Claim: Novartis hopeful for novel heart drug, despite 'modest' benefit
Verdict: SUPPORTS

Retrieved passages:
title: Novartis Institute for Tropical Diseases
text: hope to have at least two drug candidates going through clinical trials in patients by the year 2012. Novartis has also stated that the NITD will seek to make treatments developed by the NITD available without profit to the poor in developing nations in which these diseases are endemic. NITD is a small molecule drug discovery research institute. Research is currently focused on three main diseases: NITD's research model relies on global partnership with other research institutes. In 2008, NITD announced a 5-year collaborative research effort would be conducted in cooperation with the TB Alliance to develop new medicines for

title: Alliance for Heart Failure
text: Heart Failure). They have a 12-month tenure. Day-to-day decisions are made by a steering committee. The Alliance for Heart Failure is supported and funded by Bayer, Medtronic Limited, Novartis Pharmaceuticals UK Ltd, and Roche Diagnostics Ltd. Funders are not responsible for any of the materials produced by the Alliance for Heart Failure, which are created independently by the Alliance's Secretariat. In 2016, the All Party Parliamentary Group on Heart Disease, chaired by Stuart Andrew MP, held an inquiry into living with heart failure. Written and oral evidence was provided by patients, healthcare professionals, and commissioners. The Inquiry's report, Focus on

title: Novartis
text: summer of 2013, two Japanese universities retracted several publications of clinical trials that purported to show that Valsartan (branded as Diovan) had cardiovascular benefits, when it was found that statistical analysis had been manipulated, and that a Novartis employee had participated in the statistical analysis but had not disclosed his relationship with Novartis but only his affiliation with Osaka City University, where he was a lecturer. In January 2018, Novartis began being investigated by Greek authorities for allegedly bribing public officials in the 2006-2015 period. Two former prime ministers, former ministers served in the ministries of health and economy, and

title: Imatinib
text: in 2013, ruling that the substance that Novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts. One study demonstrated that imatinib mesylate was effective in patients with systemic mastocytosis, including those who had the D816V mutation in c-KIT. However,

title: Novartis
text: for diseases without effective treatment options." He also said that companies like Novartis would invest less money in research in India as a result of the ruling. Novartis also emphasised that it continues to be committed to good access to its drugs; according to Novartis, by 2013, "95% of patients in India—roughly 16,000 people—receive Glivec free of charge... and it has provided more than $1.7 billion worth of Glivec to Indian patients in its support program since it was started..." On 17 May 2010, a jury in the United States District Court for the Southern District of New York awarded

title: Novartis
text: which Novartis will hold a 36,5% stake. In March 2018, GSK announced that it has reached an agreement with Novartis to acquire Novartis’ 36.5% stake in their Consumer Healthcare Joint Venture for $13 billion (£9.2 billion). Novartis fought a seven-year, controversial battle to patent Gleevec in India, and took the case all the way to the Indian Supreme Court, where the patent application was finally rejected. The patent application at the center of the case was filed by Novartis in India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property

title: Dan Lyons
text: pharmaceutical company Novartis Pharma AG. According to an RSPCA report, the research involved transplanting pigs' hearts, kidneys, pancreatic islets or bone into wild-caught baboons or cynomolgous macaques, or transplanting the macaques' hearts into the baboons. Material from the "Diaries" appeared in September 2000 in the "Daily Express" in the UK before Imutran obtained an injunction preventing further publication. Novartis closed Imutran shortly afterwards, but said it was unrelated to the leaks. The "Express" journalists won a Genesis Award for the story. A key point of Lyons' report was that the animals' suffering was severe, but most of the procedures had

title: Eric Rose
text: severe left ventricular dysfunction and other medical problems including pulmonary hypertension, peripheral vascular disease and renal disease. 68 people received a LVAD, Thoratec’s HeartMate XVE LVAD, and 61 received drug treatment. The results surprised many medical professionals. LVAD patients lived significantly longer than those on medical treatment. Rose co-founded several biotechnology companies including Nephros, which is concerned with heart and kidney related medical devices, and between 1997 and 2009, has served at various points, as its chairman, president, chief executive and director. Between 2007 and 2016, he was chief executive of the anti-viral developer Siga Technologies, having been an executive

title: Novartis v. Union of India & Others
text: that part of Indian patent law was created in 2005, years after Novartis' initial filing. Later, during the course of prosecution, appeals, and the litigation that ensued in India, Novartis undertook studies to compare the properties of the beta crystalline form of imatinib mesylate (described in its new patent application), with the freebase form of imatinib (described in the older patent), and submitted them in affidavits. The studies showed that the beta crystalline form of the drug had increased bioavailability in rats. A United States patent was granted in 2005. In 2001 the United States Food and Drug Administration (FDA)

title: Nesiritide
text: M.D., Karen M. Whalen, B.S., Roy Guharoy, Pharm.D., William Darko, Pharm.D. Nesiritide Nesiritide (Natrecor) is the recombinant form of the 32 amino acid human B-type natriuretic peptide, which is normally produced by the ventricular myocardium. Nesiritide works to facilitate cardiovascular fluid homeostasis through counterregulation of the renin–angiotensin–aldosterone system, stimulating cyclic guanosine monophosphate, leading to smooth muscle cell relaxation. Nesiritide was believed initially to be beneficial for acute decompensated congestive heart failure. It received approval from the United States' Food and Drug Administration for this purpose in 2001 after initial non-approval. In July 2011 the results of the largest study so

title: Novartis
text: interpretation of Paragraph 3d. The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts. Although the court ruled narrowly, and took care to note that the subject application was filed during a

title: Novartis
text: information the pharmaceutical company needed. Later, it became clear, however, that then-CEO Joseph Jimenez and Cohen communicated via email multiple times during 2017, which included ideas to lower drug prices to be discussed with the president. According to the report, several of the ideas appeared later in Trump's drug pricing plan, released in early 2018, in which pharmaceutical companies were protected from reduced revenues. Novartis Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market capitalization and sales. Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren),

title: Novartis
text: slowed by problems at its key US manufacturing plant. In 2012, Novartis ranked 7th on the Access to Medicine Index, which "ranks companies on how readily they make their products available to the world’s poor." In 2010, Novartis was in the top three pharma companies (as it was in 2008). For the fiscal year 2017, Novartis reported earnings of US$7.7 billion, with an annual revenue of US$50.1 billion, an increase of 1.4% over the previous fiscal cycle. Novartis shares traded at over $77 per share, and its market capitalization was valued at over US$197.7 billion in September 2018. Novartis was

title: Medication
text: research and development. Other critics claim that patent settlements would be costly for consumers, the health care system, and state and federal governments because it would result in delaying access to lower cost generic medicines. Novartis fought a protracted battle with the government of India over the patenting of its drug, Gleevec, in India, which ended up in India's Supreme Court in a case known as Novartis v. Union of India & Others. The Supreme Court ruled narrowly against Novartis, but opponents of patenting drugs claimed it as a major victory. The environmental impact of pharmaceuticals and personal care products

title: Cytokinetics
text: with Amgen for the potential treatment of heart failure. Results from the Phase 2 clinical trial, COSMIC-HF, showed that "omecamtiv mecarbil" improved several measures of cardiac function in people with chronic heart failure. "Omecamtiv mecarbil" is currently being studied in GALACTIC-HF, an international Phase 3 cardiovascular outcomes study. Amgen holds an exclusive license to develop and commercialize "omecamtiv mecarbil" worldwide and Servier holds a sublicense in Europe and other countries. In February 2017 Cytokinetics sold to Royalty Pharma a 4.5 percent royalty on potential worldwide sales of "omecamtiv mecarbil" for $90 million in an upfront cash payment. In collaboration with

title: Novartis v. Union of India & Others
text: of Patents and Designs stating that ingredients for grant of patent "novelty" and "non obviousness to person skilled in the art" were present in the application but rejected the application on the ground that the drug is not a new substance but an amended version of a known compound and that Novartis was unable to show any significant increase in the efficacy of the drug and it, therefore, failed the test laid down by section 3(d) of the Indian Patents Act. Novartis mounted a separate and concurrent litigation before the Madras High Court arguing that section 3(d) of the Indian

title: Novartis
text: investigation into Novartis' marketing of several drugs: Trileptal, an antiseizure drug; three drugs for heart conditions - Diovan (the company’s top-selling product), Exforge, and Tekturna; Sandostatin, a drug to treat a growth hormone disorder; and Zelnorm, a drug for irritable bowel syndrome. In September 2010, Novartis agreed to pay US$422.5 million in criminal and civil claims and to enter into a corporate integrity agreement with the US Office of the Inspector General. According to "The New York Times", "Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But

title: Novartis
text: to acquire Avexis for $218 per share or $8.7 billion in total, gaining the lead compound AVXS-101 used to treat spinal muscular atrophy. In August 2018, Novartis signed a deal with Laekna-a Shanghai-based pharmaceutical company for its two clinical-stage cancer drugs. Novartis gave Laekna the exclusive international rights for the drugs that are oral pan-Akt kinase inhibitors namely; afuresertib (ASB138) and uprosertib (UPB795). In mid-October, the company announced it would acquire Endocyte Inc for $2.1 billion ($24 per share) merging it with a newly created subsidiary. Endocyte will bolster Novartis' offering in its radiopharmaceuticals business, with Endocyte's first in class

title: Ivabradine
text: with coronary artery disease and a heart rate greater than 70, but without clinical heart failure to ivabradine or placebo in addition to standard therapy. Ivabradine did not improve outcomes in this patient group. In the SHIFT study, ivabradine significantly reduced the risk of the primary composite endpoint of hospitalization for worsening heart failure or cardiovascular death by 18% (P<0.0001) compared with placebo on top of optimal therapy. These benefits were observed after 3 months of treatment. SHIFT also showed that administration of ivabradine to heart failure patients significantly reduced the risk of death from heart failure by 26% (P=0.014)

title: PCSK9
text: circulating LDL particle concentrations. Since LDL particle concentrations are thought by many experts to be a driver of cardiovascular disease like heart attacks, it is plausible that these drugs may also reduce the risk of such diseases. Clinical studies, including phase III clinical trials, are now underway to describe the effect of PCSK9 inhibition on cardiovascular disease, and the safety and efficacy profile of the drugs. Among those inhibitors under development in December 2013 were the antibodies alirocumab, evolocumab, 1D05-IgG2 (Merck), RG-7652 and LY3015014, as well as the RNAi therapeutic inclisiran. PCSK9 inhibitors are promising therapeutics for the treatment of