That U.S. Senate probe of GlaxoSmithKline and its diabetes drug Avandia may not yield any new regulatory action. But with more than 13,000 personal injury lawsuits outstanding, UBS analysts say, the company could be looking at a multibillion-dollar liability.

The safety of Avandia has been open to debate for almost three years now, and the Senate report didn’t bring up anything entirely new about the drug’s risks. The FDA already was planning to look at safety info on the diabetes med again, with a new advisory panel meeting on the schedule for this summer. The worries focus on a.) political pressure from the Congressional committee that sponsored the probe; and b.) those lawsuits.

“[O]ur concerns are solely on personal injury lawsuits,” UBS analyst Gbola Amusa said. Experts polled by UBS put the potential liability at anywhere from $1 billion to $6 billion; the bank itself expects something less than $3.5 billion. “Bellwether trials start from 1 June and will help narrow our liability range,” Amusa also notes.

Source: FiercePharma

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Now that the cardiovascular drug market has a couple of new entries, analysts are applying their skills. Their take: Eli Lilly’s clot-buster Effient has been “sluggish” out of the gate, while Sanofi-Aventis’ atrial fibrillation drug Multaq has hit the ground running. But even Multaq hasn’t made huge advances.

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According to data from IMS/Leerink Swann (as quoted by BNet Pharma), Sanofi’s Multaq captured 3,606 scrips over a five-week period. Lilly’s Effient, by contrast, accounted for only 1,823 scrips over the same period. “These IMS data reinforce our view that Effient’s U.S. launch will be muted,” Leerink’s accompanying investor note stated.

There’s a caveat, however. The drugs hit the market in the summer, when folks are vacationing, not going to the doctor to tune up their drug regimens. That’s likely to slow initial uptake. Plus, Effient’s indication for post-procedure use means that it’s started in the hospital, and drug-sales trackers don’t have access to those scrips. So its numbers could see a quick upswing once those hospital scrips move to the pharmacy.

“There will be a delay in prescription data showing up in IMS, given that initial use occurs in the hospital setting,” Lilly CFO Derica Rice told investors at a UBS conference (as quoted by Dow Jones). He added that Lilly has made “positive” progress in persuading health insurers to pay for the drug. We’ll keep an eye on the figures to see if those efforts bear fruit on the scrip side.

Source: FiercePharma

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Sanofi-aventis announced that the FDA approved Multaq (dronedarone) to reduce the risk of cardiovascular hospitalisation in patients with atrial fibrillation or atrial flutter. The company said it plans to launch the drug in the next three months.

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The FDA believes Multaq “represents a therapeutic innovation for treatment of the heart rhythm disorder of atrial fibrillation,” according to  director of the agency’s division for cardiovascular and renal drug products. However, Multaq is contraindicated for patients with severe heart failure. Sanofi-aventis explained that it will implement a risk mitigation programme that will help physicians identify appropriate patients to ensure the safe use of the product.

In response to the news, UBS analyst Gbola Amusa noted that the prescribing limits signal that Multaq may have “a slow uptake out of the gate,” with meaningful earnings contributions beginning around 2011. Nonetheless, he remarked that “the drug is now approved, ending sanofi-aventis’ streak of pipeline futility.” The analyst forecast that annual sales of Multaq, which is currently under review in Europe, will reach 1.4 billion euros ($2 billion) in 2015.

Source: FirstWord

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Multaq, Sanofi-Aventis’s treatment for heart-rhythm disorders, has made a comeback. Rejected by the FDA in 2006 because of safety concerns, the agency has approved Multaq, the company announced today.

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The drug approval is the French drug maker’s first major U.S. approval in seven years, according to Bloomberg. Late last year, Sanofi decided to discontinue development of obesity drug Acomplia, which was once thought to have much promise. Lately, the company has faced questions lately about whether its diabetes drug, Lantus, is linked to cancer.

Sanofi has predicted that Multaq, which treats atrial fibrillation and atrial flutter, eventually will bring in annual sales of more than $1 billion, notes Dow Jones Newswires.

The FDA rejected Sanofi’s initial attempt for approval because a study showed that patients on Multaq were more likely to die than those who received a placebo. The company has since conducted more research looking at patients at a less-advanced stage of heart disease.

Sanofi will also implement a risk evaluation and mitigation strategy to help “ensure the safe use of Multaq” and help health-care workers identify patients appropriate for the treatment, according to the company.

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“The drug is now approved, ending Sanofi’s streak of pipeline futility,” UBS analyst Gbola Amusa told Dow Jones.

Source: The Wall Street Journal

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UBS analysts said Bristol-Myers Squibb is not in discussions to buy a stake in Elan, Bloomberg reported. Roopesh Patel and Keyur Parekh remarked on Monday that Bristol-Myers Squibb “has confirmed to us that it is not currently in talks to buy a minority stake.”

Shares in Elan rose as much as 10 percent Monday following recent reports that the US drugmaker was one of two serious bidders for a minority stake in Elan, according to people with knowledge of discussions.

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The analysts from UBS explained that both Bristol-Myers Squibb and Elan are focused on specialty drugs for Alzheimer’s disease, Parkinson’s disease and multiple sclerosis. Patel and Parekh commented that the value of a potential deal would depend on a positive outcome for trials of experimental Alzheimer’s disease drug bapineuzumab, “which in our view has meaningful development risks,” they noted. Bapineuzumab is being jointly developed by Elan and Wyeth, which is in the process of being acquired by Pfizer.

Bristol-Myers Squibb spokesman Brian Henry commented that the company “has no comment on rumours and speculation.” Elan spokeswoman Niamh Lyons declined to comment on the matter as well.

Source: FirstWord

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GlaxoSmithKline and Pfizer announced Thursday that the drugmakers agreed to combine their HIV-drug segments into a new company focused on the research, development and commercialisation of HIV medicines. GlaxoSmithKline CEO Andrew Witty stated that “at the core of this specialist business is a broad portfolio of products and pipeline assets, which can be more effectively leveraged through the new company’s strong revenue base and dedicated research capability.”

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At the closing of the transaction, expected in the fourth quarter, GlaxoSmithKline will control 85 percent of the joint venture and Pfizer will hold 15 percent. According to the terms of the agreement, Pfizer’s interest could rise to as much as 30.5 percent in the event that certain sales and regulatory milestones are achieved. Dominique Limet, head of GlaxoSmithKline’s Personalised Medicine Strategy, was appointed CEO designate of the combined entity.

The new company will have 11 marketed products, including Combivir (lamivudine/zidovudine), Epzicom/Kivexa (abacavir/lamivudine), and Selzentry/Celsentri (maraviroc), and will hold a 19-percent share of the HIV market. The company will have 6 drugs in its pipeline, including 4 compounds in mid-stage development, as well as 17 molecules at its disposal to develop in fixed-dose combinations as possible new HIV treatments. Based on 2008 results, sales from the combined portfolio reached 1.6 billion pounds ($2.4 billion).

Commenting further on the deal, Witty remarked that “this is a new and unique way of incentivising research success and deciding how to allocate research and development capital.” He said the new company is “going to have two parents out there with, I think, a very rapid decision-making mechanism to allow it to be funded for what it needs to do.” The executive also explained that the new venture will not include GlaxoSmithKline’s vaccine programme. “Who knows down the road whether or not there would be a commercial collaboration opportunity if and when those vaccines make it to market, but they’re not currently scheduled to go into this business,” Witty noted.

In response to the news, analyst Navid Malik of Matrix Corporate Capital suggested that “GlaxoSmithKline is looking to consolidate its franchise through this tie-up with Pfizer, who are probably looking to exit HIV.” In addition, he suggested that “it’s quite a dramatic step, for two rival companies to put their pride aside and work together like this. But if they don’t there is a good chance that both their HIV businesses will fade away over time.” UBS analyst Gbola Amusa said the agreement could lead to more partnerships that result in company break ups and sales, and speculated that “we’ll look back in a few years and highlight this deal as being industry-shifting.”

Source: FirstWord

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Sanofi-aventis CEO Chris Viehbacher reportedly told employees that the company is seeking to bolster its pipeline through acquisitions and preparing to diversify business operations. Company spokesperson Jean-Marc Podvin confirmed that the CEO made a presentation to employees on January 30, but described the contents of Viehbacher’s speech as “internal” and declined to elaborate further.

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According to certain reports, the drugmaker has held talks with lenders regarding potential deals and Viehbacher told staff the company has resources totalling 4 billion euros ($5.1 billion). Analysts at UBS estimate sanofi-aventis could raise 17 billion euros to 20 billion euros ($22 billion to $26 billion).

Meanwhile, the Financial Times reported without citing sources that potential acquisition targets include Bristol-Myers Squibb, whose shares gained as much as 6 percent on Monday.

Source: FirstWord

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GlaxoSmithKline on Thursday reported that the company will undertake the first late-stage trial to test the long-term efficacy of its experimental Lp-PLA2 inhibitor darapladib in patients with chronic coronary heart disease. Patrick Vallance, head of GlaxoSmithKline’s drug discovery division, stated that “we are prepared to take a risk in an area where risk-taking is necessary if we’re going to change the treatment paradigm.”

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The STABILITY study is expected to involve more than 15 000 patients who will be randomised to receive either darapladib once-daily or placebo, in conjunction with standard care, which could include statins and hypertension medications. The trial will evaluate efficacy of long-term treatment with the Lp-PLA2 inhibitor on the incidence of first occurrence of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. GlaxoSmithKline said that the trial will last about three years. The drugmaker also plans to initiate a second 12 000-patient trial with darapladib late next year in the post-acute coronary syndrome population.

Patrick Serruys, a cardiologist who headed the steering committee of earlier tests on darapladib, commented that while statins alone have not been able to inhibit Lp-PLA2, “we don’t know what a statin will do on the necrotic core using another mechanism of action.” Serruys believes that new markers to detect risk for heart attack and stroke may be necessary given that some people who have low cholesterol can still experience those cardiovascular events. He suggested that if darapladib could demonstrate efficacy among patients who do not benefit from statins, “this could be the start of a new post-statin era.”

Commenting on the news, American College of Cardiology President-elect Alfred Bove indicated that it is unclear how reliable the ultrasound measurement system used in the trial will be, but he added “you’ve got to give these guys credit for putting $50 or $60 million on the line…It is the right pathway to look.” In September, the company reported that the drug missed the primary endpoints in the mid-stage IBIS-2 trial, but opted nonetheless to pursue late-stage testing of the drug, saying that the results showed that darapladib may lower the risk of plaque rupturing and heart attack.

Regarding the sales potential for the investigational compound, UBS analyst Gbola Amusa said he suspects the compound “could be one of the most successful drugs in history.” He added that “it’s still high-risk, high-reward; it still could be wildly successful or an outright failure.” UBS analysts speculate that the drug, which was co-discovered with Human Genome Sciences, could generate annual sales exceeding 5 billion pounds ($7.7 billion).

Source: FirstWord

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AstraZeneca CEO David Brennan on Monday stated that it was too early to forecast how Crestor (rosuvastatin) sales would be impacted by new study data showing that the drug significantly reduced the risk of cardiovascular events and related deaths in people with normal cholesterol who had elevated levels of C-reactive protein (CRP).

The executive commented that “we’ve seen a flurry of estimates from analysts about the commercial impact of [the study], some of them pretty bullish. I would urge caution when forecasting the speed of such changes.” Brennan also noted that it is “reasonable to think” that the data will be considered when the American College of Cardiology and other groups update their treatment guidelines for heart disease next year.

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Commenting on the results, Helvea analyst Odile Rundquist indicated that the latest Crestor data, combined with the drug’s use for treating atherosclerosis, will help differentiate the product from Pfizer’s Lipitor and other statins. Rochelle Chaiken, Pfizer’s global vice president of cardiovascular medicine, noted that Lipitor reduces levels of CRP “as well as Crestor”. “Ultimately, that’s what you want,” Chaiken said, adding that “if you’re looking to achieve a lower LDL, you need to increase the dose, and Lipitor has a range of safe, healthy doses.” Brennan remarked that the benefits shown by Crestor do not necessarily extend to other statins, suggesting that “we know all statins are not created equal.”

Dresdner Kleinwort’s Tim Franklin suggested that while some physicians may choose to prescribe generic statins, many will likely opt for AstraZeneca’s drug. The analyst noted that “the surprising level of risk reduction observed with Crestor compared to previous statin studies also tells us that it is not always possible to extrapolate from one product to another or from one set of data to another quite so easily.” Findings from another study found that patients using higher doses of generic statins, particularly simvastatin, which Merck & Co. markets as Zocor, were at a higher risk of developing rhabdomyolysis. Sanford C. Bernstein’s Timothy Anderson also cautioned that physicians may have concerns about the safety of aggressive long-term treatment of patients with normal cholesterol.

Helvea’s Rundquist had predicted that Crestor would generate revenue of $5.4 billion by 2012, but now expects an additional $500 million in US sales if use of the treatment is extended to new patients. Meanwhile, analysts at Morgan Stanley forecast that sales of the product could reach as much as $8 billion in 2014, while UBS’ Gbola Amusa noted that Crestor sales could increase to at least $7 billion in 2012. The drug had sales of $2.8 billion last year.

Source: FirstWord

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ImClone chairman Carl Icahn on Tuesday dismissed Bristol-Myers Squibb’s revised offer of $62 per share for the biotechnology company.

Responding to Bristol-Myers Squibb CEO James Cornelius, Icahn noted that an unidentified drugmaker, which proposed to buy the company for $70 per share has until September 28 to conduct a review of financial records before launching a formal bid. “In light of these facts, your hostile tender of $62 [per share], at this time, seems absurd,” Icahn stated. Commenting on the development, UBS analyst Roopesh Patel noted that “if the competing bidder is for real, we expect Bristol-Myers Squibb to walk away.”

Some analysts expressed that the ongoing communications between the companies were becoming distracting. Rodman & Renshaw’s Michael King called the exchanges between Cornelius and Icahn “juvenile” and remarked that the executives “should stop the nonsense and get it done, or make another agreement.”

Bristol-Myers Squibb spokesperson Brian Henry declined to comment on the response from ImClone, whose shares rose as much as 6.9 percent on Tuesday.

Source: FirstWord

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