osteoporosis

Lilly, Glenmark suspend osteoporosis trial

Maureen Martino — Fri, 24 Oct 2008 10:00:05 -0400

In a release, India's Glenmark Pharmaceuticals said its partner Eli Lilly has suspended further clinical development for GRC 6211 for osteoarthritis pain. The companies didn't give an explanation for the move, saying only that Glenmark and Lilly are currently in discussions on the way forward. "We've seen some very, very recent clinical findings on account of which we decided to put a hold on the program right now," Glenn Saldanha, Glenmark's Managing Director and CEO, told CNBC-TV18. "As of now, GRC 6211 could still progress forward or we could move some of the back-up compounds."

Glenmark and Lilly signed a $350 million deal last year in which Lilly gained rights to Glenmark's TRPV1 antagonist molecules, including GRC 6211. The collaboration between Glenmark and Lilly covers all TRPV1 antagonist molecules discovered by either company. Glenmark's Saldanha said the trial suspension won't impact the company's financial outlook.

- see Glenmark's release
- here's the Dow Jones article

GSK ends NPS's osteoporosis drug study

Maureen Martino — Fri, 26 Sep 2008 09:20:00 -0400

Bad news for NPS Pharmaceuticals: the company announced late Thursday that its partner GlaxoSmithKline would abandon a Phase II study of Ronacalaret, an osteoporosis drug. According to SEC filings cited by the Associated Press, GSK is halting the study because Ronacalaret is not effective. "GlaxoSmithKline has not communicated to the company a decision with respect to their continuation of other research and development activities under the agreement," NPS said in the filing.

GSK and NPS have been partners since 1993, and NPS has received $26.1 million in various milestone payments since then. NPS won't have to return any of that money.

- see the RTTNews article

Merck, Japan Tobacco ink osteoporosis deal

Maureen Martino — Fri, 26 Sep 2008 08:25:42 -0400

Merck has signed an agreement with Japan Tobacco to develop and commercialize JTT-305, an investigational oral osteoanabolic drug. Japan Tobacco gets an undisclosed upfront payment and could receive additional cash payments upon achievement of certain milestones. The company will also get royalties from sales of any drug candidates that receive marketing approval. Merck gains worldwide rights to JTT-305 outside of Japan.

Most osteoporosis treatments on the market today reduce fractures by preventing bone loss. JTT-305, on the other hand, cuts fractures by promoting new bone growth. The drug is in Phase II trials in Japan and in Phase I trials outside of the country.

"Partnering with JT to develop this novel compound complements Merck's portfolio of musculoskeletal drug candidates," said Alan B. Ezekowitz, MBChB, D.Phil., senior vice president and franchise head, Bone, Respiratory, Immunology and Endocrine, Merck Research Laboratories. "In the future, we believe that use of antiresorptive and osteoanabolic agents together may provide an effective way to reduce the risk of fractures in patients with osteoporosis."

- here's Merck's release

Amgen shares surge on positive D-mab data

John Carroll — Tue, 16 Sep 2008 11:57:40 -0400

Amgen investors had plenty to cheer about this morning after seeing some impressive data on D-mab's ability to reduce fractures among post-menopausal women with osteoporosis. The therapy reduced new spine fractures by 68 percent compared to placebo and reduced hip fractures by 40 percent. The news triggered a 5 percent surge in Amgen stock.

Researchers had already alerted the industry that the study had been a success, but held back the details for this week. Analysts say that an approved denosumab--a twice yearly injection--could be worth two to three billion dollars a year. But observers also note that D-mab is going to have to prove itself against standard therapies in order to reach mega blockbuster status.

On Monday Amgen released data from a study illustrating that patients preferred D-mab to Fosamax and also demonstrated greater increases of bone density.

- read Amgen's release
- check out the report from TheStreet

Amgen putting D-mab data on display this week

John Carroll — Mon, 15 Sep 2008 11:57:51 -0400

After seeing its fortunes rise and fall on the fate of its anemia drugs, Amgen will attempt to turn to a new page with the release of data from 25 studies devoted to its promising osteoporosis drug denosumab. The data blitz will take place at the annual meeting of the American Society for Bone Mineral Research in Montreal. At stake is denosumab's position in a $7 billion market.

Investors clearly believe that Amgen has a blockbuster on its hands. Its shares have risen from less than $40 to more than $60 on the drug's prospects. About 10 million people suffer from osteoporosis and the majority of them are women. Standard therapies have some harsh side effect for many patients, leaving the market open to a new therapy. Long-term safety has yet to be established, of course. Analysts have been looking for a marketing application later this year with an approval likely in 2009.

- check out the report from the Wall Street Journal

Lilly pays $35M to land TransPharma pact

John Carroll — Thu, 12 Jun 2008 10:57:39 -0400

Eli Lilly is forking over a $35 million upfront payment to nail down the worldwide licensing rights to TransPharma Medical's ViaDerm-hPTH osteoporosis product and a non-exclusive license to its ViaDerm drug delivery system. The two developers will collaborate on the ongoing Phase II trial and then Lilly will take over development responsibility. The pact includes undisclosed milestones and royalties.

"This agreement expands the scope of our osteoporosis program with a novel, patient-centered approach that builds upon our success with Evista and Forteo," commented Dr. Gwen Krivi, vice president of Lilly Research Labs. "As we focus on developing a transdermal PTH product with TransPharma, we will leverage our combined expertise, with the goal of providing patients with a product that meets their desire for an alternative to injection for PTH."

- read the release
- check out the AFX report

Merck's osteoporosis drug performs in Phase II

Wed, 28 May 2008 06:59:56 -0400

Merck's experimental osteoporosis drug odanacatib turned in positive results in a Phase II trial. The drug reduced measures of bone turnover (breakdown and rebuilding of bone) in women with breast cancer that has spread to the bones. Odanacatib beat out Novartis's med Zometam in the trial.

Odanacatib inhibits cathepsin K enzyme, which plays a key role in breaking down the protein in bone. By inhibiting cathepsin K activity, odanacatib could offer a different approach for treating metastatic bone disease.

"Based on these findings, larger Phase III studies using the 5 mg daily dose of odanacatib are being planned for patients with breast and prostate cancer," said Antonio Lombardi, M.D., senior director, Merck Research Laboratories.

- check out Merck's release for more
- read the BusinessWeek article

Amgen's D-mab beats Fosamax in trial

Wed, 28 May 2008 06:59:55 -0400

In a head-to-head trial, Amgen's twice-yearly osteoporosis drug denosumab outperformed weekly oral doses of Merck's Fosamax. D-mab, as it's known, showed greater improvement in bone mineral density in the hip and spine compared to Fosamax. "The novel means by which denosumab inhibits osteoclast-mediated bone breakdown shows the promise of RANK Ligand inhibition," said Javier San Martin, Global Development Lead for the denosumab osteoporosis program.

- see Amgen's release
- read the report for more

Wyeth gets approvable letter for bazedoxifene

Fri, 23 May 2008 06:59:58 -0400

The FDA handed Wyeth a third approvable letter for bazedoxifene, a treatment for postmenopausal osteoporosis. In the letter, the FDA said it needed more information concerning the incidence of stroke and venous thrombotic events. Wyeth said the delay was expected. "In our conference with the Agency earlier this year, they stated their desire to convene an advisory committee to review the pending new drug applications for both treatment and prevention of postmenopausal osteoporosis," said Gary L. Stiles, M.D., Wyeth's CMO. The company expects to file a response by the end of 2008. A recent IMS report predicted that bazedoxifene could become a much-needed blockbuster for Wyeth if approved.

- see this release
- here's the IMS report

Related Articles:
Wyeth's reports strong Phase III bazedoxifene data
Wyeth to slash another 1,200 jobs

SPOTLIGHT: Lilly wants to buy out 500 workers

Thu, 17 Apr 2008 06:59:53 -0400

Add up to 500 Eli Lilly workers to the pharma layoff toll. The Indianapolis-based pharma plans to offer buyout packages to 2,000 manufacturing and engineering employees who work on active ingredients for Humalog and Humulin insulin products and the Forteo osteoporosis med. The deals are designed to cut up to 500 jobs, primarily in manufacturing, but a few in R&D as well. Report

Amgen's D-mab posts positive in late-stage trial

Thu, 03 Apr 2008 07:59:58 -0400

Amgen got a badly needed boost with its announcement that its most promising experimental therapy, denosumab, significantly increased bone mineral density in a Phase III trial. The drug, delivered as a twice yearly injection, outperformed Fosamax in a study that was wrapped in January. This new study focused on the outcomes of 332 patients with post-menopausal osteoporosis.

"The effect of denosumab on wrist BMD [bone mineral density], reinforced by the BMD increases at the total body and hip regions, suggests denosumab has a positive effect on highly cortical sites," said Javier San Martin, global development lead for the denosumab osteoporosis program.

Data on another late-stage study evaluating denosumab's impact on fracture risk reduction in women with postmenopausal osteoporosis is due later this year.

- see Amgen's release on the trial
- check out the report in the Wall Street Journal

Emisphere chief sees plenty of new potential for technology

Thu, 20 Mar 2008 07:59:55 -0400

When Michael Novinski took over as CEO of Emisphere Technologies, he was acutely aware of just how unsuccessful the developer had been. For 20 years, he tells the Star-Ledger, Emisphere was never able to get a single mid-stage trial right. Efforts to develop pill versions of insulin and heparin foundered as ithe company struggled. But the former president of Organon BioSciences says the company has a lot of untapped potential. A co-development deal for a pill version of Novartis' osteoarthritis and osteoporosis therapies has been struck and Novinski believes FDA approval could be only a year or two away. Novinski also believes that more such deals involving Emisphere's eli gen technology can be struck. Meanwhile, researchers for Emisphere are on the trail of a pill for diabetes.

- read the article in the Star-Ledger

Related Articles:
Emisphere agrees to $18M settlement. Report
Emisphere fires CEO. Report

More job cuts at Nastech as stock continues slide

Wed, 13 Feb 2008 06:59:56 -0500

With its stock in a swoon, Nastech has cut 50 more positions. That's on top of the 72 jobs cut late last year after the Bothell, WA-based company announced that Procter & Gamble had pulled out of its partnership to develop a nasal spray therapy for osteoporosis. Since that time, the company's stock has lost 85 percent of their value, forcing the company to continue to restructure in order to cut costs.

"Our market capitalization has gone down from $300 million to $60 million," Gordon Brandt, Nastech's president, told the Seattle Post-Intelligencer. "It's difficult to raise capital, so we need to conserve the cash we have." Brandt says the company is also pushing ahead with programs that include a nasal spray for obesity and insulin nasal spray. It is also pushing ahead with plans to spin off its RNAi business, which has 45 workers.

- see the release on the cuts
- read the article from the Seattle Post-Intelligencer

Related Articles:
Nastech spins off RNAi unit, restructures. Report
Nastech shares wilt after P&G returns drug rights. Report
Nastech to push ahead with obesity spray trial. Report
Nastech hit on missed payment. Report

Amgen's D-mab meets trial goal

Fri, 25 Jan 2008 06:59:57 -0500

Amgen's great pipeline hope--Denosumab--has met all primary and secondary endpoints in a Phase III head-to-head trial against Fosomax. Denosumab, which is administered twice-yearly, is a fully-human monoclonal antibody for the treatment of bone loss. In the year-long study, the relative magnitude of bone mineral density improvement at the total hip was approximately 40 percent greater in the Denosumab versus the Fosomax group. A total of 1,189 women participated in the trial.

According to one analyst, Denosumab "could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients." It's the only potential blockbuster in Amgen's pipeline nearing FDA approval. Amgen hopes to file an NDA for the drug in 2009.

- see this release for more

ALSO: Amgen's sales fell 2 percent in the fourth quarter to $3.74 billion, but the company managed to eke out a $835 million profit for the period, an increase of 1 percent. Release

Related Articles:
Denosumab: Amgen's salvation? Report
Amgen touts progress in two key programs. Report
Amgen discusses the future with analysts. Report

Zosano rounds up $45M in VC

Fri, 16 Nov 2007 06:59:57 -0500

Fremont, CA-based Zosano Pharma has received $45 million in its second round, bringing its total funding thus far to $90 million. Enterprise Associates, Nomura Phase4 Ventures, HBM BioVentures and ProQuest Investments participated in the round. Zosano is developing a transdermal microprojection delivery system, a small patch and applicator that is designed as an alternative to vaccines administered with needles.

"This second closing supports our continued progress with Zosano's lead program, a PTH patch for treating osteoporosis, which is currently in Phase 2 development," said Cory Zwerling, Zosano's CEO. "Our PTH development program is on track and we are also moving other Zosano activities forward."

- see this release for more

PLUS: Woburn-MA-based BioVex has garnered $35 million in a second round of Series E financing. The company is developing biologics for the treatment and prevention of cancer and infectious disease. The money will fund BioVex's Phase III study of OncoVexGM-CSF for the treatment of melanoma as well as to complete studies in head and neck cancer and pancreatic cancer. Triathlon Medical Ventures led the round. Release

Related Articles:
BioVex raises $22M for ongoing cancer trial. Report
BioVex moving HQ to Mass. Report

Nastech spins off RNAi unit, restructures

Wed, 14 Nov 2007 06:59:56 -0500

After a rough week that saw its stock price slide by 65 percent following Proctor & Gamble's decision to bolt from a collaboration deal, Nastech Pharmaceutical is laying off workers and restructuring its operations. For now, there's no estimate on exactly how many of Nastech's 197 workers face pink slips. But Nastech wants to concentrate its focus on late-stage therapies--including the osteoporosis product once partnered with P&G.

Nastech's RNAi business is also being spun off into a separate, publicly traded biotech. A spokesman for the company told the Seattle Post-Intelligencer they were already planning the spin-off. This is the second big partner to bolt from a pact with Nastech. Last year Merck dropped out of a pact with Nastech involving an obesity therapy.

- see this release on the cuts
- read the release on the RNA spin-off
- check out the report from The Seattle Post-Intelligencer

Related Articles:
Nastech shares wilt after P&G returns drug rights. Report
Nastech to push ahead with obesity spray trial. Report
Nastech hit on missed payment. Report

ALSO NOTED: Novartis teams up with MIT; EMEA approves Galvus; and much more...

Fri, 28 Sep 2007 06:59:50 -0400

> Novartis is teaming up with MIT to develop new ways to manufacture drugs. The company will give the university $65 million over 10 years to create a new research program. Report

> Galvus, a once-daily oral treatment for type 2 diabetes, has been approved by the EMEA. Release

> Celera has earned a clinical milestone payment of $2 million from Merck. The payment was triggered by Merck's advancement of odanacatib into a Phase III clinical trial as a potential treatment for osteoporosis. Release

> Scientists at the Institute for Neurodegenerative Disorders report that they have identified a drug that could potentially treat the cognitive disorders associated with schizophrenia. Report

> A new study concludes that two enzymes--SIRT3 and SIRT4--play a key role in mitochondria, regulating the aging process. Report

And Finally... Researchers at Texas A&M University are participating in developing a medicine that is worth sneezing about: a treatment for influenza that forms a jelly when sprayed into the nose. Release

Wyeth's reports strong Phase III bazedoxifene data

Thu, 20 Sep 2007 06:59:56 -0400

At the American Society for Bone and Mineral Research Annual Meeting, Wyeth presented strong Phase III data for its osteoporosis drug. Bazedoxifene 20 mg and 40 mg significantly reduced the risk of new vertebral fractures by 42 percent and 37 percent, respectively, in a three-year study. Bazedoxifene has already been submitted to the FDA and is awaiting final approval. Earlier this year, Wyeth received an FDA approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis. In July 2007, Wyeth submitted a separate new drug application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis. This new data comes as much-needed good news for Wyeth, which has struggled with its drug development programs as of late.

- see Wyeth's release for more on bazedoxifene

Related Articles:
Wyeth stumbles badly trying to develop new drugs. Report
Wyeth stock down after several setbacks. Report
Novartis drug cuts hip-fracture deaths. Report

ALSO NOTED: Enzon sells drug interest; Generex gains new patents; Access plans trials;and much more...

Mon, 20 Aug 2007 06:59:50 -0400

> Enzon has sold a 25 percent interest in the hepatitis C drug Peg-Interferon for $92.5 million. Release

> Generex Biotechnology has been awarded new patents in Europe and Mexico. Release

> Access Pharmaceuticals says that it intends to start new human trials of ProLindac, its novel DACH platinum polymer prodrug. Release

> Score one for Novartis. Its once-yearly treatment for post-menopausal osteoporosis, Reclast, now has the FDA's blessing. FiercePharma

> Abbott Laboratories is opting to reshuffle executive responsibilities rather than filling its No. 2 management slot. FiercePharma

> Use of prescription pain pills has skyrocketed over the past several years, according to a government study. Sales of the five biggest painkillers jumped 90 percent between 1997 and 2005. FiercePharma

And Finally… Researchers say that some parents are too eager to share the results of genetic tests with children who are too young to understand what they are being told. Report

Press Release: Nastech Pharmaceutical Company To Get $42.9M In 3.25M Stake Offer

Maureen Martino — Thu, 18 Jan 2007 09:20:12 -0500

Nastech Pharmaceutical Company To Get $42.9 Million In 3.25 Million Stake Offer

BOTHELL, Wash., Jan. 18 -- Nastech Pharmaceutical Company Inc. today announced the pricing of an underwritten public offering of 3.25 million shares of its common stock at an estimated total public offering price of up to approximately $42.9 million. The offering is being made pursuant to a shelf registration that became effective on November 29, 2006. All of the shares are being sold by Nastech. UBS Investment Bank acted as sole bookrunner for the offering. The Company has granted the underwriter an option to purchase up to an additional 487,500 shares to cover over-allotments in the offering, if any.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state. A prospectus supplement and the accompanying base prospectus relating to these securities will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC's website at http://www.sec.gov. This offering of shares of common stock may be made only by means of the prospectus supplement and accompanying base prospectus, a copy of which can be obtained upon request in writing to UBS Securities LLC, 299 Park Avenue, New York, NY 10171, Attn: Equity Syndicate Desk.

About Nastech

Nastech is a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including osteoporosis, diabetes, obesity, respiratory diseases and inflammatory conditions.

Contacts: Nastech Pharmaceutical Company Inc. Ed Bell Senior Investor Relations Manager (425) 908-3639 ir@nastech.com Noonan Russo Matthew Haines (Investors/Media) (212) 845-4235

Nastech Pharmaceutical Company Inc.
CONTACT: Ed Bell, Senior Investor Relations Manager of NastechPharmaceutical Company Inc., +1-425-908-3639, ir@nastech.com; orInvestors/Media: Matthew Haines of Noonan Russo, +1-212-845-4235