Medgenics Share Discussion Threads

[237gmoney] 25/4/2013 15:13

Medgenics Reports Positive Interim Results from Ongoing Phase IIa Study of EPODURE to Treat Anemia in Dialysis Patients




Data will be used to support Phase II trial in U.S.

MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--Apr. 25, 2013-- Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of Biopump™, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today provided an update on results from the first four patients treated thus far in its ongoing Phase IIa clinical trial in Israel of EPODURE™ Biopumps to treat anemia in patients on dialysis with end-stage renal disease ("ESRD").

Each of the four patients had been receiving routine EPO injections with each dialysis session until his or her EPODURE Biopumps were administered by subcutaneous implantation. Initial and on-going experience to date in ESRD patients is in line with observations from the Company's prior Phase I/II study in anemic pre-dialysis patients with chronic kidney disease ("CKD"). To date, there have not been any procedure or drug related serious adverse events. Thus far in this single treatment study, each patient has received a single administration of EPODURE Biopumps, measured to produce between 19 to 51 IU EPO per kg per day, in place of the serial injections of EPO or ESA the patient had been receiving with each dialysis session. Following the administration of EPODURE Biopumps, the hemoglobin in these patients remained in the desired 9-11 g/dl range for approximately 2-4 months, without needing any EPO or other ESA injections. Notably, at no point following EPODURE treatment did the concentration of EPO in the serum of the patients exceed the typical normal range and always remained under 100 mU/ml.

As the first study with EPODURE Biopumps in ESRD patients on dialysis, this Phase IIa study is testing administration techniques and dosing to determine how long a single treatment using EPODURE Biopumps can replace the periodic injections of EPO or other erythropoietic stimulating agents ("ESAs") currently used in the standard care of such patients, while maintaining the patient's hemoglobin within the desired range. The current standard of care for ESRD patients on dialysis involves EPO or ESA injections with each dialysis session, which is typically three times per week. Each injection is short-lived, typically causing an extreme transient elevation of EPO in the patient's blood to levels of several thousand milliUnits/ml, typically 10-100 times the normal physiological levels, followed by a decline to ineffective levels within a few days, so the patient may not have sufficient EPO or ESA until the next injection. The high transient levels of EPO in the blood are a source of potential safety concern to many medical experts as well as to the U.S. Food and Drug Administration ("FDA"), and is in marked contrast with the normal EPO levels maintained with EPODURE, as reported above.

"These preliminary data are encouraging and we believe they will be valuable as we move forward with plans to implement a larger Phase II trial in the U.S. in the second half of 2013. When EPODURE reaches routine clinical use, we believe the ability to titrate the dose to reach the most effective dosing level based on the patient's early hemoglobin response could further extend the duration of hemoglobin maintenance," stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics.

"EPODURE Biopumps aim to provide a cost-effective way to maintain hemoglobin within a target range in anemic patients by providing sustained delivery of EPO within the normal physiological range, while avoiding the extreme elevations seen with repeat injections. We believe that EPODURE could improve the safety and efficacy of anemia treatments while enhancing patient quality of life by providing a more reliable treatment that reduces or eliminates the need for frequent EPO or ESA injections, and also could provide clear cost benefits to payers," added Dr. Pearlman.

[237gmoney] 22/4/2013 14:25

Good news out of a new patent or at least an expansion of an existing patent.

Medgenics Receives Notice of Allowance from the U.S. Patent Office for Claims That Expand IP for Its Platform Technology to Additional Therapeutic Proteins

MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--Apr. 22, 2013-- Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of Biopump™, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced the United States Patent and Trademark Office has issued a Notice of Allowance of claims that expand the Company's scope of patent coverage for additional therapeutic proteins.

The claims in the patent are directed to a dermal Biopump expressing at least one recombinant gene product from any of the following: growth hormone, interferon beta, insulin, PDGF-BB, interleukin-1 receptor agonist (IL-1Ra), peptide YY3-36, interleukin-10 (IL-10) and G-CSF. These claims, combined with the prior grant of patents for genetically modified dermal micro-organ expression of erythropoietin and interferon alpha, broaden Medgenics' scope of intellectual property in the field of genetically modified dermal micro-organs.

Upon the issuance of this patent, Medgenics' global patent portfolio will include 45 patents granted, with 79 patent applications pending.

Medgenics believes its approach to protein therapy will have multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics' technologies target a range of clinical indications within the global protein therapy market, which is forecast to reach $143 billion in 2015.

"With this allowance we have further broadened the universe of therapeutic proteins that can be delivered through our Biopump platform technology. We continue to build the value of our intellectual property worldwide with the knowledge that new therapeutic areas will be covered by our patent portfolio," stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics.

[237gmoney] 22/4/2013 11:01

The shareprice increased 7% over in the US on friday, the first rise in a month.
Still down over 20% since the recent placing and with the AGM and upcoming presentation next week hopefully the tide will start to turn here.

[237gmoney] 18/4/2013 17:15

Thought this was interesting



Baxter is counting on acquisitions and future product launches to help overcome broad economic challenges and the potential of competitors to take market share from some of its biggest-selling drugs.

[237gmoney] 18/4/2013 14:23

Good news that Medgenics are presenting at the Needham Healthcare conference on 30th April. The same day as the AGM. The share price continues to go lower in the US but the same happened last year in April before it picked up again.

I hope it will do the same this year as well.

[237gmoney] 14/4/2013 21:02

Equities research analysts at Roth Capital started coverage on shares of Medgenics (NASDAQ: MDGN) in a research note issued to investors on Wednesday, TheFlyOnTheWall.com reports. The firm set a "buy" rating and a $13.00 price target on the stock.

Medgenics (NASDAQ: MDGN) opened at 4.379 on Wednesday. Medgenics has a 1-year low of $4.21 and a 1-year high of $16.43. The stock's 50-day moving average is currently $4.86. The company's market cap is $53.5 million.

[237gmoney] 12/4/2013 09:28

I know theres not many that read this thread as Medgenics is fairly unknown but maybe its time to spread the word. The news below I believe is massive to Medgenics and its future and when the word gets out this share price will soon have its day in lights yet again. Medgenics is certainly a strong buy in my opinion at the current price but as always do your own research.



Affymax/Takeda Falure Positions Medgenics In Leading Position By Breaking Amgen's Epogen Monopoly

Apr 11, 2013 11:17:55

The FDA endured another terrible blunder when Affymax Inc. (AFFY) and Takeda Pharmaceutical (TKPHF) recalled Omontys late last month, after approving the ill-fated and dangerous anemia drug not 12 months earlier. Once hailed as a fierce contender for Amgen's (AMGN) Epogen monopoly in the $20 Billion dialysis market, the once-monthly injectable Omontys was being tested by giant Fresenius Medical (FMS) in its clinics, and the future looked rosy until five patients died of a severe allergic reaction known as anaphylactic shock. In other words, a drug that was supposed to make more red blood cells in people that were so depleted they had to spend up to four hours a day, three times per week hooked up to tubes to keep them alive killed them within 30 minutes.

I find it particularly morbid that Affymax chose to put a less-pessimistic percentage, 0.02%, on the number of fatalities. They hid behind arithmetic instead of facing the fact they made a bad drug. Not that the old standards Epogen and Procrit are any better. Epogen has an FDA black box warning, causes blood clots, and Amgen closed down manufacturing in a plant last year due to low sales. Procrit, sold by Johnson & Johnson (JNJ) has undergone multiple safety reviews since its market release years ago. Now Affymax is closing shop, using remaining cash to pay for investigations of a drug that should have been recognized in clinical trials as faulty.

With the biopump EPODURE in Phase II studies, Medgenics, Inc. (MDGN) is well on its way to delivering an effective substitute to the hazardous anemia drugs now being prescribed. Because the internally-placed "biopumps" are made of the patient's own erythropoietin-producing tissue, safety issues are minimized and Phase I trials already show it works by maintaining hemoglobin in the target range while also keeping serum EPO levels in their normal range, instead of overdose spikes inEPO levels which accompany injections of Epogen and Procrit. The multiple injections needed with those drugs are not necessary with EPODURE.

Medgenics has been delivering on its strategic plan on other fronts. Clinical trials for INFRADURE to treat the hepatitis virus are making good progress and would also treat a disease where the alternatives leave something to be desired. Last year the company beefed up its board of directors with two veterans from the financial services and biotechnology industry, added key patents in the US and Japan, and trimmed operating expenses by 21%. A public stock offering completed in February 2013 offered up $29.4 million in gross proceeds with an additional $2.3 million gross from the exercise of the over-allotment. With cash on hand and a modest yearly burn rate, Medgenics is in a good position to run its business and fund clinical trials at the same time.

I believe the FDA will be more careful when approving anemia drugs in the future, and the agency should welcome an alternative that uses the patient's own tissue to produce EPO like their kidneys used to, particularly where patients aren't at risk of getting too big a dose either because of medical incompetence or, more likely, because prescribing bigger doses means more money from the drug's spread, the difference between the price doctors and hospitals pay for the drug and the price charged to patients. This is a common problem with anemia drugs that carry a profit of as much as $300 per administration in an astounding $8 billion dollar market.

Affymax argued long and hard for Omontys, challenging clinical trial reports of a high rate of cardiovascular problems by claiming that those patients were different from patients receiving dialysis, and won approval in a 15 to 1 vote. America's premier drug and device watchdog floundered once again, continuing a terrible record for recommending drugs that hurt people.

At the end of the day, today's anemia drugs are flawed to the point of causing blood clots, heart attack, stroke and now allergic shock and death. When Medgenics finally comes through clinical trials with a safe, non-new drug method of treating the anemia from unbearable condition of chronic kidney disease, not only the FDA but doctors around the world will breathe a sigh of relief, finally able to offer patients something that isn't likely to kill them.

[237gmoney] 08/4/2013 16:20

I notice Maxim Group currently have a Buy recommendation on the stock with a $14 price target. See link below then research. Share price currently up in USA so hopefully this is the start of the bounce back.

[237gmoney] 08/4/2013 10:43

The share price has fallen over the last week, probablay due to the news of the extra 1.7m shares as part of the employee incentive scheme but the company is approaching an interesting period so I am expecting the share price to bounce back in the next 4-6 weeks.

The company have just published their 2012 Annual report last Friday and I have not yet had a chance to read all 136 pages of it but there are a few interesting snippets to note.

The final study report of the CKD trial was completed at end of the first quarter 2013. So we have results of this to look forward to. Hopefully this will be announced at the AGM on the 30th April or before.

In the Annual report, they state on PG14, "In the interim we have commenced a phase IIa study of EPODURE in dialysis patients with ESRD in Israel as our first use of EPODURE in patients with complete renal failure, and a forerunner to the U.S. phase II study. To date, four patients have been enrolled and the preliminary results look comparable to our completed CKD study."

And they carry on to say, "If the proposed phase II study produces the anticipated results, we believe this would be followed by a phase III clinical trial for product candidate approval involving hundreds of patients at multiple centers which we would anticipate conducting with a commercial partner, and using a version of the automatic processor and sealed cassettes which would be similar to that intended for commercial use."

The Annual report was signed off on 14 March so does not include the recent news that the underwriters took up their options to purchase the extra warrants.

[237gmoney] 02/4/2013 11:53

Also today the spread in MEDG has come down in line with MEDU so they are now the same price.

One of the resolutions in the AGM is to increase the Stock plan for employees by 1.7m shares. This will increase the available stock option to 2.5m for employees going forward.

The Board of directors certainly know how to look after themselves. But I don't see this a bad thing as long as the share price increases. The directors will certainly do all they can to make this happen.

[237gmoney] 02/4/2013 11:44

I see the AGM meeting will be held on the 30th April in New York.

Looking at the executive compensation, it is encouraging to see that both the CEO and the COO took a pay cut in 2012. The CEO paid himself nearly $300k less with his bonus cut by 50%.

Also the directors now own around 25% of the company in Shares. Marvin Garovoy and Joseph J. Grano have yet to buy any but do have options.

Both Legal and General and ACNYC LLC own 5.9% and 5.6% of Stock so that brings it up to over 35% held with the directors and over 5% institutions.

[237gmoney] 26/3/2013 13:55

The problem the company have is that they are not well known to potential investors, especially in the UK and Europe and presentations like the Roth Conference will help boost awareness. At the moment there is only a select few investors in the stock out there.

The Maxim growth conference which the company attended last year on 21st March is not scheduled to happen until around September time this year in New York.

There are a few conferences coming up which should be on the Radar for the Company to present at including the BoA Merril Lynch conference in Boston on 7-8th May or the Baird Growth Conference in Chicago on 7-9th May.

UBS are lining up a conference in July for small/mid caps in New York but that is maybe something to think about further down the line.

Still some good news today.

[237gmoney] 26/3/2013 13:08

News out. The Underwriters have exercised their option to purchase the extra 840k shares and 420k warrants which is good news. This gives Medgenics an extra $2.27m and underscores the confidence in the company and the Projects that are being undertaken.

This should boost the share price considering the options were at $5.25 a share with the current share price under $5 in the US. Hopefully the company can now come out with some encouraging CKD results to bring some life back to the share price as we move into the summer months.

With interim results from the clinical trials due mid 2013 their should be a bit excitment about the company heading towards the latter part of the year.

[237gmoney] 26/3/2013 09:38

I understand today to be the last day that the underwriters have to take up the extra option of the 840k shares and 420k warrents but with the price currently below the placing price unlikely they will take the option up?

The Annual report last week stated that the underwriters still hadn't taken up their option so will wait and see how it pans out later.

CKD results were due by the end of Q1 so maybe some news later on this week or early next week?

[sicilian_kan] 20/3/2013 14:03

Yes, the header needs an update post the last placing.

Will do so in the medium term. Too busy at present.

[237gmoney] 20/3/2013 12:52

The header in the fundamental data tab above is incorrect. I think advfn is unable to work out the true value of a company when it has multiple listings across multiple platforms.

Sicilian's numbers above are more accurate although now a little out of date.

With the 45 day option to take up the stock and warrants from the placing I make that deadline next Tuesday 26th? Could be wrong though.

[opaldouglas] 20/3/2013 12:34

Britishb, that would help explain why the company was trading 50% below cash value!

So I presume the header above should read 80M market cap... not 8M! Thanks scyther.

[scyther] 20/3/2013 12:01

This thread needs fixing then as it displays the wrong mcap.
The cap is nearer 90 mil

[britishb] 20/3/2013 11:54

Oh dear opal, if you think the mcap is £8m I suggest you stick with the day job. lol.

[237gmoney] 20/3/2013 11:43

OD, I make it around 30.3m shares fully diluted after the placing at £3.34 a share. The placing was done at a discount but the current share price is not far off that so that is why I chose to buy in now.

The underwriters of the placing will hopefully take up their options to buy a further 840k shares and 420k warrants in the next few weeks and I expect the new director to buy some stock as well.

With the Roth Presentation this week I would think the company may get some more exposure in the press and hopefully the CKD results look promising at the end of the quarter.

[opaldouglas] 20/3/2013 10:18

Gmoney/sicilian,

Thanks for your swift responses, I actually came across MEDU at a proactive event last year and have been keeping tabs ever since.

With near £20M in the bank and a market cap of circa £8M things look interesting, I must admit that I'm not particularly clued up with pharmaceuticals stocks in general so I find it hard to compare with comparable stocks.

Do you happen to know how many shares are in issue (fully diluted)?

OD

[sicilian_kan] 20/3/2013 08:41

I agree 237. I add that this will not go as a takeover for less than $1bn even if offered today and potentially much more later. Medgenics' plan is to license out the tech for each area (anemia, hepatitis, haemophilia etc.) with large up front payments, milestones, royalties etc. thereby maximising their revenues in due course. A takeover would need to be very, very tasty to interest the company.

[237gmoney] 20/3/2013 08:22

Opal,

As far as I see it, the company burned through $8.61m last year and ended the year with $6.43m cash and Cash equivalents. They have sinced raised $29.4m through a share issue so with nearly three months of the year gone they should still have over $30m cash in the bank with no debt.

The capital outlay for the biopump technology is very small and the margins are very attractive so this company has a great future if it can proove in clinical trials that what their doing works.

No doubt the company will be taken out by a bigger fish at some stage but the price will have to be far north of where it is today before the directors even consider an offer.

[opaldouglas] 19/3/2013 20:44

Can anyone confirm the cash balance is in fact $30m? As per 237gmoney link above. Thanks gmoney.