Orexigen Partners With Takeda for Potential Obesity Drug Contrave
Sep02

Orexigen Partners With Takeda for Potential Obesity Drug Contrave

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. At a glance, much looks the same. U.S.-based biotech company developing a potential obesity medication partners with a company based out of Japan. Biotech gets $50 mil upfront, with a tantalizing promise of more if certain milestones are met. But Arena's press release about the Eisai deal contains a few more specifics about pricing. I don't see comparable language in the Orexigen release. From Arena's release: Under the terms of the agreement, Arena will receive an upfront payment of $50 million from Eisai and, upon regulatory approval and the delivery of product supply for launch, up to an additional $90 million in milestone payments. Arena will sell lorcaserin to Eisai for a purchase price starting at 31.5% of Eisai's annual net product sales, and the purchase price will increase on a tiered basis to as high as 36.5% on the portion of annual net product sales exceeding $750 million. Arena is also eligible to receive $1.16 billion in one-time purchase price adjustment payments based on annual sales levels of lorcaserin and up to an additional $70 million in regulatory and development milestone payments. John Carroll of FierceBiotech noticed something's been missing from the obesity drug deals: U.S. companies. Noticeably absent from the deal-making are the U.S. pharma companies, several...

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Safety Data On Vivus’s Qnexa Doesn’t Cut It For FDA Panel-UPDATED
Jul15

Safety Data On Vivus’s Qnexa Doesn’t Cut It For FDA Panel-UPDATED

You have to feel for the FDA's Endocrinologic and Metabolic Drugs Advisory Committee this week. They'd just finished the Avandia slog, but there was no rest for the weary. No, instead, they got to sink their teeth into the first of the potential new obesity drugs, Vivus' Qnexa. In a vote that signals safety is king in the obesity drug realm, Qnexa got a thumbs down from the panel this afternoon. The panel was split, with 7 members recommending that FDA should approve the drug and 9 recommending against approval. The panel's take home message was that a lack of safety data led to their decision. Several journalists live-blogged the panel session. Here are the two play-by-plays I followed: Lisa LaMotta, Minyanville Adam Feuerstein, TheStreet This decision comes after what seemed like an optimistic week for Vivus. On Tuesday, when FDA released its briefing documents about Qnexa, media reports on the data suggested that even though the agency's review focused on safety, it didn't look like safety would be a dealbreaker. In a note to investors, Leerink Swann analyst Steve Yoo wrote, "Overall, we believe the language in the FDA briefing documents to be fairly benign, but the FDA is requesting a pregancy category X label that would include contraindication in pregnant women and a warning/ precaution for females of childbearing potential." At today's panel, as expected, nobody really dwelled on Qnexa's efficacy. But Vivus faced a lot of questions about safety, especially about the effects of Qnexa during a pregnancy. During clinical trials, 13 women on Qnexa gave birth, and none of the babies had birth defects. Because Qnexa is likely to be an appealing option for women of reproductive age if it's approved, panelists were concerned that more data are needed to make sure Qnexa is safe during pregnancy. That's because one of the components of Qnexa is topiramate, an epilepsy drug that is known to carry a risk of birth defects. What complicates things is that the dose of topiramate in Qnexa is lower than the dose used for treating epilepsy. It's also lower than the doses used in studies that suggested topiramate carries a risk of birth defects. The panel also discussed the other four safety concerns mentioned in the briefing documents: cardiovascular risks psychiatric events cognitive events metabolic acidosis 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. The deadline for FDA to make...

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Vivus’ Qnexa for Obesity: Connecting Activities With Adverse Effects?
Jul13

Vivus’ Qnexa for Obesity: Connecting Activities With Adverse Effects?

Today FDA posted briefing documents about Vivus' experimental weight-loss drug Qnexa. Recall that an FDA advisory committee is scheduled to meet this Thursday, July 15th, to discuss any concerns about the drug and give it either a thumbs-up or thumbs-down recommendation to the agency. Biotech journalist Lisa LaMotta of Minyanville had a great post earlier today on this subject, and she explains why these briefing documents are important. Historically, briefing documents can be a great indicator of how the eventual meeting will pan out. These documents usually show how the FDA is thinking and what questions will ultimately be raised when it comes time for an approval decision. (Although the FDA doesn’t have to follow the advice of the panel, they often do.) FDA's documents suggest that they've got no beef with Qnexa's efficacy- the stuff helps patients lose weight quite well. But the committee has safety concerns in five areas: effects on pregnant women cardiovascular risks psychiatric events cognitive events metabolic acidosis Today I tried to find a molecular link for some of these adverse effects and didn't find anything that was clear to me. Part of the problem is that scientists still aren't sure how topiramate, the monosaccharide molecule in the Qnexa combo, works. Now I'm not saying that's a bad thing. After all, we didn't know how aspirin worked for almost 100 years after it was on the market. But the chemist in me always loves to know more. Here's some of what I found. From a document at FDA's website: Topiramate appears to block voltage-dependent sodium channels Topiramate enhances the neurotransmitter GABA's activity at certain receptors Topiramate antagonizes a specific kind of glutamate receptor Topiramate blocks the enzyme carbonic anhydrase So there you have it. That's a lot of different activities for one little sugar molecule. It seems like it would be easier to connect some of these targets with a psychiatric adverse effect than it would be to say, effects on a fetus. But I'm just grasping at straws there....

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Orexigen’s Obesity Drug Candidate Contrave Gets 12/7 FDA Review Date
Jun23

Orexigen’s Obesity Drug Candidate Contrave Gets 12/7 FDA Review Date

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...

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Orexigen Gets Review Date For Obesity Drug Candidate Contrave
Jun17

Orexigen Gets Review Date For Obesity Drug Candidate Contrave

We now have the final FDA review deadline date for all three of the biggest contestants in the obesity drug race. Today Orexigen Therapeutics announced that FDA has assigned a January 31, 2011 Prescription Drug User Fee Act (PDUFA) date for the firm’s obesity drug candidate, Contrave. This is right about when people expected the date would be, given that Orexigen filed for the drug's approval back in April. The PDUFA date is the goal date for FDA to finish reviewing the company’s new-drug application. This is when folks will be watching for approval decisions. Orexigen's two biggest competitors are Arena's lorcaserin and Vivus's Qnexa. Both of the other drugs' FDA review deadlines are in October of this year. But as we've written before, if you're first to the finish line, you don't have the opportunity to learn from what came before. This is the part where I say "let's not get carried away, here": Anywhere from zero to all three of these experimental drugs could be approved by FDA. It's all about the balance between efficacy and safety. And none of the three companies developing the drug candidates has found a bigger company to partner with them on the project. Though the big companies might be waiting for a bit more clarity on the drugs' approvability, as Leerink Swann analyst Steve Yoo said in a note to investors last March. More reading on Orexigen...

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