PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia
Corporation (TWSE: 6446), a global biopharmaceutical innovator
based in Taiwan leveraging deep expertise and proven scientific
principles to deliver new biologics in hematology and oncology,
today announced the promotion of Robert B. Geller, M.D. to General
Manager. Dr. Geller joined the Company as Head of Medical earlier
this year. In his new role as General Manager, Dr. Geller will
bring his medical expertise to the team and continue to focus on
serving more patients with myeloproliferative neoplasms (MPN).
“Since joining PharmaEssentia, Dr. Robert Geller has clearly
demonstrated his strategic mindset and strong leadership,” said Dr.
Ko-Chung Lin, PharmaEssentia Founder and CEO. “Robert has made
important contributions to our BESREMi® (ropeginterferon
alfa-2b-njft) medical strategy, including our focus on expanding
the use of BESREMi as a frontline polycythemia vera treatment,
consistent with the product label and the NCCN guidelines
implemented earlier this year. More than 10,000 patients worldwide
have already been treated with BESREMi, and we believe there is
substantial opportunity for serving more patients.”
Prior to joining PharmaEssentia, Dr. Geller was most recently
the Chief Medical Officer at Aravive and Senior Vice President of
Medical Affairs at Coherus Biosciences. At Aravive, Dr. Geller
oversaw the clinical trials supporting the development of
batiraxcept, as well as safety, pharmacovigilance, and medical
affairs. At Coherus, he led the Medical Affairs team to support
UDENYCA® and the company’s oncology franchise and ophthalmology and
immunology pipelines. Dr. Geller previously held medical roles at
Heron Therapeutics, Alexion Pharmaceuticals, and Vion
Pharmaceuticals.
Earlier in his career, he was on faculty at the University of
Chicago and Emory University and served as Medical Director at
several community and regional cancer centers, as well as a Partner
in a large oncology/hematology practice. Dr. Geller received his
M.D. from Harvard Medical School/Harvard-MIT Health Science
Technology and a B.S./M.S. in physics from Massachusetts Institute
of Technology.
About PharmaEssentia
PharmaEssentia (TPEx: 6446), headquartered in Taipei, Taiwan, is
a global and rapidly growing biopharmaceutical innovator.
Leveraging deep expertise and proven scientific principles,
PharmaEssentia aims to deliver effective new biologics for
challenging diseases in the areas of hematology, oncology, and
immunology with one approved product and a diversified pipeline.
Founded in 2003 by a team of Taiwanese-American executives and
renowned scientists from U.S. biotechnology and pharmaceutical
companies, today PharmaEssentia is expanding its global presence
with operations in the U.S., Japan, China, and Korea, along with a
world-class biologics production facility in Taichung, Taiwan.
For more information about PharmaEssentia USA, visit our
website, LinkedIn or Twitter.
About Polycythemia Vera (PV)
Polycythemia vera (PV) is a cancer originating from a
disease-initiating stem cell in the bone marrow resulting in a
chronic increase of red blood cells, white blood cells, and
platelets. PV may result in cardiovascular complications such as
thrombosis and embolism, and often transforms to secondary
myelofibrosis or leukemia. While the molecular mechanism underlying
PV is still subject of intense research, current results point to a
set of acquired mutations, the most important being a mutant form
of JAK2.1
About BESREMi® (ropeginterferon alfa-2b-njft)
BESREMi is an innovative monopegylated, long-acting interferon.
With its unique pegylation technology, BESREMi has a long duration
of activity in the body and is aimed to be administered once every
two weeks (or every four weeks with hematological stability for at
least one year), allowing flexible dosing that helps meet the
individual needs of patients.
BESREMi has orphan drug designation for the treatment of
polycythemia vera (PV) in adults in the United States. BESREMi has
been approved in more than 40 countries, with approval from the
European Medicines Agency (EMA) in 2019, by the U.S. Food and Drug
Administration (FDA) in 2021, and by the Pharmaceuticals and
Medical Devices Agency (PMDA) in Japan in 2023. It was invented by
PharmaEssentia and is manufactured in the company’s Taichung,
Taiwan plant, which was cGMP certified by Taiwan Food and Drug
Administration (TFDA) in 2017 and by EMA in January 2018.
PharmaEssentia retains full global intellectual property rights for
the product in all indications.
BESREMi was approved with a boxed warning for risk of serious
disorders including aggravation of neuropsychiatric, autoimmune,
ischemic and infectious disorders.
Please see full Prescribing Information, including Boxed
Warning.
Indication
BESREMi is indicated for the treatment of adults with
polycythemia vera.
Important Safety Information
WARNING: RISK OF SERIOUS DISORDERS
Interferon alfa products may cause or
aggravate fatal or life-threatening neuropsychiatric, autoimmune,
ischemic, and infectious disorders. Patients should be monitored
closely with periodic clinical and laboratory evaluations. Therapy
should be withdrawn in patients with persistently severe or
worsening signs or symptoms of these conditions. In many, but not
all cases, these disorders resolve after stopping therapy.
CONTRAINDICATIONS
- Existence of, or history of severe psychiatric disorders,
particularly severe depression, suicidal ideation, or suicide
attempt
- Hypersensitivity to interferons including interferon alfa-2b or
any of the inactive ingredients of BESREMi.
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic
impairment
- History or presence of active serious or untreated autoimmune
disease
- Immunosuppressed transplant recipients
WARNINGS AND PRECAUTIONS
- Depression and Suicide: Life-threatening or fatal
neuropsychiatric reactions have occurred in patients receiving
interferon alfa-2b products, including BESREMi. These reactions may
occur in patients with and without previous psychiatric illness.
Other central nervous system effects, including suicidal ideation,
attempted suicide, aggression, bipolar disorder, mania and
confusion have been observed with other interferon alfa products.
Closely monitor patients for any symptoms of psychiatric disorders
and consider psychiatric consultation and treatment if such
symptoms emerge. If psychiatric symptoms worsen, it is recommended
to discontinue BESREMi therapy.
- Endocrine Toxicity: These toxicities may include worsening
hypothyroidism and hyperthyroidism. Do not use BESREMi in patients
with active serious or untreated endocrine disorders associated
with autoimmune disease. Evaluate thyroid function in patients who
develop symptoms suggestive of thyroid disease during BESREMi
therapy. Discontinue BESREMi in patients who develop endocrine
disorders that cannot be adequately managed during treatment with
BESREMi.
- Cardiovascular Toxicity: Toxicities may include cardiomyopathy,
myocardial infarction, atrial fibrillation and coronary artery
ischemia. Patients with a history of cardiovascular disorders
should be closely monitored for cardiovascular toxicity during
BESREMi therapy. Avoid use of BESREMi in patients with severe or
unstable cardiovascular disease, (e.g., uncontrolled hypertension,
congestive heart failure (≥ NYHA class 2), serious cardiac
arrhythmia, significant coronary artery stenosis, unstable angina)
or recent stroke or myocardial infarction.
- Decreased Peripheral Blood Counts: These toxicities may include
thrombocytopenia (increasing the risk of bleeding), anemia, and
leukopenia (increasing the risk of infection). Monitor complete
blood counts at baseline, during titration and every 3-6 months
during the maintenance phase. Monitor patients for signs and
symptoms of infection or bleeding.
- Hypersensitivity Reactions: Toxicities may include serious,
acute hypersensitivity reactions (e.g., urticaria, angioedema,
bronchoconstriction, anaphylaxis). If such reactions occur,
discontinue BESREMi and institute appropriate medical therapy
immediately. Transient rashes may not necessitate interruption of
treatment.
- Pancreatitis: Pancreatitis has occurred in 2.2% of patients
receiving BESREMi. Symptoms may include nausea, vomiting, upper
abdominal pain, bloating, and fever. Patients may experience
elevated lipase, amylase, white blood cell count, or altered
renal/hepatic function. Interrupt BESREMi treatment in patients
with possible pancreatitis and evaluate promptly. Consider
discontinuation of BESREMi in patients with confirmed
pancreatitis.
- Colitis: Fatal and serious ulcerative or hemorrhagic/ischemic
colitis have occurred in patients receiving interferon alfa
products, some cases starting as early as 12 weeks after start of
treatment. Symptoms may include abdominal pain, bloody diarrhea,
and fever. Discontinue BESREMi in patients who develop these signs
or symptoms. Colitis may resolve within 1 to 3 weeks of stopping
treatment.
- Pulmonary Toxicity: Pulmonary toxicity may manifest as dyspnea,
pulmonary infiltrates, pneumonia, bronchiolitis obliterans,
interstitial pneumonitis, pulmonary hypertension, and sarcoidosis.
Some events have resulted in respiratory failure or death.
Discontinue BESREMi in patients who develop pulmonary infiltrates
or pulmonary function impairment.
- Ophthalmologic Toxicity: These toxicities may include severe
eye disorders such as retinopathy, retinal hemorrhage, retinal
exudates, retinal detachment and retinal artery or vein occlusion
which may result in blindness. During BESREMi therapy, 23% of
patients were identified with an eye disorder. Eyes disorders ≥5%
included cataract (6%) and dry eye (5%). Advise patients to have
eye examinations before and during BESREMi therapy, specifically in
those patients with a retinopathy-associated disease such as
diabetes mellitus or hypertension. Evaluate eye symptoms promptly.
Discontinue BESREMi in patients who develop new or worsening eye
disorders.
- Hyperlipidemia: Elevated triglycerides may result in
pancreatitis. Monitor serum triglycerides before BESREMi treatment
and intermittently during therapy and manage when elevated.
Consider discontinuation of BESREMi in patients with persistently,
markedly elevated triglycerides.
- Hepatotoxicity: These toxicities may include increases in serum
alanine aminotransferase (ALT), aspartate aminotransferase (AST),
gamma-glutamyl transferase (GGT) and bilirubin. Liver enzyme
elevations have also been reported in patients after long-term
BESREMi therapy. Monitor liver enzymes and hepatic function at
baseline and during BESREMi treatment. Discontinue BESREMi in
patients who develop evidence of hepatic decompensation
(characterized by jaundice, ascites, hepatic encephalopathy,
hepatorenal syndrome or variceal hemorrhage) during treatment.
- Renal Toxicity: Monitor serum creatinine at baseline and during
therapy. Avoid use of BESREMi in patients with eGFR <30 mL/min.
Discontinue BESREMi if severe renal impairment develops during
treatment.
- Dental and Periodontal Toxicity: These toxicities may include
dental and periodontal disorders, which may lead to loss of teeth.
In addition, dry mouth could have a damaging effect on teeth and
mucous membranes of the mouth during long-term treatment with
BESREMi. Patients should have good oral hygiene and regular dental
examinations.
- Dermatologic Toxicity: These toxicities have included skin
rash, pruritus, alopecia, erythema, psoriasis, xeroderma,
dermatitis acneiform, hyperkeratosis, and hyperhidrosis. Consider
discontinuation of BESREMi if clinically significant dermatologic
toxicity occurs.
- Driving and Operating Machinery: BESREMi may impact the ability
to drive and use machinery. Patients should not drive or use heavy
machinery until they know how BESREMi affects their abilities.
Patients who experience dizziness, somnolence or hallucination
during BESREMi therapy should avoid driving or using
machinery.
- Embryo-Fetal Toxicity: Based on the mechanism of action,
BESREMi can cause fetal harm when administered to a pregnant woman.
Pregnancy testing is recommended in females of reproductive
potential prior to treatment with BESREMi. Advise females of
reproductive potential to use an effective method of contraception
during treatment with BESREMi and for at least 8 weeks after the
final dose.
ADVERSE REACTIONS
The most common adverse reactions reported in > 40% of
patients in the PEGINVERA study (n=51) were influenza-like illness,
arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal
pain. In the pooled safety population (n=178), the most common
adverse reactions greater than 10%, were liver enzyme elevations
(20%), leukopenia (20%), thrombocytopenia (19%), arthralgia (13%),
fatigue (12%), myalgia (11%), and influenza-like illness (11%).
DRUG INTERACTIONS
Patients on BESREMi who are receiving concomitant drugs which
are CYP450 substrates with a narrow therapeutic index should be
monitored to inform the need for dosage modification for these
concomitant drugs. Avoid use with myelosuppressive agents and
monitor patients receiving the combination for effects of excessive
myelosuppression. Avoid use with narcotics, hypnotics or sedatives
and monitor patients receiving the combination for effects of
excessive CNS toxicity.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Based on mechanism of action and the role of
interferon alfa in pregnancy and fetal development, BESREMi may
cause fetal harm and should be assumed to have abortifacient
potential when administered to a pregnant woman. There are adverse
effects on maternal and fetal outcomes associated with polycythemia
vera in pregnancy. Advise pregnant women of the potential risk to a
fetus.
- Lactation: There are no data on the presence of BESREMi in
human or animal milk, the effects on the breastfed child, or the
effects on milk production. Because of the potential for serious
adverse reactions in breastfed children from BESREMi, advise women
not to breastfeed during treatment and for 8 weeks after the final
dose.
- Females of Reproductive Potential: BESREMi may cause
embryo-fetal harm when administered to a pregnant woman. Pregnancy
testing prior to BESREMi treatment is recommended for females of
reproductive potential. Advise female patients of reproductive
potential to use effective contraception during treatment with
BESREMi and for at least 8 weeks after the final dose.
- Pediatric Use: Safety and effectiveness in pediatric patients
have not been established.
- Geriatric Use: In general, dose selection for an elderly
patient should be cautious, usually starting at the low end of the
dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function and of concomitant disease or
other therapy.
Forward Looking Statement This press release may contain
forward looking statements, including statements regarding the
clinical benefits to be derived from ropeginterferon alfa-2b, the
commercial opportunity and competitive positioning, new indications
or labeling for ropeginterferon alfa-2b, and business prospects for
ropeginterferon alfa-2b. For those statements, we claim the
protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995
and similar legislation and regulations under Taiwanese law. These
forward-looking statements are based on management expectations and
assumptions as of the date of this press release, and actual
results may differ materially from those in these forward looking
statements as a result of various factors. These factors include
whether BESREMi is successfully commercialized and adopted by
physicians and patients, the extent to which reimbursement is
available for BESREMi, and the ability to receive FDA and other
regulatory approvals for additional indications for BESREMi. We do
not undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date
hereof.
© 2024 PharmaEssentia Corporation. All rights reserved.
PharmaEssentia, the PharmaEssentia logo, and BESREMi are
trademarks or registered trademarks of PharmaEssentia
Corporation.
UDENYCA® is a registered trademark of Coherus Biosciences,
Inc.
1 Cerquozzi S, Tefferi A. Blast transformation and fibrotic
progression in polycythemia vera and essential thrombocythemia: a
literature review of incidence and risk factors. Blood Cancer J.
2015;5, e366; DOI:10.1038/bcj.2015.95
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Media Contacts: Muriel Huang,
muriel_huang@pharmaessentia.com