Posts Tagged → Arena
This week brought a stream of bad news on the pharma job front, with at least four companies announcing substantial cutbacks. Worse, scientists were the main target for layoffs at three of those companies—Sanofi-Aventis, Arena, and Elan. As everyone’s favorite employment watchdog Chemjobber commented on an In the Pipeline post about cuts at Abbott: When, when, when will it stop? Here’s a look back at the news from this week:
–Sanofi is shedding 90 research jobs at its Bridgewater, N.J., site as part of “the evolution of the R&D portfolio towards more biologic-based therapies,” the company told C&EN. The French pharma firm is ceasing chemical library and chemical development activities, including pharmaceutical development and analytical science. Meanwhile, discovery-stage laboratory activities within several groups, including Lead Identification Technologies, Structure, Design & Informatics, and Analytical Sciences, will be reduced.
Some people will be shifted over to the company’s Molecular Innovative Therapeutics group, which will be transformed into “a cluster of small multidisciplinary biotechs with specialized expertise in key diverse therapeutic approaches.” This new approach sounds an awful lot like what GlaxoSmithKline has been doing over the last two years—creating smaller, more independent units in the hopes of mimicking the culture and innovative spirit of small biotechs.
–Arena Pharmaceuticals is cutting 25% of its staff, or 66 employees, by the end of March. The move isn’t unexpected. Last fall, FDA gave the San Diego-based biotech a thumbs down for its obesity drug lorcaserin based on concerns that it had caused tumors in rats. Now, FDA is asking for a slew of new data, meaning Arena will be unlikely to refile its application for approval until 2012, analysts say. See here and here for more on its lorcaserin trials and tribulations.
–Abbott is slashing 1,900 jobs in the U.S., mirroring layoffs it made last year in Europe following its acquisition of Solvay Pharmaceuticals. The cuts will come from its commercial and manufacturing operations, with over half the job losses concentrated in Northern Illinois. In a conference call, Abbott CEO Miles D. White blamed the restructuring on several factors: the slow recovery of the global economy, costs associated with healthcare reform, European pricing pressures, and a harsher regulatory environment that has made it tough for drugs to get approved.
–And last but not least, Elan has laid off 10% of its staff, or about 130 workers, with its R&D site in South San Francisco most heavily impacted. Researchers accounted for about half of the job losses.
If we’ve missed any layoffs that chemists should be aware of, drop us a note or leave a comment.
Apparently, third time’s a charm in the obesity drug world. Yesterday afternoon, an FDA advisory panel recommended approving Contrave, an obesity pill being developed by Orexigen Therapeutics and Takeda. The positive vote came just months after two other obesity drugs, Vivus’ Qnexa and Arena Pharmaceutical’s Lorqess, were rejected.
There are plenty of caveats to the good news. First, FDA doesn’t always follow the advice of its advisory committees, although most analysts seem confident Contrave will make it onto the market. But Orexigen and Takeda will likely need to conduct a large, post-approval study to track cardiovascular issues, the details of which would be hammered out with FDA.
Second, excitement over the next pill for obesity should be tempered with the reality that Contrave has shown only minimal weight loss. Contrave is a combination of two already-approved drugs, the antidepressant buproprion and the addiction treatment naltrexone.
All that said, Orexigen stands to collect more money from Takeda if Contrave makes it to the finish line. Takeda paid just $50 million upfront to license the obesity drug, and will take on the lion’s share of the costs of a post-approval study.
The thumbs up for Contrave could also be good news for Vivus’ Qnexa, also a combination of two existing drugs (phentermine and topiramate). In July, an FDA advisory committee, concerned about the lack of long-term safety data for the drug, voted against its approval. FDA backed up that decision in October, issuing a complete response letter (its version of a rejection) citing birth defect worries and cardiovascular risks.
But yesterday’s panel was mainly focused on the cardiovascular risks associated with Contrave, and Qnexa is a cleaner drug on that front. One panel member, University of California, Davis, neurologist Michael Ragowski, even said he’d rather prescribe Qnexa versus Contrave. Vivus plans to submit a formal response to the CRL later this month, and FDA would provide its feedback in January. If all goes well, Vivus could gain approval for Qnexa in the second half of 2011, analysts say. Investors seemed optimistic on its chances, as Vivus’ stock is up over 20% in pre-market trading.
Orexigen is holding a conference call at 4:15pm this afternoon, to discuss the panel. If anything interesting comes out of it, we’ll be sure to update readers!
At first glance, the documents don’t contain any big surprises in terms of safety or efficacy. And Orexigen’s had time to learn from what happened at the Lorqess and Qnexa panel meetings.
That said, Adam Feuerstein makes an interesting comparison- to Meridia, Abbott Labs’ diet pill that was pulled from the market this fall because of its cardiovascular risks. We’ve known that Contrave can raise blood pressure, but the memory of Meridia may influence some of FDA’s outside experts.
Contrave’s cardiovascular risk profile somewhat resembles Abbott Lab’s Meridia, which was recently pulled off the market after a September advisory panel meeting. Eight of the 10 experts who will be reviewing Contrave Tuesday voted to recommend Meridia’s withdrawal from the market due to the drug’s cardiovascular risks. These eight experts are the people Orexigen needs to be most worried about Tuesday.
An analyst at Rodman & Renshaw in New York had similar concerns in an interview with Bloomberg.
“They may have to do a thorough cardiovascular study before approval,” said Elemer Piros, an analyst at Rodman & Renshaw in New York, in a telephone interview today. “The clear precedent is Meridia. It’s so fresh in our minds that I don’t think the FDA wants to embark on a public experiment in an uncontrolled setting without this information.”
So if more studies will be needed, it’s a good sign that Leerink Swann analysts Joshua Schimmer and Steve Yoo are impressed with Orexigen’s long-term safety strategy, according to a note sent to investors.
While no FDA panel is without risk and the track record of obesity drugs at the Endocrine Division is unquestionably poor, we have been impressed with OREX’s strategic approach to tackling Contrave’s safety-issues head on and its rational explanation for a post-approval study commitment.
That’s important because at least some of what sank Vivus’s Qnexa at its FDA advisory panel evaluation was a desire for more long-term data.
But at the end of the day, panelists who voted ‘no’ felt like more long-term safety data was in order. From Feuerstein’s liveblog:
one of the “no” votes says obesity is a chronic disease, so tell me what happens to patients as they stay on the medication for years.
Like Qnexa, Contrave is a combination of two drugs that are already FDA-approved. But it remains to be seen whether Orexigen has learned enough from Vivus’s experience to put together a convincing case for the FDA panel.
Options abound for following Tuesday’s meeting. Lisa LaMotta, now at Elsevier Business Intelligence, will be covering the panel live. Follow her @BioWriterChik. Feuerstein will as well, @adamfeuerstein. And FDA will webcast the panel here.
Tomorrow is the deadline for the Food and Drug Administration to make a decision about whether or not to approve Arena Pharmaceuticals’ experimental obesity drug Lorqess (lorcaserin). In advance of the decision I’ve recapped some Lorqess news and information from the last several months. We will update you when FDA’s decision comes in.
Of the three potential new diet pills racing to reach the market, Lorqess (lorcaserin) is the only one where the active ingredient is a completely new molecule. Its competition, Vivus’s Qnexa and Orexigen’s Contrave, are both combinations of drug molecules that have already been FDA-approved for other conditions.
Lorqess targets an appetite-suppressing serotonin receptor located in the brain. It’s the same receptor that was targeted by fenfluramine, an ingredient in the infamous Fen-Phen obesity drug combo. Fenfluramine was associated with heart valve damage and a fatal lung disorder- it was pulled from the market in 1997.
Lorcaserin is different from fenfluramine- it is more selective for the specific subtype of serotonin receptor found in the brain and avoids the one that’s found in the heart. Arena’s idea behind Lorqess was that a more selective drug might have the weight-loss benefits with fewer side effects. Arena has had to pay special attention to safety throughout lorcaserin’s development and they haven’t run into heart valve trouble.
In July, Arena landed a partner for marketing Lorqess- Japan’s Eisai.
But last month, when an FDA panel met to discuss Lorqess, the outcome was disappointing for Eisai and Arena. Background materials for the panel session raised questions about malignant tumors that occurred in rats given high doses of lorcaserin. And the panel itself recommended that FDA not approve Lorqess by a 9 to 5 vote. The panel decided not enough data was available to assuage concerns about safety, and was also concerned about how the drug would work in a wider population than was tested during clinical trials. In the aftermath of the panel recommendation, analysts suggested a number of pieces of data that Arena could provide to improve its overall package of information about Lorqess, and thus the drug’s chances. But many of the suggestions, which included a detailed study of the mechanism behind the rat tumors, and a Phase II proof of concept trial of lorcaserin and phentermine in diabetics, take years, not months.
Today’s FDA decision is sure to set the tone for the next couple of months, since Lorqess is the first of the three big contenders to be judged. FDA could decide to ask for more data on Lorqess, or make a decision outright. Stay tuned.
Arena Pharmaceuticals’ obesity drug candidate Lorqess was summarily dismissed by an FDA advisory committee yesterday, leaving many to wonder: what’s next? The panel had few questions about the drug’s efficacy, but voted it down in large part due to worrisome data showing high doses of the compound caused tumors in rats. So is there a way forward for Lorqess? Or will it be relegated to the annals of Dead-in-the-Water Obesity Drugs?
Analysts have mixed opinions on how Arena could get itself out of this pickle. Some think the biotech could salvage the drug if it could offer up one key piece of information: the mechanism of action of the tumors seen in rats.
In a call with analyst this morning, Arena suggested it had already proven this point, noting that the presentation by Gary Williams, an expert on the mechanisms of carcinogenesis, showed that the rat findings did not translate to humans. “It’s a shame there were no carcinogenicity experts on the panel,” Arena’s president and CEO Jack Lief said. “My view is they were having difficulty understanding our presentation.” The company didn’t offer much guidance as to what other data it had on hand or other studies it could conduct to close the book on the issue.
Other industry watchers are focused on another issue the panel had: the unrealistic patient population in which Arena chose to test lorcaserin. They thought the people in the trial were not close enough to the kind of folks who would really be taking the drug in the real world–in other words, people with the kind of health complications typically associated with obesity.
Later this year, Arena will release data from its BLOOM-DM study, which is meant to test the drug’s efficacy in diabetics. Cowen & Co’s Phil Nadeau suggested that trial may satisfy the agency’s patient population worries.
But JPMorgan’s Cory Kasimov was less optimistic about the diabetes data providing reassurance about the drug’s safety. “With only 604 patients randomized to either drug or placebo (not to mention dropouts), it’s just way too small to generate any satisfactory answers,” Kasimov said in a note last night. Not to mention the drug has to show it still works in this tough-to-treat group.
BMO Capital analyst Jason Zhang suggested that another path forward would be for Arena to conduct a Phase II proof of concept trial of lorcaserin and phentermine in the right patient population (i.e. diabetics). He thinks the combination should be more effective at helping people shed weight than lorcaserin alone, and notes that data from Arena and academic researchers suggest the duo would not have the same heart issues that sank the fenfluramine-phentermine combo. And improved weight loss might shift the risk-to-benefit ratio enough to make FDA more comfortable with approving the drug. The quandary, however, is that even if a combination trial was effective, chances are slim that anyone would cough up the money for a large, Phase III study.
The bottom line: doctors are unlikely to be writing out prescriptions for Lorqess any time soon. Analysts have taken sales estimates for the drugs off of their spreadsheets for the near future, with most saying 2013 is the most realistic timeframe for it to make it to the market.
This morning Orexigen Therapeutics became the second of the three leaders in the obesity drug race to partner with a larger company. They’ve successfully courted Takeda, which now gets exclusive marketing rights to obesity drug Contrave in the U.S., Canada, and Mexico, if the drug gets regulatory approval. Orexigen’s shares soared on the news, first released in the pre-dawn hours this morning.
In the deal, Orexigen gets $50 million upfront from Takeda and could nab up to $1 billion more, depending on whether Contrave meets certain regulatory and sales milestones. Further details about the agreement are available on an Orexigen press release.
Contrave refresher: Contrave is a combination of two drugs already on the market: naltrexone, which is typically used to manage alcohol or opioid dependence, and the antidepressant bupropion. Orexigen’s developed a sustained-release formulation of those active ingredients. This is thought to alleviate the nausea that cropped up in clinical trials, but also could come in handy in terms of real-world prescriptions if the drug is approved. People might want to save money by taking the generic versions of Contrave’s two components but it isn’t clear how that would work for them.
In July we covered the first partnership deal in the obesity drug race, that of Eisai and Arena Pharmaceuticals, which is developing the obesity drug candidate lorcaserin. It’s worth stepping back to compare and contrast the deals. Continue reading →
Arena Pharmaceuticals has landed a partner for marketing its weight loss drug, lorcaserin- Japan’s Eisai. This makes Arena the first of the three big contenders in the obesity drug race to nab a partner.
In the deal, announced in the wee hours of this morning, Arena gets $50 million upfront from Eisai, and stands to make more in milestone payments upon delivering the product for launch time, if lorcaserin gets approved by the FDA. Still more additional payments, which could total up to $1.16 billion, will be tiered based on how well lorcaserin sells. Eisai gets exclusive U.S. rights to market the drug. Arena’s stock jumped this morning on the news.
You can get the specifics on the deal from Arena’s press release.
OK. You know it’s news when the company provides snazzy photos with the press release.
Arena said last month it planned to go it alone with lorcaserin if it couldn’t find a partner. But at the time, Leerink Swann analyst Steve Y. Yoo said in a report to investors that “the best source of funding, in our view, would be an upfront payment by a partner for lorcaserin.”
Well, now Arena’s got that cash. What does it mean for the obesity drug race as a whole?
Around the interwebs a few folks are wondering whether the terms of the deal still signal some caution on the part of Eisai.
My two cents are that in the obesity area, safety may reassure potential partners more than efficacy does.
As we wrote back in 2009, lorcaserin disappointed investors as early Phase III trial results came to light, because the compound met some but not all of FDA’s numerical weight-loss benchmarks.
But lorcaserin’s safety profile is very good. Perhaps it’s because Arena had the most to prove. Lorcaserin targets the same serotonin receptor as fenfluramine, an ingredient in the infamous Fen-Phen obesity drug combo. Fenfluramine was associated with heart valve damage and a fatal lung disorder- it was pulled from the market in 1997.
But lorcaserin is different from fenfluramine- it is more selective for one specific subtype of serotonin receptor and avoids the one that’s found in the heart. Arena has had to pay special attention to safety throughout lorcaserin’s development and they haven’t run into heart valve trouble.
Given the history of failures in the weight-loss drug field (Fen-Phen, rimonabant, etc), and given that a weight loss drug will be taken by many people who are otherwise healthy and may not even be clinically obese, it could be that safety will turn out to be king.
Mark December 7, 2010 on your obesity drug watch calendar. Orexigen Therapeutics has just announced that on that date, an advisory committee at FDA is tentatively set to review the company’s new drug application for its obesity drug candidate, Contrave.
Symbolically, I can imagine folks might’ve preferred a different date. December 7, is, after all, best remembered as a day that will live in infamy.
But the December date is good for Orexigen in other ways. It’s much later than July 15, when FDA is set to evaluate Vivus’s experimental obesity drug Qnexa. We’ve already written about Orexigen’s opportunities to learn from its competitors.
Here’s more of what we’ve written before about Contrave.
Contrave, like Qnexa, is a combination of two drugs already on the market, bupropion and naltrexone. As we explained in 2009, Orexigen’s developed a sustained-release formulation of those active ingredients. This is thought to alleviate the nausea that cropped up in clinical trials, but also could come in handy in terms of real-world prescriptions if the drug is approved. People might want to save money by taking the generic versions of Contrave’s two components but it isn’t clear how that would work for them.
Arena Pharmaceuticals has said that if it can’t find a partner for bringing its experimental obesity drug lorcaserin to market, it plans to go it alone. Today the company announced a deal that will give them $35.5 million, which will certainly help should that come to pass.
The agreement is with Deerfield Management Company, a privately owned hedge fund sponsor that mainly invests in the healthcare area.
This is good news for Arena, Leerink Swann analyst Steve Y. Yoo said in a report to investors. The influx of funds should allow Arena to operate into the 2nd quarter of 2011 without any further financing, he says.
This funding might also come in handy because FDA’s endocrinologic and metabolic division, which will evaluate lorcaserin, is in for a busy October, Yoo adds. Not only is another experimental obesity drug, Vivus’s Qnexa, on the docket, there are two other drug candidates to be dealt with as well. Minor delays in the regulatory process might crop up because of this backlog, he says, and the funding provides a cushion for Arena in case delays do happen.
However, Yoo says that “the best source of funding, in our view, would be an upfront payment by a partner for lorcaserin.”
But will that happen? Adam Feuerstein, senior columnist at TheStreet., doesn’t think so, and he’s not holding out hope for Arena’s competitors in the obesity drug race either. On Twitter (@adamfeuerstein) this morning he wrote:
$ARNA raises more $ thru Deerfield. WIll $VVUS, $ARNA or $OREX partner before FDA panels/approval decisions? Looking increasingly unlikely.
And in other Arena news: Yesterday the company announced that the FDA advisory panel will discuss lorcaserin on September 16.
The obesity news just keeps coming this week. In a regulatory form filed with the Securities and Exchange commission today, Orexigen Therapeutics made corrections to some of the weight loss data it reported from a Phase III clinical trial of its experimental obesity drug Contrave. The corrections make the numbers look a little less sunny than before. However, the data still meet the FDA’s benchmark for clinically significant weight loss, the company writes in the filing.
Reading the filing was fascinating for me- in addition to legalese it includes a slideshow presentation for investors. Now, I’m used to seeing slideshows chockablock with structures, but this time there wasn’t a single structure to be seen. Bar graphs dominate, with pie charts a close second. The slides have a little bit of everything- much more than just clinical data. There’s even a slide (#62, for the curious) that outlines the company’s sales strategy with drug reps.
Just a few weeks ago Orexigen announced it was filing for FDA approval of Contrave. It’s not clear how this adjustment will affect the timeline for the drug’s evaluation, if at all. But even if it does lead to some delays, as an analyst reached by BusinessWeek speculates, FDA was already scheduled to finish making decisions on Contrave’s two big obesity drug competitors-Arena’s lorcaserin and Vivus’s Qnexa- first anyway.
Orexigen’s stock price went down in response to today’s news. But in the end what’s going to matter is which of the three drugs get approved, and not just their weight-loss effectiveness, but the balance they offer between weight-loss effectiveness and safety.
WSJ’s Health Blog breaks down just what FDA’s benchmarks for obesity drugs are:
Under FDA guidelines for clinical trials of obesity treatments, one of two goals must be met. A trial must show that at least 35% of the drug group lost at least 5% of body weight, but that group must be double the percentage of patients with similar weight loss on the placebo. Alternatively, a study can show that patients had an average weight loss that was at least five percentage points higher than the placebo group’s loss.