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
Archive for the 'Company News' Category
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 »
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 »
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 »
Another osteoporosis drug manufacturer plans job cuts (GlaxoSmithKline, Boniva)
Posted by Dr.Osteo on October 24, 2007
The list of big pharma companies cutting jobs this year continues to increase and among this list the number of osteoporosis manufacturers is also increasing. Today we received confirmation that GSK will cut jobs.
Speculations on the GSK CafePharma board guess there will be 1,000 jobs cut.
” We know now that whoever redneck larry is that he does not work for gsk. Because if he did and he had access to the intranet to hear chris viebachers talk on there that we are indeed laying people off!!! Granted its nowhere near as bad as originally thought by most. He said 1000 jobs of which 500 have been handled by not filling positions. Plus 100 mdm/dsm positions and 250 in house people. So 500 out of work reps on both sides of the company is not bad. There are 24 regions on each side so that equals out to 2 reps per region on both sides. Not bad…Redneck larry, how do you say these are not layoffs???”
Oct. 24 (Bloomberg) — GlaxoSmithKline Plc, Europe’s largest drugmaker, reported third-quarter profit fell 5.8 percent as its Advair asthma treatment and Avandia diabetes pill lost sales to competing medicines.
Global job cuts will be necessary to reduce expenses by 700 million pounds ($1.43 billion) by 2010, London-based Glaxo said today in a statement, declining to specify how many positions would be affected. The earnings missed estimates, and the stock fell as much as 2.3 percent.
Avandia sales dropped 38 percent after a May 21 New England Journal of Medicine report linked the drug to a higher heart attack risk. The medicine was Glaxo’s second-best seller in 2006, bringing in $3.3 billion. Sales of Glaxo’s best-selling drug, Advair, gained 7 percent to 835 million pounds, compared with a 34 percent increase for AstraZeneca Plc’s rival Symbicort.
“The market is all geared toward the cost control measures,” Nick Turner, an analyst at Mirabaud Securities in London, who rates Glaxo “neutral,” said in a telephone interview. “If you dissect through that and look at the top line growth, it’s pretty anemic really.”
Net income declined to 1.31 billion pounds ($2.68 billion), or 23.5 pence a share, from 1.39 billion pounds, or 24.4 pence, a year earlier, Glaxo said today in the statement. The earnings missed the median estimate of 24 pence a share of 12 analysts surveyed by Bloomberg. Revenue dropped to 5.48 billion pounds from 5.64 billion pounds.
Shares Fall
Glaxo shares fell 29 pence, or 2.3 percent, to 1,231 pence at 1:21 p.m. in London. The stock has fallen 8.5 percent this year. The U.K. drugmaker raised its dividend for the full year 10 percent to 53 pence a share.
The drugmaker will determine the size and structure of the job cuts after consulting with employees, Chief Executive Officer Jean-Pierre Garnier said on a conference call with reporters. Sales forces in growth areas such as vaccines and cancer treatments may expand while those for products for chronic diseases, where sales are slowing, will be trimmed, he said.
About 40 percent of the 700 million-pound savings will come from manufacturing, and 40 percent from selling and administration, Glaxo said. The remainder will come from research and development. Manufacturing of Glaxo medicines no longer protected by patents may be moved to lower-cost countries, and workforces there expanded, Garnier said.
Restructuring Charges
The reductions will generate 350 million pounds in pretax savings next year, partly mitigating the impact to earnings from generic competition and lower Avandia sales, Glaxo said. The pharmaceutical company will take charges of about 1.5 billion pounds from 2007 to 2010 because of the restructuring.
The company expects the U.S. Food and Drug Administration to decide on its Cervarix vaccine for cervical cancer by Jan. 28 and on Gepirone ER for depression and Requip XL for Parkinson’s disease this year.
In the third quarter, the agency delayed or failed to approve new versions of Glaxo’s Requip for restless leg syndrome, Imitrex for migraines and Lamictal for epilepsy.
“The FDA is more hesitant in taking a stand on new medicines and this is overall a negative factor for the industry and for GSK,” Garnier said in an interview. “This slowdown is creating problems for all the companies. We have to adjust to this environment.”
Articles of interest
Posted in Company News, Osteo Gossip | Tagged: osteoporosis, glaxosmithkline, Osteoporosis treatment, Boniva, GSK, Avandia, | No Comments »
Is Roche (Boniva) next on the list of manufacturers to cut jobs?
Posted by Dr.Osteo on October 24, 2007
BOSTON (Reuters) - A Boston jury on Tuesday found that the patents on Amgen Inc’s (AMGN.O: Quote, Profile, Research) top-selling anemia drugs are valid, blocking Roche Holding AG (ROG.VX: Quote, Profile, Research) from launching a rival medicine in the United States and sending Amgen shares up more than 2 percent.
The jury, following a six-week trial in U.S. District Court in Boston, found all of Amgen’s patent claims were valid and that Roche’s drug infringed three of them.
Judge William Young, who presided over the trial, had previously issued a pretrial ruling that Roche’s Mircera infringes the most important of Amgen’s patents that were in dispute. The jury would have had to find that patent invalid for Roche to have any chance of prevailing.
Amgen’s anemia drugs, Aranesp and Epogen, generated sales in 2006 of nearly $7 billion, roughly half of Amgen’s total revenue. The drugs, used to combat anemia in chemotherapy and kidney patients, are man-made versions of a human hormone called erythropoietin, or EPO, that stimulates production of oxygen-carrying red blood cells.
The judge said that if Roche wishes to contest the ruling, it must file briefs within 60 days. Roche said it was evaluating its legal options, including a possible appeal. A Roche executive had said earlier this month that it would not launch the drug in the United States if it lost the trial.
Sales of Amgen’s drugs were already being hit by concerns they were being overused and are facing new restrictions from government agencies and insurance companies.
Eric Schmidt, an analyst with Cowen & Co, said the Amgen win was somewhat expected given the judge’s earlier ruling on infringement, but that a loss could have really hurt.
“To have your anemia business already on the rocks because of safety issues and then to be facing a competitor in that marketplace, that would have been very tough for Amgen,” Schmidt said. Continued…
Articles of interest
Posted in Company News | Tagged: Boniva, osteoporosis, Osteoporosis treatment, roche | No Comments »
Head to head data of Denosumab versus Fosamax Expected February 2008
Posted by drboneloss on October 22, 2007
NEW YORK, Sept 28 (Reuters) - Amgen Inc (AMGN.O: Quote, Profile, Research) said on Friday it expects to receive head-to-head data in February on its most important drug in development, denosumab, versus alendronate, which is sold by Merck & Co (MRK.N: Quote, Profile, Research) as Fosamax, for treating post-menopausal osteoporosis.
Amgen, the world’s largest biotechnical company, also said it expects to have Phase 3 post-menopausal osteoporosis fracture data in the second half of 2008, and is on target to review the entire post-menopausal osteoporosis data set in the second half of 2008.
The update on the development pipeline was given by Amgen’s executive vice president of Research and Development, at UBS Global Life Sciences Conference on Sept. 27. (Reporting by Ilaina Jonas)
Posted in Alendronate (Fosamax, Fosamax Plus D), Clinical Trials, Company News, Denosumab (AMG 162) | Tagged: Alendronate, amgen, Denosumab, Fosamax, fracture data, head to head, Merck, new treatment, osteoporosis, Phase 3 post-menopausal osteoporosis fracture data | No Comments »
