Effort Seeks to Address Needs of People with Periodic Paralysis, an
Ultra Rare Disease
HAWTHORNE, N.Y.--(BUSINESS WIRE)--May 2, 2016--
Taro Pharmaceutical Industries Ltd. (NYSE:TARO) (“Taro” or the
“Company”) today announced that its U.S. subsidiary, Taro
Pharmaceuticals U.S.A., Inc., will now make Keveyis™ (dichlorphenamide)
available to distributors at no cost for the treatment of primary
periodic paralysis, an ultra-rare and debilitating disease. As a result,
Taro will cease commercial sales and related promotional activities for
Keveyis and bear all costs associated with its manufacture. In the near
term, patients will continue to receive the medicine through Diplomat as
the Company evaluates the best option for keeping pharmacy dispensing
fees to patients as low as possible.
“We embarked on this decade-long journey to help a patient community in
need and we are proud that it resulted in Keveyis, the first medicine
approved for the treatment of periodic paralysis,” said Kal Sundaram,
Chief Executive Officer of Taro USA. “Through heartfelt testimonials,
patients have told us how their lives have changed for the better thanks
to this treatment being available. This decision extends our desire to
ensure that anyone with a prescription will continue to have access to
the medicine regardless of insurance status or ability to pay.”
In establishing the original price for Keveyis, Taro sought to balance
the investment needed to educate the patient and physician community
about a largely unknown disease while also ensuring that access to
patients wasn’t hindered. Through its Keys2Care support program,
patients have had an average out-of-pocket cost of less than $25 per
month. For some, treatment has been free through the Company’s Patient
Although Taro expected to treat only a few hundred patients with
Keveyis, it has become clear that reaching such a small pool of people
is more difficult than previously anticipated. Among the 5,000 people
estimated to be living with Periodic Paralysis, less than 1,500 are
believed to be diagnosed. Among these patients, a mix of lifestyle
modifications and medicines prescribed off-label are often used to
manage their disease. While we have continued to invest significantly in
this effort, sales have been less than one million dollars since launch.
Given the high costs and resources required to identify and reach a
limited number of viable patients, Taro realizes that it cannot sustain
its current level of investment. Based on these learnings, Taro now
believes that it can better serve all stakeholders, including patients,
by ceasing commercial sales and related promotional activities for
About Periodic Paralysis
Periodic paralyses are a group of rare hereditary disorders that cause
episodes of muscle weakness or paralysis. Many patients often endure
decades of diagnostic ‘missteps,’ with a significant delay between the
onset of symptoms and diagnosis. Types of periodic paralyses are
differentiated by criteria including underlying genetic mutations and
changes in blood-potassium during attack. Hypokalemic and hyperkalemic
are two common types of periodic paralyses.
Keveyis is indicated for the treatment of primary hyperkalemic periodic
paralysis, primary hypokalemic periodic paralysis, and related variants.
IMPORTANT SAFETY INFORMATION
In clinical studies, the most common side effects of Keveyis were a
burning or pricking sensation, 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.
Keveyis is not for everyone. Do not take Keveyis if you:
Are on a high-dose aspirin regimen
Are allergic to sulfa-based drugs
Have liver, kidney, or certain lung conditions
Are pregnant, planning to become pregnant, or nursing
Are under 18 years old
Taking Keveyis may cause a drop in the amount of potassium (an
electrolyte) in your body, which can lead to heart problems. Ask your
doctor if you need to eat foods that contain high amounts of potassium
while taking Keveyis.
Your body may produce too much acid or may not be able to remove enough
acid from body fluids while taking Keveyis. Your doctor will run tests
on a regular basis to check for signs of acid buildup and may reduce
your dose or stop your treatment with Keveyis.
Keveyis may also increase the risk of falls, especially in elderly
patients and patients taking high doses of Keveyis. Use caution when
driving, operating machinery, or performing any other hazardous
activities while taking Keveyis, as this medication may cause drowsiness.
Tell your doctor if you experience worsening of your periodic paralysis
For additional safety information, please see Full Prescribing
Information at www.keveyis.com.
The release will be accessible on Taro’s website at www.taro.com.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based
pharmaceutical company, dedicated to meeting the needs of its customers
through the discovery, development, manufacturing and marketing of the
highest quality healthcare products. For further information on Taro
Pharmaceutical Industries Ltd., please visit the Company’s website at www.taro.com.
SAFE HARBOR STATEMENT
Certain statements in this release may be considered forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements include, but are not limited
to, statements that do not describe historical facts or that refer or
relate to events or circumstances that the Company “estimates,”
“believes,” or “expects” to happen or similar language. Although
the Company believes the expectations reflected in such forward-looking
statements to be based on reasonable assumptions, it can give no
assurances that its expectations will be attained. Factors that
could cause actual results or events to differ include risks related to
industry, market and regulatory conditions, delays or prevention caused
by governmental regulation of pharmaceutical products, and other risks
detailed from time to time in the Company’s SEC reports, including its
Annual Reports on Form 20-F. Forward-looking statements are
applicable only as of the date on which they are made. The
Company undertakes no obligations to update, change or revise any
forward-looking statement, whether as a result of new information,
additional or subsequent developments or otherwise.
inVentiv Health, United Health Claims Database Analysis, October
Charles, G., Zheng, C., Lehmann-Horn, F., Jurkat-Rott, K., & Levitt,
J. (2013). Characterization of hyperkalemic periodic paralysis: a
survey of genetically diagnosed individuals. Journal of Neurology,
Cavel-Greant, D., Lehmann-Horn, F., & Jurkat-Rott. The impact of
permanent muscle weakness on quality of life in periodic paralysis:
a survey of 66 patients. Acta Myologica, 31(2), 126–133.
National Institute of Neurological Disorders and Stroke. NINDS
Familial Periodic Paralyses Information Page. Available at: http://www.ninds.nih.gov/disorders/periodic_paralysis/periodic_paralysis.htm.
Published March 12, 2012. Accessed February 29, 2016.
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Source: Taro Pharmaceutical Industries Ltd.
Taro Pharmaceutical Industries Ltd.
William J. Coote, (914)