An FDA advisory panel recommended that the agency approve Amgen’s denosumab to treat certain patients with osteoporosis, but did not support approval for the drug as a preventive measure against bone loss in low-risk patients, Amgen reported on Thursday. Advisory committee member Clifford Rosen remarked that “we still don’t have enough data at three years out that we can advocate for a preventive indication.”

[ad]

At a panel meeting, the committee voted that the FDA should approve Amgen’s drug to treat osteoporosis in postmenopausal women and to treat bone loss in men undergoing hormone ablation for prostate cancer. However, the panellists declined to support denosumab for treating bone loss in women undergoing hormone ablation for breast cancer. In addition, Amgen explained that committee members did not recommend denosumab to prevent bone loss in low-risk patients in any of these patient groups.

Furthermore, panellists suggested that denosumab be limited to women who have tried other treatments, until additional long-term safety data for denosumab are available regarding potential risks for developing serious infections and certain cancers. The committee voted against using the drug in patients with breast cancer who have osteoporosis, citing concerns that the compound could hasten tumour growth. “We don’t know how safe this molecule is to be given to patients with established cancer,” explained panellist Gulbu Uzel.

If approved, the panel also recommended that the FDA require a risk management plan for denosumab. Speaking at the meeting, Catherine Stehman-Breen, Amgen’s vice president of global development, told the panel that denosumab has a “favorable safety profile,” with most adverse events being “mild-to-moderate.” Amgen officials also indicated that long-term studies on the drug to be used to track safety issues are currently underway, and that the company intends to conduct post-approval studies.

Commenting on the news, Cowen and Co.’s Eric Schmidt said he believes that the worst-case scenario for Amgen would be a requirement for a patient registry for the compound, noting that “if it were to get one, the market for this drug would be very limited.”

Source: FirstWord

Popularity: 7% [?]

In FDA documents released ahead of an advisory panel meeting for Amgen’s denosumab, agency staff noted that the drug is effective at increasing bone mineral density and reducing fracture risk, but raised concerns about study data showing a slightly increased risk of malignant tumours and serious infections in patients who took the drug. “Of particular concern…is whether the risk/benefit balance for the osteoporosis prevention indication, both for patients with and without cancer, supports approval,” the reviewers explained.

[ad]

According to available trial data, FDA staff said 4.1 percent of patients taking Amgen’s RANK Ligand inhibitor reported serious infections, versus 3.3 percent of patients given placebo. Higher infection rates among denosumab-treated patients were observed with regard to skin, ear, and urinary tract infections, including an increase in skin infections that required hospitalisation. In addition, regulatory staff noted that data from six clinical trials suggested that women taking denosumab were slightly more likely to develop cancers of the breast, pancreas, intestine and reproductive system. The staff also said there was a “potential for tumour progression in patients with cancer.”

Amgen is asking for approval to sell denosumab for the treatment and prevention of osteoporosis in postmenopausal women, and the treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer. The advisory committee will meet on August 13, while the FDA is expected to render its decision on the drug in October.

Commenting on the concerns raised by FDA staff, BMO Markets analyst Jason Zhang said the safety issues were “not surprising,” but he indicated there was speculation that regulators will order a strict risk-management plan for denosumab. Cowen & Co.’s Eric Schmidt wrote that a risk programme or warning label “would significantly impair denosumab’s potential for osteoporosis,” however he believes the drug has “robust potential in oncology.” Analyst Geoff Meacham of JPMorgan Chase & Co. remarked that he views the briefing documents “as relatively benign and supportive of approval with a broad label.”

Source: FirstWord

Popularity: 7% [?]

Bayer and Onyx reported preliminary results from a mid-stage study on Wednesday which showed that Nexavar (sorafenib), in combination with Roche’s Xeloda (capecitabine), significantly extended progression-free survival in patients with advanced breast cancer, compared to Xeloda alone. Lead investigator Jose Baselga remarked that “one goal of this study was to evaluate the success of an all-oral regimen, which may represent a unique treatment option for patients with breast cancer.” Onyx shares rose as much as 24.3 percent on Wednesday.

[ad]

The randomised trial involved 229 patients with locally advanced or metastatic HER-2 negative breast cancer who had received no more than one prior chemotherapy, and who were given either Nexavar or placebo twice daily, plus treatment with Xeloda. The companies stated that full results will be presented at a future scientific meeting.

Commenting on the news, Cowen & Co. analyst Eric Schmidt remarked that “enthusiasm is somewhat tempered” because the duration of benefit is not known and because it is unclear how long trials of the drug in breast cancer will take. Nexavar is already approved in countries worldwide to treat kidney and liver cancers.

Source: FirstWord

Popularity: 5% [?]

Genentech on Monday reported a second case of progressive multifocal leukoencephalopathy (PML) which resulted in the death of a 73-year-old patient who had been treated with Raptiva (efalizumab) for about four years for chronic plaque psoriasis. The case follows another that was reported in October involving a 70-year-old patient who died after taking the drug for approximately the same length of time.

[ad]

The company said that the medical information available for both cases suggests that the drug “likely increases the risk of PML and that prolonged exposure to Raptiva and older age may further increase the risk.” Genentech noted that the drug’s prescribing information was updated in October to include a boxed warning about the risk of serious infections, including PML, in patients who take Raptiva, and indicated that it is working with the FDA to determine what steps to take next.

Commenting on the development, Cowen and Co. analyst Eric Schmidt remarked that the latest case was “not shocking” given the previously reported instance of PML.

Raptiva, which is approved for the treatment of plaque psoriasis, garnered $107 million in US sales last year.

Source: FirstWord

Popularity: 3% [?]

Shares of Biogen Idec fell nearly 10% and shares of Elan fell more than 20% in after-hours trading on the latest report of a serious brain infection in a patient taking Tysabri, the multiple sclerosis drug co-marketed by the companies.

[ad]

This is familiar ground. Both companies saw sharp declines this summer on a report that two patients taking the drug developed progressive multifocal leukoencephalopathy, or PML. (The chart at left, which goes through the close of trading yesterday, shows the summer decline but not the latest one.)

It’s a big deal because three cases of PML, which can be deadly, were enough to take the drug off the market a few years back. Tysabri was re-introduced under a strict safety program, which includes surveillance to catch the infection early.

“The fact that the PML case was detected early indicates that the safety monitoring program appears to be doing its job,” a spokeswoman for the National MS Society told the WSJ.

After the two cases were reported in the summer, the FDA announced some modifications to the drug’s label, but didn’t make any major regulatory changes.

Patients and doctors may take the news in stride. “Since the last two cases were disclosed we’ve had about 3,000 patients on the drug — about 1,000 a month … I think every case that comes along next will have minimal impact as long as that rate stays about 1 in 1,000,” Cowen & Co analyst Eric Schmidt told Reuters.

Source: The Wall Street Journal

Popularity: 3% [?]

Some analysts on Wednesday predicted that Genentech’s strong third-quarter results will drive Roche to raise its offer to acquire the company. In July, Roche proposed to purchase the shares in Genentech that the drugmaker does not already own for $89 per share, or about $43.7 billion, which was rejected by Genentech’s board of directors as too low.

Oppenheimer & Co.’s Bret Holley commented that “we do not see anything in the third quarter results that will disappoint Roche, and we believe this should increase the company’s resolve to complete an acquisition,” adding that “we continue to believe that Roche will increase its offer to $102 to $110 a share.”

In contrast, other analysts anticipate that given current economic conditions, the Swiss drugmaker is likely to propose an offer that is only modestly higher than the original proposal. Lazard Capital Markets’ Joel Sendek lowered his projection to $98 per share, while analysts at Citigroup also decreased their target price, from $108 per share to $96. Roche did not comment on the speculation, but a spokesperson commented that the company “remains committed to the transaction.”

In related news, Genentech’s president of product development Susan Desmond-Hellman noted that the company expects to release data this quarter from the late-stage C-08 study on Avastin as an adjuvant therapy in patients with colon cancer. Regarding the impact of the results, Cowen and Co.’s Eric Schmidt remarked that “while we think the outcome of [the trial] is no better than a coin toss, success would drive dramatic ($5 billion-plus) upward revisions to Avastin sales,” adding that “as Roche would need to pay up upon any success, Genentech shares appear to have upside with minimal downside into the next interim analysis.”

Source: FirstWord

Popularity: 7% [?]