Braeburn Pharmaceuticals said last week that it named Michael Derkacz as president and CEO of the buprenorphine implant-maker. Most recently, Derkacz worked as senior VP and head of global central nervous system and pain therapeutic areas for Teva Pharmaceuticals (NYSE:TEVA).
Behshad Sheldon, who helped to found Braeburn in 2012, is slated to step down from Braeburn as president & CEO effective immediately, but will remain on as a consultant.
“Mike is an accomplished and highly successful commercial leader, with deep expertise in launching new products, creating highly effective teams, and focused organizational leadership,” chairman Dr. Seth Harrison said in prepared remarks. “We welcome Mike to Braeburn at this important moment in the Company’s growth, as we drive commercial efforts for our first approved product and finalize regulatory filings seeking approval of our flagship opportunity, CAM2038.”
“We are grateful for the leadership and resolve Behshad has demonstrated, guiding Braeburn through clinical and regulatory challenges, resulting in the U.S. Food and Drug Administration approval for our 1st product, as well as NDA readiness for CAM2038 and the creation of a strong clinical pipeline,” Harrison added.
“Braeburn represents a compelling and unique opportunity to make an important difference for patients suffering serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia,” Derkacz said. “With a broad portfolio of products, utilizing innovative technologies, Braeburn is poised to lead the way at a time when there is universal alignment among physicians, patients, payers, and the U.S. Government around the high sense of urgency to provide novel and effective treatments for those suffering from addiction. I look forward to working with the talented team at Braeburn to build upon the impressive track record of success they have achieved to date.”
“Braeburn has been built on the mission to develop and deliver individualized, long-acting medicines to patients that suffer from serious, stigmatized neuropsychiatric disorders, such as opioid addiction, chronic pain, and schizophrenia,” Sheldon said. “I am proud of all we have accomplished and have great confidence that the team can build on the foundation set and attain the exciting clinical and commercial milestones anticipated in the years ahead.”
This week, Braeburn and Knight Therapeutics (TSE:GUD) said that Health Canada has agreed to review Knight’s new drug submission for Probuphine, a buprenorphine subdermal implant designed to treat opioid drug dependence.
CytRx CMO, COO departs
CytRx Corp. (NSDQ:CYTR) said this month that its chief operating and medical officer, Dr. Daniel Levitt, will step down effective July 7 and that the position will be eliminated. The company’s senior VP of drug development, Scott Wieland, is also planning to depart effective June 30.
The company also said that Dr. Shanta Chawla, who is CytRx’s VP of clinical development, was promoted to senior VP of drug development. In that role, Chawla will be responsible for the company’s on-going clinical drug development and regulatory functions, according to CytRx.
“Dr. Shanta Chawla who is a Board certified physician has played a key role in the late-stage development and NDA submissions of several oncology drugs and has been involved in the day-to-day clinical development of aldoxorubicin for more than three years,” chairman & CEO Steven Kriegsman said in prepared remarks. “Together with the rest of our clinical and regulatory team and external regulatory counsel Dr. Margaret Hurley, a renowned drug development strategist, we remain well-equipped to execute on the regulatory strategy for aldoxorubicin.”
Dave Anderson plans to continue to serve as CFO until July 31, at which point he will become a senior advisor to the CEO and remain with Alexion until the end of August, the company reported.
“I couldn’t be more pleased to welcome Paul to Alexion,” CEO Ludwig Hantson said in prepared remarks. “Paul is a world-class CFO who has distinguished himself in the biopharmaceutical industry. He brings deep experience and a proven track record of managing a global organization, executing successful financial and capital allocation strategies to deliver long-term shareholder value, and cultivating strong relationships with the investment community. He is an outstanding addition to our team and we look forward to his leadership, insights and partnership as we position Alexion for its next stage of growth.”
“I’ve worked in the biopharmaceutical industry for many years, and I have been consistently impressed with Alexion and the life-changing therapies the company has brought to patients with rare diseases,” Clancy said. “I’m very excited to join Alexion and look forward to working with the leadership team and leading the finance organization to build upon the company’s strong fundamentals and drive future growth and shareholder value.”
“Dave Anderson will work closely with Paul to ensure a smooth and seamless transition,” Hantson said. “We appreciate the valuable contributions that Dave has made during his tenure. We wish Dave all the best in his future endeavors.”
“I want to thank Paul for his more than 16 years of distinguished service to Biogen, and especially for his last 10 years as our CFO,” Biogen CEO Michel Vounatsos added. “Paul helped transform Biogen into the global biotechnology leader it is today and helped to prepare us for the bright future we believe lies ahead.”
Dicerna appoints chief medical officer
Dicerna Pharmaceuticals (NSDQ:DRNA) last week named Dr. Ralf Rosskamp as chief medical officer, effective June 15. He will be in charge of the company’s clinical development, medical affairs and regulatory functions, according to the Cambridge, Mass.-based company.
“Dr. Rosskamp is an accomplished biopharmaceutical executive with extensive global drug development and product launch experience across numerous therapeutic areas, including large population diseases such as cardiovascular disease, and, more recently, rare and orphan diseases,” president & CEO Douglas Fambrough said in prepared remarks. “His in-depth experience, combined with his proven success in working with global regulatory agencies to obtain multiple drug approvals, including most recently the FDA approval of Natpara for the treatment of a rare endocrine disorder called hypoparathyroidism, will be a huge asset to Dicerna. Dr. Rosskamp will play an integral role as we seek to advance our lead product, DCR-PHXC, into the clinic in early 2018, and continue to advance our broad pipeline of other promising GalXC-based drug candidates.”
Most recently, Rosskamp served as chief medical officer for Summit Therapeutics, where he oversaw the clinical development of drugs targeting Duchenne muscular dystrophy and the disease caused by Clostridium difficile bacteria.
“I am delighted to join Dicerna at this pivotal time, and to have the opportunity to lead the clinical development of the company’s pipeline of novel RNAi compounds,” Rosskamp said. “Dicerna has developed a differentiated technology platform that has generated a strong and growing pipeline of pre-clinical candidates capable of silencing genes in the liver across a spectrum of diseases, opening up a range of therapeutic opportunities for the company. I look forward to working closely with the Dicerna team to initiate clinical studies early next year for its lead program, DCR-PHXC, which is being developed for patients with primary hyperoxaluria type 1, a devastating and rare genetic disease with limited treatment options.”
Previously, Zelenkofske served at AstraZeneca (NYSE:AZN), Sanofi (NYSE:SNY), Boston Scientific (NYSE:BSX) and Novartis (NYSE:NVS). Most recently, he was VP and therapeutic area head of cardviovascular/metabolism for AstraZeneca.
“Steve is a proven leader with both important industry and clinical practice experience,” CEO Matt Kapusta said in prepared remarks. “He has worked effectively in both large and small corporate environments and has an accomplished track record leading clinical research through all phases of development and onto successful regulatory approvals. As we advance our hemophilia B and Huntington’s disease programs through the clinic, expanding our medical and clinical capabilities in the United States will become increasingly important, and Steve’s broad experience will be instrumental in helping uniQure deliver our gene therapy candidates to patients.”
““I am excited about this very promising opportunity at uniQure,” Zelenkofske said. “I look forward to working with the team to advance the clinical development of the Company’s gene therapy programs and to collaborate with research colleagues to further identify opportunities in the early stage pipeline.”
“On behalf of the company’s Board of Directors, leadership team and employees, I want to thank Christian for his tremendous contributions during the past years of growth and transition at uniQure,” Kapusta added. “This includes his leadership in executing a successful Phase I/II clinical program in hemophilia B, establishing clinical operations, medical affairs and pharmacovigilance teams, and achieving regulatory accomplishments for the hemophilia B program through Breakthrough Therapy and Prime designations. Christian worked tirelessly in these areas and this success would not have been possible without his effort and support.”
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