Marketed
Products:
Samaritan has collaborative relationships with other pharmaceutical
companies to commercialize branded approved prescription products
in selected niche territories, such as, in Greece, Albania,
Bosnia, Bulgaria, Croatia, Cyprus, Czech Republic, Egypt,
FYROM, Hungary, Montenegro, Poland, Romania, Serbia, Slovakia,
Slovania, Syria and Turkey. We use our expertise to register
approved drugs with regulatory agencies in the country we
have acquired the rights for; and then, upon regulatory approval,
we distribute, market and sell these products. Currently,
we have in-licensed the rights to sell eleven drugs, Amphocil
from Three Rivers Pharmaceuticals, Elaprase and Replagal from
Shire Pharmaceuticals, Infasurf from Ony, Inc, the Rapydan pain patch from EUSA, and Mepivamol,
Methadone, Morphine Sulphate, Naloxone, Naltrexone, and Oramorph
from Molteni Farmaceutici. Our efforts are focused on speciatlist
physicians in private practice or at hospitals and major medical
centers in our territories. Below is a description of our
in-licensed products.
FUNGAL
INFECTION THERAPY
TERRITIORIES
PRODUCT
DESCRIPTION AND DOSAGE
AMPHOCIL®
(Amphotericin B Cholesteryl
Sulfate Complex for Injection) Injectable
Form
Ireland
Greece
Cyprus
AMPHOCIL®(am-fo-sil)
is a lipid form of amphotericin B indicated for the treatment of invasive
aspergillosis, a life threatening systemic fungal infection. Amphocil®
is indicated for the treatment of severe systemic and/or deep mycoses
in cases where toxicity or renal failure precludes the use of conventional
amphotericin B in effective doses, and in cases where prior systemic antifungal
therapy has failed. Fungal infections successfully treated with Amphocil®
include disseminated candidiasis and aspergillosis. Amphocil® has
been used successfully in severely neutropenic patients.
Amphocil® is an
approved FDA prescription product owned by Three Rivers Pharmaceuticals,
Inc. and marketed by Three Rivers Pharmaceuticals, Inc. in the US. Samaritan
signed an exclusive distribution deal for Greece and Cyprus with Three
Rivers on December 14, 2005. Three Rivers added the territory of Ireland
to Samaritan's existing exclusive licensing agreement to market Amphocil
in Greece and Cyprus in October 2007.
Samaritan is now marketing
Amphocil® in Greece.
FABRY
DISEASE
TERRITIORIES
PRODUCT
DESCRIPTION AND DOSAGE
REPLAGAL®
(agalsidase alfa)
Injectable Form
Greece
Cyprus
REPLAGAL®(re-pla-gal)
is a long-term enzyme replacement therapy used to treat patients with
a confirmed diagnosis of Fabry Disease. Fabry Disease is caused by a deficiency
of an enzyme, alpha-galactosidase A (also called ceramidetrihexosidase),
involved in the breakdown of fats.
Replagal® will
be sold and distributed by Samaritan on a named patient basis until the
pricing and the reimbursement of Replagal® is established in Greece
and Cyprus, with the relevant regulatory authorities. Samaritan signed
an exclusive licensing agreement with Shire Pharmaceuticals for the marketing
and sale of Replagal® in Greece and Cyprus which became effective
April 13, 2007.
HUNTER
SYNDROME
TERRITIORIES
PRODUCT
DESCRIPTION AND DOSAGE
ELAPRASE®
(idursulfase) Injectable
Form
Greece
Cyprus
ELAPRASE®(el-a-prase)
is a human enzyme replacement therapy for the treatment of Hunter syndrome,
also known as Mucopolysaccharidosis II (MPS II). Hunter syndrome is a
rare, life-threatening genetic condition that results from the absence
or insufficient levels of the lysosomal enzyme iduronate-2-sulfatase.
Without this enzyme, cellular waste products accumulate in tissues and
organs, which then begin to malfunction.
Elaprase® was
granted marketing authorization for the long-term treatment of patients
with Hunter's disease by the European Commission in January 2007. Elaprase®
is the first, and only, enzyme replacement therapy for Hunter's disease
patients and was launched in the U.S. in July 2006.
Elaprase® will
be sold and distributed by Samaritan on a named patient basis until the
pricing and the reimbursement of Elaprase® is established in Greece
and Cyprus, with the relevant regulatory authorities. Samaritan signed
an exclusive licensing agreement with Shire Pharmaceuticals for the marketing
and sale of Elaprase® in Greece and Cyprus which became effective
March 1, 2007.
RESPIRATORY
DISTRESS SYNDROME (RDS)
TERRITIORIES
PRODUCT
DESCRIPTION AND DOSAGE
INFASURF®
(Calfactant) Intratracheal Suspension
Turkey
Serbia
Bosnia
F.Y.R.O.M.
Albania
Egypt
Syria
INFASURF®(in-fa-surf)
treats and prevents Respiratory Distress Syndrome (RDS). This syndrome
occurs when infants lack surfactant, a natural substance normally produced
in the body, which is necessary for lungs to function normally. Infasurf®
is used exclusively in hospitals with a neonatal intensive care unit (NICU)
and is administered by neonatologists, neonatal nurses, neonatal nurse
practitioners and respiratory therapists.
On January 16, 2007,
Samaritan signed an exclusive agreement with Siraeo, Ltd for the marketing
and distribution of the product Infasurf® in Turkey, Serbia, Bosnia,
Macedonia, Albania, Egypt and Syria. Infasurf® is an approved FDA
prescription product owned by ONY, Inc. and marketed by Forest Laboratories
in the US.
Currently, Samaritan
Pharmaceuticals is utilizing the US FDA approved regulatory file in preparing
marketing applications for Infasurf® with regulatory authorities in
Turkey, Serbia, Bosnia, F.Y.R.O.M., Albania, Egypt and Syria to gain country
marketing authorization drug approval.
NARCOTIC
ANALGESICS
(PAIN RELIEF MEDICATIONS)
TERRITIORIES
PRODUCT
DESCRIPTION AND DOSAGE
ORAMORPH®
(morphine sulphate)
Oral Solution
Greece
Cyprus
ORAMORPH®(Orr-a-morf) is
morphine sulphate in an oral solution and is used for managing moderate
to severe chronic pain for more than a few days. It works by dulling the
pain perception center in the brain. Oramorph® is approved by the Italian
Ministry of Health (The equivalent to the US FDA) and is marketed by Molteni
in Italy.
Oramorph®
is approved by the Italian Ministry of Health (The equivalent to the US
FDA) and is owned by Molteni Farmaceutici, Inc. and marketed by Molteni
Farmaceutici, Inc. in Italy.
On January 1, 2007,
Samaritan entered into an exclusive licensing agreement with Molteni Farmaceutici
for the marketing and distribution of Oramorph® in the countries of Greece
and Cyprus.
Currently, Oramorph
has a Greek marketing authorization. Oramorph can only be sold in Greece
via a centralized government tender. Samaritan is preparing a tender application
for the next request by Greek authorities for applications.
MORPHINE SULPHATE®
(morphine sulphate)
Injectable Form
Greece
Cyprus
MORPHINE
SULPHATE ®
(mor-fene sul-fate) relieves moderate to severe pain by binding to brain
receptors. Morphine Sulphate may be used to control the pain following surgery,
child birth, and other procedures. It may also be used to treat the pain
associated with cancer, heart attacks, sickle cell disease and other medical
conditions.
On January 1, 2007,
Samaritan entered into an exclusive licensing agreement with Molteni Farmaceutici
for the marketing and distribution of Morphine
Sulphate®
in the countries of Greece and Cyprus. Samaritan has received its first
tender purchase order of Morphine Sulfate and Pethidine from the Institute
of Pharmaceutical Research and Technology (IFET).
Currently, Morphine
Sulphate® can only be sold in Greece and Cyprus via a centralized government
tender. Samaritan is preparing a tender application for the next request
by Greek authorities for applications.
PETHIDINE®
(peth-i-dine)
Injectable Form
Greece
Cyprus
PETHIDINE
® (peth-i-dine)
indicated for the treatment of moderate to severe pain, and may be prescribed
as a preoperative medication, support of anesthesia, and obstetric analgesia.
Samaritan has
received its first tender purchase order of Morphine Sulfate and Pethidine
from the Institute of Pharmaceutical Research and Technology (IFET).
Currently, Pethidine®
can only be sold in Greece and Cyprus via a centralized government tender.
Samaritan is preparing a tender application for the next request by Greek
authorities for applications.
RAPYDAN®(Rap-e-dan)
Rapydan® is indicated for local dermal analgesia on intact skin, and consists
of a thin, uniform, local anesthetic formulation with an integrated, oxygen-activated
heating component that is intended to enhance the delivery of the local
anesthetic. The drug formulation is an eutectic mixture of lidocaine 70
mg and tetracaine 70 mg. Rapydan® is indicated to provide local dermal
analgesia for superficial venous access and superficial dermatological
procedures such as excision, electrodessication and shave biopsy of skin
lesions.
On August 3, 2007,
Samaritan signed an exclusive agreement with EUSA for the marketing and
distribution of the product RAPYDAN® in Greece and Cyprus. Rapydan®
is an approved FDA prescription product under the name SYNERA® and
is owned by ZARS Pharmaceuticals, Inc. and marketed by Endo Pharmaceuticals,
Inc. in the US.
Currently, Samaritan
Pharmaceuticals is utilizing the US FDA approved regulatory file in preparing
marketing applications for Rapydan® with regulatory authorities in
Greece and Cyprus to gain country marketing authorization drug approval.
METHADONE
HCL® (meth-a-done)
is an opiate agonist.
Methadone
HCL® prevents
heroin or morphine from interacting with receptors for natural painkillers
called endorphins, blocking the effects of the addictive drugs and reducing
the physical cravings. Methadone
HCL® is
approved by the Italian Ministry of Health (The equivalent to the US FDA)
and is owned by Molteni Pharmaceuticals, Inc. and marketed by Molteni Farmaceutici,
Inc. in Italy.
On January 1, 2007,
Samaritan entered into an exclusive licensing agreement with Molteni Farmaceutici
for the marketing and distribution of Methadone
HCL®
in the countries of Greece and Cyprus.
Currently, Methadone
HCL® can only be sold in Greece and Cyprus via a centralized government
tender. Samaritan is preparing a tender application for the next request
by Greek authorities for applications.
NALOXONE
MOLTENI®
(naloxone hydrochloride)
Injectable Form
Greece
Cyprus
NALOXONE
MOLTENI ® (nal-ox-own) is
an opioid antagonist which reverses the effects of opioid overdose, for
example heroin and morphine overdose. Specifically, Naloxone is used in
opioid overdoses for countering life-threatening depression of the central
nervous system and respiratory system.
On
January 1, 2007, Samaritan entered into an exclusive licensing agreement
with Molteni Farmaceutici for the marketing and distribution of Naloxone
Molteni ® in the countries of Greece and Cyprus.
Currently, Naloxone
Molteni® will be sold and distributed by Samaritan on a named patient
basis until the pricing and the reimbursement of Naloxone Molteni® is
established in Greece and Cyprus, with the relevant regulatory authorities.
NALTREXONE
HCL®
(naltrexone hydrochloride)
Oral Tablet Form
Greece
Cyprus
NALTREXONE®(nal-trex-own) is
an opioid antagonist which is used to help people who have a narcotic or
alcohol addiction stay drug free. Naltrexone HCL® is used after the patient
has stopped taking drugs or alcohol. It works by blocking the effects of
narcotics or by decreasing the craving for alcohol.
Naltrexone
HCL® is approved by the Italian Ministry of Health (The equivalent to
the US FDA) and is owned by Molteni Farmaceutici, Inc. and marketed by
Molteni Farmaceutici, Inc. in Italy.
On January 1, 2007,
Samaritan entered into an exclusive licensing agreement with Molteni Farmaceutici
for the marketing and distribution of Naltrexone HCL® in the countries
of Greece and Cyprus.
Currently, Samaritan
Pharmaceuticals is utilizing the Italian Ministry of Health approved regulatory
file in preparing marketing applications for Naltrexone HCL® with regulatory
authorities in Greece and Cyprus to gain country marketing authorization
drug approval.
ANESTHESIA
TERRITIORIES
PRODUCT
DESCRIPTION AND DOSAGE
MEPIVAMOL®
(Mepivacaine) Injectable
Form
Greece
Cyprus
MEPIVAMOL®
(Me-piv-a-mol) is an effective and reliable local anesthetic of intermediate
duration and low systemic toxicity. It is widely used for regional anesthetic
procedures such as IVRA, infiltration, epidural blockade, plexus and peripheral
nerve blockade. Mepivamol® is approved by the Italian Ministry of Health
(The equivalent to the US FDA) and is owned by Molteni Farmaceutici, Inc.
and marketed by Molteni Farmaceutici, Inc. in Italy.
On January 1, 2007, Samaritan entered into an exclusive
licensing agreement with Molteni Farmaceutici for the marketing and distribution
of Mepivamol®
in the countries of Greece and Cyprus. Currently, Samaritan Pharmaceuticals
is utilizing the Italian Ministry of Health approved regulatory file in
preparing marketing applications for Mepivamol®
with regulatory authorities in Greece and Cyprus to gain country marketing
authorization drug approval.
