TORONTO, Sept. 30, 2014 /CNW/ - Concordia Healthcare Corp. ("Concordia" or the "Company") (TSX: CXR) (OTCQX: CHEHF), a diverse healthcare company focused on
legacy pharmaceutical products, orphan drugs, and medical devices for
the diabetic population, today announced that its subsidiary, Concordia
Pharmaceuticals Inc. ("CPI"), has completed the previously announced acquisition of Zonegran®
(zonisamide) for commercialization and sale in the United States,
including Puerto Rico.
CPI acquired Zonegran from Eisai Inc. ("Eisai") for US$90 million in
cash, plus approximately US$1.3 million for purchased inventory.
"The acquisition of Zonegran for commercialization and sale in the
United States and Puerto Rico further diversifies Concordia's growing
pipeline of legacy drugs," said Mark Thompson, CEO of Concordia. "In
addition, we believe that Zonegran will provide sustainable revenue
going forward."
Zonegran is an antiepileptic drug (AED) originally created by Dainippon
Pharmaceutical Co., Ltd. (currently Sumitomo Dainippon Pharma Co.,
Ltd.). Zonegran was first approved by the U.S. Food and Drug
Administration in March 2000 as an adjunctive therapy in the treatment
of partial seizures in adults with epilepsy. It is available in 25mg
and 100mg capsules. Zonegran is a registered trademark of Sumitomo
Dainippon Pharma Co., Ltd.
Management paid for the acquisition through debt financing. Accordingly,
General Electric Capital Corporation ("GE Capital") has provided an
incremental senior secured credit facility of up to $95,000,000 (the
"Incremental Term Loan") by way of an amendment and restatement of the
existing credit agreement among GE Capital, Healthcare Financial
Services, as agent, the Company, as borrower, certain credit parties
party thereto, and certain lenders party thereto, dated May 14, 2014.
All obligations of the Company under the Incremental Term Loan are
secured by existing first priority perfected security interests in the
assets of the Company and the assets of its subsidiaries.
Torreya Partners acted as financial advisor to Concordia.
About Concordia
Concordia is a diverse healthcare company focused on legacy
pharmaceutical products, orphan drugs, and medical devices for the
diabetic population. The Company's pharmaceutical business consists of
ADHD-treatment Kapvay® (clonidine extended release tablets), head lice treatment Ulesfia® (benzyl alcohol) Lotion, asthma-related medication Orapred ODT® (prednisolone sodium phosphate orally disintegrating tablets),
irritable bowel syndrome treatment Donnatal® (belladonna alkaloids, phenobarbital), and Zonegran® (zonisamide) for
treatment of partial seizures in adults with epilepsy. Concordia's Specialty Healthcare Distribution (SHD) division, Complete
Medical Homecare, distributes medical supplies targeting diabetes and
related conditions. Concordia's orphan drug division, Pinnacle, markets
PHOTOFRIN® in the United States.
Concordia operates out of facilities in Oakville, Ontario; Lenexa,
Kansas (near Kansas City, Missouri); Chicago, Illinois; Bridgetown,
Barbados; and Charlottesville, Virginia.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families,
and helping to increase the benefits health care provides. As the U.S.
pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a
passionate commitment to patient care that is the driving force behind
our efforts to help address unmet medical needs. We are a fully
integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of commercial
focus include oncology and specialty care. To learn more about Eisai
Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation
organization that includes R&D facilities in Massachusetts, New Jersey,
North Carolina and Pennsylvania, as well as a global demand chain
organization that includes manufacturing facilities in Maryland and
North Carolina.
Notice regarding forward-looking statements:
This release includes forward-looking statements regarding Concordia and
its business, which may include, but is not limited to, statements with
respect to the acquisition, the impact of the acquisition on
Concordia's financial performance (including with respect to its
revenues), Concordia's growth and other factors. Often, but not always,
forward-looking statements can be identified by the use of words such
as "plans", "is expected", "expects", "scheduled", "intends",
"contemplates", "anticipates", "believes", "proposes" or variations
(including negative and grammatical variations) of such words and
phrases, or state that certain actions, events or results "may",
"could", "would", "might" or "will" be taken, occur or be achieved.
Such statements are based on the current expectations of Concordia's
management, and are based on assumptions and subject to risks and
uncertainties. Although Concordia's management believes that the
assumptions underlying these statements are reasonable, they may prove
to be incorrect. The forward-looking events and circumstances discussed
in this release may not occur by certain specified dates or at all and
could differ materially as a result of known and unknown risk factors
and uncertainties affecting Concordia, including risks regarding the
pharmaceutical industry, the failure to obtain regulatory approvals,
economic factors, market conditions, the equity markets generally,
risks associated with growth and competition, risks associated with the
acquisition and many other factors beyond the control of Concordia.
Although Concordia has attempted to identify important factors that
could cause actual actions, events or results to differ materially from those described in
forward-looking statements, there may be other factors that cause
actions, events or results to differ from those anticipated, estimated
or intended. No forward-looking statement can be guaranteed. Except as
required by applicable securities laws, forward-looking statements
speak only as of the date on which they are made and Concordia
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, or otherwise.
Indication for Zonegran
ZONEGRAN is indicated as adjunctive therapy in the treatment of partial
seizures in adults with epilepsy.
Important Safety Information about Zonegran
CONTRAINDICATIONS
ZONEGRAN is contraindicated in patients who have demonstrated
hypersensitivity to sulfonamides or zonisamide.
WARNINGS
Potentially Fatal Reactions to Sulfonamides: Fatalities have occurred,
although rarely, as a result of severe reactions to sulfonamides
(zonisamide is a sulfonamide) including Stevens-Johnson syndrome, toxic
epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis,
aplastic anemia, and other blood dyscrasias. Such reactions may occur
when a sulfonamide is re-administered irrespective of the route of
administration. If signs of hypersensitivity or other serious reactions
occur, discontinue zonisamide immediately.
Serious Skin Reactions
Consideration should be given to discontinuing ZONEGRAN in patients who
develop an otherwise unexplained rash. If the drug is not discontinued,
patients should be observed frequently. Seven deaths from severe rash
[i.e. Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis
(TEN)] were reported in the first 11 years of marketing in Japan.
Serious Hematologic Events
Two confirmed cases of aplastic anemia and one confirmed case of
agranulocytosis were reported in the first 11 years of marketing in
Japan, rates greater than generally accepted background rates. There
were no cases of aplastic anemia and two confirmed cases of
agranulocytosis in the US, European, or Japanese development programs.
There is inadequate information to assess the relationship, if any,
between dose and duration of treatment and these events.
Oligohidrosis and Hyperthermia in Pediatric Patients
Oligohidrosis, sometimes resulting in heat stroke and hospitalization,
is seen in association with zonisamide in pediatric patients. The
practitioner should be aware that the safety and effectiveness of
zonisamide in pediatric patients have not been established and that
zonisamide is not approved for use in pediatric patients.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Zonegran, increase the risk of
suicidal thoughts or behavior in patients taking these drugs for any
indication. Patients treated with any AED for any indication should be
monitored for the emergence or worsening of depression, suicidal
thoughts or behavior, and/or any unusual changes in mood or behavior.
Metabolic Acidosis
Zonisamide causes hyperchloremic, non-anion gap, metabolic acidosis
(i.e., decreased serum bicarbonate below the normal reference range in
the absence of chronic respiratory alkalosis). This metabolic acidosis
is caused by renal bicarbonate loss due to the inhibitory effect of
zonisamide on carbonic anhydrase. Generally, zonisamide-induced
metabolic acidosis occurs early in treatment, but it can develop at any
time during treatment. Metabolic acidosis generally appears to be
dose-dependent and can occur at doses as low as 25 mg daily. The
relatively high frequencies of varying severities of metabolic acidosis
observed in one study of pediatric patients (compared to the frequency
and severity observed in various clinical trial development programs in
adults) suggest that pediatric patients may be more likely to develop
metabolic acidosis than adults.
Seizures on Withdrawal
As with other AEDs, abrupt withdrawal of ZONEGRAN in patients with
epilepsy may precipitate increased seizure frequency or status
epilepticus. Dose reduction or discontinuation of zonisamide should be
done gradually.
Teratogenicity
Women of child bearing potential who are given zonisamide should be
advised to use effective contraception. Zonisamide was teratogenic in
mice, rats, and dogs and embryolethal in monkeys when administered
during the period of organogenesis. A variety of fetal abnormalities,
including cardiovascular defects, and embryo-fetal deaths occurred at
maternal plasma levels similar to or lower than therapeutic levels in
humans. These findings suggest that the use of ZONEGRAN during
pregnancy in humans may present a significant risk to the fetus.
Cognitive/ Neuropsychiatric Adverse Events
Use of ZONEGRAN was frequently associated with central nervous
system-related adverse events. The most significant of these can be
classified into three general categories: 1) psychiatric symptoms,
including depression and psychosis, 2) psychomotor slowing, difficulty
with concentration, and speech or language problems, in particular,
word-finding difficulties, and 3) somnolence or fatigue.
Patients should be cautioned about the possibility of somnolence and
fatigue and special care should be taken by patients if they drive,
operate machinery, or perform any hazardous task.
PRECAUTIONS
General
Somnolence is commonly reported, especially at higher doses of
ZONEGRAN. Zonisamide is metabolized by the liver and eliminated by the
kidneys; caution should therefore be exercised when administering
ZONEGRAN to patients with hepatic and renal dysfunction.
Kidney Stones
Among 991 patients treated during the development of ZONEGRAN, 40
patients (4.0%) with epilepsy receiving ZONEGRAN developed clinically
possible or confirmed kidney stones. The development of nephrolithiasis
may be related to metabolic acidosis. The analyzed stones were composed
of calcium or urate salts. In general, increasing fluid intake and
urine output can help reduce the risk of stone formation, particularly
in those with predisposing risk factors. It is unknown, however,
whether these measures will reduce the risk of stone formation in
patients treated with ZONEGRAN.
Effect on Renal Function
In several clinical studies, zonisamide was associated with a
statistically significant 8% mean increase from baseline of serum
creatinine and blood urea nitrogen (BUN) compared to essentially no
change in the placebo patients. The increase appeared to persist over
time but was not progressive; this has been interpreted as an effect on
glomerular filtration rate (GFR). There is no information about
reversibility, after drug discontinuation, of the effects on GFR after
long-term use. ZONEGRAN should be discontinued in patients who develop
acute renal failure or a clinically significant sustained increase in
the creatinine/BUN concentration. ZONEGRAN should not be used in
patients with renal failure (estimated GFR < 50 mL/min) as there has
been insufficient experience concerning drug dosing and toxicity.
Sudden Unexplained Death in Epilepsy
During the development of ZONEGRAN, nine sudden unexplained deaths
occurred among 991 patients with epilepsy receiving ZONEGRAN for whom
accurate exposure data are available. Although this rate exceeds that
expected in a healthy population, it is within the range of estimates
for the incidence of sudden unexplained deaths in patients with
refractory epilepsy not receiving ZONEGRAN. Some of the deaths could
represent seizure-related deaths in which the seizure was not observed.
Status Epilepticus
Estimates of the incidence of treatment emergent status epilepticus in
ZONEGRAN-treated patients are difficult because a standard definition
was not employed. Nonetheless, in controlled trials, 1.1% of patients
treated with ZONEGRAN had an event labeled as status epilepticus
compared to none of the patients treated with placebo. Among patients
treated with ZONEGRAN across all epilepsy studies (controlled and
uncontrolled), 1.0% of patients had an event reported as status
epilepticus.
ADVERSE REACTIONS
The most commonly observed adverse events related to treatment with
ZONEGRAN at an incidence of at least 4% greater than placebo were
somnolence (17% vs. 7%), anorexia (13% vs. 6%), dizziness (13% vs. 7%),
ataxia (6% vs. 1%), agitation/irritability (9% vs. 4%), and difficulty
with memory (6% vs. 2%) and/or concentration (6% vs. 2%).
POST MARKETING EXPERIENCE
The following serious adverse reactions are reported voluntarily from a
population of uncertain size: acute pancreatitis, rhabdomyolysis,
creatine phosphokinase increased. Therefore, it is not possible to
estimate their frequency or establish a causal relationship to drug
exposure.
Drug Interactions
Effects of ZONEGRAN on the pharmacokinetics of other antiepilepsy drugs
(AEDs): Zonisamide had no appreciable effect on the steady state plasma
concentrations of phenytoin, carbamazepine, or valproate during
clinical trials. Zonisamide is not expected to interfere with the
metabolism of other drugs that are metabolized by cytochrome P450
isozymes.
Effects of other drugs on ZONEGRAN pharmacokinetics: Drugs that induce
liver enzymes increase the metabolism and clearance of zonisamide and
decrease its half-life. Concurrent medication with drugs that either
induce or inhibit CYP3A4 would be expected to alter serum
concentrations of zonisamide.
Drug Interactions with CNS Depressants
Concomitant administration of ZONEGRAN and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because
of the potential of zonisamide to cause CNS depression, as well as other
cognitive and/or neuropsychiatric adverse events, zonisamide should be used with caution
if used in combination with alcohol or other CNS depressants.
Other Carbonic Anhydrase Inhibitors
Concomitant use of ZONEGRAN, a carbonic anhydrase inhibitor, with any
other carbonic anhydrase inhibitor (e.g., topiramate, acetazolamide or
dichlorphenamide), may increase the severity of metabolic acidosis and
may also increase the risk of kidney stone formation. Therefore, if
ZONEGRAN is given concomitantly with another carbonic anhydrase
inhibitor, the patient should be monitored for the appearance or
worsening of metabolic acidosis.
Pregnancy Category C (see WARNINGS, Teratogenicity)
Zonisamide may cause serious adverse fetal effects, based on clinical
and nonclinical data. Zonisamide was teratogenic in multiple animal
species. ZONEGRAN should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Physicians are advised to recommend that pregnant patients taking
ZONEGRAN enroll in the NAAED Pregnancy Registry.
Use in Nursing Mothers
Zonisamide is excreted in human milk. Because of the potential for
serious adverse reactions in nursing infants from ZONEGRAN, a decision
should be made whether to discontinue nursing or to discontinue drug,
taking into account the importance of the drug to the mother.
Please see Zonegran® full prescribing information.
SOURCE Concordia Healthcare Corp.
