Bayer's Zevalin

Bayer says that it has won an extended approval from the European Commission for its radioimmunotherapy treatment Zevalin.The green light means that Zevalin ([90Y]-ibritumomab tiuxetan) can be used in the course of a first-line therapy after remission induction in previously untreated patients with follicular lymphoma. The drug has been approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkin’s lymphoma since 2004.The approval is based on data from a Phase III trial which showed that, when used as first-line consolidation therapy - which is given after a patient responds to a first-line induction therapy, ie chemotherapy, Zevalin significantly prolonged progression-free survival time from 13.5 months to 37 months.Anton Hagenbeek of the Academic Medical Centre, Amsterdam, and lead investigator of the aforementioned trial, said “it is particularly impressive that with one single infusion of Zevalin, we have achieved prolongation of median progression-free survival by two years, with a favourable toxicity profile”. He added that the results show radioimmunotherapy “is a very effective single agent in the treatment of follicular lymphoma”, which is one of the most common types of indolent NHL.Encouraging AMD data for VEGF Trap-EyeBayer has also presented encouraging 32-week follow-up results from a Phase II study of its vascular endothelial growth factor blocker, VEGF Trap-Eye, in age-related macular degeneration, the leading cause of blindness for people over 65 in the USA and Europe.The data, which was presented at Association for Research in Vision and Ophthalmology meeting in Fort Lauderdale, demonstrated that patients on VEGF Trap-Eye – which is being developed with Regeneron Pharmaceuticals – achieved a 6.6 mean letter gain in visual acuity versus baseline at week 16 following 12 weeks of fixed dosing, which was maintained to week 32. The decrease in retinal thickness was also maintained for all dose groups at 32 weeks.Bayer and Regeneron are hoping that VEGF Trap-Eye will become a strong competitor to Genentech’s Lucentis (ranibizumab) and the two companies are carrying out two Phase III trials comparing the two compounds.

Merck's Cordaptive in News

In a blow to the drugmaker, the agency has issued a non-approvable letter for Cordaptive, which Merck hoped would revive its cholesterol franchise, now that Zocor is beset by generic rivals and Vytorin is under siege due to the controversial Enhance study.
Instead, Merck execs are scurrying to understand the FDA decision, which the drugmaker failed to reveal. “We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile,” Peter Kim, Merck’s chief scientist, says in a statement. Abbott must be happy - its Simcor pill was approved two months ago.
The pill contains an extended-release form of niacin, which is a vitamin, and a chemical called laropiprant to stop flushing, a dilation of blood vessels that causes redness and an unpleasant burning sensation on the neck and face. Flushing is a common side effect of niacin-based drugs, and the biggest reason many patients stop taking current products, including Niaspan.
Merck hoped to market Cordaptive as a way to reducing facial flushing while simultaneously lowering LDL, or bad cholesterol, and raising HDL, or good cholesterol. Given the failure of Pfizer’s torcetrapib, some docs expressed skepticism last year over the prospects for Cordaptive. The Pfizer pill caused unexpected deaths, and a recent Cordpative study revealed an increase in liver enzymes and had an impact blood sugar for diabetics.
At the same time, Committee for Medicinal Products for Human Use recommended approval in Europe. And though some investors remained concerned about risks to blood platelets, some Wall Street analysts expected FDA approval; Sanford Bernstein’s Tim Anderson, for instance, forecast $808 million in sales by 2012.

Merck in News (29 April 2008)

Singulair: Merck & Co., Schering-Plough receive FDA not-approvable letter for combination allergy treatmentMerck & Co. and Schering-Plough announced that they received a not-approvable letter from the FDA for an allergy treatment that combines Merck’s Singulair (montelukast) with Schering-Plough’s Claritin (loratadine) in a single tablet.
The companies' joint venture, Schering-Plough/Merck Pharmaceuticals, indicated that it is evaluating the agency’s response but did not provide further details. Schering-Plough spokesperson Lisa Ellen added that “we’re…still evaluating the future of the joint venture as well.”

Fosamax increases risk of atrial fibrillation, study suggestsResults from a study published in the Archives of Internal Medicine suggest that women taking Merck & Co.'s osteoporosis drug Fosamax (alendronate) had a higher risk of atrial fibrillation, compared with those who did not receive the drug.
In the study, researchers examined data from 719 women with a confirmed atrial fibrillation incident between October 2001 and December 2004, as well as data from 966 women without atrial fibrillation. Study lead researcher Susan Heckbert noted that the findings showed that "having ever used alendronate was associated with an 86-percent higher risk of newly detected atrial fibrillation compared with never having used the drug." Nonetheless, Heckbert commented that the benefits of bisphosphonates such as Fosamax generally outweigh the risks for patients at high risk of fractures.
In response, a spokesperson for Merck noted that a recent study published in the BMJ showed no evidence linking the use of bisphosphonates to an increased risk of atrial fibrillation

Wyeth Lays Off Another 1,200 Employees

The drugmaker last Friday notified employees that still more jobs are going, a Wyeth spokesman confirms. This follows an announcement last month that 1,240 sales positions would be eliminated as part of what Wyeth execs are calling ‘Project Impact.’
The moves come as Wyeth grapples with various problems. Although the FDA recently approved the Pristiq antidepressant, the drugmaker has otherwise run into one setback after another in winning permission to market other drugs. Over the past year, the FDA has bounced a drug, demanded more data or a new patient study. Meanwhile, Wyeth expects generic competition for the Protonix heartburn med, one of its biggest sellers with sales of $1.9 billion.
Prior to the cutbacks, Wyeth execs acknowledged plans to eliminate 4 percent of its global workforce of appoximately 50,000 people by mid-year and 6 percent by year’s end. The latest cuts were made among employees “in all capacities,” the spokesman says, while declining to confirm that the Fort Dodge animal health business was spared. As we have already pointed out, 141 jobs were eliminated at Wyeth’s Pearl River, New York, plant as part of the latest round of layoffs.

Viread Approved for Hep B in EU

EU grants approval for Gilead's Viread in hepatitis Bby Bryan DeBusk
Gilead announced that the European Commission granted marketing authorisation for once-daily Viread (tenofovir disoproxil fumarate) as a treatment for chronic hepatitis B.
The drugmaker noted that the decision was based primarily on data from two ongoing Phase III trials examining the safety, tolerability and efficacy of the drug compared with Gilead's Hepsera in patients with the disease.
The company also indicated that applications are pending in the US, Canada and Australia for the use of Viread in chronic hepatitis B

GSK to acquire Sirtris for USD 720 MM

GlaxoSmithKline reported that it entered into an agreement to purchase Sirtris Pharmaceuticals for $22.50 per share in a transaction valued at about $720 million. GlaxoSmithKline said the deal is expected to boost its metabolic, neurology, immunology and inflammation research efforts.
Sirtris' lead drug candidate, SRT501, is currently in Phase II testing for diabetes, with results anticipated later this year.

Wyeth and ViroPharma halt development of thier HCV candidate

Wyeth and ViroPharma have decided to discontinue development of their hepatitis C drug HCV-796, after concerns about hepatotoxicity were raised during a Phase II trial last year.
CEO of ViroPharma Vincent Milano commented that "significant activities were undertaken to determine a clear path forward for HCV-796; however, the risk associated with potential hepatotoxicity ultimately posed too high of a hurdle to merit further development." ViroPharma also stated that the two companies do not plan to collaborate on future development of hepatitis C drugs

Ranbaxy could earn additional USD 1.5 billion in next 6 years

AstraZeneca entered into an agreement to settle US patent infringement litigation with Ranbaxy over Nexium. Under deal terms, Ranbaxy will be allowed to sell a generic version of Nexium under licence from AstraZeneca starting on May 27, 2014. Ranbaxy will have a 180-day period of exclusivity as the only distributor for generic Nexium, and conceded – as part of the agreement – that "all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable." No financial terms of the deal were disclosed.
In addition, the drugmakers entered into an agreement under which Ranbaxy will manufacture a portion of AstraZeneca's US supply of Nexium from May 2010, as well as the treatment's active ingredient from May 2009. Furthermore, the companies signed distribution deals that allow Ranbaxy to be the distributor for authorised generic versions of hypertension compound Plendil and proton pump inhibitor Prilosec in the US.
Ranbaxy CEO Malvinder Singh stated that the agreements with AstraZeneca could earn as much as $1.5 billion in revenue over the next six years