Lilly and BioMS Medical Announce Global Licensing and Development Agreement
Lilly to Acquire Exclusive Rights to Novel Late-Stage Molecule for the
Treatment of Multiple Sclerosis
INDIANAPOLIS and EDMONTON, Alberta, Dec. 17 /PRNewswire-FirstCall/ --
Eli Lilly and Company (NYSE: LLY) and BioMS Medical Corp. (TSX: MS) today
announced that the two companies have entered into a licensing and
development agreement granting Lilly exclusive worldwide rights to BioMS
Medical's lead multiple sclerosis (MS) compound, MBP8298. The compound is
currently being evaluated in two pivotal phase III clinical trials in
secondary progressive MS (SPMS) and one phase II clinical trial in
relapsing-remitting MS (RRMS).
Under the terms of the agreement, Lilly and BioMS Medical will
collaborate on the development of MBP8298 and will also share in certain
development costs with Lilly being responsible for future R&D,
manufacturing and marketing activities. BioMS Medical will receive an
upfront payment of $87 million, as well as potential development and sales
milestones up to $410 million and escalating royalties on sales
commensurate with the current stage of development of the product if
MBP8298 is successfully commercialized. BioMS Medical will continue to
oversee the current clinical trials. Other terms of the deal were not
disclosed.
"Lilly is pleased to add yet another promising late-stage compound to
our portfolio," said Dr. William W. Chin, M.D., vice president of discovery
research and clinical investigation for Lilly. "Multiple sclerosis is a
disease with significant unmet patient needs. MBP8298 has shown potential
in slowing the progression of secondary progressive MS, and thus may
provide an effective therapeutic option for patients with this debilitating
disease. We are also hopeful that MBP8298 may prove beneficial in treating
patients with relapsing remitting MS. We intend to fully leverage our
expertise in neuroscience to continue the development of this novel
molecule."
"We are very pleased to collaborate with Lilly on the worldwide
development of MBP8298," said Kevin Giese, President and CEO at BioMS
Medical. "Lilly's well established leadership in the neurology arena and
considerable resources, expertise and proven ability to launch
first-in-class drugs will help MBP8298 to realize its full development and
commercial potential."
The transaction is expected to become effective in the first quarter of
2008, contingent upon clearance under the Hart-Scott-Rodino Anti-Trust
Improvements Act, if required. At closing, Lilly would expect a charge to
earnings for acquired in-process research and development. The exact amount
of the charge has not yet been determined, but is estimated to be $0.05 per
share. Lilly's 2008 pro forma adjusted earnings per share guidance remains
unchanged at $3.85 to $4.00. On a reported basis, including the charge for
this transaction with BioMS Medical, Lilly now expects its 2008 earnings
per share to be in the range of $3.80 to $3.95. See the reconciliation
below for further detail.
Reconciliation of 2008 Earnings Per Share Expectations:
2008 2007
Expectations Expectations % Growth
-------------- -------------- ----------
E.P.S. (reported) $3.80 to $3.95 $2.74 to $2.79 36% to 44%
Eliminate estimated
in-process research and
development charge
associated with BioMS
Medical in-licensing .05
Eliminate asset
impairments and
restructuring charges
associated with
previously announced
manufacturing decisions - .08
Eliminate special charges
related to adjustment to
insurance recoverable - .06
Eliminate in-process
research & development
charges associated with
ICOS, Hypnion, and Ivy
acquisitions and OSI,
Glenmark and MacroGenics
in-licensing transactions - .63
Include pro forma as if
the ICOS acquisition was
completed on January 1,
2006 - (.01)
-------------- --------------
E.P.S. (pro forma
adjusted) $3.85 to $4.00 $3.50 to $3.55 8% to 14%
-------------- -------------- ----------
About MBP8298
MBP8298 is a synthetic peptide that consists of 17 amino acids having a
sequence identical to that of a portion of human myelin basic protein
(MBP). MBP8298 is being developed for the potential treatment of multiple
sclerosis (MS), an autoimmune disease caused by immune attack against
normal components of the central nervous system. The sequence of MBP8298 is
associated with the autoimmune process in MS patients with certain immune
response genes (HLA types DR2 and/or DR4); MS patients having these genes
represent 65 to 75 percent of all MS patients.
The apparent mechanism of action of MBP8298 is the induction or
restoration of immunological tolerance with respect to ongoing immune
attack as a result of high doses of peptide delivered periodically by the
intravenous route. The potential benefit of MBP8298 for any individual
patient is therefore expected to be related to the role this peptide plays
in that patient's immune system. The degree of immunomodulation achieved
will depend on the relationship among the peptide, HLA molecules and T
cells.
The results of phase II and long-term follow-up treatment of MS
patients with MBP8298, published in 2006 in the European Journal of
Neurology (EJN), showed that MBP8298 safely delayed median time to disease
progression for five years (versus placebo) in progressive MS patients with
HLA types DR2 and/or DR4. Thus, MBP8298 has the potential to be used as a
tailored therapy for patients genetically determined to express the
appropriate HLA molecules.
MBP8298 is being developed in three late-stage clinical trials:
-- MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS
(SPMS) patients in Canada and Europe.
-- MAESTRO-03: A pivotal phase III trial for SPMS patients in the United
States.
-- MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS)
patients in Europe.
About Multiple Sclerosis
Multiple sclerosis (MS) is thought to affect as many as 2.5 million
people worldwide, including approximately 75,000 in Canada, 400,000 in the
United States and more than 500,000 in Europe. It is a disease that affects
more women than men, with onset typically occurring between 20 and 50 years
of age. MS is caused by damage to myelin, the protective sheath surrounding
nerve fibers in the central nervous system, which interferes with messages
from the brain to the body. Symptoms of MS may include vision problems,
loss of balance, numbness, difficulty walking and paralysis. Approximately
40 percent of all MS patients have the secondary progressive form of the
disease.
BioMS Medical Conference Call
BioMS Medical management will host a conference call at 8:30 a.m. (EST)
on Tuesday December 18, 2007 to discuss the global licensing and
development agreement with Lilly. Participants may listen via an audio web
cast, accessible through the Company's website at http://www.biomsmedical.com or
via telephone. The telephone conference number is 416-644-3420 or toll-free
at 1-800-731-6941.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs.
Additional information about Lilly is available at http://www.lilly.com.
About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and
commercialization of novel therapeutic technologies. BioMS Medical's lead
technology, MBP8298, is for the treatment of multiple sclerosis and is
being evaluated in two pivotal phase III clinical trials for secondary
progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in
the United States. It additionally is being evaluated for relapsing
remitting MS patients in a Phase II trial in Europe entitled MINDSET-01.
Additional information about BioMS Medical is available at
http://www.biomsmedical.com .
This news release contains forward-looking statements. These statements
are subject to known and unknown risks and uncertainties that may cause
actual future experience and results to differ materially from the
statements made. Factors that might cause such a difference include, among
others, the completion of clinical trials, the FDA and other foreign review
processes and other governmental regulation, Lilly's and BioMS Medical's
abilities to successfully develop and commercialize drug candidates,
competition from other pharmaceutical companies, the ability to effectively
market products, and other factors described in Lilly's most recent filings
with the Securities and Exchange Commission. Lilly undertakes no duty to
update forward looking statements. C-LLY
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
