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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Celgene signs Concert pact, apremilast impresses for PsA
Apremilast is an orally available small molecule inhibitor of PDE4 being developed byCelgene for ankylosing spondylitis, psoriasis, and psoriatic arthritis.[1][2]
Celgene signs Concert pact, apremilast impresses for PsA
Celgene Corp has entered into a collaboration with Concert Pharmaceuticals which will focus on developing deuterium-modified compounds targeting cancer and inflammation. ………..read all at
The drug is currently in phase III trials for the three indications. Apremilast, an anti-inflammatory drug, specifically inhibits phosphodiesterase 4. In general the drug works on an intra-cellular basis to moderate proinflammatory and anti-inflammatory mediator production.
Apremilast is being tested for its efficacy in treating “psoriasis, psoriatic arthritis and other chronic inflammatory diseases such as ankylosing spondylitis, Behcet’s disease, and rheutmatoid arthritis.”
- Apremilast Palace Program Demonstrates Robust and Consistent Statistically Significant Clinical Benefit Across Three Pivotal Phase III Studies (PALACE-1, 2 & 3) in Psoriatic Arthritis” (Press release). Celgene Corporation. 6 September 2012. Retrieved 2012-09-10.
- “US HOT STOCKS: OCZ, VeriFone, Men’s Wearhouse, AK Steel, Celgene”. The Wall Street Journal. 6 September 2012. Retrieved 2012-09-06.
Turning Off Cancer’s “Master Regulator”
Researchers have identified a gene that, when repressed in tumor cells, puts a halt to cell growth and a range of processes needed for tumors to enlarge and spread to distant sites. The Johns Hopkins researchers hope that this “master regulator” gene may be the key to developing a new treatment for tumors resistant to current drugs………from……………..
GENNewsHighlights
read all at
http://www.genengnews.com/gen-news-highlights/turning-off-cancer-s-master-regulator/81248318/
Ferring Pharmaceuticals begins phase III trials of elobixibat, a new investigational compound for chronic idiopathic constipation
ELOBIXIBAT
Ferring Pharmaceuticals begins phase III trials of elobixibat, a new investigational compound for chronic idiopathic constipation
Ferring Pharmaceuticals today MAY 2, 2013, announced it has initiated enrolment of patients in two phase III clinical trials of the investigational compound elobixibat for the treatment of chronic idiopathic constipation (CIC), a common gastrointestinal disorder affecting approximately 14% of the general population1. The two studies, Echo 1 and Echo 2, will be conducted at close to 200 sites worldwide and will enroll nearly 1700 patients. The studies aim to demonstrate the efficacy and safety of repeated daily doses of elobixibat against placebo over a period of up to 26 weeks.
Elobixibat is a first-in-class compound with a novel physiological mechanism of action. It acts locally in the gut with minimal systemic exposure to enhance the amount of luminal bile acids in the colon by a partial inhibition of the Ileal Bile Acid Transporter (IBAT). This potentially increases colonic fluid secretion and motility. Ferring acquired the global marketing rights for elobixibat, excluding Japan and a small number of Asian markets, from Albireo AB in 2012.
“We are pleased to begin Phase III studies on elobixibat for the treatment of chronic idiopathic constipation,” said Pascal Danglas, Executive Vice President, Clinical and Product Development at Ferring. “CIC causes significant discomfort to sufferers and seriously impacts their quality of life. Studies have shown that patients are not satisfied with current treatments.”
About chronic idiopathic constipation
Chronic idiopathic constipation (CIC) is among the most common diseases throughout the world, affecting approximately 14% of the general population particularly women and the elderly1. Patients with CIC often experience hard and lumpy stools, straining during defecation and a sensation of incomplete evacuation, as well as discomfort and bloating. CIC adversely affects a person’s quality of life and is associated with significant health care expenditure2. Studies show that nearly 50% of CIC sufferers are not satisfied with available treatments3 underscoring the unmet medical need in this area.
About Ferring Pharmaceuticals:
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of gastroenterology, reproductive health, urology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 90 countries. To learn more about Ferring or its products please visit www.ferring.com.
Elobixibat is an IBAT inhibitor,[1] in clinical testing as of December 2012 for the treatment of chronic constipation and irritable bowel syndrome with constipation (IBS-C). It works by blocking the enterohepatic circulation of bile acids, increasing the bile acid concentration in the gut, which accelerates intestinal passage and softens the stool.
The drug was developed by Albireo AB, who licensed it to Ferring Pharmaceuticals for further development and marketing.[2][3]
Albireo has partnered with Ajinomoto Pharmaceuticals, giving the Japan-based company the rights to further develop the drug and market it throughout Asia.[4]
- “INN for A3309 is ELOBIXIBAT”. AlbireoPharma. Retrieved 5 December 2012.
- H. Spreitzer (27 August 2012). “Neue Wirkstoffe – Elobixibat”. Österreichische Apothekerzeitung (in German) (18/2012): 24.
- “Ferring Pharmaceuticals Acquires Licensing Rights for Elobixibat from Albireo AB”(Press release). Ferring Pharmaceuticals. 3 July 2012.
- “Ajinomoto Pharmaceuticals and Albireo Announce Japan and Asia License Agreement for Elobixibat”. Albireo. Retrieved 5 December 2012.
Human medicines European Public Assessment Report EPAR : Rilutek, riluzole, Revision: 17,
Riluzole is a drug used to treat amyotrophic lateral sclerosis. It delays the onset ofventilator-dependence or tracheostomy in selected patients and may increase survival by approximately 3–5 months
It is marketed by Sanofi-Aventis with the brand name Rilutek.
read all at
Zhejiang Hisun Pharma inlicenses China rights to liver cancer drug (ThermoDox) from Celsion Corporation
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| (7S,9S)-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione |
doxorubicin
Jan. 25, 2013
LINK
Heat–activated liposome encapsulated doxorubicin – NIHR Horizon …Heat–activated liposome encapsulated doxorubicin (ThermoDox) for hepatocellular carcinoma.
Zhejiang Hisun Pharma inlicenses China rights to liver cancer drug (ThermoDox) from Celsion Corporation
About ThermoDox
The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. ThermoDox® has been granted orphan drug designation in both the U.S. and Europe. In addition to meeting the U.S. FDA and European EMA enrollment objectives, the Phase 3 Study has also enrolled a sufficient number of patients to support registration filings in China, South Korea and Taiwan, three of the largest potential markets for ThermoDox® around the world.
Terms of the Deal
Under the terms of the agreement, Hisun will pay $5 million to Celsion immediately, while Celsion will provide Hisun with support for its ThermoDox® manufacturing development program. This payment is non-refundable and comes in advance of Celsion’s expected reporting of results from its pivotal Phase III trial (the HEAT Study) in hepatocellular carcinoma (HCC), also known as primary liver cancer later this month.
In addition, the companies anticipate signing an agreement in which Celsion provides Hisun an exclusive option to license ThermoDox® for the Greater China market, which includesChina, Hong Kong and Macau. This option period will be secured by a second $5 millionpayment that must be received by Celsion from Hisun within 60 days after execution of the Technology Development Agreement. The key provisions of the anticipated license agreement have been negotiated and agreed to by the parties and provide a basis for a definitive contract. These provisions are:
- A credit of $10 million from the two payments ($5 million for the technology development agreement and $5 million for the exclusive option) toward a non-refundable upfront license payment of $25 million due to Celsion at signing of the definitive license agreement.
- An approximate 10 year total value to Celsion of well over several hundred million US dollars, which includes:
- $55 million in upfront milestone and regulatory milestone payments within the next 18 months;
- $45 million in milestone payments for reaching certain sales targets; and
- Escalating double-digit royalties on net sales of ThermoDox® in the Greater China Territory.
- Hisun will serve as both the manufacturer and distributor of the ThermoDox® drug product for the Greater China Territory, and also take responsibility for local regulatory activities including submitting approvals in China to the state Food and Drug Administration (sFDA).
Deal Rationale
“Pursuing this arrangement with Hisun allows us to evaluate the fastest path to the Chinamarket, potentially the largest opportunity in the world for ThermoDox®. A long-term partnership will provide the greatest synergies with respect to sales, marketing, distribution, and manufacturing, which could ensure significant value to the ThermoDox® asset,” saidMichael H. Tardugno, Celsion’s President and Chief Executive Officer. “In addition, this partnership provides Hisun and Celsion with immediate access to an accelerated pathway for sFDA review and approval of ThermoDox®, a business strategy with exceptional potential to serve China’s HCC population, and strong, uncompromised economics for both parties.”
Mr. Hua Bai, CEO and Chairman of Hisun, stated, “We are extremely excited to pursue this arrangement with Celsion. Hisun is well positioned to provide ThermoDox® — potentially one of the most important and innovative drugs to treat HCC to patients in China, the world’s largest market. China is one of the countries with the highest HCC incidence and mortality and, up until now, there has not been any standard of care for treating HCC in China.
This joint effort will most likely facilitate the local manufacturing and commercial launch inChina, thereby providing physicians with more options for better care and prolonging the survival of HCC patients. In the meantime, we are also hopeful that this collaboration will enable Hisun to increase its focus on more innovative drugs. Given the fact that we are a leading Chinese pharmaceutical company with international standards of R&D and manufacturing technology, Hisun will seek to manufacture and supply the global markets, along with distribution exclusivity in Greater China. This venture will help spearhead Hisun’s globalization in manufacturing and commercialization capabilities.”
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer today is approximately 26,000 cases per year in the United States, approximately 40,000 cases per year in Europeand is rapidly growing worldwide at approximately 750,000 cases per year, 55 percent of which are in China, due to the high prevalence of Hepatitis B and C in developing countries. . The World Health Organization estimates that primary liver cancer may become the number one cancer worldwide, surpassing lung cancer, by 2020.
The standard first-line treatment for liver cancer is surgical resection of the tumor; however, 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
Doxorubicin trade name Adriamycin; also known ashydroxydaunorubicin) is a drug used in cancer chemotherapy. It is an anthracyclineantibiotic, closely related to the http://en.wikipedia.org/wiki/Natural_product” rel=”nofollow”>natural product daunomycin, and like all anthracyclines, it works by intercalating DNA, with the most serious adverse effect being life-threatening heart damage. It is commonly used in the treatment of a wide range of cancers, includinghematological malignancies, many types of carcinoma, and soft tissue sarcomas.
The drug is administered intravenously, as the hydrochloride salt. It may be sold under the brand names Adriamycin PFS, Adriamycin RDF, or Rubex.[2] Doxorubicin is photosensitive, and containers are often covered by an aluminum bag and/or brown wax paper to prevent light from affecting it.
Doxorubicin is available in liposome-encapsulated forms as Doxil, Caelyx and Myocet.
Doxorubicin is commonly used to treat some leukemias and Hodgkin’s lymphoma, as well as cancers of the bladder, breast, stomach,lung, ovaries, thyroid, soft tissue sarcoma, multiple myeloma, and others.[2] Commonly used doxorubicin-containing regimens are AC (Adriamycin, cyclophosphamide), TAC (Taxotere, CA), ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine), BEACOPP, CHOP(cyclophosphamide, Adriamycin, vincristine, prednisone) and FAC (5-fluorouracil, Adriamycin, cyclophosphamide).
Doxil (see below) is used primarily for the treatment of ovarian cancer where the disease has progressed or recurred after platinum-based chemotherapy, or for the treatment of AIDS-related Kaposi’s sarcoma.[7]
- Laginha, K.M. “Determination of Doxorubicin Levels in Whole Tumor and Tumor Nuclei in Murine Breast Cancer Tumors.”Clinical Cancer Research. October 1, 2005. Vol. 11 (19). Retrieved on April 19, 2007.
- “Doxorubicin (Systemic).” Mayo Clinic. Last updated on: June 15, 1999. Retrieved on April 19, 2007. Archived April 3, 2007 at the Wayback Machine
- Weiss RB (December 1992). “The anthracyclines: will we ever find a better doxorubicin?”. Seminars in Oncology 19 (6): 670–86. PMID 1462166.
- Tan C, Tasaka H, Yu KP, Murphy ML, Karnofsky DA (March 1967). “Daunomycin, an antitumor antibiotic, in the treatment of neoplastic disease. Clinical evaluation with special reference to childhood leukemia”. Cancer 20 (3): 333–53. doi:10.1002/1097-0142(1967)20:3<333::AID-CNCR2820200302>3.0.CO;2-K.PMID 4290058.
- Arcamone F, Cassinelli G, Fantini G, et al. (1969). “Adriamycin, 14-hydroxydaunomycin, a new antitumor antibiotic from S. peucetius var. caesius“. Biotechnol Bioeng 11 (6): 1101–10. doi:10.1002/bit.260110607. PMID 5365804.
- Di Marco A, Gaetani M, Scarpinato B (February 1969). “Adriamycin (NSC-123,127): a new antibiotic with antitumor activity”. Cancer Chemother Rep 53 (1): 33–7. PMID 5772652.
- “DOXIL Product Information.” Ortho Biotech Products, L.P. Retrieved on April 19, 2007. Archived September 21, 2007 at the Wayback Machine
Bedaquiline
Bedaquiline
Fast-track approval for treatment of tuberculosis
May 3, 2013
Bedaquiline (Sirturo) represents a new class of anti-TB drugs called diarylquinolines that have a novel mechanism of action to stop replication of TB. It has FDA approval for treatment of multi-drug resistant pulmonary TB. The drug has not been evaluated with extra-pulmonary TB affecting the CNS. Standard treatment involves a four-drug regimen with isoniazid, rifampin and pyrazinamide (PZA). A recent meta-analysis showed the percentage of patients dying from TB was 3% in non-HIV patients, 9.2% in HIV-infected patients and 30.9% in HIV-infected patients with multi-drug resistant TB. This drug achieved fast-track approval by the FDA due to risks associated with multi-drug resistant TB.
Recent clinical trials included patients with pulmonary TB and used the same dosing strategy (400 mg orally twice daily for two weeks followed by 200 mg three times per week). The clinical endpoint was the time to…
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Human medicines European Public Assessment Report EPAR : Pantecta Control, pantoprazole, Revision: 3,
Human medicines European Public Assessment Report EPAR : Pantecta Control, pantoprazole, Revision: 3,
pantoprazole
* The original URL is http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001099/human_med_000967.jsp&mid=WC0b01ac058001d124
Pantoprazole (sold under various brand names including Somac, Tecta, Pantoloc, Controloc, Protium, Protonix, Pantecta, Pantoheal, Pantpas, Ppi-40, and Neoppi) is a proton pump inhibitor drug that inhibits gastric acid secretion.
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Country
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Patent Number
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Approved
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Expires (estimated)
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| Canada | 2428870 | 2006-05-23 | 2021-11-17 |
| Canada | 2092694 | 2005-04-05 | 2011-09-06 |
| Canada | 2341031 | 2006-04-04 | 2019-08-12 |
| United States | 7544370 | 2006-12-07 | 2026-12-07 |
| United States | 4758579 | 1993-07-19 | 2010-07-19 |
sNDA- FDA OKs HIV Drug Sustiva
EFAVIRENZ
FDA OKs HIV Drug Sustiva
Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of SUSTIVA® (efavirenz) in HIV-1 Infected Pediatric Patients
Approval offers a once-daily option as part of a regimen for HIV-1 infected infants as young as three months and weighing at least 3.5 kg
“Capsule sprinkle” administration allows dosing in patients who cannot swallow capsules or tablets
“Bristol-Myers Squibb recognizes the importance of offering alternative methods of administration of HIV medicines, including for pediatric patients who cannot swallow tablets or capsules, and their caregivers who help manage their treatment,”
Bristol-Myers Squibb Company first week may 2013, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for SUSTIVA® (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg. This approval offers a once-daily option as part of a regimen for this population and includes a “capsule sprinkle” administration method for patients who cannot swallow capsules or tablets. Detailed information about the “capsule sprinkle” method is provided in the ‘Instructions for Use’ at the end of the Patient Information section of the Package Insert.
SUSTIVA is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was originally approved in the U.S. in 1998 to treat HIV-1 infected children three years of age or older and weighing at least 10 kg. SUSTIVA is not to be taken by patients who are allergic to efavirenz, or to any of its ingredients.
“Bristol-Myers Squibb recognizes the importance of offering alternative methods of administration of HIV medicines, including for pediatric patients who cannot swallow tablets or capsules, and their caregivers who help manage their treatment,” said Brian Daniels, M.D., Senior Vice President, Global Development and Medical Affairs. “This approval is one example of our enduring commitment to the HIV patient community.”
This sNDA was based on results from three open-label studies that evaluated the pharmacokinetics, safety, and antiretroviral activity of SUSTIVA in combination with other antiretroviral agents in 182 antiretroviral-naïve and –experienced HIV-1 infected pediatric patients (three months to 21 years of age) for a median of 123 weeks. Virologic and immunologic response was observed across all ages at the end of the studies, as measured by HIV RNA and CD4 cell count.
New Drug Approvals 