Category: Therapies

  • Axcan Pharma CEO Explains Impact of Axcan-Eurand Merger

    Axcan has completed its acquisition of Eurand N.V., a global specialty pharmaceutical company with operating units in the United States and Europe. In a February 11 letter, Axcan President and CEO Frank Verwiel explained how the merger will affect its customers:

    Dear Customer:

    We are pleased to announce, effective immediately, the combination of two leading specialty pharmaceutical companies focused on improving the quality of care and health of our patients. Based on the acquisition of Eurand by Axcan, the operations of both companies will be merged.

     

    Combining our strengths will result in a global specialty pharmaceutical company with complementary GI and CF capabilities, a diversified and strengthened product and technology portfolio, broader development pipeline, an expanded manufacturing footprint and enhanced R&D capabilities. Most importantly, this merger will enhance our ability to meet the needs of the patients and caregivers we serve by bringing together our world-class talent, technologies, and brands. These brands include our portfolio of products for patients with Cystic Fibrosis, such as ZENPEP®, Scandishake®, and the AquADEKs™ and SourceCF® Multivitamin lines.

     

    The process of integrating our two companies is underway, but in the meantime, each of the respective companies will be operating as before, without interruption to the high level of service and support that you expect and deserve. Therefore, at this time, your existing relationships will remain the same. As part of this transition, we will be exploring new ways to enhance our popular comprehensive patient support program, ZPoints®, to take advantage of our new combined resources. We will let you know if there are any changes that may impact you at any point in the near future. We are committed to maintaining business continuity and a seamless customer experience throughout the integration process. Please contact your current representative with any questions.

     

    Stronger together, Axcan and Eurand will create a remarkable organization designed to serve the evolving needs of our patients and caregivers. We value your business and look forward to continuing to work with you to improve the lives of patients with Cystic Fibrosis.

     

    Sincerely,

     

    Frank Verwiel, MD

    President and Chief Executive Officer

  • Cystic Fibrosis at the Presidential State of the Union VIA SCIENCEMAG.ORG

    “Science gets its moment in Obama’s 2015 State of the Union”

    VIA SCIENCEMAG.ORG

    By David Malakoff

    Science rarely makes a major appearance in the President’s annual State of the Union address. Tonight’s speech by President Barack Obama maintained that tradition – but he did take a few moments in the 60-minute address to stake out a strong defense of his administration’s policies to combat climate change, and to preview a new “precision medicine” initiative that aims to tap genetic and other information to improve treatments for human diseases.

    “I want the country that eliminated polio and mapped the human genome to lead a new era of medicine – one that delivers the right treatment at the right time,” Obama said.  “In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable.  Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”

    The White House has yet to release any other details about the initiative – such as whether it will involve additional funding for biomedical research — but it appears to refer to a rapidly growing research area also known as “personalized medicine.” The personalized approach attempts to take account of each person’s unique biological make-up to design effective treatments, and avoid using those that won’t work. Knowing that a cancer tumor contains certain genetic traits, for example, can help clinicians pick the best drugs.

    Obama’s reference to the approach’s value in treating cystic fibrosis appeared, in part, to be a reference to medical student William Elder, Jr., of Colorado, who the White House invited to sit with First Lady Michelle Obama in the audience. Elder “was diagnosed with cystic fibrosis when he was eight years old, at a time when most cystic fibrosis patients were only expected to live to early adulthood,” according to a White House statement. “But thanks to a unique collaboration between the Cystic Fibrosis Foundation, patients, researchers, and a pharmaceutical company, Bill, now 27, expects to live a long, full life.  He benefits from a medication that targets the underlying cause of the disease for a small subset of cystic fibrosis patients.”

    In addressing climate issues, Obama noted that “2014 was the planet’s warmest year on record.  Now, one year doesn’t make a trend, but this does – 14 of the 15 warmest years on record have all fallen in the first 15 years of this century.”

    “I’ve heard some folks try to dodge the evidence by saying they’re not scientists; that we don’t have enough information to act,” he continued, in a comment clearly aimed at Republican politicians who have used that line in an effort to avoid taking a position on the reliability of climate science. “Well, I’m not a scientist, either.  But you know what – I know a lot of really good scientists at NASA, and at NOAA, and at our major universities.  The best scientists in the world are all telling us that our activities are changing the climate, and if we don’t act forcefully, we’ll continue to see rising oceans, longer, hotter heat waves, dangerous droughts and floods, and massive disruptions that can trigger greater migration, and conflict, and hunger around the globe.  The Pentagon says that climate change poses immediate risks to our national security.  We should act like it.”

    “And that’s why… over the past six years, we’ve done more than ever before to combat climate change, from the way we produce energy, to the way we use it,” Obama said. “And that’s why I will not let this Congress endanger the health of our children by turning back the clock on our efforts.  I am determined to make sure that American leadership drives international action.  In Beijing, we made an historic announcement – the United States will double the pace at which we cut carbon pollution, and China committed, for the first time, to limiting their emissions.  And because the world’s two largest economies came together, other nations are now stepping up, and offering hope that, this year, the world will finally reach an agreement to protect the one planet we’ve got.”

    Tonight was not the first time that Obama has spoken out on climate change in his State of the Union addresses.  In last year’s speech, he flatly stated that “climate change is a fact.”

    Another White house guest in the crowd was Nicole Hernandez Hammer, a climate activist who has focused her work on climate change’s impacts in Florida. Hammer, who came to the U.S. from Guatemala as a child, “has studied how the cities and regions most vulnerable to the effects of climate change and sea-level rise also have large Hispanic populations — something she learned firsthand growing up in South Florida,” according to a White House statement. Formerly a project director Florida Atlantic University’s Center for Environmental Studies, Hammer has consulted with Union of Concerned Scientists and now serves Florida field manager for the Moms Clean Air Force, a group seeking to “further the public’s awareness of climate change on children’s health,” the White House says in a blog post.

    A third guest — who got a shout out from Obama during the speech – was NASA astronaut Scott Kelly, who later this year is slated to become the first American to attempt a year-long stay aboard the International Space Station. His brother Mark, a former NASA astronaut who gained national attention after an assassination attempt on his wife, former Representative Gabrielle Giffords (D-AZ), was a guest at last year’s speech.

    Scott Kelly and his crewmates “will carry out hundreds of research experiments and work on cutting-edge technology development that will inspire students here at home in science, technology, engineering and math,” the White House statement says. Scientists also will compare medical data from Scott and Mark, “to gain insight into how the human body responds to longer durations in space,” information that could prove useful for planning a future mission to Mars, the White House suggests.

    “Last month, we launched a new spacecraft as part of a re-energized space program that will send American astronauts to Mars,” Obama said tonight. “In two months, to prepare us for those missions, Scott Kelly will begin a year-long stay in space.  Good luck, Captain – and make sure to Instagram it.”

    With reporting by Puneet Kollipara

  • With Resurgence in Polymyxin Use, CHMP Revises Label via Medscape.com

    SOURCE

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended revisions to the product information for antibiotics known as polymyxins (colistin or colistimethate sodium) for the treatment of serious infections that are resistant to standard antibiotics.

    Polymyxins, first introduced in the 1960s, fell out of use after the development of newer antibiotics with fewer adverse effects. In recent years, however, there has been a resurgence in polymyxin use as bacteria have become more resistant to the newer agents, leading to concern about whether the old dosing and pharmacokinetic information on the label was accurate. Thus, the CHMP reviewed the available clinical, pharmacologic, and pharmacokinetic data.

    The committee cautions that there are “significant gaps” in those data, particularly with regard to pharmacokinetics in special populations such as children and patients with renal impairment. Research is currently underway and should yield more information. In the meantime, the CHMP determined that the product information should be updated with the following information, based on what is currently known:

     

    • Doses of colistimethate sodium should always be expressed in international units. However, because milligrams are often used in the literature, the label will include a conversion table.

    • Intravenous colistimethate sodium is indicated in adults and children (including newborns) for the treatment of serious infections resulting from Gram-negative pathogens when few other treatment options are available. Coadministration with another antibiotic should be considered when possible.

    • On the basis of very limited information, CHMP determined that the recommended dose in adults is 9 million IU daily in two or three divided doses as a slow intravenous infusion. Critically ill patients should receive a loading dose of 9 million IU. In patients with renal impairment, doses should be reduced according to creatinine clearance.

    • The suggested dose for children is 75,000 to 150,000 IU/kg daily in three divided doses.

    • Where appropriate, adult doses of 125,000 IU for intraventricular administration, and no more than this for intrathecal administration, are recommended.

    • Great caution is urged in using intravenous colistimethate sodium together with other potentially nephrotoxic or neurotoxic medications.

    • Colistimethate sodium solutions can be given by inhalation the management of chronic pulmonary infections resulting from Pseudomonas aeruginosa in adults and children with cystic fibrosis. The recommended dose in adults is 1 to 2 million IU given two or three times a day, and in children, the recommended dose is 0.5 to 1 million IU twice daily, adjusted according to the severity of the condition and the response.

    Oral, topical, and dry powder inhalation polymyxin products were not covered in this review.

    The CHMP recommendations will now be forwarded to the European Commission, which will issue a final decision “in due course.”

    The US Food and Drug Administration has not taken similar action. “There are no active FDA safety reviews of [polymyxin] products. As with all drugs, we will continue to monitor for safety issues and take appropriate action if needed,” an FDA spokesperson told Medscape Medical News.

    SOURCE