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Press Release

Strongbridge Biopharma plc Launches the Uncovering Periodic Paralysis Genetic Testing Program


Posted on: 25 Sep 17

DUBLIN, Ireland and TREVOSE, Pa., Sept. 25, 2017 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq:SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced the launch of a genetic testing program for hyperkalemic or hypokalemic periodic paralysis. Primary Periodic Paralysis is a rare inherited disorder characterized by recurrent, progressive, and debilitating episodes of muscle weakness and temporary paralysis that affects approximately 4,000 to 5,000 diagnosed individuals in the United States.

“We are pleased to launch the Uncovering Periodic Paralysis genetic testing program, which builds upon our current suite of patient and physician services already being offered through the Strongbridge CareConnection Program,” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. “Primary Periodic Paralysis patients have historically been underserved, and we are proud to offer them robust support from Strongbridge’s patient- and physician-focused programs. Additionally, given the early market interest in KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis, and to better serve the needs of patients and the physicians who treat them, we are expanding our 12-person field force team to 21 employees by early November.”

Uncovering Periodic Paralysis is a no-cost program that offers genetic testing for those who qualify. Although genetic testing can confirm a suspected diagnosis, the absence of a genetic alteration does not preclude diagnosis of this disease. The Periodic Paralysis Panel includes testing of the three genes that are most commonly-associated with periodic paralysis: SCN4A, CACNA1S, and KCNJ2.

“Strongbridge’s genetic testing program will provide an early diagnostic testing measure for Primary Periodic Paralysis, a serious neuromuscular disease that sometimes takes up to 20 years to accurately diagnose,” said Deborah Cavel-Greant, president, Periodic Paralysis International. “The availability of this test may help relieve patients and their families of a significant emotional burden and pave the way for more timely and effective treatment.”

“There is a growing awareness of periodic paralysis and access to tests such as this may help shorten the diagnostic journey for patients,” said Steve Cannon M.D., PhD, neurologist and professor of Physiology at UCLA. “Access to more reliable genetic testing will empower medical professionals with the right information to facilitate improved clinical management of the disease.”

Periodic Paralysis Panel Eligibility
An individual must:

  • Be at least 18 years old
  • Have experienced more than one occurrence of episodic muscle weakness/paralysis attacks, or episodic pain after attacks
  • Episodes are provoked by at least one of the common triggers for hyperkalemic or hypokalemic periodic paralysis, e.g. potassium, carbohydrates, rest after exercise, cold exposure, or stress

Family Variant Testing
For any patient that is newly diagnosed via Uncovering Periodic Paralysis, Strongbridge will offer no-cost Family Variant Testing to any first-degree relative. Requirements include:

  • A pathogenic or likely pathogenic variant was found on the gene panel test
  • Order must occur within 90-days of new diagnosis

For more information about the program, please visit: UncoveringPeriodicParalysis.com.

About Strongbridge Biopharma 

Strongbridge Biopharma is a commercial-stage global biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge's first commercial product is KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis. KEVEYIS has orphan drug exclusivity status in the U.S. through August 7, 2022. In addition to establishing this neuromuscular disease franchise, the Company has a clinical-stage pipeline of therapies for rare endocrine diseases. Strongbridge's lead compounds include RECORLEV (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome, and veldoreotide, a next-generation somatostatin analog being investigated for the treatment of acromegaly, with potential additional applications in Cushing's syndrome and neuroendocrine tumors. Both RECORLEV and veldoreotide have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strongbridgebio.com.

About KEVEYIS

KEVEYIS® (dichlorphenamide) is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. In clinical studies, the most common side effects of KEVEYIS were a numbness or tingling, difficulty thinking and paying attention, changes in taste, and confusion. These are not all of the possible side effects that you may experience with KEVEYIS. Talk to your doctor if you have any symptoms that bother you or do not go away. You are encouraged to report side effects to Strongbridge Biopharma at 1-855-324-8912, or to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch/. For additional KEVEYIS important safety information and the full prescribing information visit www.keveyis.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements. These statements relate to future events and involve known and unknown risks, including, without limitation, uncertainties regarding Strongbridge's strategy, plans, size of patient population and objectives of management for future operations. The words "anticipate," "estimate," "expect," "intend," "may," "plan," "potential," "project," "target," "will," "would," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.

Contacts:

Corporate and Media Relations
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
lrocco@elixirhealthpr.com

Investor Relations
U.S.:
The Trout Group
Marcy Nanus
+1 646-378-2927
mnanus@troutgroup.com

Europe:
First House
Mitra Hagen Negård
+47 21 04 62 19
strongbridgebio@firsthouse.no

USA
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Tel. +1 610-254-9200
Fax. +1 215-355-7389

GlobeNewswire
globenewswire.com

Last updated on: 25/09/2017

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