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I think that something very deep is rotten in TARO,
The sooner the Indians will takeover and clean the stables,
the better. I would take what's left from my money and run.
True. It ain't over yet.
Do you think that if they lose the patent case at a trial,
they'll have to pay more than the hundreds of millions worth
they are are already selling?
"new stent [graft] covered with biological tissue "
Yes and I was about to ask if it would be possible in your opinion to treat this kind of biological cover so it would become drug eluting. Those covered stents have a bigger surface area than other stents.
Geron's telomerase inhibitor results in CLL
These are just early transient results. I would not make anything out of it except toxicity. You do not really expect a real effect after such short exposure.
I believe the sentence
"and pigs will fly"
expresses the odds of such scenario
>Analysts pleased with Teva's Lotrel ruling<
Well, I know it sounds stupid, but I'm pleased too
Exactly Aslan, I'm referring to Jostent, Symbiot and such, being used for SVG, aneurysms and artery perforations. From what I have found the sales are about $500M a year.
The reason I'm interested is a new stent covered with biological tissue (horse pericardium)that was approved in Europe.
TEVA vs NVS 1:0
New MRI Image Technique Predicts Early Onset of AD-
Who is going to pay for MRI tests?
Do you or anyone on board know the market size of the covered stents from Abbott - the Jostent line?
TIA, genisi
The market is going down 1.4%
TEVA only 0.2% down as I type.
Huge project in India
ELBIT MEDICAL IMAGING LTD. ANNOUNCES JOINT VENTURE FOR A
LARGE SCALE LUXURY RESIDENTIAL PROJECT IN BANGALORE,
INDIA
Tel-Aviv, Israel, June 7, 2007, Elbit Medical Imaging Ltd. (NASDAQ: EMITF) (“EMI”) today announced that on June 5th, 2007 it has executed a Framework Heads of Terms for the establishment of a joint venture with one the leading real estate developers in Bangalore, India, which became valid on June 6th, 2007 following
fulfillment of certain pre-conditions. The joint venture company to be established (“JV Company”) will be held 50% by each of EMI and the local partner. Subject to the fulfillment of certain conditions, the JV Company will acquire ownership and development rights in approximately 190 acres of land situated in an upscale section of Bangalore. Additionally, the Indian partner will assign to the JV Company joint development rights with the owners of an adjacent area of land measuring approximately 100 acres. The consummation of the transaction is subject to fulfilment
of certain agreed conditions, principally the satisfactory completion of due diligence investigations, and change of zoning to parts of the subject area.
Subject to the fulfillment of the conditions to closing, it is anticipated that EMI will invest an aggregate amount of approximately 7.200 million Rupees (approximately $180 million) in the land acquisition transactions, of which $ 50 million has been paid as an advanced payment upon signature of the Heads of Terms. Such advance payment will be returned to EMI should the preliminary conditions of the Agreement not be fulfilled.
EMI intends to offer to its controlled subsidiary company, Plaza Centers NV (LSE:PLAZ) to take up a 50% participation in EMI’s share of the joint venture. Plaza Centers’ participation requires the approval of its various corporate organs.
snip
Here is one I'll be watching:
QBI prepares for Nasdaq IPO
The company’s first quarter revenue was triple its revenue for 2006 as a whole.
Gali Weinreb 6 Jun 07 17:53
Israeli start-up Quark Pharmaceuticals Inc. (formerly Quark Biotech Inc.) yesterday filed a revised prospectus with US Securities and Exchange Commission (SEC) for an IPO on Nasdaq. As “Globes” first reported, the prospectus states that the company will issue five million shares at $12-14 per share, to raise $60-70 million at a company value of $219-256 million, after money.
The underwriters are JP Morgan, Banc of America Securities LLC, CIBC World Markets, and CE Unterberg Towbin. Quark has granted the underwriters a green shoe option to buy 750,000 shares, which will increase the amount of the IPO by up to $9 million. If the IPO goes ahead as planned, the company will be traded under the symbol “QURK”.
Quark is a drug development company, which took the market by surprise when it signed an agreement with Pfizer Inc. (NYSE:PFE; LSE:PFZ), granting an exclusive worldwide license to Quark’s novel human gene RTP-801 and to molecules that modify its expression or function. RTP-801 is involved in the development of pathologic blood vessels which accelerate the progression of age-related macular degeneration.
The updated prospectus states that Pfizer paid Quark $26.1 million through the end of March, and that it could pay up to $299 million if the three drugs that are the subject of the agreement are approved, and pay an additional $309 million depending on sales after the approval, in addition to royalties on the sales.
Quark has developed technology that enables it to discover genes responsible for various diseases, and to use this knowledge to develop drugs that intervene in the expression of these genes. The technology is derived from Silencing RNA (SiRNA), proteins that selectively silence particular genes.
Quark posted $14.4 million revenue in the first quarter of 2007 from its cooperation agreements with Pfizer and two Japanese company, compared with $4.8 million revenue in 2006 as a whole.
The company is also known for its largest investor: Oracle founder and CEO Larry Ellison, who has invested $50 million in the company for a 43% stake.
TEVA AND ACTIVE BIOTECH TO INITIATE PIVOTAL PHASE III TRIAL PROGRAM OF ORAL LAQUINIMOD FOR RELAPSING MULTIPLE SCLEROSIS
Jerusalem, Israel and Lund, Sweden, June 7, 2007
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and Active Biotech AB (OMX NORDIC: ACTI) today announced that the companies are initiating a clinical Phase III program for laquinimod, a novel once-daily, orally administered immunomodulatory compound for the treatment of relapsing multiple sclerosis (RMS). The studies will now begin following the successful conclusion of a second phase II study and the outcome of discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA).
The companies are to commence two global Phase III trials of laquinimod during this year. The Phase III trials will take place in centers in the United States, Europe, and other locations worldwide, to further confirm the results of the Phase II trials.
“We are extremely excited about initiating the Phase III clinical program for oral laquinimod, as we believe laquinimod is a potential new and convenient treatment option for MS patients,” said Shlomo Yanai, President and CEO of Teva Pharmaceutical Industries Ltd. “The accelerated development of oral laquinimod is part of our commitment to MS patients to develop additional improved therapies that combine superior efficacy and excellent safety.” “Laquinimod has the potential to be a novel, orally-administered disease modifying treatment for people
suffering from multiple sclerosis,” said Sven Andréasson, President and CEO of Active Biotech. “Laquinimod would represent a milestone for patients as it would provide them with an efficacious and safe treatment, as well as a new drug delivery option that is suitable for long-term treatment.”
U-Tacs Awarded $ 110 Million Order By Thales UK
To Provide ISTAR Capability For UK Armed Forces
Haifa, Israel, June 7, 2007- Elbit Systems Ltd. (NASDAQ:ESLT) announced that its UK company with Thales UK - UAV Tactical Systems Ltd. (U-TacS) has been awarded a contract worth approximately $110 million by Thales UK to provide an urgent intelligence, Surveillance, Target Acquisition and reconnaissance (ISTAR) support capability for the UK Armed Forces. The program, will commence immediately and will take place over the next
few years.
The contract includes the provision of Hermes® 450 UAV systems, as well as training of the UK MoD staff in use and maintenance of the system, and the provision of contractor logistic support (CLS) and program management services. This work will be managed from the U -TacS facility in Leicester, UK, which currently employs approximately 100 personnel. U -TacS also provides the core UAV systems for the Thales UK Watchkeeper UAV system.
The President and CEO of Elbit Systems, Joseph Ackerman said: "Once again, we are proud to be a part of a winning team together with Thales UK in a project based on the High End tactical Hermes® 450 UAV, globally recognized as a brand name for UAV
customers worldwide."
U-TacS is held 51% by Elbit Systems with the balance being owned by Thales UK.
ELBIT MEDICAL IMAGING LTD. ANNOUNCES - INSIGHTEC RECEIVES
EUROPEAN CE MARK FOR EXABLATE® 2000 TREATMENT OF PAIN
CAUSED BY BONE METASTASES
Tel-Aviv, Israel, June 6, 2007 - Elbit Medical Imaging Ltd. (NASDAQ:EMITF)(“EMI”) today announced that, its subsidiary (in which EMI holds indirectly approximately 52%), InSightec Ltd., announced today that its ExAblate® 2000
system has received the CE Mark certification for pain palliation of bone metastases.
Bone is the third most common organ to which cancer metastasizes, after the lungs and liver. Almost all patients with metastatic prostate cancer have skeletal metastases and in breast cancer, bone is the second most common site of metastatic spread,
affecting 90% of patients with progressive breast cancer. It is estimated 100,000 in Europe are diagnosed with bone metastases every year. Most cancer patients suffer from pain; controlling it and managing its symptoms are important treatment goals.
In clinical studies, which supported the CE mark certification, patients reported their pain levels using VAS (Visual Analog Score), a pain questionnaire used to monitor changes in pain levels and assess the efficacy of pain management. The majority of patients reported an immediate improvement in pain scores. Many also reported that they stopped using any analgesic pain relief.
“ExAblate 2000 has been used to successfully treat uterine fibroids non-invasively
with Magnetic Resonance guided Focused Ultrasound (MRgFUS) and this second CE Mark represents a significant milestone in our quest to expand the potential applications of this non-invasive, innovative therapy for oncology applications providing improved care for patients around the world,” said Dr. Kobi Vortman,
President and CEO of InSightec.
“This procedure can alleviate the patient’s pain, has the potential to lower reliance on
analgesics and provide patients with the opportunity for improved quality of life.”
Credit Suisse upgrade
Wednesday June 6, 8:18 am ET
Teva Pharma Shares Rise on Analyst Upgrade and Prediction of Better Sales
NEW YORK (AP) -- Shares of Teva Pharmaceutical Industries Ltd. rose in premarket electronic trading Wednesday after an analyst upgraded the stock, saying new product and generic drugs will increase the company's profits over the next two years.
Credit Suisse analyst Marc Goodman said pain relief drug Oxycontin, asthma inhaler ProAir, a generic version of osteoporosis drug Fosamax and others will help the Israeli company improve its sales. He raised his earnings per share estimates by 8 cents, to $2.34, for 2007, and by 10 cents, to $2.65, for 2008.
"Consensus earnings estimates are too low for 2007 and 2008," Goodman said. He upgraded the stock to "Outperform" from "Neutral," and raised his price target to $48 from $40 per share.
Teva shares gained 42 cents to $39.95 premarket, up from Tuesday's closing price of $39.53. The stock has traded between $29.22 and $40.89 in the last year.
Thanks for digging this one up.
I'm off to the ILSI (Israel's biggest biomed annual convention),
Lots of interesting programs are being presented.
http://www.ilsi.org.il/about_event.asp?ID=21
Not even XTL people themselves I'm afraid:)
Oh and BTW the way they reported the news here on TASE was a bit sneaky in my opinion because the headline was
"XTL announced today that it has completed the analysis of results from a Phase I clinical trial with XTL-2125 in patients with chronic Hepatitis".
One less in the HCV arena. The writing was on the wall when XTLB shifted to the pain arena by purchasing DOVP's molecule.
XTL Biopharma stops developing XTL-2125 for hepatitis C
By Robert Daniel
Last Update: 3:17 AM ET Jun 6, 2007
TEL AVIV (MarketWatch) -- XTL Biopharmaceuticals Ltd., (XTLB) the Rehovot, Israel, drug developer, said it stopped developing XTL-2125, a potential treatment for chronic hepatitis C. In a Phase I trial, XTL said, "HCV-RNA viral load reductions in patients treated with XTL-2125 were not significantly different from those observed in the placebo group." The company has bicifadine, which treats neuropathic pain, "as a lead product in late-stage clinical development," and its XTL-DOS program for hepatitis C is "very promising," Chief Executive Ron Bentsur said in a statement. The company also said it continues its efforts to broaden its product line by licensing and acquiring clinical-stage products.
And good luck until college football starts up again:)
After all, what's $190M more or less for TEVA:)
BTW, Lider based the positive expectations on something that judge Akerman (hope i spelled the name right) said regarding NVS
and the piles of paper they loaded him with. This sounds like gossip to me but Lider also say that this judge spoke in favour of TEVA.
positive news will drive the stock and negative news will hurt it but in the long run it is just an episode for TEVA which is an outstanding company.
This is one analyst (Lider) who dared sharing positive expectations. CIBC were more careful saying how the stock will react in case of winning or losing in court.
If you are long TEVA, you should not be so tensed.
No news yet, it will be out later today. In the meantime, Lider which is one of the local analyst covering TEVA raised its target prise to $52 on expectation of a victory in court today.
Elbit Systems unit get $18m Marine Corps order
Talla-Tech will provide the Marines with rugged hand-held computers for situational awareness.
Amir Keidan 5 Jun 07 12:06
Elbit Systems Ltd. (Nasdaq: ESLT; TASE: ESLT) unit Tallahassee Technologies Inc. (Talla-Tech) has received $18.5 million in orders from the US Marine Corps for the company’s rugged hand-held computers, which provide situational awareness for dismounted Marines.
Talla-Tech is a wholly-owned US subsidiary of Elbit Systems’ subsidiary Tadiran Communications Ltd.. Elbit Systems completed an offer to purchase for Tadiran Communications in April and delisted it from the TASE.
The Marine Corps chose the Talla-Tech Rugged Personal Digital Assistant (RPDA-57), which is based on both the Microsoft Windows CE and Microsoft Windows Mobile operating system. Elbit Systems noted that Talla-Tech and Tadiran Communications have supplied rugged computers to the Marine Corps since 1998 in both mounted and dismounted configurations.
[There are difficulties in controlling inhalation of inhale ATT probably due to heterogeneous breathing patterns of the patients. Method were improved as shown In this paper from 2003 (PARI's device was also tested) but efficacy is still a problem. And there's the threat from Arriva Pharmaceuticals which develop a nebulized formulation of rAAT (they are also developing a gel formulation), currently undergoing phase II.]
Peripheral deposition of alpha1-protease inhibitor using commercial inhalation devices.
Eur Respir J. 2003 Aug;22(2):263-7
Brand P, Beckmann H, Maas Enriquez M, Meyer T, Müllinger B, Sommerer K, Weber N, Weuthen T, Scheuch G.
Clinical Research Group Aerosols in Medicine of the GSF-Institute for Inhalation Biology and the Asklepios Clinic for Respiratory Medicine, Gauting, Germany. brand@inamed.de
Patients with hereditary alpha1-proteinase inhibitor (alpha1-PI) deficiency are at risk of developing lung emphysema. To prevent the development of this disease, alpha1-PI replacement therapy via inhalation may be a more convenient and effective therapy than the intravenous administration of the drug. In order to optimise this treatment approach, lung deposition of inhaled radiolabelled alpha1-PI (Prolastin) was studied using four different commercial inhalation devices (PARI-LC Star, HaloLite, and AKITA system in combination with LC Star and Sidestream) in six patients with alpha1-PI deficiency and mild-to-severe chronic obstructive pulmonary disease. The time required to deposit 50 mg of the Prolastin (5% solution) in the lung periphery was used as a measure for the efficiency of delivery. The time was calculated from measurements of total and peripheral lung deposition of the radiolabelled alpha1-PI. This time was shortest for the AKITA system (18-24 min) and significantly higher for the PARI-LC Star (44 min) and the HaloLite (100 min). The higher efficiency of drug delivery using the AKITA system is due to the fact that this device controls breathing patterns, which are optimised for each patient individually.
Inhaled Alpha-1 Antitrypsin - Kamada
In a conference I attended on May, David Tsur kamada's CEO said that they already know that the inhaled dose is about 25% of the injectable one. Given the limitation of plasma supply, these are good news.
If efficacy will work fine, they will try the inhaled delivery for other indications such as Cistic Fibrosis which suppose to be more profitable.
MIVT
The trial mentioned by III in post #1260 will only be the pilot.
I see that they will start soon this trial http://clinicaltrials.gov/ct/show/NCT00474084?order=1
with BioSync Scientific which is an Indian company they acquired. I understand that they will do some (my bet is it will be a large part) of the trials in India. Am I wrong assuming that the location of the trials in a 3rd world country is somehow bearish regarding reliability of the data?
I don't know if you are aware of this one
http://www.photothera.com/
which has a non invasive program in phase III
http://clinicaltrials.gov/ct/show/NCT00419705?order=1
It had a 1% drop at TASE and will probably do the same at NASDAQ.
Estimates are that if TEVA wins, sells of Lortel could add 10-15 cents profit per share for 2007. I guess this kind of news will help the price climb above $40. Most analyst have target price around $45 for the next 12 months. Here is what Dew thinks regarding the patent issue
http://www.investorshub.com/boards/read_msg.asp?message_id=20011889
Until a ruling from a judge in the U.S. District Court for the District of New Jersey which is expected in the near future, TEVA is selling the amount that had reached distributors and customers before the initial temporary restraining order on May 19.
Estimations are that they delivered a 3 months stock.
found some answers here:
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070525:MTFH25660_2...
UPDATE 3-Amgen to appeal as EU experts reject Vectibix drug
Fri May 25, 2007 10:13 AM ET
(Adds Amgen stock move)
By Ben Hirschler
LONDON, May 25 (Reuters) - The European Medicines Agency dealt a blow to Amgen Inc. <AMGN.O> on Friday by recommending its drug Vectibix should not be approved for treating colorectal cancer.
The world's biggest biotech company said it would appeal against the decision, which would block one of its key new medicines getting to market in the European Union.
Its stock slipped nearly 1 percent in early Nasdaq trade.
Amgen, based in Thousand Oaks, California, said it was confident available data showed Vectibix improved progression-free survival in patients with later-stage disease for whom other chemotherapy treatments had failed.
But experts from the London-based agency criticised the design of the main clinical study used in Amgen's submission and said they were concerned there was not sufficient evidence to show the drug's benefits.
"In the first few weeks of the study, many of the patients originally receiving best supportive care alone started to receive Vectibix after their disease had got worse, making it difficult to compare the effects of Vectibix and best supportive care alone," the agency said.
"In addition, Vectibix only had a very small effect in increasing the time until the disease got worse or the patient died, in comparison with best supportive care. Studies also showed that patients receiving Vectibix had increases in side effects."
Vectibix, which was approved last year in the United States, has been seen as a key medicine in the development pipeline of U.S.-based Amgen.
But it suffered a setback in March when Amgen discontinued a trial of the medicine, in combination with other drugs, after it was shown to reduce chances of survival for colon cancer patients, leading analysts to slash sales forecasts.
Vectibix, which is also facing tough competition from ImClone Systems Inc.'s <IMCL.O> Erbitux, had sales of $59 million in the three months to March, its second full quarter on the market.
In Europe, Erbitux is marketed by Germany's Merck KGaA <MRCG.DE>, whose shares advanced 1 percent to 99.24 euros by 1345 GMT following news of the setback for the rival product.
Amgen has had a torrid time recently, with its shares hit hard since January by concerns over its best-selling anaemia drug Aranesp.
>European Regulators Reject AMGN’s Vectibix<
Do you know why Vectinix was rejected?
I did not post this one for 2 reasons,
It was posted on Dew's board and the headline is annoying (not to say untrue).
Good to have you back, now I can have my traditional
SHLAF SHTUNDE every day :)
Idit
>Can anyone recall another case where a judge
restrained sales of an authorized generic?
That’s what just happened with Lotrel.<
Apotex.
Teva Provides Update on Generic Lotrel(R) Litigation
Monday May 21, 2:31 pm ET
http://biz.yahoo.com/bw/070521/20070521006221.html?.v=1
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) announced today that the United States District Court for the District of New Jersey has vacated a temporary order restraining Teva's launch of its amlodipine besylate/benazepril products, AB rated to Novartis' Lotrel®. Instead, the Court has ordered Teva and Novartis not to sell or offer further generic product, beyond what has already been commercialized, including any authorized generics, until at least the completion of a status call with the Judge next Tuesday, May 29, 2007.
snip
>court cases are decided based on technical arguments that are unique to each case<
Meaning who has smarter lowers :)