Tag Archives: Chief Scientific Officer

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Islet Sciences Announces Cell Transplant Journal's Release on Novel Methods of Isolating Piglet Isle

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Islet Sciences Announces Cell Transplant Journal’s Release on Novel Methods of Isolating Piglet Islets

NEW YORK–(BUSINESS WIRE)– Islet Sciences, Inc., (ISLT) a clinical stage company engaged in the research, development and commercialization of therapeutics in the field of diabetes, announced today that Cell Transplant Journal released on novel methods of isolating piglet islets, a technology owned by Islet Sciences.

“This release is another validator of our approach to tackling this worldwide disease,” stated John Steel, Islet Sciences Chairman and Chief Executive Officer. “We continue to make solid important strides in executing our business strategy and this paper represents another clear milestone. Importantly, with our long term supply agreement with Spring Point Project, an FDA approved facility for porcine tissue, this novel methodology for potential production of unlimited islet cells, provides a crucial foundation for our goal to provide islet cell replacement therapy for persons with insulin dependent diabetes. Islet Sciences initial targeted group are diabetics that have had kidney transplants and may benefit from the opportunity to have islet therapy to augment outcomes.”

“This work is exciting in that we have developed a novel method of producing viable piglet islets that is reproducible and scalable in doses of islets that will be required to transplant into patients with insulin dependent diabetes,” stated Dr. Jonathan Lakey, Chief Scientific Officer and Chairman of the Scientific Advisory Board of Islet Sciences.

Below is a link and copy of the Abstract:

http://www.ncbi.nlm.nih.gov/pubmed/23394130#

In vitro maturation of viable islets from partially digested young pig pancreas

Abstract

Isolation of islets from market size pig is costly, with considerable islet losses from fragmentation occurring during isolation and tissue culture. Fetal and neonatal pigs yield insulin unresponsive islet-like cell clusters that become glucose responsive after extended periods of time. Both issues impact clinical applicability and commercial scale-up. We have focused our efforts on a cost-effective scalable method of isolating viable insulin responsive islets. Young Yorkshire pigs (mean age 20 days, range 4-30 days) underwent rapid pancreatectomy (<5 min) and partial digestion using low dose collagenase, followed by in vitro culture at 37°C and 5% CO₂ for up to 14 days. Islet viability was assessed using FDA/PI or Newport Green and function assessed using glucose stimulated insulin release (GSIR) assay. Islet

From: http://www.dailyfinance.com/2013/04/12/islet-sciences-announces-cell-transplant-journals-/

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Bristol-Myers Squibb Announces Appointment of Francis Cuss as Executive Vice President and Chief Sci

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Bristol-Myers Squibb Announces Appointment of Francis Cuss as Executive Vice President and Chief Scientific Officer, Effective July 1; Elliott Sigal Plans to Retire

NEW YORK–(BUSINESS WIRE)– Bristol-Myers Squibb Company (NYS: BMY) today announced the appointment of Francis Cuss, MB BChir, FRCP, 58, as executive vice president and chief scientific officer, effective July 1 after Elliott Sigal, M.D., Ph.D., 61, retires. Dr. Sigal has served as the company’s chief scientific officer since 2004 and on the company’s Board of Directors since 2011. He will retire from both positions effective June 30, 2013. Drs. Sigal and Cuss will continue to work together until that time.

“Francis is a strong and collaborative leader with broad experience in both discovery and development,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “He has been a key member of our productive R&D team who, under Elliott’s leadership, has delivered our strong portfolio and pipeline. As our company embarks on the next phase of pipeline execution, this is a natural time for Francis to lead our R&D team. Having worked closely with Francis since 2010 when I invited him to join my Senior Management Team immediately after becoming CEO, I know that he can ensure the continuation of both the leadership and strategy that have been the hallmarks of our success.”

“Elliott has been a key leader in the development and execution of our company’s strategy to become a BioPharma leader,” said Andreotti. “He and his team have become one of the most productive and innovative R&D organizations in the industry. Elliott has had a significant impact on the transformation of our company and, most importantly, on the patients we serve. I am grateful for the many things that Elliott and I have been able to accomplish together.”

“I am honored to have the opportunity to lead this talented R&D team to fulfill our mission and find new ways to discover, develop and deliver innovative medicines for patients with unmet medical needs,” said Cuss.

Dr. Cuss has a strong medical background, and broad experience in both research and development. Prior to joining Bristol-Myers Squibb, Dr. Cuss led teams in the successful development and approval of several blockbuster medicines. At Bristol-Myers Squibb, Dr. Cuss has a proven track record of leading our company’s research organization to become among the most efficient in the industry. He has built a high-performing team, and has delivered a differentiated and innovative early and mid-stage pipeline including making significant contributions in the advancement of our company’s Hepatitis C and immuno-oncology portfolios, particularly PD-1.

Dr. …read more

Source: FULL ARTICLE at DailyFinance

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Islet Sciences Appoints Dr. Eitan Akirav to Scientific Advisory Board

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Islet Sciences Appoints Dr. Eitan Akirav to Scientific Advisory Board

NEW YORK–(BUSINESS WIRE)– Islet Sciences, Inc., (OTC.BB: ISLT) a biotechnology company engaged in development and commercialization of patented technologies for the next generation of therapy for persons with Diabetes, today announced that Dr. Eitan Akirav has joined its Scientific Advisory Board.

“This key addition to our Scientific Advisory Board is a testament to the solid progress we have made and the leading edge therapies for diabetes that we are focused on providing,” stated Dr. Jonathan Lakey, Chief Scientific Officer and Chairman of the Scientific Advisory Board of Islet Sciences. “As we bolster our overall team we are proud to add Dr. Akirav to our organization and look forward to announcing additional milestones over the coming year.”

“I am pleased to announce this strategic addition to our Scientific Advisory Board as we continue to make significant progress on our growth strategy,” said John Steel, Chairman and CEO of Islet Sciences. “The expertise and deep industry relationships Dr. Akirav brings along with his significant knowledge in the field of diabetes will be quite helpful to the company moving forward. Dr. Akirav’s recent co-authorship of the American Diabetes Association study titled “Immune Therapy and β-Cell Death in Type 1 Diabetes” is clearly groundbreaking and we are thrilled that he has chosen to be a part of our esteemed Scientific Advisory Board.”

Dr. Akirav stated, “My laboratory is involved in the development of new diagnostic assays for the detection of β cell loss in diabetes. By joining Islet Sciences‘ Scientific Advisory Board I hope to deepen our collaboration and advance the company’s mission towards finding a cure for Type 1 Diabetes.”

Dr. Eitan Akirav is a Research Scientist at Winthrop-University Hospital and an Assistant Professor of Research at Stony Brook University School of Medicine in Long Island, NY. His novel work in the field of diabetes mellitus includes the development of a method for measuring dead β cell DNA in the blood. Together with Dr. Kevan Herold of Yale University, Dr. Akirav’s method provides, for the first time, a real time measurement of β cell loss during the phases of pre-diabetes, disease diagnosis, and following clinical intervention. In addition, Dr. Akirav focuses on understanding the interactions between β cells and the islet endothelium, while identifying novel factors that can improve β cell function and promote cell regeneration. Dr. Akirav collaborates with colleagues at numerous global institutions. He received a B.Sc. from Tel Aviv University (Summa Cum Laude), a M.Sc. from the University of Toronto, and a Ph.D. and postdoctoral training from …read more
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Early versus Delayed Treatment with Laquinimod Demonstrated Significant Reduction in Risk of Disabil

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Early versus Delayed Treatment with Laquinimod Demonstrated Significant Reduction in Risk of Disability Progression – Results of Three-Year ALLEGRO Study in Relapsing-Remitting Multiple Sclerosis

  • Data presented at the 65th Annual Meeting of the American Academy of Neurology (AAN) showed early treatment with laquinimod demonstrated significant benefit in terms of slowing disability progression compared to delayed treatment
  • 36-month data affirmed the safety profile demonstrated in the ALLEGRO pivotal clinical trial
  • Additional animal preclinical data demonstrated laquinimod restored myelination in the brain and spinal cord

JERUSALEM & LUND, Sweden–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. (NYS: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today top-line results from the open-label extension of the Phase III ALLEGRO study that assessed the progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared the effectiveness of laquinimod in patients who received 36 months (early-start) versus those who received 24 months of laquinimod treatment (delayed-start). Laquinimod is an oral, once daily, investigational drug in Phase III studies for RRMS.

Of the 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% participated in the open-label extension and 87% completed one year of the open-label phase. Overall, during the entire conduct of the study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of Laquinimod (11.8% risk of confirmed disability progression vs 16.7%, HR = 0.62, p < 0.0038).

“The results of this longer-term study of laquinimod suggest a robust benefit in terms of early treatment for RRMS and in potentially delaying disability, which is a primary goal of RRMS treatment,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd. “The development of laquinimod’s clinical profile has been full of exciting revelations about the compound’s unique mechanism of action, and we were dually encouraged by the preclinical data which demonstrated a potential direct effect on neuroregenerative processes.”

The study also supports a favorable safety and …read more
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New Data Show Azilect® (rasagiline tablets) Provided Clinical Benefit in Patients with Early Parkins

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New Data Show Azilect ® (rasagiline tablets) Provided Clinical Benefit in Patients with Early Parkinson’s When Added to Sub-Optimally Controlled Patients on Dopamine Agonist Therapy

Results Add to Evidence for Azilect as an Effective and Well-Tolerated Treatment Option at Different Stages of the Progression of Parkinson’s Disease (PD)

JERUSALEM–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. (NYS: TEVA) and H. Lundbeck A/S announced today that a double-blind, placebo controlled, randomized, multicenter study of Azilect® (rasagiline tablets) met its primary endpoint. The study, known as ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease), assessed the efficacy and tolerability of Azilect as add-on treatment to dopamine agonists compared to placebo. While the efficacy of Azilect as adjunct to levodopa has been established in previous studies (leading to its indication as adjunct therapy to levodopa), its efficacy in combination with dopamine agonist monotherapy has not previously been studied.

Results from the study demonstrated that the addition of Azilect 1mg/day provided a statistically significant improvement (Primary endpoint: treatment effect ± SE -2.4 ± 0.95 [95% CI -4.3,-0.5, p=0.012]) in total Unified Parkinson’s Disease Rating Scale (UPDRS) score (Parts I, II and III, version three) from baseline to week 18 in patients sub-optimally controlled with dopamine agonist monotherapy compared to placebo. Azilect was well-tolerated with no significant difference in adverse events compared to placebo.

“The positive outcome of this study is important news for the PD community, for patients and physicians,” said Robert A. Hauser, M.D., M.B.A., Director, Parkinson’s Disease & Movement Disorders Center at the University of South Florida and primary investigator of the study. “In addition to rasagiline providing symptomatic benefit to patients sub-optimally controlled with dopamine agonist monotherapy, the study confirmed that rasagiline is well-tolerated and provided proof-of-concept for adding rasagiline to dopamine agonist therapy.”

As a monoamine oxidase B (MAO-B) inhibitor, Azilect acts by increasing available synaptic dopamine. This mode of action provided the rationale for add-on therapy to dopamine agonists in the management of PD.

“The ANDANTE data continue to clarify the clinical profile of Azilect and the role it plays in helping to meet the needs of those living with PD, at multiple points in the progression of their disease,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “Teva is committed to the continued research and understanding of Azilect in PD and to sharing important findings like these with the scientific community.”

…read more
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Teva to Present New Research on CNS Product Portfolio and Pipeline at 2013 American Academy of Neuro

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Teva to Present New Research on CNS Product Portfolio and Pipeline at 2013 American Academy of Neurology Annual Meeting

LATE-BREAKING ORAL PRESENTATION PLANNED FOR AZILECT ® (RASAGILINE TABLETS)

JERUSALEM–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. (NYS: TEVA) today announced that 15 abstracts highlighting study results for Parkinson’s disease (PD) and relapsing-remitting multiple sclerosis (RRMS) will be presented during the 65th American Academy of Neurology (AAN) annual meeting in San Diego, Calif., March 16-23, 2013. New data for AZILECT® (rasagiline tablets), an MAO-B inhibitor for the treatment of PD, will be presented as part of the meeting’s Emerging Science program (formerly known as Late-Breaking Science) on Wednesday, March 20th at 5:45pm PST.

“We are pleased with the variety of topics and quality of research results that will be presented at AAN this year,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “Teva’s legacy in CNS is grounded in our commitment to ongoing collaboration with academia, medical institutions, and patient advocacy groups to find innovative solutions for patients who live with chronic and debilitating diseases, such as RRMS and Parkinson’s disease.”

Featured presentations include:

  • Results from a Phase IV clinical study evaluating AZILECT® as Add on to Dopamine Agonists in the Treatment of Parkinson’s disease (ANDANTE).
  • Findings from the first year of follow-up in the Therapy Optimization in Multiple Sclerosis (TOP MS) study, the largest prospective Phase IV study conducted in RRMS, providing insight into the impact of adherence to therapy, as well as data demonstrating that more patients on COPAXONE® (glatiramer acetate) persisted with treatment than those on beta interferon (IFN).
  • Results from the Phase III ALLEGRO study in RRMS at 36 months, comparing the progression of disability and safety of patients treated with laquinimod for three years (Early-Start) and in patients originally treated with placebo in the double-blind (DB) phase and switched to laquinimod treatment (Delayed-Start) in the open-label (OL) phase of the ALLEGRO trial.

Platform Presentation/Poster Session Details:


AZILECT
 ®

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Sucampo Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2012 Financial and Operating Resu

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Sucampo Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2012 Financial and Operating Results

Fourth Quarter Net Income Reported of $13.5 million; Full-Year Net Income Reported of $4.8 million;

Fourth Quarter Total Revenues Increased 145% to $34.9 million; Full-Year Revenues Increased 49% to $81.5 million;

Company to Host Conference Call Today at 5:00 pm Eastern

BETHESDA, Md.–(BUSINESS WIRE)– Sucampo Pharmaceuticals, Inc. (“Sucampo”) (NAS: SCMP) , a global pharmaceutical company, today reported its consolidated financial results for the quarter and full year ending December 31, 2012.

For the fourth quarter of 2012, total revenue grew approximately 145%, to $34.9 million from $14.2 million for the same period in 2011. Net sales of AMITIZA® (lubiprostone), as reported to us by our partner increased 31% to $74.6 million for the fourth quarter of 2012, compared to $56.8 million in the same period of 2011. During the fourth quarter of 2012, Sucampo reported product sales revenue and cost of goods sold primarily representing sales of AMITIZA to Abbott Japan Co., Ltd. (Abbott) in Japan. Sucampo reported $5.0 million of product sales revenue and $3.0 million of cost of goods sold compared to nil in 2011, respectively. Sucampo also received a $15.0 million milestone payment from Abbott associated with the initial sale of AMITIZA in Japan.

“This was a tremendous year of achievement for Sucampo,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo. “With the approval of the sNDA for RESCULA®, we now have two FDA approved products marketed in the United States. As the first-ever prescription medicine approved in Japan for chronic constipation, we launched AMITIZA in Japan and received a $15 million milestone payment related to the first commercial sale of AMITIZA. We look forward to upcoming catalysts for 2013, including the continued rollout of RESCULA in the U.S., the PDUFA date for opioid-induced constipation for AMITIZA in the U.S., the launch of AMITIZA in the U.K. and Switzerland, and the continued development of our pipeline.”

Sucampo reported a net income of $13.5 million, or $0.32 per diluted share, for the fourth quarter of 2012 compared to a net income of $2.7 million, or …read more
Source: FULL ARTICLE at DailyFinance

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Synta Announces Appointment of Sumant Ramachandra, M.D., Ph.D. as President, Research and Developmen

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Synta Announces Appointment of Sumant Ramachandra, M.D., Ph.D. as President, Research and Development

LEXINGTON, Mass.–(BUSINESS WIRE)– Synta Pharmaceuticals Corp. (NAS: SNTA) today announced the appointment of Dr. Sumant Ramachandra as President, Research and Development.

Prior to Synta, Dr. Ramachandra was Senior Vice President, Research and Development (R&D), Regulatory and Medical Affairs, and Chief Scientific Officer of Hospira, a specialty pharmaceuticals and medical device company. At Hospira, Dr. Ramachandra led a 1,200 person R&D organization and was recognized for his achievements and contributions as a healthcare leader in PharmaVoice’s “100 of the Most Inspiring People,” Diversity MBA’s “Top 100 Under 50 Diverse Executive Leaders,” and Chicago Business’ “Crain’s 40-under-40.”

Prior to joining Hospira in 2008, Dr. Ramachandra was Vice President and oncology portfolio therapeutic area leader at Merck & Co. (formerly Schering-Plough), and prior to Merck/Schering-Plough he was therapeutic area head for medical oncology at Pfizer (formerly Pharmacia). At these companies, Dr. Ramachandra drove the development, regulatory approval, and market expansion studies for numerous oncology products.

“Sumant brings a broad range of development and regulatory leadership experience, as well as a unique perspective having led both oncology development at large pharmaceutical companies, and the broader range of R&D functions at a large, global specialty pharma company,” said Safi Bahcall, President and CEO, Synta. “Sumant’s experiences with a wide range of drugs, manufacturers, pharma companies, payors, providers, and regulatory agencies will enhance our ability to realize the full potential of our product pipeline to benefit patients.”

“The programs at Synta can change the treatment of many types of cancers,” said Dr. Ramachandra. “In addition, Synta’s culture of innovation, collaboration, and commitment to speed and excellence in execution are exciting and critical to success in our industry. I am very much looking forward to being part of the Synta team and contributing to bringing these new drugs to cancer patients.”

Dr. Ramachandra received a bachelor’s degree in biochemistry from Rutgers University, and M.D. and Ph.D. degrees from the University of Medicine and Dentistry-New Jersey Medical School. He conducted his residency at the Harvard-affiliated Massachusetts General Hospital (MGH). Dr. Ramachandra also earned a master’s of business administration from the Wharton Business School at the University of Pennsylvania.

About Synta Pharmaceuticals

Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with …read more
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Sucampo Pharmaceuticals Announces Fourth Quarter and Full Year 2012 Financial Results and Operating

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Sucampo Pharmaceuticals Announces Fourth Quarter and Full Year 2012 Financial Results and Operating Highlights Teleconference and Webcast

BETHESDA, Md.–(BUSINESS WIRE)– Sucampo Pharmaceuticals, Inc. (NAS: SCMP) , a global pharmaceutical company, today announced that it will host a webcast and teleconference with senior management to discuss its financial results and operating highlights for the fourth quarter and full year ended December 31, 2012, on Wednesday, March 13, 2012, at 5:00 pm Eastern. The press release announcing the financial results and operating highlights is expected to be released after the close of the capital markets that day.

Investors interested in accessing the live audio webcast of the teleconference may do so at http://investor.sucampo.com/phoenix.zhtml?c=201197&p=irol-calendar and should log on 10 to 15 minutes before the teleconference begins in order to download any software required. Presentation slides will be available via the webcast links. A replay of the webcast will also be available on the Company’s website for several days after the live event. Alternatively, investors may dial 800-688-0836 (domestic) or 617-614-4072 (international) and use passcode 62809438. A replay of the teleconference will be available by dialing 888-286-8010 (domestic) or 617-801-6888 passcode 95378400, approximately two hours after the teleconference concludes. The archive of the teleconference will remain available for 30 days.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman, Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones, naturally occurring fatty acid metabolites that have emerged as promising compounds with unique physiological activities, can be targeted for the treatment of unmet or underserved medical needs. For more information, please visit www.sucampo.com.

Sucampo Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of …read more
Source: FULL ARTICLE at DailyFinance