Daily Archives: October 24, 2014

AMRI to Announce Third Quarter Results on November 5, 2014

ALBANY, N.Y., Oct. 24, 2014 /PRNewswire/ — AMRI (NASDAQ: AMRI) today announced it will issue third quarter financial results before the opening of the U.S. financial markets on Wednesday, November 5, 2014. Following the release …

New, Convenient Option Aims to Improve Asthma Management for Sufferers in Singapore

The modern aerosol inhaler flutiform® for the first time brings together two well-established asthma medications (fluticasone & formoterol)

SINGAPORE, Oct. 24, 2014 /PRNewswire/ — Mundipharma announced today the launch in Singapore of flutiform®, a new combination therapy for the maintenance treatment of asthma. flutiform® combines for the first time two of the most effective asthma medications[1] in a single, portable aerosol inhaler.

A recent survey of asthma sufferers in Singapore found that only one-quarter of respondents take their asthma medication daily as it is prescribed, mainly because management of their condition did not seem relevant to them. 41% don’t see the need in taking their medication regularly if they’re not experiencing incapacitating symptoms or asthma attacks.[2]

“What many patients don’t realise is that they can significantly reduce the chance of serious asthma attacks simply by using their inhalers regularly. This is especially important with the return of the haze even in moderate amounts, it can exacerbate their condition,” said Dr Chan Tiong Beng, Consultant Respiratory Physician and Intensive Care Cough & Chest Specialist, Mount Elizabeth Medical Centre. “By using two of the most effective asthma drugs available, flutiform® helps make it easier for my patients to adhere to their inhaler schedules and ultimately to prevent attacks.”

Providing regular treatment/control of asthma and fast symptom relief within one to three minutes of use,[3] the combination of fluticasone, an inhaled corticosteroid (ICS); and formoterol, a long-acting beta2-agonist (LABA), used in flutiform® has proven safe and effective in phase III trial results.[4],[5] The new option has also demonstrated comparable performance and is preferred by doctors and considered more effective than these combinations — salmeterol/fluticasone and budesonide/formoterol.[6],[7],[8]

Asthma is common in Singapore, affecting about 5% of adults and 20% of children.[9] However, patients often underestimate the seriousness of their condition until the onset of severe symptoms. According to the recently-conducted REALISETMAsia survey of asthma patients, while 94% of Singaporean respondents consider their asthma to be well-controlled, only 25% have asthma that is controlled according to clinical guidelines.

To further increase convenience for patients and to improve adherence to medication regimens, flutiform®‘s novel drug combination is housed in a traditional inhaler device that patients are already familiar with, eliminating the need to learn new techniques. The device also provides a dose counter for patients to easily keep track of medicine intake.

“Asthma still represents an important clinical challenge despite currently available treatments. With the insights garnered from REALISETMAsia, we recognised the need for making asthma management easier for patients” said Raman Singh, President, Mundipharma Asia Pacific, Latin America, Middle East and North Africa. “With flutiform®, we are offering effective medicines in an easy-to-use inhaler. Our ultimate goal is to help asthma patients live in a world where their condition is no longer a daily battle, and where they are able to live happier and more fulfilled lives.”

The REALISE(TM) Asia Survey found that many Asian patients with asthma believe their condition is under control, but symptoms suggest otherwise

The REALISE(TM) Asia Survey found that many Asian patients with asthma believe their condition is under control, but symptoms suggest otherwise

About Asthma

Asthma is a chronic (long-term) inflammatory disorder of the airways which leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Asthma is a serious condition affecting over 70 million[i] people in Asia. Patients with poorly managed asthma are at an increased risk of exacerbations, hospitalisation and death. Poorly managed asthma can also have a huge impact on a person’s quality of life and day-to-day activities.[ii]

About flutiform®

flutiform® is a combination treatment for asthma, bringing together, for the first time, the inhaled corticosteroid (ICS) fluticasone propionate and the long-acting beta2-agonist (LABA) formoterol fumarate in a single inhaler. flutiform® is indicated for adults and adolescents (aged >=12 years) with asthma that is either not adequately controlled with an ICS plus an as-needed short-acting beta2-agonist, or is already adequately controlled with an ICS plus LABA.[10] Mundipharma International Limited is licensed by Jagotec AG, a SkyePharma Group company, as the authorised distributor of the product for Europe and most other territories outside Japan and the Americas.

About REALISETM Asia

The REALISETM Asia, REcognise Asthma and LInk to Symptoms and Experiences, survey, sponsored by Mundipharma Pharmaceuticals Pte Ltd and developed in partnership with asthma experts, is a survey of asthma patients in Asia which aimed to assess patient attitudes and behaviours towards their disease. The survey was conducted with 2,467 people with asthma aged 18-50 across 8 Asian countries. In order to take part in the survey, respondents must have received at least two prescriptions for their asthma in the past two years and also had to be active on social media.

About Mundipharma

The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world’s pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis. http://www.mundipharma.com.sg/

For media enquiries, please contact:

Mundipharma (Singapore)

Stephenie Vasko

Tel: +65-6303-9732

Email: stephenie.vasko@mundipharma.com.sg

Edelman Public Relations Worldwide (Singapore)

Isaac Tan

Tel: +65-6494-1552

Email: isaac.tan@edelman.com

Notes:

[1] Bodzenta-Lukaszyk A, et al. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulmonary Med. 2011;  11: 28.

[2] Mundipharma Pte Ltd data on file: REALISE Asian Asthma Patient Survey Results, 2014.

[3] FLUTIFORM® Inhaler HSA-approved Prescribing Information (May 2014).

[4] Pearlman DS, et al. Fluticasone propionate/formoterol fumarate combination therapy has superior efficacy to both fluticasone and formoterol alone. Abstract presented at ERS, 24-28.09 2011 in Amsterdam, Netherlands.

[5] Bodzenta-Lukaszyk A, et al, Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler: Respiratory Medicine. 2011; 105:5, 674-682.

[6] Bodzenta-Lukaszyk A, et al. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulmonary Med. 2011;  11: 28

[7] Bodzenta-Lukaszyk A, et al. Fluticasone/formoterol combined in a single aerosol inhaler vs budesonide/formoterol for the treatment of asthma: a non-inferiority trial. Abstract presented at ERS, 24-28.09 2011 in Amsterdam, Netherlands.

[8] M Thomas, J Haughney, D Price. Physicians’ attitudes towards combination therapy with inhaled corticosteroids and long-acting beta2-agonists: an observational study in UK specialist care. J PragObs Res 2011;2:25-31.

[9] Singapore Health Promotion Board, 9 Apr 2013.

[i] The International Union Against Tuberculosis and Lung Disease. The Global Asthma Report 2011. Available from: http://globalasthmareport.org/2011/images/files/Global_Asthma_Report_2011.pdf. Last accessed on 22 April 2014.

[ii] Sims, E J; Price, D; Haughney, J; Ryan, D & Thomas, M. Allergy Asthma Immunol Res. Current Control and Future Risk in Asthma Management. Oct 2011; 3(4): 217–225.

®: FLUTIFORM is the Registered Trademark of Jagotec AG used under licence by Mundipharma.

Photo – http://photos.prnasia.com/prnh/20141024/8521406230

The TransMedics® Organ Care System (OCS™) Heart Technology Was Used to Perform The World’s First Series of Adult Human Heart Transplants From Donors After Circulatory Death (DCD Donors) at St Vincent’s Hospital in Sydney, Australia

ANDOVER, Mass., Oct. 24, 2014 /PRNewswire/ — TransMedics announces that its OCS™ Heart technology was used to preserve and assess the world’s first series of three successful adult heart transplant procedures from hearts donated from donors after circulatory death (DCD) by the St. Vincent’s Hospital Heart Transplant team. All patients who received these groundbreaking transplants have recovered very well. This achievement represents a pivotal new milestone in heart transplantation worldwide, and it was carried out following pioneering basic and translational research undertaken by the Victor Chang Cardiac Research Institute and St Vincent’s Hospital using the OCS™ Heart technology.

These hearts were retrieved from donors whose hearts had stopped beating. Currently, these DCD donors are not considered for heart transplantation due to the limitations of cold storage preservation technique. These hearts were retrieved, resuscitated to a normal beating state and clinically assessed using the TransMedics OCS™ Heart technology. The OCS™ technology platform is the only medical device capable of maintaining donor organs in near physiologic and functioning state outside of the human body from the time the organ is removed from the donor until it is ready to be transplanted into a suitable recipient.

“The OCS™ Heart system was paramount to the success of this clinical milestone in heart transplantation as it enabled us to fully assess the donor heart function and metabolic state before transplantation,” said Dr. Kumud Dhital, Prof. of Cardiothoracic Surgery at St. Vincent’s Hospital and the lead surgeon who performed the DCD heart transplants.

“The ability to safely transplant a donor heart from DCD donors could be a paradigm shift to potentially increase the pool of viable donor hearts to help more patients suffering from end-stage heart failure,” said Dr. Waleed Hassanein, President and CEO of TransMedics, Inc. “We are actively engaged in four large pivotal trials for hearts, lungs and livers in the U.S. to bring the revolutionary OCS™ technology to the U.S. market hopefully starting in 2015,” said Dr. Hassanein.

What is the TransMedics Organ Care System (OCS™)?

Since the advent of organ transplantation, the cornerstone of organ preservation has been cold ischemic storage (placing organs on ice). Although this method is intended to reduce the extent of organ damage during transport, significant deterioration of the donated organ still occurs. The longer the organ is kept on ice, the greater the damage. Moreover, the cold storage technique does not enable any resuscitative or assessment while the organ is being transported from donor to recipient. Given the limitations of cold storage, it is estimated that globally 60-65% of donor hearts cannot ultimately be used for transplantation.

TransMedics has developed the world’s only portable medical device capable of overcoming the limitations of cold storage for organ transplantation. The OCS™ technology was designed to provide a comprehensive solution to all three key limitations of the cold storage technique, as it:

  • Minimizes cold ischemia injury by perfusing the heart with warm oxygenated blood;
  • Optimizes the condition of the organ by replenishing oxygen, nutrients, and hormones that would otherwise become depleted;
  • Provides continuous monitoring and assessment of the organ until the point of transplantation

These unique capabilities of the OCS technology have the potential to:

  • Increase utilization of current donor organs
  • Improve patient survival
  • Reduce post-transplant complications
  • Improve cost-effectiveness of the transplant procedure

About TransMedics, Inc.

TransMedics Inc. is the world’s leader in portable ex-vivo machine perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation. For more information, please visit www.TransMedics.com.

Photo –

http://photos.prnewswire.com/prnh/20141024/154161

Paul G. Allen Increases Commitment To Fight Ebola To $100 Million

— Partners with U.S. State Department and World Health Organization to Evacuate and Treat Infected Humanitarian Workers;

— Collaborates with University of Massachusetts Medical School to Provide Training and Equipment;

— Coordinates and Optimizes Global Giving by Launching “Fund a Need” Donation Platform

SEATTLE, Oct. 24, 2014 /PRNewswire/ — Philanthropist Paul G. Allen today increased his commitment to Tackle Ebola to at least $100 million and called on the global community to join the cause. This crisis requires a multi-pronged approach to solving it. As such, Mr. Allen is leading the following initiatives:

Humanitarian Aid Worker Medevac Fund and Medevac Transport:
Effectively addressing the Ebola crisis requires the continued commitment of medical professionals. One of the key challenges in their recruitment is the lack of a clear medevac pathway should they become infected and require treatment.

Mr. Allen has committed to solving this challenge by funding the development and manufacture of two medevac containment units, which the U.S. State Department will use to safely evacuate medical professionals from West Africa. In addition, Mr. Allen has partnered with the World Health Organization to increase its capacity to coordinate the logistics required to transport international aid workers.

Cost of medevac transport can also be a barrier for organizations to commit to sending their critical care professionals. To address this, Mr. Allen has established the Ebola Medevac Fund, designed to address the gap between what insurance will cover and the actual transport costs. The $2.5 million fund is designed as a dollar to dollar matching grant with the Paul G. Allen Family Foundation.

University of Massachusetts Medical School (UMMS):
Another important component to tackling this crisis is ensuring education, supplies and medical professionals are on the ground. Mr. Allen is donating to UMMS to help provide training, medical workers and lab equipment for relief efforts in Liberia. The partnership with UMMS will focus on providing decontamination and lab equipment to district hospitals as well as community outreach and education to provide monitoring and support to staff in order to reopen closed district hospitals.

Fund a Need:
Mr. Allen also has created a way for individuals to contribute to specific organizations and fund critical response needs through TackleEbola.com. The donation platform is designed to coordinate and optimize individual global giving.

Donations of all sizes will go to funding the solutions required to treat, contain and prevent the spread of Ebola. Donors will be able to select the need that they are most interested in funding and 100 percent of that contribution will be applied to that need. The site also offers a way for donors to view the impact of their combined contributions with updates on progress towards goals.

Supporting Quotes:
“The Ebola virus is unlike any health crisis we have ever experienced and needs a response unlike anything we have ever seen,” Mr. Allen said. “To effectively contain this outbreak and prevent it from becoming a global epidemic, we must pool our efforts to raise the funds, coordinate the resources and develop the creative solutions needed to combat this problem. I am committed to doing my part in tackling this crisis.”

“We thank Paul Allen and his foundation for their contribution on this crucial issue,” said Andrew O’Brien, Special Representative for Global Partnerships, U.S. Department of State. “We hope that this sets a much needed example for what will be robust and rapid private sector leadership, working in partnership with the U.S. government. Mr. Allen’s #TackleEbola campaign is providing an important catalyst to help us get medical responders to West Africa to fight Ebola at its epicenter. His leadership is timely and greatly augments the work that the U.S. government, international organizations, NGOs, and others are doing on the ground every day.”

“We at the University of Massachusetts Medical School are grateful for the support of the Paul G. Allen Family Foundation, which will allow us to specifically work with our strategic partners and our Liberian colleagues to help stem the Ebola epidemic and strengthen Liberia’s fragile health care system,” said Michael F. Collins, MD, Chancellor of the University of Massachusetts Medical School. “Our academic collaborative has worked productively in the past with the Liberian leadership and health care workforce, and we look forward to continuing that partnership by engaging directly with our Liberian collaborators and providing on-the-ground relief, training and supplies.”

Mr. Allen’s Contributions to Date:
From the early days of the outbreak, Mr. Allen and the Paul G. Allen Family Foundation have focused on finding, funding and coordinating strategic solutions that could be deployed quickly and would address some of the most critical needs. To date, Mr. Allen has already helped implement the following solutions:

  • A contribution to the American Red Cross to fund equipment, volunteers and educational materials in Guinea, Sierra Leone and Liberia. (August 2014)
  • A matching grant to Global Giving, which more than 700 donors doubled in only four days. Ten groups received funding to distribute sanitation supplies, conduct training sessions and produce public service announcements. (August 2014)
  • A partnership with UNICEF to airlift 50,000 protection kits into Liberia. (September 2014)
  • A partnership with Airlink to execute a continuous air bridge to deliver critically needed medical protective gear and pharmaceuticals. (September 2014)
  • A grant to the CDC Foundation to establish CDC emergency operations centers in the most-affected countries, Guinea, Liberia and Sierra Leone. These centers are helping to develop a systematic response with improved data management and communication systems for disease and patient contact tracing, which will ultimately help to detect and stop the disease from spreading. (September 2014)
  • Funding to Medical Teams International (MTI) to help provide infrastructure, housing and transportation needs for MTI’s staff in Liberia. (September 2014)
  • A partnership with Doctors Without Borders/Medecins Sans Frontieres (MSF) to support their existing Ebola emergency programs in Guinea, Liberia and Sierra Leone. (September 2014)
  • A grant to BBC Media Action to support education and communications programs in the affected countries aimed at increasing public knowledge and awareness, supporting the government in responding to the crisis and instilling safer health practices among local audiences. (October 2014)

The Ebola Medevac Fund will be administered by the Silicon Valley Community Foundation. For more information, visit www.tackleebola.com and follow @TackleEbola and @PaulGAllen on Twitter or Facebook.

Press Contacts:

Alexa Rudin
Vulcan Inc.
+1-206-342-2230
alexar@vulcan.com

Dana Lengkeek
Burson-Marsteller
+1-415-994-4008
dana.lengkeek@bm.com

WuXi Congratulates TaiMed Biologics on Receiving Orphan Drug Designation for Ibalizumab from U.S. FDA

SHANGHAI, October 24, 2014 /PRNewswire/ — WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading pharmaceutical, biotechnology, and medical device R&D services company with operations in China and the United States, today congratul…