|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 email@example.comTo contact the editor responsible for this story: Beth Williams at firstname.lastname@example.orgThis 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.
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.
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).
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 analysed 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.
(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 email@example.comTo contact the editor responsible for this story: Beth Williams at firstname.lastname@example.orgThis 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.
The Zacks Analyst Blog Highlights: Amarin, Amgen, Gilead Sciences, Biogen and Kiniksa Pharmaceuticals
AbbVie's (ABBV) oral JAK inhibitor, upadacitinib, receives approval in Europe for treating rheumatoid arthritis under the trade name of Rinvoq.
Catalyst Biosciences, Inc. (CBIO), today announced it has entered into a global license and collaboration agreement with Biogen Inc. (BIIB) for the development and commercialization of pegylated CB 2782 (CB 2782-PEG) for the potential treatment of geographic atrophy (GA) associated dry age-related macular degeneration (dry AMD). Under the terms of the agreement, Biogen will receive an exclusive worldwide license to develop and commercialize CB 2782-PEG and Catalyst’s other anti-C3 proteases for the potential treatment of dry AMD. Catalyst will perform pre-clinical and manufacturing activities and Biogen will be solely responsible for funding the pre-clinical and manufacturing activities and performing Investigational New Drug (IND)-enabling activities, worldwide clinical development, and commercialization.
Biogen's (BIIB) gosuranemab fails to meet primary endpoint in a phase II study evaluating gosuranemab (BIIB092) in patients with progressive supranuclear palsy, a degenerative brain disorder.
Today, Biogen Inc. (BIIB) announced topline results from the Phase 2 PASSPORT study of gosuranemab (BIIB092) for progressive supranuclear palsy (PSP). The primary endpoint, as measured by the PSP rating scale (PSPRS) at week 52, was not statistically significant. In addition, the study did not demonstrate efficacy on key clinical secondary endpoints.
(Bloomberg Opinion) -- No drug for Alzheimer’s disease does anything but treat symptoms of the degenerative ailment. The first medicine that can do more will be an enormous breakthrough. Biogen Inc. thinks it has that drug in aducanumab. It’s a treatment the company previously announced was a failure in March, but in a highly unusual move, it is trying to resurrect the medicine and gambling that it can win Food and Drug Administration approval. The company presented an expanded case for the medication at a medical meeting on Thursday.The argument over whether the drug works and is approvable may be the sector’s biggest battleground. Biotech investing is full of so-called binary events — data releases or regulatory decisions that make or break a stock. Most come for startups. Biogen employs 7,800 people, and its market cap has swung by more than $10 billion twice on aducanumab updates. Unfortunately for bulls, Thursday’s presentation did little to suggest that the drug has much of a chance.The evidence that Biogen’s medicine works is more confusing than convincing. The company halted two identically designed trials earlier this year after a preplanned analysis found that aducanumab was unlikely to succeed. After looking at new data that came in after the cutoff point for that first analysis, however, Biogen found that aducanumab had a statistically significant impact on cognitive decline in one trial. Even though the second test was still a messy failure, the company decided to push for approval anyway. This reversal adds all sorts of statistical muddiness to even the positive trial.If regulators are somehow convinced to ignore those issues, the drug’s impact looks small even in Biogen’s favored set of patients. Add in the failed trial, and the benefit is even more uncertain. The FDA might be more comfortable with that ambiguity if the drug had no side effects. That’s not the case for aducanumab, which can cause brain swelling and microhemorrhages. The burden of proof should be especially high because every other medicine testing the same mechanism for treating Alzheimer’s has failed. The company further developed its arguments for FDA leniency on Thursday with a significant focus on a theory that a mid-study dosing change and a staggered start time explains the divergence in the two studies. Fancy charts and post-hoc data slicing can’t change the fact that this is a messy trial with inconsistent results. At best, Biogen made a case for running a new clean trial to test its dosing hypothesis, not for putting this drug on the market. An approval of aducanumab would have a bigger impact than most FDA decisions. It could lead to the spending of billions of dollars in a rapid and widespread uptake of a drug that might not work and could even harm patients. It would also make mincemeat of the FDA’s approval standards and encourage more companies to press forward with questionable data.Some investors, including those that sent Biogen’s stock up about 4.5% in the aftermath of the presentation, will continue to hope. The FDA is indeed increasingly flexible when patients don’t have options, and there may be no more significant unmet need than Alzheimer’s. The agency also isn’t immune to political and patient pressure, which will be immense in this case. Biogen’s Chief Scientific Officer Al Sandrock hinted at hard-sell tactics to come, suggesting at a recent conference that the FDA would doom more people to dementia if it required another clinical trial before approval. The upside from approval would be enormous; the world needs a treatment for Alzheimer’s disease and pent-up demand from millions of patients would most likely generate huge sales. The downside is just as significant, however. If the drug fails, investors will flee a company with flat-lining growth, a weak pipeline and a tarnished management team. Statistics and high standards are likely to win out in the end. Neither are on Biogen’s side.To contact the author of this story: Max Nisen at email@example.comTo contact the editor responsible for this story: Daniel Niemi at firstname.lastname@example.orgThis 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.
Aurinia's (AUPH) lupus candidate, voclosporin, met primary endpoint of renal response rate in a late-stage study. An NDA is expected in the first half of 2020.
Biogen (BIIB) posts favorable top-line results from a phase II study evaluating BIIB059 for treating cutaneous and systemic lupus erythematosus. The study tastes success by achieving its main goal.
Biogen's (BIIB) shares decline following a rating downgrade by an analyst at Robert W. Baird on concerns related to approval of Alzheimer's disease candidate, aducanumab.
Today, Biogen Inc. (BIIB) announced positive top-line results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells, in patients with lupus. “There is substantial unmet medical need for people with lupus given the limited number of treatment options available to help manage this difficult-to-treat and chronic disease,” said Nathalie Franchimont, M.D., Ph.D., Vice President, Lupus and Multiple Sclerosis Portfolio at Biogen.