- Scott Brun, M.D. Named Senior R&D
Advisor -
Horizon Therapeutics plc (Nasdaq: HZNP) today announced changes
to its research and development organization structure. Effective
immediately, Elizabeth H.Z. Thompson, Ph.D., group vice president,
clinical development and external search; Srini Ramanathan, Ph.D.,
group vice president, development sciences and San Francisco site
head and Melanie Gloria, senior vice president, R&D operations,
will report to Timothy Walbert, chairman, president and chief
executive officer.
In addition, Scott Brun, M.D. will serve as senior advisor to
the R&D leadership team. Scott is an accomplished physician
executive with more than 20 years of wide-ranging drug development
and business development experience. Most recently, Scott served as
vice president of scientific affairs and head of AbbVie Ventures, a
corporate venture fund responsible for investment opportunities
within the company’s R&D therapeutic focus areas.
Shao-Lee Lin, M.D., Ph.D., executive vice president, research
and development and chief scientific officer is no longer with the
Company and a search will be initiated in the near-term for her
replacement.
“During the last two years, we have made significant progress in
building an R&D team and pipeline, including the development
and early approval of TEPEZZA as well as expanding the clinical
profile of KRYSTEXXA,” said Timothy Walbert, chairman, president
and chief executive officer, Horizon. “Liz, Srini and Melanie have
been integral to our R&D success and I am confident that their
collective leadership, along with Scott’s experience, will set us
up for long-term success. I would like to thank Shao-Lee for her
contributions to Horizon’s growth and wish her the best of luck in
her future endeavors.”
About Horizon
Horizon is focused on researching, developing and
commercializing medicines that address critical needs for people
impacted by rare and rheumatic diseases. Our pipeline is
purposeful: we apply scientific expertise and courage to bring
clinically meaningful therapies to patients. We believe science and
compassion must work together to transform lives. For more
information on how we go to incredible lengths to impact lives,
please visit www.horizontherapeutics.com, follow us @HorizonNews on
Twitter, like us on Facebook or explore career opportunities on
LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to anticipated
changes in Horizon’s R&D team and reporting structure; future
results of Horizon’s R&D initiatives; and business and other
statements that are not historical facts. These forward-looking
statements are based on Horizon’s current expectations and
inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
relating to Horizon’s ability to successfully implement its
business strategies; risks inherent in developing novel medicine
candidates and existing medicines for new indications; risks
associated with regulatory approvals; risks in the ability to
recruit, train and retain qualified personnel; and those risks
detailed from time-to-time under the caption "Risk Factors" and
elsewhere in Horizon’s filings and reports with the SEC. Horizon
undertakes no duty or obligation to update any forward-looking
statements contained in this press release as a result of new
information.
About TEPEZZA
INDICATION
TEPEZZA is indicated for the treatment of Thyroid Eye
Disease.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Infusion Reactions: TEPEZZA may cause infusion reactions.
Infusion reactions have been reported in approximately 4% of
patients treated with TEPEZZA. Reported infusion reactions have
usually been mild or moderate in severity. Signs and symptoms may
include transient increases in blood pressure, feeling hot,
tachycardia, dyspnea, headache and muscular pain. Infusion
reactions may occur during an infusion or within 1.5 hours after an
infusion. In patients who experience an infusion reaction,
consideration should be given to premedicating with an
antihistamine, antipyretic, or corticosteroid and/or administering
all subsequent infusions at a slower infusion rate.
Preexisting Inflammatory Bowel Disease: TEPEZZA may cause
an exacerbation of preexisting inflammatory bowel disease (IBD).
Monitor patients with IBD for flare of disease. If IBD exacerbation
is suspected, consider discontinuation of TEPEZZA.
Hyperglycemia: Increased blood glucose or hyperglycemia
may occur in patients treated with TEPEZZA. In clinical trials, 10%
of patients (two-thirds of whom had preexisting diabetes or
impaired glucose tolerance) experienced hyperglycemia.
Hyperglycemic events should be managed with medications for
glycemic control, if necessary. Monitor patients for elevated blood
glucose and symptoms of hyperglycemia while on treatment with
TEPEZZA. Patients with preexisting diabetes should be under
appropriate glycemic control before receiving TEPEZZA.
Adverse Reactions
The most common adverse reactions (incidence ≥5% and greater
than placebo) are muscle spasm, nausea, alopecia, diarrhea,
fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and
dry skin.
For additional information on TEPEZZA, please see Full
Prescribing Information at TEPEZZAhcp.com.
About KRYSTEXXA
INDICATIONS AND USAGE
KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid
specific enzyme indicated for the treatment of chronic gout in
adult patients refractory to conventional therapy.
Gout refractory to conventional therapy occurs in patients who
have failed to normalize serum uric acid and whose signs and
symptoms are inadequately controlled with xanthine oxidase
inhibitors at the maximum medically appropriate dose or for whom
these drugs are contraindicated.
Important Limitations of Use: KRYSTEXXA is not recommended
for the treatment of asymptomatic hyperuricemia.
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS AND INFUSION REACTIONS
Anaphylaxis and infusion reactions have been reported to
occur during and after administration of KRYSTEXXA. Anaphylaxis may
occur with any infusion, including a first infusion, and generally
manifests within 2 hours of the infusion. However, delayed-type
hypersensitivity reactions have also been reported. KRYSTEXXA
should be administered in healthcare settings and by healthcare
providers prepared to manage anaphylaxis and infusion reactions.
Patients should be premedicated with antihistamines and
corticosteroids. Patients should be closely monitored for an
appropriate period of time for anaphylaxis after administration of
KRYSTEXXA. Serum uric acid levels should be monitored prior to
infusions, and healthcare providers should consider discontinuing
treatment if levels increase to above 6 mg/dL, particularly when 2
consecutive levels above 6 mg/dL are observed.
The risk of anaphylaxis and infusion reactions is higher in
patients who have lost therapeutic response.
Concomitant use of KRYSTEXXA and oral urate-lowering agents may
blunt the rise of sUA levels. Patients should discontinue oral
urate-lowering agents and not institute therapy with oral
urate-lowering agents while taking KRYSTEXXA.
In the event of anaphylaxis or infusion reaction, the infusion
should be slowed, or stopped and restarted at a slower rate.
Patients should be informed of the symptoms and signs of
anaphylaxis and instructed to seek immediate medical care should
anaphylaxis occur after discharge from the healthcare setting.
CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND
METHEMOGLOBINEMIA
Patients should be screened patients for G6PD deficiency prior
to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been
reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA
should not be administered to these patients.
GOUT FLARES
An increase in gout flares is frequently observed upon
initiation of anti-hyperuricemic therapy, including treatment with
KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need
not be discontinued. Gout flare prophylaxis with a non-steroidal
anti-inflammatory drug (NSAID) or colchicine is recommended
starting at least 1 week before initiation of KRYSTEXXA therapy and
lasting at least 6 months, unless medically contraindicated or not
tolerated.
CONGESTIVE HEART FAILURE
KRYSTEXXA has not been studied in patients with congestive heart
failure, but some patients in the clinical trials experienced
exacerbation. Caution should be exercised when using KRYSTEXXA in
patients who have congestive heart failure, and patients should be
monitored closely following infusion.
ADVERSE REACTIONS
The most commonly reported adverse reactions in clinical trials
with KRYSTEXXA were gout flares, infusion reactions, nausea,
contusion or ecchymosis, nasopharyngitis, constipation, chest pain,
anaphylaxis and vomiting.
Please see Full Prescribing Information and Medication Guide
for more information.
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version on businesswire.com: https://www.businesswire.com/news/home/20200124005447/en/
Tina Ventura Senior Vice President, Investor Relations
Investor-relations@horizontherapeutics.com Ruth Venning
Executive Director, Investor Relations
Investor-relations@horizontherapeutics.com U.S. Media
Contact: Geoff Curtis Executive Vice President,
Corporate Affairs and Chief Communications Officer
media@horizontherapeutics.com Ireland Media Contact:
Gordon MRM Ray Gordon ray@gordonmrm.ie
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