Terry , Great info. Lots going on in the biosimilar space. Roche is right. Avastin is not approved for ophthalmic use. So, will they have to pay?
Hey, look around. Go to other MB's. This is one of the best boards out there. Yeah, there is the occasional influx of newbies when news comes out, this is natural. But this board consists of relatively, very smart owners of a company. We are generally well informed. We do have opposing viewpoints..(i.e. Hernando, Anit-sense) But, even they bring up excellent points regarding the company, its products and its pipeline. I have to agree with them on many occasions. If we are right by being long, then maybe one day we'll celebrate. If not, then we suck it up and say we did our DD, and for right or wrong we believed in capitalism. I still believe big Pharma needs this little company. GLTA.
All this fight over Bio-similars!. Just make a better drug, with a better delivery matrix, that keeps biosimilars away.....FOREVER!. I don't get it. Get the platform going with Tethadur, then make Bio_betters, then tell the competition to hit the road! In so doing you drop the price a little, expand the market, kill the competition...... No, I guess not, we go to court?
OK. I see your point. Either way, the big pharma must deal with: 1) Bio-similars....then, go to court over it. 2) Bio- Betters, would eliminate this need....Due to the better drug, being delivered over a longer period. What's the fricken' point! If it's better, will there be a need for biosimilar?.....Market share back to the original Pharma.
Tom, It would seem appropriate that a license deal would be first. Yet, Tethadur data is readily available for these companies. I'm very sure that drugs like the breast cancer drug Herceptin are being delivered via sustained release in pre-clincal work.. How can Roche sit any longer on the sidelines with their ophthalmic drugs, as Eylea eat into their Lucentis market share? What would waiting any longer do for them? It's a daily butt kicking from Eylea. I'm scratching my head over it, get the clinical work moving!
Here's a nice dollar break down that shows how REGN's Eylea is movin' and groovin'.
Eylea's main competitor is Roche's (NASDAQOTH: RHHBY ) and Novartis' (NYSE: NVS ) blockbuster drug Lucentis. Lucentis was approved for AMD in 2006, CRVO in 2010, and DME in 2012. Last year, Novartis, the company responsible for commercialization outside the U.S., reported international Lucentis sales of $2.38 billion. According to Roche, the company responsible for U.S. sales, revenue from Lucentis climbed to nearly $500 million for the most recent quarter.
However, Lucentis growth has slowed following Eylea's launch. Last year, 76% of Novartis' Lucentis non-U.S. sales were tied to AMD, down from 89% in 2012. And in the U.S., sales of Lucentis fell 9% year-over-year in the fourth quarter of 2012, prior to growth returning thanks to the DME approval.
There are two major reasons behind Eylea's market share growth. First, Eylea comes with a more patient friendly dosing schedule. It's injected once-monthly for the first three months, then every two months thereafter. While Novartis' and Roche's Lucentis can be used less frequently thanks to a change to its label in 2013, Lucentis is most effective when dosed monthly.
Fewer doses is particularly attractive given the two drugs offer similar efficacy.
In DME, for example, Lucentis patients could read a mean 12.5 more letters from baseline on a standard eye chart at 24 months. That was significantly better than the mean 2.6 letter improvement on placebo injections. That matches up pretty evenly with Eylea patients, who saw a mean change of 11.5 letters after two years and 12.5 letters after one year.
3. Pricing power that keeps revenue chugging
The second reason Eylea is winning scripts for AMD and CRVO is its lower -- but still profit friendly -- treatment cost. Eylea costs $1,850 per dose, less than Lucentis' $2,000 price tag. Thanks to Eylea's favorable dosing schedule, a full year of Eylea costs about $16,000, which is $8,000 less than Lucentis. That advantage gives insurers plenty of incentive to push Eylea rather than Lucentis, particularly given that the two drugs offer similar efficacy.
As a result, Eylea got off to a fast start with U.S. sales eclipsing $250 million a quarter just a year after winning approval in November 2011. More patients, the CRVO indication approval, and ongoing injections for current patients helped lift U.S. sales to more $400 million in the fourth quarter of 2013.
That fourth quarter performance brought Eylea's U.S. net sales to $1.4 billion last year, up 68% from 2012. Sales outside the U.S., where Bayer has responsibility for commercialization, were $472 million in 2013 -- not bad for the drug's first full year in those markets.
Fool-worthy final thoughts
Regeneron may have a future competitor given positive results from a mid stage trial that combined Lucentis with Ophthotech's (NASDAQ: OPHT ) Fovista. During phase 2 studies, that combination outperformed Lucentis alone, improving vision by 10.6 letters on a standard eye chart at 24 weeks, versus 6.5 letters for Lucentis.
Based on that, Ophthotech began phase 3 trials last August; however Regeneron investors shouldn't be too nervous yet given data from those trials aren't likely until 2016.
Thanks to improving share growth in AMD and a potential approval in DME later this year, Regeneron is guiding for between $1.7 billion and $1.8 billion in U.S. sales in 2014. Assuming the FDA does approve the drug for DME when it decides on August 18th, sales should continue to ramp in 2015 as the drug wins over doctors and nets DME approval in additional overseas markets. That has analysts projecting Eylea's peak annual sales may reach $4.7 billion in 2018. A projection that solidifies the drug's megablockbuster status.
It's only speculative, but Roche may be one of the possible suitors for pSivida's Tethadur. An acquisition just makes sense. This would simplify the splits with all the drug applications that may fit with Roche. Here's the take from the CEO, stepping down this week:
he company—which walked away from a proposed $7 billion deal to buy gene-sequencing group Illumina Inc. ILMN +3.38% in 2012 to avoid overpaying—would continue to look at external opportunities for investment, departing Chairman Franz Humer told The Wall Street Journal.
Roche generated 16.4 billion Swiss francs ($18.6 billion) in free cash flow last year, and analysts expect it to return to a net cash position in 2015.
"I think the accumulation of cash adds to the strategic flexibility that Roche is gaining—strategic and financial flexibility," Mr. Humer said.
"Any acquisition needs to make scientific sense, it needs to make strategic sense and it needs to make financial sense. We don't need to spend that cash," he added.
A Swiss-Austrian and a lawyer by training, Mr. Humer is expected to step down Tuesday after 13 years as chairman of Roche and 10 years as its chief executive, from 1998 to 2008. Mr. Humer, 67 years old, will remain chairman of Diageo DGE.LN +1.79% PLC and a nonexecutive director at Citigroup Inc. C +2.56% Christoph Franz, chief executive of Deutsche Lufthansa AG LHA.XE +2.02% , is set become Roche's new chairman this week.
Mr. Humer revived Roche's fortunes around the turn of the millennium, selling its vitamin division after a price-fixing scandal and turning the company into a cancer and personalized-medicine specialist through the acquisitions of diagnostics group Boehringer Mannheim and biotech group Genentech.
Now the world's largest drug group by market capitalization, at 233 billion Swiss francs, Roche reported a 17% rise in earnings to 11.16 billion Swiss francs in 2013. The results got a boost from sales of cancer drugs, which are four of its five best sellers.
But in recent years, Roche has faced more competition to its leading cancer franchise. Rivals have been attracted by good success rates in regulatory approvals and the high prices they can charge for new drugs.
Tom, Very good points here. But has the FDA done anything right yet, when it comes to "doing the right thing"? It might be the insurance companies that start the process. The FDA has it's own ways of screwing things up. To the insurance companies, it's always just about the money, not the "right thing to do". We'd have a better chance with the money people.
Terry, The last 3 CRL's mentioned manufacturing concerns on ALIM's part. Wouldn't that be the first thing you did? Clean up whatever it is you have to clean up. That was cash out the window, and after 3 Fricken' years? That's what I think.
Terry, I have not, nor am I familiar with the drugs. Interesting that Paul Ashton was involved though, yes? Maybe that's where the Codrug of pSivida started gaining potential.
I don't know how it effects the stock tomorrow, if it were to dip I say buy more. There are too many things not priced in the this great little company.
It's always something, even with sales up 23%, ALIM stumbles. At least the product didn't get into the eyes of patients. Waiting to hear the CC.
Thank you for your in-depth clarity to the matter. I'm still watching the company closely. Will take a position in the company.
Do you all realize how terrible you all sound. This board sucks. Endless, needless, pointless bashing each other, to the point of throwing up. I thought it would end after a couple of months. It goes on and on and on and on. Grow up, all of you. It's a shame. It's a good company that will find it's way, though you're doing nothing to inform anyone.
Just out article regarding Biosimilar competition:
Moody's: AbbVie, Amgen and Roche most exposed to biosimilar drugs market
Global Credit Research - 25 Feb 2014
New York, February 25, 2014 -- Companies are racing to expand the global biosimilar drugs market, Moody's Investors Service says in a new report, "Biosimilars: Parsing the Industry's Pipelines." And while biosimilar products have been launched in Asia and Europe, they are at least three years away in the US, the world's largest pharmaceutical market.
Biosimilar drugs are follow-on versions of complex biotechnology, or "biotech," drugs.
"We expect development of biosimilar drugs to continue at a rapid pace," says Senior Vice President, Michael Levesque. "But while in Europe more than a dozen products are now commercialized, in the US no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilars."
Many of the largest branded biotech products in the US market today are now in biosimilar development by at least one company, Levesque says, and the pipeline is expanding. Blockbuster biotechs facing biosimilar development include AbbVie's Humira, Amgen's Neulasta and Roche's MabThera/Rituxan.
The downside risk for biotech companies is long term, rather than immediate, but the most exposed will be AbbVie, Amgen and Roche. While the erosion curve will be much less steep than it is for traditional pharmaceutical products, those companies are among those that will face sales declines.
But upside opportunities will be spread among many players, Levesque says. "While the biosimilar drugs market is still evolving, entrants include not only traditional generic players like Novartis and injectable pharmaceutical manufacturer Hospira, but a number of branded drug makers such as Amgen, through a partnership with Actavis, and Pfizer.
Read more: Moody's: AbbVie, Amgen and Roche most exposed to biosimilar drugs market - FiercePharma