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OLGX Announces Solid Ex-U.S. Licensing Agreement with Servier –
This is from Matt Kaplan from Ladenburg
We Reiterate Our Buy Rating and $4 Price Target on OLGX.
Highlights
Osteologix announces signing of a licensing agreement with Servier for ex-U.S.
rights to NBS-101. Based on the terms of the agreement OLGX will receive: up to
12 million Euros ($15.6 million) in upfront and milestone payments; 30 million Euros
($39 million) of guaranteed minimum royalty payments based on mid- to low- single
digit royalties on product sales. Furthermore, OLGX will receive additional milestone
payments and royalties based on development milestones and sales in Japan.
Importantly, Servier will be responsible for all ex-U.S. expenses associated with the
development, regulatory approval processes and commercialization of the product.
We are impressed with the terms of the deal and by the company, Servier, OLGX
established the agreement with. As the innovator of Strontium for the treatment of
osteoporosis with the introduction of Protelos to ex-U.S. markets, we believe Servier
represent the ideal partner for NBS-101. Additionally, we believe NBS-101
represents an important asset for Servier as it will now allow them to maintain their
Strontium franchise well beyond the anticipated expiration of the Protelos patents
expected in the late 2014 to August 2015 time frame. In our view, this licensing deal
indicates Servier has a high level of commitment to Strontium as a treatment for
osteoporosis. Consequently, we feel the Servier deal reduces the risk NBS-101 will
fail to become a significant product for the treatment of osteoporosis in ex-U.S.
markets.
? Osteologix maintains ownership of U.S. rights to NBS-101. OLGX met with the
FDA in 2009 and based on these discussions, the Company needs to complete an
additional Phase II study examining bone mineral density (BMD) as well as a single
Phase III study to file an NDA in the U.S., which will likely take two years to complete.
If the results of the Phase II BMD clinical trials are positive, we expect OLGX to work
in collaboration with a larger pharmaceutical company to execute a Phase III program
in an effort to seek approval for NBS-101 in the U.S.
? Servier deal reduces risk of dilution. Prior to the Servier transaction we believed
OLGX had cash to fund operations to 4Q 2010. The $15.6 million in upfront and
milestone payments strengthen OLGX’s cash position. However, depending on the
breakdown and timing of the upfront and milestone payments, OLGX may need to
further augment the Company’s cash position to continue U.S. development efforts to
maximize the value of their asset in the U.S. .
? We reiterate our BUY rating. We do not believe OLGX’s current market cap of
$14 million captures the value of either the Servier ex-U.S. partnership or the
potential for the product in the U.S. We continue to believe Osteologix represents a
unique opportunity to invest in a late-stage/Phase III-ready compound which
addresses a large indication at a very attractive valuation. We view the Servier ex-
U.S. partnership agreement as a major value driver for the Company as it
significantly de-risks the product’s potential in these markets. Further, we do not
believe the value of the strong intellectual property surrounding NBS-101 in U.S. is
reflected in the current stock price.
Nordic Biotech K/S remains the largest shareholder. Nordic, a private venture capital firm based in Denmark,
owns approximately 68% OLGX common stock. Additionally, as long as Nordic owns over 20% of the company,
OLGX is only allowed 7 board members, with 3 of the 7 members appointed by Nordic. As the majority
shareholder, all transactions (including, but not limited to: M&A, going private, financings, and other significant
transactions) are subject to Nordic approval (in other words, Nordic has strong veto power).
Protelos (strontium ranelate) sales remain strong and continue to grow. Strontium ranelate, a similar
osteoperosis drug marketed by privately held Servier continues to show sales growth in Europe being very strong
in new markets, with moderated growth in certain countries. As a reminder, Protelos is not approved in the U.S.
Protelos ex-U.S. sales were $205 million in 2007, $248 million in 2008, and $290 million in 2009. The growth in the
revenue from 2007 supports our belief physicians view the potential for anaphylactic reactions essentially as a nonissue
which must be monitored for and is addressable by discontinuation of therapy. The rate of observed
anaphylactic reactions is lower than that seen with several other approved drugs. We continue to believe the
occurrence of DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) associated with strontium ranelate
may be associated with the synthetic ranelate salt (which is not used in any other therapeutic agent). Investors
should keep in mind NBS-101 is strontium malonate which is a naturally occurring salt used in other approved
drugs and has demonstrated an improved efficacy and safety profile over Protelos in clinical trials.
Osteologix appears to have a strong patent estate for NBS-101. NBS-101 fully issued patents in the
European Union, the U.S., Australia and Japan provide coverage through 2024 (with extensions possible
through 2026). The USPTO issued a U.S. Patent titled “Water-Soluable Strontium Salts for Use in the Treatment of
Cartilage and/or Bone Conditions” with specific claims covering NBS-101 (strontium malonate) for the treatment of
osteoporosis and related bone conditions. We believe the U.S. patent covering NBS-101 through 2024 solidifies the
U.S. IP position and will allow the Company to consummate a partnership for the product in 2010. Additionally, OLGX
won its First Opposition in the E.U. when the European Patent Office upheld the Company’s NBS-101 patent in Europe in
April 2009, which we believe validates the findings of enhanced bioavailability (BA) with malonate salt were not “obvious”
and increases the potential value of the product for a partnership in Europe. We believe the upholding of the patent by
the EPO represented an important victory for Osteologix for a number of reasons including: First, it validated the
potential value of the product for a partnership in Europe. Second, it validated the findings of enhanced
bioavailability (BA) with the malonate salt were not “obvious”. In other words, the EPO found, since the malonate
salt is not widely used or a well know salt in drug formulation and it has not already been shown to demonstrate an
increase in BA for a wide range of compounds, it was not “obvious” malonate would increase BA. Third, the EPO
agreed malonate salt definitely increased BA. Importantly, OLGX also filed IP surrounding combination use of
strontium with other therapies, and have applications related to manufacturing, osteonecrosis, and arthritis.
Osteologix Inc. Announces Plans to File for European Marketing Authorization for Proprietary Osteoporosis Drug
this drug could be approved in 2012 in Europe. That is pretty unbelievable. It has better biovailability than the drug that is selling over 300 million dollars a year. And this is a once a day pill as opposed to a sachet. that is a big deal
Companies:Osteologix, Inc.
Press Release Source: Osteologix Inc. On Wednesday December 9, 2009, 8:15 am EST
GLEN ALLEN, Va.--(BUSINESS WIRE)--Osteologix Inc. (OLGX.OB) announced today that the company anticipates that it will be prepared to file a marketing application in 2011 in the European Union for its proprietary second-generation strontium therapy, NB S101 (strontium malonate). If successful, this will be Osteologix' first marketing approval of NB S101 for the treatment of postmenopausal osteoporosis.
Following the successful completion of the company's initial Phase 2 study comparing NB S101 (strontium malonate) to Protelos® (strontium ranelate), which is marketed by Les Laboratoires Servier (Servier), Osteologix sought feedback on its development program from various regulatory authorities. As a result of these discussions, Osteologix has determined that the company will be positioned to pursue a European Marketing Application for NB S101 as a treatment for post-menopausal osteoporosis. The company expects that it can complete the additional development work in 2010 and will be prepared to file a marketing application during the first half of 2011. This pathway is in keeping with the Company's overall strategy of developing its once-daily strontium tablet for the osteoporosis market. Osteologix has initiated discussion with potential regional and global partners and believes that the selected partner(s) will be able to begin marketing the novel product by 2012, providing them with at least 12 years of patent protection in the European Union.
"Following the regulatory meetings, we now believe we are well positioned to leverage our existing data package combined with new clinical data that we expect to generate in the next year to obtain European approval for our lead product. Our strategy to obtain approval for NB S101 is in keeping with current regulatory directives," said Philip J. Young, President and CEO of Osteologix. Young continued: "We are well on our way to achieving a significant milestone for Osteologix and our stakeholders. We believe that our product will be a significant addition to the osteoporosis market, and we anticipate that our product will benefit the millions of women with osteoporosis who are in search of a safe and tolerable therapy.”
As previously reported during the 35th European Symposium on Calcified Tissue, the Phase 2 study comparing NB S101 to Protelos demonstrated that NB S101 was safe and well tolerated in the target patient population with the frequency and types of adverse events comparable to those with the active comparator, Protelos (strontium ranelate). NB S101 induced a significant dose-dependent reduction in bone resorption relative to placebo. In addition, all three doses of NB S101 significantly increased bone mineral density (BMD) as measured at the total hip and lumbar spine.
Strontium ranelate, marketed in Europe since 2004 by Servier as Protelos or Osseor®, is the only prescription strontium-based therapy for the treatment of osteoporosis. This year the product is projected to reach sales of more than $300 million, with approximately 80% of this revenue being generated in Europe. Unlike Protelos (strontium ranelate), which is formulated as a powder and packaged in a sachet, NB S101 (strontium malonate) is manufactured as a tablet. Young further states, "We believe our tablet will be preferred over a powder formulation, and should rapidly garner significant market share. We expect the overall strontium market to grow as NB S101 establishes itself as a viable alternative for the treatment of osteoporosis.”
About Osteologix
Osteologix develops proprietary therapeutics for the treatment of unmet medical needs in bone disease and women's health. The Company's lead product, NB S101, is being evaluated in a phase II clinical trial for the treatment of osteoporosis. Based on the Company's own data as well as data from phase III clinical trials conducted on a similar drug that is approved for sale in Europe, Osteologix believes that NB S101 increases formation of new bone and decreases loss of existing bone. Osteologix further believes that NB S101 will provide patients with greater convenience and fewer side effects than drugs currently approved for osteoporosis in the United States, Europe and elsewhere. For more information please visit, www.osteologix.com.
Forward Looking Statements
Certain of the statements set forth in this press release constitute "Forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may" "project," "plan," "will," "should," "could," "would," or words or expressions of similar meaning, including without limitations statements about Osteologix’ plans for regulatory approval of NB S101, clinical trial plans, uses and benefits of NB S101 and plans to enter into an agreement with a global or regional partner for the development and commercialization of NB S101. All such forward looking statements involve risks and uncertainties, including, but not limited to Osteologix’s ability to: enroll and conduct required clinical trials to support regulatory approval of NB S101, obtain regulatory approval for NB S101, raise additional capital necessary to fund its clinical trials and operations; maintain, protect and enforce its intellectual property rights; identify and negotiate agreements with third parties for the continued development and commercialization of NB S101 and retain and hire key personnel. Additional risk and uncertainties include the identification of potential adverse side-effects or toxicities involving NB S101, the effect of competition and proprietary rights of third parties and other factors affecting the health care industry in general, including pricing pressure and regulatory and reimbursement changes. There can be no assurance that such forward-looking statements will prove to be accurate and Osteologix undertakes no obligation to update any forward-looking statements.
Contact:
Osteologix Inc.Investor and Media Contact:Baxter Phillips, IIISr. Director, Corporate Development804.747.6026
Osteologix to Highlight Osteoporosis Drug Opportunity at the Rodman and Renshaw 11th Annual Healthcare Conference
Osteologix to Highlight Osteoporosis Drug Opportunity at the Rodman and Renshaw 11th Annual Healthcare Conference
Sep. 8, 2009 (Business Wire) -- Osteologix, Inc. (OTCBB:OLGX) today announced that in light of recent announcements and set-backs in the field of Osteoporosis, the company believes it is positioned to take advantage of a significant gap in the market, and will discuss its development of a safe and effective treatment for Osteoporosis at the Rodman and Renshaw 11th Annual Healthcare Conference. Philip J. Young, President and CEO of Osteologix, will present the company’s corporate overview at 10:50 a.m. ET on Wednesday, September 9, at the New York Palace Hotel in New York City. The live audio webcast and slide presentation can be accessed by visiting www.osteologix.com and clicking the link provided under “Latest News”.
About Osteologix
Osteologix is a specialty biopharmaceutical company committed to improving the health of those afflicted with musculoskeletal diseases, such as osteoporosis, by developing innovative therapies. Its lead investigational product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit www.osteologix.com.
Osteologix Receives Key U.S. Patent Allowance for Novel Osteoporosis Drug
May 27, 2009 8:30:00 AM
Copyright Business Wire 2009
Email Story Discuss on ZenoBank
View Additional ProfilesGLEN ALLEN, Va.--(BUSINESS WIRE)-- Osteologix, Inc. (OTCBB:OLGX) today announced that is has received a Notice of Allowance from the U.S. Patent and Trademark Office for its U.S. Patent Application Number 11/269,289 titled "Water-Soluble Strontium Salts for Use in Treatment of Cartilage and/or Bone Conditions" reporting allowance of claims covering the treatment of osteoporosis and related bone conditions using NB S101 (strontium malonate), the Company's lead osteoporosis drug candidate. The Company expects the patent will issue in the second half of 2009; the patent's 20-year term would expire in 2024. The company has a number of other pending patent applications covering various aspects of the NB S101 drug program including composition, manufacturing and method of use patent applications.
"Based on the Notice of Allowance and the claims allowed by the USPTO, we believe the intellectual property protections established by this US patent allowance, coupled with our recently upheld European equivalent, will significantly enhance our ability to finalize strong development collaborations with potential partners to complete the Phase III development of NB S101 in osteoporosis," stated Philip J. Young, President and Chief Executive Officer of Osteologix.
About NB S101
NB S101 (strontium malonate) is a novel dual acting bone agent, or DABA, which clinical studies demonstrate, significantly improves bone density. This dual action on bone- a significant medical need that is not served by currently marketed treatments - suggests that NB S101 could fundamentally change the treatment paradigm of patients with osteoporosis. Importantly, NB S101 helps to build bone in a manner similar to the body's own natural process by gently rebalancing bone metabolism in a way that favors strong bone development.
About Osteoporosis
Osteoporosis is the most common bone disease in humans and, according to the National Osteoporosis Foundation (NOF), 10 million Americans are estimated to have the disease and almost 34 million more are estimated to have osteopenia or low bone mass, placing them at increased risk for osteoporosis. The most severe consequence of osteoporosis is skeletal fracture. Osteoporosis is responsible for more than 1.5 million fractures annually and direct expenditures for hip fractures are estimated to cost society more than $18 billion annually, and by 2025 direct annual expenditures are expected to increase to $25 billion. According to NOF, one in two women and one in four men over age 50 can be expected to have an osteoporosis-related fracture at some time. Osteologix is developing NB S101 with physician thought leaders throughout the world to help treat the low bone mass in osteoporosis and ultimately lower the risk of bone fracture.
About Osteologix
Osteologix is a specialty biopharmaceutical company committed to improving the health of those afflicted with musculoskeletal diseases, such as osteoporosis. Its lead investigational product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit www.osteologix.com.
Forward Looking Statements
Certain of the statements set forth in this press release constitute "Forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may" "project," "plan," "will," "should," "could," "would," or words or expressions of similar meaning. All such forward looking statements involve risks and uncertainties, including, but not limited to: statements regarding Osteologix's research and development programs; proposed marketing and sales; patents and regulatory approvals; the effect of competition and proprietary rights of third parties; the need for and availability of additional financing and access to capital; and the seeking of joint development, licensing or distribution and collaboration and marketing arrangements with pharmaceutical companies. There can be no assurance that such forward-looking statements will prove to be accurate and Osteologix undertakes no obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements.
Source: Osteologix, Inc.
----------------------------------------------
Osteologix
Baxter Phillips
III
Sr. Director
Corporate Development
804-747-6026
Osteologix Receives U.S. Patent Allowance for Osteoporosis Drug Manufacturing Patent
May 19, 2009 8:01:00 AM
Copyright Business Wire 2009
Email Story Discuss on ZenoBank
View Additional ProfilesGLEN ALLEN, Va.--(BUSINESS WIRE)-- Osteologix, Inc. (OTCBB:OLGX) today announced that is has received a Notice of Allowance from the U.S. Patent and Trademark Office for its U.S. Patent Application Number 11/579,773 titled "High Yield and Rapid Synthesis Methods for Producing Metallo-Organic Salts" reporting allowance of claims covering certain manufacturing processes for NB S101 (strontium malonate), the Company's lead osteoporosis drug candidate. The Company expects the patent will issue in the second half of 2009; the patent's 20-year term would expire in 2025.
This patent allowance expands the Company's patent portfolio that also includes the recently upheld European patent in which the European Patent Office (EPO) maintained the validity of the Company's European Patent No. EP 1,534,305 B9, "Treating Cartilage and Bone Conditions with Water Soluble Strontium Salts". This patent offers protection for the use of NB S101(strontium malonate) for the treatment of osteoporosis and related conditions while confirming that the innovative product, NB S101, demonstrated a significant increase in bioavailability over the EMEA approved Protelos(R) (strontium ranelate).
About Osteologix
Osteologix is a specialty biopharmaceutical company committed to improving the health of those afflicted with musculoskeletal diseases, such as osteoporosis. Its lead investigational product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit www.osteologix.com.
Forward Looking Statements
Certain of the statements set forth in this press release constitute "Forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may" "project," "plan," "will," "should," "could," "would," or words or expressions of similar meaning. All such forward looking statements involve risks and uncertainties, including, but not limited to: statements regarding Osteologix's research and development programs; proposed marketing and sales; patents and regulatory approvals; the effect of competition and proprietary rights of third parties; the need for and availability of additional financing and access to capital; and the seeking of joint development, licensing or distribution and collaboration and marketing arrangements with pharmaceutical companies. There can be no assurance that such forward-looking statements will prove to be accurate and Osteologix undertakes no obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements.
Source: Osteologix, Inc.
----------------------------------------------
Osteologix
Inc.
Baxter Phillips
III
Sr. Director
Corporate Development
804-747-6026
Protellos five year data
The Strength Of Strontium Ranelate - Protects Bones For At Least Five Years, Remodels Bone Architecture
05 Jun 2006
In previous clinical trials strontium ranelate has proven effective in preventing fractures for up to three years. But according to new data presented today at the IOF World Congress on Osteoporosis in Toronto, Canada that window of opportunity can now be extended to at least five years.
Jean-Yves Reginster, Professor of Epidemiology, Public Health and Health Economics at the University of Liege, Belgium, reported (see conference Abstract No. OC24) that in the phase III Spinal Osteoporosis Therapeutic Intervention (SOTI) trial, strontium ranelate reduced the risk of new vertebral fractures by about 30 percent over four years. In the Treatment Of Peripheral Osteoporosis (TROPOS) trial, which has been running a little longer, those taking the drug for five years had about a 25 percent reduction in vertebral fractures and a 15 percent reduction in non-vertebral fractures, such as those of the thigh. �These results demonstrate, uniquely for anti-osteoporotic treatments, that strontium ranelate provides sustained efficacy over five years against both vertebral and non-vertebral fractures,� said Reginster.
Because other existing treatments have not demonstrated such robust effects in prospective, pre-planned, double-blind, placebo-controlled studies, postmenopausal osteoporotic women stand to benefit from the proven efficacy and tolerability of strontium treatment, according to Reginster.
In two other studies presented at the IOF WCO this week, Georges Boivin and colleagues at the INSERM, Universite Claude Bernard, Lyon, France and J. Yebin Jiang and colleagues at the University of California and the University of Michigan Osteoporosis and Arthritis Lab report on just how strontium ranelate contributes to bone strength.
Boivin (see conference Abstract No. P310) reported that strontium is incorporated into new bone but does not make its way into older bone, which remains virtually free of strontium even after three years of treatment. His findings, based on high resolution X-ray microanalysis, also suggests that strontium does not affect the quality of the bone mineral, but it does affect the quantity. �We believe that the microarchitecture of bone is improved in those taking strontium ranelate. It appears that the bone mass is increased with a normal degree of mineralization,� said Boivin. The best way to think of this is to imagine bone as a tube filled with styrofoam packing. On strontium ranelate, the nature of the packing does not change, but the amount of packing and how it fits together does.
That theory is supported by the findings of Jiang and colleagues, who reported (see conference Abstract No. OC40) that strontium does, in fact, rearrange bone architecture. Bone is made up of two different types of structure, a spongier honeycomb core and a harder outside layer called cortical bone. Jiang reported that the bone making up the honeycomb appears as flatter, plate-like mineral in samples taken from patients treated with strontium ranelate, whereas in control samples the bone appears as rod-like structures. He also reported that the outer cortical bone becomes thicker. �The three-dimensional changes in trabecular and cortical bone may improve bone mechanical strength, explaining the decreased risk for fracture in those on strontium ranelate treatment,� said Jiang.
Both groups obtained their data by analyzing biopsies taken from those enrolled in the TROPOS, SOTI and also the STRATOS phase II clinical trials for strontium ranelate. Boivin and colleagues used high resolution X-ray microradiography to determine the degree of mineralization of pelvic bone samples. Jiang and colleagues used a sophisticated micro computerized tomography scanner, better known as a micro CAT scanner, to measure the three-dimensional structure of the bone, also taken from the pelvis. Boivin compared 35 samples taken from patients treated with various doses of strontium ranelate, with 22 samples taken from those given placebo. Jiang and colleagues measured similar numbers of samples, 20 from the treatment group and 21 controls.
Bisphophonates - Medicine that Keeps on Giving
Boivin's findings also suggest that because strontium is laid down at the surface of newly formed bone mineral, it may be rapidly cleared from the bone once treatment is stopped. Bisphosphonates, on the other hand, are released only very slowly from bone and continue to appear in the urine for years after treatment is stopped according to researchers from the Netherlands (see conference Abstract No. OC25). The finding should caution against prescribing the drugs for young girls who suffer from osteoporosis or brittle bone disorders such as osteogenesis imperfecta.
Bisphosphonates are the most widely prescribed treatment for those with, or at risk for, osteoporosis. Like strontium, bisphosphonates are incorporated into bone where they stop the bone mineral from being dissolved away. They are known to be slowly released from bone but just how long they remain imbedded in the mineral is uncertain. However, at the IOF WCO, Socrates Papapoulos and colleagues at Leiden University, report that the bisphosphonate pamidronate can still be detected in urine eight years after treatment has stopped.
�Up to now it has been hypothesized in the literature that bisphosphonates trapped in the bone are slowly released once therapy is stopped, but now we show for the first time that that phenomenon is real,� said Papapoulous.
The researchers tested urine samples from 6 children who had been given pamidronate for 4-10 years. Urinary measurements were taken up to 13 years after treatment was suspended. Pamidronate was measurable in urine of all patients except one, who had received treatment for 6 years, and drug was measured 13 years after stopping treatment.
The long half-life of bone bisphosphonates probably explains why osteoporotic women who have taken bisphosphonates for a long time have reduced bone mineral loss after stopping treatment. But there is a small cloud to this silver lining-�we need to be cautious about administering bisphosphonates to young girls because there is very little data on the effects of these drugs on embryonic development,� said Papapoulous.
Combination Therapy Packs One-Two Punch
Silvano Adami, University of Verona, Italy, and colleagues reported that women who have completed a course of another hormone therapy, parathyroid hormone, maintain better bone strength if they begin taking the Selective Estrogen Receptor Modulator (SERM) raloxifene once the parathyroid treatment has ended (see conference Abstract No. OC22).
�The results tell us that after a course of parathyroid treatment it is important to begin taking an anti-resorber, such as raloxifene, as soon as possible,� said Adami.
Parathyroid hormone is one of very few therapies that actually stimulates bone formation but the treatment is limited to two years or less in most countries. This has left doctors and patients wondering what the best course of action is once the hormone therapy has ended. SERMs are compounds that mimic only some of the action of estrogen. As such, they have different efficacies and side effects to hormone replacement therapy.
Adami and colleagues measured bone mineral density in 329 women who had been on parathyroid for one year then switched to either raloxifene or a placebo for a subsequent year. The researchers found that at the end of the second year, women who followed the parathyroid therapy with the estrogen mimic had a 2.3% higher bone density at the hip than those who had taken a placebo after the hormone treatment.
The researchers are planning to continue this study to see how long the benefit of the sequential parathyroid/raloxifene therapy persists.
Problems with New Hormone Replacement Therapy
In the recent LIFT trial to measure the efficacy of the estrogen hormone replacement therapy tibolone. Steve Cummings, Director of the San Francisco Coordinating Center, University of California, San Francisco and lead investigator, reported that follow up analysis showed that women who had taken the drug had about half as many vertebral fractures as those who had taken placebo (see conference Abstract No.OC38).
However, this trial was halted due to increased incidence of stroke. �The increased risk of stroke was unexpected and will limit the use of tibolone for prevention of osteoporosis and fracture,� said Cummings. He also suggested that women and physicians should weigh the benefits and risks and consider alternatives before prescribing tibolone for any indication.
Osteoporosis, in which the bones become porous and break easily, is one of the world's most common and debilitating diseases. The result: pain, loss of movement, inability to perform daily chores, and in many cases, death. One out of three women over 50 will experience osteoporotic fractures, as will one out of five men 1, 2, 3. Unfortunately, screening for people at risk is far from being a standard practice. Osteoporosis can, to a certain extent, be prevented, it can be easily diagnosed and effective treatments are available.
The International Osteoporosis Foundation (IOF) is the only worldwide organization dedicated to the fight against osteoporosis. It brings together scientists, physicians, patient societies and corporate partners. Working with its 170 member societies in 84 locations, and other healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved treatment of osteoporosis.
1 Melton U, Chrischilles EA, Cooper C et al. How many women have osteoporosis? Journal of Bone Mineral Research, 1992; 7:1005-10
2 Kanis JA et al. Long-term risk of osteoporotic fracture in Malmo. Osteoporosis International, 2000; 11:669-674
3 Melton LJ, et al. Bone density and fracture risk in men. JBMR. 1998; 13:No 12:1915
IOF World Congress on Osteoporosis, held every two years, is the only global congress dedicated specifically to all aspects of osteoporosis. Besides the opportunity to learn about the latest science and developments in diagnosis, treatment and the most recent socio-economic studies, participants have the chance to meet and exchange ideas with other physicians from around the world. All aspects of osteoporosis will be covered during the Congress which will comprise lectures by invited speakers presenting cutting edge research in the field, and 35 oral presentations and more than 680 poster presentations selected from 720 submitted abstracts. More than 70 Meet the Expert Sessions covering many practical aspects of diagnosis and management of osteoporosis are also on the program.
For more information on osteoporosis and IOF please visit:
http://www.osteofound.org
Osteologix OLGX important info about phase 3
one phase 3 trial makes this easier to partner
We are designing our development plan for NB S101 for osteoporosis to comply with both U.S. and European guidelines. On February 17, 2009, we held a meeting with the FDA regarding the proposed development of NB S101. Based on feedback from the FDA meeting, we believe that the continued development of NB S101 will require an additional phase II trial and only one large, well-controlled phase III trial.
The FDA and EMEA require positive results from phase III studies before they will approve an NDA. In order to obtain approval for a new drug for the treatment of osteoporosis, current regulatory guidelines require placebo-controlled double-blind studies with fracture reduction as the primary endpoint. An adequate fracture-prevention trial represents a significant time and resource investment, as the treatment duration in the required clinical studies can be up to three years, although recent trials have been conducted with a two-year treatment duration and more recently an advisory group has recommended that these trials be reduced to 18 to 24 months in duration. These trials raise ethical questions concerning the use of placebo groups when approved drugs are available to treat osteoporosis, and both European and U.S. regulatory authorities are currently debating whether continued use of such trials can be recommended. If future guidelines prevent or limit the use of placebo control in such studies, we may plan to alternatively conduct a non-inferiority study against an established osteoporosis treatment or otherwise modify our plans based on any new guidelines established for approval of drugs to treat or prevent osteoporosis.
Based on the current FDA and EMEA guidelines and anticipated changes, we anticipate the primary objective of a phase III study will be to evaluate the ability of NB S101 to prevent incident vertebral fracture. We also anticipate that we would collect data on non-vertebral fractures, spine, hip and forearm BMD, and biochemical markers of bone and cartilage turnover. We estimate that the phase III study may enroll up to 3,000 osteoporotic women, comparing one dose of NB S101 to placebo over a two- to three-year treatment period, with a possible two-year extension. Based on continuing analysis of the phase II data and discussions with regulatory agencies, we are continuing statistical assessments before we finalize any phase III clinical trial design and determine the specific number of patients needed.
http://www.sec.gov/Archives/edgar/data/1...
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OSTEOLOGIX (OLGX) this company has what appears to be a better drug than Protelos which is selling at a run rate of 300 million a year in Europe. It is over 60 percent owned by Nordic Biosciences, which is why the stock is so thinly traded. If you can build a position I believe there is huge upside.
Osteologix Announces Win Versus Opposition for its European Patent
Covering NBS-101 for Osteoporosis – Reiterating Buy on OLGX.
Highlights
• Osteologix wins in patent dispute in Europe as its NBS-101 patent is upheld by
the European Patent Office (EPO). We believe the upholding of the patent by the
EPO represents an important victory for Osteologix for a number of reasons
including: First, it validates the potential value of the product for a partnership in
Europe. Second, it validates the findings of enhanced bioavailability (BA) with the
malonate salt were not “obvious”. In other words, the EPO found, since the
malonate salt is not widely used or a well know salt in drug formulation and it has not
already been shown to demonstrate an increase in BA for a wide range of
compounds, it was not “obvious” malonate would increase BA. Third, the EPO
agreed malonate salt definitely increased BA. Fourth, it increases our confidence for
the issuance of the patent in the US by the USPTO. We expect the USPTO could
complete its review of the patent by 2Q 2009 and the issuance of the patent in the
U.S. would represent an important catalyst for the Company and its partnership
prospects for the product. For background on this patent: In May of 2003
(International filing date May 2004), Osteologix filed in the EU a patent entitled
“Water-soluble strontium salts for use in treatment of cartilage and/or bone
conditions” which protects strontium salts with specific water solubility profiles,
excluding strontium ranelate. The EPO issued this patent, European Patent # EP-
1,534,305B9, in October 2006, with an expiration date in May 2024. However, in
July 2007, Intellectual Property Services of Paris, France filed a Notice of Opposition
against Osteologix’s European Patent requesting the EPO revoke the entire patent.
Importantly, Osteologix conducted a wide series of chemical modeling and animal
tests to fully define the ideal solubility profile and to optimize the BA of strontium
using a wide variety of organic and inorganic salts. From this testing they identified
strontium malonate as the most ideal salt for development as an oral drug. They
also conducted a number of human clinical trials including Phase I PK/PD studies
and a Phase II trial demonstrating efficacy. Importantly, OLGX also filed IP
surrounding combination use of strontium with other therapies, and have
applications related to manufacturing, osteonecrosis, and arthritis.
As of September 30, 2008 Osteologix had $5.3 million in cash. We believe
Osteologix $5.3 million in cash as of September 30, 2008 represents sufficient cash
to design a Phase III program, continue work on the IP issuance and continue
negotiating with potential partners. We believe Osteologix could need to raise
additional capital to show strength to potential partners in order to maximize the
value of their asset.
• We reiterate our BUY rating. We continue to believe Osteologix represents a
unique opportunity to invest in a late-stage compound which addresses a large
indication at a very attractive valuation. Additionally, we believe USPTO action on a
key patent for the company expected during 2Q 2009 and confirmation of the
regulatory pathway from FDA expected later this year could serve as important
catalysts for OLGX.
Long-term (8 year) data for strontium ranelate (Protelos) detail the positive efficacy data for 893 patients.
Patients from two double-blind, placebo-controlled, five-year Phase III trials (SOTI Study and the TROPOS Study),
which included a total of 6740 postmenopausal women with osteoporosis, were enrolled into a three-year openlabel
extension study. All Protelos treated patients received 2g per day. The efficacy data clearly indicate bone
mineral density (lumbar >25% increase and femoral neck >10% increase) increased continuously during the study
in Protelos treated patients. Additionally, the cumulative incidence of vertebral (14.9% yrs 1-3 vs 13.7% yrs 5-8)
and non-vertebral (11.2% yrs 1-3 vs 12% yrs 5-8) fractures remained unchanged during the three year extension
study from the first three years of the controlled trials. We are impressed with BMD and fracture incidence results
as they verify the durability of Protelos’ efficacy and because they occurred despite an increased risk associated
with aging Protelos treatment
during the 3 year open label extension study mitigates an increase in vertebral or non-vertebral fracture rates as
the cumulative fracture incidence remained stable/unchanged during the three year extension study when
compared to the incidence observed during the first three years of the placebo-controlled phase in the SOTI and
TROPOS trials. We are impressed with BMD and fracture incidence results as they verify the durability of Protelos’
efficacy and they occurred despite an increased risk associated with aging.
Protelos sales have rebounded and continue to grow following reports of anaphylactic reactions during 4Q
2007. Strontium ranelate continues to show sales growth in Europe (we believe revenues are at >$300 million
annual run rate), being very strong in new markets, with moderated growth in certain countries. The rebound in the
revenue ramp during 2Q 2008, supports our belief that physicians will view the potential for anaphylactic reactions
essentially as a non-issue which must be monitored for and is addressable by discontinuation of therapy. The rate
of observed anaphylactic reactions is lower than that seen with several other approved drugs. We continue to
believe the occurrence of DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) associated with
strontium ranelate may be associated with the synthetic ranelate salt which is not used in any other therapeutic
agent. Investors should remember that NBS-101 is strontium malonate which is a naturally occurring salt used in a
couple other approved drugs.
Upcoming Milestones Product Event Timing
NBS-101 FDA regulatory meeting, Pre-Phase III 1Q 2009
NBS-101 Initiate Phase III program 2009
NBS-101 Partnership 2009
NBS-101 Action on Key IP by USPTO 2Q 2009
Osteologix reported 4Q 2008 results with a lower burn than expected. The
Company reported a net loss of $1.1 million, or ($0.04) per share versus our estimate of
a net loss of $1.8 million, or ($0.06) per share. Overall, the Company has a burn rate of
approximately $350,000 per month resulting in expenses which were $0.7 million lower
than our estimate. The lower expenses are largely due to a lower than estimated R&D
and SG&A expenses. We project 2009 operating expenses to be lower than 2008 with
R&D expenses of $1.65 million and SG&A expenses of $2.6 million. Additionally, based
on the status of the IP in the US and Europe combined with the Company’s ongoing
interaction with the FDA, we project OLGX could sign a partnership for NBS-101 by late
2009/early 2010. Further, we believe a number of catalysts expected during the next
three quarters including: of patent issuance by the USPTO for NBS-101; conclusion of
discussions with the FDA regarding the appropriate design of Phase III trials; and a
potential corporate partnership for NBS-101, could serve as important drivers for the
stock.
As of December 31, 2008 Osteologix had $4.4 million in cash. We believe
Osteologix $4.4 million in cash as of YE 2008 represents sufficient cash to design a
Phase III program, continue work on the IP issuance and continue negotiating with
potential partners. We believe Osteologix could need to raise additional capital to show
strength to potential partners in order to maximize the value of their asset.
• We reiterate our BUY rating. We continue to believe Osteologix represents a unique
opportunity to invest in a late-stage/Phase III-ready compound which addresses a large
indication at a very attractive valuation. Additionally, we believe USPTO action on a key
patent for the company expected during 2Q 2009 and confirmation of the regulatory
pathway from FDA expected later this year could serve as important catalysts for
OLGX.
Osteologix Prevails in European Patent Opposition for Osteoporosis Drug
EPO Division Finds Use of NB S101 Novel with Superior Bioavailability Over Protelos®
I thought these guys were dead
Punk Initiated Coverage
Bone Up, seems more than just you paying attention to OLGX. I was just informed Punk Zeigel initiated on them, pretty bold in front of the company's upcoming P2 data. But I too think the story is pretty low risk for a P2 drug, having read several of servier's publications.
Great Presentation by Young at BIO Investor Forum:
http://www.osteologix.com/wb0051.php?oid=4
New content on the website is a major improvement.
Stephan Christgau, Ph.D., Principal Scientist with Osteologix’s Clinical Development Team and co-discoverer of the CTX-1 bone resorption marker highlighted the key data in this study:
• A single 1 gram dose of NB S101 was as effective as 2 grams of Protelos® (strontium ranelate) in increasing strontium to levels proven to prevent fracture
• The proprietary formulation of NB S101(strontium malonate), provides greater bioavailability than the comparator strontium formulation of strontium ranelate
• Bone resorption assessed with the CTX-1 marker indicated an acute dose dependent effect of NB S101 to reduce bone resorption
“Based on these Phase I data, we are extremely confident that NB S101 will meet its primary endpoints in the Phase II STRONG Study,” commented Malene Weis, M.Sc.Pharm., Director of Clinical Development at Osteologix. “We believe that the positive effect NB S101 exerts on bone turnover will be a welcome contribution to the osteoporosis treatment paradigm. We look forward to presenting our Phase II data to the scientific community in the fourth quarter of 2007.”
Philip J. Young, President and CEO of Osteologix added, “Importantly, the previously approved strontium formulation has been extremely well received by the patient and physician community in Europe. According to independent market analysis, strontium ranelate sales are expected to exceed $200 million in 2007. Should NB S101 continue to show positive results it will be well poised to capture a significant world wide market share when approved for commercial sale”.
The NB S101 Program and the STRONG Study
Osteologix has conducted extensive preclinical and clinical drug research with its proprietary DABA, NB S101. The Phase II STRONG Study evaluating NB S101 is a randomized, double-blind, placebo-controlled, parallel-group dose response study in 289 postmenopausal women. The results will provide data on the effects of NB S101 on bone metabolism, bone mineral density, safety, tolerability and pharmacokinetics. The primary endpoint in the trial is the change in patients' bone resorption, as measured by the biochemical marker CTX-1. Data from this trial will be reported in the fourth quarter of 2007.
About NB S101
NB S101 is a novel dual acting bone agent, or DABA, the active component of which significantly improves bone density and reduces fracture risk. In preclinical studies, NB S101 has demonstrated significant beneficial effects by reducing bone resorption and increasing high quality strong bone formation and bone mineralization. This dual action on bone– a significant medical need– suggests that NB S101 could fundamentally change the treatment paradigm of patients with osteoporosis. Importantly, NB S101 helps to build bone in a manner similar to the body’s own metabolic processes by rebalancing bone metabolism in a way that favors strong bone development. Osteologix has a competitive intellectual property position. A key patent for NB S101 has been issued in EU providing protection out to 2024, with US patents published and currently pending.
About Osteoporosis
Osteoporosis is the most common bone disease in humans and, according to the National Osteoporosis Foundation (NOF), 10 million Americans are estimated to have the disease and almost 34 million more are estimated to have osteopenia or low bone mass, placing them at increased risk for osteoporosis. The most severe consequence of osteoporosis is skeletal fracture. Osteoporosis is responsible for more than 1.5 million fractures annually and direct expenditures for hip fractures are estimated to cost society more than $18 billion annually. According to NOF, one in two women and one in four men over age 50 can be expected to have an osteoporosis-related fracture at some time.
About Osteologix
Osteologix is a specialty pharmaceutical company committed to developing innovative therapies for the treatment and prevention of musculoskeletal diseases. The Company’s vision is to improve the health of those afflicted with musculoskeletal diseases such as osteoporosis. Its lead product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit www.osteologix.com.
Osteologix Presents Positive Osteoporosis Drug Data to International Audience of Physicians
Data Demonstrates the Improved Strontium Bioavailability of NB S101 to Strontium Ranelate
Data from NB S101 Phase II Clinical Study Expected in Fourth Quarter
SAN FRANCISCO - Osteologix Incorporated (OTCBB: OLGX.OB), a specialty pharmaceutical company, announced today data from a Phase I clinical study on its Dual Acting Bone Agent (DABA), NB S101. The data was presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Honolulu, Hawaii. The presentation titled, “Improved Strontium Bioavailability in a New Tablet Formulated Strontium Salt”, demonstrated that the Company’s lead osteoporosis drug candidate, NB S101 (strontium malonate), had greater strontium bioavailability than a similar drug, (strontium ranelate) approved for sale in Europe. The data presented to the international audience formed the basis for the Company’s Phase II clinical study evaluating the effect of NB S101 in modulating bone turnover and improving bone mineral density in women with low bone mass. Data from this Phase II clinical trial will be reported the fourth quarter of 2007.
CE Unterburg Presentation this week.
The new CEO seems to do a great job delivering the story. The issue is, will the ongoing trial deliver the expected results at the end of this year, or at least similar results to the Protelos studies.
RedChip Client: Osteologix, Inc. (OLGX.OB) Announces Q1 2007 Research Update
Osteologix has completed its enrollment in the “Strong Study”, completed its phase II clinical trial, introduced a new and improved dosage form of Strontium, and treated osteoporosis in several European countries.
The results from phase II should be received in the next seven month. If the results meet the target endpoint, the stock is expected to see substantial appreciation. The analyst stated, “At current price levels, OLGX deserves a Buy rating.”
The analyst concluded, “We initiated coverage of Osteologix in January with a Speculative Buy rating and a 12 month price target of $3.88. Our target price is based on the present value of the estimated future share price of $7.56 and a 10 percent discount factor. If revenues reached $42 million in 2014 and 50 million shares were outstanding, Osteologix would generate revenues per share of $0.84 in 2014. At the biotech industry’s current 9 times P/S multiple, this implies a future price of $7.56 for OLGX shares. We believe that at current price levels, this stock has a relatively low level of risk with enormous upside potential.'’
"Please see the disclaimers on the QualityStocks.net website."
RedChip Upgrades Osteologix Rating from “Speculative Buy” to “Buy”
Osteologix has recently made strong moves and passed major milestones which have been primary motivators for RedChip’s upgraded rating.
In the past week, the company announced that it raised approximately $5 million in private placement financing. The CEO commented, “Management believes that the funds received from this financing will enable us to continue operations into the second half of next year, beyond our next critical developmental milestone, which is the release of data results from our Phase II study in the treatment of osteoporosis.”
The company has also completed its enrollment in the “Strong Study”, completed its phase II clinical trial, introduced a new and improved dosage form of Strontium, and treated osteoporosis in several European countries.
Their product’s dual action ability to increase bone density while reducing bone resorption, sets the company apart from the rest of the industry and makes it a compelling choice in the pharmaceutical market.
"Please see the disclaimers on the QualityStocks.net website."
do you know the OS of this one??
A new biotech to watch: Osteologix.
They have a strontium based orally available osteoporosis drug in Phase 2. Similar to Servier's Protelos, which is approved in EU, but contains a different salt making OLGX's version intellectually different allowing for IP (which is filed) and allowing for a pill formulation.
This will be exciting to watch.
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