Insmed Receives Authorization for Reimbursement for SomatoKine
2004-07-12 19:14 (New York)
Named Patient Program from France and Italy; Newly Appointed Chief Business
Officer Expands the Named Patient Program
Health/Medical Writers / Business Editors
BIOWIRE2K
RICHMOND, Va.--(BUSINESS WIRE)--July 12, 2004
Insmed Incorporated (Nasdaq:INSM) today announced the
French authorities have authorized the use of and reimbursement for
SomatoKine(R) (rhIGF-I/rhIGFBP-3) in the treatment of an infant with a
rare and life-threatening type of extreme insulin resistance. Insmed
also announced that the Italian authorities have authorized the use of
and reimbursement for SomatoKine(R) in the treatment of a patient with
Primary Lateral Sclerosis (PLS), a rare life debilitating
neuromuscular disorder. SomatoKine(R) is being made available to the
physicians treating these patients through Insmed's named patient
program. Four European countries have now authorized reimbursement for
the use of SomatoKine(R) in specific therapeutic indications.
Newly appointed Chief Business Officer and Executive Vice
President of Commercial Operations Philip J. Young stated, "We are
very proud that we are able to provide this pioneering therapy to
these patients in desperate need of treatment. Leprechaunism, the most
severe form of insulin resistance, and PLS are only two of the many
indications we are pursuing where there is clearly an unmet medical
need that we can satisfy with SomatoKine(R). The value of this therapy
has been recognized by European authorities as we are receiving annual
reimbursement well in excess of $100,000 per patient."
Leprechaunism is a rare genetic disorder characterized by extreme
insulin resistance. Syndromes of extreme insulin resistance appear to
result from genetic defects in the insulin receptor or insulin action
pathways. Data describing the effects of treatment of this child with
Leprechaunism will be presented at the European Society of Pediatric
Endocrinology, to be held September 10-13 in Basel, Switzerland.
Primary Lateral Sclerosis is a rare neuromuscular disorder
characterized by progressive muscle weakness in voluntary muscles. PLS
belongs to a group of disorders known as motor neuron diseases,
including ALS (Lou Gehrig's disease). Symptoms include difficulty with
balance, weakness and spasticity in the hands, feet and legs. There is
currently no cure for PLS.
The investigational drug will be made available to physicians for
their patients, who in the physician's opinion may benefit from
SomatoKine(R). Patients may be treated at an initial dose of
0.5mg/kg/day at a reimbursement cost of $360.00/0.60ml vial and
$450.00/0.75ml vial. Physicians should contact Insmed Incorporated;
patient inquiries cannot be accepted.
About Philip Young
Mr. Young brings over 20 years of successful pharmaceutical
experience in product development, launch and commercialization to
Insmed. Prior to joining Insmed, Mr. Young served in various senior
executive positions, including President and Chief Executive Officer,
for early stage biotechnology companies. From 1998-2000, Mr. Young was
Vice President and General Manager of Neurex Pharmaceuticals, where he
was responsible for developing and managing the commercial and
clinical strategies for new product launches and expanding label
indications. Mr. Young played a key role in the $750 million
acquisition of Neurex by Elan. Prior to Neurex, Mr. Young was Business
Director and General Manager of the Peptide Hormones Division at
Pharmacia (Pfizer (NYSE:PFE)) where, under his leadership, strategies
were developed which led to the successful launch of Genotropin for
pediatric and adult growth hormone deficiency. Mr. Young also served
for seven years at Genentech (NYSE:DNA) where he was the Product
Manager of Growth Hormone Products. Mr. Young was an integral member
of the team that managed the FDA regulatory pathway and commercial
launch for Nutropin, Genentech's growth hormone product.
More on SomatoKine(R)
Insmed's SomatoKine(R) (Mecasermin rinfibate) is a proprietary
delivery composition of insulin-like growth factor-I (IGF-I) bound to
its primary binding protein, IGFBP-3. The novel compound is
administered as a once-daily subcutaneous injection, which can restore
IGF levels to physiological relevant levels. In diabetic subjects,
administration of SomatoKine(R) demonstrated a significant improvement
in blood sugar control and a significant reduction in daily insulin
use. Following severe burn injury, in both children and adults,
administration of SomatoKine(R) demonstrated a significant improvement
in muscle protein synthesis and a significant reduction in the
inflammatory response associated with the trauma. Following recovery
from hip fracture, administration of SomatoKine(R) has demonstrated a
significant improvement in functional recovery and bone mineral
density. SomatoKine(R) is currently in a pivotal Phase III clinical
trial for the treatment of Growth Hormone Insensitivity Syndrome
(GHIS), a severe growth disorder.
About Insmed Incorporated
Insmed is a biopharmaceutical company focused on the discovery and
development of drug candidates for the treatment of metabolic diseases
and endocrine disorders with unmet medical needs. For more
information, please visit www.insmed.com.
Statements included within this press release, which are not
historical in nature, may constitute forward-looking statements for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. Forward-looking statements in this
press release include, but are not limited to, levels of reimbursement
and demand for SomatoKine statements regarding planned clinical
trials, our regulatory and business strategies, plans and objectives
of management and growth opportunities for existing or proposed
products. Such forward-looking statements are subject to numerous
risks and uncertainties, including risks that product candidates may
fail in the clinic or may not be successfully marketed or
manufactured, the company may lack financial resources to complete
development of product candidates, competing products may be more
successful, demand for new pharmaceutical products may decrease, the
biopharmaceutical industry may experience negative market trends and
other risks detailed from time to time in the company's filings with
the Securities and Exchange Commission. As a result of these and other
risks and uncertainties, actual results may differ materially from
those described in this press release. For further information with
respect to factors that could cause actual results to differ from
expectations, reference is made to reports filed by the Company with
the Securities and Exchange Commission under the Securities Exchange
Act of 1934, as amended. The forward-looking statements made in this
release are made only as of the date hereof and Insmed disclaims any
intention or responsibility for updating predictions or financial
guidance contained in this release. |
