Viagra patent extended upto 2020

U.S. men seeking a generic version of Viagra (sildenafil citrate) - the first and the most popular prescription drug for Erectile Dysfunction (ED) - are going to have to wait for a few more years. Viagra's patent, originally scheduled to expire in late March of 2012, has been extended to April of 2020. That's good news for the manufacturer, Pfizer, Inc., of course, but it's also good news for patients suffering from Erectile Dysfunction.

There has been a lot of informed speculation in recent years about what would happen when Viagra finally did become available in generic form. Acclaimed pharmaceutical industry observer and reporter Jim Edwards has written about that issue for this site (links are below). Several drug companies were poised to leap on the opportunities presented by the expired patent - most notably, Teva Pharmaceuticals, which gained tentative approval from the Food and Drug Administration (FDA) to market a generic version of Viagra.

In March of 2010, however, Pfizer sued Teva for patent infringement, based on a second Pfizer patent which runs until 2019. This second patent is sometimes referred to as a "method-of-treatment patent." Pfizer argued that even though sildenafil was to come up for grabs in 2012, Pfizer should retain exclusive rights to market it as an ED treatment until 2019. Pfizer ultimately prevailed against Teva in a 12-day bench trial held in the summer of 2011, and it was declared that the company's Viagra patent would stand solid through 2019.

Early in 2012, Pfizer was granted an additional six months of U.S. patent protection for Viagra, because the company is studying the effect of another one of its products containing Viagra's active ingredient, sildenafil, in children with pulmonary hypertension. With this latest development, Pfizer's patent for Viagra stands through April of 2020.

Consequently, there is still no legal "generic Viagra" available in the United States - despite what some online advertisers claim - nor is there an over-the-counter (OTC) version of this drug yet. Prescription Viagra, the "little blue pill," remains the only legal option for U.S. shoppers seeking the proven ingredient sildenafil as a treatment for Erectile Dysfunction.http://www.accessrx.com/research/viagra-patent-expires/

Biotechnological pharmaceuticals

Biotechnological pharmaceuticals from Gaurav Kr

GSK and Genmab announce European submission to regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)

ofatumumab

Friday 4 October 2013, London UK

GlaxoSmithKline plc and Genmab A/S [OMX: GEN] announced today the submission of a variation to the Marketing Authorisation to the European Medicines Agency (EMA) for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.

http://www.pharmalive.com/gsk-and-genmab-file-for-european-approval-of-arzerra

old clip

GlaxoSmithKline is to start a new Phase III study of ofatumumab as a treatment for pemphigus vulgaris, a rare autoimmune disorder of the skin, according to partner Genmab. The Danish biotech and the drug major are long-term partners on ofatumumab which is already marketed, as Arzerra, for chronic lymphocytic leukaemia.

http://www.pharmatimes.com/Article/13-07-04/GSK_tests_ofatumumab_in_rare_skin_disorder.aspx

Ofatumumab(trade name Arzerra, also known as HuMax-CD20) is a human monoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory tofludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia. This makes ofatumumab the first marketing application for an antibody produced by Genmab, as well as the first human monoclonal antibody which targets the CD20 molecule that will be available for patients with refractory CLL.

A Case of Idiopathic Pulmonary Hypertension

A Case of Idiopathic Pulmonary Hypertension from Stanley Medical College, Department of Medicine

future--------------TYROSINE KINASE INHIBITORS CINACIGUAT,RIOCIGUAT-ACTIVATORS OF GUANYLYL CYCLASE

Indian Medicinal Plants An Illustrated Dictionary

Indian Medicinal Plants An Illustrated Dictionary

Pharmaceutical R&D and its impact on global health

FACTS AND FIGURES 2012 - IFPMA

www.ifpma.org/.../IFPMA_-_Facts_And_Figures_2012_LowResSingleP...‎

Pharmaceutical R&D and its impact on global health . ...... An early-phase compound mayhave a promising outlook, but only preclinical and clinical trials will ... IFPMA (2012) Framework for action on NCDs – 2011–12 progress report. Geneva: ...

see pdf file at

http://www.ifpma.org/fileadmin/content/Publication/2013/IFPMA_-_Facts_And_Figures_2012_LowResSinglePage.pdf

Selexys Enrolls Sickle Cell Pain Trial

Selexys Pharmaceuticals Corporation, a privately held biopharmaceutical company that is developing therapies to treat inflammatory and thrombotic diseases, announced that enrollment has been initiated in SUSTAIN, a phase 2, multicenter, randomized, placebo-controlled, double-blind, 12-month study to assess safety and efficacy of the anti-P-selectin monoclonal antibody SelG1 with or without hydroxyurea therapy in sickle cell disease patients with sickle cell-related pain crises.

http://www.dddmag.com/news/2013/08/selexys-enrolls-sickle-cell-pain-trial?et_cid=3431535&et_rid=523035093&type=headline

MICROENCAPSULATION: ADVANCEMENTS IN TECHNOLOGY AND ITS PATENTS

Microcapsule is a tiny sphere including core material/internal phase or fill, coated with/surrounded by wall know as shell, coating or membrane. The usual size range of the microcapsule lies between 1 to 1000 μm. The technique is usually applied for targeted drug delivery, protection of the molecule and stability if the core material. Microencapsulation system offers potential advantages over conventional drug delivery systems and also established as unique carrier systems for many pharmaceuticals. This article contains the traditional and the recent techniques, including their patents, for the preparation of microcapsules. Solvent exchange method, coacervation, polymerization, hot melts etc are several recent techniques are used for the preparation of the microcapsules. The microencapsulation technique, as Novel drug Delivery System (NDDS), is widely applied for delivery of probiotics, drugs, pesticide, food etc. Although significant advances have been made in the field of microencapsulation, still many challenges need to be rectified during the appropriate selection of core materials, coating materials and process techniques.... read all at
http://www.pharmatutor.org/articles/microencapsulation-advancements-technology-patents

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Microencapsulation from Themani55555

150 Years of Bayer: Success Through Science-Based Innovation

Wolfgang Plischke, Member of the Board of Management, Bayer AG, explains what has made the company so successful
Read more

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Alexza Pharmaceuticals Announces European Launch of ADASUVE® (Staccato® Loxapine)

LOXAPINE

MOUNTAIN VIEW, Calif., July 30, 2013 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (ALXA) today announced that the company's commercial partner Grupo Ferrer Internacional, S.A. has initiated sales of ADASUVE^® inhalation powder, pre-dispensed (Staccato^® Loxapine) in the European Union ("EU").  ADASUVE is now available in Germany.  The first sale and shipment of product by Ferrer triggers a $1.25 million milestone payment to Alexza, pursuant to the Company's collaboration agreement with Ferrer.

http://finance.yahoo.com/news/alexza-pharmaceuticals-announces-european-launch-130000571.html

Loxapine (Loxapac, Loxitane) is a typical antipsychotic medication, used primarily in the treatment of schizophrenia. It is a member of the dibenzoxazepine class and structurally related to clozapine (which belongs to the chemically akin class ofdibenzodiazepines). Several researchers have argued that Loxapine may behave as an atypical antipsychotic.

Loxapine may be metabolized by N-demethylation to amoxapine, a tetracyclic antidepressant

Schmutz, J.; Kunzle, F.; Hunziker, F.; Gauch, R.; Helv. Chim. Acta 1967, 50, 245.

Sanofi gets EU CHMP nod for a new formulation of Insuman for the treatment of type 1 diabetes

On 25 July 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the addition of a new formulation to the marketing authorisation of the medicinal product Insuman. The new formulation, Insuman Implantable, is an insulin solution for infusion (400 IU/ml) that is delivered into the intra-peritoneal cavity via an implantable pump device (MiniMed). It has been developed as a replacement for another insulin product called Insuplant, which is no longer manufactured
read at
http://www.pharmaintellect.com/2013/07/sanofi-gets-eu-chmp-nod-for-new.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmainvest+%28PharmaInvest%29

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The Health Benefits of Ginger

The Health Benefits of Ginger

Why Vertex Earnings Prospects Are So Bright

Why Vertex Earnings Prospects Are So Bright
Motley Fool
With few drugs targeting cystic fibrosis and almost half of patients suffering from the particular mutation that the study targeted, Vertex could well have identified a blockbuster in the space. Moreover, with an ongoing phase 3 trial of another ...

http://www.fool.com/investing/general/2013/07/25/why-vertex-earnings-prospects-are-so-bright.aspx

Vertex Pharmaceuticals has a couple of approved drugs, including its Kalydeco cystic fibrosis drug and its Incivek treatment for hepatitis C. But it also has some promising prospects in the development stage. With the company having reported some positive study results during the quarter, Vertex saw its shares soar as more investors got aboard the biotech's bandwagon. Let's take an early look at what's been happening with Vertex Pharmaceuticals over the past quarter and what we're likely to see in its quarterly report

Scripps Research Institute Scientists Find a Potential Cause of Parkinson’s Disease that Points to a New Therapeutic Strategy

 For a high-resolution image see: http://www.scripps.edu/news/press/
images/reed_steve/reed_steve.jpg
LA JOLLA, CA – July 24, 2013 – Biologists at The Scripps Research Institute (TSRI) have made a significant discovery that could lead to a new therapeutic strategy for Parkinson’s disease.
The findings, recently published online ahead of print in the journal Molecular and Cell Biology, focus on an enzyme known as parkin, whose absence causes an early-onset form of Parkinson’s disease. Precisely how the loss of this enzyme leads to the deaths of neurons has been unclear. But the TSRI researchers showed that parkin’s loss sharply reduces the level of another protein that normally helps protect neurons from stress.
 http://www.scripps.edu/news/press/2013/20130724reed.html

New therapy for pancreatic cancer: Phase III clinical trial currently recruiting Australian patients

Currently there is a clinical trial that is recruiting patients from around the globe including sites across Australia. The trial is testing MM-398; a therapy that uses the latest in nanotechnology to deliver the chemotherapeutic agent irinotecan encased in a liposome to cancer patients.¹ In particular this trial, named NAPOLI-1 (NAnoliPOsomaL Irinotecan) is recruiting patients with pancreatic cancer who have previously been treated with the chemotherapy agent gemcitabine unsuccessfully i.e. their disease has gone on to spread/progress despite this treatment.<sup>2,3
read all here

http://www.virtualmedicalcentre.com/news/new-therapy-for-pancreatic-cancer-phase-iii-clinical-trial-currently-recruiting-australian-patients/18708</sup>


irinotecan

Irinotecan (Camptosar, Pfizer; Campto, Yakult Honsha) is a drug used for the treatment of cancer.

Irinotecan prevents DNA from unwinding by inhibition of topoisomerase 1. In chemical terms, it is a semisynthetic analogue of the natural alkaloid camptothecin.

Its main use is in colon cancer, in particular, in combination with other chemotherapy agents. This includes the regimen FOLFIRI, which consists of infusional 5-fluorouracil,leucovorin, and irinotecan.

Irinotecan received accelerated approval by the U.S. Food and Drug Administration (FDA) in 1996 and full approval in 1998. During development, it was known as CPT-11.

Irinotecan is activated by hydrolysis to SN-38, an inhibitor of topoisomerase I. This is then inactivated by glucuronidation by uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1). The inhibition of topoisomerase I by the active metabolite SN-38 eventually leads to inhibition of both DNA replication and transcription.

Merrimack currently has six oncology therapeutics in clinical development, multiple product candidates in preclinical development and an active Systems Biology-driven discovery effort. 
MM-398
(Nanotherapeutic)

• Indication:
• Description:
• Target

• Pancreatic Cancer (2^nd line, 2 indications), Colorectal Cancer, Glioma
• Nanotherapeutic
• Encapsulated irinotecan

MM-398 is a nanotherapeutic consisting of the chemotherapuetic irinotecan, encapsulated in a liposomal sphere. MM-398 is designed to rely on the natural blood flow of the tumor to direct the therapy directly to the site of the cancer and minimize exposure to non-target cells.

MM-398 in the Clinic

MM-398 is being evaluated in clinical trials for its ability to treat tumors resistant to chemotherapy across multiple types of cancers, including pancreatic, lung, colorectal and glioma. The FDA and the European Medicines Agency granted MM-398 orphan drug designation in 2011 for the treatment of patients with metastatic pancreatic cancer who have previously failed treatment with the chemotherapy drug gemcitabine. Our Phase 3 study, NAPOLI-1 (NAnoliPOsomaL Irinotecan), is currently underway.
posters
http://merrimackpharma.com/library/research/mm-398-preclinical-posters

Fadrozole (marketed as Afema by Novartis) for the treatment of breast cancer.

 

Fadrozole (INN, marketed as Afema by Novartis) is an aromatase inhibitor^[1] that has been introduced in Japan for the treatment of breast cancer.

It is selective.^[2]

1. Raats JI, Falkson G, Falkson HC (January 1992). "A study of fadrozole, a new aromatase inhibitor, in postmenopausal women with advanced metastatic breast cancer". J. Clin. Oncol. 10 (1): 111–6. PMID 1530798.
2. Browne LJ, Gude C, Rodriguez H, Steele RE, Bhatnager A (February 1991). "Fadrozole hydrochloride: a potent, selective, nonsteroidal inhibitor of aromatase for the treatment of estrogen-dependent disease". J. Med. Chem. 34 (2): 725–36.doi:10.1021/jm00106a038. PMID 1825337.

Aromatase inhibitors (AIs) are a class of drugs used in the treatment of breast cancer and ovarian cancer inpostmenopausal women. AIs may also be used off-label to treat or prevent gynaecomastia in men.

Aromatase is the enzyme that synthesizes estrogen. As breast and ovarian cancers require estrogen to grow, AIs are taken to either block the production of estrogen or block the action of estrogen on receptors.

Types of AIs

There are 2 types of aromatase inhibitors (AIs) approved to treat breast cancer:

• Irreversible steroidal inhibitors, such as exemestane (Aromasin), forms a permanent and deactivating bond with the aromatase enzyme.

• Non-steroidal inhibitors, such as anastrozole (Arimidex), inhibit the synthesis of estrogen via reversible competition for the aromatase enzyme.

Aromatase inhibitors work by inhibiting the action of the enzyme aromatase, which converts androgens into estrogens by a process called aromatization. As breast tissue is stimulated by estrogens, decreasing their production is a way of suppressing recurrence of the breast tumor tissue. The main source of estrogen is the ovaries inpremenopausal women, while in post-menopausal women most of the body's estrogen is produced in peripheral tissues (outside the CNS), and also a few CNS sites in various regions within the brain. Estrogen is produced and acts locally in these tissues, but any circulating estrogen, which exerts systemic estrogenic effects in men and women, is the result of estrogen escaping local metabolism and spreading to the circulatory system.

Cancer drug tested in pet dogs is now bound for human trials

PAC 1
Thanks to a new $2 million investment, a drug that spurs cancer cells to self-destruct while sparing healthy cells is on the road to human clinical trials. The compound, known as PAC-1, has so far proven safe and has promising anti-cancer effects in cell culture, in mouse models of cancer and in pet dogs with spontaneously occurring lymphomas and osteosarcomas.

If PAC-1 (pack one) makes it through the U.S. Food and Drug Administration’s Investigational New Drug review, the first human (Phase I) clinical trial of the drug will begin in mid-2014. The investor, who wishes to remain anonymous, has an option to invest another $2 million to take the drug into human trials. The clinical work will be conducted at the University of Illinois Cancer Center in Chicago.

http://news.illinois.edu/news/13/0717cancer_drug_PaulHergenrother_TimFan.html

Photo by
L. Brian Stauffer

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University of Illinois chemistry professor Paul Hergenrother, left, and veterinary clinical medicine professor Tim Fan led a study of an anti-cancer compound in pet dogs that is now headed for human clinical trials.
PAC-1 (first procaspase activating compound) is a synthesized chemical compound that selectively induces apoptosis, or cell suicide, in cancerous cells. PAC-1 has shown good results in mouse models and is being further evaluated for use in humans. In 2010 a published study showed PAC-1 to be safe to research dogs, and a second study published later that same year reported that a PAC-1 derivative (called S-PAC-1) was well tolerated in a small Phase I Clinical Trial of pet dogs with lymphoma. Even at low doses of S-PAC-1, tumors regressed in 1/6 dogs, and the disease was stabilized (no additional tumor growth) in 3/6 dogs