Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber
ANTONY, France, August 27, 2008 /PRNewswire-FirstCall/ –
- Oralair(R) Grasses 300IR Highly Positive Clinical Results in a Pharmacodynamic Study Conducted in an Allergen Challenge Chamber
Stallergenes S.A. announces the highly positive results of a new study conducted in an Allergen Challenge Chamber (ACC).
The study on Oralair(R) Grasses included 86 adult patients exposed to grass pollen challenge with different treatment durations: 1 week, 1 month, 2 and 4 months without a titration phase. Use of rescue medication was not allowed.
The outcomes of this trial in line with the objectives were: - An onset of action starting on the seventh day (statistically significant at one month) - An efficacy plateau reached on challenge at the first month - A highly statistically significant effect of Oralair(R) Grasses versus placebo (p=0.0003) on the average symptom score (RTSS). The magnitude of efficacy (34%)1 was similar to the findings of the Previous studies VO34 (in adults) and VO52 (in a paediatric population) - A Cohen score of 0.79 corresponding to a large effect size
Safety results, with only well-known local adverse events, and efficacy results were consistent with the findings of Oralair(R) Grasses studies previously conducted in adults (VO34) and children (VO52) in phase III trials.
“This study has demonstrated a clear consistency with the outcomes of previous pivotal studies. It opens the way for ACC as a new tool for phase II studies reducing the unpredictability of pollination. Moreover, it confirms the therapeutic effect of Oralair(R) Grasses and the very fast onset of action on the symptoms,” said Olivier de Beaumont.
1 on median scores
ABOUT THE STUDY
This was a randomised, double-blind, parallel-group, placebo-controlled, single centre, phase I study to assess, subsequent to allergen challenge in an allergen exposition chamber, the efficacy and time course of sublingual immunotherapy (SLIT) administered as 300IR allergen-based tablets once daily to 86 adults suffering from grass pollen rhinoconjunctivitis. The main objectives of the study were to assess the efficacy of grass pollen extract SLIT tablets compared to placebo on the average Rhinoconjunctivitis Total Symptom Score (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes), to evaluate the onset of action after different treatment durations (1 week, 1 month, 2 and 4 months) through the challenge test, to identify immunological parameters as possible biomarkers for SLIT, and to assess safety. Since patients were not allowed to take any rescue medication, the symptom score was not impacted by its usage and the difference between the placebo and active group was due exclusively to the effect of the Oralair(R) Grasses tablet.
ABOUT THE ALLERGEN CHALLENGE CHAMBER (ACC)
The Allergen Challenge Chamber is already recognized as a supportive study by the FDA and the European Medicines Agency (EMEA). The interest of ACC as an assessment tool for clinical development is confirmed. The Allergen Challenge Chamber (ACC) offsets the unpredictability of the pollen season, and thereby avoids the variable nature of pollens and patient exposure and facilitates follow up.
About oralair(R) Grasses
Oralair(R) Grasses is a fast-dissolving tablet that has demonstrated high efficacy in treating allergic rhinoconjunctivitis to grass pollen starting with the first season, lasting throughout the pollen season, and at the pollen peak, on:
- Poly- and mono-sensitised patients, as well as asthmatic patients, - Every individual symptom, and in particular on nasal congestion and watery eyes.
Oralair(R) Grasses is a pre-seasonal treatment: it has to be started four months before the pollen season, be maintained throughout the season, and then stopped and restarted the following season.
Oralair(R) Grasses contains a mix of 5 standardised grass allergens: perennial rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum), as a daily dose of 300 IR, so as to mimic patients’ natural exposure.
In June 2008, Stallergenes was granted a marketing authorisation for Oralair(R) Grasses in adults, by PEI (Paul Ehrlich Institute), the biological branch of the German health agency.
Based on the positive results of the paediatric pivotal study (VO52), Stallergenes has applied in July 2008 for the paediatric extension of the product’s indications.
The clinical development programme has already enrolled around 1600 patients to date. A long term pivotal study is proceeding according to schedule, and is currently in its second year. The company plans to file two INDs for adult and paediatric trials with the FDA this year.
About Stallergenes
Stallergenes is a European biopharmaceutical company dedicated to desensitisation therapies for the prevention and treatment of allergy-related respiratory diseases, e.g. rhinoconjunctivitis and allergic asthma. A pioneer and leader in sublingual desensitisation treatments, Stallergenes devotes 16% of its turnover to Research and Development and is actively involved in the development of a new therapeutic class: sublingual desensitisation tablets.
In 2007, Stallergenes had a turnover of 147 million euros and provided desensitisation treatments to more than 500,000 patients.
Stallergenes is listed on Euronext Paris (Compartment B) and is part of the sample composing the SBF 120 index.
ISIN Code: FR0000065674 Reuters Code: GEN.PA Bloomberg Code: GEN.FP Additional information is available at http://www.stallergenes.com
CONTACT: Contacts: Albert Saporta - Chairman and C.E.O, Tel:+33-1-55-59-20-04. Christian Thiry - Chief Financial Officer, Tel:+33-1-55-59-20-95 - Email: . StallergenesPress Relations: Lise Lemonnier - Communications Manager, Tel.:+33-1-55-59-20-96 - Email: . Investors andanalysts relations: Lucile de Fraguier - Pavie Finance, Tel.:+33-1-42-15-04-39 - Email: investorrelations@stallergenes.fr llemonnier@stallergenes.fr contact@pavie-finance.com
Ticker Symbol: (:GEN)
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Paliperidone palmitate
Treatment for Schizophrenia
FDA Issues Complete Response Letter for Paliperidone Palmitate
FDA Issues Complete Response Letter for Paliperidone Palmitate for the Treatment of Schizophrenia
TITUSVILLE, N.J., August 26, 2008 /PRNewswire/ — Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional data before it will approve the company’s New Drug Application (NDA) for paliperidone palmitate, an investigational once-monthly atypical antipsychotic intramuscular injection for treating schizophrenia and preventing recurrence of its symptoms.
The letter outlined remaining questions that need to be addressed prior to granting approval for paliperidone palmitate. The agency does not require any additional studies.
J&JPRD is currently evaluating the FDA complete response and intends to work with the agency to resolve any outstanding questions. The NDA for paliperidone palmitate was submitted in October 2007.
Paliperidone palmitate utilizes the NanoCrystal(R) Technology patented by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc.
Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of Johnson & Johnson, the world’s most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the U.S. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
About Janssen
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., based in Titusville, N.J., is the only large pharmaceutical company in the U.S. dedicated solely to mental health. As the company celebrates its 50th year in mental health, it currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more information about Janssen, visit www.janssen.com.
J&JPRD and Janssen are subsidiaries of Johnson & Johnson.
About NanoCrystal Technology
NanoCrystal(R) Technology is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc . For more information about Elan’s drug delivery technologies, visit www.elan.com/EDT.
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
CONTACT: Media, Kara Russell, +1-609-730-3592, or Srikant Ramaswami,+1-908-927-7978; or Investors, Louise Mehrotra, +1-732-524-6491, or TinaPinto, +1-732-524-2034, both of Johnson & Johnson
Web site: http://www.jnj.com/http://www.elan.com/EDT/
Ticker Symbol: (:JNJ),(NYSE:ELN)
Terms and conditions of use apply
Copyright 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Tel-Aviv Court Rules in Favor of Sun Pharmaceutical; No Special Tender Offer Necessary in Taro Offer
MUMBAI, India, August 26, 2008 /PRNewswire/ — Sun Pharmaceutical Industries Ltd. today announced it was victorious in all elements of its defense of the litigation brought against it in the Tel-Aviv District Court by Taro Pharmaceutical Industries Ltd. (Taro) and certain of its directors.
The Tel-Aviv Court yesterday rejected Taro’s contention that Sun Pharma should have conducted a “special tender offer” under Israeli Law. As a result, Sun Pharma will be in a position to complete the previously announced Tender Offer by its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd. (Alkaloida). Following the closing of the Tender Offer, all conditions to Sun Pharma’s Option Agreement to acquire all the shares held by the controlling shareholders of Taro will be satisfied and the controlling shareholders will have to deliver their shares.
In a well reasoned and comprehensive decision, Honorable Judge Dr. Michal Agmon-Gonen J. of the Tel-Aviv District Court ruled that it was “disingenuous” for Taro’s directors to claim now, over a year after they approved the transaction, that a special tender offer was required. The court stated that the directors should have “studied the agreements” prior to their being signed, and should have confirmed then that they were in the company’s best interest. The court stated that the directors cannot claim now that they suddenly decided a special tender offer is necessary.
Dilip Shanghvi, Chairman and Managing Director, Sun Pharma said, “It is clear based on yesterday’s ruling that the lawsuit by Taro’s independent directors was part of a calculated effort by Barry Levitt to avoid living up to his obligations under the Option Agreement. It is time for Dr. Levitt and his family to live up to the contract and do what is required of them under the Option Agreement.”
With respect to those directors who are also shareholders, the court stated that “these shareholders benefited from Sun’s investment, which basically saved Taro from collapse,” and characterized their conduct in challenging Sun Pharma’s exercise of its contractual option as “grave.”
The court also ordered Taro and the other plaintiffs to pay Sun Pharma’s costs related to the litigation.
The complete terms and conditions of the tender offer are set out in the Offer to Purchase, which is filed with the U.S. Securities and Exchange Commission. Taro shareholders may obtain copies of all of the offering documents, including the Offer to Purchase, free of charge at the SEC’s website (www.sec.gov) or by directing a request to MacKenzie Partners, Inc., the Information Agent for the offer, at 105 Madison Avenue, New York, New York 10016, (212) 929-5500 (Call Collect) or Call Toll-Free (800) 322-2885, Email: . tenderoffer@mackenziepartners.com
Greenhill & Co., LLC is acting as the Dealer Manager for the Tender Offer and MacKenzie is acting as the Information Agent for the Tender Offer.
About Sun Pharmaceutical Industries Ltd.
Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, U.S. and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at www.sunpharma.com.
Contacts Uday Baldota Tel +91 22 6645 5645, Xtn 605 Tel Direct +91 22 66455605 Mobile +91 98670 10529 E mail uday.baldota@sunpharma.com Brunswick Group for Sun Pharma Nina Devlin / Andrea Shores +1 212 333 3810 Arad Communications for Sun Pharma Gali Dahan +972 3 7693320 Mira Desai Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455606 Mobile +91 98219 23797 Email mira.desai@sunpharma.com MacKenzie Partners Robert Marese +1 212 929 5500 Greenhill Ashish Contractor +1 212 389 1537
CONTACT: Uday Baldota, +91-22-6645-5645, Xtn 605, Direct, +91-22-66455605,Mobile, +91-98670-10529, , or Mira Desai, +91 226645 5645, Xtn 606, Direct, +91-22-66455606, Mobile, +91-98219-23797,, both of Sun Pharma; Nina Devlin or Andrea Shoresof Brunswick Group, +1-212-333-3810, or Gali Dahan of Arad Communications,+972-3-7693320, all for Sun Pharma; Robert Marese of MacKenzie Partners,+1-212-929-5500; Ashish Contractor of Greenhill, +1-212-389-1537 uday.baldota@sunpharma.com mira.desai@sunpharma.com
Web site: http://www.brunswickgroup.com/http://www.sunpharma.com/
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
drugscom967:http://www.drugs.com/news/tel-aviv-court-rules-favor-sun-pharmaceutical-no-special-tender-offer-necessary-taro-offer-13373.html
Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for Byetta
SAN DIEGO and INDIANAPOLIS, August 26, 2008 /PRNewswire-FirstCall/ — Amylin Pharmaceuticals, Inc. and Eli Lilly and Company in a conference call today provided context and additional information regarding the August 18, 2008 U.S. Food and Drug Administration (FDA) update to a prior alert for BYETTA(R) (exenatide) injection referencing pancreatitis. The companies were aware of the pancreatitis cases referenced in the alert, as well as others, and previously reported these cases to the FDA. The complete conference call replay will be available through Amylin’s and Lilly’s corporate websites after the call.
Since 2006, the U.S. prescribing information for BYETTA has included information about pancreatitis. A recent study has also shown that patients with type 2 diabetes were at nearly three times the risk of developing pancreatitis than those without diabetes.(1) While a definite causal relationship between BYETTA and pancreatitis has not been proved, to better understand the suspected relationship, Amylin and Lilly continue to pursue a comprehensive drug safety program that includes extensive internal and external review of individual cases, and clinical and epidemiologic studies.
“At Amylin and Lilly, patient safety is our foremost concern. We are committed to continuing to work closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products,” said Orville G. Kolterman, Senior Vice President, Research and Development at Amylin. “It is important to understand that pancreatitis, an inflammatory condition of the pancreas, is a rare event. Further, the characteristics and complications of the pancreatitis cases in patients on BYETTA are consistent with pancreatitis in the general population. We believe BYETTA continues to have a positive benefit-risk profile for patients with type 2 diabetes.”
About BYETTA(R) (exenatide) injection
BYETTA is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained A1C control, low incidence of hypoglycemia when used with metformin or a thiazolidinedione, and progressive weight loss. BYETTA was approved in April 2005 and has been used by approximately one million patients since its introduction. For full prescribing information, visit www.BYETTA.com.
About Diabetes
Diabetes affects more than 21 million in the United States and an estimated 246 million adults worldwide.(2,3) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.(4)
According to the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(5) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(6) Data support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(7,8)
Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2 diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems digesting food or those who have severe disease of the stomach or kidney.
When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is the most common side effect when first starting BYETTA, but decreases over time in most patients.
If patients experience the following severe and persistent symptoms (alone or in combination): abdominal pain, nausea, vomiting, or diarrhea, they should talk to their healthcare provider because these symptoms could be signs of serious medical conditions. BYETTA may reduce appetite, the amount of food eaten, and body weight. No changes in dose are needed for these side effects. These are not all of the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.
For full prescribing information, visit www.BYETTA.com.
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin’s research and development activities leverage the company’s expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California with over 2,000 employees nationwide. Further information about Amylin Pharmaceuticals is available at www.amylin.com.
Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly’s current diabetes products visit, www.lillydiabetes.com.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA and the revenues generated from BYETTA may be affected by competition; unexpected new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; label expansion requests not being submitted in a timely manner or receiving regulatory approval; or manufacturing and supply issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin’s and Lilly’s most recently filed SEC including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements.
1. Noel R, Braun D, Patterson R, Bloomgren G. Increased risk of acute pancreatitis observed in patients with type 2 diabetes. 24th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. Copenhagen, Denmark. International Society for Pharmacoepidemiology: 2008.
2. The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed June 2, 2008.
3. “All About Diabetes.” American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed June 6, 2008.
4. “Direct and Indirect Costs of Diabetes in the United States.” American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed June 6, 2008.
5. Saydah SH, Fradkin J and Cowie CC. “Poor Control of Risk Factors for Vascular Disease Among Adults with Previously Diagnosed Diabetes.” JAMA: 291(3), January 21, 2004.
6. Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.
7. Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.
8. Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.
CONTACT: Alice Izzo of Amylin, office, +1-858-642-7272, or cell,+1-858-232-9072; or Kindra Strupp of Lilly, office, +1-317-277-5170, orcell, +1-317-554-9577
Web site: http://www.amylin.com/http://www.lilly.com/http://www.BYETTA.com/http://www.lillydiabetes.com/
Ticker Symbol: (NASDAQ-NMS:AMLN),(NYSE:LLY)
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
drugscom967:http://www.drugs.com/news/amylin-pharmaceuticals-eli-lilly-provide-context-fda-alert-byetta-13374.html
Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery
- Clinical data showing unprecedented 89% reduction in risk of GIST relapse with use of Gleevec after surgery are basis for FDA, EMEA, Swissmedic filings
EAST HANOVER, N.J., August 27, 2008 /PRNewswire/ — Novartis announced today that Gleevec(R) (imatinib mesylate) tablets* has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST). FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months(1). Similar regulatory submissions have been filed in the European Union and Switzerland and will be filed in other countries shortly.
* Known as Glivec(R) (imatinib) outside the US, Canada and Israel.
The Gleevec submissions are based on data from a Phase III, double-blind, randomized, multicenter, international study of more than 700 GIST patients who had surgery to remove their tumors. The results showed a dramatic 89% reduction in risk of kit-positive GIST returning after surgery (adjuvant setting) in patients treated with Gleevec versus placebo(2).
In early 2007, the study met its primary efficacy endpoint, showing an advantage for Gleevec in recurrence-free survival. At that time, following the recommendation of the independent study data monitoring committee to stop the trial accrual early, the study investigators made public the interim results and offered Gleevec to patients receiving placebo(3).
Approximately half of all patients with newly diagnosed GIST are considered candidates for surgical resection, or removal of their tumors. Of those who have the surgery, about half will suffer a recurrence(4). If approved for this indication, Gleevec will be the first treatment option available to GIST patients after surgery to reduce the risk of disease recurrence or to possibly prevent the disease from returning.
“The dramatic clinical results from this study of Gleevec in the adjuvant GIST setting are especially encouraging when we consider the incremental benefit we typically see with other adjuvant therapies for solid tumors,” said Rainer Boehm, MD, Executive Vice President, North American Region Head, Novartis Oncology. “The adjuvant use of Gleevec, if approved, would represent an important advance in the ongoing post-surgery management of GIST.”
Gleevec is currently indicated in both the US and EU for the first-line treatment of metastatic or unresectable (inoperable) kit-positive GIST. If approved, the use of Gleevec for the treatment of GIST in the adjuvant setting would add to its eight current indications, which include Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) and five other rare diseases. Novartis also has a therapy for the treatment of carcinoid tumors and acromegaly and multiple treatments in the pipeline targeting rare diseases.
Filing data
The study on which the regulatory filing is based compared the recurrence-free survival of GIST patients taking Gleevec 400 mg/day versus placebo for one year immediately following surgery. The results showed that 98% of patients receiving Gleevec remained recurrence free at one year following surgery compared to approximately 82% of those receiving placebo(3). This shows that as a result of adjuvant therapy with Gleevec, there was an 89% reduction in risk of GIST returning(2).
The study, known as ACOSOG Z90001, was conducted at multiple cancer centers throughout the US and Canada, under a Cooperative Research and Development Agreement between Novartis and the National Cancer Institute (NCI). The study was led by the American College of Surgeons Oncology Group (ACOSOG).
The investigators reported that Gleevec therapy was well tolerated by most patients, with side effects similar to those observed in previous clinical trials with Gleevec. These include nausea, diarrhea and swelling (edema)(3).
About gastrointestinal stromal tumors (GIST)
Gastrointestinal stromal tumors (GIST) belong to a group of cancers known as soft tissue sarcomas. They are the most common sarcomas and can be found most often in the stomach and small intestine. The incidence of GIST is estimated to be 4,500 - 6,000 new cases per year in the US (15-20 cases per million population)(5), of which more than 90% are kit-positive(6). Kit — also known as CD117 — is a protein that, when mutated, has been identified as one of the major causes of GIST.
About Gleevec
Gleevec(R) (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. Follow-up is limited to 5 years. Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha (IFN-alpha) therapy; adult patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL); adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements; adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-KIT mutation or with c-KIT mutational status unknown; adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1- PDGFR alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR alpha fusion kinase-negative or unknown; adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP); patients with KIT (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). The effectiveness of Gleevec in GIST is based on objective response rate. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Important safety information(7)
Fetal harm can occur when Gleevec is administered to a pregnant woman; therefore, women of childbearing potential should be advised to not become pregnant while taking Gleevec tablets and to avoid breast-feeding while taking Gleevec tablets because of the potential for serious adverse reactions in nursing infants. Sexually active female patients taking Gleevec should use adequate contraception. If the patient does become pregnant while taking Gleevec, the patient should be advised of the potential hazard to the fetus.
In adult Ph+ CML patients, severe (NCI Grades 3/4) lab abnormalities — including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (<1%-33%) and hepatotoxicity (approx 5%) — and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion, pulmonary edema, and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%), and musculoskeletal pain (2%-9%) were reported among patients receiving Gleevec*. Severe fluid retention appears to be dose-related, was more common in the advanced-phase studies (where the dosage was 600 mg/day), and is more common in the elderly.
* Numbers indicate the range of percentages in 4 studies among adult patients with Ph+ CML in blast crisis, accelerated phase, and chronic phase.
In HES/CEL patients, instances of Grade 3 leukopenia, neutropenia, lymphopenia, and anemia were reported.
For DFSP, severe (NCI Grades 3/4) lab abnormalities included anemia (17%), thrombocytopenia (17%), neutropenia (8%) and increased creatinine (8%).
In GIST, severe (NCI Grades 3/4) lab abnormalities (400 mg/day; 600 mg/day) — including neutropenia (10%; 11%), anemia (3%; 9%), thrombocytopenia (0%; 1%) and hepatotoxicity (6%; 8%) — and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion or ascites; 3%; 8%) and superficial edema (6%; 5%), hemorrhage (6%; 11%), abdominal pain (11%; 4%), nausea (6%; 4%), diarrhea (3%; 7%) and musculoskeletal pain (6%; 1%) were reported among patients receiving Gleevec.
Severe congestive heart failure and left ventricular dysfunction have occasionally been reported. Most of the patients with reported cardiac events have had other comorbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.
Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse reactions, or hematologic adverse reactions. Therapy with Gleevec was discontinued for drug-related adverse reactions in 2.4% to 5% of adult patients with Ph+ CML and for adverse reactions in 5% of KIT+ GIST patients. None of the 5 patients in the ASM study discontinued Gleevec due to drug-related events or abnormal laboratory values. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months).
A 25% decrease in the recommended dose should be used for patients with severe hepatic impairment.
Some GIST patients (5%) were reported to have severe gastrointestinal (GI) bleeds and/or intratumoral bleeds. GI tumor sites may have been the source of GI bleeds.
Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, increased intracranial pressure, papilledema, and GI perforation.
In patients with HES and cardiac involvement, cases of cardiogenic shock/left ventricular dysfunction have been associated with the initiation of imatinib therapy. The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures, and temporarily withholding imatinib. MDS/MPD disease and systemic mastocytosis may be associated with high eosinophil levels. Performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD or ASM associated with high eosinophil levels. If either is abnormal, the prophylactic use of systemic steroids (1-2 mg/kg) for 1-2 weeks concomitantly with imatinib should be considered at the initiation of therapy.
Bullous dermatologic reactions (eg, erythema multiforme and Stevens- Johnson syndrome) have also been reported. In some cases, the reaction recurred upon re-challenge. Several postmarketing reports describe patients able to tolerate the reintroduction of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following resolution or improvement of the bullous reaction.
Consider potential toxicities-specifically liver, kidney and cardiac toxicity, and immunosuppression from long-term use.
Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6 and CYP2C9. Dosage of Gleevec should increase by at least 50%, and clinical response should be carefully monitored, in patients receiving Gleevec with a potent CYP3A4 inducer such as rifampin or phenytoin. Examples of commonly used drugs that may significantly interact with Gleevec include ketoconazole, acetaminophen, warfarin, erythromycin and phenytoin. (Please see full Prescribing Information for other potential drug interactions).
For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablets to reduce exposure to iron.
Common side effects of Gleevec tablets
The majority of adult Ph+ CML patients who received Gleevec in clinical studies experienced adverse reactions at some time, but most were mild to moderate in severity. The most frequently reported adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps (28%-62%), vomiting (23%-58%), diarrhea (43%-57%), musculoskeletal pain (38%- 49%) and rash and related terms (36%-47%).*+
* Numbers indicate the range of percentages in 4 studies among adult patients with Ph+ CML in blast crisis, accelerated phase, and chronic phase.
+ For more detailed study information, please see full Prescribing Information.
The adverse reactions and safety profile for Ph+ ALL, MDS/MPD, ASM and HES/CEL were generally similar to the safety profile for Ph+ CML.
The most frequently reported drug-related adverse reactions reported in the Ph+ ALL studies were mild nausea, vomiting, diarrhea, myalgia, muscle cramps and rash, which were easily manageable. Superficial edemas were also a common finding in all studies and were described primarily as periorbital or lower-limb edemas. However, these edemas were rarely severe and may be managed with diuretics, other supportive measures, or, in some patients, by reducing the dose of Gleevec.
Frequently reported adverse reactions (all Grades) in the seven MDS/MPD patients assessed were nausea (57%); diarrhea and muscle cramps (43% each); anemia, fatigue, arthralgia and periorbital edema (29% each).
All ASM patients experienced at least one adverse reaction at some time. The most frequently reported adverse reactions were diarrhea, nausea, ascites, muscle cramps, dyspnea, fatigue, peripheral edema, anemia, pruritus, rash and lower respiratory tract infection.
All HES/CEL patients experienced at least one adverse reaction, the most common being gastrointestinal, cutaneous and musculoskeletal disorders. Hematologic abnormalities were also frequent, with instances of Grade 3 leukopenia, neutropenia, lymphopenia and anemia.
Frequently reported adverse reactions (all Grades) in the 12 DFSP patients assessed included nausea and fatigue (42% each); periorbital, peripheral and eye edema (33% each); diarrhea, vomiting, rash, lacrimation increased and anemia (25% each); face edema, pyrexia, exertional dyspnea, rhinitis, and anorexia (17% each).
The majority of patients who received Gleevec in the GIST study experienced adverse reactions at some time. Most adverse reactions were mild to moderate in severity. The most frequently reported adverse reactions (400 mg/day; 600 mg/day) (all Grades) were superficial edema (81%; 77%), nausea (63%; 74%), muscle cramps (47%; 58%), diarrhea (59%; 70%), fatigue (48%; 53%), abdominal pain (40%; 37%), rash and related terms (38%; 53%), vomiting (38%; 35%), musculoskeletal pain (37%; 30%) and hemorrhage (26%; 34%).*
* For more detailed study information, please see full Prescribing Information.
Supportive care may help management of some mild-to-moderate adverse reactions so that the prescribed dose can be maintained whenever possible. However, in some cases, either a dose reduction or interruption of treatment with Gleevec may be necessary.
Gleevec tablets should be taken with food and a large glass of water to minimize GI irritation. Gleevec tablets should not be taken with grapefruit juice and other foods known to inhibit CYP3A4.
Patients should be informed to take Gleevec exactly as prescribed, not to change their dose or stop taking Gleevec unless they are told to do so by their doctor. If patients miss a dose, they should be advised to take their dose as soon as possible unless it is almost time for their next dose, in which case the missed dose should not be taken. A double dose should not be taken to make up for any missed dose.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “priority review”, “risk”, “commitment”, “potentially”, “will”, “if approved”, “possibly”, “encouraging”, “would”, or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Gleevec or regarding potential future revenues from Gleevec. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Gleevec to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gleevec will be approved for any additional indications or labelling in any market. Nor can there be any guarantee that Gleevec will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Gleevec could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , which provides healthcare solutions that address the evolving needs of patients and societies. Focused on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
For more information
Additional information regarding Gleevec and Novartis Oncology can be found on the websites www.novartisoncologyvpo.com, www.gleevec.com, www.us.tasigna.com and www.novartisoncology.us.
References
1. Fast Track, Priority Review and Accelerated Approval. US Food and Drug Administration - Center for Drug Evaluation and Research. http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm. Accessed 31 July 2008.
2. Internal data.
3. Z9001: A Phase III Randomized Double-blind Study of Adjuvant STI571 (Gleevec(R)) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST). http://www.cancer.gov/clinicaltrials/ACOSOG-Z9001. Accessed June 2008.
4. Van den Abbeele A., Benjamin R., Blanke C, et al. Clinical Management of GIST. Recurrence patterns and prognostic factors for survival. 2003;1-24.
5. American Cancer Society. Cancer Reference Information. Detailed Guide for Gastrointestinal Stromal Tumors. Key Statistics. http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_the_Key_Statisti cs_About_Gastrointestinal_Stromal_Tumors.asp?rnav=cri. Accessed 22 February 2008.
6. US Department of Health and Human Services. Agency for Healthcare Research and Quality (AHRQ). Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 2. Imatinib for Gastrointestinal Stromal Tumors (GISTs). Available at: http://www.ahrq.gov/clinic/ta/gist/gist1.htm
7. Gleevec(R) (imatinib mesylate) tablets prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; Nov 2007.
Media Contacts Media only: Kim Fox, Novartis Oncology, P: +1 862 778 7692 Dana Kahn Cooper, P: +1 732 817 1800, C: +1 732 239 6664 Investors only: Jill Pozarek, Novartis Corporation, +1-212-830-2445
CONTACT: Media, Kim Fox, Novartis Oncology, +1-862-778-7692, or P: +1 212830 2445, or Dana Kahn Cooper, +1-732-817-1800, C, +1-732-239-6664; orInvestors, Jill Pozarek of Novartis Corporation, +1-212-830-2445
Web site: http://www.novartis.com/
Ticker Symbol: (NYSE:NVS)
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
drugscom967:http://www.drugs.com/news/gleevec-receives-fda-priority-review-first-therapy-reduce-recurrence-gastrointestinal-stromal-13372.html
NICE Final Guidance Recommends Lucentis As Cost-Effective Treatment for Wet AMD
NICE Final Guidance Recommends Lucentis As Cost-Effective Treatment for Wet AMD, a Leading Cause of Blindness
Lucentis is only approved therapy to demonstrate improvement in vision and vision-related function in vast majority of wet AMD patients
NICE decision secures access to innovative medication for eligible patients with wet AMD in England and Wales
BASEL, Switzerland, August 27, 2008 - The National Institute for Health and Clinical Excellence (NICE) has recommended Lucentis® (ranibizumab) as a cost-effective therapy for all eligible patients with wet age-related macular degeneration (AMD), an eye disease that is the leading cause of blindness in people over the age of 50.
The announcement is an important development for patients because NICE determines access to medicines in England and Wales based on agreed standards of cost-effectiveness. The final guidance comes at the end of a rigorous review which assessed the potential benefits of Lucentis for patients relative to the cost of the medicine.
“The final guidance is excellent news for patients with wet AMD who are in need of access to this highly effective treatment,” said Mr Winfried Amoaku, Associate Professor of Ophthalmology and Hon Consultant Ophthalmologist (Retinal Specialist), University Hospital, Nottingham, and Vice-President of the Royal College of Ophthalmologists, UK. “Wet AMD is a debilitating disease that can rapidly lead to loss of vision and all too often, to loss of independence and quality of life for patients. When fully implemented, the NICE decision will ensure that patients have access to Lucentis for as long as they need to preserve or improve their vision.”
Lucentis was developed specifically for use in the eye and is the only approved therapy shown to improve vision and vision-related function in a vast majority of patients with wet AMD. The NICE decision was based on data from clinical trials involving more than 7,000 patients, demonstrating that Lucentis enabled patients to read on average an additional four lines (21 letters) on an eye-chart compared to those receiving no treatment. This benefit was sustained for two years[1],[2],[3].
The review evaluated all medications approved for treating wet AMD in the UK, and heard evidence from health professionals, health economic experts and patient groups.
The final NICE guidance includes a reimbursement scheme under which the first 14 injections in each affected eye will be funded by the UK National Health Service (NHS), while the drug costs for any subsequent Lucentis injections will be reimbursed by Novartis[4].
“We are committed to working in partnership with health authorities to ensure that as many patients as possible with wet AMD can benefit from treatment with Lucentis,” said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. “This reimbursement scheme is an important collaboration that will ensure patients living with wet AMD in England and Wales receive the best possible care.”
Lucentis has been approved in more than 70 countries and has already received positive health economic assessments in a number of other countries including Australia, Belgium, Canada, France, the Netherlands, Scotland, South Korea and Sweden.
AMD is a degenerative eye disease affecting the macula - the central part of the retina at the back of the eye that is responsible for the central vision necessary for everyday activities like reading, driving, telling time or identifying faces. Approximately 25 to 30 million people worldwide are living with the disease, which is a major burden on healthcare systems.
There are two types of AMD: dry and wet. Neovascular or ‘wet’ AMD accounts for about 15% of all AMD cases, but the majority of vision loss. It is associated with the growth of pathological new vessels under the macula that are fragile and leak fluid and blood. If not treated, scar tissue develops and destroys the macula.
Lucentis is an anti-VEGF (vascular endothelial growth factor) therapy that works by binding to and neutralizing all forms of VEGF-A, a protein that is believed to cause abnormal blood vessel growth and leakage beneath the macula.
Lucentis was developed by Genentech and Novartis Pharma AG. Genentech has the commercial rights to Lucentis in the US, while Novartis has exclusive rights in the rest of the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “potential”, “will”, “committed”, “believed”, or similar expressions, or by express or implied discussions regarding potential additional reimbursement approvals or health economic assessments for Lucentis or regarding potential future revenues from Lucentis. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Lucentis to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lucentis will be approved for reimbursement in any additional markets. Nor can there be any guarantee that Lucentis will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Lucentis could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
References
[1] Rosenfeld, PJ et al, for the MARINA Study group. Ranibizumab for Neovascular Age-Related Macular Degeneration. N Engl J Med 2006;355(14):1419-31.
[2] Brown, D et al, for the ANCHOR Study group. Ranibizumab versus Verteporfin for Neovascular Age-Related Macular Degeneration. N Engl J Med 2006;355(14):1432-44.
[3] Data on file, Novartis.
[4] NICE Final Guidance. Ranibizumab and pegaptanib for age-related macular degeneration. At www.nice.org.uk.
# # #
Novartis Media Relations
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com Ulrike Engels-Lange
Novartis Pharma Communications
+41 61 324 8790 (direct)
+41 79 264 4140 (mobile)
ulrike.engels_lange@novartis.com
e-mail: media.relations@novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944
Ruth Metzler-Arnold +41 61 324 9980 North America:
Pierre-Michel Bringer +41 61 324 1065 Richard Jarvis +1 212 830 2433
John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445
Thomas Hungerbuehler +41 61 324 8425 Edwin Valeriano +1 212 830 2456
Isabella Zinck +41 61 324 7188
e-mail: investor.relations@novartis.com e-mail: investor.relations@novartis.com
drugscom967:http://www.drugs.com/news/nice-final-guidance-recommends-lucentis-cost-effective-wet-amd-13375.html
Ark’s Vitor commences patient enrolment into Phase III pilot study
LONDON, 27 August 2008: Ark Therapeutics Group plc (“Ark” or the “Company”) today nnounces that enrolment of patients into its Phase III pilot study for VitorTM (Study 208) has commenced. VitorTM is Ark’s product to treat cachexia (involuntary muscle wasting) associated with cancer.
Study 208 is a blinded, randomised, placebo controlled, multicentre trial in up to 64 patients being conducted in five countries in Europe. The trial will study the effect of VitorTM on patients with non-small cell lung cancer who are already experiencing clinical signs of cachexia. Patients will be assessed for their rate of muscle wasting during an initial blinded study run-in period of up to 6 weeks, and thereafter randomised to active or control treatment for a further 12 week period. Total weight loss, lean body mass and other physical markers of cachexia will be assessed using a variety of methodologies. The study results will provide data to support the design of the final Phase III programme.
VitorTM has been awarded Fast Track Status by the FDA reflecting the high clinical need for an effective product to treat cachexia, which affects up to 70% of patients with solid tumours and is the most frequently reported cause of death in these patients. A Special Protocol Assessment (SPA) process was opened with the FDA in 2007. The Company is expected to enter full Phase III development in 2009 following completion of this pilot study.
A Phase II/III study of VitorTM in 165 patients has already been completed in the USA and Europe, where treatment showed a significant effect compared with placebo in reducing the rate of daily weight loss in patients with small cell lung and colon cancer.
Nigel Parker, CEO of Ark, commented: “Having secured approvals from all the various committees in the countries involved in the trial, we are pleased to report this clinical progress on VitorTM with patients entering the trial as expected. We look forward to providing an update on the trial’s progress in due course.”
Enquiries
Ark Therapeutics Group plc Tel: +44 (0)20 7388 7722
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer
Financial Dynamics Tel: +44 (0)20 7831 3113
David Yates / Sue Quigley
Bristol-Myers Squibb and Pfizer Provide Update on Apixaban Clinical Development Program
PRINCETON, N.J. & NEW YORK–(BUSINESS WIRE)–Aug 26, 2008 - Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc (NYSE: PFE) provided an update on the apixaban clinical development program today. The companies announced that new Phase II data in acute coronary syndrome patients (ACS) will be presented at the upcoming meeting of the European Society of Cardiology (ESC). In addition, Bristol-Myers Squibb and Pfizer reported that an early evaluation of results from a Phase III study of apixaban for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement indicates that the primary endpoint of this study was not met.
The Phase III VTE prevention study known as ADVANCE-1 compared apixaban, a novel, oral Factor Xa inhibitor given at a dose of 2.5 mg, twice daily, to the FDA-approved dose of enoxaparin, 30 mg given twice daily. The primary efficacy outcome was a composite of symptomatic or asymptomatic deep vein thrombosis, pulmonary embolism, and death by any cause. The rate of the primary efficacy endpoint on apixaban was numerically similar to that observed with enoxaparin (9.0% vs. 8.9%, p=.064), but did not meet the pre-specified statistical criteria for non-inferiority compared to enoxaparin. The actual enoxaparin VTE rate of 8.9 percent was lower than the expected VTE rate of 16 percent seen in previous similar clinical trials, resulting in an inability to demonstrate non-inferiority.
In ADVANCE-1, there were no unexpected findings in adverse events for apixaban compared to enoxaparin. The major bleeding event rate for apixaban was numerically lower, but was not significantly lower, than enoxaparin (0.7% vs. 1.4%, p=.053). The composite rate of clinically relevant non-major bleeding and major bleeding was significantly less in patients who received apixaban than those who received enoxaparin (2.9% vs. 4.3%, p =.034).
Full results of the ADVANCE-1 trial have been submitted to the American Society of Hematology Meeting (ASH) for presentation in December.
ADVANCE-1 results confirm the characteristics of apixaban as reported previously in phase II studies. The companies are considering further studies with different protocols in preventing VTE in knee surgery and will not submit the U.S. filing for VTE prevention in the 2nd half of 2009, as previously communicated. The results of ADVANCE -1 do not necessitate any changes in protocols of any other ongoing apixaban studies. Programs directed towards prevention of VTE including EMEA registrational studies, treatment of VTE, and in the prevention of stroke in atrial fibrillation continue as planned.
“Bristol-Myers Squibb and Pfizer remain enthusiastic and committed to the clinical development program for apixaban,” said Jack Lawrence, vice president, Research and Development, Bristol-Myers Squibb. “Bristol-Myers Squibb and Pfizer anticipate that the results of APPRAISE-1 being presented at ESC will provide important insight into the potential use of apixaban for the secondary prevention of cardiovascular events in patients with acute coronary syndrome, which affects an estimated 2.7 million people around the world every year.”
About the Apixaban Clinical Program
Apixaban, an oral, factor Xa inhibitor in a new class of agents that have shown therapeutic potential to prevent and treat blood clots, is currently being explored in the EXPANSE clinical trial program which includes eight Phase III clinical studies involving approximately 45,000 patients worldwide. The ADVANCE-2 and 3 trials are investigating the safety and efficacy of apixaban 2.5 mg twice daily compared to enoxaparin 40 mg once daily in patients undergoing major orthopedic surgery. The ADOPT study is investigating apixaban for one month compared to standard of care (enoxaparin 40 mg once daily for at least 6 days followed by placebo) for the prevention of VTE in hospitalized patients who are medically ill and at risk of VTE.
Apixaban is also in Phase III trials studying the prevention of stroke and other thromboembolic events in patients with atrial fibrillation (AF). The AF program consists of two trials. The ARISTOTLE trial is investigating apixaban compared to warfarin in approximately 15,000 patients with atrial fibrillation. The AVERROES trial is investigating apixaban compared to aspirin in approximately 5,600 patients with atrial fibrillation who are ineligible for vitamin K antagonists (VKA) treatment or haven’t tolerated previous VKA treatment.
The VTE treatment program consists of two trials. The AMPLIFY trial is a 6-month trial investigating apixaban compared to enoxaparin plus warfarin in approximately 4,800 patients with acute DVT or PE. The AMPLIFY-EXT trial is a 12-month trial investigating apixaban compared to placebo for extended treatment to prevent recurrent VTE in approximately 2,400 patients who have completed 6 to 12 months of treatment for DVT or PE.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information visit www.bms.com.
About Pfizer
Founded in 1849, Pfizer is the world’s largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. For more information visit www.pfizer.com.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the clinical trials described in this release will support a regulatory filing or that the product will receive regulatory approval. There can be no assurance that if approved, the product described in this release will be commercially successful. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2007, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Pfizer Forward-Looking Statement
The information contained in this release is as of August 26, 2008. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a product candidate, apixaban, including its potential benefits that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such product candidate as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and in its reports on Form 10-Q and Form 8-K.
Contact
Media:
BMS
Laura Hortas, 609-252-4587
laura.hortas@bms.com
or
Pfizer
Vanessa Aristide, 212-733-3784
vanessa.aristide@pfizer.com
or
Investors:
BMS
John Elicker, 212-546-3775
john.elicker@bms.com
or
Pfizer
Jennifer Davis, 212-733-0717
jennifer.m.davis@pfizer.com
Photocure Announces Positive Phase II Results with Visonac for Acne
Studies demonstrate efficacy and safety of VisonacTM and the potential for a simplified Photodynamic Therapy (PDT) procedure for treatment of moderate to severe acne
Oslo, Norway, August 27, 2008 – Photocure announces positive preliminary results from two Phase II studies carried out with VisonacTM its 2nd generation PDT treatment for moderate to severe acne. The first study showed that Visonac™ achieved similar efficacy results when compared to previous PDT approaches for the treatment of acne but was much better tolerated, while the second study confirmed that the overall Visonac™ procedure could be simplified. The final results from these two studies will provide Photocure with important information to design its overall Phase III VisonacTM program. The results from these studies will be presented to FDA and European regulatory agencies prior to beginning the Phase III program for Visonac.
Visonac™ treatment demonstrates excellent efficacy with reduced pain and redness
The larger of the two Phase II studies recruited 150 patients from 14 sites in US. The primary aim of the study was to establish an effective dose of VisonacTM that was well tolerated. This study was blinded and the patients were randomized into three treatment groups:
* 8% Visonac™ cream plus red light illumination * 4% Visonac™ cream plus red light illumination and * Vehicle cream (containing no Visonac™) plus red light illumination
In this study red light illumination began 90 minutes after the application of the cream. Tolerability was closely monitored during and after the illumination. Importantly the study showed that side effects such as pain and redness were substantially reduced compared to previous studies where a more aggressive treatment regime has been used. A dose-response relationship was seen with respect to pain and redness, with even the highest Visonac™ dose being well tolerated in this study population.
In this study the efficacy of Visonac™ therapy was evaluated over time with the maximum efficacy being seen 6 weeks after the last of four treatments. At this visit, there was a 54% reduction in the total number of acne lesions in the 8% Visonac™ cream plus red light illumination group compared to a 37% reduction in acne lesions in the vehicle cream plus red light illumination group. In the 4% Visonac™ group, the reduction in the number of acne lesions was similar to the vehicle group. The efficacy results from this study are similar to the results shown in previous studies with a more aggressive treatment which caused more pain and redness than the 8% Visonac™ treatment regime.
Simplified Visonac™ Treatment Procedure Confirmed
The second Visonac™ study, which was designed to evaluate whether occlusion was a necessary element of the PDT procedure, recruited a total of 44 patients at two sites in Canada. All patients received 8% Visonac™ cream plus red light illumination. In previous acne studies, using PDT, the areas to be treated have been covered by an occlusive dressing following application of the Visonac™ cream in order to facilitate the uptake of the Visonac™ into the skin. However, this process was regarded as time-consuming by dermatologists.
The results from this study clearly showed that the efficacy of the Visonac ™ PDT procedure for the treatment of acne could be maintained without the use of occlusive dressing. This is an important finding as it is anticipated that this simpler procedure would be much more appealing to dermatologists making them more willing to treat moderate to severe acne patients with Visonac™ PDT.
Dr. Kjetil Hestdal, President and CEO of Photocure, commenting on today’s announcement said “When we began the development of Visonac™ we were seeking to provide a much improved treatment option for patients with moderate to severe acne. The results from these two studies clearly highlight that we are well on our way to achieving this goal. The fact that we have been able to deliver good efficacy results with Visonac™ , while at the same time reducing pain and redness will be of major benefit to patients. The second study which has demonstrated that we can simplify the overall treatment procedure with Visonac™ while delivering equivalent efficacy, is expected to help increase the penetration of Visonac™ PDT into the overall acne market. We look forward to confirming these positive findings in our Phase III program for Visonac™.”
Dr. David Pariser, lead investigator for the US Phase IIb study commented: “” There is a large medical need for a new topical treatment for patients with moderate to severe acne especially in the US. This Phase IIb study provides strong clinical evidence that Visonac™ PDT delivers high efficacy and improved tolerability when compared to current treatment options.”
About VisonacTM
Visonac PDT is a photodynamic therapy that combines the Visonac cream with controlled illumination by a red light source. Visonac cream contains methyl aminolevulinate, the same active substance that is used in Metvix® cream. The cream is applied to the acne area to be treated and after a short incubation time, the skin is illuminated with red light. The PDT procedure kills bacteria and appears to have a beneficial effect on sebaceous glands and inflammatory cells.
About acne
Acne is a common skin condition which affects up to 85% of adolescents. Each year, US dermatologists register nearly 3 million visits concerning acne. Of those who seek medical advice from a dermatologist, about 50% have moderate and 20% have severe acne.
Current therapies for these patients include oral antibiotics and isotretinoin, both products that may have significant adverse effects. There is thus a clear medical need for a safe and efficacious topical treatment for acne patients.
Professor John F. Thompson to Present at Perspectives in Melanoma XII, Thursday October 2, 2008
KNOXVILLE, Tenn.–(BUSINESS WIRE)–Aug 26, 2008 - Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that the Lead Investigator for its phase 2 melanoma study, Professor John F. Thompson, MD, will present clinical data on PV-10 at the Perspectives in Melanoma XII meeting at The Hague, The Netherlands. Professor Thompson’s presentation, entitled “PV-10 Chemoablation of cutaneous and subcutaneous metastatic melanoma,” is scheduled for the afternoon symposium on emerging therapies scheduled for approximately 2:20 pm local time on Thursday October 2nd, 2008.
“The presentation by Professor Thompson is expected to report data from the completed phase 1 clinical trial, as well as providing an update on the current phase 2 study,” noted Craig Dees, PhD, CEO of Provectus.
Dees continued, “Professor Thompson is one of the world’s foremost authorities on melanoma treatment and the global lead investigator for our PV-10 clinical trials. He recently made a presentation on July 25, 2008, at the inaugural Sydney Cancer Conference 2008, which can be accessed via our website (www.pvct.com). In addition, ‘The 7:30 Report,’ a highly acclaimed Australian Broadcasting Corporation current affairs program airing in Australia, ran a story entitled: ‘Melanoma breakthrough: a simple and less invasive cure’ on the treatment of melanoma with PV-10, which is also accessible on Provectus’ website.
Dees continued, “We announced recently that the first twenty-five percent (20 of 80) of melanoma subjects have been treated in the phase 2 study, with enrollment continuing at centers in Brisbane and Sydney, Australia, and at the M.D. Anderson Cancer Center in Houston, TX. We expect to announce additional sites in Australia and the U.S. in the coming months.”
According to the American Cancer Society, in 2008 more than 62,000 people are expected to be diagnosed with melanoma in the in the US , the most serious form of skin cancer, leading to over 8,000 deaths this year.
About Perspectives in Melanoma XII
With a wealth of new data in this rapidly evolving field, Perspectives in Melanoma XII is designed to provide a comprehensive overview of recent advances and rigorous discussions of the most current and controversial topics in clinical research and contemporary therapy for melanoma. Led by authorities and current investigators in the field, the program will discuss several of the most promising and important on-going clinical trials. State-of-the-art presentations by experts in molecular biology, genetics, and immunology will provide a valuable educational experience for all melanoma-related disciplines.
For further details visit: http://www.imedex.com/appweb/announcements/a030-01.asp
About Provectus Pharmaceuticals, Inc. (www.pvct.com)
Provectus Pharmaceuticals is a development stage company that specializes in development of oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of their proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.
Contact
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, 866-594-5999 #30
or
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP â?? Investor Relations
Bill Gordon, SVP â?? Media Relations
212-564-4700
Next Page »
