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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Amgen sets up China JV with Zhejiang Beta for Panitumumab,Vectibix
Amgen is expanding its activities in China and establishing a joint venture with Zhejiang Beta Pharma Co to sell its colon cancer drug Vectibix, Panitumumab.
http://www.pharmatimes.com/Article/13-05-10/Amgen_sets_up_China_JV_with_Zhejiang_Beta.aspx
Panitumumab (INN), formerly ABX-EGF, is a fully human monoclonal antibody specific to the epidermal growth factor receptor (also known as EGF receptor, EGFR, ErbB-1 and HER1 in humans).
Panitumumab is manufactured by Amgen and marketed as Vectibix. It was originally developed by Abgenix Inc.
It was approved by the U.S. Food and Drug Administration (FDA) for the first time in September 2006, for “the treatment of EGFR-expressing metastatic colorectal cancer with disease progression” despite prior treatment. Panitumumab was approved by the European Medicines Agency (EMEA) in 2007, and by Health Canada in 2008 for “the treatment of refractory EGFR-expressing metastatic colorectal cancer in patients with non-mutated (wild-type) KRAS”.
Panitumumab was the first monoclonal antibody to demonstrate the use of KRAS as a predictive biomarker.
In July 2009, the FDA updated the labels of two anti-EGFR monoclonal antibody drugs (panitumumab and cetuximab) indicated for the treatment of metastatic colorectal cancer to include information about KRAS mutations.
FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)
fluticasone furoate
vilanterol
May 10, 2013 — The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
COPD is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third leading cause of death in the United States.
Breo Ellipta works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.
The challenges facing the pharmaceutical industry through to 2020
The challenges facing the pharmaceutical industry through to 2020
link on slideshare is
by Irish Pharmaceutical Healthcare Association (IPHA) on Nov 12, 2009
- 22,073 views on slideshare
Presentation delivered by Mr Sandy Johnston, PriceWaterhouseCoopers at the Irish Pharmaceutical Healthcare Association Annual Meeting 2009.
US green light for Warner Chilcott’s new contraceptive
May 10, 2013
US regulators have issued a green light for Warner Chilcott’s new oestrogen/progestin-based oral contraceptive, which is yet to be given an official trade name.
The product is a chewable combination of norethindrone acetate and ethinyl estradiol and ferrous fumarate tablets, approved by the US Food and Drug Administration for the prevention of pregnancy.
The oral contraceptive regimen consists of 24 white active chewable tablets that contain the active ingredients, followed by four brown non-hormonal placebo tablets containing ferrous fumarate.
Approval was based on data from a six-month clinical trial involving 743 women aged 18-45 years, which showed the risk of getting pregnant to be about one-four in 100 women during the first year of use.
second nod, may10 2013–The US Food and Drug Administration has given the green light to Novartis’ Ilaris as a treatment for a serious form of childhood arthritis.
my old post for first nod
Novartis’ Ilaris canakizumab has become the first biologic drug to be approved in the EU to treat the symptoms of gouty arthritis
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | IL-1β |
Novartis’ Ilaris has become the first biologic drug to be approved in the EU to treat the symptoms of gouty arthritis in another gain for the interleukin-1 beta inhibitor.
march01,2013
First biologic drug approved for condition in Europe
The European Commission (EC) cleared llaris (canakizumab) for the treatment of adult patients who have suffered at least three gouty arthritis attacks in the previous 12 months, but who are unsuitable for treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine or repeated courses of corticosteroids.
Gouty arthritis – commonly known as gout – is an “excruciating condition”, according to Novartis division head David Epstein, who noted that Ilaris offers new hope to patients who do not currently have treatment options.
Data from two phase III trials of Ilaris in acute gouty arthritis attacks showed that patients treated with the drug experienced significantly greater pain relief compared to the injectable steroid triamcinolone acetonide, while most adverse events were mild to moderate in severity.
The most frequent side effects were infections, and particularly upper respiratory tract infections and nasopharyngitis.
Ilaris was launched in the US and EU in 2009 as a treatment for an auto-inflammatory condition called cryopyrin-associated periodic syndrome (CAPS). The rarity of that condition has meant sales have been relatively small, coming in at $72m last year, albeit a 56 per cent gain over 2011.
Gouty arthritis is a much bigger market for the drug and, along with a juvenile arthritis indication Novartis is pursuing, could push Ilaris towards blockbuster status with sales in excess of $1bn a year.
“Our vision is to realise the potential of Ilaris wherever IL-1 beta plays a key role and available treatment options don’t give patients the help they need,” said Epstein.
EU approval comes after the US FDA knocked back Ilaris for gouty arthritis, saying in 2011 that Novartis needed to provide more data on the drug’s risk-benefit profile, specifically its potential to leave patients vulnerable to infections.
Gout has been a tricky indication for drug developers to crack, with the FDA turning down another CAPS treatment – Regeneron’s IL-1 inhibitor Arcalyst (rilonacept) – in 2012 on the grounds of inadequate safety data and concern about a risk of malignancy.
One success came in 2010 when Savient secured approval for its Krystexxa (pegloticase) drug as a second-line treatment after oral xanthine oxidase inhibitors in patients with severe debilitating chronic tophaceous gout.
However, the drug has failed to make significant inroads because of a high price and tendency to stimulate neutralising antibodies that limit its therapeutic effect, according to Decision Resources.
There is still a great demand for safer and more effective therapies with the phase III pipeline featuring another potential blockbuster in the form of AstraZeneca/Ardea Biosciences URAT1 inhibitor lesinurad.
Canakinumab (INN, trade name Ilaris, previously ACZ885)[1] is a human monoclonal antibody targeted at interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family, including interleukin-1 alpha.[2]
Canakinumab was approved for the treatment of cryopyrin-associated periodic syndromes (CAPS) by the US FDA on June 2009[3] and by the European Medicines Agency in October 2009.[4] CAPS is a spectrum of autoinflammatory syndromes including familial cold autoinflammatory syndrome, Muckle–Wells syndrome, and neonatal-onset multisystem inflammatory disease.
Canakinumab was being developed by Novartis for the treatment of rheumatoid arthritis but this trial has been discontinued.[5] Canakinumab is also in phase I clinical trials as a possible treatment for chronic obstructive pulmonary disease.[6]
References
- Dhimolea, Eugen (2010). “Canakinumab”. MAbs 2 (1): 3–13. doi:10.4161/mabs.2.1.10328. PMC 2828573. PMID 20065636.
- Lachmann, HJ; Kone-Paut I, Kuemmerle-Deschner JB et al. (4 June 2009). “Use of canakinumab in the cryopyrin-associated periodic syndrome”. New Engl J Med 360 (23): 2416–25. doi:10.1056/NEJMoa0810787. PMID 19494217.
- “New biological therapy Ilaris approved in US to treat children and adults with CAPS, a serious life-long auto-inflammatory disease” (Press release). Novartis. 18 June 2009. Retrieved 28 July 2009.
- Wan, Yuet (29 October 2009). “Canakinumab (Ilaris) and rilonacept (Arcalyst) approved in EU for treatment of cryopyrin-associated periodic syndrome”. National electronic Library for Medicines. Retrieved 14 April 2010.
- “clinicaltrials.gov, Identifier NCT00784628: Safety, Tolerability and Efficacy of ACZ885 (Canakinumab) in Patients With Active Rheumatoid Arthritis”. Retrieved 2010-08-21.
- Yasothan U, Kar S (2008). “Therapies for COPD”. Nat Rev Drug Discov 7 (4): 285. doi:10.1038/nrd2533.
Monoclonal Antibody Therapeutic Uses
Array Announces Global Phase 3 Trial Evaluating MEK162 In Patients With Low-Grade Serous Ovarian Cancer
MEK-162:
5-((4-bromo-2-fluorophenyl)amino)-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzo[d]imidazole-6-carboxamide.
May 6, 2013
Array BioPharma Inc. today announced that it will initiate a global Phase 3 clinical trial in patients with recurrent low-grade serous ovarian cancer (LGSOC) during the summer of 2013. The study, called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer), will evaluate the efficacy and safety of MEK162 compared to standard chemotherapy treatments and is designed for worldwide regulatory submissions, including with the U.S. Food and Drug Administration and the European Medicines Agency. Array invented MEK162 and licensed worldwide rights to develop and commercialize the drug to Novartis in April 2010. The MILO study follows a recent announcement by Novartis detailing plans to initiate Phase 3 trials of MEK162 in both NRAS- and BRAF-mutant melanoma and will be covered as part of the Novartis/Array co-development agreement under which costs are capped annually and in total for Array.
MEK162 (ARRY-162) is an oral, highly selective MEK inhibitor. In preclinical studies, MEK162 showed significant antitumor activities in cell lines and animal models. MEK162 is now being investigated in trials in advanced solid tumors. Recent research confirms that the MEK pathway acts as a central axis in the proliferation of different tumors including melanoma, non-small cell lung, head/neck and pancreatic cancers. And MEK inhibition, either alone or in combination with other agents, is an important therapeutic strategy in treating cancer. ARRY-162 is a novel, orally active, potent, selective, non-ATP-competitive inhibitor of MEK 1 / 2 that has the potential to treat a range of malignant diseases. (source:http://www.arraybiopharma.com/ProductPipeline/Cancer/MEK.asp).
1. Combinations comprising methotrexate and DHODH inhibitors By Godessart Marina, Nuria; Pizcueta Lalanza, Maria Pilar From PCT Int. Appl. (2010), WO 2010083975 A1 20100729.
2. Combinations comprising methotrexate and DHODH inhibitors By Godessart Marina, Nuria; Pizcueta Lalanza, Maria Pilar From Eur. Pat. Appl. (2010), EP 2210615 A1 20100728.
3. Combination of (a) a phosphoinositide 3-kinase inhibitor and (b) a modulator of Ras/Raf/Mek pathway By Garcia-Echeverria, Carlos; Maira, Sauveur-Michel; Stuart, Darrin; Wee, Susan; Fritsch, Christine; Nagel, Tobi From PCT Int. Appl. (2010), WO 2010006225 A1 20100114.
4. Combination comprising DHODH inhibitors and methotrexate for treatment of autoimmune, inflammatory and proliferative disorders By Godessart Marina, Nuria; Pizcueta Lalanza, Maria Pilar From PCT Int. Appl. (2009), WO 2009153043 A1 20091223.
5. Combination comprising DHODH inhibitors and methotrexate for treatment of autoimmune, inflammatory and proliferative disorders By Godessart Marina, Nuria; Pizcueta Lalanza, Maria Pilar From Eur. Pat. Appl. (2009), EP 2135610 A1 20091223
Teva and Alexza Announce Teva’s License to Market ADASUVE® in the U.S.
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 anatypical antipsychotic.
Loxapine may be metabolized by N-demethylation to amoxapine, a tetracyclic antidepressant.
Adasuve® (loxapine) inhalation powder is approved in the U.S. for the acute treatment of agitation associated with schizophrenia and bipolar disorder
May 8, 2013
Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd (NYSE: TEVA), and Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) announced today that the companies have entered into an exclusive U.S. license and supply agreement for ADASUVE (loxapine) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Teva will be responsible for all U.S. commercial and clinical activities for ADASUVE, including U.S. post-approval clinical studies, and has gained rights to conduct additional clinical trials of ADASUVE for potential new indications in neurological disorders. Alexza will be responsible for manufacturing and supplying ADASUVE to Teva for commercial sales and clinical trials.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions, including agitation, acute repetitive seizures and insomnia. Alexza’s products are based on the Staccato®system, a hand-held inhaler that is designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.
Study Shows Eritoran Can Protect Against Lethal Flu Infection
eritoran
read all at
Eritoran is an investigational drug for the treatment of severe sepsis, an excessiveinflammatory response to an infection. It is being developed by the Japanese pharmaceutical company Eisai Co. and administered intravenously as the sodium salteritoran tetrasodium.
In a phase III clinical trial, eritoran did not perform better than existing treatments for the treatment of sepsis
Fibrocell’s azficel-T enters phase II trial for burn scars
Azficel-T, an intradermal autologous fibroblast therapy, for the potential treatment of restrictive burn scars
3 may 2013
Fibrocell Science has begun a phase II trial of azficel-T, its intradermal autologous fibroblast therapy, for restrictive burn scars.
The double-blind, randomized, placebo-controlled study will assess the range of motion, brief pain index and scar appearance in 21 patients with burn scars. Primary efficacy and safety endpoints will be evaluated at 6 months.
David Pernock, Chairman and CEO of Fibrocell, said: “In addition to the aesthetic benefits of autologous fibroblasts, we are encouraged by their potential for the treatment of restrictive burn scarring. Patients have experienced the functional benefits of fibroblasts in individual case studies and we hope to confirm those benefits in the phase II trial”
New Drug Approvals 