In total, BioMS has exclusive licenses to over 100 granted patents in over 30 countries throughout the world.
Toronto Stock Exchange Symbol: MS.TO
BioMS Medical Corp
6030 88th Street
Edmonton, AB T6E 6G4
P: +1 780.413.7152
F: +1 780.408.3040
For further information please visit our website at http://www.biomsmedical.com/
Pacific Corporate Trust Co.,
625 Howe Street
Vancouver, BC V6C 3B8
Shares Outstanding: 91,163,323 (as of August 15, 2008)
26,021,528 warrants and 9,001,000 stock options.
BioMS Medical Corp. (BioMS) is a development-stage company engaged in the development and commercialization of a medical treatment for multiple sclerosis (MS). BioMS has licensed a synthetic peptide technology, MBP8298, for the treatment of MS. During the year ended December 31, 2006, MBP8298 had undergone Phase I and II clinical trials. BioMS is conducting three clinical trials for MBP8298: MAESTRO-01, MAESTRO-03 and MINDSET-01. MAESTRO-01 is a Phase II/III trial in Canada and western Europe evaluating MBP8298 for the treatment of secondary progressive MS (SPMS). The trial has completed recruitment of over 550 patients at 48 trial sites in 10 countries. In 2006, BioMS received clearance from the United States Food and Drug Association (FDA) to conduct a Phase III trial evaluating MBP8298 for the treatment of SPMS. MINDSET-01 is a Phase II trial in Europe evaluating MBP8298 for the treatment of relapsing remitting MS. The trial is a randomized, double-blind study.
December 17, 2007 - 4:30 PM EST
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, IN and EDMONTON, AB, 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:
Expectations Expectations % Growth
--------------- --------------- ----------
E.P.S. (reported) $3.80 to $3.95 $2.74 to $2.79 36% to 44%
in-process research and
development charge associated
with BioMS Medical in-licensing .05
Eliminate asset impairments
and restructuring charges
associated with previously
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%
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
- 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 www.biomsmedical.com or via telephone. The telephone conference number is 416-644-3420 or toll-free at 1-800-731-6941.
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 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 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.
SOURCE BioMS Medical Corp.
Source: PR Newswire (December 17, 2007 - 4:30 PM EST)
News by QuoteMedia
U.S. - BIOMS MEDICAL CP (BOMSF.PK) AVOID
Edmonton biotech firm may be key to multiple sclerosis breakthrough
Kelly Riddell, Bloomberg
Published: Friday, December 26, 2008
Science and Technology
University of Alberta
WASHINGTON -- BioMS Medical Corp., a one-drug biotechnology company in Edmonton, Alberta, may hold a partial answer as to how Eli Lilly & Co. will replace US$9.9-billion in sales threatened by expiring patents.
Lilly signed a US$497-million licensing and development agreement for BioMS's dirucotide, potentially the first treatment for advanced forms of multiple sclerosis to come to market. The medicine, which entered final trials, has so far escaped side effects such as influenza-like symptoms, fatigue and skin cancer that were reported by Basel, Switzerland-based Novartis AG on fingolimod, another late-stage drug in testing for the disease.
A mid-level study of dirucotide, involving 218 subjects, had "very impressive features to it," according to Bill Chin, Lily's vice president of discovery and clinical investigation. The drug represents a chance for "a breakthrough," he said.
Multiple sclerosis affects about 2.5 million people worldwide. Most approved therapies treat early-stage MS and make up a US$6-billion market that may double by 2013, according to research firm Frost & Sullivan in New York. Dirucotide may generate sales of more than US$5-billion, said Douglas Loe, an analyst at Toronto-based Versant Partners Inc. who rates BioMS shares 'buy.'
Approval of the drug and a potential takeover of BioMS by Indianapolis-based Lilly may increase the $236-million (US$194-million) market value of the Canadian company's shares by fivefold to as much as 25-fold, according to Mr. Loe.
The shares, which have declined 36% this year, may reach $9.62 in 12 months, according to a Bloomberg survey of four analysts. They closed at $2.50 in Toronto on Dec. 24.
Lilly faces the possible loss of more than half of last year's revenue when patents on its top-selling drugs -- Zyprexa, Cymbalta, Gemzar and Humalog -- expire by 2013.
The drugmaker declined to comment on the possibility of an acquisition and "looks forward" to a continued partnership with BioMS, said Christine Van Marter, a spokeswoman.
BioMS's hurdle for dirucotide in clinical trials will be to prove that the antigen it selected, in this case a myelin-based protein, is the most effective therapy to block the immune-system response associated with MS, said John Richert, executive vice president of research and clinical programs for the National Multiple Sclerosis Society in New York. "This drug could be a very important advance, but it also represents a significant challenge to researchers," Mr. Richert said.
Cambridge, Massachusetts-based Biogen Idec Inc. and Elan Corp., in Dublin, Ireland, removed the MS drug Tysabri from the market in February 2005 after three patients contracted a brain illness and two died. Four cases, with one death, were reported since the drug was reintroduced in the U.S. in 2006. Tysabri is aimed at treating an earlier stage of MS called relapsing-remitting.
BioMS was founded by Clifford Giese, a 61-year-old Alberta native who went into semiretirement after selling an automotive oil-change business 21 years ago. He licensed the drug from the University of Alberta in 2000 and took the company public in 2001.
While he had no interest in biotech, Mr. Giese wanted to save his wife, Robin, who was diagnosed with MS in 1977, he said.
"We were desperate to find a cure, to find or do anything that would stop the progression of her disease," said Mr. Giese. "I was told about a peptide that looked promising, so we decided to give it a go."
Now, after 12 years on the treatment, Robin Giese said she wakes up every morning to exercise, plays with her five grandchildren in the afternoon and attends parties with her husband in the evening. She suffers from secondary progressive, an advanced form of the disease.
Before entering the clinical trial for dirucotide, "I was consistently tired and needed help doing the most minor tasks," the 60-year-old said in an interview in her kitchen. Today, "I keep improving. I've experienced no side effects."
Most sufferers are first given a diagnosis of relapse-remitting, an early form of the disease marked by occasional flare-ups. More than 50% eventually progress to Robin Giese's condition, characterized by continuous deterioration.
Mr. Giese predicted that Dirucotide will be approved and sold in Canada and Europe in 2010, followed by approval from the U.S. Food and Drug Administration about a year later.
BioMS lost money until the third quarter of 2008, when it recorded its first profit on a payment from Lilly for completing an interim analysis of the drug.
The University of Alberta is the company's biggest shareholder, with a 19% stake, according to data compiled by Bloomberg. The Edmonton-based school received the interest as part of its licensing agreement with the company.
Mr. Giese, BioMS's chairman, is the fourth-largest shareholder, with 1.9%. His brother, Kevin, owns 1.1%, according to Bloomberg data.
"We view ourselves as a long-term investor because the prospects for the company are very favorable," said Ron Ritter, the university's director of investments and treasury. "We hope dirucotide is a highly successful product, and all indications are the clinical trials will prove that."
In mid-2009 BioMS will hand off dirucotide to Lilly so it can complete clinical testing and eventually sell the product. At any time during testing, Lilly can break its agreement with BioMS, which has no other drug in its pipeline.