Nastech Pharmaceutical Co. (NSTK US) dropped $5, or 36 percent, to $8.99 for the biggest drop since March 2006. The developer of medicines given by nasal spray said Procter & Gamble Co. (PG US) ended a collaboration on the development of a drug to treat the bone-thinning disease osteoporosis. source bloomberg
Nastech Pharmaceutical and P&G end collaboration for osteoporosis treatment
Posted by Dr.Osteo on November 9, 2007
Posted in Company News | Tagged: osteoporosis, procter & gamble, P&G, Osteoporosis treatment, Nastech | No Comments »
The mystery behind Reclast (Zoledronic Acid) atrial fibrillation
Posted by Dr.Osteo on November 5, 2007
Side effects with Reclast overall were mild, however there was an increased incidence of atrial fibrillation versus placebo. In particular, serious atrial fibrillation occurred more frequently in the zoledronic acid group - 50 vs. 20 patients with placebo, (P<0.001).
THE MYSTERY is that atrial fibrillation occurred after 30 days (in 47 of the 50 patients), while any electrolyte imbalances from zoledronic acid occurred within 9-11 days of infusion. Source NEJM
So Novartis currently doesn’t know why that happened… do you know?
Articles of interest
- Why my doctors will not prescribe Reclast!!!
- FDA warning on Reclast
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Posted in Zoledronic acid (Reclast, Aclasta, Zometa) | Tagged: Novartis, osteoporosis, Osteoporosis treatment, Zoledronic Acid, reclast, atrial fibrillation, | 3 Comments »
DMS Will Post First Full-Year Profit in Six Years
Posted by Dr.Osteo on October 30, 2007
Diagnostic Medical Systems SA, the French maker of X-ray bone measure devices for osteoporosis, will post a profit this year for the first time since 2001 as it introduces new products to compete with Royal Philips Electronics NV, Chief Executive Officer Antoine Rabaste said. “We had an excellent first half and the second half will be at least at the same level,” Rabaste said in a telephone interview from Montpellier, France. DMS’s net income as a percentage of sales will rise to more than 10 percent in the second half, he said. Profit under that measure, excluding one- time gains, was at 9.7 percent in the first half.
DMS had first-half net income of 2.6 million euros ($3.7 million) compared with a net loss of 900,000 euros a year earlier, the company said in a statement yesterday. Nine-month revenue through September increased 38 percent. Full-year 2007 sales will beat a previous target of 20 percent growth, Rabaste confirmed.
DMS’s shares rose 11 cents, or 2.3 percent, to 4.81 euros in Paris, valuing the company at 38.7 million euros.
The company is starting sales of a new digital radiology machine named “Da Vinci,” Rabaste said. DMS expects between 4 million euros and 7 million euros of additional revenue in 2008 from the new product, he said.
`Da Vinci’ Product
“Very high technology products will help us to enter countries with high potential in Western Europe,” Rabaste said. DMS is introducing the “Da Vinci” after solving technology problems on another radiology system, the “Paladio,” he said.
“On the Paladio we had a problem on a detector but today we use the same detector used by our rivals Philips and Siemens,” Rabaste said. “We’re at the same technology level with them but we’ve got a price advantage.”
The company plans to sell three “Da Vinci” digital radiology machines this year and to deliver 30 to 50 in 2008, Rabaste said. The “Da Vinci” can be used for all most common radiology tests, including bone and lung scans, which represent 85 percent of the radiology market, he said.
DMS is also introducing “Stratos,” a new ultrasound machine for osteoporosis tests. (source)
Posted in Company News | Tagged: osteoporosis, stratos, DMS, Diagnostic Medical Systems, X-ray bone measure device, Paladio, | No Comments »
Nastech Q3 net loss doubles and P&G is not paying them
Posted by Dr.Osteo on October 30, 2007
Nastech Pharmaceutical Co Inc’s (NSTK.O: Quote, Profile, Research) revenues for the quarter fell to $1.9 million from $5.5 million a year ago, which included $4.8 million from Nastech’s deal with Procter & Gamble (PG.N: Quote, Profile, Research) for developing an osteoporosis drug — a parathyroid hormone nasal spray known as PTH1-34.
The Bothell, Washington-based company third-quarter net loss doubled due to lower revenue and higher spending, and the company’s shares fell more than 8 percent in after-market trade.
In December last year, Nastech said the $15 million it expected to get in 2006 for the P&G deal would be deferred, and it would get $5 million in 2007 on starting an added mid-stage trial and the remaining $10 million on starting a late-stage study.
Nastech is yet to receive these payments.
In Monday’s conference call with analysts, Nastech executives did not provide much clarity on the status of this development program, which is in mid-stage trials.
“They (P&G) are really controlling the information flow on this program for commercial and scientific reasons,” said Nastech’s executive vice president of clinical research and medical affairs, Gordon Brandt.
Needham and Co analyst Mark Monane said by phone that this delay was “classic big pharma,” and that P&G was moving at its own pace.
PTH1-34, currently sold as a once-daily injectable product, has been shown to increase bone mineral density and reduce fractures, Nastech said on its Web site. (source)
Posted in Company News | Tagged: osteoporosis, P&G, Osteoporosis treatment, parathyroid hormone, PTH1-34, Nastech, osteoporosis nasal spray | No Comments »
Boning Up: Journal Tightens Disclosure Policy
Posted by Dr.Osteo on October 27, 2007
Over the past three years, a controversy raged concerning a study about Procter & Gamble’s Actonel osteoporosis med in the Journal of Bone and Mineral Research. Although the tale was complicated and sordid, at its heart was the issue of corporate influence over study data and the responsibilities of a journal to act as a credible gatekeeper of information. For these reasons, the astonishing spat between the journal, P&G and a UK researcher, Aubrey Blumsohn, gained considerable media attention. Now, though, the journal promises to behave, well, differently.What caused this ruckus? To keep it simple, an Actonel study was conducted by Blumsohn and Richard Eastell, a Sheffield University colleague, and the results were favorable. However, they had divided the work. Blumsohn subsequently learned that P&G never allowed Eastell to perform his own analysis of Actonel data. Blumsohn, who suspected P&G was mostly concerned with how Actonel would fare with Merck’s Fosamax, went back to analyze samples and asked P&G for the raw data, but was refused.
Meanwhile, P&G analyzed the data and wrote up the final results for him to present at the American Society of Bone and Mineral Research, which publishes the journal. And a P&G ghostwriter was assigned to ready the work for publication, listing both men as authors. Eastell’s previous Actonel research indicated “all authors had full access to the data and analyses,” which alarmed Blumsohn, who worried about being accused of scientific fraud. The study was eventually published in 2004, with data that Blumsohn argued was massaged by P&G. (For a complete rundown, read this trail of e-mails, or a 2005 story in Slate).
For three years, Blumsohn fought with P&G to release the data, and with the journal to correct the mistaken info. The journal balked and delayed, prompting Blumsohn to question its integrity.
For their part, the journal editors claim they were “hamstrung” by a lack of necessary info needed to act. Eventually, P&G acquiesced and, last year, the journal published a Statement of Concern, and began requiring disclosure of potential conflicts of interest by all authors and that all authors attest that they had full access to underlying study data. And clinical trials must be registered before subjects are enrolled.
In its latest issue, however, the journal published an editorial in which researchers must now confirm that they’re “not aware of any disagreement about the content, analyses, or conclusions of their manuscript by anyone who has made a contribution to the work contained.” And there was a separate article noting that the an as ASBMR task force voted to adopt Association of American Medical Colleges principles for reporting clinical trials.
The journal never explicity acknowledges any mistakes, but by virtue of adopting new procedures, this can be interpreted as a mea culpa, of sorts. In the end, the editors write that there are lessons to be learned, starting with this one: “The ultimate protection to science is open discussion.” Indeed. (source)
Posted in Alendronate (Fosamax, Fosamax Plus D), Company News, Risedronate (Actonel, Actonel w/Ca) | Tagged: osteoporosis, P&G, Osteoporosis treatment, Actonel, Fosamax, Aubrey Blumsohn, | No Comments »
Osteologix has a new osteoporosis drug SB101 in phase II trials
Posted by drboneloss on October 26, 2007
Osteologix to Present at NASDAQ MarketSite During EQUITIES 2007 Transatlantic Conference
SAN FRANCISCO–(BUSINESS WIRE)–Sep 28, 2007 - Osteologix Inc. (OTC Bulletin Board: OLGX), a specialty pharmaceutical company developing innovative therapies for the treatment and prevention of musculoskeletal diseases, today announced that Philip J. Young, President and CEO of Osteologix, will present a corporate overview highlighting the Company’s Phase II Osteoporosis clinical trial, the STRONG Study, Friday, September 28 at 8:50 a.m. during the EQUITIES 2007 Transatlantic Conference to be held at to be held at the NASDAQ MarketSite in New York City. A live audio webcast and slide presentation will be available via the internet by visiting www.equitiesmagazine.com.
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.
About NB S101
NB S101 is a novel dual acting bone agent, or DABA, the active component of which significantly improves bone mineral 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.
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.
Posted in Company News, Strontium | Tagged: new osteoporosis treatment, osteoloix, sb101, stontium, Strontium | No Comments »
Endometrial and Ovarian Safety of Bazedoxifene in the Prevention of Postmenopausal Osteoporosis
Posted by drboneloss on October 26, 2007
Bazedoxifene Prevents Osteoporosis in Postmenopausal Women: Presented at ASRM
WASHINGTON, DC — October 24, 2007 — An optimal selective oestrogen receptor modulator (SERM) would display agonistic activity in bone and on serum lipids, with minimal or antagonistic activity in breast and endometrial tissue.
A novel SERM, bazedoxifene, appears to have oestrogen antagonistic potential in both the breast and endometrium, according to a study presented here at the 63rd Annual Meeting of the American Society for Reproductive Medicine (ASRM).
JoAnn V. Pinkerton, MD, Medical Director, Midlife Health Center, and Professor, Department of Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, Virginia, United States, discussed the results in an interview here on October 15.
Prior to this study, tamoxifen was used for the treatment and prevention of oestrogen receptor-positive breast cancers, Dr. Pinkerton said. But this agent is known to increase the risk of uterine cancer, she added.
Raloxifene prevents breast cancer and does not increase the risk of uterine cancer, she added. However, researchers showed that raloxifene in combination with systemic oestrogen results in an increase in hyperplasia, she said.
“Bazedoxifene, in the preclinical work, protected against endometrial stimulation. And what we found in this study is that, using bazedoxifene alone, there is no increased risk of the endometrial stimulation, and no ovarian stimulation,” she said.
Dr. Pinkerton presented the results of her 2-year randomised, double-blind, phase 3 clinical trial, conducted at 101 sites in Canada, Europe, and the United States.
A total of 1,583 healthy, postmenopausal women with a mean age of 57.6 years were treated with one of the following five treatment regimens: bazedoxifene (10 mg, 20 mg, or 40 mg); raloxifene 60 mg (active comparator); placebo.
A total of 1,116 (70.5%) women had an intact uterus and were evaluable for endometrial safety; 1,387 (87.6%) had not undergone prior oophorectomy and were therefore evaluable for ovarian safety. The women were evaluated by endometrial biopsy and transvaginal ultrasound.
Statistical analysis of endometrial thickness data was performed by analysis of covariance method, with baseline endometrial thickness as the covariate. The Fisher exact test was used for comparison between the different treatment groups, looking at changes from baseline in ovarian volume, incidence of ovarian cysts, and incidence of endometrial hyperplasia.
The results show that for subjects in the bazedoxifene treatment groups, endometrial thickness remained stable, with no statistically significant changes from baseline after 2 years of therapy, according to the researchers.
Incidences of endometrial polyps after 2 years were similar for bazedoxifene 10 mg, 20 mg, and 40 mg (2.2%, 3.4%, and 2.3%, respectively) and similar to placebo-treated patients (3.5%). A relatively higher incidence of polyps occurred in the
Interestingly, hyperplastic polyps occurred only in the raloxifene and placebo treatment groups.
There were no significant differences between treatment groups when analysing for incidence of gynaecological adverse events (AEs). The most common AE was breast pain, which occurred in 3.7% of women treated with 10 mg bazedoxifene, in 3.4% of women treated with 20 mg bazedoxifene, in 2.8% of women on 40 mg bazedoxifene, in 2.6% of women on 60 mg raloxifene, and in 2.6% of women on placebo.
“Looking at the bone density data, bazedoxifene was shown to have oestrogen agonist activity in the bone, with improvement in bone density in the vertebral spine and hip,” explained Dr. Pinkerton, adding that the therapy “significantly decreased the risk for vertebral fracture in postmenopausal women with osteoporosis.”
“The suggestion is that bazedoxifene has a unique effect on the endometrium. So now, ongoing multicentre trials are evaluating the combination of bazedoxifene and conjugated oestrogens for efficacy at preventing bone loss and safety with regards to the breast and endometrium, to see if it can relieve hot flushes, prevent bone loss, without stimulating the breast or the uterus,” concluded Dr. Pinkerton.
By Crina Frincu-Mallos, PhD
Source: http://www.docguide.com/news/content.nsf/news/852571020057CCF68525737E004AC8AE
The study was funded by Wyeth Research Inc.
Posted in Bazedoxifene (Aprela, Viviant), Clinical Trials, Evista (raloxifene) | Tagged: Aprela, bazedoxifene, cancer, Eli Lilly, evista, osteoporosis, raloxifene, Viviant, wyet | 1 Comment »
Galapagos signs up to one billion euros deal with J&J
Posted by Dr.Osteo on October 25, 2007
BRUSSELS, Oct 24 (Reuters) - Belgian biotechnology company Galapagos (GLPG.BR: Quote, Profile, Research) said on Wednesday it had signed a deal potentially worth up to one billion euros with Johnson & Johnson (JNJ.N: Quote, Profile, Research) unit Janssen Pharmaceutica.
Galapagos, which specialises in bone and joint diseases, will enter into a global alliance with Janssen on rheumatoid arthritis research. Highlights include up to 430 million euros in development and regulatory milestone payments should more than one product be launched and up to 346 million euros of sales milestones as well as double-digit royalties.
“This deal gives the company access to the necessary funds and expertise to bring its RA products much closer to the market. Together with the GSK deals, this significantly improves Galapagos’s long-term potential and reduces the risk profile of the company”, KBC Securities said in morning research note.
Galapagos already has a major alliance with GlaxoSmithKline (GSK.L: Quote, Profile, Research) in osteoarthritis, with up to 186 million euros in milestone payments and potential double-digit royalties.
Van de Stolpe said he saw the Janssen deal as a model for its other programme for brittle bone disorder osteoporosis.
“We believe that pharma is looking for a risk-sharing alliance and is willing to pay big bucks and share the upside through royalty agreements,” he said. source
On 26 June 2007 – Galapagos NV announced today that Wyeth has exercised its right to license three proprietary bone anabolic drug targets from their 2003 research agreement in osteoporosis, resulting in a €1.05 million milestone payment to Galapagos.
This is the second milestone reached in the osteoporosis collaboration initiated in November 2003. In the collaboration, Galapagos has applied its osteoporosis disease expertise to discover and validate novel drug targets for Wyeth. In November 2004, Wyeth selected a set of these targets for internal validation. Today’s milestone announcement is the result of Wyeth licensing three targets for its internal drug discovery research efforts. Under the terms of the 2003 agreement, Galapagos could receive milestone payments of up to €30 million from the collaboration. The targets involved in the Wyeth collaboration are unrelated to the suite of proprietary validated targets in Galapagos’ own osteoporosis program.
“Wyeth licensing targets identified by Galapagos speaks to the strengths and uniqueness of our target discovery approach,” said Onno van de Stolpe, Chief Executive Officer of Galapagos. “The expertise which led to this milestone with Wyeth also forms the basis for our own portfolio of novel targets in osteoporosis.” source
Posted in Company News | Tagged: , galapagos, glaxosmithkline, GSK, J&J, osteoarthritis, osteoporosis, rheumatoid arthritis | No Comments »
Ligand receives $250,000 milestone payment from Wyeth for Bazadeoxifene
Posted by drboneloss on October 24, 2007
Ligand Pharmaceuticals has received a milestone payment of $250,000 from Wyeth, on Wyeth’s submission of a market authorization application to the European Medicines Agency to market bazedoxifene for the prevention and treatment of osteoporosis. The payment arises from an agreement between the two companies and reflects progress in the development of bazedoxifene, a selective estrogen receptor modulator. Bazedoxifene is a synthetic drug that was designed to reduce the risk of osteoporotic fractures while protecting breast and uterine tissues. Wyeth received an approvable letter from the FDA for the treatment of osteoporosis and submitted a second new drug application for bazedoxifene for the prevention of osteoporosis.
John Higgins, Ligand’s president and chief executive officer, said: “We are very pleased with the excellent progress Wyeth has made advancing bazedoxifene toward regulatory approval in both the US and Europe. The recent EMEA and FDA submissions illustrate the potential of our strategy to increase shareholder value by partnering with key pharmaceutical companies whose development capabilities capitalize on our strong drug discovery science.”
Other articles on bazaedoxifene:
Bazedoxifene for hot flahses: phase 3 data
Posted in Bazedoxifene (Aprela, Viviant), Company News | Tagged: Aprela, bazedoxifene, hot flahses, ligand, osteoporosis, phase III data osteoporosis, Viviant, Wyeth | No Comments »
Voltaren Gel first approved topical prescription treatment for pain associated with osteoarthritis
Posted by Dr.Osteo on October 24, 2007
- First US approval for a prescription NSAID (non-steroidal anti-inflammatory drug) treatment that can be applied directly to site of osteoarthritis pain
- Voltaren Gel the only prescription topical medication proven to significantly reduce osteoarthritis pain in both the knees and the joints of the hands
- Offers highly effective pain relief with minimal drug absorption throughout the body - shown to be 94% less than comparable oral diclofenac treatment
Basel, October 22, 2007 - Voltaren� Gel (diclofenac sodium topical gel) 1% has received US regulatory approval as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis.
The US Food and Drug Administration (FDA) granted the approval for Voltaren Gel, which is a non-steroidal anti-inflammatory (NSAID) medication, for use in treating pain associated with osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.
Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint.
Clinical trials have demonstrated Voltaren Gel to be highly effective in treating osteoarthritis pain in the hands and knees, which are the body’s most commonly affected joints. It is the first topical osteoarthritis treatment to have proven its effectiveness in both the hands and knees through clinical trials.
Voltaren Gel, which will be marketed in the US by the OTC business unit since this is the case in many other countries, delivers effective pain relief with a favorable safety profile as its systemic absorption is 94% less than the comparable oral diclofenac treatment. more…
Posted in Treatment News | Tagged: Novartis, osteoporosis, Osteoporosis treatment, osteoarthritis, Voltaren Gel, | No Comments »
