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Sadly very sadly............
Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial
In Secondary Progressive Multiple Sclerosis
INDIANAPOLIS, Indiana and EDMONTON, Alberta, July 27, 2009 – Eli Lilly and Company (NYSE: LLY) and BioMS Medical Corp. (TSX: MS) today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO-01 Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study.
The data also showed that dirucotide was generally well tolerated. There were no unexpected safety or tolerability issues. The most common side effect reported was injection site reaction. More details of the MAESTRO-01 study results are expected to be presented at a medical conference later this year.
Lilly and BioMS also announced they would discontinue ongoing clinical trials – including MAESTRO-02 and MAESTRO-03 – and review the available data from these studies. MAESTRO-02 is an open-label follow-on study to MAESTRO-01. MAESTRO-03 is a 510-patient U.S. Phase III clinical trial designed to evaluate dirucotide for the treatment of SPMS that completed enrollment in August 2008. Lilly and BioMS will inform regulatory agencies and provide instructions to investigators outlining the process for discontinuing the studies. Patients involved in studies who have questions should contact their study investigator.
“The MAESTRO-01 study was well designed and executed, and we believe these data, while disappointing, are very instructive for us and for the larger MS community,” said John Hayes, vice president of Lilly Research Laboratories. “We look forward to further conversations with BioMS Medical about this project.”
"We are obviously disappointed by this result and will be working closely with our clinical team to evaluate these data and the available data from MAESTRO-02 and MAESTRO-03 to determine our next steps,” said Kevin Giese, President and CEO of BioMS Medical. "We are fortunate to have suitable resources in place to remain flexible to pursue whatever options emerge once we understand these results more fully.”
BioMS Medical Webcast
Participants may listen to a discussion of the outcome of the MAESTRO-01 study by Kevin Giese, President and CEO of BioMS Medical. The audio webcast is accessible through the Company’s web site at www.biomsmedical.com.
About MAESTRO-01
MAESTRO-01 was a multi-center, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of dirucotide in patients with SPMS. The study was conducted in Canada and nine countries in Europe and included 612 patients being administered either dirucotide or placebo intravenously every six months for a period of two years.
The primary clinical endpoint for the trial was defined as a statistically significant increase in the time to progression of the disease, as measured by the EDSS, in patients with HLA-DR2 and/or HLA-DR4 immune response genes. It is estimated that up to 70% of all multiple sclerosis patients are HLA-DR2 and/or HLA-DR4 positive. The EDSS is the standard for measuring impairment in MS.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, progressive, often disabling disease that attacks the central nervous system. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, resulting in disrupted nerve impulses traveling to and from the brain and spinal cord. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.iii,
MS is thought to affect as many as 2.5 million people worldwide, including approximately 400,000 in the United States. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age.v
Approximately 30-40 percent of all MS patients have the secondary progressive form of the disease, in which irreversible disability accumulates more steadily, with or without relapses. There are few treatment options available for these patients.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of 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, dirucotide, is for the treatment of multiple sclerosis. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.
Promising Multiple Sclerosis Treatment
BOS2331 writes: "BioMS Medical Corp. (MS.TO) is a Canadian company undergoing Phase 3 trials in Canada and Europe for its patented peptide treatment for multiple sclerosis, and its U.S. Phase 3 trials are just underway. To date, the trial has successfully passed six safety reviews and the drug has shown effectiveness in slowing the progression of secondary progressive multiple sclerosis (SPMS) with no relevant side effects. Interim data is expected in mid-2008.
"I believe it is the best and most effective MS treatment at this stage, and the pharmas are beginning to line up. The management team is a formidable group that is committed to bringing this drug to people."
The answer to my question is in todays news release. I posted the releases on another board
#msg-35228333
I looked at them in the past but haven't kept up. Does anyone know (roughly) when results are expected? TIA
Long Term Hold.
Wow, this looks v. interesting...
Odds are very good for MS.TO .. Personally, since I am a poor trader, I am holding my position.. Luckily I got in 2007 at lower prices so I am willing to see it thru..
And I agree it would have much bigger following and higher prices if this was trading in US..
Edmonton biotech firm may be key to multiple sclerosis breakthrough
Kelly Riddell, Bloomberg
Published: Friday, December 26, 2008
Related Topics
Robin Giese
Clifford Giese
Medical Technology
Science and Technology
University of Alberta
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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.
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Press Release Source: BioMS Medical Corp.
BioMS Medical recognized at Scrip Awards 2008
Thursday December 11, 5:30 pm ET
Toronto Stock Exchange Symbol: MS
EDMONTON, Dec. 11 /CNW/ - BioMS Medical Corp (TSX: MS - News), a leading developer in the treatment of multiple sclerosis (MS), today announced that the Company was the recipient of the "Licensing Deal of the Year Award" at the 4th Annual Scrip Awards held in London, U.K. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company (Lilly) exclusive worldwide rights to dirucotide, for the treatment of MS, in exchange for an US$87 million upfront payment, potential development and sales milestones up to US$410 million and escalating royalties on sales.
"We are honored to receive this award which recognizes the significance of the alliance between BioMS and our partner Lilly," said Kevin Giese, President and CEO of BioMS Medical. "This partnership demonstrates a mutual commitment focused on developing an effective therapeutic option for patients with secondary progressive MS, a debilitating disease of global proportion for which there are limited treatment options."
About The Scrip Awards 2008
---------------------------
The Scrip Awards, hosted by Informa Healthcare - one of the world's leading medical and scientific publishers - brings together hundreds of senior-level industry experts at one of the industry's most prestigious and hotly contested awards ceremony, to highlight the achievements of pharmaceutical companies throughout the year. For further information visit http://scripawards.com.
About BioMS Medical Corp.
-------------------------
BioMS Medical is a Canadian biotech company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, dirucotide (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. For further information please visit our website at http://biomsmedical.com
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information
Tony Hesby, Ryan Giese, Corporate Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax, E-mail: rgiese@biomsmedical.com, Internet: http://biomsmedical.com_;_ James Smith, Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: jsmith@equicomgroup.com
--------------------------------------------------------------------------------
Source: BioMS Medical Corp.
BioMS Medical Announces Third Quarter 2008 Results
Thursday November 6, 6:05 pm ET
Toronto Stock Exchange Symbol: MS
EDMONTON, Nov. 6 /CNW/ - BioMS Medical Corp. (TSX: MS - News), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the third quarter ended September 30, 2008. BioMS Medical, in partnership with Eli Lilly and Company (Lilly), is developing dirucotide (MBP8298), a drug for the treatment of MS undergoing pivotal trials in Canada, Europe and the U.S.
"The third quarter saw positive developments in the dirucotide development plan, with completion of the interim analysis resulting in a significant milestone payment from our partner Lilly," said Kevin Giese, President and CEO of BioMS Medical. "Dirucotide was also granted fast track designation by the U.S. FDA, another important achievement which could potentially accelerate the development and review process for this important MS drug."
Currently, BioMS is conducting three clinical trials and one open-label follow-on trial for dirucotide (MBP8298):
- MAESTRO-01: A randomized, double-blind pivotal phase II/III trial in
Canada and Europe evaluating dirucotide (MBP8298) for the treatment
of secondary progressive MS (SPMS). The study has completed full
recruitment of 611 patients at 47 trial sites in 9 countries. To
date, there have been nine positive safety reviews from the Data
Safety Monitoring Board (DSMB). Full analysis of this trial is
expected in the second half of 2009.
- MAESTRO-02: An open-label follow-on study to the MAESTRO-01 pivotal
trial. Eligible patients who have successfully completed the blinded,
placebo controlled MAESTRO-01 trial may choose to receive dirucotide
(MBP8298) on an un-blinded basis. To date, approximately 95% of
patients enrolled in MAESTRO-01 have proceeded to MAESTRO-02.
- MAESTRO-03: A U.S. pivotal phase III trial evaluating dirucotide
(MBP8298) for the treatment of SPMS. The trial is fully recruited
with approximately 510 patients enrolled at 68 sites across the U.S.
To date, the DSMB has conducted three reviews of the data from this
trial and has recommended it continue.
- MINDSET-01: A phase II clinical trial evaluating dirucotide (MBP8298)
for the treatment of relapsing-remitting MS (RRMS). The randomized,
double-blind study has completed recruitment with 218 patients
enrolled at 24 trial sites in six countries across Europe. The DSMB
has completed six safety reviews to date and recommended that the
trial continue as per the protocol. Completion of the double-blind
phase of the trial is expected at the end of 2008 with results
anticipated in the first quarter of 2009.
Financial Results
The consolidated net income for the three months ended September 30, 2008 was $6.3 million or $0.07 per share compared with a net loss of $10.9 million or ($0.12) per share for the three months ended September 30, 2007. The consolidated net loss for the nine months ended September 30, 2008 was $0.8 million or ($0.01) per share compared with a loss of $35.5 million or ($0.43) per share for the same period in 2007.
Revenue for the three months ended September 30, 2008 was $16.1 million compared to $nil for the same period of 2007. Revenue for the nine months ended September 30, 2008 was $40.1 million compared to $nil for the same period of 2007. The revenue is the result of recognizing a portion of the upfront payment and development milestone for the positive interim analysis related to the MAESTRO-01 clinical trial received from the licensing agreement with Lilly.
Total consolidated expenses for the three months ended September 30, 2008 were $11.8 million compared to $10.6 million for the same period of 2007. Total consolidated expenses for the nine months ended September 30, 2008 were $45.4 million compared to $36.0 million for the period of 2007.
Research and development expenses for the three months ended September 30, 2008 totaled $10.1 million compared to $9.1 million for the three months ended September 30, 2007. Research and development expenses for the nine months ended September 30, 2008 totaled $32.6 million compared to $29.6 million for the same period of 2007. It is expected that total research and development expenses will remain constant over the next two years as the MAESTRO-01 and MINDSET-01 clinical trials near completion and MAESTRO-02 and MAESTRO-03 increase in number of patients under treatment. General and administrative expenses were $1.3 million for the three months ended September 30, 2008 compared to $1.1 million for the three months ended September 30, 2007. General and administrative expenses were $11.6 million for the nine months ended September 30, 2008 compared to $5.2 million for the same period of 2007.
As at September 30, 2008, cash and short-term investments totaled $98.8 million compared to $38.0 million at December 31, 2007. As at September 30, 2008, the Company had working capital of $94.0 million (excluding the current portion of deferred revenue which does not represent a cash obligation) compared to $34.8 million at December 31, 2007. Management estimates that the current working capital is sufficient for the Company to meet its obligations in respect of the currently initiated clinical trials for which it is responsible under the Lilly agreement.
As at September 30, 2008 there were 91,086,323 common shares, 26,021,528 warrants and 9,161,500 stock options of the Corporation issued and outstanding.
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, dirucotide (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. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide (MBP8298) in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.
This press release may contain forward-looking statements, which reflect the Corporation's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information
Tony Hesby, Ryan Giese, Corporate Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax, E-mail: rgiese@biomsmedical.com, Internet: www.biomsmedical.com
James Smith, Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: jsmith@equicomgroup.com
--------------------------------------------------------------------------------
Source: BioMS Medical Corp.
Thanks Sultan. Sorry I've kind lost track. The company has often been on my mind, but I haven't been following it of late, but I'm guilty regarding many companies I've had interest in..............IMO when this drug does come to market it will be the biggest thing in the drug industry. The trials have been lengthy, but its understandable if they want to some day get this approved by the US Drug Administration. I appreciate you letting me know of the news. Of all the drug companies this one drug will do so much good with helping those suffering with MS. Its been in the making for years now, and I was convinced that this should have come to the market long ago because I believe it works, but things don't work like this, to bad for all these lengthy trials, many could have forgone all their misery. Its complex to bring it to the market.
I am surprised you have not posted anything here.. You realize of course the stock is taking off on this news..
http://www.nationalpost.com/story.html?id=1115836
http://www.biomsmedical.com/maestro_03.asp
Product Overview - MBP8298
Product Information
MBP8298 is a synthetic peptide that consists of 17 amino acids linked in a sequence identical to that of a portion of human myelin basic protein (MBP). MBP8298 has been developed for the treatment of multiple sclerosis (MS), and is based on over 26 years of research.
MS is generally considered an autoimmune disease, caused by immune attack against normal components of the central nervous system. The specificity of the immune attack at the molecular level is determined in each case by the HLA type of the individual patient, and HLA type is known to be one factor that contributes to susceptibility to MS. The MBP8298 synthetic peptide is a molecular replicate of the site of attack that is dominant in MS patients with HLA haplotypes DR-2 or DR-4. These HLA types are found in 65-75% 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 at this molecular site. High doses of antigen delivered periodically by the intravenous route are expected to suppress immune responses to the administered substance. The potential benefit of MBP8298 for any individual patient is therefore expected to be related to the extent to which his or her disease process is dominated by autoimmune attack at the site represented by this synthetic peptide .
The results of phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology (EJN), showed that MBP8298 safely delayed median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.
BioMS Medical Provides Update On Pipeline Products
Friday May 9, 12:00 pm ET
- HYC750 out-licensed to Orcrist -
Toronto Stock Exchange Symbol: MS
EDMONTON, May 9 /CNW/ - BioMS Medical Corp (TSX: MS - News), a leading developer in the treatment of multiple sclerosis (MS), today announced an update on its pipeline products, HYC750 and development with BioCyDex Inc.
ADVERTISEMENT
The Company has entered into a Royalty and Assignment Agreement with Orcrist Bio. Inc. for HYC750, a technology based on hyaluronic acid that has a number of potential therapeutic uses and is being developed as a treatment for the side effects of chemotherapy.
BioMS held an exclusive worldwide license to HYC750 from the University of Alberta. As a result of the Royalty and Assignment Agreement, BioMS has terminated its license with the University of Alberta and the University has entered into a direct license with Orcrist. BioMS will assign all BioMS owned patents relating to HYC750 and transfer all HYC750 assets to Orcrist. Under the terms of the agreement, BioMS will receive certain milestone payments in addition to a royalty on net sales of products which otherwise would have infringed on patents related to the HYC750 technology.
"This asset purchase from BioMS and the exclusive worldwide license with the University of Alberta for the HYC750 technology and product provides Orcrist with a near clinical stage asset. We are excited about the progress BioMS has made with this product over the past few years and look forward to advancing it into the clinic and positioning it for lucrative markets and underserved clinical indications," commented Orcrist's President and CEO, Mr. Gary Voncina.
BioMS also reported it is ceasing its development activities with respect to BioCyDex. Future development or licensing activities will be the responsibility of BioCyDex.
"These developments allow BioMS to retain its primary focus on advancing our lead multiple sclerosis technology, MBP8298, in partnership with Eli Lilly and Company and to potentially expand our product pipeline with therapies in clinical stages or therapeutic areas that are more in keeping with our strategic focus," said Kevin Giese, President and CEO of BioMS Medical. "In addition we are very pleased with the HYC750 transaction in that it allows Orcrist to successfully capitalize on our earlier development work, while permitting us to retain access to some of the potential value it may hold."
About Orcrist Bio. Inc.
-----------------------
Orcrist Bio Inc. (http://www.orcristbio.com) is a biotechnology company dedicated to developing and commercializing promising therapeutics for areas in which a clear market opportunity exists. Orcrist's lead program revolves around HYC750, a novel stem cell mobilizer compound that promotes the egress of stem cells and other blood cells from the bone marrow into the blood, from which they can be harvested and applied toward treating chemotherapy-related white blood cell depletion. Orcrist is actively looking to add to its pipeline exploring the innate properties of HYC750 and its effects on stem cells, as well as through in-licensing opportunities of other products with clear market potential. Orcrist is located in Calgary, Alberta. The company is financed by its founders and by private investors.
BioMS Medical announces first quarter 2008 results
Thursday May 15, 5:00 pm ET
Toronto Stock Exchange Symbol: MS
The consolidated net loss for the first quarter ended March 31, 2008 was $6.7 million or ($0.07) per share compared to a consolidated net loss of $12.9 million or ($0.17) per share for the first quarter of the previous year.
Revenue for the three months ended March 31, 2008 was $12.8 million compared to $nil for the first three months of the previous year. The revenue is the result of recognizing a portion of the upfront payment received on the completion of the licensing agreement with Eli Lilly and Company.
Total consolidated expenses for the three months ended March 31, 2008 were $22.2 million compared to $13.3 million for the first three months of the previous year.
http://biz.yahoo.com/cnw/080515/bioms_q1_2008_results.html?.v=1
BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board
Toronto Stock Exchange Symbol: MS
EDMONTON, April 15 - BioMS Medical Corp. (TSX: MS), a leading
developer in the treatment of multiple sclerosis (MS), today announced that
the independent Data Safety Monitoring Board (DSMB) has reviewed data from the
Company's on-going MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298
for the treatment of secondary progressive MS and recommended that the trial
continue.
This was the second of several regularly scheduled reviews by the DSMB
that will occur over the duration of the trial. The purpose of the DSMB is to
provide objective, independent safety monitoring of the trial.
To date, more than 65% of the total number of required patients have been
enrolled in the Company's MAESTRO-03 clinical trial, with full enrollment
anticipated for the end of the first half of 2008.
About MAESTRO-03
----------------
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized,
double-blind study enrolling approximately 510 patients at more than
60 clinical sites who will be administered either MBP8298 or placebo
intravenously every six months for a period of two years. The primary clinical
endpoint for the trial is defined as a statistically and clinically
significant increase in the time to progression of the disease as measured by
the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or
HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or
HLA-DR4 positive).
March 18, 2008 - 5:00 PM EDT
BioMS Medical Announces 2007 Year End Results
Toronto Stock Exchange Symbol: MS
EDMONTON, March 18 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis ('MS'), today announced financial and operational results for the year ended December 31, 2007.
'We continue to focus on the worldwide development of MBP8298, our proprietary synthetic peptide drug for the treatment of multiple sclerosis, which is being evaluated in several late-stage trials in the U.S., Canada and across Europe,' said Kevin Giese, President and CEO of BioMS Medical. 'The magnitude of the partnership we formed with Lilly at the end of 2007 for the global rights to MBP8298 underscores the enormous potential of our drug and is a validation of all the years of hard work performed by our team.'
Currently, BioMS is conducting three clinical trials and one open-label follow-on trial for MBP8298:
- MAESTRO-01: A pivotal phase II/III trial in Canada and Western Europe
evaluating MBP8298 for the treatment of secondary progressive MS
('SPMS'). On January 22, 2007, BioMS announced that the trial had
completed full recruitment of 611 patients at 47 trial sites in
10 countries. Patients are administered either MBP8298 or placebo
every six months for a period of two years. To date, there have been
eight positive safety reviews from the Data Safety Monitoring Board
('DSMB'). An interim analysis on the first 200 patients is expected
in mid-2008.
- MAESTRO-02: An open-label follow-on study to the MAESTRO-01 pivotal
trial. Eligible patients who have successfully completed the blinded,
placebo controlled MAESTRO-01 trial may choose to receive MBP8298 on
an un-blinded basis.
- MAESTRO-03: A U.S. pivotal phase III trial evaluating MBP8298 for the
treatment of SPMS. Enrollment for the randomized, double-blind study
was initiated in June, 2007 and to date there has been in excess of
200 patients enrolled. The trial will include approximately 510
patients at approximately 65 sites across the U.S. The DSMB has
conducted its first review of the data from this trial and has
recommended it continue. The trial is expected to complete enrollment
in mid-2008.
- MINDSET-01: A phase II clinical trial evaluating MBP8298 for the
treatment of relapsing-remitting MS ('RRMS'). The randomized,
double-blind study has completed recruitment with 218 patients
enrolled at 24 trial sites in 6 countries across Europe. The DSMB has
completed three safety analyses to date and recommended that the
trial continue as per the protocol.
Licensing and Development Agreement
On December 17, 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to its lead MS compound, MBP8298. Under the terms of the agreement, Lilly and BioMS will collaborate on the development of MBP8298 and will also share in certain development costs with Lilly being responsible for future research and development, manufacturing and marketing activities. The transaction closed on January 25, 2008 with the receipt of an upfront payment of US$87 million. BioMS has the potential to receive additional development and sales milestones of up to US$410 million and escalating royalties on sales commensurate with the current stage of development of the product if MBP8298 is commercialized. BioMS will continue to oversee the current trials. The completion of the transaction resulted in licensing bonuses, as contemplated in a number of pre-existing employment agreements, paid to all Company personnel in February 2008 of $9.0 million which was reviewed and approved by the independent Compensation Committee, and supported by an independent compensation consultant review.
Financial Results
The consolidated net loss for the year ended December 31, 2007 was $47.2 million or ($0.56) per share compared with a consolidated net loss of $40.9 million or ($0.62) per share for the previous year. The consolidated net loss for the fourth quarter ended December 31, 2007 was $11.7 million or ($0.13) per share compared with a consolidated net loss of $14.1 million or ($0.20) per share for the fourth quarter of the previous year.
Total consolidated expenses for the year ended December 31, 2007 were $48.0 million compared to $42.2 million for the previous year. Total consolidated expenses for the three months ended December 31, 2007 were $12.1 million compared to $14.4 million for the same quarter of the previous year.
Research and development expenses for the year ended December 31, 2007 totaled $38.9 million compared with $35.2 million in 2006. The increase was due primarily to the start up and initial enrollment of patients in the MAESTRO-02 follow-on trial, the full enrollment and continuation of the MINDSET-01 clinical trial and the start-up and commencement of enrolment of the MAESTRO-03 clinical trial. It is expected that research and development expenses will increase over the next two years as the current clinical trials for MBP8298; MAESTRO-01, MAESTRO-02, MAESTRO-03 and MINDSET-01, continue in Canada, Europe and the U.S.
Research and development expenses were $9.3 million for the fourth quarter ended December 31, 2007 compared to $12.5 million for the fourth quarter of the previous year. The reduction in expenses was the net result of reduced costs for the MAESTRO-01 trial, as more patients are completing or near completion of their two years on the trial, and a reduction in the number of batches of MBP8298 manufactured in the year, offset by start-up costs for the MAESTRO-02 and MAESTRO-03 trials.
General and administrative expenses were $7.5 million for the year ended December 31, 2007 compared to $5.4 million for the year ended December 31, 2006. General and administrative expenses were $2.3 million for the three months ended December 31, 2007 compared with $1.5 million for the fourth quarter of 2006. The increase was primarily due to expenses related to conducting partnering discussions with various interested parties.
During the year, the Corporation strengthened its cash position through the issuance of 16,100,000 units by way of a public offering at $2.75 per share, for gross proceeds of $44.3 million.
At December 31, 2007, cash and short-term investments totaled $38.0 million as compared to $43.1 million at December 31, 2006. At December 31, 2007, the Corporation had working capital of $34.8 million as compared to $37.4 million at December 31, 2006. The Corporation's cash position and working capital were increased by $87 million in January 2008 with the completion of the agreement with Lilly and the receipt of the upfront payment. Management estimates that the current working capital is sufficient for BioMS to meet its obligations in respect of the currently initiated clinical trials through to the end of the MAESTRO-01 clinical trial.
As at December 31, 2007 there were 91,410,323 Class 'A' common shares of the Corporation issued and outstanding.
Notice of AGM
BioMS will be holding its Annual General Meeting on Friday, May 9, 2008 at 2:00 pm (MST) at the Delta Edmonton South Hotel and Conference Centre, 4404 Gateway Boulevard, Edmonton, Alberta.
About BioMS Medical Corp.
-------------------------
BioMS Medical is a biotechnology corporation 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. For further information please visit our website at www.biomsmedical.com.
March 3, 2008 - 8:02 AM EST
BioMS Medical's relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board
Toronto Stock Exchange Symbol: MS
EDMONTON, March 3 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.
This was the third of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
MINDSET-01 Trial
----------------
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.
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. For further information please visit our website at www.biomsmedical.com.
BioMS Medical's relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board
Toronto Stock Exchange Symbol: MS
EDMONTON, March 3 - BioMS Medical Corp. (TSX: MS), a leading
developer in the treatment of multiple sclerosis (MS), today announced that
the independent Data Safety Monitoring Board (DSMB) for the Company's phase II
MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has
completed a safety analysis and recommended that the trial continue as per the
protocol.
This was the third of several regularly scheduled reviews by the DSMB
that will occur over the duration of the trial. The purpose of the DSMB is to
provide objective, independent safety monitoring of the trial.
MINDSET-01 Trial
----------------
The MINDSET-01 phase II, double-blind, placebo-controlled trial is
designed to evaluate the safety and efficacy of MBP8298 in patients with
relapsing-remitting MS. The fifteen month trial is fully enrolled with 218
patients at 24 sites in 6 countries. The objectives of the study are to
demonstrate safety and efficacy of MBP8298 versus placebo as measured by
relapse rate, MRI activity and disease progression.
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. For further information
please visit our website at www.biomsmedical.com.
This press release may contain forward-looking statements, which reflect
the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not limited to,
changing market conditions, the successful and timely completion of clinical
studies, the establishment of corporate alliances, the impact of competitive
products and pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to time in the
Company's ongoing quarterly and annual reporting. Certain of the assumptions
made in preparing forward-looking statements include but are not limited to
the following: that MBP8298 will continue to demonstrate a satisfactory safety
profile in ongoing and future clinical trials; and that BioMS Medical Corp.
will complete the respective clinical trials within the timelines communicated
in this release. We undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax,
E-mail: rgiese@biomsmedical.com, Internet: www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail:
jsmith@equicomgroup.com
Hey Buddy, I couldn't figure out what you were talking about. LOL. You said you created a new board. I was thinking, thats nice, what kinda board? Board game? Board for the house? :)
I guess I'm allowed to be a Dumba** once in awhile. :)
Well I'm taking a look. But let me be the first to say GL with this.
Gem
I have been following this company off and on for a couple of years..........it has a serious product and Eli-Lilly was smart to have gotten involved, surprised that the other pharms weren't jumping all over this long before now. I have been slow to create a board for this. This should be viewed as a long term hold. It hasn't been a big flyer but who knows what may happen from this point on........my best to everyone who gets in on this one. Its a stock you have buy thru your broker considering its Toronto. It also trades on the pinksheets but this is where everyone wants to be. This where the trading is at and where the news comes in.
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Patents
In total, BioMS has exclusive licenses to over 100 granted patents in over 30 countries throughout the world.
BioMS Medical
Toronto Stock Exchange Symbol: MS.TO
COMPANY ADDRESS:
BioMS Medical Corp
6030 88th Street
Edmonton, AB T6E 6G4
P: +1 780.413.7152
F: +1 780.408.3040
http://www.timeanddate.com/worldclock/city.html?n=250
For further information please visit our website at http://www.biomsmedical.com/
Transfer Agent
Pacific Corporate Trust Co.,
625 Howe Street
10th Floor
Vancouver, BC V6C 3B8
Canada
http://www.pctc.com/PCTCPortal/Public/PCTCContactUs.aspx#van
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.
UPDATES
http://investorshub.advfn.com/boards/quotes.asp?ticker=MS.TO
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:
-------------------------------------------------------
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 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 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
www.quotemedia.com
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
Related Topics
Robin Giese
Clifford Giese
Medical Technology
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.
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