Thursday, February 12, 2015

Rhopressa & Trabodenoson: Two New Glaucoma Meds

I am copying and pasting an article from Reuters: New wave of drugs poised to shake up glaucoma treatment BY TONI CLARKE WASHINGTON Tue Feb 10, 2015 1:10am EST (Reuters) - For the first time in 20 years, patients suffering from the eye disease glaucoma may soon have new treatments as several young companies look to shake up the $5.6 billion global market There is no cure for glaucoma, which damages the optic nerve and is expected to affect more than 4 million Americans by 2030, up from 2.7 million today. But treatments help patients manage the disease and may prevent the onset of blindness. The new treatments promise to improve outcomes and reduce side-effects associated with current medicines, exploiting a long dearth of innovative new products for the disease. No new class of medicine has been introduced since Pfizer Inc’s Xalatan, known generically as latanoprost, in 1996. The newcomers aim to disrupt market-leaders Alcon, a division of Novartis AG, Allergan Inc, Pfizer and Valeant Pharmaceuticals International Inc. Leading the pack is Aerie Pharmaceuticals Inc, which plans to launch its novel eye-drop Rhopressa in 2017 and another treatment, Roclatan, a year later. The company sold 6.7 million shares for $10 each in its 2013 market debut. They now top $26. Following Aerie is Inotek Pharmaceuticals, whose trabodenoson eye-drop is entering late-stage trials expected to be completed by 2017. Inotek has announced plans to sell 4.6 million shares at between $13 and $15 each in an IPO expected soon. Drugs to combat glaucoma, the second-leading cause of blindness in the world, work by reducing pressure inside the eye. Aerie and Inotek's drugs are the first to target the trabecular network, the main drain through which fluid flows out of the eye, though they do so in different ways. Taking a different approach is Ocular Therapeutix Inc, which is developing a tiny device that can be inserted into the eye to deliver regular medication. The product is in mid-stage clinical trials. Ocular's shares have risen to more than $30 from their IPO price of $13 last year. "There's a new graduating class of next-generation treatments," said William Slattery, partner at Deerfield Management Company L.P., which holds shares in Aerie and recently provided the company with $125 million in financing. Prostaglandins are the most widely-prescribed glaucoma drugs. They include latanoprost, Alcon’s Travatan, and Allergan’s Lumigan. But prostaglandins can cause eye redness and changes to eye pigmentation and eyelash length. Most patients need extra therapies such as timolol, a decades-old beta-blocker that lowers eye pressure but can slow a patient’s heart beat. Rhopressa and trabodenoson work differently. They do not cause changes to eye pigmentation or lash length, though Rhopressa can still cause red eye. Experts say even incremental improvements in treatments would be welcome. "We continue to have people who are going blind from glaucoma and that's a problem," said Dr. Wiley Chambers, deputy director of the U.S. Food and Drug Administration’s transplant and ophthalmology products. "We need alternatives." WAVE OF INNOVATION So far, analysts are betting that Aerie's second drug, Roclatan, will be the most effective at lowering eye pressure. It is a fixed-dose combination product that includes Rhopressa and latanoprost. Both those constituents cause red eye, however. Inotek's trabodenoson does not appear to cause red eye, making it a potentially attractive product for physicians to prescribe as an add-on therapy. The company is also testing it in a fixed dose combination with latanoprost. Vicente Anido Jr., Aerie's chief executive, predicts that Rhopressa and Roclatan could generate $1 billion apiece worldwide a year. "We think we could end up being the next Allergan or Alcon," he said. Some analysts agree with Anido's projections, and say that Aerie could become a takeover target if late-stage clinical trial data to be released mid-year are positive. But Catherine Daly, a neurology and ophthalmology analyst at research and consulting firm GlobalData Healthcare, thinks Aerie's projections are too high. She sees combined sales closer to $600 million. "It's going to take a lot to move people away from using prostaglandins, which have a long track record," she said. Daly predicts sales of trabodenoson will be less than half those of Rhopressa and Roclatan, in part because Aerie is projected to reach the market first. In addition, Aerie's drugs may work in a broader patient population, including those whose eye pressure is normal but are still losing vision. Inotek, which last year hired long-time biotech executive David Southwell as its chief executive, has received less attention than Aerie. That could change after the company goes public. Southwell is a former investment banker and canny dealmaker. As chief financial officer at Human Genome Sciences he oversaw that company's $3 billion sale to GlaxoSmithKline Plc in 2012. The wave of innovation comes as big drugmakers are getting out of eye-care or consolidating. The most innovative of the big company products appears to be Bausch & Lomb's Vesneo, which represents an advance on existing therapies and could be on the market by next year. It combines latanoprost with nitric oxide to add an extra pressure-lowering boost. The company has said the drug could generate $500 million in u.s. sales and $1 billion globally. Alcon, whose glaucoma treatment revenues stood at $1.3 billion last year, said it was "evaluating external partnerships" for access to new glaucoma technologies. Firms are also working on new drug delivery mechanisms. Allergan's bimatoprost SR is in late-stage clinical trials and could become the first long-acting implant to reach the market. Still, it faces competition from several small firms including Ocular Therapeutix, pSivida and Mati Therapeutics. “By using their own proprietary delivery platforms with other prostaglandin drugs they could become major competitors to Allergan in the future,” Daly said. (Editing by Stuart Grudgings)

Monday, February 9, 2015

RWATCH M26 Smartwatch Review and Help w/ "Please install BT Notifier in smartphone" Error

So for Christmas I asked for a Samsung Gear smartwatch to pair with my Samsung Galaxy s5. Well I didn't get one. Not surprising b/c they're $200+. I thought about buying one for myself but then...*I* didn't want to spend $200 either! I mean I almost did, but I haven't yet. After a little internet research I ended up buying one of these doodads from China for $35 from I got it after a few weeks...slow shipping b/c it's from China and who wants to pay for expensive shipping? That's one of the points of this is that I'm trying to save money here! So after I went and got it from the post office (b/c it required a signature) I took it to my office and started playing with it at lunch. It came with a charging cable so I plugged it in (using my own usb "box") and charged it. The 1st problem I encountered was the software: the instructions came with a QR code to download the software for the phone, problem was when you use the QR code you're directed to a Chinese website. Well that's a problem if, like me, you don't read Chinese. So I went to the Play Store and searched "RWATCH" and downloaded the RWATCH app! Installed it, turned the watch on and bluetooth-paired it with my Galaxy s5...everything seemed to work until I tested to see if I could get a text message, I got an error: "Please install BT Notifier in smartphone". Uh oh. So I started Googling. Based on some android forums I had read, I installed, tried and then uninstalled 3 more apps that did not solve the problem, including an app actually named "BT Notifier". I was still getting the dreaded "Please install BT Notifier in smartphone" error. Very frustrating! I have the new (as of Feb 2015) "Lollipop" android iOS and I suspect this was part of the problem. Finally, buried in one of the many forums I found a suggestion to get an app called " EDIT: SmartWatch7.1.3.apk (See 2nd comment below) " This was totally the solution! I downloaded and installed the app and it made me register with an email address, login and password, which I then had to use to actually log into the app. After some setup to allow push notifications, etc I tried it out and it totally works! When the phone is BT paired with the RWATCH I can call and make calls, receive and read SMS, and even use the OK GOOGLE/Google Voice commands to open apps, send SMS, etc. My "Assistant" app (android version of Siri) even talks to me thru the speaker and reacts to commands from the mic on the watch! It's pretty cool! I'm having fun with it! Hopefully if someone googles "Please install BT Notifier in smartphone error", this post may come up and save them some grief! Good luck saving money out there!

Wednesday, February 4, 2015

Alcon's "Pazeo" Receives FDA Approval

Once a day ocular antihitsamine (anti-itch): "FDA has approved olopatadine hydrochloride ophthalmic solution (Pazeo, Alcon, a division of Novartis) 0.7% for the treatment of ocular itch relief related to eye allergies. Pazeo is a 1-drop daily ocular itch relief product for allergic conjunctivitis." Olopatadine is the same drug as the old "Patanol" and "Pataday", except in a more concentrated form (0.7% for Pazeo vs 0.1% and 0.2% for Patanol and Pataday, respectively). The itch relief is supposed to last longer with the increased concentration.

Monday, January 26, 2015

1-800-CONTACTS and the Terrible, Horrible, No Good, Very Bad Unilateral Pricing Policy

So over the weekend I read this article about a legislative fight in Oregon: Basically 1-800-CONTACTS is presenting a bill into the Oregon State Legislature trying to make it illegal in that state for manufacturers to set a unilateral pricing policy. I predicted this in JUNE: Here's the jist of it if you're a consumer and you want to understand how this affects you. In the 90's when disposable soft contacts became all the rage, OD's were making a killing selling contacts. Along came 1-800-CONTACTS who negotiated deals directly with the contact lens manufacturers (mainly Johnson & Johnson for their Acuvue products, but all of the big manufactuers eventually followed suit). They were able to get special pricing from J&J because they bought in bulk. Hundreds of thousands of boxes all at once for a very low price, to be warehoused and sold directly to consumers, bypassing the OD's. First by phone (hence the now-antiquated "1-800" moniker because who these days is really all that worried about long distance charges?) and then later on the web. Contact lens prices plummeted. Patients benefitted. Now 1-800-CONTACTS (and others) made a killing. OD's lost a major source of revenue. So much revenue, in fact, that to make up for it the docs came up with "contact lens fitting fees" because they literally couldn't afford to spend the time and effort on the exam and follow up visits only to have the patient "walk" with their Rx and buy contacts from 1-800-CONTACTS for literally less than the OD could buy them from J&J. The market stayed this way basically for most of the 90's and all of the 2000's with 1-800-CONTACTS making plenty of money. This did not please OD's for many reasons: one is the obvious cut in revenue. But there were others: 1-800-CONTACTS marketed directly to the consumer. They did (and do) shady things to sell contacts. For instance: when you order a box of contacts, they are required to contact your OD to "verify" the Rx. Contacts are medical devices and need to fit correctly, etc and laws are in place to make sure that you are ordering and 1-800-CONTACTS is selling you the contacts your doctor Rx'd...not just whatever you want or whatever is the cheapest or whatever 1-800-CONTACTS makes the most money on or has in stock. In most states if the doctor does not respond to the verification request within 48 hrs, 1-800-CONTACTS has the right to "fill" the Rx w/o the verification. They call this "passive verification". In other words, if the OD doesn't respond they are assuming the OD is okay with it. Well take a guess when 1-800-CONTACTS would fax the verification request? How about Friday at 5:15pm? Then by Sunday at 5:15pm they are ready to ship! Monday at 9am when the fax machine is checked and it turns out the patient hasn't had an eye exam in 3.5 years...TOO LATE! The order has been shipped! Genius. These and other practices made the OD's and the 1-800 companies virtual enemies. The OD's were no saints, either. They invented the idea of "private label" contacts...negotiating a SEPARATE deal directly with a contact lens manufacturer to have contacts "branded" under a different name so that they are not available to be bought from 1-800-CONTACTS at all. It was a game and both sides were playing. I even did it (had a private label brand) in the early 2000's, until I slowly realized what most OD's finally realized: there is no money in contact lens sales anymore. We don't even really try to make money on it at all. We just upped all of our exam fees (including contact lens fitting fee) to make up for the lost revenue. Fast forward to summer of 2014 when the economy was not great and contact lens sales sagged (because let's be honest here: when things are bad people will wear their old glasses instead of spending money on new contacts). The contact lens manufacturers were hurting a little and J&J and Alcon both had new products they were trying to get docs to Rx. Each of those companies instituted a "unilateral pricing policy": the three words that I knew would hurt 1-800-CONTACTS. Unilateral pricing means nobody gets a sweetheart deal. It used to be that the more boxes you bought at one time directly from the manufacturer, the less each box cost. Buy 1 box: get Price A. Buy 50 boxes: get Price A-15%. Buy 100 boxes get Price A-20% and so on. Well the way that the 1-800-CONTACTS model works is based on bulk purchasing. They buy 10,000 boxes at a time and getting HUGE, HUGE discounts for doing it. Then they warehouse the lenses and sell them piecemeal direct to the consumer for less than anyone else can offer. The old pricing policy is literally what drives 1-800-CONTACTS! I knew the instant I saw the words "unilateral pricing policy" that the folks who were going down were the 1-800's. And now of course it turns out that it's true. 1-800-CONTACTS has put up a bill in Oregon. They want to make "unilateral pricing policies" illegal in that state. WONDER WHY THEY WOULD WANT TO DO THIS? Because they lost their advantage. Now they cannot buy a box of contacts any cheaper than anyone else can...AND SO THEY CAN'T SELL THEM ANY CHEAPER, EITHER. If the price of the box is literally the same cost from your OD as it is from a mail-order place...why would anyone order online? If the cost is the same, why would a patient want to wait 5 days and sign for a UPS package, etc from 1-800-CONTACTS when they could have their OD hand them a box on the spot? The answer of course is that they wouldn't. So I can only presume 1-800-CONTACTS is being financillay impacted by this. I don't have any data except that it's a pretty obvious and logical scenario, and I predicted it in June, and now 1-800-CONTACTS is lobbying in Oregon. Hmm. They're doing it under the guise that they are championing the cause of the poor contact lens patient who just wants to save some money. The problem, of course, is that they are trying to control the pricing of a product they sell...BUT DON'T MANUFACTURE. Sure prices are going up. It's true. But as I alluded to earlier, prices are going up b/c demand is down, and the lower demand has made the manufacturers need to increase cost in order to offset the lower demand. So here is 1-800-CONTACTS trying to make it ILLEGAL for the manufacturers to set their OWN PRICING for the products THEY MAKE. Uh...does anyone else see a problem here? I mean I know Oregon is a blue state but this is not socialism. Under a free market system you cannot force a manufacturer to sell their own product at a price that *YOU* deteremine. But of course they know Oregon is a kind of liberal market that may be swayed by a "think of the children!" campaign and they are trying to set a precedent for the coming fights in other states, or at least that's my conspiracy theory. Regardless, 1-800-CONTACTS is hurting and they're making moves to try and make unilateral pricing policies illegal. They don't care if it ostracizes the prescribing OD's (they did that a long time ago) or even the manufacturers! They're desperate. They MUST have their special sweetheart pricing deal in order for their model to work. Without the special pricing their whole system falls apart because they have no advantage and therefore no niche. And it must be falling apart for them to be fighing so hard spending big bucks on lobbying to try and hilariously force a manufacturer to be UNABLE TO SET THEIR OWN PRICING! They can pretend it's "for the patients", but it's not. They're not making any money and they're desperate. So...the 1-800-CONTACTS bubble REALLY is bursting.

Thursday, January 22, 2015

EP Available on NoiseTrade

The Michael Prince EP is now available for free download and streaming from NoiseTrade as well! FREE STUFF!

Tuesday, January 20, 2015

Artwork is Done for Self-Titled EP

Coming soon! A few more weeks, probably. Still mixing and mastering