Ligand receives $250,000 from Wyeth
17 Oct 2007
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.”
Wyeth’s desvenlafaxine reduces vasomotor symptoms in menopausal women
16 Oct 2007
According to the company, this significant reduction was seen as early as week one. The common adverse drug reactions (greater than or equal to 5% of either desvenlafaxine group) in this study were asthenia, hypertension, anorexia (loss of appetite), constipation, diarrhea, dry mouth, nausea, dizziness, insomnia, somnolence and mydriasis.
Ginger Constantine, vice president of women’s healthcare at Wyeth Pharmaceuticals, said: “There are more than 10 million menopausal women who experience moderate to severe hot flashes and night sweats. Only a small percentage of menopausal women use FDA-approved treatments, all of which are hormone-based.Wyeth is committed to continuing to develop desvenlafaxine as a potential non-hormonal treatment option for women with moderate to severe vasomotor symptoms associated with menopause.”
David Archer, lead investigator of the 12-week study and professor in the Department of Obstetrics and Gynecology at Eastern Virginia Medical School, Clinical Research Center, added: “Additional treatment options are important for the millions of US women experiencing hot flashes and night sweats associated with menopause. Vasomotor symptoms can be quite disruptive for women in performing their daily activities.”
Wyeth and Progenics to initiate Phase II trials of methylnaltrexone
16 Oct 2007
Approximately 40 sites will participate in each of these two studies, which are being conducted by Wyeth. Each trial is expected to enroll approximately 120 patients who are receiving opioids to help manage their chronic pain and have opioid-induced constipation (OIC). Both studies are expected to take approximately six months to complete.
Each study will separately evaluate a different oral formulation of methylnaltrexone, including the formulation that exhibited positive preliminary results in a Phase I study. The companies plan to assess the safety and dose-response of oral methylnaltrexone as measured by the occurrence of spontaneous bowel movements during the treatment period. The studies are expected to assist in determining the formulation and doses to be advanced into Phase III studies.
Drugmakers voluntarily withdraw infant cough medicines
15 Oct 2007
The voluntary recall affects medicines made by Johnson and Johnson, which markets Tylenol, and Wyeth, which makes Dimetapp and Robitussin.The recall only affects medicines labeled for infants, not those intended for use in children age two years and older.
“It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately,” said Linda Suydam, president of the Consumer Healthcare Products Association (CHPA).
“The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority.”
The CHPA and its member companies recommended the FDA to strengthen the labels on all oral OTC children’s cough and cold medicines from ‘ask a doctor’ before using to ‘do not use’ in children under two years.
According to the FDA, which is planning to discuss the safety and effectiveness of cough and cold drug product use in children, some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used.
Wyeth and Zealand Pharma advance arrhythmia treatment into Phase I trial
12 Oct 2007
This is the second Zealand-developed gap junction modifier, known as ZP1609 (GAP-134), that Wyeth has advanced into clinical trials. ZP1609 has shown pharmacological effects in animal models of both ventricular and atrial arrhythmias, and with its oral formulation, the molecule represents a novel paradigm for the potential chronic prevention of cardiac arrhythmias.
In the heart, gap junctions are responsible for conducting electrical impulses between cells to maintain the heart’s normal rhythm. Gap junction modulation is considered a promising and novel mechanism of action for the treatment of cardiovascular disorders, according to the companies.
Zealand granted Wyeth rights to the unique Zealand compound library for novel compounds with potential gap junction modifying properties. From this library the two companies have identified ZP1609 (GAP-134), a small modified dipeptide, as a potent and selective gap junction modifier with oral bioavailability.
Wyeth and Karo Bio discontinue atherosclerosis drug development
25 Sep 2007
The compound, LXR-623, had been in Phase I testing for the treatment of atherosclerosis. While LXR-623 demonstrated efficacy on biomarkers for atherosclerosis, it had an unfavorable profile for further development.
Per Olof Wallstrom, president of Karo Bio, said: “Unfortunately compounds do fail in the process but this is part of the development of pharmaceuticals. We remain optimistic about LXR as a target for treatment of atherosclerosis and for the prospects for new molecules for development.The learnings generated from the LXR-623 program will be valuable as additional potential compounds move forward.”
Swedish pharmaceutical firm Karo Bio said that the company and Wyeth remain committed to the research partnership and to advancing a new lead compound under the terms of the collaboration, which was recently extended until August 31, 2008.
European committee issues positive opinion on Torisel
24 Sep 2007
The committee for medicinal products for human use (CHMP)’s opinion for Torisel will now be forwarded to the European Commission for final approval, anticipated in November 2007. Torisel has an orphan medicinal product designation in the European Union for the treatment of renal cell carcinoma.Torisel inhibits the mTOR (mammalian target of rapamycin) kinase, an important regulator of cell proliferation, cell growth and cell survival, according to Wyeth.
Robert Ruffolo, president of Wyeth, said: “The CHMP’s positive opinion underscores the importance of Torisel, which has been shown to extend median overall survival in patients with advanced kidney cancer when compared with interferon-alpha.”
Wyeth reports reduction in new vertebral fractures with bazedoxifene
21 Sep 2007
A post-hoc subgroup analysis of women at higher fracture risk showed that bazedoxifene 20mg reduced the incidence of non-vertebral fracture by 52% relative to placebo.
With regard to the safety and tolerability observed in this clinical trial, a non-statistically significant increase in the incidence of venous thromboembolic events was observed in all active treatment groups compared with the placebo group. No safety concerns related to the reproductive systems, including breast, were observed in the bazedoxifene treatment groups.
Wyeth received an approvable letter relating to its pending new drug application for bazedoxifene for the prevention of postmenopausal osteoporosis from the FDA on April 23, 2007. In July 2007, Wyeth submitted a separate new drug application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis.The efficacy data for bazedoxifene presented at the meeting represents only a portion of the totality of safety and efficacy data that the company has submitted to the FDA.
In the trial, which enrolled 7,492 postmenopausal women between the ages of 55 and 85 with moderate to severe osteoporosis, bazedoxifene showed significant risk reduction, compared with placebo, for new vertebral fractures. Specifically, the three-year incidences of new vertebral fracture were 2.3%, 2.5%, 2.3% and 4.1% in the bazedoxifene 20mg, bazedoxifene 40mg, raloxifene 60mg and placebo groups, respectively.
Wyeth and Progenics begin new studies for methylnaltrexone
13 Sep 2007
Two of these trials will investigate the use of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients outside of the palliative care population. The third trial will investigate the use of intravenous methylnaltrexone for managing post-operative ileus in a surgical setting in patients at high risk for post-operative ileus.
The companies are studying intravenous methylnaltrexone in Phase III trials to manage post-operative ileus in patients undergoing segmental colectomy surgical procedures. All of the studies are intended to investigate additional patient populations for methylnaltrexone.
Paul Maddon, founder, CEO and CSO of Progenics, said: “Opioid-induced constipation and post-operative ileus represent important medical needs for which there currently are no approved prescription therapies. Since the beginning of the collaboration, Wyeth and Progenics have made considerable strides in the clinical, regulatory and commercial development of methylnaltrexone. These trials are designed to further our understanding of the compound in opioid-induced constipation and post-operative ileus.”
New drug application submission is planned for intravenous methylnaltrexone for managing post-operative ileus in early 2008 based on the ongoing Phase III studies in patients undergoing segmental colectomy. Additionally, the companies recently announced positive preliminary results from a Phase I clinical trial of a new oral formulation of methylnaltrexone.
US court denies Wyeth’s injunction on generic Protonix
07 Sep 2007
The US district court in New Jersey denied the motion for a preliminary injunction by drugmakers Wyeth and Altana who were aiming to stop Israel-based Teva from launching generic versions of Protonix.
Teva has a 180-day period of marketing exclusivity, which will begin to run from the date of first commercial marketing or a final court decision, CNN reported.
Teva and Sun Pharmaceutical Industries have challenged the patent for Protonix, which expires in 2010 in the US. A trial date has not been set.
In 2006, Protonix generated sales of $1.8 billion, making it Wyeth’s third best-selling product.