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Let me have a word with the Missus and then we'll see :)
Excellent advice!
I'll take CANFY!!!
Since this is your money, I'd say neither.
Open a saving account for your grandchildren instead
Hi DT,
If you had free $5K, what would you prefer
to invest in at present: PSTI or CANFY?
Tia
Hi M, nice to see a friendly follower of the Israel-Medical-Healthcare such as yourself
I sold the remaining of my Bioline shares when the stock jumped (unjustifiably imo on the HCV program) earlier this year and have not followed closely since, and anyway the Celiac Disease program is just entering the clinic.
Nice to see your still checking in. Since you are handing out free advice and I didn't get in on CANFY I was wondering if you had thoughts on BLRX. Do you have any insights on their Celiac Disease program? I'd just as soon not pay for their AML program so I've been waiting to do more DD.
I am? why, thank you dearie!!!
Join the CANFY #board-25711 not too
busy there (as of yet?)
Ahalan Dovi MATOK
I'm still in Can-Fite. Always liked the team and science and think they have a decent shot at several goals.
Hey Idit, your input on CANFY?
#board-25711
It took a while, but Evogene has finally filed for a US IPO:
#msg-92307662
GVHD
Procognia wins Health Canada deal
Health Canada will use the company's glycosylation analysis products and services for research on biotherapeutic products.
14 April 13 12:44, Globes' correspondent
Glycoanalysis company ProCognia (Israel) Ltd. (TASE:PRCG) is providing glycosylation analysis products and services to the Biologics and Genetic Therapies Directorate of Health Canada, for research on biotherapeutic products. Procognia's share price rose 7.8% by midday to NIS 0.538, giving a market cap of NIS 13 million.
Procognia CEO Dr. Ruth Ben-Yakar said, “We are very proud of Health Canada’s choice to use our glycosylation analysis products and services for research of various biotherapeutic products. We regard it as a vote of confidence in the capabilities of our technologies and of our services”.
Carbohydrates are known to affect the activity, stability and safety of biological products, including therapeutic proteins, vaccines, and stem cells, making it highly important to characterize them in biopharmaceutical products in general and biosimilars in particular. “Our products and technologies enable analysis of carbohydrates throughput the process of development and manufacturing of biological products, hence enabling our customers in making informed decisions regarding their products for directing manufacturing conditions towards the desired glycosylation profiles” added Dr. Ben-Yakar.
Published by Globes [online], Israel business news - www.globes-online.com - on April 14, 2013
Hadasit Bio co obtains FDA orphan drug status
Enlivex Therapeutics is developing Apocell for treating graft-versus-host disease in bone marrow transplants.
3 April 13 13:26, Globes' correspondent
Hadasit Bio Holdings Ltd. (TASE:HDST; Bulletin Board: HADSY) portfolio company Enlivex Therapeutics Ltd. has obtained orphan drug status from the US Food and Drug Administration (FDA) for its Apocell treatment for graft-versus-host disease (GVHD). GVHD affects 70% of patients who receive bone marrow transplants from an unrelated donor, and can be lethal.
"The main achievement of orphan drug status is the seven years exclusivity, guaranteeing no competition irrespective of patents, and significant regulatory easements, which we believe will shorten marketing approval of the drug in the US, reducing costs," said Enlivex CEO Alon Moran.
"The results of clinical trials of Apocell showed strong efficacy and safety indications of the treatment, which allows transplants from unrelated donors while minimizing severe GVHD complications. We intend to pursue development of the drug from a Phase IIb clinical trial through full marketing approval in the US."
GVHD affects 30,000 people annually in the US and Europe. It is basically an autoimmune disease, in which the body's immune system attacks the implant as a foreign body. There is no effective treatment for the disease. Current treatments involve suppressing the body's immune system, but this exposes patients to disease.
Apocell induces tolerance in the patient's immune system by activating the natural cell death mechanism, apoptosis, immediately after a bone marrow transplant.
"FDA orphan drug status for Enlivex's Apocell is important regulatory recognition of the drug's necessity," said Hadasit Bio CEO Ophir Shahaf.
Hadasit Bio, a unit of Hadasit - the Technology Transfer Company of Hadassah Medical Organization , owns 92% of Enlivex. Hadasit Bio's share price rose 23.5% by early afternoon on the TASE to NIS 0.358, giving a market cap of NIS 45 million. The share closed at $1.60 on the Bulletin Board yesterday.
Published by Globes [online], Israel business news - www.globes-online.com - on April 3, 2013
Glycoanalysis co Procognia to collaborate with SBH Sciences
SBH Sciences will also serve as a local center for Procognia's glycosylation analysis services.
7 April 13 13:15, Globes' correspondent
Glycoanalysis developer ProCognia (Israel) Ltd. (TASE:PRCG) has signed a strategic collaboration and co-promotion agreement with Boston-based biotechnology services provider SBH Sciences Inc. The companies provide complementary services to the biopharmaceutical and pharmaceutical industries, and they will offer joint sales and marketing activities for these services. Procognia's share price rose 18.3% by early afternoon to NIS 0.58, giving a market cap of NIS 14 million.
SBH Sciences will also serve as a local center for Procognia's glycosylation analysis services, and will be responsible for shipment of samples for analysis to Procognia’s main facility in Israel.
Procognia CEO Dr. Ruth Ben-Yakar said, “We are looking forward to collaborate with SBH Sciences, an experienced and innovative contract research organization with diverse services, products and capabilities, and we believe that through this collaboration we would provide our customers with access to unique and high quality tools for efficient and successful development of their products."
SBH Sciences president and CEO Dr. Raphael Nir added, “We are excited to be working with Procognia, leaders in glycobiology and glycosylation analysis. Our complementary capabilities would provide on-time exemplary customer service that will give our customers a competitive edge in the industry".
Published by Globes [online], Israel business news - www.globes-online.com - on April 7, 2013
BioLineRx: Upcoming Catalyst With Potential Multi Billion-Dollar Schizophrenia Drug
Jan 15 2013, 08:01
BioLineRx's (BLRX) engages in identifying, in-licensing and developing therapeutic candidates. Its lead clinical therapeutic candidate under development is BL-1020, which is in Phase II/III clinical trials to improve cognitive function in schizophrenia patients. BL-1020 is an orally available, first in class GABA enhanced antipsychotic that combines dopamine antagonism with GABAergic activity.
BL-1020 is being tested against Johnson & Johnson's (JNJ) schizophrenia drug Risperdal, which generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007.
According to Wikipedia:
Risperdal is the trade name for risperidone, an antipsychotic drug which is mainly used to treat schizophrenia but also used for other conditions. Due to its strong serotonin, dopaminergic, and adrenergic antagonism, risperidone was approved by the FDA in 1993 for the treatment of schizophrenia. In 2007, risperidone was approved as the only drug agent available for the treatment of this disease in youths, ages 13-17. It was also approved that same day in the treatment of bipolar disorder for people ages 10-17. In 2006, the FDA approved risperidone for the treatment of irritability in children and adolescents with autism. This decision was based in part on a study of autistic people with severe problems containing violent meltdowns, aggression, and self-injury.
With all of the above indications, it is evident risperidone is an important and versatile drug.
Recently, a pair of companies announced they were on track in the early development with another candidate using risperidone. Earlier this month, Durect Corporation (DRRX) announced its licensee, Zogenix (ZGNX) reported positive single-dose pharmacokinetic results from the Phase I clinical trial of Relday, a once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia.
Zogenix needed this bit of good news as its pain killer drug Zohydro was shot down by an FDA Advisory Committee by a vote of 11-2 against recommending the drug to the FDA for approval, causing its stock price to plummet 42% on December 10th, 2012.
BioLine uses risperidone as the positive control for antipsychotic efficacy in its phase II/III CLARITY trial. The study is designed as a randomized, double-blind clinical trial to examine acute (6 weeks) and long-term (6 months) antipsychotic and cognitive efficacy, safety and tolerability of BL-1020. The cognition primary endpoint measure will utilize the MATRICS Cognitive Consensus Battery (MCCB), and cognitive benefit will be assessed by comparing the change from baseline in total MCCB score. These scores will compare BL-1020 to risperidone at the landmarks of six, 12 and 24 weeks.
Significant upcoming Catalyst:
BioLine will present the Phase II/III CLARITY trial results during the week of March 18, 2013. These results will tell us just how effective the drug is. Although specific data will not be released, the strength of the cognition signal will be crystal clear to the Company and its investors.
For example, if the company reports that only, say, 100 patients are needed to complete the study (meaning a total of ~335 patients in the study, since the interim analysis will be done on ~235 patients), then this means that the cognition signal is much stronger than anticipated, since Bioline originally powered the study with an assumption that it would need 450 patients to achieve statistical significance. On the other hand, if it needs another 1,000 patients, it will be clear that the signal is very weak.
So what is the big deal with another schizophrenia drug? As mentioned above, JNJ's Risperdal has raked in billions of dollars in revenue before going off of patent protection in 2010. BL-1020 has patent protection through 2033. The preliminary results for BL-1020 indicate it's as effective, if not more effective and safer than Risperdal. If the data that is expected to be released in March confirms the previous results, we can expect a massive move in the stock price.
Acadia (ACAD), recently reported positive Phase III data for its drug Pimavanserin, which is in development as a potential treatment for Parkinson's disease psychosis (PDP). Pimavanserin is specific to PDP and has the potential to be a multi-billion dollar drug if approved as evident by Acadia's stock price surging over 200% intraday on 11/27/12, hitting a high of $6.50 (over $7 in the pre-market trading session).
Pimavanserin's first Phase III study failed to meet its primary endpoint, but after re-tailoring the trial, Acadia has now seen success with the drug. While PDP is different from schizophrenia, both are defined as a form of psychosis. The market potential for both combined is massive, demonstrated in part by Risperdal's 7 year revenue of over $24B.
It's also worth noting that Acadia ended development of its own schizophrenia drug AM-831 in July of 2012. Acadia and its partner Meiji Seika Pharma Co. stated that the drug did not meet certain criteria for advanced testing - drug companies know treatment for schizophrenia is a very lucrative market.
Below, let's take a look at a balance sheet summary for BioLine.
Balance Sheet
Total Cash (mrq):
$26.38M
Total Cash Per Share (mrq):
$1.75
Total Debt (mrq):
$44.85K
Total Debt/Equity (mrq):
0.24
Current Ratio (mrq):
3.91
Book Value Per Share (mrq):
1.25
Shares Outstanding5:
15.06M
Float:
12.33M
Market Cap (intraday): $43.08M
I have highlighted the numbers that stick out to me above in bold. Bioline having a $43M market cap has to be the result of the company flying under the radar of speculative investors and traders. If positive results are announced in March, I have to think the stock will at least gap up over 100% because BL-120 could be worth billions if ultimately approved for sale.
Bioline having $1.75 cash per share is good, along with $26.3M in cash and a current burn rate of about $4.5M a quarter. This gives the company over a year of breathing room to operate before they might have to engage in a possible cash raise.
BL-120 is not the only drug the company has in its pipeline:
Drugs in Clinical trials:
BL-1020 Schizophrenia (Currently in Phase II/III trial)
BL-1040 AMI (Currently in CE Mark Registration Trial)
BL-5010 Skin lesions (Phase I/II complete)
BL-7040 Inflammatory Bowel Disease ( Phase II)
BL-8040 Acute myeloid leukemia & other hematological cancers (Phase II ready)
BL-1021 Neuropathic Pain (Currently in Phase I trial)
Drugs in Pre-clinical:
BL-8020 HCV
BL-6030/1 Bacterial Infection (BIJ)
BL-7010 Celiac Disease
BL-5040 Cachexia (BIJ)
BL-7020 Psoriasis (BIJ)
BL-7060/EDP29 AMI
BL-8010/EDP30 Retinopathy
BL-8030 HCV
I find the potential of Bioline to be very enticing since the company has only a $43M market cap and over $26M in the bank. As mentioned above, I feel Bioline has been flying under the radar and offers a good opportunity at its current price level in addition to the strong catalyst coming up soon.
Sarepta (SRPT) was flying under the radar until it recently grabbed investor attention with positive data releases for Eteplirsen, which is in Phase II clinical stage for the treatment of Duchenne muscular dystrophy (DMD). In July 2012, following a 1:6 reverse split, Sarepta was trading around $3.30 a share. Currently the stock trades for over $27 as investors and traders have taken notice of the huge developing story at Sarepta. I believe Sarepta could be one of the largest percentage gainers this year in the entire stock market, and could see a stock price nearing $75 a share if the FDA grants the company early marketing approval under the newer FDA Safety & Innovation Act and/or the Breakthrough Therapy Act.
While it's not likely that Bioline will see a stock price move near the eight fold move Sarepta made, I do feel it's a good bet its price could see a very large gain if the CLARITY trial results are positive in March. Additionally, the stock should experience solid appreciation in anticipation of the these results.
(click to enlarge)
The stock has formed a longer term rounding bottom and is showing signs of reversal after breaking out of its down channel. The MACD and RSI are very bullish. First target appears to be the 38.2% retrace at $4.00.
Overall, I like Bioline for at least a nice catalyst trade, and expect the stock to be trading much higher over the next month. If the Phase II data release is positive, which it should be, I would expect a stock price over $5.
Additional disclosure: Disclaimer: This article is intended for informational and entertainment use only, and should not be construed as professional investment advice. They are my opinions only. Trading stocks is risky -- always be sure to know and understand your risk tolerance. You can incur substantial financial losses in any trade or investment. Always do your own due diligence before buying and selling any stock, and/or consult with a licensed financial adviser.
Chiasma teams with Roche
The strategic development deal includes a $65 million down payment, $530 million in milestone payments, and double-digit royalties.
18 February 13 14:46, Gali Weinreb
Chiasma Inc., which develops oral versions of biological drugs, has signed a strategic development agreement with Roche AG (SWX: ROG). The deal is extraordinary in terms of the financing: a $65 million down payment for Chiasma, followed by $530 million in milestone payments and double-digit royalties on net sales.
The deal is Roche's largest commercialization agreement with an Israeli drug development company to date. Chiasma's product, Octreolin, is a biological drug for the treatment of acromegaly, which is caused by excessive excretion of the growth hormone, resulting in abnormal growth of bones and internal organs, which can lead to heart problems, increased perspiration, and sleeping difficulties. The excess excretion is caused by a benign tumor in the pituitary gland. The tumor can sometimes be surgically removed to cure acromegaly, but not always.
The global acromegaly market is estimated at $1.8 billion, of which $1.4 million is for a drug made by Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ). Octreolin is an oral version of Novartis's drug, and if it is commercialized, Roche will compete with it against Novartis.
The drug is currently administered by frequent and very painful injections deep into the muscle or beneath the skin, with a long, thick needle. The injection requires up to 90 seconds to deliver, because the substance is very viscous. Chiasma COO Roni Mamluk told "Globes", "You see the needle and get chills. You usually have to receive the injection once a month from a nurse, because it very hard to administer the injection at home."
Mamluk says that Octreolin replaces the drug with an oral product, which was made possible by Chiasma's proprietary technology, which briefly opens tiny gaps in the intestinal wall allowing the absorption of the drug. Biological drugs, such as peptides, cannot usually be absorbed through the intestinal wall, because they dissolve in transit. Chiasma's capsule is administered twice a day. The product is undergoing a Phase III clinical trial. The company found no side effects of the drug, after nine months. Mamluk believes that the drug can be launched in 2015, at which point the company will see double-digit royalties.
Chiasma was founded in the early 2000s, but went through several crises before being reinvented in 2008 under Mamluk and CEO Frederic Price, an American. Price and Chiasma's legal adviser are based in the US, and the company has 50 development staff in Israel.
Chiasma's investors, most of which have been with it from the beginning, include MPM Ventures, Abingworth, Arch Venture Partners, F2 and F3 Ventures, and 7 - Med Health Ventures LP. Ofer Hi Tech Ltd. invested in the company's early rounds, but not in subsequent ones. Chiasma raised $38 million in its last financing round.
Published by Globes [online], Israel business news - www.globes-online.com - on February 18, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013
BiolineRX hopes for breakthrough with schizophrenia drug
CEO Dr. Kinneret Savitzky: Good interim results could speed up talks with potential partners for developing the drug.
10 February 13 16:27, Gali Weinreb
2013 is shaping up to be an interesting year for drug development company BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX). The company procured new products during 2012, and consolidated its dual-listing status, and even raised capital on Nasdaq.
2013 will be marked with results of clinical trials on several new and veteran drugs under development. One of the most important results will be published in mid-March, when the company will announce the interim results of the Phase IIb clinical trial for its leading product, BL-1020, for the treatment of schizophrenia. The results will be based on a study of 235 patients.
Last week, BiolineRX raised $8 million from OrbiMed Advisors LLC, which bought ADR's, which track the company's share on the TASE at a ratio of 1:10, on Wall Street at $3 per ADR, a 24% discount on the closing price the day before. Sources inform ''Globes'' that BiolineRX and Orbimed were in talks for months, and had even discussed a bigger investment, which was dropped because it would dilute the holdings of BiolineRX's current shareholders. Orbimed, through Orbimed Israel, manages more than $200 million for investment in Israeli life sciences companies alone.
Israeli capital market sources complained about the discount offered to investment institutions in the offering, as well as the previous offering to US investors only, with no corresponding offer to Israeli investors. Regardless, the investment was a strong signal for BiolineRX, as Orbimed invested in the company just before the publication of the interim results for BL-1020, on the assumption that the company's value will rise afterwards. Orbimed also apparently believes in the company's pipeline, business model, and management.
Bioline's share price 9.3% on the TASE today to NIS 1.63, after rising 1% on Nasdaq to $3.92 on Friday, giving a market cap of $84 million.
It is important to adjust expectations about the clinical trial's results," BiolineRX CEO Dr. Kinneret Savitzky told "Globes". "We won't see them and we cannot announce them. An independent committee will see them and advise us whether it is worthwhile to continue, and if so, how many more patients we should recruit. The fewer patients the better, because that means that the difference between the test group and the control was clearly demonstrated in the first 235 patients. If they demand 1,000 new patients, there is probably no point in continuing."
BiolineRX is ready for a scenario to recruit an additional 200-250 patients for the study, in which case final results will probably be ready by the end of the year. "We believe that good interim results could be the basis for speeding up talks with potential partners for developing the drug," says Savitzky.
The uniqueness of BL-1020 is that improves cognition in schizophrenia (such as memory and calculation), and not just the psychosis. A Phase III clinical trial on a similar product by Eli Lilly & Co. (NYSE: LLY) recently failed. "The mechanism of that drug is completely different from ours," calms Savitzky.
"Globes": What if the trial fails?
Savitzky: "We believe in the product, otherwise we would not conduct such a large study on our own. But precisely because of this question, we founded BiolineRX as a company with a range of products in different fields. In this industry, it is too risky to rely on just one product."
BiolineRX's second most important product is BL-1040 to support cardiac tissue after a heart attack. Ikaria Inc., which acquired the drug's development rights, is conducting the clinical trial, which will be probably be the last trial before commercialization. "It is hard to recruit patients for a study of this kind, which is why it is being held in 90 centers," says Savitzky. "It isn't cheap, and Ikaria is going full speed ahead."
Upgrading BiolineRX's US standing
To fill the pipeline, in the past year BiolineRX acquired two products in the advanced development stage. The first product is a blood cancer treatment bought from Clal Biotechnology Industries Ltd. (TASE: CBI) unit Biokine Therapeutics Ltd. The drug BL-8040 (formerly BKT-140) for the treatment of acute myeloid leukemia (AML) and other types of hematological cancer, acts by vacuuming the tumor cells from their location to improve the effect of chemotherapy. A clinical trial is scheduled to begin in mid-2013 and be completed in 2014, with interim results due later this year.
The second product is for hepatitis. "We will begin the first human clinical trial soon. We opted for a fairly large trial, which could be the basis for acquiring the product," says Savitzky.
Hepatitis was a hot field in 2012, with the biggest acquisition in the sector amounting to $11 billion. Two other products failed, and two more are waiting their fate. "This is a very dynamic field, and there's a feeling that the market will soon decide on the components of the cocktail. It doesn’t matter what's in it; we can complete that later, because while other drugs act directly on the virus, we're targeting the patient's cells, disrupting the virus's ability to exploit them."
BiolineRX also has a product for the treatment of skin lesions, BL-5010, which has already been approved for marketing, but potential partners want another study. "This product can be commercialized quickly, because it mostly relies on the private market and not on insurance indemnification," says Savitzky.
Two other products ready for clinical trials are BL-7040 for the treatment of inflammatory bowel disease and BL-7010, which aims to treat celiac disease by absorbing gluten.
As for BiolineRX's financial standing, CFO Philip Serlin says that the company had $26 million in cash at the end of September 2012, and that it burned $15-18 million a year, a rate which will continue over the coming years. 40% of the company's shares are traded as ADRs on Nasdaq. Ayer Capital Management LP, a US fund that specializes in the life sciences owns 6%, and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) owns 4.4% after investing in Orbimed. "Teva has a director on the board, and we are unaware of any plans to sell the shares," says Savitzky.
Do you want a permanent strategic partner in the company?
"That is one of many options, but there is nothing specific right now."
Published by Globes [online], Israel business news - www.globes-online.com - on February 10, 2013
Rosetta Green was a spin-off from ROSG but ROSG sold almost all its stake for peanuts. MON is shopping/investing in Israel for the 4th time now (Beeologics, Evogene, abseeds).
Rosetta Green was a spin-off from ROSG but ROSG sold almost all its stake for peanuts. MON is shopping/investing in Israel for the 4th time now (Beeologics, Evogene, abseeds).
Is Rosetta Green connected in any way to ROSG?
Not more than is written:
MON—Does anyone on this board have info on this purported deal?
http://seekingalpha.com/article/1154011-monsanto-to-further-strengthen-its-crop-bioengineering-position-with-rosetta-green
Is Rosetta Green connected in any way to ROSG?
Biocancell reports positive pancreatic cancer results
There was no deterioration in the condition of patients who received the high dosage of the drug.
4 February 13 16:35, Globes' correspondent
Biocancell Therapeutics Ltd. (TASE:BICL) today announced positive results in a Phase IIb clinical trial of BC-819 for the treatment of pancreatic cancer. After completing the first stage of the study, there was no deterioration in the condition of patients who received the high dosage of the drug. The drug was also found to be safe by all the patients.
In the study, BC-819 is being administered in conjunction with the standard chemotherapy for pancreatic cancer, gemcitabine. The results reaffirm the positive safety and efficacy results of the previous trials of the drug for this indication.
The 11 patients in the trial were divided into two groups, each of which received a different dosage of BC-819: five patients received an 8-mg dosage, and six patients received a 12-mg dosage. Nine of the patients had no deterioration in the disease for three months (progression-free survival), including all six patients treated with the 12-mg dosage. The Data Safety Monitoring Board (DSMB) found no side effects related to the drug, and there was no difference in safety between the high and low dosages; the severe side effects seen were either related to the disease, to gemcitabine, or to the injection delivery of BC-819 into the pancreas.
In addition, Biocancell plans to publish the final results of the Phases IIb clinical trial of BC-819 for the treatment of bladder cancer during the first quarter of 2013 and it is seeking a partner for a Phase III trial.
Published by Globes [online], Israel business news - www.globes-online.com - on February 4, 2013
GIVN-finally???
#msg-83854969
Brainsway treatment sharply reduces smoking addiction
84% of smokers in a trial of the company's Deep TMS device stopped smoking.
24 January 13 14:56, Globes' correspondent
Brainsway Ltd. (TASE:BRIN) today announced that a trial of its Deep TMS (transcranial magnetic stimulation) enabled smokers to give up cigarettes. 84% of the participants in the study who received frequent treatments gave up smoking at the end of the six-month course of treatment. 36% of the people were still not smoking after the six-month post treatment monitoring period.
The 115 participants in the study were divided into three groups: one group received a placebo, the second group received infrequent treatments, and the third group received frequent treatments. Half of the participants in each group first received a stimulant to temporarily increase the desire to smoke. 78 patients completed the study: 32 who received frequent treatments, 14 who received infrequent treatments and 32 who received the placebo. The infrequent treatments were terminated when the interim results showed that they were ineffective in stopping smoking.
Earlier this month, the US Food and Drug Administration (FDA) and Health Canada approved the Deep TMS device for the treatment of depression in patients who do not respond to drugs.
Published by Globes [online], Israel business news - www.globes-online.com - on January 24, 2013
INSL keeps flying up and away!!!
I followed this stock too!!!
(sold it out yesterday, today would have
been even better)
Brainsway as well (just sold my position today)
Stuck however with Brainstorm (BCLI), but i believe
its day will come soon!!!
Brainsway CEO: US distribution deal close
Uzi Sofer told "Bloomberg": We are in discussions with several large companies interested in partnering with us.
21 January 13 10:11, Guy Katzovich
Brainsway Ltd. (TASE:BRIN) expects to reach an agreement this quarter for a medical-device company to market its non-invasive system to treat depression in the US, CEO Uzi Sofer told "Bloomberg" in an interview.
Earlier this month, Brainsway obtained US Food and Drug Administration (FDA) approval to use the company's Deep TMS (transcranial magnetic stimulation) device for the treatment of depression in patients who fail to respond to medication during a depression episode.
Currently, these patients receive electroconvulsive therapy (ECT), despite the strong negative image of the therapy. One million ECT treatments are carried out in the US each year. Sofer says that Deep TMS is just as effective as ECT, but without the side effects. There has been no comparative clinical trial of the two therapies to date.
Sofer told "Bloomberg", "We are in discussions with several large companies interested in partnering with us. Our next step is to reach a deal with a distributor." He declined to disclose which companies Brainsway was in talks with, though he said they included some of the largest in the industry.
Sofer also told "Bloomberg", "We are looking to be in the Nasdaq because this is the right place to be,” said Sofer. “The reason is not so much to raise money as it is to give the company its real valuation."
"Bloomberg" notes that that a US listing may boost Brainsway’s value by exposing it to more investors and possibly attracting analyst coverage, and that no analysts follow the company. It adds that Brainsway's share price has soared 68% this year after winning US and Canadian regulatory approval, and that the company would join drug developer Kamada Ltd. (TASE: KMDA) and translation software developer Babylon Ltd. (TASE:BBYL) in seeking Nasdaq listings this year as trading in Tel Aviv dwindles.
Published by Globes [online], Israel business news - www.globes-online.com - on January 21, 2013
I have posted once on Roy's board about this interesting little com. #msg-64676775 and it did very well since.
InsuLine jumps on German indemnification deal
The InsuPad already has CE Mark certification, and Insuline is in the process of registering it in Germany's healthcare products catalogue
20 January 13 16:09, Globes' correspondent
The share price of InsuLine Medical Ltd. (TASE: INSL) jumped today, after it obtained conditional indemnification from German insurer Barmer GEK for the company's InsuPad insulin patch for diabetics. InsuLine's share price rose 19.3% to NIS 2.64, giving a market cap of NIS 210 million. If the clinical trial underway demonstrates that the InsuPad is effective, Barmer will indemnify purchases of the product for €98 plus €1.66 per patient per day for the product's kit of 30 disposable elements, for a total of €690 a year.
The InsuPad already has CE Mark certification, and Insuline is in the process of registering it in Germany's healthcare products catalogue
InsuLine said that the indemnification is higher than its current estimates, as stated in its financial reports to date, and which it used to register the InsuPad in Germany's healthcare products catalogue.
InsuLine cautioned that there was no assurance that the final indemnification that Barmer or other insurers will pay will be the amount stated in the approval, and that the final indemnification could be less.
Published by Globes [online], Israel business news - www.globes-online.com - on January 20, 2013
Sure, GOOG auto/robotic translation, no problem
Can-Fite stayed sponsor forum
Fite CEO, Prof. Pnina Fishman stayed forum sponsor and answered questions and questions browsing system
17.01.2013 | 11:07 | a sponsor | 2 Gas Come visit the forum visit the forum and Nftboa Biomed
Welcome to Prof. Pnina Fishman. What news brings technology developed by the company and what makes the drug company?
The technology is based on a family of drugs that target specific purpose on the inflammatory cells and cancer which A3 adenosine receptor. The goal is for the diseased cells only. All drugs are small molecules. The drug binds only for so healthy body cells are not affected. As a result, treatment is specific and Drug ARE maximum safety profile. As demonstrated in the treatment of 1000 patients treated to date drugs company.
What are the pharmaceutical development pipeline of the company and what is the size of the market which they turn?
First drug development pipeline is now developing CF101 her treatment of psoriasis (Phase 2/3) and for the treatment of rheumatoid arthritis (Phase 2b). Psoriasis market size is over $ 3 billion and is expected to grow in the next 5 years to $ 6.5 billion. Arthritis market size is about $ 15 billion. The second drug, CF102, the company is developing for the treatment of primary liver cancer (stage 2). Market exists today only one drug, Nexavar, and the market size is expected to reach - $ 2 billion in 2015. The third drug, CF602 designates the company to treat sexual dysfunction, a market about $ 4 billion. Fite group, as part of activities of the subsidiary Aoftlix, drugs advanced stages of clinical development to treat dry eye among them (Phase 3), glaucoma (Phase 2) and Owad Vitis (Stage 1).
Can you explain to us what the nature and components of the agreement with the Japanese and Korean?
Agreement with the Japanese company, SKK, signed in 2006, is a drug licensed for the CF101. Japan for the treatment of autoimmune diseases (not including eye disease) and includes $ 19.5 million franchise fee paid subject to milestones and significant royalties from sales.
Agreement with Korean company Kwang Dong Pharmaceutical signed in 2008 provides drug licensed the CF101 Korea arthritis treatment only and includes $ 2 million franchise fee and investment subject to milestones and significant royalties from sales. To date, the Company received over $ 8 million.
What is the business strategy of the company?
The company develops innovative medicines given tablets. The company has developed advanced skills to perform all development processes and build value for its products as proof of concept clinical trials in humans. The Company's business strategy includes providing regional or global licenses stages of development international pharmaceutical companies that market the drugs after proof of efficacy in advanced clinical trials (phase 2 or 3).
Which drug development pipeline register from the first what are the implications of this for the company?
Apparently plotting to treat psoriasis will be the first to sign up. Based on the size of the market and the need for small molecule drugs that are given tablets which have maximum safety profile. However, the company expects will join a strategic partner before drug registration. Such an event will be accompanied by significant revenue from license fees and company royalties.
What is the importance of the positive results obtained in the interim report of the trial psoriasis?
Published results included a summary of the 100 patients and added to the results of Phase 2 are published in the past. Was complete correlation between the results of the previous and current when now the results were even better because we have treated drug beyond three months. Linear response of the hospital for treatment and the dose given to the maximum activity was identical in both experiments and provided proof of complete clinical programming drug efficacy in patients with this disease. The good results are a confirmation entire technology platform and using the cure of autoimmune and inflammatory diseases such as psoriasis. All these lead to flooding of the value of the Company's operations and the great interest of the leading companies in this field.
What is competition in the market in which the company works?
Competing pharmaceutical market in inflammatory diseases (autoimmune) is primarily biological drugs proven effectiveness, but their treatment is very expensive and is characterized by severe side effects. Market are now a number of small molecules such as drug developing advanced the Apremilast of Celgene Corporation which efficacy and safety of the drug - CF101 cost her.
Competition in liver cancer is only one drug found in the market, Nexavar, known by - 1 billion. This drug is toxic to the liver and therefore patients with advanced liver disease can not get a signal treatment. Efficacy and safety of the drug - drug CF102 and the ability to protect liver function, Special Topics attractiveness of the drug market.
Of the drug the CF602, the market for drugs to treat sexual dysfunction is about $ 4 billion and in the coming years will become drugs such as Viagra and generic Cialis, certainly that there is a demand for such medication.
Whether the company is in the development stage that justifies joining a strategic partner?
The company systematically advanced stage. According to the strategy that built the company should join forces with a partner when we are the results of advanced clinical trials. Indeed interim report positive results have psoriasis and arthritis are we waiting for opening the possibility to realize this step.
What is the advantage you see the establishment Aoftlix and fragmentation of Applied eyes?
Development of drugs for eyes is an interesting and important niche biotechnology. Investors are dedicated to this field. Multiple indications and the good clinical results obtained justify splitting this activity. Value we have built through this process and the fact that the company trades in the U.S. market, which assesses the biotechnology field, opens a wide horizon progress Aoftlix company financially as well as clinically.
Whether the results obtained in the experiment that examines the efficacy of liver cancer are consistent with the drug found in the market?
The results obtained in the experiment phase 1/2 clinical trial in the CF102 show that the difference in drug the Nexavar, which causes toxic effects in the liver, drug the CF102 supports liver function and therefore constitutes a drug safer and more convenient for patients and can be treated even in patients who are at the stage of liver disease advanced. In addition, the results show that it can be treated with drugs to the CF102 in patients who have failed the drug Nexavar ..
What renewal notice published today on CF102 to treat cancer patients?
Thorough analysis made by the Company completed clinical trial results in patients with liver cancer, we found the most effective dose. Company yesterday filed a patent that protects the use of the drug in doses effective. Statement further noted that one of the hospital, the patient still CF102, recorded life span of over 3 years.
In addition, an article summarizing the results of the clinical trials conducted by the company this week the journal Science published a leading oncology. We are proud that the scientific community has and cherishes the experimental results
How about biotechnology sector in Israel?
Israel's biotechnology sector today is one of the best in the world. Israel's ability to develop and grow a technology has been here for many years and the last decade took shape centered and thriving industry. Capital market positioning contributed greatly to this industrial sector and we are confident that he would see fruit company listed.
What is the importance of work as the company's U.S. regulatory standpoint?
The company develops all the drugs and indications under U.S. regulation while maintaining most of all the rules and requirements of the FDA. The drug is under the supervision and control of four different departments at the FDA. This gets recognition from regulatory authorities in (270.2 ? 1.46%) - other world and there will expedite the registration and marketing.
What achievements Fite (40 ? 0.25%) - in 2012?
In 2012 we continued to prove and establish the advantage of pharmaceutical company (the CF101 and CF102-) in terms of safety profile, which is certainly exceptionally good relative biological drugs sold in markets to which we turn.
We reported positive interim results of Phase II / III for the treatment of psoriasis and proven effective c major indices tested. Efficacy was rising linearly. Throughout the treatment period.
We have completed a successful move to split the activity in the eyes by way of a reverse merger with a shell company in the U.S. new subsidiary Aoftlix.
We received patent approval in China for the treatment of dry eye until 2026.
Successful final results achieved in Phase I / II patients with liver cancer. Reception drug orphan drug status. FDA.
Further clinical results obtained, we applied for a patent for a pharmaceutical company to improve sexual function (CF602).
What are the major events expected Well Pate (40 ? 0.25%) - in 2013?
Publication of results of a Phase III trial for the treatment of dry eye syndrome.
Publication of final results of the experiment IIb rheumatoid arthritis.
Publication of interim results in Phase II for Bglakomh.
Complete mobilization of all patients in Phase II / III patients with psoriasis.
Submission of the Phase II protocol liver cancer.
Submission of the Phase II protocol Baubiaitis.
Completion of Level II ADR listing.
How Fite intends to finance (575 ? 0%) the activity in the coming quarters?
Can-Fite diverse pipeline of drugs that are the most advanced stages of development. Accordance with the company's business model and work plan stated, continue making positive clinical results in one or more drugs in development will allow the company to promote and conduct transactions commercialization with multinational companies.
In 2013 alone, the company expects to publish final results of three advanced clinical trials, which also results from a Phase III drug for the treatment of dry eye syndrome. We believe that these events will create and flood value of the company.
At the same time, the company faced with a number of other commercial options to fund operations, including the receipt of additional payments in respect of the licensing agreements we signed. In this context, I can note that an extra charge possible from Seikagaku Hifanit for meeting the milestone of development in treating rheumatoid arthritis, after this day the company has already received $ 7.5 million to a total of payments may reach $ 19 million
And now some questions came surfers sponsor
What is the expected completion date of the current experimental psoriasis and publicized the results?
Also when you start Seikagaku the second phase of the experiment - 101 in Japan and what the next payment that is supposed to pay so Pate (40 ? 0.25%) - next milestone?
The expected date of the end of the experiment Company will strive to finish the Guillaume hospital during the year 2013 and publish the results in the first half of 2014. SKK begin Phase 2 after the publication of the trial results - Fite. This is the next milestone and payment is significant.
Is the drug therapy of autoimmune and inflammatory may be on the basis of chronic (lifelong) or there is complete healing of the disease?
The use of these diseases are chronic and that due to market size
So much for questions and browsing, thanks to Prof. Pnina Fishman, Can-Fite Company on hosting a forum sponsor Biomed
CANFY
Dubi, If you wanna translate for ghmm :)
http://www.sponser.co.il/Article.aspx?ArticleId=29476
ProCognia
New owners, new management, same science, still mainly a service provider. So still not a direct competitor to MNTA.
ProCognia was once considered MNTA’s foremost competitor, but Idit all but wrote them off as a serious threat few years ago (#msg-33839321).
Is there a rationale to reconsider?
ADHD treatment co Alcobra files for Nasdaq IPO
The life sciences company reportedly plans to raise $15-20 million at a company value of $100 million.
14 January 13 17:11, Gali Weinreb
Alcobra Ltd., which is developing a treatment for attention deficit hyperactivity disorder (ADGD), today filed a draft prospectus with the US Securities and Exchange Commission (SEC) to hold an IPO on Nasdaq. The company reportedly plans to raise $15-20 million at a company value of $100 million, before money.
If the offering goes ahead, it will be the first IPO by an Israeli life sciences company on Nasdaq since 2010 (by D Medical Industries Ltd. (Bulletin Board: DMEDF); TASE:DMED), which has since been relegated from Nasdaq). There have been a few IPOs by Israeli life sciences companies over the past decade, including Rosetta Genomics Ltd. (Nasdaq:ROSG), Syneron Medical Ltd. (Nasdaq: ELOS), Omrix Biopharmaceuticals, and other companies listed through reverse mergers with stock market shells.
Alcobra was founded in 2008 by 7 Health Ventures partner Dalia Megiddo and Udi Gilboa, whose investments include InsuLine Medical Ltd. (TASE: INSL), and they are its main shareholders. They are behind the idea of using an existing drug for the treatment of alcoholism to treat ADHD, after clinical trials for the first indication found that the drug improves attention.
Alcobra's drug, MG01CI, is undergoing a Phase II clinical trial, and the company has a development agreement with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) that is potentially worth hundreds of millions of dollars. But when the time came for Teva to exercise its option to continue development of the drug, it asked for an extension.
"The timing was problematic for us, coming two weeks after Teva CEO announced his resignation," says Alcobra CEO Dr. Yaron Daniely. Alcobra gambled and rejected the request for an extension, to prevent product development delays. "There were other parties interested in us," says Daniely.
Teva still owns a minority stake in Alcobra. Former Teva VP innovative ventures Dr. Aharon Schwartz now serves as Alcobra's chairman.
It is difficult to know whether Alcobra made the right decision. Although it has avoided a year of possible paralysis, it suits Teva's new strategy, and it may still be able to find a new partner. Meanwhile, Alcobra is moving forward on its own, and the clinical trial for its drug is neither long nor expensive. Daniely believes that the drug can be launched within 2-3 years, but it will later need a strong partner for marketing.
"Every launch of a new ADHD product in the past ten years cost $1 billion," Daniely told "Globes". "The US market alone is worth $4 billion."
There are currently two main families of ADHD drugs: stimulants like Ritalin; and non-stimulants like Strattera, made by Eli Lilly & Co. (NYSE: LLY). "Ritalin and its peers are hard to manage, because they can also be used as drugs, so patients must renew their prescriptions every 30 days," says Daniely. "Strattera was one of the most successful launches of all time, and it had $600 million in sales in its second year, until severe side effects appeared. Eli Lilly has stopped promoting the drug, but it has maintained its level of sales. This shows the advantages of non-stimulant treatments in the eyes of doctors and consumers."
Daniely believes that MG01CI has the best of both worlds: it has few side effects, an immediate effect, and no high, which means that it will not come under narcotics regulations.
"Globes": Why raise capital now, instead of finding a strong partner?
Daniely: "This is an opportunity to raise money at a good valuation, and we're raising capital while keeping close ties with all the players in the market. We believe that the company's value will rise after the Phase III clinical trial."
Published by Globes [online], Israel business news - www.globes-online.com -
ProCognia completes global glycoanalysis center
The center's three branches in the US, Germany, and India will provide analysis of complex sugar molecules in biological medicines and biosimilars.
14 January 13 11:41, Kobi Yeshayahou
ProCognia (Israel) Ltd. (TASE:PRCG) has completed construction of its global glycoanalysis center for analyzing and monitoring sugar structures in biological medicines and biosimilars for biopharmaceutical companies. The center is part of the company's strategy to expand its services and product lines.
At the glycoanalysis center, ProCognia will use a range of proven applied glycoanlysis technologies, and it plans to begin offering products and services immediately. The company believes that the center will greatly boost sales, shorten sale processes, and might facilitate future collaborations.
The new center will strengthen ProCognia's presence in its key markets in the US, Europe, and Asia, where most biopharmaceutical companies are located. The company will have local marketing and customer support centers to improve customer access in the target markets.
Glycoanalysis is a critical part of the development and production of biological medicines and biosimilars, which are genetically engineered proteins that include complex sugar molecules. The structure of these molecules has a material effect on the medicines' characteristics, efficacy, and safety profiles. Consequently, demand for glycoanalysis by the drugs' developers, which totaled $128 billion in 2011, is growing 11% a year.
ProCognia CEO Dr. Ruth Ben-Yakar said, "In view of the growth in the company's sales and our focus on the marketing and sale of glycoanalysis services for biological medicines through the use of a range of technologies, we decided to greatly expand our access to customers worldwide, and we established the new center and its branches. Establishment of the center will enable us to provide an optimal response to the market's needs, expand our access to our customers, and increase awareness of the high added value of the company's services. The new center is now operating in our main markets through three support centers in Germany, the US, and India, and should help our sales teams to greatly boost the company's sales."
ProCognia's share price rose 10% by midday to NIS 0.56, giving a market cap of NIS 13 million.
Published by Globes [online], Israel business news - www.globes-online.com - on January 14, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013
You can compare the language used by the FDA:
Brainsway's device is approved for the treatment of Major Depressive Disorder in patients who have failed to respond to antidepressant medications in their current episode of depression.
Neuronetics' device is approved for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.
Antidepressants are 1st line and a patient can try one of the TMS treatments before ECT.
Here is what i read:
FDA approves Brainsway's depression treatment device
The approval is also an important breakthrough for the company, and opens an important US market.
9 January 13 12:03, Globes' correspondent
Brainsway Ltd. (TASE:BRIN) today announced that it has obtained US Food and Drug Administration (FDA) clearance for use of its Deep TMS (transcranial magnetic stimulation) device for the treatment of depression in patients who fail to respond to therapeutics during a depression episode. The company adds that the FDA approval for this indication is generally broader than the definition given by the company's TMS device rival.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000813023&fid=1725
I read somewhere that Brainsway's depression treatment device
is by far superior to that of Neuronetics!
Where i read or who claims so is beyond my limited
memory capacity
I think i may have read it by Brainstorm management
statement, but i am not sure!
CANFY
Not a too bad translation considering
the auto/robotic GOOG translation
#msg-83365887
Brainsway's depression treatment device is the second FDA approved TMS device for treating depression. Neuronetics has its device in the market since Oct. 08 #msg-34025303. Wonder how are they doing.
FDA approves Brainsway's depression treatment device
The approval is also an important breakthrough for the company, and opens an important US market.
9 January 13 12:03, Globes' correspondent
Brainsway Ltd. (TASE:BRIN) today announced that it has obtained US Food and Drug Administration (FDA) clearance for use of its Deep TMS (transcranial magnetic stimulation) device for the treatment of depression in patients who fail to respond to therapeutics during a depression episode. The company adds that the FDA approval for this indication is generally broader than the definition given by the company's TMS device rival.
Brainsway said that the FDA certification of the Deep TMS device for use in the US for such a broad indication is further demonstration of the device's efficacy and safety in treating depression, and could be an important milestone in changing the treatment for depression. The approval is also an important breakthrough for the company, and opens an important US market, which the company estimates at tens of billions of dollars a year.
Brainsway said that it was considering how to market and distribute the Deep TMS device in the US and other countries, including collaborations with experienced companies in the business.
Brainsway's share price rose 35% by midday, after trading in the share was resumed, to NIS 44.79, giving a market cap of over NIS 500 million.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000813023&fid=1725
Published by Globes [online], Israel business news - www.globes-online.com - on January 9, 2013
OK so nothing I can listen to. Even if I'd come I probably would need a translator . Sometime we'd like to visit but probably not ready for a couple years.
Thanks again for the info! I'll have to look more at the Eye indications. Does the lack of a complete dose response cause you to be more cautious especially with your other point about placebo crossovers? I didn't see them listed in the JP Morgan agenda
http://jpmorgan.metameetings.com/webcasts/healthcare13/agenda.html
Thanks for the replies and info. I saw OPLI is pretty thin (like yesterdays .50 move on little volume) and their balance sheet isn't exactly loaded so not as if their liquidation could be a boon for CanFite.
Your observation at the 12 week mark with the Placebo was pretty insightful. Made me more wonder if the Psoriasis is more clearing up on its own and drug effect is small. They say about 2mg was chosen to go forward an in the one presentation it looks like they tried 1mg and 2mg. Do you know if they had less efficacy at a higher dose? I saw they are trying 4mg in RA so curious about that (Obviously I'd be considered if so).
My thinking was Psoriasis is a pretty big market and given their market cap they'ld only need a small fraction to justify a much higher share price the same for the RA drug.
I don't know about their ED drug it seems not worth the effort (unless someone picks it up) and haven't looked at their Eye Indications (via OPLI).
Its quite interesting given their market cap. I'll probably want to hear a presentation or two before considering a position hopefully they'll present somewhere or do conference calls.
You're right, this is very confusing as Can-Fite's stake in OPLI is valued higher than market value of CANFY and it was almost two and half times a year ago before Denali (DCMG) changed to OphthaliX (OPLI).
Can-Fite
Market cap is about $26M (97M NIS) see http://www.tase.co.il/TASEEng/General/Company/companyMainData.htm?companyID=001272&subDataType=0&shareID=01094473
Correction that 46 million was for OPLI (actually closer to 47). For CANFY it looks like the ADRS are a 50-1 ratio and there are 273,379,902 shares listed on the TASI which would mean about 5.5 million in CANFY equivalent. I would wait till someone more familiar posts something as I'm still looking at them and could have easily missed/misinterpreted something!
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