SEC schreef:maar het businessmodel is op het randje van het criminele, terminaal zieke mensen niet willen genezen omdat ze niet genoeg geld hebben... dat kan niet blijven duren.
Zonder de medicatie dat die bedrijven ontwikkelen maken ze zelfs helemaal geen kans.
Dat is een probleem dat voor heel wat bedrijven geldt: onze technologie is immers zo ver gevorderd dat we mensen kunnen voederen, genezen, drinkwater geven,... waar dat vroeger niet kon. Alleen de prijs die eraan vast hangt maakt dat dit niet gebeurt.
Je kan daar in ware Zeitgeist stijl over discussiëren, wat zeker een verhit debat oplevert tussen markteconomen en post-scarcity economen...
Maar daarna is het business as usual. De farma sponsort zowel Clinton als Trump, wiens brood men eet, diens woord men spreekt en van regulatie zal niet veel in huis komen. Het was altijd zo, waarom zou het nu anders zijn?
Dan de zal de faire waarde van Gilead langzaam naar boven komen.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 21, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that two Phase 3b switch studies evaluating Odefsey® (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) for the treatment of HIV-1 infection met their primary objectives. The ongoing studies were designed to explore the efficacy and safety of Odefsey among virologically suppressed adult patients switching from the tenofovir disoproxil fumarate (TDF)-based regimens Complera® (emtricitabine 200mg/rilpivirine 25mg/tenofovir disoproxil fumarate 300mg) (Study 1216) or Atripla® (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) (Study 1160). Odefsey combines Gilead's emtricitabine and tenofovir alafenamide with rilpivirine, marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Odefsey maintained similar rates of virologic suppression as the TDF-based regimens in both studies based on the proportion of patients with HIV-1 RNA levels (viral load) <50 copies/mL. At Week 48, virologic suppression was maintained in 94 percent of patients taking Odefsey and in 94 percent of patients taking Complera in Study 1216 (difference: -0.3 percent; 95 percent CI: -4.2 percent to +3.7 percent), and in 90 percent of patients taking Odefsey versus 92 percent of patients taking Atripla in Study 1160 (difference: -2.0 percent; 95 percent CI: -5.9 percent to +1.8 percent).
Compared to the TDF-based regimens, Odefsey demonstrated statistically significant improvements in bone mineral density (BMD) at the hip and spine (p<0.001) in both studies. Additionally, improvements in total and tubular proteinuria statistically favored Odefsey in both studies (p<0.001). Study regimens were generally well tolerated, and general safety and discontinuation rates due to adverse events were comparable in the two studies. The most commonly reported adverse events for Odefsey included upper respiratory tract infection, diarrhea, nasopharyngitis, cough and headache. Gilead plans to submit these data for presentation at scientific conferences in 2016.
"As people are living longer with HIV, there is an increasing need for safe and tolerable treatment options to help address the long-term health needs of people living with HIV," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "Results from these two studies support the efficacy, as well as the renal and bone safety profile, of Odefsey as a new treatment option for virologically suppressed patients."
Odefsey was approved in the United States on March 1, 2016, and is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels =100,000 copies/mL. Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) for at least six months with no history of treatment failure and no known resistance to the individual components of Odefsey. No dosage adjustment of Odefsey is required in patients with estimated creatinine clearance =30 mL per minute.
Odefsey has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B. See below for important safety information.
About Studies 1216 and 1160
Study 1216 is a Phase 3b, randomized, double-blind, multicenter study among 630 virologically suppressed adults (HIV-1 RNA levels <50 copies/mL) on a stable regimen of Complera for = six consecutive months. Patients were randomized 1:1 to either maintain their Complera regimen or switch to Odefsey. Study 1160 is a Phase 3b, randomized, double-blind, multicenter study among 875 virologically suppressed adults (HIV-1 RNA levels <50 copies/mL) on a stable regimen of Atripla for = six consecutive months. Patients were randomized 1:1 to either maintain their Atripla regimen or switch to Odefsey. The studies will follow patients for 96 weeks after randomization.
The studies are ongoing. The primary objective of each study is to evaluate the efficacy of switching from Complera or Atripla to Odefsey in HIV-1 positive subjects who are virologically suppressed as determined by the proportion of subjects with HIV-1 RNA <50 copies/mL at Week 48 as defined by the FDA snapshot algorithm. The secondary objectives are to evaluate the bone safety of the regimens by the percent change from baseline in hip and spine BMD at Week 48 and Week 96, to evaluate the safety and tolerability of the treatment arms through Week 48 and to evaluate the efficacy, safety and tolerability of the treatment arms through Week 96.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 22, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company's Type II variation application for once-daily Truvada® (emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.
The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union (EU).
The Type II variation application is based on the results of two large placebo-controlled trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. In studies of Truvada for PrEP, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada's safety and tolerability profile when used as part of an HIV treatment regimen.
"The CHMP's opinion moves the medical community closer to being able to offer an additional HIV prevention tool to people at high risk of HIV acquisition across the entire EU," said Professor Jean-Michel Molina, MD, PhD, Hôpital Saint Louis in Paris and University of Paris 7. "Evidence supports pre-exposure prophylaxis, in combination with safer sex practices, to reduce the risk of sexually acquired HIV and we look forward to the potential public health impact of PrEP, in addition to increasing access to testing and universal treatment of people living with the disease, in helping to lower HIV transmission rates in Europe."
Worldwide, clinical guidelines support the use of PrEP, in combination with existing prevention measures such as condoms, to prevent the sexual transmission of HIV in adults at high risk of HIV infection. Truvada for PrEP should not be used in individuals with unknown or positive HIV-1 status, as Truvada alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking Truvada. Truvada is approved for PrEP in Australia, Canada, Kenya, Peru, South Africa and the United States. Regulatory submissions are pending in Brazil, Taiwan and Thailand. Additionally, within the EU, Truvada is currently available for PrEP in France under a Temporary Recommendation for Use by the French regulatory agency (ANSM).
The use of Truvada for PrEP is investigational in the EU and its safety and efficacy have not been established.
En wacht dus tot dit wat rendement geeft .
Als bedrijf geloof ik er wel in, als de beurs dit nu ook nog doet, dan zal het wel goedkomen, zeker?
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• New commercial DuoBody technology platform collaboration with Gilead
• Genmab granted Gilead an exclusive license to create a bispecific antibody with the DuoBody technology and an option to obtain a second exclusive license
Copenhagen, Denmark; August 10, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today it has entered an agreement to grant Gilead Sciences, Inc. an exclusive license and an option on a second exclusive license, to use the DuoBody® technology platform to create and develop bispecific antibody candidates for a therapeutic program targeting HIV. Under the terms of the agreement, Genmab will receive an upfront payment of USD 5 million from Gilead Sciences.
Genmab is entitled to potential development, regulatory and sales milestones of up to USD 277 million for the first product and further milestones for subsequent products. In addition, Genmab will be entitled to single-digit royalties on Gilead's sales of any commercialized products. Similar terms would apply if Gilead exercises the option to the second license.
"We are pleased to add this agreement with Gilead to our growing list of commercial collaborations for our innovative DuoBody platform and we are particularly excited that the potential for DuoBody bispecific antibodies for treating HIV will be explored," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
This commercial license agreement follows a research collaboration between Genmab and Gilead Sciences for the DuoBody technology signed in 2014.
This agreement is not expected to have a material impact on Genmab's 2016 financial guidance.
About the DuoBody Platform
The DuoBody platform is an innovative platform for the discovery and development of bispecific antibodies that may improve antibody therapy of cancer, autoimmune, infectious and central nervous system disease. Bispecific antibodies bind to two different epitopes either on the same, or on different targets (also known as dual-targeting) which may improve the antibodies' specificity and efficacy in inactivating the disease targets. DuoBody molecules are unique in combining the benefits of bispecificity with the strengths of conventional antibodies which allows DuoBody molecules to be administered and dosed as other antibody therapeutics. Genmab's DuoBody platform generates bispecific antibodies via a fast and broadly applicable process which is easily performed at standard bench, as well as commercial, manufacturing scale.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX® (daratumumab) for the treatment of heavily pretreated or double refractory multiple myeloma. Daratumumab is in clinical development for additional multiple myeloma indications and for non-Hodgkin's lymphoma. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more information visit http://www.genmab.com" onclick="window.open(this.href);return false;.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: email@example.com
This Company Announcement contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on http://www.genmab.com" onclick="window.open(this.href);return false;. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.
Company Announcement no. 33
CVR no. 2102 3884
1260 Copenhagen K
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