HAWTHORNE, N.Y.--(BUSINESS WIRE)--Dec. 23, 2016--
Taro Pharmaceutical Industries Ltd. (NYSE:TARO) (“Taro” or the
“Company”) today announced the sale of U.S. rights to Keveyis®
(dichlorphenamide) to Strongbridge Biopharma plc (Strongbridge), a
global commercial-stage biopharmaceutical company focused on the
development and commercialization of therapies for rare diseases with
significant unmet need. Keveyis was approved by the U.S. Food
and Drug Administration (the “FDA”) in August 2015 to treat primary
hyperkalemic and hypokalemic periodic paralysis, a group of rare
hereditary disorders that cause episodes of muscle weakness or
paralysis. Keveyis has orphan designation status through August 2022.
Under the terms of the purchase agreement, Strongbridge will provide
Taro with upfront and deferred payments of $8.5 million in two
installments; Taro is also eligible to receive additional future
payments upon the achievement of certain sales unit milestones.
Strongbridge expects to commercially launch Keveyis in the U.S. in April
2017. Taro has agreed to continue to manufacture Keveyis for
Strongbridge, under an exclusive supply agreement at least for the
period of Keveyis orphan exclusivity, subject to certain commercial
terms and conditions, including minimum supply purchases.
“We are proud of our work in making Keveyis the first FDA-approved
treatment option for people living with primary periodic paralysis,”
said Kal Sundaram, Chief Executive Officer of Taro. “In maintaining our
commitment to patients, we have selected a partner in this sale with the
expertise to reach the patients and physicians needed to improve patient
outcomes and deepen understanding of the disease.”
Since ceasing commercialization in May 2016, Taro has been supplying
Keveyis to patients through a compassionate use program. Strongbridge is
committed to continuing this program through the expected launch in
April 2017, and is committed to working with existing U.S. Keveyis
patients to ensure continuity of treatment. Keveyis patients may call
1-844-KEVEYIS for more information.
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 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 Keveyis important safety information, please see
full prescribing information at www.keveyis.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 are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. 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,
including without limitation statements in this press release regarding
the commercializing and market acceptance of Keveyis, the expected April
2017 launch date of Keveyis, the achievement of certain Keveyis sales
unit milestones, statements regarding Strongbridge’s commitments and
plans, and delays or prevention caused by governmental regulation of
pharmaceutical products. Factors that could cause actual results
to differ include general domestic and international economic
conditions, industry and market conditions, changes in the Company's
financial position, litigation brought by any party in any court in
Israel, the United States, or any country in which Taro operates,
regulatory and legislative actions in the countries in which Taro
operates, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161223005197/en/
Source: Taro Pharmaceutical Industries Ltd.
Taro Pharmaceutical Industries Ltd.
Mariano Balaguer, (914)
VP, Chief Financial Officer
J. Coote, (914) 345-9001