CaroRx antibody was designed to block adherence to teeth of the bacteria that causes cavities. Apparently, the CaroRx antibody was difficult to purify; the affinity of Protein A for the murine Ig domain was too low and protein G was necessary for sufficient affinity chromatography. Furthermore, the article states that several other chromatographic media had shown little potential as purification steps for the hybrid slgA-G from tobacco leaf extracts. The article also indicates that the authors were unable to control for human-like glycosylation in tobacco, but that such was not a problem because people are exposed to plant glycans every day in food without ill effect.
WO9949024, which lists Wycoff as an inventor, Planet Biotechnology Inc. as the applicant, describes the use of the variable regions of Guy’s 13 to make a secretory antibody from tobacco. The application contains only two examples – the first a working example and the second a prophetic example. Working Example 1 describes the transient production of an anti-S. mutans SA I/III (variable region from Guy’s 13) in tobacco. The tobacco plant was transformed using particle bombardment of tobacco leaf disks. Transgenic plants were then screened by Western blot “to identify individual transformants expressing assembled human slgA” (p. 25). Prophetic Example 2 states that in a transformation system for Lemna gibba (a monocot), bombardment of surface-sterilized leaf tissue with DNA- coated particles “is much the same as with” tobacco (a dicot). The prophetic example also stops at screening by immunoblot analysis for antibody chains and assembled slgA, and states that the inventors “expect to find fully assembled slgA.” [0014] Another article proposed the use of an anti-RSV glycoprotein F IgA antibodies (mlgA, dlgA, and slgA). Berdoz et al. “In vitro Comparison of the Antigen-Binding and Stability Properties of the Various Molecular Forms of IgA antibodies Assembled and Produced in CHO Cells.” Proc. Natl. Acad. Sci. USA 96; 3029-3034 (March 1999). The slgA antibody was made in CHO cells sequentially transfected with chimeric heavy and light chains, human J-Chain, and human secretory component, respectively. Single clones were generated to express the mlgA (clone 22), the dlgA (clone F), and the slgA (clone 6) (p. 3031).
Still other articles proposed, for example: (1) anti-HSV mlgA made in maize (Karnoup et al. Glycobiology 15(10); 965-981 (May 2005)) (which states that at that time there had been little success in the application of IgA class antibodies to therapeutic use because of the difficulty in producing the dimeric form in mammalian cells at economic levels); (2) anti-C. difficile toxin A chimeric mouse-human monomeric and dimeric IgA made in CHO cells (Stubbe et al. Journal of Immunology 164; 1952-1960 (2000)); (3) anti-N. meningitidis chimeric IgA antibodies were produced in BHK cells cotransfected with human J-Chain and/or human secretory component (Vidarsson et al., Journal of Immunology 166; 6250-6256 (2001)); (4) mti-Pseudomonas aeruginosa 06 lipopolysaccharide chimeric mouse/human mlgAl made in CHO cells (Preston et al. Infection and Immunity 66(9); 4137- 4142 (September 1998)); (5) anti-Plasmodium mlgA made in CHO cells (Pleass et al. Blood 102(13); 4424-4429 (December 2003)) (which states that unlike their parental mouse IgG antibodies, the mlgA antibodies failed to protect against parasitic challenge in vivo); and (5) ^^-Helicobacter pylori urease subunit A slgA and dlgA (Berdoz et al. Molecular
Immunology 41(10); 1013-1022 (August 2004)). [0016] For a review article discussing passive and active protection against pathogens at mucosal surfaces, see Corthesy. “Recombinant Immunoglobulin A: Powerful Tools for Fundamental and Applied Research.” Trends in Biotechnology 20(2); 65-71 (February 2002).
Still other articles propose the use of IgA antibodies as a treatment for cancer.
For example, one article describes a Phase la trial of a muring anti-transferrin receptor IgA antibody (Brooks et al. “Phase la Trial of Murine Immunoglobulin A
Antitransferrin Receptor Antibody 42/6.” Clinical Cancer Research 1(11); 1259-1265 (November 1995)). Another article describes a human anti-Ep-CAM mIgA made in BHK (baby hamster kidney) cells (Huls et al. “Antitumor Immune Effector Mechanisms Recruited by Phase Display-Derived Fully Human IgGl and IgAl Monoclonal Antibodies.” Cancer Research 59; 5778-5784 (November 1999)). Still another article describes an anti-HLA Class II chimeric mIgA antibody made in BHK cells (Dechant et al. “Chimeric IgA Antibodies Against HLA Class II Effectively Trigger Lymphoma Cell Killing.” Blood 100(13); 4574- 4580 (December 2002)). Yet other articles describe anti-EGFR mIgA or dlgA antibodies made in CHO, including Dechant et al. “Effector Mechanisms of Recombinant IgA
Antibodies Against Epidermal Growth Factor Receptor.” Journal of Immunology 179; 2936- 2943 (2007), Beyer et al. “Serum- Free Production and Purification of Chimeric IgA
Antibodies.” Journal of Immunology 346; 26-37 (2009) (stating that as of 2009, IgA antibodies have not been commercially explored for problems including lack of production and purification methods), and Lohse et al. “Recombinant Dimeric IgA Antibodies Against the Epidermal Growth Factor Receptor Mediate Effective Tumor Cell Killing.” Journal of Immunology 186; 3770-3778 (February 2011).
For a review article on anti-cancer IgA antibodies, see Dechant et al. “IgA antibodies for Cancer Therapy. ” Critical Reviews in Oncology/Hematology 39; 69-77 (2001); states that compared with infectious diseases, the role of IgA in cancer immunotherapy is even less investigated).
IL17 and IFN-garama inhibition for the treatment of autoimmune inflammation
The IL-17 family of cytokines has been associated with the pathogenesis of autoimmune diseases and is generally blamed for the pathogenic symptoms of autoimmune inflammation. Overexpression of IL-17 is a hallmark for autoimmune diseases like rheumatoid arthritis, systemic lupus erythematomatosus, inflammatory bowel disease, multiple sclerosis, and psoriasis (Yao Z et. al., J Immunol, 155(12), 1995, 5483-6. Chang S H, et.al, Cytokine, 46, 2009, 7-11; Hisakata Yamada et.al, Journal of Inflamm. Res., 3, 2010, 33-44)).
The IL-17 cytokine family comprises six members, out of which IL-17 A and IL-17F are the best characterized. IL-17A and IL-17F exist as homo- as well as as heterodimers (IL-17AA, IL-17AF, IL-17FF). IL-17A and IL-17F are clearly associated with inflammation (Gaffen S H, Cytokine, 43, 2008, 402-407; Torchinsky M B et al, Cell. Mol. Life Sci., 67, 2010, 1407- 1421).
The secretion of IL-17 is predominantly caused by a specific subtype of T helper cells termed TH-17 cells. IL-23, TGFp and IL-6 were shown to be important factors leading to conversion of nai‘ve CD4+ T-cells to THl 7 cells. It was also reported that TGF and IL-6 potently induce in synergy THl 7 differentiation. Important transcription factors for the secretion of IL-17 from TH17 cells are RORyt and STAT3 (IvanovJ et.al. Cell 126, 2006, 1121-1133). IL-17 induces pro-inflammatory cytokines (IL-6, TNF- and IL-lb) and Chemokines (CXCL1,GCP-2,CXCL8 or IL-8,CINC,MCP-1). It increases the production of nitric oxide prostaglandin E2 and matrix-metalloproteinases. As a consequence of these events neutrophil infiltration, tissue damage and chronic inflammation occurs (PECK A et.al, Clin Immunol., 132(3), 2009, 295-304).
Before the recognition of the importance of IL-17 in autoimmune inflammation, IFN-gamma derived from THl cells was believed to be an important cytokine that drives autoimmune disorders (Takayanagi H et. al. Nature, 408, 2000, 600-605. Huang W. et. al. Arthritis Res. Ther., 5, 2002, R49-R59) The secretion of IFN-gamma is a key feature of the THl effector cell lineage and the secretion is regulated by the transcription factors T-bet and STAT4 (Bluestone JA et. al. Nat Rev Immunol, 11, 2009, 811-6). Infiltration of activated T-cells and elevation of M-CSF, IL-10 and TNF support this notion (Yamanda H et.al Ann. Rheu. Dis., 67, 2008, 1299-1304; Kotake S et.al. Eur. J. Immunol, 35, 2005, 3353-3363).
Recently, a more complex situation was proposed, where hybrid TH17/TH1 cells induced by IL-23 and IL-6 in concert with IL-1 secrete IL-17 and IFN-gamma. These cells are under the control of the transcription factors RORyt and T-bet, confirming the notion, that these are true hybrids of THl and THl 7 cells. It was also demonstrated that these double producing cells are the pathogenic species in IBD and EAE (Buonocore S et.al. Nature, 464, 2010, 1371-5; Ghoreshi K. et. al. Nature, 467, 2010, 967-971).
Compounds which target and suppress both IL-17 and IFN-gamma are predisposed for the treatment of autoimmune disorders.
The effectiveness of blocking IL-17 signaling as therapeutic treatment in autoimmune diseases has already been proven in clinical trials with e.g. monoclonal antibodies against IL- 17A (AIN457, secukinumab; Ly2439821,ixekizumab; RG4934) and/or the IL-17 receptor IL- 17RA (AMG827, brodalumab).
Positive results have been reported for the treatment of rheumatoid arthritis, psoriasis and uveitis (Hueber W et al, Sci. Transl. Med., 2, 2010, 52ra72, DOI: 10.1126/scitranslmed.3001107; van den Berg W B e/ al, Nat. Rev. Rheumatol, 5, 2009, 549-553), ankylosing spondylitis and spondyloarthritides (Song I-H et al, Curr. Opin. Rheumatol., 23, 2011, 346-351).
Secukinumab is currently under investigation in clinical trials for psoriatic arthritis, Behcet disease, uveitits, inflammatory bowel disease, Crohn’s disease, multiple sclerosis (Kopf M et al., Nat. Rev. Drug Disc, 9, 2010, 703-718; Song I-H et al, Curr. Opin. Rheumatol., 23, 2011, 346-351).
Brodalumab, Ixekizumab and RG4934 are currently in clinical trials for the treatment of rheumatoid arthritis, psoriasis and/or psoriatic arthritis (Kopf M et al, Nat. Rev. Drug Disc, 9, 2010, 703-718; clinicaltrials.gov; Medicines in development for skin diseases, 201 1, published by PhRMA, www .phrma. com) .
With regard to blocking of IFN-gamma signaling as therapeutic treatment in autoimmune diseases, the IFN-gamma-specific monoclonal antibody AMG811 is currently under clinical investigations for the treatment of systemic lupus erythematosus (Kopf M et al., Nat. Rev. Drug Disc, 9, 2010, 703-718).
ALCAFTADINE
Alcaftadine is used to prevent eye irritation brought on by allergic conjunctivitis. It is a H1histamine receptor antagonist.
It was approved by the U.S. Food and Drug Administration in 2010 under the trade name Lastacaft.
| Active Ingredient | Form | Dosage | Drug Type | Application | Product | |
|---|---|---|---|---|---|---|
| ALCAFTADINE | SOLUTION/DROPS; OPHTHALMIC | 0.25% | RX | 022134 | 001 |
There are 1 patent(s) protecting ALLERGAN’s LASTACAFT.
The last patent expires on 2013-11-21.
| Patent | Expiration | |
|---|---|---|
| US5468743 | Imidazo[2,1-b]benzazepine derivatives, compositions and method of use
The present invention is concerned with novel imidazo[2, 1-b][3]benzazepines of formula ##STR1## the pharmaceutically acceptable addition salts and stereochemically isomeric forms thereof, wherein each of the dotted lines independently represents an optional bond; R.sup.1 represents hydrogen, halo, C.sub.1-4 alkyl or C.sub.1-4 alkyloxy; R.sup.2 represents hydrogen, halo, C.sub.1-4 alkyl or C.sub.1-4 alkyloxy; R.sup.3 represents hydrogen, C.sub.1-4 alkyl, ethenyl substituted with hydroxycarbonyl or C.sub.1-4 alkyloxycarbonyl, C.sub.1-4 alkyl substituted with hydroxycarbonyl or C.sub.1-4 alkyloxycarbonyl, hydroxyC.sub.1-4 alkyl, formyl or hydroxycarbonyl; R.sup.4 represents hydrogen, C.sub.1-4 alkyl, hydroxyC.sub.1-4 alkyl, phenyl or halo; R.sup.5 represents hydrogen, C.sub.1-4 alkyl or halo; L represents hydrogen; C.sub.1-6 alkyl; C.sub.1-6 alkyl substituted with one substituent selected from the group consisting of hydroxy, halo, C.sub.1-4 alkyloxy, hydroxycarbonyl, C.sub.1-4 alkyloxycarbonyl, C.sub.1-4 alkyloxycarbonyl-C.sub.1-4 alkyloxy, hydroxycarbonylC.sub.1-4 alkyloxy, C.sub.1-4 alkyloxycarbonylamino, C.sub.1-4 alkylaminocarbonyl, C.sub.1-4 alkylaminocarbonylamino, C.sub.1-4 alkylaminothiocarbonylamino, aryl, aryloxy and arylcarbonyl; C.sub.1-6 alkyl substituted with both hydroxy and aryloxy; C.sub.3-6 alkenyl; C.sub.3-6 alkenyl substituted with aryl; or, L represents a radical of formula –Alk–Y–Het.sup.1 (a-1),–Alk–NH–CO–Het.sup.2 (a-2)or –Alk–Het.sup.3 (a-3); provided that 6,11-dihydro-11-(4-piperidinylidene)-5H-imidazo[2,1-b][3]benzazepine is ecxluded, which are useful antiallergic compounds.Compositions comprising said compounds, methods of using and processes for preparing the same.
|
2013-11-21 |
Exclusivity is marketing rights granted by the FDA to the ALLERGAN.
Exclusivity ends on 2015-07-28.
| Date | Supplement No. | Action | Documents |
|---|---|---|---|
| 2010-07-28 | 000 | Approval |
Diagram showing orientation and location of different beta-glucan linkages.
Examples of various β-glucan glycosidic linkages.
beta 1, 3- glucan and beta 1, 6- glucan.
Food Ingredient Sourced From Yeast
The shiitake mushroom contains beta-glucans.
β-Glucans (beta-glucans) are polysaccharides of D-glucose monomers linked by β-glycosidic bonds. β-glucans are a diverse group of molecules that can vary with respect to molecular mass, solubility, viscosity, and three-dimensional configuration. They occur most commonly as cellulose in plants, the bran of cereal grains, the cell wall of baker’s yeast, certain fungi, mushrooms and bacteria. Some forms of beta glucans are useful in human nutrition as texturing agents and as soluble fibersupplements, but can be problematic in the process of brewing.
Oat is a rich source of the water-soluble fibre (1,3/1,4) β-glucan, and its effects on health have been extensively studied the last 30 years. Oat β-glucans are the only dietary fiber currently recognized by the European Food Safety Authority (EFSA) to be able to reduce a disease risk. Oat β-glucans can be highly concentrated in different types of oat brans.
“Barley has more beta glucan fiber than any other grain” claims a report on DiabetesHealth website ; 11 sources are listed.
Yeast and medicinal mushroom derived β-glucans are notable for their ability to modulate the immune system. One study has shown that insoluble (1,3/1,6) β-glucan, has greater biological activity than that of its soluble (1,3/1,4) β-glucan counterparts.The differences between β-glucan linkages and chemical structure are significant in regards to solubility, mode of action, and overall biological activity.
β-GLUCAN
‘Gecono’ β-Glucan (GNP80), derived from fresh food grade brewer’s yeast or baker’s yeast, is akind of ‘new resource food material’ developed by unique innovative biotechnologies. Its maincomponent is yeast sourced immunocompetent polysaccharide which has two isomers structured asbeta 1, 3- glucan and beta 1, 6- glucan. The former one which can greatly enhance human immunity isproved to have the anti-tumor, anti-radiation, anti-aging and free radical scavenging activities. It is animportant biological effect response agent.
Appearance: White or light yellow powder.
Features：
●A good Immune activator.
●A powerful free radical scavenger.
●Activate macrophages or neutrophil leukocyte to scavenge cell debris caused by radiation.
●Help the macrophages recognize and destroy the mutated cells.
●Help speed up the recovery of damaged tissue to produce cell factor( IL-1) .
●Enhance the activities of the other substances like antibiotics, antifungal and antiparasitic.
●Reduce the low-density lipoprotein( LDL) level and increase the high-density lipoprotein(HDL)
level in the blood to reduce the hyperlipidemiaoccurrence.
Applications：
●Health food supplements.
●Capsules and tablet health food.
●Beverages & functional oral liquid.
●Pharmaceutical & cosmetic ingredients.
●Other anti-aging，anti-radiation functional foods.
Package：25kg / bag, double-ply composite bag.
Shelf Life：24 months
Storage：Please store in dry condition and avoid explosion in open air. No shipment with noxious
chemicals.
Shanghai Genon Biotech Co.,Ltd
Address：No.88 Cailun Road Zhangjiang Hi-Tech Park, Shanghai, China Post Code：201210
Contact：Amy Tel：0086-21-5138 0613 Mobile: 15201937160 Fax：0086-21-58951012
Email: guyimei@hotmail.com ; amygoo@cngenon.com
Website：http://www.breweryeast.cn
cut paste of mail
Dear Sirs,
We got your info on line, and we are professional manufacturer of Beta 1,3,1,6-D-Glucan from 100% natural Brewer’s Yeast in Shanghai, China.
Beta-glucan can strengthen the immune system and in turn fend off cold,flu and even cancer. Additonally,beta-glucan increases the body`s denfense against the harmful effects of stress.
In additon to being available in food, beta-glucan supplements can help with following health problems:
·allergies ·asthma ·cancer
·Crohn`s disease ·chronic fatigue syndrome
·diabetes ·fibromyalgia
·high cholesterol ·reheumatoid arthritis
·ulcerative colitis
Beta glucan 70%min / 80%min, the price is very competitive now.
We have 4 factories in China to produce brewer yeast series products: yeast powder, yeast extract (seasoning, fermentation), yeast cellwall, selenium yeast, etc.
Feel free to contact me if you are interested.
Best regards
Amy
Micro protein: Yeast extract, Beta-glucan, Yeast cell wall, Organic selenium and Brewer yeast etc.
Animal protein: Hemoglobin Plasma and Nutritional Peptide etc.
With Fine Quality and Competitive Price.
Skype: amy007387
Mobile: +86-15201937160
Tel：+86-21-51380613
E-mail: guyimei@hotmail.com
Fax：86-21-58951012
Shanghai Genon Biotech Co.,Ltd.
Possible therapeutic applications for Rooibos in the management of stress-related and metabolic diseases
http://www.chemistryviews.org/details/news/5309541/Health_Benefits_of_Rooibos_Tea.html
New Drug Approvals 
