Healthcare Industry News: KALYDECO
News Release - September 4, 2012
Vertex Announces Appointment of Stuart A. Arbuckle as Chief Commercial OfficerCAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)--Vertex Pharmaceuticals Incorporated (VRTX) today announced the appointment of Stuart A. Arbuckle as Executive Vice President and Chief Commercial Officer. Mr. Arbuckle has more than 25 years of experience in leading global sales and marketing efforts at biopharmaceutical companies. He will oversee Vertex’s commercial team, which is responsible for the company’s sales, marketing, patient support, market research and other activities that support the approved use of INCIVEK® (telaprevir) in the U.S. and the ongoing global launch of KALYDECOTM (ivacaftor). Mr. Arbuckle will begin his employment with Vertex effective today and will serve as a member of Vertex’s executive team, reporting directly to the company’s Chairman, President and Chief Executive Officer, Jeffrey Leiden, M.D., Ph.D.
"Stuart brings to Vertex a unique blend of commercial expertise and scientific training that will prove invaluable to the continued launch of KALYDECO for cystic fibrosis and in our efforts to treat more people with hepatitis C,” said Dr. Leiden. “Stuart has a bold vision for our commercial growth and expansion that will shape our future in hepatitis C and cystic fibrosis and position the company for continued success as we advance our pipeline. His experience and commitment to patients will complement that of our executive team, and I look forward to his insights at this exciting time for our company.”
“With INCIVEK and KALYDECO, Vertex transformed the treatment of hepatitis C and cystic fibrosis, and I believe the company is positioned to make even further advances in these and other serious diseases in the years ahead,” said Mr. Arbuckle. “I have always viewed Vertex as a company grounded in science, and I am excited by their commitment to integrating commercial insights into their research and development efforts. By addressing the specific needs of the hepatitis C, cystic fibrosis and other patient communities early in the development process, I believe the company will be positioned to rapidly advance its pipeline while focusing on what is in the best interest of patients and those who care for them.”
Prior to joining Vertex, Mr. Arbuckle held multiple commercial leadership roles at Amgen, Inc., a 17,000-person biotechnology company. As Vice President and General Manager, Oncology Business Unit, he led sales, marketing, patient advocacy and access efforts for Amgen’s portfolio of cancer medicines. He was responsible for sales and marketing efforts for Aranesp®, Neulasta® and NEUPOGEN®, which accounted for more than $5 billion in sales in 2011, and led the successful launches of XGEVA® and Nplate®. Most recently, he served as Vice President and Regional General Manager where he led efforts to expand Amgen’s presence in Japan and emerging markets in Asia, the Middle East and Africa.
Prior to these roles, Mr. Arbuckle spent more than 15 years at GlaxoSmithKline (GSK) plc, where he held sales and marketing roles of increasing responsibility for medicines aimed at treating respiratory, metabolic, musculoskeletal, cardiovascular and other diseases. He joined GSK after earning a degree in pharmacology and physiology from the University of Leeds in the United Kingdom. Mr. Arbuckle currently serves as a national board member of the Cancer Support Community, an international non-profit dedicated to providing support, education and hope to people affected by cancer.
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 2,000 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.
Vertex's press releases are available at www.vrtx.com.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO (ivacaftor)
KALYDECO (150mg tablets) is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.
KALYDECO is not for use in people with CF due to other mutations in the CFTR gene. It is not effective in CF patients with two copies of the F508del mutation (F508del/F508del) in the CFTR gene.
High liver enzymes (transaminases, ALT and AST) have been reported in patients receiving KALYDECO. It is recommended that ALT and AST be assessed prior to initiating KALYDECO, every 3 months during the first year of treatment, and annually thereafter. Patients who develop increased transaminase levels should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST of greater than 5 times the upper limit of normal. Following resolution of transaminase elevations, consider the benefits and risks of resuming KALYDECO dosing. Moderate transaminase elevations are common in subjects with CF. Overall, the incidence and clinical features of transaminase elevations in clinical trials was similar between subjects in the KALYDECO and placebo treatment groups. In the subset of patients with a medical history of elevated transaminases, increased ALT or AST have been reported more frequently in patients receiving KALYDECO compared to placebo.
Use of KALYDECO with medicines that are strong CYP3A inducers such as the antibiotics rifampin and rifabutin; seizure medications (phenobarbital, carbamazepine, or phenytoin); and the herbal supplement St. John's Wort substantially decreases exposure of KALYDECO which may diminish effectiveness. Therefore, co-administration is not recommended.
The dose of KALYDECO must be adjusted when concomitantly used with potent and moderate CYP3A inhibitors.
KALYDECO can cause serious adverse reactions including abdominal pain and high liver enzymes in the blood. The most common side effects associated with KALYDECO include headache; upper respiratory tract infection (the common cold), including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; and dizziness. These are not all the possible side effects of KALYDECO. A list of the adverse reactions can be found in the full product labeling for each country where KALYDECO is approved. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.
Please see full U.S. Prescribing Information for KALYDECO at www.KALYDECO.com and the EU Summary of Product Characteristics for KALYDECO at http://goo.gl/N3Tz4.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR INCIVEK
INCIVEK (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.
Important Safety Information
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control, including birth control pills, vaginal rings, implants or injections, may not work during treatment with INCIVEK.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including skin reactions, rash and anemia that can be severe. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com.
Source: Vertex Pharmaceuticals
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