- Joseph Turgeon has more than 30
years of experience in the biotech industry, including 22 years at
Amgen; until recently was Spectrum’s Chief Commercial
Officer
- Thomas Riga promoted to Senior Vice
President and Chief Commercial Officer; Tom has more than 15 years’
experience in the biotech industry, which includes Amgen, Eli
Lilly, and Dendreon; until recently was Spectrum’s VP of Corporate
Accounts
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in hematology and oncology, today
announced the promotion of Joseph Turgeon to President and Chief
Operating Officer. Mr. Turgeon was previously Senior Vice President
and Chief Commercial Officer. Spectrum also announced the promotion
of Thomas Riga to Senior Vice President, Chief Commercial Officer.
Mr. Riga was previously Vice President, Corporate Accounts.
“We are fortunate to have an experienced, passionate, and
inspiring leader like Joe Turgeon spearhead the company,” said
Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of
Spectrum Pharmaceuticals. “Joe was responsible for building a top
sales organization and for launching four of the world’s
top-selling biologicals, during his over two decades at Amgen. With
a rare depth of experience in the biotechnology industry, a keen
understanding of our business, and very strong leadership skills,
Joe is uniquely qualified for this position. He has been
instrumental in helping Spectrum execute our strategy since he
joined us in 2012. With multiple launches and NDAs planned in the
coming years, I believe Joe’s leadership is exactly what Spectrum
needs to become a leader in hematology/oncology.”
“I take up this new role with honor, humility, and confidence,”
said Joseph Turgeon, President and Chief Operating Officer. “We
have an exciting year ahead of us, with several meaningful
milestones. Our base business remains strong, and could be further
strengthened with the potential FDA approval of Beleodaq™ later
this year. The ongoing proof-of-concept study SPI-2012 has the
potential to take Spectrum to the next level. I am committed to
improving lives of patients, to improving prospects for our
shareholders, and to bringing out the best in our team.”
Joseph Turgeon joined Spectrum in October 2012 and brings over
30 years of pharmaceutical sales experience, including various
executive leadership roles at Amgen. Prior to joining the Company,
he spent 22 years at Amgen Inc. as Vice President, Sales, where he
built and led the sales organization across multiple areas,
including oncology, inflammation, and bone health. Mr. Turgeon
was responsible for launching most of the drugs at Amgen. At
Spectrum, he has built a world-class sales organization that has
increased efficiency and visibility. He was also instrumental in
the launch of Marqibo® (vinCRIStine sulfate LIPOSOME injection)
last year in a record time of about 7 weeks. Mr. Turgeon holds
a B.S. from Jacksonville University, where he studied microbiology
and economics.
Thomas Riga brings over 15 years of pharmaceutical sales and
management experience in various positions at Amgen, Eli Lilly, and
Dendreon. Since joining Spectrum, Mr. Riga has been instrumental in
the reorganization of the Corporate Accounts function, and in
successful partnership and renegotiation with various partners. He
has co-led the Commercial contracting strategy and attracted some
of the industry’s top talent to join Spectrum.
Ken Keller resigned as Executive Vice President, Chief Operating
Officer of the company to pursue other opportunities.
“I would like to personally thank Ken for his contributions to
the company,” added Dr. Shrotriya. “On behalf of the team at
Spectrum, I wish him the best in his future endeavors.”
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in oncology and hematology. Spectrum
and its affiliates market four oncology drugs ─ FUSILEV®
(levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate
injection), also marketed in the U.S.; ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has
worldwide marketing rights; and MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) for intravenous infusion, for which the Company
has worldwide marketing rights. Spectrum's strong track record in
in-licensing and acquiring differentiated drugs and expertise in
clinical development have generated a robust, diversified, and
growing pipeline of product candidates in advanced-stage Phase 2
and Phase 3 studies. More information on Spectrum is available at
www.sppirx.com.
About Marqibo®
Marqibo is a novel, sphingomyelin/cholesterol
liposome-encapsulated formulation of vincristine sulfate.
Vincristine, a microtubule inhibitor, is FDA approved for the
treatment of adult patients with Philadelphia chromosome-negative
(Ph-) acute lymphoblastic leukemia (ALL) in second or greater
relapse or whose disease has progressed following two or more
anti-leukemia therapies. (The encapsulation technology, utilized in
this formulation, has been shown to provide prolonged circulation
of vincristine in the blood).
Please see important safety information below and the full
prescribing information for Marqibo at
www.marqibo.com.
Indication and usage
Marqibo is a liposomal vinca alkaloid indicated for the
treatment of adult patients with Philadelphia chromosome-negative
(Ph-) acute lymphoblastic leukemia (ALL) in second or greater
relapse or whose disease has progressed following two or more
anti-leukemia therapies. This indication is based on overall
response rate. Clinical benefit such as improvement in overall
survival has not been verified.
Important safety information
CONTRAINDICATIONS
- Marqibo is contraindicated in patients
with demyelinating conditions including Charcot-Marie-Tooth
syndrome
- Marqibo is contraindicated in patients
with hypersensitivity to vincristine sulfate or any of the other
components of Marqibo (vinCRIStine sulfate LIPOSOME injection)
- Marqibo is contraindicated for
intrathecal administration
WARNING
See full prescribing information for
complete boxed warning.
- For Intravenous Use Only — Fatal if
Given by Other Routes
- Death has occurred with intrathecal
use
- Marqibo (vinCRIStine sulfate
LIPOSOME injection) has different dosage recommendations than
vinCRIStine sulfate injection. Verify drug name and dose prior to
preparation and administration to avoid overdosage.
Warnings and Precautions
For Intravenous Use Only
For Intravenous use only. Fatal if given by other routes.
Extravasation Tissue Injury
Only administer through a secure and free-flowing venous access
line. If extravasation is suspected, discontinue infusion
immediately and consider local treatment measures.
Neurologic Toxicity
Sensory and motor neuropathies are common and are cumulative.
Monitor patients for symptoms of neuropathy, such as hypoesthesia,
hyperesthesia, paresthesia, hyporeflexia, areflexia, neuralgia, jaw
pain, decreased vibratory sense, cranial neuropathy, ileus, burning
sensation, arthralgia, myalgia, muscle spasm, or weakness, both
before and during treatment. Orthostatic hypotension may occur. The
risk of neurologic toxicity is greater if Marqibo is administered
to patients with preexisting neuromuscular disorders or when other
drugs with risk of neurologic toxicity are being given. In the
studies of relapsed and/or refractory adult ALL patients, Grade ≥ 3
neuropathy events occurred in 32.5% of patients. Worsening
neuropathy requires dose delay, reduction, or discontinuation of
Marqibo.
Myelosuppression
Monitor complete blood counts prior to each dose of Marqibo. If
Grade 3 or 4 neutropenia, thrombocytopenia, or anemia develops,
consider Marqibo dose modification or reduction as well as
supportive care measures.
Tumor Lysis Syndrome
Tumor lysis syndrome (TLS) may occur in patients with ALL
receiving Marqibo. Anticipate, monitor for, and manage.
Constipation and Bowel Obstruction
Ileus, bowel obstruction, and colonic pseudo-obstruction have
occurred. Marqibo can cause constipation. Institute a prophylactic
bowel regimen to mitigate potential constipation, bowel
obstruction, and/or paralytic ileus, considering adequate dietary
fiber intake, hydration, and routine use of stool softeners, such
as docusate. Additional treatments, such as senna, bisacodyl, milk
of magnesia, magnesium citrate, and lactulose may be
considered.
Fatigue
Marqibo can cause severe fatigue. Marqibo dose delay, reduction,
or discontinuation may be necessary.
Hepatic Toxicity
Fatal liver toxicity and elevated levels of aspartate
aminotransferase have occurred. Elevated levels of aspartate
aminotransferase of Grade ≥3 occurred in 6-11% of patients in
clinical trials. Monitor hepatic function tests. Reduce or
interrupt Marqibo for hepatic toxicity.
Embryofetal Toxicity
Marqibo can cause fetal harm when administered to a pregnant
woman. Vincristine sulfate liposome injection was teratogenic or
caused embryofetal death in animals. Women of childbearing
potential should avoid becoming pregnant while being treated with
Marqibo. There are no adequate and well-controlled studies of
Marqibo in pregnant women and there were no reports of pregnancy in
any of the clinical studies in the Marqibo clinical development
program. If this drug is used during pregnancy, or if the patient
becomes pregnant while taking this drug, the patient should be
apprised of the potential hazard to a fetus [see Use in Specific
Populations].
Adverse Reactions
The most common adverse reactions (> 30%) were constipation
(57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral
neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia
(34%), decreased appetite (33%), and insomnia (32%).
The most commonly reported SAEs included febrile neutropenia
(20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress
(6.0%), and cardiac arrest (6.0%).
Twenty-eight percent of patients experienced adverse reactions
leading to treatment discontinuation. The most common adverse
reactions that caused treatment discontinuation were peripheral
neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome
(2%).
Deaths occurred in 23% of patients in study 1. The non-leukemia
related causes of deaths were brain infarct (1), intracerebral
hemorrhage (2), liver failure (1), multi-system organ failure (2),
pneumonia and septic shock (3), respiratory failure (4), pulmonary
hemorrhage (1), and sudden cardiac death (1).
Drug Interactions
No formal drug interaction studies have been conducted with
Marqibo. Marqibo is expected to interact with drugs known to
interact with non-liposomal vincristine sulfate.
Simultaneous oral or intravenous administration of phenytoin and
antineoplastic chemotherapy combinations that included
non-liposomal vincristine sulfate has been reported to reduce blood
levels of phenytoin and to increase seizure activity.
CYP3A Interactions
Vincristine sulfate, the active agent in Marqibo, is a substrate
for cytochrome P450 3A isozymes (CYP3A); therefore, the concomitant
use of strong CYP3A inhibitors should be avoided (e.g.,
ketoconazole, itraconazole, voriconazole, posaconazole,
clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir,
ritonavir, saquinavir, telithromycin). Similarly, the concomitant
use of strong CYP3A inducers should be avoided (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin,
rifapentine, phenobarbital, St. John's Wort).
P-glycoprotein Interactions
Vincristine sulfate, the active agent in Marqibo, is also a
substrate for P-glycoprotein (P-gp). The effect of concomitant use
of potent P-gp inhibitors or inducers has not been investigated; it
is likely that these agents will alter the pharmacokinetics or
pharmacodynamics of Marqibo. Therefore the concomitant use of
potent P-gp inhibitors or inducers should be avoided.
Use in Specific Populations
Pregnancy
Pregnancy Category D [see Warnings and Precautions]
Based on its mechanism of action and findings from animal
studies, Marqibo can cause fetal harm when administered to pregnant
women.
If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential hazard to a fetus. In an embryofetal developmental
study, pregnant rats were administered vincristine sulfate liposome
injection intravenously during the period of organogenesis at
vincristine sulfate doses of 0.022 to 0.09 mg/kg/day. Drug-related
adverse effects included fetal malformations (skeletal and
visceral), decreases in fetal weights, increased numbers of early
resorptions and post-implantation losses, and decreased maternal
body weights. Malformations were observed at doses ≥ 0.044
mg/kg/day in animals at systemic exposures approximately 20-40% of
those reported in patients at the recommended dose.
Nursing Mothers
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk and because of the
potential for serious adverse reactions in nursing infants, a
decision should be made whether to discontinue nursing or
discontinue the drug, taking into account the importance of the
drug to the mother.
Pediatric Use
The safety and effectiveness of Marqibo in pediatric patients
have not been established.
Geriatric Use
Safety and effectiveness in elderly individuals have not been
established. In general, dose selection for an elderly patient
should be cautious, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy.
Renal Impairment
The influence of renal impairment on the safety, efficacy, and
pharmacokinetics of Marqibo has not been evaluated.
Hepatic Impairment
Non-liposomal vincristine sulfate is excreted primarily by the
liver. The influence of severe hepatic impairment on the safety and
efficacy of Marqibo has not been evaluated. The pharmacokinetics of
Marqibo was evaluated in patients with moderate hepatic dysfunction
(Child-Pugh B) secondary to melanoma liver metastases. The
dose-adjusted maximum plasma concentration (Cmax) and area under
the concentration-time curve (AUC) of Marqibo in patients with
moderate hepatic impairment was comparable to the Cmax and AUC of
patients with ALL who had otherwise normal hepatic function.
About BeleodaqTM
Beleodaq is a pan-HDAC inhibitor being studied in multiple
clinical trials as a single agent or in combination with
chemotherapeutic agents for the treatment of various hematological
and solid cancers. Its anticancer effect is thought to be mediated
through multiple mechanisms of action, including the inhibition of
cell proliferation, induction of apoptosis (programmed cell death),
inhibition of angiogenesis, and the induction of differentiation.
Beleodaq has been shown to have activity in tumors that had become
resistant to anticancer agents such as the platinums, taxanes, and
topoisomerase II inhibitors.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements are based on management's current beliefs and
expectations. These statements include, but are not limited to,
statements that relate to our business and its future, including
certain company milestones, Spectrum's ability to identify,
acquire, develop and commercialize a broad and diverse pipeline of
late-stage clinical and commercial products, leveraging the
expertise of partners and employees around the world to assist us
in the execution of our strategy, and any statements that relate to
the intent, belief, plans or expectations of Spectrum or its
management, or that are not a statement of historical fact. Risks
that could cause actual results to differ include the possibility
that our existing and new drug candidates may not prove safe or
effective, the possibility that our existing and new applications
to the FDA and other regulatory agencies may not receive approval
in a timely manner or at all, the possibility that our existing and
new drug candidates, if approved, may not be more effective, safer
or more cost efficient than competing drugs, the possibility that
our efforts to acquire or in-license and develop additional drug
candidates may fail, our lack of sustained revenue history, our
limited marketing experience, our dependence on third parties for
clinical trials, manufacturing, distribution and quality control
and other risks that are described in further detail in the
Company's reports filed with the Securities and Exchange
Commission. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the
information contained in this press release except as required by
law.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, ZEVALIN®
and MARQIBO® are registered trademarks of Spectrum Pharmaceuticals,
Inc and its affiliates. BELEODAQ™, REDEFINING CANCER CARE™ and the
Spectrum Pharmaceuticals logos are trademarks owned by Spectrum
Pharmaceuticals, Inc. Any other trademarks are the property of
their respective owners.
© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum PharmaceuticalsShiv KapoorVice President, Strategic
Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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