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Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) Anchors Israeli Takeover?
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV) closed the chapter of Israeli IPOs in the U.S. in 2015. But more Israeli technology and biotech companies are expected to list in the U.S. this year depending on market demand. Kitov seems poised to benefit from a surge in interest in Israeli stocks.
According to EVP of Listings Services at NASDAQ, Nelson Griggs, at least three Israel-based companies have already done their initial filing for IPO in the U.S. for this year. Those companies will be looking to enter the U.S. public market when the environment is conducive.
Some four Israeli companies with market value in the band of $500 to $750 million could raise between $75 and $130 million when they IPO in the U.S., according to Griggs. Of the various non-U.S. companies listed on NASDAQ, the majority are based in Canada, China followed by Israel. That’s a sign of appetite for Israeli stocks in the U.S. and more companies in the country are hoping to capitalize on that goodwill to tap in the U.S. investor pool.
Kitov closes chapter on a slow year
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV)’s September 2015 listing in the U.S. closed the chapter of Israeli companies that listed in the U.S. on that year. But the year only saw 7 Israeli IPOs compared to 12 in the previous year. Nevertheless, Kitov shares could edge up as investors show more love for Israeli companies.
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV) beyond the IPO wave
But beyond the IPO wave, Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV) has company-specific catalysts that could drive gains in the stock in the next few years. The company recently updated on its clinical programs, saying that a study of its drug candidate called KIT-302 met key FDA standards.
Following the success of the study, Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV) said it had moved closer to seeking FDA approval of KIT-302 later this year. The company is also gearing up to bring the drug to market in 2017.
Kitov Creates Pill for Safely Treating Osteoarthritis Pain and Hypertension
NEW YORK, NY / ACCESSWIRE / May 3, 2016 / Combining two existing generic drugs, a new, safer solution to osteoarthritis pain is found; Kitov's drug passed Phase III with stunning results;
Drug companies run the range of novel new therapies and creative use of older medicines. This latter category is exciting because FDA approval is easier - clinical trials have already been done and safety issues solved. But not all pharma firms travel this path successfully until Kitov Pharmaceuticals Holdings LTD (NASDAQ: KTOV), whose work treating a pervasive worldwide medical condition costing healthcare billions of dollars, found a way.
Kitov takes existing drugs and makes them work better together. Its first indication is osteoarthritis (NYSE:OA), or degenerative joint disease where cartilage of the hips, knees and spine breaks down and inflammation sets in, causing pain. The condition gradually worsens, and no cure exists. Over-the-counter pain relievers are the drug of choice, but they cause an increase in blood pressure which, in turn, can lead to cardiovascular disease (NYSE:CVD).
Ingeniously mixing celecoxib, a non-steroidal anti-inflammatory drug (NSAID) originally marketed by Pfizer Inc. (NYSE:PFE) as Celebrex until going generic in 2014, and amlodipine besylate, another Pfizer drug sold as Norvasc for lowering blood pressure until patent expiration in 2007, Kitov's lead compound, KIT-302, tackles pain and the unfortunate result of using NSAIDs for pain - hypertension. Nothing like it has been developed before.
Late last year, Kitov scored big when its drug hit a primary efficacy endpoint in Phase III in a trial designed to measure drops in blood pressure in those receiving KIT-302. Separated into four groups, 152 patients treated over two weeks received KIT-302, Norvasc alone, Celebrex alone, or placebo. Trial results were analyzed after 17 months, post-treatment, its goal to show Kitov's drug lowered daytime systolic blood pressure by half as compared to patients receiving only Norvasc.
It worked. Patients taking Norvasc - mean reduction in daytime blood pressure of 8.8 mm Hg (as recorded by blood pressure cuff); patients taking KIT-302 - mean reduction of same of 10.6 mm Hg, a statistically significant result and enough for FDA to entertain a new drug application, for which Kitov plans to submit this year with expected marketing approval in 2017.
There's more: further data drilling showed KIT-302's beneficial effect on blood pressure was not limited to daytime systolic measures, but to nighttime as well, enhancing the drug's power. Celebrex alone was shown to increase blood pressure, as research predicted. End result - Kitov has created a new, safe way to take NSAIDs, revolutionizing the management of OA pain with one pill.
Research is peppered with references correlating OA, NSAIDs and hypertension with risk of CVD. Advil, Motrin and Aleve (Tylenol is found not effective in battling OA pain) make the body retain fluid which decreases kidney function, which in turn causes blood pressure to rise, putting stress on the heart. One seminal study showed a telling link between NSAID use and CVD: where NSAIDs were taken, the result was a four-fold surge in opportunity of heart attack and stroke. Another study comprising 10,000 people with OA showed higher risk of CVD, often leading to death, no doubt due to NSAID use.
Given the widespread prevalence of OA - over 27 million people in the US alone with medical costs of $154 billion, half of which have hypertension - and the drawbacks of current treatment, pharma firms are clamoring for a piece of the market. Likewise, our overburdened healthcare system would embrace new, effective and safe methods to treat OA, considered the top cause of disability in the US and in the top ten throughout the rest of the world.
One inexpensive path would be to reassign existing medications to OA, which is what's been done with Eli Lilly and Company's (NYSE:LLY) Cymbalta, a popular anti-depression drug approved for OA pain in 2010. Same side effects apply: nausea, drowsiness, constipation and change in appetite. In 2014, FDA required that Cymbalta carry a black box warning, the agency's highest form of conveying risk, urging users to recognize suicidal thoughts. Further, fainting may occur in those taking blood pressure medicine, which constitutes a high percentage of aging people with OA.
Trials using monoclonal antibodies directed at blocking a nerve growth factor associated with OA pain have been fraught with misfortune. A clinical hold was issued from the FDA for this class of drugs after a large Phase III trial sponsored by Pfizer was halted in 2013 when its compound caused bone deterioration and actually accelerated OA. The trial has resumed after FDA lifted the ban, but there is no mention of changes to the drug to prevent prior adverse effects and, even if successful, doctors might be hesitant to prescribe it given its stigma.
Another large Phase III using a different monoclonal antibody in the same class was terminated several weeks ago by Johnson & Johnson (NYSE:JNJ). Although reason cited was a "strategic portfolio prioritization", the drug, in-licensed in 2008, was part of the company's 2015 list of future blockbusters with sales topping $1 billion annually, which stretches credibility that the decision was not made out of safety concerns.
Regardless of whether monoclonal antibodies work in OA without side effects, I doubt patients would choose a series of uncomfortable and inconvenient injections over a pill.
Kitov came public in November 2015 in a 1:1 combination of American Depository Shares and warrants, for gross proceeds of $13 million. Operating loss in fiscal 2015 was $4 million and depending whether research and development costs subside and operating expense remains steady, runway is limited. Kitov's Phase III was small relative to most, creating risk that larger populations taking the drug may show less efficacy or greater adverse effects. Patents are not yet issued so protection is a concern. Resources to develop new combination drugs may not be available without raising more money. Trading is thin, allowing for volatility.
For investors, Kitov embodies a rare ground floor opportunity to benefit from an exceptional drug that treats two diseases for the price of one, selling into multi-billion dollar markets, providing a solution to physicians hesitant to recommend NSAIDs due to heart effects, and lending significant cost savings to health care payors. KIT-302, if approved, is likely to be widely prescribed. In the future, new Kitov combination drugs would follow KIT-302's pattern of low development risk and efficient regulatory pathways, returning a quicker than usual return on investment.
Roy, do you follow KTOV?
If so, you are invited
to chime in the board.
TIA
Kitov Pharmaceuticals Reports Additional Data from its Phase III Trial on the Beneficial Blood Pressure Effects of KIT-302
- KIT-302 could address a major safety concern in the use of pain medication for the healthcare community
- Study data shed new light on optimal usage of NSAIDs, the most widely prescribed class of drugs
- Synergistic effect on blood pressure reduction demonstrated with KIT-302's two components was present at all times of day and with both blood pressure parameters
TEL AVIV, Israel, Dec. 17, 2015 /PRNewswire/ -- Kitov
Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced more data from its successfully concluded Phase III trial for its lead drug candidate, KIT-302. Data showed the favorable blood pressure effects of KIT-302 were present in all blood pressure variables measured in the study. These data not only confirm the top line findings of the study, they further reveal the benefits of using of a combination drug to improve patient safety when using pain medications.
A combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.
The primary efficacy endpoint, which Kitov's Phase III study successfully met, was based on the difference in daytime systolic blood pressure reduction between patients treated with amlodipine and those treated with amlodipine plus celecoxib. The mean reductions were 8.8 mm Hg for the patients treated with amlodipine alone and 10.6 mm Hg for patients treated with the KIT-302 components (amlodipine plus celecoxib). This difference met the FDA's primary efficacy endpoint statistical requirements with a p value of 0.001..
Upon further review of its Phase III clinical results, Kitov has determined that the blood pressure reduction synergy seen with combining celecoxib and amlodipine, is seen not only in the study's primary efficacy endpoint of daytime systolic blood pressure, but was also present in all other blood pressure variables. This beneficial effect of celecoxib on blood pressure was not present when celecoxib was administered alone, rather celecoxib was shown to elevate blood pressure relative to placebo, when administered by itself.
"These new data show that KIT-302 may have a very significant impact on how nonsteroidal anti-inflammatory drugs (NSAIDs) are used in the future. As the largest consumed class of drugs on the market, NSAIDs are generally a better chronic pain reduction alternative than narcotics. However, NSAIDs still carry a black box warning in its labeling from the FDA due to their side effect of hypertension and associated risks including heart attack and stroke," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer. "KIT-302, by combining a widely used NSAID with amlodipine, the only once-a-day calcium blocker, actually reduces all blood pressure measures, and therefore may offer a new, safer choice for doctors and their patients."
"Moreover, we believe the medical community will take great interest in this study's findings and its implications for pain management and hypertension," Dr. Waymack added.
The blood pressure reduction synergy was also seen for daytime diastolic blood pressure measurements. After two weeks of treatment the reduction for this variable with amlodipine alone was 5.5 mm Hg, while for patients treated with KIT-302's components the reduction was 7.6 mm Hg. For nighttime systolic blood pressure after two weeks of treatment the reduction with amlodipine therapy alone was 6.3 mm Hg, while for patients treated with KIT-302's components the reduction was 10.7 mm Hg. For nighttime diastolic blood pressure after two weeks of treatment the reduction with amlodipine alone was 3.1 mm Hg, while for patients treated with KIT-302's components the reduction was 7.2 mm Hg.
To summarize, the synergy in blood pressure reduction demonstrated with KIT-302's two components was present at all times of day and with both blood pressure measures. Although celecoxib when combined with amlodipine appears to have a synergistic effect and lowers blood pressure, it has the opposite effect when administered by itself.
Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib, are non-steroidal anti-inflammatory drugs (NSAIDs) which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.
BiondVax to Bring Long-Awaited Universal Flu Vaccine to the Market
#msg-118902505
TASE moves to limit exploitative listings by foreign companies: #msg-118569313.
ELBIT IMAGING LTD. ANNOUNCES THAT INSIGHTEC ANNOUNCES THAT THE FDA HAS
APPROVED EXABLATE SYSTEM FOR TREATMENT IN THE USA
Tel Aviv, Israel, October 7, 2015, Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today that it was informed by InSightec’s Ltd. ("InSightec"), that the United States Food and Drug Administration (FDA) has approved InSightec next generation Exablate system to treat symptomatic uterine fibroids and changed the labeling to allow consideration for women who desire to maintain fertility. The updated labeling specifies that ablation of uterine fibroid tissue can now be considered for women with symptomatic uterine fibroids, who desire to retain fertility and spare their uterus.
InSightec estimates that such change in labeling provides younger women suffering from symptomatic fibroids access to a new, non-invasive treatment option that is safe, effective and keeps their uterus intact without compromising their existing ability to get pregnant. The approval is based on accumulated, documented clinical data on 118 patients’ pregnancies post Exablate MRgFUS treatments.
FDA approval of INSIGHTEC’s next generation Exablate system offers treating physicians a more advanced technology.
The Company holds approximately 82.7% of the share capital of Elbit Medical Technologies Ltd. ("Elbit Medical") (TASE: EMTC-M) (on a fully diluted basis) which, in turn, holds approximately 29.6% of the share capital in InSightec (on a fully diluted basis).
With good reasoning, TASE is
practically dead! (Well, not
exactly, but surely needs an
oxygen infusion)
MYL plans to list on TASE:
http://finance.yahoo.com/news/mylan-comments-meritless-perrigo-lawsuit-192000278.html
Over the last three days VASCULAR BIOGENICS LTD's shares have advanced 51.12% and in the past one week it has moved up 61.03%.
Haven't followed those closely.
Your take on VBLT? RDHL?
TIA
They had to wrap it up before Yom-Kippur
https://en.wikipedia.org/wiki/Yom_Kippur
(Sorry for the Jewish joke, but this is the Israel-Medical-Healthcare board after all...)
They had to rap it up before Yom-Kippur
https://en.wikipedia.org/wiki/Yom_Kippur
(sorry for the Jewish joke but it is the Israel-Medical-Healthcare board...)
Does it smell like a financing is coming ?
No other news out. Doesn't smell right.
Is that really the only driver here? Seems unfathomable!
CANF going crazy!
Shana Tova,
ktsat nachat!
VBLT too!
Replace dust=smoke and you got it!
Smoke gets in your eyes
They asked me how I knew
My true love was true
I of course replied
Something here inside cannot be denied
They said "someday you'll find all who love are blind"
When your heart's on fire,
You must realize, smoke gets in your eyes
So I chaffed them and I gaily laughed
To think they could doubt my love
Yet today my love has flown away,
I am without my love (without my love)
Now laughing friends deride
Tears I cannot hide
So I smile and say
When a lovely flame dies, smoke gets in your eyes
(Smoke gets in your eyes, smoke gets in your eyes)
Never trust this kind of interviews. Besides, I cannot hear nor see anything because of the dust
http://news.nationalgeographic.com/2015/09/150908-middle-east-dust-storm-haboob-weather/?utm_source=GooglePlus&utm_medium=Social&utm_content=link_gp20150909news-duststorm&utm_campaign=Content
Shana Tova!
Thanks D.T. I assume you listened
to the short interview?
Shana Tova, best wishes!
Dubi
BVXV - met with them once long time ago and got a negative impression on their reliability so didn't follow closely since. Perhaps I will look again after this trial is done:
http://www.biondvax.com/2015/09/02/biondvax-announces-intent-to-launch-a-phase-2-trial-in-the-united-states-in-collaboration-with-the-u-s-national-institutes-of-health/
I read this news on several blog. I came to know about Novartis on http://www.ilexmedical.com/brands.php?act=cat . They are one of the biggest pharmaceutical companies in the world that shows a great interest in Israel health care market. Since long, they were involved in manufacturing drugs and clinical trials, however, now looking to expand their venture in many such medical fields too.
Novartis seeks new Israeli technologies
David Epstein
15/02/2015, 15:43
Amiram Barkat
Novartis exec David Epstein says having invested in Israel's Gamida Cell and BioLineRx, Novartis is hungry for more.
Novartis AG (NYSE: NVS), the world's biggest pharmaceutical company, recently increased its interest in Israel. For a long time, the company was active in marketing and clinical trials in Israel, and now it is involved in investment as well.
Over the past year, Novartis has invested $35 million in Israel’s Gamida Cell, with an option to acquire it in the future for $165 million, plus royalties, by mid-2016. Novartis also signed a deal with BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX), under which BioLineRx will seek and develop Israeli technologies for Novartis. This is a double vote of confidence in the Israeli market: Novartis both recognizes that there is sufficient technology here to justify seeking it, and also believes that Israel’s BioLineRx is suitable for developing these technologies in early stages.
The person directing Novartis’s general strategy is David Epstein, who has served as Novartis Pharmaceuticals Division Head since 2010, directly under Novartis CEO Joseph Jimenez. In effect, Epstein’s activity will in one way or another affect the health of us all, and also Novartis’s access to Israel.
Epstein is an oncologist, and his appointment to lead the pharmaceutical division indicates the company’s growing focus on cancer treatment. During his tenure, the Novartis pharmaceuticals division has taken some important steps, such as acquiring personalized medicine competency, significantly reducing manpower, including in development, and selling its vaccine activity to GSK, while acquiring GSK’s cancer activity, in one of the most creative deals in the pharmaceutical industry.
The Novartis pharmaceuticals division under Epstein is today, according to the company, a focused division, with a promising product pipeline, open access to partnerships, and an appetite for acquisitions, but not for mega-mergers.
"Globes" spoke with Epstein about Novartos's investments in Israel.
Novartis recently made two investments in Israel, following a long period in which no such investments were made. Can you tell us about them?
“We decided to strengthen our ties with young start-ups that have interesting technologies, and when we examined our investment portfolio, it became clear that our exposure to Israel is very limited, despite the fact that there’s a great deal of talent and innovation in Israel. So we invested time in meeting key figures in Israel, and based on this, we have made two deals thus far. The investment in Gamida Cell came from our intention to give strategic priority to developing cell therapy and gene therapy technologies. Gamida has an advanced stem-cell cancer treatment product.
“In addition, we wanted to find a partner that has a deep familiarity with the Israeli market - with the start-ups and with the universities in Israel, and that is why we chose BioLineRx, which has been operating in Israel for a long time, in order to better connect with opportunities in Israel.”
What is your impression of the two investments you have made so far?
“The investments are new. Gamida has advanced a lot since we met, the team is very talented. The partnership with BioLineRx is fresher, but it has a lot of openness and wonderful accessibility. So, all in all, we have had a good start, but we are still in very early stages, particularly with regards to BioLineRx.”
Are there more options on the table?
“Novartis announced that it will carry out targeted acquisitions. In Israel, it will probably be primarily through BioLineRx. Under the terms of the investment in BioLineRx, the company is meant to take the money, identify the Israeli start-ups, and then acquire the rights to develop their technologies. We will be able to buy these technologies from them, if they advance well.
“The key to the success of the Israeli market,” says Epstein, “is its access to the generics market, which can create a lot of value, but it’s important to be diligent about quality control processes. Because, oftentimes, mostly with Indian products, they are not of high enough quality. Just look at the recent scandals in the US surrounding the Indian generics company Ranbaxy and others - it is important to know from whom you are buying. Novartis is the second-largest manufacturer in the world, and we manufacture very high quality products. The largest is, of course, Teva, which is a big advantage for Israel.”
At the annual J.P. Morgan Healthcare Conference, which took place in January, Novartis indicated another area of focus - digital healthcare. The company announced a partnership with Google, under which the Novartis eye-care division, Alcon, will license smart lenses from Google Ventures. Novartis previously founded a digital-healthcare investment fund with chip manufacturer Qualcomm.
Published by Globes [online], Israel business news - www.globes-online.com - on February 15, 2015
Lol. Modesty becomes you!
Any special reason for CANF
to rally at such an outstanding
pace 4 days in a row?
Anyone know if there is are any US traded incubators? Xenia is traded on the TASE.
Thanks
It looks like CBI.TA hasn't traded since April 3:
http://www.cbi.co.il/tase-stock-chart
Do you know why?
No, I never owned either but followed DiaPep277 out of respect for Irun Cohen and scientific curiosity.
Btw, Teva sold its share in Andromeda (~16%) back to to CBI, for $72M about 2 months ago.
That might be the most back-end-loaded biotech buyout I've ever seen! Do you own either company?
DiaPep277 sold to Hyperion Therapeutics, Inc. (NASDAQ: HPTX):
http://investors.hyperiontx.com/releasedetail.cfm?ReleaseID=842174
Brainsway CEO Uzi Sofer told "Reuters" the company is aiming for thousands of installations for different diseases.
"The company is aiming for thousands of installations for different diseases in the future," Brainsway Ltd. (TASE:BRIN) CEO Uzi Sofer told "Reuters", predicting strong growth of the company. "We hope this trend will continue and even get stronger."
Sofer told "Reuters" that he was optimistic about a study being done at Harvard University on whether Brainsway's system can help with epilepsy.
Brainsway has launched its non-invasive deep transcranial magnetic stimulation (TMS) treatment for depression, and is conducting clinical trials of the device for the treatment of other neurological disorders. The device is a helmet that shoots magnetic pulses into the brain of patients with neurological disorders to stimulate neurons and improve function in the affected areas.
Brainsway obtained US Federal Drug Administration (FDA) approval last year for treating patients with major depression disorder. Other trials are underway for treating Parkinson's and Alzheimer's, addictions, and stress and eating disorders.
"Reuters" calls the technology a "tamer, safer and more precise version of electro-shock therapy and has been used for years." It quotes Brainsway as saying that its technology is unique because it can penetrate deeper than any other non-invasive method being used, allowing it to target areas of the brain that were until now unreachable.
Brainsway has installed over 70 of its units, mostly in the US. The company's revenue rose to NIS 4.3 million in 2013 from NIS 1.4 million in 2012, and netloss narrowed to NIS 15.4 million from NIS 21.2 million. Earlier this month, it raised $11.8 million this month to boost production lines.
Brainsway CTO Ronen Segal told "Reuters, "Many of the big players in this market, including medical device companies and even pharmaceutical companies" have taken notice and that there is potential for collaboration in areas like distribution and R&D.
Published by Globes [online], Israel business news - www.globes-online.com - on March 25, 2014
Hi, Dubi. It's curious that both MDT and HSIC are playing a role in this program. Regards, Dew
Itamar signs Medtronic deal for sleep device
{Any personal interest Dew?}
17/03/2014, 17:14
Gali Weinreb
The sleep apnia diagnosis product will be marketed through cardiologists.
Itamar Medical Ltd. (TASE:ITMR) has signed an exclusive marketing agreement with Medtronic Corporation (NYSE: MDT), to market the company's sleep apnea diagnostic product to a select segment of the US market - patients with atrial fibrillation. The financial terms of the deal were not disclosed.
The collaboration will begin as a pilot, and if it is successful, Medtronic will be awarded exclusivity for this market, and will agree to order a predetermined minimum of Itamar's products and to invest a predetermined sum in marketing.
Under the agreement, Henry Shein Inc. (Nasdaq: HSIC), one of the leading medical devices distributors in the US, will handle the product's logistics distribution (without the marketing). Henry Shein already has a marketing agreement with Itamar Medical for dental products.
Itamar Medical has cardiology diagnostic and sleep apnea diagnostic devices; the agreement with Medtronic covers the latter. Sleep apnea worsens the condition of patients with heart problems, including patients fitted with pacemakers. Medtronic has established a strategy to offer doctors who use it products the option of providing more comprehensive care to cardiology patients, and therefore wants to offer the sleep apnea diagnostic product for these patients.
The cardiology and sleep markets overlap: sleep disorders, especially sleep apnea, in which Itamar Medical specializes, can be an indication of heart disease, both as a cause and as a consequence.
The collaboration also fits in with Itamar Medical's strategy of marketing its sleep apnea products to cardiologists, at least in the US market.
Although Medtronic has held a stake in Itamar Medical since it was founded, and currently owns 21.6% of the company, this is the first time that the companies have signed a commercial agreement.
This is Itamar Medical's second agreement for its sleep apnea product in as many months, after signing an agreement with Philips Healthcare covering Japan the world's second largest sleep apnea market.
Published by Globes [online], Israel business news - www.globes-online.com - on March 17, 2014
Re CANF, can you reply to this
#msg-94962194 in its board?
Tia
Dubi
(back from isolation?
Constitutional Crisis LOOMS - Real BIRTH Certificate Surfaces -
CareFusion invests $100m in CME
CareFusion will buy a 40% stake in Caesarea Medical Electronics, which produces infusion pump systems.
9 December 13 15:50, Shiri Habib-Valdhorn
Healthcare technology developer CareFusion Corporation (NYSE: CFN) will acquire 40% of Israeli infusion pump systems manufacturer Caesarea Medical Electronics Ltd. (CME) for $100 million, giving a company value of $250 million (NIS 875 million). CareFusion collaborates with CME, including the purchase of its technology.
CME CEO Zvi Barak founded the company in 1993, and he and his wife, Anat, are the sole shareholders in equal shares. No Israeli or foreign venture capital funds have ever invested in the company. CME carries out all its manufacturing in Israel and has 250 employees.
CME develops and produces a range of infusion and syringe pumps and related accessories and disposable administration sets for hospitals and homecare use. The company's infusion pumps are known for their compact and highly portable design, making them ideal for specialty applications such as IV and epidural anesthesia and pain management, infusions during MRI procedures, hospital and home nutrition, and other uses. The pumps are sold in 60 countries worldwide, mostly outside the US.
CareFusion has the right to make additional investments to increase its stake to become the majority owner of CME. CME will continue to operate independently from CareFusion, including the retention of its existing distributor network in its markets.
CME said, "CareFusion's becoming a major shareholder in the company will enable us to increase our business and expand our global deployment to new countries. We will continue to operate as an independent company based in Israel, and keep our network of distributors. In the coming months, we plan to complete construction of a new building as part of the expansion of our plan in the Caesarea industrial park. The company has always taken care to provide job diverse opportunities to its employees and potential workforce from the area, and we hope to continue to do so."
"This investment creates a strategic, long-term relationship with CME, which has great people and great technology that is very complementary to our infusion portfolio," said CareFusion chairman and CEO Kieran Gallahue.
Published by Globes [online], Israel business news - www.globes-online.com - on December 9, 2013
The missus seems quite optimistic and VERY
enthusiastic in regards prospects and potential!
Seems she is not the only one!!!
Kamada reports positive results in diabetes study
Kamada plans to initiate a Phase II/III trial with Glassia with newly diagnosed type one diabetes pediatric and young adult patients.
31 October 13 13:36, Globes' correspondent
Kamada Ltd. (Nasdaq: KMDA); TASE: KMDA) has reported positive results in the extension study of a Phase I/II clinical trial with its lead product Glassia for the treatment of pediatric patients with a recently diagnosed type 1 diabetes.
In type 1 diabetes, the ability of pancreatic cells to produce insulin is compromised, and, with time, progressive deterioration of beta-cell reserve occurs due to the continuous autoimmune attack. New interim data from the ongoing extension study showed that 20 months from diagnosis of type 1 diabetes and 10 months following the last Glassia infusion, 60% of study subjects who participated (12/20) in the extension portion of the Phase I/II trial had peak C-peptide levels greater than 0.2 pmol/ml (average >0.4 pmol/ml), which indicates a functioning beta cell capacity, and is a higher percentage than expected without intervention.
In addition, patients continued to attain International Society for Pediatric and Adolescent Diabetes (ISPAD) treatment targets with an average hemoglobin sugar level (HbA1C) of 7.5%, and the majority of patients (75%) presented HbA1C levels even lower than 7.5%, which is the clinically desired level for glycemic control in pediatric diabetic patients who usually demonstrate a more severe or volatile form of T1D disease compared with adults.
No safety issues were reported.
Kamada CEO David Tsur said, "We are delighted that these interim data from the extension study continue to demonstrate the positive signals seen in our analysis of study results. These positive data may potentially represent a breakthrough in the treatment of this disease, and encourage us to actively move forward with plans to advance the clinical development of Glassia in this indication.
"Importantly, the preservation of beta cells may allow patients to reduce dependence on external insulin and eventually decrease disease complications such as cardiovascular disease, kidney failure, eye disease, severe wounds and more. These complications remain an unmet need that is still inadequately answered with existing therapies, which include insulin, diet and behavioral treatment."
Kamada plans to initiate a Phase II/III trial with Glassia with newly diagnosed type one diabetes pediatric and young adult patients in Israel by the end of the year to test Glassia's efficacy in stopping the progression on the disease and maintaining the pancreas's ability to produce insulin. The company may expand the study to other countries.
Published by Globes [online], Israel business news - www.globes-online.com - on October 31, 2013
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