Gilead jaunumu topā
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08.02.2015
Vācijas valdība ieguvusi no Gilead diskontu uz preparātu C hepatīta ārstēšanai.
Kā ziņo "FirstWord Pharma", atsaucoties uz vācu biznesa laikrakstu "WirtschaftsWoche", amerikāņu farmācijas kompānija Gilead Sciences piedāvājusi Vācijai pirmos diskontus uz preparātiem Sovaldi un Harvoni, kas paredzēti C hepatīta ārstēšanai. Kā norāda Gilead Sciences biznesa direktore Vācijā Karstena Novoča, diskonts, kas saskaņots ar četrām veselības obligātās apdrošināšanas sistēmas kompānijām, 12 nedēļas ilga ārstēšanās kursa izmaksas ar inovatīvajiem preparātiem samazinājis par 60 tūkstošiem eiro.
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According to German business weekly WirtschaftsWoche, Gilead Sciences has conceded the first discounts in Germany on its hepatitis C drugs Sovaldi and Harvoni, as reported in Interactive Investor.
Carsten Nowotsch, head of the company's German operations, said that discounts from the list price of 60,000 euros per treatment had been negotiated with four of the country's tatutory health insurers.
"Thirty-five percent of people with statutory health insurance are already profiting from the discount agreements," Nowotsch remarked, adding that more such contracts could follow.
(http://www.firstwordpharma.com/node/1259866?tsid=28#axzz3RAXaXEJ8 )
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Strides Arcolab parakstījusi licences vienošanos ar Gilead par ARV preparātu TAF.
Indijas farmācijas kompānija Strides Arcolab paziņojusi par licences vienošanās noslēgšanu ar amerikāņu farmācijas kompāniju Gilead Sciences. Saskaņā ar darījuma noteikumiem Strides saņem neekskluzīvas tiesības ražot eksperimentālo ARV preparātu Tenofovir alafenamide (TAF) un nodarboties ar tā distribūciju. Šo preparātu paredzēts lietot 112 valstīs vai nu vienu pašu kā monoterapijas līdzekli vai kombinācijā ar citiem preparātiem. Kā norāda "The Economic Times", Gilead nodos indiešu kompānijai tehnoloģijas, kas ļaus ražot lētākus TAF analogus. Pats preparāts, kas pieder nukleotīdo inhibitoru transkriptāzes klasei un klīnisko pētījumu gaitā uzrādīja augstu efektivitāti, patlaban tiek izskatīts FDA.
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Strides Arcolab inks pact with Gilead Sciences for HIV drug.
NEW DELHI: Pharma major Strides Arcolab has entered into a licensing agreement with US-based Gilead Sciences Inc to manufacture and distribute latter's low-cost Tenofovir Alafenamide (TAF) product used for HIV treatment in developing countries.
In a BSE filing, Strides Arcolab said, "It has entered into a licensing agreement with Gilead Sciences, Inc under which Gilead has extended non-exclusive rights to Strides to manufacture and distribute Tenofovir Alafenamide (TAF), both as a single agent product and in combination with other drugs."
(http://articles.economictimes.indiatimes.com/2015-01-20/news/58268145_1_gilead-sciences-strides-arcolab-hiv-drug )
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Gilead paplašina darbojošos līgumu par preparāta GS-5816 analogu.
Amerikāņu farmācijas kompānija Gilead Sciences paziņojusi par licencētā līguma paplašināšanu. Tas noslēgts ar astoņām ģenēriķu kompānijām par eksperimentālā preparāta GS-5816 (NS5A inhibitors) ražošanu. Preparāts paredzēts C hepatīta ārstēšanai gan kā monoterapijas līdzeklis, gan kā perorālās terapijas līdzeklis kombinācijā ar preparātu GS-5816/Sovaldi, ziņo "FirstWord Pharma". Ja FDA to atbalstīs, minētās zāles tirgos 91 valstī. Patlaban GS-5816, kas paredzēts C hepatīta vīrusa sešu pamatgenotipu ārstēšanai, atrodas trešo klīnisko pētījumu stadijā kopā ar Sovaldi.
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Gilead Sciences said that it will expand existing agreements and allow eight companies to manufacture the experimental hepatitis C drug GS-5816, as well as a single tablet regimen combining the NS5A inhibitor with Sovaldi (sofosbuvir), once approved, for distribution in 91 developing countries.
GS-5816 is currently being investigated in late-stage studies as part of a single tablet regimen with Sovaldi for the treatment of all six genotypes of hepatitis C, with data expected in the second half of the year. Gilead noted that if authorised, the combination "would become the first pan-genotypic, all-oral single tablet regimen" for hepatitis C, which the company indicated would be "particularly important for developing countries, where genotype testing is often unreliable or not readily available."
Gregg Alton, Gilead's executive vice president of corporate and medical affairs, commented "this compound will offer over 90 percent cure rate for all genotypes, with one pill a day for 12 weeks." Alton said the company will ask India's health ministry to waive clinical trials and expedite approval for the combination therapy. "In many of the resource limited environments around the world, it's very difficult, and not feasible to do genotyping," Alton remarked, adding "it's an expensive diagnostic that's simply not available many places."
In September last year, Gilead granted non-exclusive licensing agreements allowing seven drugmakers to manufacture Sovaldi for distribution in 91 developing countries. The deals also allow the companies to produce Harvoni, a single tablet regimen combining Sovaldi with ledipasvir. According to Gilead, eight Indian-based generic manufacturers now hold licenses to manufacture the company's hepatitis C medicines: Biocon, Cadila Healthcare, Cipla, Hetero Labs, Mylan, Ranbaxy, Sequent Scientific and Strides Arcolab.
Sovaldi was approved by the FDA in December 2013 and gained clearance from the European Commission in January 2014. The drug was authorised in India in January this year, while Gilead noted that regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria.
Earlier this month, India's patent office rejected one of the patents on Sovaldi, with Gilead later indicating that it will appeal the ruling. "We believe there were procedural mistakes and don't believe it was a proper decision," Alton said.
(http://www.firstwordpharma.com/node/1259856#axzz3RAXaXEJ8 )
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