Showing posts with label FDA decisions. Show all posts
Showing posts with label FDA decisions. Show all posts

Monday, April 3, 2017

3 Revolutionary Drugs for Chronic Pain


Flexion Therapeutics, Cara Therapeutics, and Nektar Therapeutics have entirely new ideas for how to treat chronic pain, and those ideas may reshape the market.


Flexion Therapeutics (NASDAQ:FLXN), Cara Therapeutics (NASDAQ:CARA), and Nektar Therapeutics (NASDAQ:NKTR) may soon offer patients suffering from chronic pain a better option than opioids. Here's how these companies plan to reshape the way doctors treat the 39 million Americans with chronic pain.

Tackling knee pain

Flexion Therapeutics' Zilretta is under review by the Food and Drug Administration (FDA) as a new approach to treating knee pain caused by osteoarthtritis, and positive results from trials suggest it could eventually replace corticosteroid injections for millions of patients.
A man rubs his knee because of chronic knee pain.
IMAGE SOURCE: GETTY IMAGES.
The FDA will issue a go/no-go decision on Zilretta on Oct. 6, and data from studies may be compelling enough for a green light. In trials, Zilretta patients enjoyed a median 50% reduction in knee pain, and, more importantly, that pain relief was maintained throughout a three-month period. If Zilretta's effectiveness holds up in the real world, there's a good chance it will win support with doctors and patients because pain relief from corticosteroids typically wears off within weeks -- long before the next scheduled quarterly injection.
Roughly 5 million people currently receive corticosteroid shots because of their pain, and management thinks Zilretta could fetch $2,000 per patient per year. If this estimate is on target, it won't take a lot of market share for Zilretta to be a top seller. 
Recently, rumors have surfaced that acquisition-hungry Sanofi SA (NYSE:SNY) is kicking Flexion Therapeutics' tires. It wouldn't shock me if those rumors are true. Sanofi has attempted to buy Medivation and Actelion in the past year, so it's clearly on the hunt for acquisitions. Importantly, Sanofi already markets Synvisc-One -- a hyaluronan injection used to treat knee pain -- which generates $400 million per year, so it's already got the sales force in place to turn Zilretta into a winner. 

Outperforming opioids

Cara Therapeutics thinks CR845's ability to relieve pain with less risk of addiction could allow it to capture a big share of the 24 million pain prescriptions written for opioids every year.
Instead of targeting mu-opioid receptors in the nervous system like opioids, CR845 relieves pain at the source by targeting kappa-opioid receptors in the periphery of the body. Because CR845 is designed not to pass easily through the blood-brain barrier, it delivers less of a euphoric high than opioids.
CR845 is being studied in hip and knee pain in osteoarthritis patients, and management just reported data showing that it can help reduce chronic itch in dialysis patients.
The potential to elbow market share away from opioids and deliver greater relief to dialysis patients is exciting, but more trials are required before Cara Therapeutics can file for FDA approval of CR845. Because more work needs to be done, it may be a while before this drug makes it to market. Nevertheless, this company's opportunity is big, and that makes tracking its progress worthwhile.
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Improving the standard

Like CR845, Nektar Therapeutics' NKTR-181 may eventually reduce pain patients' need for opioids. But, unlike CR845, NKTR-181 still targets mu-opioid receptors in the nervous system to deliver pain relief.
However, it does so selectively. And it's specifically designed to cross the blood-brain barrier slowly to reduce euphoria. By more precisely targeting the receptors and limiting euphoria, it may deliver similar relief to opioids with less of a risk of abuse.
Last week, the company announced results from a trial testing NKTR-181 for chronic back pain, and that trial's data didn't disappoint. NKTR-181 reduced pain relative to a placebo, and it did so without causing opioid-like levels of euphoria.
Those findings sent Nektar Therapeutics shares soaring, but the company hasn't announced its plans to file for FDA approval yet. Instead, management is searching for a bigger peer to partner with on the drug. Assuming it secures a deal, an FDA filing should come shortly thereafter, with an official regulatory decision coming 10 months later.
Todd Campbell

Monday, March 6, 2017

5 FDA Decisions to Watch Out for in Mar 2017

Image result for food and drug administration
FDA, which gave its nod to 22 treatments last year, has given its approval to 5 drugs so far in 2017. This includes Synergy’s Trulance (treatment of chronic idiopathic constipation (CIC) in adults), Amgen’s (AMGN - Free Report) Parsabiv (treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis), Marathon’s Emflaza (Duchenne muscular dystrophy), Valeant’s (VRX - Free Report) Siliq (moderate-to-severe plaque psoriasis) and Lexicon’s Xermelo (treatment of carcinoid syndrome diarrhea).

Roche Holding AG
 (RHHBY - Free Report) will also be getting a response from the FDA for Ocrevus (ocrelizumab) -- the FDA action date for this candidate was extended by three months to Mar 28, 2017 in Dec 2016. The extension resulted from additional data submitted by Roche related to the commercial manufacturing process for the drug. Roche is looking to get the drug approved for relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Roche, a Zacks Rank #5 (Strong Sell) stock, has underperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 3.1% compared to the industry gain of 6.6%.
Here is a look at a few important regulatory events scheduled for the month of March.

First up is drugmaker Merck & Co., Inc. (MRK - Free Report) which is awaiting two FDA decisions this month for its anti-PD-1 therapy, Keytruda. While a decision regarding the approval status of Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high cancer is expected by Mar 8, a decision regarding the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients with cHL who have relapsed after three or more prior lines of therapy should be out by mid-March. Keytruda, one of Merck’s new products, is already approved for different types of cancer and brought in sales of $1.4 billion in 2016. Merck is working on expanding the label of the product. Merck, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 26.5% compared to the industry gain of 6.6%.




Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) will get to know about the approval status of their eczema treatment, Dupixent, by Mar 29, 2017. Dupixent, which has blockbuster potential, is being investigated for other indications as well including asthma and nasal polyps. A confirmatory phase III study for the asthma indication is ongoing and positive results would allow the company to file for FDA approval in the fourth quarter of 2017. While both Sanofi and Regeneron are Zacks Rank #3 stocks, you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sanofi has performed better than the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 10.8% during this period. Regeneron, on the other hand, has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining 7.2% over the last one year compared to the industry decline of 2.5%.

Science-driven biopharmaceutical company Radius Health, Inc. (RDUS - Free Report) is also awaiting a response from the FDA for its regulatory application for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis. A response from the agency should be out by Mar 30. Radius is currently working on putting a commercial structure in place so that the product can be launched immediately after gaining approval. The Zacks Rank #3 stock has outperformed the Zacks-categorized Medical-Drugs industry over the past one year with shares gaining 24.8% compared to the industry gain of 4.9%.

With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance -- companies which hit the bull’s eye become overnight success stories with shares even doubling or tripling on positive news while negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.
by Arpita Dutt 
Source:https://www.zacks.com/stock/news/251688/5-fda-decisions-to-watch-out-for-in-mar-2017