TAMPA, Fla., May 23, 2013—The National Association of Specialty Pharmacy™ (NASP™) announced today that Diane E. Sullivan, Vice President, Specialty Payer & Channel Group Pfizer Specialty Care, has joined the NASP Board of Directors.

“This is an exciting time for the industry and for NASP,” Sullivan, who joined Pfizer in 2009 as Vice President, US Specialty Care Customers.  “I am honored to be selected to work with my fellow board members to advance the organization’s goals and the industry.”

Sullivan leads a team of specialty brand payer marketers, specialty customer marketers and specialty customer account managers to work with payers, intermediaries and distribution channel customers. Her team works with these customers to communicate each specialty brand’s value story, ensure patients have access to the Pfizer specialty brands prescribers recommend, and engage with customers in branded programs that focus on improving patient outcomes.

At Pfizer, Sullivan is a member of the North America Leadership Team and the Global Women’s Council as well as Chair of the US Women’s Council, and Sponsor of Collegeville’s Disabilities Colleague Network.

“Diane is a strategic thinker and leader who has been extremely active in the pharmacy and healthcare fields,” Gary M. Cohen, RPh, BSPharm, NASP CEO and Co-Founder, said. “She will bring a valuable perspective to NASP and will help contribute to the growth of the specialty pharmacy industry.”

Prior to joining Pfizer, Sullivan was employed with Wyeth and GlaxoSmithKline. At Wyeth she  led the Healthcare Systems Marketing team which included both brand and customer marketers. While at GlaxoSmithKline, she held leadership roles in managed care, brand marketing, new product development, acquisition integration, licensing, strategy and marketing capability development in US Pharmaceuticals, R&D and Worldwide Consumer Healthcare. She was selected as a Rising Star by the Healthcare Businesswomen’s Association and was a member of the GSK Consumer Healthcare North America Leadership Team.

Sullivan has served on the Boards of a number of Philadelphia-based non-profits including Leadership Philadelphia, the Support Center for Child Advocates and is on the Advisory Boards of the Professional Women’s Roundtable and the United Way Women’s Initiative.

NASP, founded in 2012, represents specialty pharmacy professionals in all practice settings and highlights the unique value its members bring to patients and the healthcare system by focusing on building collaboration among all industry associations to improve patient outcomes.  Specialty pharmacy is the fastest growing segment in the industry today and NASP provides valuable benefits to members by creating a strong, unified voice for all stakeholders. Through the Specialty Pharmacy Education Center (SPEC), NASP will the most comprehensive online source of education specific to specialty pharmacy.  SPEC will also provide education needed to earn and maintain professional certification through the Specialty Pharmacy Certification Board (www.spcboard.org).

Source: National Association of Specialty Pharmacy (www.nasprx.org)

Media Contact: Gary Cohen, This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Dominant multiple sclerosis (MS) drug maker, Biogen Idec Inc, announced yesterday that it has applied to the US Food and Drug Administration (FDA) for authorization of its third injectable MS drug.

The Biologics License Application (BLA) was submitted for approval of Plegridy (peginterferon beta-1a), a pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS).  This is a new version of Biogen’s Avonex. The drugs both contain interferon beta, however Plegridy contains polyethylene glycol or peg for an increased exposure of the drug. With this added polymer, MS patients are able to take doses less frequently. Additionally, Plegridy is administered subcutaneously instead of intramuscularly for less pain.

Submission for regulatory approval was based on results from year one of the two year Phase 3 ADVANCE study, where the drug met all primary and secondary endpoints. Plegridy showed to significantly reduce disease activity including relapses, disability progression and brain lesions when compared to placebo. It showed favorable safety and tolerability profiles at one year.

“This finding demonstrates our dedication to the treatment of MS, both through the discovery of new medications and the development of innovative solutions that enhance treatment for people living with this disease,” Douglas E. Williams, PhD, Executive Vice President of Research and Development at Biogen Idec stated. “We believe that based on the efficacy and safety Plegridy has demonstrated, in addition to its less frequent dosing schedule, it has the potential to become a preferred interferon treatment option.”

According to the company, in addition to the BLA filing with the FDA, it plans to submit a Marketing Authorization Application (MAA) for the drug to the European Medicines Agency (EMA) in the next few weeks.

Currently, Biogen’s other MS drugs include Avonex, Tecfidera and Tysabri.

Source: Biogen Idec Inc.

Last Updated: 5/22/13; 10:55PM EST

Bayer HealthCare recently announced data from its interim analysis of an extension of a late-stage trial with riociguat showing long-term safety and sustained clinical benefits in patients with pulmonary arterial hypertension (PAH).

The ongoing PATENT-2 trial is the open-label long-term extension of the pivotal Phase III study PATENT-1. An interim analysis was presented at the American Thoracic Society International Conference in Philadelphia, PA. The results support the safety and clinical benefits from the PATENT-1 trial.

“Despite the availability and advantages of several approved PAH therapies, the prognosis for patients remains poor and mortality remains high. The interim results of PATENT-2 support the benefits of riociguat that were seen in the PATENT-1 trial. We are confident that, together, these results reinforce the role of riociguat, if approved, as a new treatment in the armamentarium against PAH,” Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development stated.

Data from the first interim analysis of PATENT-2 showed that riociguat was well tolerated with a good long-term safety profile for both treatment-naïve and pre-treated PAH patients. According to the company, headache, dizziness, dyspepsia, and hypotension were the most frequent drug-related adverse events. For patients who continued riociguat treatment, further improvemeds were seen in the six minute walking distance (6MWD).  In PATENT-2, after an additional 12 weeks of treatment the 6MWD had increased further in former riociguat patients compared with baseline of pivotal PATENT-1 trial.

The presentation of the interim analysis follows the priority review that was recently granted to riociguat by the US Food and Drug Administration (FDA).

Source: Bayer HealthCare

Last Updated: 5/21/13; 3:30PM EST

Today, Baxter International Inc. and Halozyme Therapeutics, Inc. announced that the European Commission has granted Baxter marketing authorization for HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.

“HyQvia offers patients with primary and secondary immunodeficiencies the ability to administer their treatment in a single subcutaneous site every three to four weeks. This represents an important advance for patients who are managing chronic disease as HyQvia combines key benefits of intravenous and subcutaneous administration into one product,” Ludwig Hantson, PhD, President of Baxter’s BioScience Business stated. “We look forward to introducing HyQvia in the coming weeks to support physicians and adult immunodeficient patients in Europe.”

According to the company, the European Commission has granted Baxter marketing authorization in all European Union (EU) Member States. Baxter will introduce the drug in select countries during 2013 and will expand launch to other EU countries in 2014.

HyQvia is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which assists in the dispersion and absorption of the IGSC, increasing the bioavailability. Hyaluronidase is a licensed product from Halozyme Therapeutics.

The approval was based on results from a Phase III clinical trial, which evaluated the safety and effectiveness of the drug in preventing acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously.  The study’s objective was to infuse a three or four-week dose of the treatment in a single subcutaneous site.

“We are delighted that these patients who depend on immunoglobulin replacement treatment will have access to HyQvia,” Gregory I. Frost, PhD, President and Chief Executive Officer at Halozyme Therapeutics said in a statement.

Source: Baxter International Inc.

Last Updated: 5/21/13; 9:35AM EST