MEDICAL Novartis
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`8/30/00 PA Wire 00:00:00
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`PA NEWS
`Copyright © 2004 PA News Limited. All rights reserved.
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`August 30, 2000
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`MEDICAL Novartis
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`NOVARTIS ANNOUNCES POSITIVE TRIAL RESULTS FOR TWO NOVEL TRANSPLANTATION DRUGS
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`:: PRNewswire, London, August, 30. This press release is transmitted on behalf of Novartis.
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`Rome, Italy - At the 18th International Congress of the Transplantation Society Novartis presented encouraging data
`today from two series of trials on Certican (everolimus) (RAD) and on FTY720, two new transplant drugs, that are
`designed to reduce the incidence of acute rejection following organ transplantation.
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`Certican is a novel proliferation signal inhibitor (PSI) designed to protect transplant recipients from acute and chronic
`rejection and from the toxicities of conventional agents. Certican, currently in Phase III clinical development, has been
`studied in more than 3,200 patients and found to be an effective and generally safe immunosuppressive agent. Certican
`is expected to hold the promise to reduce chronic rejection by affecting the mechanism associated with vascular rejection
`and by inhibiting growth-factor driven smooth muscle cell proliferation.
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`"As we continue to refine our clinical understanding of immunosuppression, our goal is to provide new therapeutic
`options that reduce the risk of organ rejection and enhance long-term outcomes for transplant recipients," said
`Drummond Paris, Global Head of the transplantation business at Novartis. "These data demonstrate the advances
`Novartis is making in novel anti-rejection therapies."
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`In addition, Certican may offer the potential to reduce concomitant medications such as steroids. Certican is being
`developed to be used with Neoral and was well tolerated in clinical studies up to doses of 5 mg/day. Safety and preliminary
`efficacy studies of Certican in de novo renal transplant patients at six months demonstrated Certican as a potent
`immunosuppressant that is well tolerated with a low rate of opportunistic infections.
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`FTY720 is a novel immunosuppressant with a unique mechanism of action, currently in Phase II pre-clinical trials. In
`vivo studies of FTY720 demonstrate its ability to prolong allograft survival with remarkable potency. Very recent data
`show that extrapolated to the transplantation situation, the intact immunity to systemic infection during treatment with
`FTY720 may provide a striking advantage compared to classical immunosuppressive agents.
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`FTY720 has been shown to efficiently prevent rejection of solid organ grafts. Furthermore, it has been shown that
`combined treatment with FTY720 plus Neoral prolongs cardiac allograft survival in preclinical studies. The molecule
`shows synergy with Neoral+Certican, suggesting the potential for use in multi-drug combinations.
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`:: Additional Novartis advances in transplant therapies
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` © 2017 Thomson Reuters. No claim to original U.S. Government Works.
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`MEDICAL Novartis
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`ERL is an advanced enteric-coated IMPDH (inosine monophosphate dehydrogenase) inhibitor designed to provide
`improved gastrointestinal (GI) tolerability which would allow maintenance of potent therapeutic dosing. Continuous
`therapeutic dosing will potentially lead to better long-term outcomes for patients. Studies are underway to explore
`a potential GI benefit over mycophenolate mofetil (MMF). This may represent a significant advance over MMF
`since approximately one-third of MMF patients suffer from GI complications. ERL is currently in Phase III clinical
`development.
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`Novartis also presented data from two new studies that demonstrate that changing the procedures used for monitoring
`blood levels of Neoral, the most widely-used immunosuppressant therapy among liver and kidney transplant recipients,
`significantly reduces the incidence of acute rejection. The studies show that measuring Neoral blood levels two hours
`post-dosage (C2) as opposed to the conventional trough (C0) monitoring, improved clinical outcomes without raising
`the incidence of adverse events. These findings have broad application to the transplant community worldwide.
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`The foregoing press release contains forward-looking statements that can be identified by terminology such as
`"demonstrated in studies," "designed to ," "shows," "is expected to," "potentially," "may" or similar expressions. Such
`forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the
`actual results to be materially different from any future results, performance, or achievements expressed or implied by
`such statements. In particular, management's expectations regarding the above mentioned products, as well as future
`development results, could be affected by, among other things, uncertainties relating to clinical trials and product
`development; unexpected regulatory actions or government regulation generally; the company's ability to obtain or
`maintain patent and other proprietary intellectual property protection; and competition in general.
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`:: About Novartis
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`Novartis is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care,
`and animal health. In 1999, the Novartis Group (including Agribusiness) achieved sales of CHF 32.5 billion and invested
`more than CHF 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,400 people
`and operates in more than 140 countries around the world. In July 2000, a novel organizational structure for the
`Group's pharmaceutical operations was unveiled. The new entities-"Primary Care," "Specialty Businesses" and "Mature
`Products"-wil
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`create focused and entrepreneurial business units and integrate all critical business functions. The Group most recently
`announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemical business
`of AstraZeneca in the second half of 2000.
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`Http://www.transplantvpo.com
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`UNS
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`Philippa Jones at Ruder Finn Public Relations Tel +1 212 593 5818
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`---- Index References ----
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`Company: NOVARTIS AG; ASTRAZENECA PLC
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`News Subject: (Legal (1LE33); Technology Law (1TE30); Major Corporations (1MA93))
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`Industry: (Pharmaceuticals & Biotechnology (1PH13); Clinical Outcomes (1CL11); Healthcare Services (1HE13);
`Surgery (1SU58); Manufacturing (1MA74); Transplantation (1TR43); Healthcare (1HE06); Healthcare Cost-Benefits
`(1HE10); Healthcare Practice Specialties (1HE49); Surgical Specialties (1SU42))
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`Region: (Western Europe (1WE41); Europe (1EU83); Central Europe (1CE50); Switzerland (1SW77))
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`Language: EN
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`Other Indexing: (18TH INTERNATIONAL CONGRESS; ASTRAZENECA; ERL; GI; MMF; NOVARTIS;
`NOVARTIS GROUP; RUDER FINN PUBLIC; SEEDS; TRANSPLANTATION SOCIETY) (Additional Novartis;
`Certican; Global Head; MEDICAL Novartis; Novartis; Philippa Jones; Primary Care)
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`Word Count: 1150
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`End of Document
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`© 2017 Thomson Reuters. No claim to original U.S. Government Works.
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` © 2017 Thomson Reuters. No claim to original U.S. Government Works.
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