|Bid||285.53 x 1400|
|Ask||285.50 x 800|
|Day's Range||284.91 - 287.99|
|52 Week Range||215.78 - 344.00|
|Beta (5Y Monthly)||1.05|
|PE Ratio (TTM)||10.21|
|Earnings Date||Jan 29, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||304.29|
(Bloomberg Opinion) -- Today’s Food and Drug Administration moves much faster than it used to. That may not always be a good thing. A review of drug approvals by the agency from researchers at Harvard Medical School released Tuesday found that the FDA is approving drugs more rapidly with weaker evidence than it did in the past. That can be beneficial when it leads to needed medicines getting to market quickly, and I believe that’s the agency’s intent. As the study’s authors highlight, however, this emphasis on speed and flexibility could be eroding standards. It may be time for a gut check.The gold standard for demonstrating efficacy — and the surest way of winning drug approval — is to demonstrate success in large, well-controlled studies that result in a hard outcome. But there are faster ways to get to market. In 1992, Congress created the accelerated approval program, which can green light medicines based on “surrogate” endpoints that predict rather than confirm benefit for patients, or those that have shown a shorter-term benefit. It’s one of several initiatives that have changed how the agency works. According to the study, 80.6% of approvals between 1995 and 1997 were supported by at least two pivotal trials. That number dropped to 52.8% between 2005 and 2017. Companies that get accelerated approval have to prove their drug works with a confirmatory trial in order to gain full approval, but there’s no hard timetable no when that must be done. Thus, drugmakers often don't hurry to conduct those tests. This is problematic at best, dangerous at worst.Here’s just one case: In 2016, Sarepta Therapeutics Inc. sought approval of a medicine to treat a rare muscle-wasting disease in young boys based on weak evidence from a tiny trial. In the face of significant public pressure, the FDA approved Exondys 51 even though one of its scientists called the treatment “an elegant placebo” in a report. Sarepta is selling the drug for over $300,000 a year but has continually delayed a confirmatory trial. It’s now years away from completion, and there have been no real consequences for the delay.When companies do complete post-approval trials, it sometimes reveals a mistake. Eli Lilly & Co.’s cancer drug Lartruvo got accelerated approval in 2016. Lilly then pulled the medicine from the market last year after a larger trial found no benefit. That’s a rare outcome, but there are many expensive drugs on the market that have never moved beyond surrogate endpoints. A study of 93 accelerated cancer drug approvals between 1992 and 2017 found that only 19 had proved to help patients live longer in a followup trial. There are some good reasons for faster approvals, as former FDA Commissioner Scott Gottlieb outlined in a Twitter response this week to a critical New York Times editorial penned on Jan. 11. Scientists are better at evaluating the safety of medicines and trial design has improved, for example. And advances have made it easier to create drugs that target small populations and have dramatic effects, Gottlieb wrote.He makes good points. But the agency arguably hasn’t found the right balance between embracing advances and maintaining a high bar. It certainly has a ways to go on post-approval follow up. America is entirely unable to control the price of new medicines; the approval of marginal drugs has financial consequences. The FDA will soon face one of its most important and controversial decisions yet. Biogen Inc. is seeking approval for the first purportedly disease-modifying Alzheimer’s drug — a medicine that could be used by millions of people and cost billions — without good evidence that it works. The agency often uses unmet need as a justification for shifting standards, and there’s no bigger unmet need than Alzheimer’s. That doesn’t justify an approval based on one failed trial and another that is a questionable success at best.The agency will have to decide whether to review or approve the medicine in the next year or so. This choice is an opportunity to resist public pressure and move back toward demanding firmer proof of efficacy before drugs hit the market. To contact the author of this story: Max Nisen at firstname.lastname@example.orgTo contact the editor responsible for this story: Beth Williams at email@example.comThis column does not necessarily reflect the opinion of Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinionSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
The R&D; pipeline at Ionis Pharmaceuticals (IONS) is unsurpassed, we believe, by most leading biotech and even global drug companies, suggests biotech expert Jay Silverman, contributing editor to The Medical Technology Stock Letter.
With competition encroaching, Alexion executives are pushing plans to more than double the company’s product portfolio in the next three years, including at least one “high risk, high reward” drug candidate.
Announcement of Periodic Review: Moody's announces completion of a periodic review of ratings of Biogen Inc. New York, January 14, 2020 -- Moody's Investors Service ("Moody's") has completed a periodic review of the ratings of Biogen Inc. and other ratings that are associated with the same analytical unit. The review was conducted through a portfolio review in which Moody's reassessed the appropriateness of the ratings in the context of the relevant principal methodology(ies), recent developments, and a comparison of the financial and operating profile to similarly rated peers.
Biogen (BIIB) signs deals with Pfizer to acquire rights to a CNS candidate and develop it as potential therapy to treat certain symptoms/disorders related to Alzheimer's disease and Parkinson's disease.
Benzinga Pro's Stocks To Watch For Monday WESCO (WCC) - The company agreed to purchase Anixter (AXE) in a $4.5 billion merger. WESCO will pay Anixter shareholders $100/share. lululemon (LULU) - Shares ...
Biogen Inc. said Monday it will buy from Pfizer Inc. a potential treatment for behavioral and neurological symptoms, as a potential treatment for Alzheimer's and Parkinson's, for an upfront payment of $75 million and up to $635 million in potential milestone payments. The asset is a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for use across various pychiatric and neurological diseases. Biogen plans to develop the asset for the treatment of Sundowning in Alzheimer's disease (AD) and Irregular Sleep Wake Rhythm Disorder (ISWRD) in Parkinson's disease. "Many patients with Alzheimer's and Parkinson's suffer from debilitating sleep disorders and agitation, and we believe that the regulation of the circadian rhythm may hold promise in addressing these challenging behavioral and neurological symptoms," said Alfred Sandrock, chief medical officer at Biogen. Pfizer's stock rose 0.5% in premarket trading while Biogen shares fell 0.9%. Over the past three months, Pfizer's stock has gained 9.4% and Biogen shares have soared 32.8%, while the Dow Jones Industrial Average has advanced 7.5%.
Biogen Inc. (BIIB) today announced an agreement to acquire from Pfizer Inc. (PFE) PF-05251749, a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases. In particular, Biogen plans to develop the Phase 1 asset for the treatment of Sundowning in Alzheimer’s disease (AD) and Irregular Sleep Wake Rhythm Disorder (ISWRD) in Parkinson’s disease (PD).
The biotech has already seen its shares buffeted by issues with an experimental Alzheimer’s drug. Now it faces a decision that could hasten generic producers taking a bite out of 40% of its revenues.
A young biotech startup hoping to map out the actions of cells throughout the body has signed its second major drug development partner with biotech giant Biogen.
Starting Monday, executives and investors in the biotech, pharmaceutical, and medical-device sectors, among others, gather in San Francisco for J.P. Morgan’s annual health-care conference.
If biotech stocks were red hot at the end of 2019, expect them to be scorching next week. The J.P. Morgan Health Care Conference kicks off next Monday in San Francisco, Calif.
Today BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Invitae Corporation (NYSE: NVTA) announced that Biogen (NASDAQ: BIIB), Encoded Therapeutics, Neurogene, Praxis Precision Medicines and PTC Therapeutics joined Behind the Seizure®, an innovative, cross-company collaboration that aims to provide faster diagnosis for young children with epilepsy. The program will also be expanded to make no-charge testing available for healthcare providers to order for any child under the age of eight who has an unprovoked seizure.
Biogen stock popped in mid-October after the biotech company said a broader analysis showed some promise for its Alzheimer's treatment, aducanumab. Is now the time to buy Biogen stock?
Multiple sclerosis treatment Tecfidera has been Biogen’s top seller since 2015. If the patent holds up, the company could maintain exclusivity until early 2028.
Nearly all the price increases were less than 10%, with the median rise around 5%, a media report said.
Drugmakers including Bristol-Myers Squibb Co, Gilead Sciences Inc, and Biogen Inc hiked U.S. list prices on more than 50 drugs on Wednesday, bringing total New Year's Day drug price increases to more than 250, according to data analyzed by healthcare research firm 3 Axis Advisors. Reuters reported on Tuesday that drugmakers including Pfizer Inc, GlaxoSmithKline PLC and Sanofi SA were planning to increase prices on more than 200 drugs in the United States on Jan. 1.
For the first time in several years, not one, but two new products for Alzheimer’s disease are expected to be submitted for FDA approval next year.
Hedge funds are known to underperform the bull markets but that's not because they are bad at investing. Truth be told, most hedge fund managers and other smaller players within this industry are very smart and skilled investors. Of course, they may also make wrong bets in some instances, but no one knows what the […]
(Bloomberg Opinion) -- For all the flak the pharmaceutical industry has taken for its exorbitant pricing practices, there's no getting around the fact that it's been a pretty stunning decade for medical progress.Multiple new categories of medicines have moved from dreams and lab benches into the market and people’s lives, and investors who came along for the ride often reaped extraordinary profits. The Nasdaq Biotech Index is up 360% over the last 10 years to the S&P 500's 190%. And that’s without mentioning the hundreds of billions of dollars in takeovers that rewarded shareholders with windfalls. As 2020 approaches, it's worth highlighting how far we've come in the past 10 years in developing new therapies and approaches to treating disease, even as politicians grapple with how to rein in health-care costs without breaking an ecosystem that incentivizes the search for new discoveries. Here are some of the decade’s biggest medical breakthroughs:Cell therapies: First approved in the U.S. two years ago, these treatments still sound like science fiction. Drugmakers harvest immune cells from patients, engineer them to hunt tumors, grow them by the millions into a living drug, and reinfuse them. Yescarta from Gilead Siences Inc. and Novartis AG’s Kymriah — the two treatments approved so far — can put patients with deadly blood cancers into remission in some cases. At the beginning of the decade, academics were just beginning early patient tests. It’s still early days for the technology, and some issues are holding these drugs back. There are significant side effects, and the bespoke manufacturing process is expensive and time-consuming. That has contributed to a bruising price tag: Both of the approved medicines cost over $350,000 for a single treatment. And for now, cell therapy is mostly limited to very sick patients who have exhausted all other alternatives. Luckily, more options are on their way. Some drugmakers are focused on different types of blood cancers. Others hope to mitigate side effects or create treatments that can be grown from donor cells to reduce expenses and speed up treatment. In the longer run, companies are targeting trickier solid tumors. Scientists wouldn't be looking so far into the future without this decade’s extraordinary progress. Gene therapies: Researchers have spent years trying to figure out how to replace faulty DNA to cure genetic diseases, potentially with as little as one treatment. Scientific slip-ups and safety issues derailed a wave of initial excitement about these therapies starting in the 1990s; the first two such treatments to be approved in Europe turned out to be commercial flops. This decade, the technology has come of age. Luxturna, a treatment developed by Spark Therapeutics Inc. for a rare eye disease, became the first gene therapy to get U.S. approval in late 2017. Then in May came the approval of Novartis AG’s Zolgensma for a deadly muscle-wasting disease. The drugs have the potential to stave off blindness and death or significant disability with a single dose, and, unsurprisingly, Big Pharma has given them a substantial financial endorsement. Roche Holding AG paid $4.7 billion to acquire Spark this year, while Novartis spent $8.7 billion in 2018 to buy Zolgensma developer Avexis Inc. Dozens of additional therapies are in development for a variety of other conditions and should hit the market in the next few years. They offer the tantalizing potential not just to cure diseases, but to replace years of wildly expensive alternative treatment. If drugmakers can resist the temptation to squeeze out every ounce of value by doing things like charging $2.1 million for Zolgensma, there’s potential for these treatments to save both lives and money. RNA revolution: The above treatments modify DNA; this group uses the body’s messaging system to turn a patient’s cells into a drug factory or interrupt a harmful process. Two scientists won a Nobel Prize in 2006 for discoveries related to RNA interference (RNAi), one approach to making this type of drug, showing its potential to treat difficult diseases. That prompted an enormous amount of hype and investment, but a series of clinical failures and safety issues led large drugmakers to give up on the approach. Sticking with it into this decade paid off.Alnylam Inc. has been working since 2002 to figure out the thorny problems plaguing this class of treatments. It brought two RNAi drugs for rare diseases to the market in the past two years and has more on the way. The technology is also moving from small markets to larger ones: Novartis just paid $9.7 billion to acquire Medicines Co. for its Alnylam-developed drug that can substantially lower cholesterol with two annual treatments.Ionis Pharmaceuticals Inc. and Biogen Inc. collaborated on Spinraza, a so-called antisense drug that became the first effective treatment for a deadly rare disease. It was approved in late 2016 and had one of the most impressive drug launches of the decade. And Moderna Therapeutics rode a wave of promising messenger RNA-based medicines to the most lucrative biotechnology IPO of all time in 2018. From pharma abandonment to multiple approvals and blockbuster sales potential in under 10 years. Not bad! Cancer immunotherapy: Scientists had been working on ways to unleash the human immune system on cancers well before the 2010s without much luck. Checkpoint inhibitors — drugs that release the brakes on the body's defense mechanisms — have since produced outstanding results in a variety of cancers and are the decade’s most lucrative turnaround story. Merck got a hold of Keytruda via its 2009 acquisition of Schering-Plough, but it was far from the focus of that deal. Once Bristol-Myers Squibb & Co. produced promising results for its similar drug, Opdivo, Merck started a smart development plan that has turned Keytruda into the world’s most valuable cancer medicine. It’s now available to treat more than 10 types of the disease, and has five direct competitors in the U.S. alone. Analysts expect the category to exceed $25 billion in sales next year.If anything, the drugs may have been too successful. Copycat efforts are pulling money that could fund more innovative research. There are thousands of trials underway attempting to extend the reach of these medicines by combining them with other drugs. Some are based more on wishful thinking than firm scientific footing. Still, the ability to shrink some previously intractable tumors is a considerable advance. If drugmakers finally figure out the right combinations and competition creates pricing pressure that boosts access, these medicines will do even more in the years to come. Conquering hepatitis C: From a combined economic and public-health standpoint, a new group of highly effective hepatitis C medicines may outstrip just about anything else on this list so far. Cure rates for earlier treatments weren’t especially high; they took some time to work and had nasty side effects. The approval of Gilead’s Sovaldi in 2013, followed in time by successor drugs such as AbbVie Inc.’s Mavyret, have made hepatitis C pretty easily curable in a matter of weeks. For Gilead, getting to market rapidly with its drug proved enormously profitable; it raked in over $40 billion in revenue in just three years. Hepatitis C causes liver damage over time that can lead to transplants or cancer. The existence of a rapid cure is a significant long-term boon even if the initial pricing on the drugs made them, in some cases, prohibitively expensive. Sovaldi notoriously cost $1,000 per pill at launch and over $80,000 for a course of treatment. The good new is, treatments have become a lot more affordable, which should allow this class of drugs to have a broad and lasting positive health impact.Hepatitis C is one of the relatively few markets where the drug-pricing system has worked well. As competing medicines hit the market, the effective cost of these treatments plummeted. That, in turn, made the drugs more accessible to state Medicaid programs and prison systems, which operate on tight budgets and care for populations with higher rates of hepatitis C infection. Louisiana has pioneered the use of a “Netflix model,” under which the state paid an upfront fee for unlimited access to the drug. It’s an arrangement that will help cure thousands of patients, and other states are likely to follow its lead.Many of the medicines highlighted in this column have list prices in the six figures, a trend that’s helped drive up America’s drug spending by more than $100 billion since 2009. Building on this decade’s medical advances is going to lead to even more effective medicines that will likely come with steeper prices. I’d like to hope that policymakers will come up with a solution that better balances the need to reward innovation with the need to keep medicines accessible. That would really be a breakthrough.To contact the author of this story: Max Nisen at firstname.lastname@example.orgTo contact the editor responsible for this story: Beth Williams at email@example.comThis column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinion©2019 Bloomberg L.P.