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FDA issued warning for Byetta about possible kidney problems, including renal failure:
http://www.reuters.com/article/marketsNews/idCNN0245793420091102?rpc=44
IDIX has initiated a Phase II clinical trial evaluating IDX184+ SoC for 14 days and doses of up to 200mg (Patients will continue on treatment with pegylated interferon and ribavirin for 14 more days):
http://finance.yahoo.com/news/Idenix-Pharmaceuticals-prnews-2318795928.html/print?x=0
Not that simple in this case. In addition to being the chairman of both Teva and Protalix, Pontifax VC fund, which was founded by Eli Hurvitz has invested in PLX. Maybe if there's a bid from another player, Teva can get in the game.
You're right, he served as Teva's President and CEO for over 25 before becoming the Chairman. This of course doesn't change my point of the conflict of interests.
It is called - ViiV Healthcare (reminds me of my son's favorite game console - Wii)
http://www.viivhealthcare.com/
Before srsmgja jumps: Copaxone took two price hikes of 10% each, in Jan and in Apr 2009.
Typo correction: in the first sentence it should have been 3Q09 US sales of Copaxone not 2Q09.
Teva misses revenue estimates
http://www.globes.co.il/serveen/globes/docview.asp?did=1000510471&fid=942
However, Copaxone sales hit record, as third quarter earnings per share beat analyst expectations.
Generic pharmaceuticals giant Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) reported third quarter net profit of $806 million, 28% above the corresponding quarter of 2008.
In-market sales of Teva's MS drug Copaxone reached a record $776 million, up 38% compared to the third quarter of 2008. Copaxone has a global market share of approximately 30% in MS treatments. In the US, in-market sales increased 53% compared with the corresponding quarter, to reach $540 million. In-market sales outside the US totaled $236 million, up 12% in dollar terms, compared to the corresponding quarter. In local currencies, in-market sales of Copaxone outside the U.S. grew 23%.
On a per share basis, Teva's non-GAAP profit was $0.89, which beat consensus analyst estimates by $0.01.
Net sales were $3.55 billion, up 25% compared to the third quarter of 2008. However, analysts had expected about $3.63 billion in revenue for the quarter.
Teva said that its acquisition of Barr contributed to the growth in Teva's sales across the globes, particularly in the U.S., Russia, Poland, Germany, and Croatia.
Teva generated $1.025 billion cash flow from operations. CEO Shlomo Yanai said it was the first time Teva crossed the $1 billion mark for that item.
Yanai said, "All of our business units and geographies continued to grow during the quarter, with especially strong sales of Copaxone, which continued to strengthen its position as the world’s leading therapy for the treatment of multiple sclerosis, and of ProAir, the leading Albuterol inhaler in the U.S.
"This is the time of year when we develop our workplan and update our strategy for the next few years. The process this year is an especially inspiring one, as the more closely we analyze the opportunities ahead, the more excited we become about Teva’s futurewhich, in both the near and long-term, looks very bright.”
North America pharmaceutical sales accounted for 63% of total pharmaceutical sales, reaching $2.16 billion. The figure was 34% higher than the third quarter of 2008. Quarterly sales benefited from the launch of generic versions of Ortho Tri-Cyclen Lo and Eloxatin in the quarter, as well as continuing sales of generic versions of Lotrel, Adderall XR), Yasmin, Protonix, as well as Copaxone and ProAir.
As of October 23, 2009, Teva had 210 product applications awaiting final FDA approval, including 40 tentative approvals. Collectively, the brand products covered by these applications had annual U.S. sales of over $113 billion. Of these applications, 136 were “Paragraph IV” applications challenging patents of branded products. Teva believes it is the first to file on 83 of the 136 applications, relating to products with annual U.S. branded sales exceeding $54 billion.
2Q09 US sales of Copaxone were $540M, +53% year-over-year and +22% quarter-over-quarter.
Teva Q3 profit higher as Copaxone sales jump
http://www.reuters.com/article/marketsNews/idCNL350118420091103?rpc=44
By Tova Cohen
* Q3 EPS ex-items $0.89, vs $0.88 forecast
* Q3 revenue up 25 percent to $3.55 billion
* Copaxone sales up 38 percent to $776 million
* Teva continues to seek acquisitions -CEO
TEL AVIV, Nov 3 (Reuters) - Teva Pharmaceutical Industries (TEVA.O), the world's largest generic drugmaker, reported higher quarterly net profit on Tuesday, boosted by sales of its multiple sclerosis drug Copaxone and respiratory business.
Teva President and Chief Executive Shlomo Yanai said he did not believe a generic version of Copaxone, the number one MS treatment, would reach the market any time soon.
"We think it's well protected legally and structurally. It is difficult to make an alternative because of its complexity, this will need clinical trials," he told reporters.
Teva last month sued Mylan Inc (MYL.O), alleging that the company's application to market a copycat version of Copaxone was infringing Teva patents, which extend until 2014.
Yanai said oral treatments for MS being developed would not substitute injectables such as Copaxone as they have some disadvantages. Teva is also developing an oral treatment for MS.
"It will take a long time till these products get market share," Yanai said. "MS is a complicated disease. It's an autoimmune disease so drugs have side effects that are not simple. People react better to some drugs than others so switching drugs is complicated."
Excluding one-off items Israel-based Teva (TEVA.TA) posted third-quarter earnings of 89 cents a share diluted, up 16 percent from a year earlier.
Revenue rose 25 percent to $3.55 billion.
Analysts expected Teva to earn 88 cents a share, excluding items, on revenue of $3.63 billion, according to Thomson Reuters I/B/E/S.
Global sales of Copaxone rose 38 percent to $776 million.
Strong sales of inhaler ProAir helped sales of Teva's global respiratory business rise 37 percent to $243 million.
Teva said a stronger dollar negatively impacted quarterly sales by $160 million, or 6 percent.
SHARES SLIP
Teva shares were down 0.4 percent at 190 shekels at midday, compared with declines of 1.7 percent in the broader market.
Analyst Gilad Alper of brokerage Excellence Nessuah noted that sales outside the United States were in line with forecasts, leading him to conclude that the U.S. generic market is showing signs of weakness either because consumers were saving on medicine or due to pricing pressures.
He said the gross margin was slightly lower than in the second quarter, "a disappointing result given the strength of the highly profitable Copaxone in the quarter".
"This again leads us to conclude that the U.S. generic market is showing signs of weakness or intense competition," said Alper, who rates Teva's shares as "outperform".
But Yanai said investors should not determine trends based on one quarter.
"This quarter was thin in new launches," he told reporters. "The generic buisness is good. It's developing and if one quarter looks weak it's just one quarter's volatility."
He added that 2009 as a whole was thin on new launches.
Teva said cash flow from operations topped $1 billion for the first time.
Yanai would not comment on plans for acquisitions, including the sale of German generic drugmaker Ratiopharm, which has asked bidders to submit offers by Nov. 4. Teva is said to be among the suitors preparing bids.
"We are constantly hearing speculation about Teva making acquisitions. Let me say that Teva is an acquiring company," Yanai said. "We are scrutinising the industry constantly looking for opportunities."
The rationale for any acquisition is that the company be a strategic fit for Teva with good economics and be accretive within a year, he added.
Teva declared a dividend of 0.6 shekels (15.9 cents) a share to be paid on Nov. 26, up from 0.45 shekels a year earlier.
I think we can safely assume now that Graves's resignation for unstated reasons a few weeks before the annual AASLD meeting was curious indeed but no longer bearish.
Schering-Plough Reports Potent Antiviral Activity With Narlaprevir (SCH 900518), an Investigational, Once-Daily Protease Inhibitor for Hepatitis C
http://finance.yahoo.com/news/ScheringPlough-Reports-Potent-prnews-3315123991.html?x=0&.v=1
Interim results of Phase IIa NEXT-I study presented at American Association for the Study of Liver Diseases (AASLD) Annual Meeting
* Press Release
* Source: Schering-Plough Corporation
* On 5:30 pm EST, Monday November 2, 2009
BOSTON, Nov. 2 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1. In the lead-in arms of the study, in which patients received a 4-week lead-in of PEGINTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) followed by the addition of narlaprevir, 85-87 percent of patients achieved rapid virologic response (RVR), compared to 58-75 percent of patients in the no lead-in narlaprevir arms and no patients in the PEGINTRON and REBETOL control arm. RVR, defined in this study as undetectable virus (HCV RNA) at week 4 of narlaprevir treatment, is recognized as an important predictor for achieving sustained virologic response. These interim results from the NEXT-1 study were reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.[1]
"These interim results, while preliminary, are very encouraging, and showed that narlaprevir has potent antiviral activity in hepatitis C," said John Vierling, M.D., professor of medicine and surgery, chief of hepatology, Baylor College of Medicine, Houston, and the lead investigator of the study. "In this study, once-daily narlaprevir greatly improved viral clearance at week 4 of treatment in genotype 1 hepatitis C infection compared to the control group. We look forward to further results from this ongoing study."
Importantly, patients in the lead-in narlaprevir arms also achieved improved rates of early virologic response (EVR), defined as undetectable virus at week 12 of treatment, with 85-87 percent of patients having undetectable virus at week 12 of narlaprevir treatment compared to 17 percent of patients at week 12 in the control arm.
Narlaprevir is a next-generation oral HCV protease inhibitor that achieves once-daily dosing through the use of low-dose ritonavir as a metabolic inhibitor. The NEXT-1 study evaluates 12 weeks of narlaprevir 200 mg or 400 mg once-daily or 100 mg twice daily with low-dose ritonavir (100 mg) in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (600-1400 mg daily), followed by PEGINTRON and REBETOL alone for an additional 12 or 36 weeks (24 or 48 weeks total). The study includes two treatment arms in which patients receive a 4-week lead-in of PEGINTRON and REBETOL prior to receiving narlaprevir 200 mg or 400 mg once-daily in the above regimen. All patients in the narlaprevir arms have completed narlaprevir dosing. The control arm is PEGINTRON and REBETOL alone for 48 weeks.
In this study, the rate of adverse events in the narlaprevir arms was similar to that in the peginterferon and ribavirin control arm, except for an increase in anemia (there were no discontinuations due to anemia) and an increase in low neutrophil counts (with no clinical sequelae). The most frequently seen adverse events up through 12 weeks of treatment were fatigue, nausea, flu-like illness, headache and insomnia. No increase in skin adverse events (rash or pruritus) beyond what was seen in the peginterferon and ribavirin control was observed.
A new imaging study supports niacin's positive effect on change in carotid artery wall area:
http://content.onlinejacc.org/cgi/content/abstract/54/19/1787?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Justin+MS+Lee&searchid=1&FIRSTINDEX=0&sortspec=date&resourcetype=HWCIT
BTW, full results of the ARBITER-HALTS 6 study will be presented Monday, November 16, 2009 at the AHA meeting, discussant - John J Kastelein.
Most analysts and scientists think the trial was halted because Niaspan outperformed Zetia.
A buyout by Teva is very problematic because this would mean a conflict of interests as Eli Horvitz is serving as Protalix' chairman and the president of Teva...
Shire's ADHD sales force are going to be very busy as Intuniv was approved early Sep and marketing should start soon.
I was wondering if SGP will test boceprevir with Pegasys as I'd expect modestly better results (such as higher proportion of patients able to achieve SVR with a shortened course of therapy) for boceprevir if dosed with Pegasys. I'm not aware of such study.
Living Without Blockbusters
http://www.forbes.com/forbes/2009/1116/companies-sanofi-aventis-pharm-living-without-blockbusters.html?feed=rss_news
Matthew Herper, 11.16.09, 12:00 AM ET
France's Sanofi-Aventis, the world's fourth-biggest drugmaker, used to act like the stereotype of its home country: arrogant and snooty. The company, listed on the New York Stock Exchange, held earnings calls with market analysts at 2:00 a.m. East Coast time. "Anyone in New York had to listen in their pajamas," says Christopher Viehbacher, who became the company's chief executive in December 2008.
Another example: In the early 2000s the company bet heavily on an obesity drug, Acomplia, that its consultants touted as potentially the biggest medicine ever. But when side effects emerged, Sanofi-Aventis barely commented on the problem. The drug was yanked globally in 2008 because of a link to suicide.
Viehbacher, 49, is out to change the $37 billion (2008 sales) company, created in the 2004 acquisition of Aventis by Sanofi-Synthelabo. One of his first acts was to move the earnings calls to the afternoon Paris time. When the drug safety police this year linked Lantus, the company's $4-billion-a-year long-acting insulin, to cancer, he responded quickly, assembling a committee of experts on diabetes and tumors to refute the connection.
Viehbacher's assignment to Sanofi initially seemed like a booby prize. He had just lost a contest to run his previous employer, number two drugmaker GlaxoSmithkline, in which executives were given specific tasks and evaluated on how well they did, like on a reality TV show. It's possible his forthrightness and outsider mentality hurt him at Glaxo. But that may be just what's needed to energize Sanofi, which is facing many of the problems plaguing every large drugmaker, including Pfizer (the largest), Glaxo and Novartis.
U.S. patents are expiring on many big sellers, including Plavix, the $10 billion heart pill that Sanofi sells with Bristol-Myers Squibb, and Eloxatin, the company's $2 billion cancer drug. In the U.S., at least, sales are going to crater. Sanofi, like most drugmakers, has been unable to invent new medicines that will make up sales lost to generic versions of old ones.
Refreshingly, Viehbacher doesn't pretend that this problem is going to be fixed by some stroke of managerial brilliance on his part. "Betting the farm and waiting for the next blockbuster is not going to work," says Viehbacher. "It doesn't matter what I do in research and development. I'm not going to come up with enough new drugs."
"He's facing down the demons of the company," says Douglas Sobelman, a pharmaceutical analyst at Bernstein Research.
Viehbacher has promised that sales won't drop below 2008 levels. He has at the same time taken the bold step pledging to cut research and development, the lifeblood of any drug firm, by 20% to $5 billion by 2011. This won't hurt productivity, he insists, because the problem with drugmakers' R&D isn't a lack of money but a failure to exploit innovative thinking. To that end he is changing the structure of the research labs, from monoliths to smaller units that are either entrepreneurial (racing to develop a drug) or exploratory (looking for new biology to study).
As he waits for new R&D to kick in--and that will take years--Viehbacher is pushing hard into emerging markets. Pharma growth is flat in the U.S. and Europe, which accounted for two-thirds of the $770 billion spent on drugs last year, according to drug data firm IMS Health. But sales are climbing 13% a year in places like China, Latin America and India, which are just developing their taste for Western medicines. Sanofi already has a sizable presence in many of these markets, unlike Pfizer and Merck, which are just bulking up. Bernstein Research ranks Sanofi as the biggest company in emerging markets, with 14% of sales coming from these regions (see table).
"I have a billion dollars in Africa," Viehbacher boasts. "Nobody does a billion dollars in Africa." In 1982 his firm entered the Chinese market, where patients must buy drugs from hospitals. This year purchases of drug companies in Brazil, Mexico and India have boosted its presence. (They were among nine acquisitions just this year, totaling $10 billion.)
Even Sanofi's research laboratories are focused on emerging markets. A vaccine for dengue fever is one of the company's most important projects, being tested in 4,000 kids in Thailand. It won't ever sell much in the U.S. but could be big in Asia and Latin America.
Bernstein is skeptical that Viehbacher can hit his revenue goals, given the loss of patent protection on established drugs and the big cut in R&D. The company's pipeline, Bernstein notes, is "semidevoid of tangible late-stage products." Still, Sanofi's stock is up 20% this year, compared with 10% for a drug industry benchmark, on analysts' projection of a 20% jump in earnings in 2009, to $12 billion.
Viehbacher continues to try to upset Sanofi's standard operating procedure. Earlier this year he bought, for $500 million, a biotech called BiPar Sciences that was making a promising drug for breast cancer. With a staff of only 18 people, BiPar had managed to get the drug, for a rare form of breast cancer that resists all current treatments, into midstage trials. Lower-level Sanofi executives started putting in place an 18-member board of directors for BiPar--as big as the company's staff. Viehbacher had to tell his underlings to leave BiPar alone. Says Viehbacher, "We don't want to necessarily Sanofize these companies."
All true but my hunch is that all these recent talks are about marketing agreement not buying. In any case, I don't see Teva as a buyer.
By "GSK’s Combivir/Kivexa" you make it sound like Combivir, which consists of Retrovir and lamivudine is the same as Kivexa, which consists of Abacavir and lamivudine.
FWIW, my personal view is that Copaxone is an immunomodulator NOT immunosuppressant. When speaking of immunosuppressants in MS the most notable ones are azathioprine, cyclophosphamide, methotrexate, and mitoxantrone.
AstraZeneca Probes Aspirin Impact on Brilinta Trial
http://www.bloomberg.com/apps/news?pid=20601102&sid=aJ744vImT8cY#
By Trista Kelley
Oct. 29 (Bloomberg) -- AstraZeneca Plc is looking into whether greater use of aspirin reduces the effectiveness of its experimental clot-busting medicine Brilinta, which analysts had estimated would bring in $1 billion a year.
AstraZeneca’s Brilinta beat Sanofi-Aventis SA and Bristol- Myers Squibb Co.’s blood thinner Plavix in a study, preventing 16 percent more heart attacks, strokes and deaths. The trial included more than 18,000 patients in 43 countries. Those in North America may have done worse on Brilinta, a finding that raised questions among analysts about potential U.S. sales. London-based AstraZeneca said today that researchers noticed a link between higher doses of aspirin and Brilinta’s potency.
Brilinta is one of four medicines AstraZeneca planned to seek approval for this year to offset declining sales of products that will lose patent protection. The U.K. drugmaker withdrew its application for lung cancer therapy Zactima yesterday after an analysis showed the drug didn’t improve patients’ survival. Third-quarter profit rose 23 percent.
“Of the four drugs due for filing this year: Zactima has been pulled; Brilinta looks very weak to us now, and that leaves two,” said Navid Malik, an analyst at Matrix Corporate Capital in London, in a note to clients. “With 40 percent of revenues going generic in the next five years, we would be highly concerned about AstraZeneca’s future earnings and sales potential.”
Shares Fall
The shares fell 37 pence, or 1.3 percent, to 2,752 pence at in London. AstraZeneca has fallen 2 percent this year, compared with a gain of 4.1 percent in the Bloomberg Europe Pharmaceutical Index.
AstraZeneca said aspirin use is one of several possible explanations for the Brilinta results being examined. The company still expects to file the drug for U.S. approval later this quarter and sought European approval on Oct. 26.
“While no definitive explanation has been found to date, further analyses suggest a possible association between aspirin dose and the primary efficacy results” for Brilinta, AstraZeneca said in a statement. “The company and the trial investigators are continuing to explore these and other hypotheses, as well as other follow-on analyses of the trial data set, and plan to publish in due course.”
AstraZeneca reached an “agreement in principle” in September to pay $520 million to settle a U.S. investigation over allegations the company marketed its antipsychotic drug Seroquel for unapproved uses, U.S. spokesman Tony Jewell said today.
Seroquel Investigation
“The investigation also related to selected physicians who participated in clinical trials involving Seroquel,” he said in an e-mailed statement. He said he couldn’t provide further details.
AstraZeneca faces several lawsuits by individual states brought on behalf of Medicaid programs, alleging the company withheld information about the risks of Seroquel and promoted the drug for off-label purposes. The states, which include South Carolina and Pennsylvania, are seeking reimbursement of funds spent on prescriptions and alleged injuries to patients.
“AstraZeneca continues to defend itself” in these lawsuits, Jewell said in an interview.
The federal agreement settlement follows similar settlements by makers of rival antipsychotic drugs including New York-based Pfizer Inc. and Eli Lilly & Co. of Indianapolis.
Profit Rose
Net income was $2.12 billion, up from $1.73 billion a year earlier, AstraZeneca said today. Earnings excluding restructuring and other one-time costs gained to $1.68 a share from $1.32, beating the $1.38 mean estimate of 19 analysts surveyed by Bloomberg.
The U.S. ordered 40 million doses of AstraZeneca’s nasal spray vaccine against swine flu, adding $453 million in revenue for the second half.
The sales boost comes as AstraZeneca makes headway with a plan to eliminate 11 percent of its workforce by 2010 and faces cheaper copies of seven drugs by 2014, including its three biggest sellers: Nexium for ulcers, the Crestor cholesterol- lowering treatment, and the antipsychotic Seroquel. AstraZeneca won U.S.approval for Onglyza, a diabetes treatment it markets with Bristol-Myers, on Aug. 3.
Earnings Forecast
Third-quarter earnings were bolstered by manufacturing setbacks that halted shipments of Novartis AG’s generic version of heart medicine Toprol XL, triggering a fourfold increase in U.S. sales to $293 million for the quarter. The delays continue to boost earnings, Chief Financial Officer Simon Lowth said on a conference call.
AstraZeneca expects full-year earnings per share to be $6.20 to $6.40, up from a previous forecast of $5.70 to $6, in constant currency terms. The appreciation of the dollar during the quarter eased costs, which are in pounds and Swedish kronor, while hampering revenue. Third-quarter sales gained 5.4 percent to $8.2 billion, compared with 21 analysts’ mean estimate of $7.97 billion.
GlaxoSmithKline Plc, AstraZeneca’s larger London-based rival, yesterday reported a 30 percent increase in third-quarter profit after currency gains and orders for the Relenza flu drug boosted revenue.
It should be very nice up there after the rain we had in the past few days :)
More buyout rumors flying (take VI or VII, who's counting?)
http://www.globes.co.il/serveen/globes/docview.asp?did=1000509670&fid=942
Roche discloses the results of first Phase III clinical study using Taspoglutide
http://www.roche.com/investors/ir_update/inv-update-2009-10-29.htm
First Phase III clinical trial of Roche's weekly taspoglutide meets primary end-point of change in HbA1c
Significant superiority on HbA1c versus twice-daily exenatide demonstrated in this head-to-head study
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that headline results from its Phase III study, T-emerge 2 (subcutaneous weekly taspoglutide versus subcutaneous twice-daily exenatide, as add-on to metformin, a thiazolidinedione [TZD], or metformin and a TZD), showed that the trial met its primary endpoint of change in HbA1c. Superiority versus exenatide was demonstrated.
“We are pleased that these results from our first head to head Phase III trial reinforce taspoglutide’s profile as a potential best-in-class GLP-1, supporting its use as an important and convenient new future therapy for patients with type 2 diabetes”, said Jean-Jacques Garaud, Head of Pharma Development, Roche.
The results showed that taspoglutide demonstrated superior HbA1c reduction versus exenatide following 24 weeks of treatment. The study analysis included 1189 patients, equally randomized into three active arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks, and exenatide 10 mcg twice daily). Taspoglutide was generally well tolerated. The most frequently reported adverse events among taspoglutide and exenatide treated patients were nausea and vomiting.
Data from T-emerge 2 will be submitted for presentation at upcoming international scientific meetings. In addition, seven other phase III trials exploring taspoglutide in patients with diabetes are ongoing.
Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market taspoglutide, except in Japan where these rights are shared with Teijin and in France where Ipsen may elect to retain co-marketing rights.
About T-emerge 2
T-emerge 2 is an open-label, 24-week core study, to demonstrate non-inferiority (with a pre-specified test for superiority) versus twice-daily exenatide, involving 1189 patients, equally randomized into three active arms (taspoglutide at doses of 10 and 20-mg, and exenatide 10 mcg). All patients continue into long-term extension of the study.
About the T-emerge Program
The T-emerge Phase III clinical trial programme is designed as multicenter, multi-country, randomized, controlled (active or placebo), double-blind and open studies. Over 6000 patients will be enrolled in the eight studies that comprise the T-emerge programme. Studies include two parallel taspoglutide arms including 10 mg once weekly and 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks. Four of the eight studies have active comparators, including exenatide, sitagliptin, insulin glargine and pioglitazone.
About Taspoglutide...snip
Rumor says the buyer is Roche
Elron nears sale of insulin pump co Medingo
http://www.globes.co.il/serveen/globes/docview.asp?did=1000508193
Adi Ben-Israel 26 Oct 09 10:46
Elron Electronic Industries Ltd. (Nasdaq: ELRN; TASE: ELRN), the high-tech investment arm of Nochi Dankner-controlled IDB Holding Corp. Ltd. (TASE:IDBH) has received a non-binding offer for portfolio company Medingo Ltd. for $150-170 million in cash. The offer could rise to $185-213 million, depending on milestones to be agreed upon.
Elron did not disclose who made the inquiry. Elron has been selling assets in order to raise capital to repay its $50 million bank debt.
Medingo has developed the Solo miniature insulin dispensing patch pump for diabetics. The company has obtained US Food and Drug Administration (FDA) marketing certification for the insulin pump.
If a sale is made, Elron will report a net capital gain of $54-80 million, while parent company Discount Investment Corporation (TASE: DISI) may report a capital gain of $25-38 million. Elron owns 92% of Medingo, including 83% held through Rafael Development Corporation (RDC), a joint venture held in equal shares with Rafael Advanced Defense Systems Ltd..
If Elron sells Medingo, this will be the second large sale of a portfolio company this year. In August, it sold its 15.24% stake in NetVision Ltd. (TASE: NTSN)for NIS 228 million to Discount Investment and sister company Clal Industries and Investments Ltd. (TASE: CII), as part of Dankner's effort to rationalize IDB's corporate structure. Elron will report a small capital gain on this sale, which it will use to reduce its bank debt.
The risk for JC viral reactivation due to long-term use of Tysabri is much higher than for becoming newly infected. Therefore, the tests are aiming to screen for the presence of the virus itself or for signs of its reactivation. I haven't seen any data on IgM/acute phase, but perhaps we'll see them in the future as this is being studied recently just like the reactivation issue:
http://content.nejm.org/cgi/content/abstract/361/11/1067
On CNS side effects of VVUS drug, I've posted similar thoughts (http://siliconinvestor.advfn.com/readmsg.aspx?msgid=26052980). Safety profile looks approvable to me although the FDA will probably ask for a panel review as well as REMS program, especially since obesity drugs are expected to be overused. Other problems I see for VVUS are reimbursement (that goes for all obesity branded drugs), use of Qnexa's generic components, and possible IP issue with JNJ.
Being a JCV positive is considered a risk factor for PML. So are long term use with Tysabri and immunosuppressive treatment. By screening for JCV before giving the drug, the risk for PML should be markedly reduced.
VRTX - interim analysis of data from 94 patients from Study 107
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=419250
* 57% of prior treatment null responder patients achieved an SVR with a 48-week telaprevir-based regimen
* 90% of prior treatment relapsers and 55% of prior treatment partial responders achieved an SVR with 24-week or 48-week telaprevir-based regimens
* Results provide further support for the ongoing Phase 3 registration study, REALIZE, in treatment-failure patients
Vivus, Analyst in Obesity Drug Side-Effect Spat
By Adam Feuerstein, thestreet.com
Did a winner emerge from this week's Obesity Society meeting?
It's kind of hard to tell. The meeting, which wraps today, was a bit anti-climatic. Data presentations from the three small drug makers racing to develop new weight-loss drugs were largely in-line, offering little new information from what investors had already seen.
Perhaps Arena Pharmaceuticals(ARNA Quote) can lay claim to the top prize, but only because its stock dropped less -- 3% from Friday through Tuesday -- than its competitors. Orexigen Therapeutics(OREX Quote) shares fell 8% in the same time frame while shares of Vivus(VVUS Quote) lost 9%.
Vivus played a central role in what may be the only excitement to emerge from the Obesity Society meeting. The stock fell 15% Tuesday after Cowen issued a note to clients that accused Vivus of hiding the extent to which central nervous side effects of its weight-loss drug Qnexa had forced patients to withdraw from two phase III studies.
According to a Cowen analysis of data from two phase III trials presented Saturday, 2.6% and 2.1% of patients treated with full-dose Qnexa, respectively, dropped out of the studies due to cognitive side effects like "disturbance in attention" or "forgetfulness." This is compared to a placebo dropout rate of 0.8% and 0.3% in the two studies.
Cowen says Vivus didn't disclose these dropouts when the company reported top-line data from the Qnexa trials in September.
"We believe adverse events such as "disturbance in attention," "memory impairment," "amnesia," "aphasia" and "cognitive disorder" -- even if relatively rare -- will prove to be serious regulatory hurdles for a weight-loss drug. Therefore, we now have reduced conviction in the approvability of Qnexa, and partnering prospects also may be reduced," wrote Cowen analyst Ian Sanderson.
Reached on his cell phone, Vivus chief financial officer Tim Morris says Sanderson's analysis is bunk.
"The side effects of Qnexa are expected and within the profile of topiramate. They are mild and manageable and even lower than what you see on the topiramate monotherapy label," said Morris.
A bit of explanation is in order. Qnexa is made up of two currently approved drugs, combined in a proprietary formulation to promote significant weight loss. One of the drugs is phentermine, a generic weight-loss drug still available. The other drug in Qnexa is Johnson & Johnson's(JNJ Quote) topiramate, used to treat epilepsy and migraines.
The use of topiramate comes with well-known cognitive side effects, so the fact that some of these side effects are showing up in Qnexa patients is neither surprising nor alarming, says Morris, adding that Vivus has been particularly encouraged since the reported side event rate for Qnexa is actually lower than what you'd typically see with topiramate.
Morris said the way Cowen conducted its analysis to reach the 2.6% and 2.1% Qnexa patient drop out rates over-states the issue and is not consistent with the way the Food and Drug Administration typically analyzes safety data.
He also defended the way Vivus previously reported top-line Qnexa safety data in September as entirely proper. "We report data consistent with FDA practice and there was no intention to selectively disclose," he says.
Qnexa has demonstrated greater weight loss than either of the obesity drugs from Arena or Orexigen Therapeutics. And Vivus' stock price has outperformed its rivals in recent weeks. But if Qnexa has an Achilles heel, it's the drug's side effect and tolerability profiles.
Of course, the only opinion that matters about Qnexa's side effect profile is the one to be issued sometime next year by the FDA after it reviews the drug for approval.
Ilaris got European Union regulatory approval for treating CAPS:
http://www.reuters.com/article/healthcareSector/idUSLS32787220091028
AstraZeneca pulls Zactima combination submission
LONDON (MarketWatch) -- Drugmaker AstraZeneca (LSE:UK:AZN) (NYSE:AZN) siad Wednesday that it has withdrawn the regulatory submissions for the use of its Zactima 100mg drug in combination with chemotherapy in patients with advanced non-small cell lung cancer. The application was withdrawn from the U.S. FDA and the European Medicines Agency, having been submitted in June. The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy as well as preliminary feedback from regulatory agencies that the current package with progression-free survival as the primary endpoint may not be sufficient for approval, the firm said.
I see that they took the 160mg per day dose to phase III. So my guess is it'll be fine with the seizures SE. On efficacy I see a big if also cause previous data were from a 3 months trial and I doubt the effect will last in a longer trial.
Teva may make acquisition in first half of 2010
Oct. 27, 2009 Bloomberg , THE JERUSALEM POST
Teva Pharmaceutical Industries Ltd., the world's biggest maker of generic drugs, probably will purchase a company in the first half of 2010 to boost long-term growth, Bank Hapoalim Ltd. said.
"Teva's growing cash box, along with the global financial crisis that led some companies to sell parts of their businesses, creates an opportunity for Teva to acquire companies around the world," Gilad Sarig, an analyst at Bank Hapoalim in Tel Aviv, wrote in a report published on Tuesday.
Teva is probably examining the market to find the best candidates to keep growth going as 2011 could be a challenging year for the company, Sarig said.
Teva, which bought Barr Laboratories Inc. for $7.4 billion last year, is ready for another "major" acquisition and may look beyond generic drugs for the purchase, Chief Executive Officer Shlomo Yanai said on June 18.
Different non invasive test for JC virus:
Reviving Tysabri
http://www.forbes.com/2009/10/27/ms-crohn-elan-business-healthcare-tysabri.html?feed=rss_business_healthcare
Matthew Herper, 10.27.09, 3:59 PM ET
Worries about a potentially deadly side effect have long impeded sales of the multiple sclerosis drug Tysabri, made by Elan. But now the medicine's inventor says he has created a diagnostic test that might reveal those patients who are less at risk of the side effect. That could increase the market for the drug, which is already a $1 billion seller.
Ted Yednock, a researcher at the South San Francisco labs of Elan, invented the antibody that would become Tysabri in 1992. It offered a new way of curtailing the immune system, which goes haywire in MS and the gastrointestinal ailment Crohn's disease. The drug was approved to treat MS in November 2004.
But only three months after that approval, Tysabri was withdrawn. The immune suppression caused by the drug was allowing a usually dormant virus to infect patients' brains, causing a brain-destroying condition called progressive multifocal leukoencephalopathy (PML). Estimating that the virus occurred in one in 1,000 treated patients, the Food and Drug Administration allowed Tysabri to re-enter the U.S. market in July 2006.
Ever since, Yednock, 52, has been on a quest to understand the virus that causes PML. When Tysabri was pulled, researchers thought that most--90% or more--of human beings were infected with the virus that leads to PML (named JC, after the first two patients to get PML). Yednock says that work done by his team shows that only 50% of patients are infected with the JC virus, meaning that there are many patients for whom Tysabri might bear little PML risk at all.
Even with the specter of PML, 60,900 patients have chosen to take Tysabri, which is given by infusion and is very effective at preventing the brain lesions caused by MS.
Yednock's quest is taking on more urgency, as worries about PML continue to build. The risk of PML rises as patients get more infusions of Tysabri, and as time passes more PML cases are a certainty. On its most recent conference call, executives at Biogen Idec, Elan's partner on the drug, said that the FDA might want to add discussion of this increase to the product's label.
On Oct. 23, European regulators said that 23 cases of PML had been reported, far more than investors had expected. Wall Street analysts who cover Biogen for Bernstein, Deutsche Bank and Oppenheimer all said this could mean the risk of PML had doubled. The FDA-approved labeling for Tysabri puts the risk of PML at 1 in 1,000. With the new cases included, it could be 1 in 400, according to the analyst reports. Most analysts are skeptical that Elan and Biogen-Idec can reach their stated goal of getting 100,000 people on the drug.
Yednock says that the problem with PML testing up until now has been that the JC virus looks a lot like an evolutionary cousin, the BK virus. Antibody tests developed for JC virus were also set off by the BK virus, but BK virus doesn't cause the PML brain infection.
For some patients with JC virus, the virus is excreted in urine. By collecting blood samples from those people, Yednock had a group of patients he knew were infected with JC, allowing him to start developing a test that captured them all.
The test Yednock and his colleagues developed found that something like 50% of the patients have JC virus. There are eight cases of patients who developed PML where Elan and Biogen-Idec have blood samples going back long before the infection happened. All of those cases had JC virus antibodies in their bloodstreams a year before they got PML. "That's a pretty good starting point," says Yednock.
Elan has transferred the assay to a commercial laboratory, a step toward making it available to patients. The test, which uses antibodies to detect the presence of JC virus, could be done with just a saliva sample. It has not been evaluated by regulators or the larger scientific community, but the hope is that doctors might be able to use it to pick which patients are the best candidates for Tysabri therapy.
At a medical meeting Tuesday in San Diego, researchers working with Elan were set to present new analyses of already public clinical trials of Tysabri in Crohn's disease, a condition in which the immune system attacks the intestine, causing bleeding and sometimes requiring surgery. The new analyses show that Tysabri may work best in Crohn's patients who have already failed Crohn's drugs like Remicade, from Johnson & Johnson, and Humira, from Abbott Laboratories.
That's a nice step forward, but the PML risk needs to be clearly established. It would help Tysabri's makers a lot if they could identify patients who aren't at risk at all.
Late-Stage Products Looking for a Home
Criteria for inclusion:
a) Program is in phase-3 or beyond and is non-partnered.
b) Company does not have enough cash to bring the product to market.
Edits: Removed – MDVN (MDV-3100 partnered with Astellas)
Stock Product Stage Comments
----- --------------- --------------------- -----------------------------
ARNA Lorcaserin Phase 3 Obesity
BPAX Libigel Phase 3 ~2010 Submit Adequate Safety
CHTP Droxidopa Pivotal Phase III Orthostatic hypotension. Results expected 02/09.
CRGB Abiraterone Phase 3 Prostate cancer
DYAX DX-88 for HAE BLA filed 9/24/08 (CABG indication partnered w CBST)
GNVC TNFerade Pivotal Phase III Pancreatic cancer
JAV Dyloject Phase III Approved in UK. Post operative Pain (injectable)
JAV Ketamine Phase III Acute moderate-to-severe pain (intranasal)
OREX Contrave Phase 3 Obesity
OXGN Zybrestat Phase 3 Anaplastic thyroid cancer
Pharming Rhucin Pre-BLA Rejected in EU
Protalix prGCD Phase III Gaucher's disease. Not enough cash for a commercial infrastructure
RPRX Proellex Phase 3 Uterine fibroids
SVNT Puricase BLA filed Treatment refratory gout
MBRX sold to Ligand Pharmaceuticals for only $3.2M:
http://www.tradingmarkets.com/.site/news/Stock%20News/2603095/#
Judge seals damage award against Wyeth
http://www.philly.com/inquirer/business/20091027_Judge_seals_damage_award_against_Wyeth.html
By Miriam Hill
A Philadelphia jury yesterday awarded punitive damages to an Illinois woman who said Wyeth's Prempro hormone replacement therapy caused her breast cancer, but the world will have to wait at least another month before anyone knows how much.
As the jury in Common Pleas Court was nearing a verdict on how much to award to punish Wyeth, which last week completed a merger with Pfizer Inc., company lawyers asked Judge Sandra Mazer Moss to seal the amount until a verdict is reached in a similar case also being tried in Philadelphia. The judge agreed.
In late September, the eight-person jury decided that Prempro caused Peoria, Ill., resident Connie Barton's invasive breast cancer and awarded her $3.7 million in compensatory damages. But the jurors also found that Wyeth intentionally ignored evidence that the drug could cause cancer and so awarded Barton, 64, punitive damages.
Wyeth's attorneys George McDavid and Michael Scott argued that a public announcement of punitive damages in the Barton case could bias jurors in the other case, referred to as Kendall v. Wyeth.
Barton's attorney, Zoe Littlepage, argued that the public's right to know outweighed those concerns and that Wyeth had failed to prove damage, not just speculate that it could occur. Littlepage also said she feared that Wyeth would use the tactic to delay repeatedly as 9,000 cases involving Pfizer/Wyeth menopause drugs make their way through the courts.
Mazer Moss, who oversees the Common Pleas Court's Complex Litigation arm, said that while she respected the public's right to know, she had to balance that against the "interest in a fair trial" in the Kendall case.
After deliberations yesterday, two jurors said they would not discuss the amount but they did say they thought the decision should have been made public immediately. Jurors Joanne Gwardyak and Jennifer Young said they saw the decision to seal the verdict as an attempt to hide negative news about Wyeth. They said they thought the Kendall jury would be able to be fair even if the verdict was made public.
"Every case is different," Gwardyak said.
A Pfizer spokesman said the company did not agree with the outcome of the case.
"We are disappointed with the jury's verdict and will weigh all of our legal options regarding our next steps in this case," Pfizer said in a statement.
Barton was diagnosed with cancer in 2002, five years after she began taking Prempro to treat menopausal symptoms. McDavid had argued that Barton had breast cancer before she began taking Prempro.
More than six million women have taken hormone-replacement medicines to treat menopause symptoms such as hot flashes, night sweats, and mood swings.
Prempro sales fell significantly after a U.S. study in 2002 linked the therapy to breast cancer and cardiovascular risks.
The company has now lost five of eight trials over its hormone-replacement drugs since cases began reaching juries in 2006.
Some of the verdicts were set aside, and others are on appeal, according to Bloomberg News.
Health ministry suspects 'journalists' at meetings are drug company spies
http://www.haaretz.com/hasen/spages/1123823.html#at
By Dan Even
The Health Ministry has been looking into suspicions that two people posing as journalists at meetings of the committee selecting drugs included in the public health basket are unofficial representatives of pharmaceutical firms who are banned from the meetings.
Starting last year, an unidentified man started attending meetings of the committee and presenting himself as a journalist. His presence drew the suspicions of representatives of the Health Ministry, who are familiar with all the journalists covering health issues in Israel.
The individual had followed the deliberations of the committee and taken notes developments during the meeting.
In late September, efforts were made to clarify the man's identity with the newspaper where he allegedly worked, and he stopped coming to the meetings.
In early October, another unidentified person came to the meetings, presenting himself as a journalist, and he too stopped coming after checks into his identity started.
There are suspicions that the two were representatives of pharmaceutical firms sent to follow the developments at the meetings in order to gather commercial intelligence.
In recent years, pharmaceutical firms have complained that there is a lack of transparency at the "medicine basket" committee because they are not allowed to attend. Moreover, the firms argue that the members of the committee, because of the lack of transparency, fail to provide adequate justification for excluding certain medicines from the basket.
The Health Ministry decided three years ago to open the meetings to journalists and allow the publication of a synopsis of each meeting at the Health Ministry's Web site.
Real time intelligence on what is happening in the committee can serve pharmaceutical firms in lobbying members of the committee.
As a result of the incident with the unidentified "journalist," the Health Ministry restricted entrance to the committee's meetings to journalists covering health issues, and exceptions are only made by previous arrangements with the spokesman's office at the ministry.
"The deliberations of the committee on the health basket are made transparent via the health reporters," the Health Ministry said. "It is unfortunate that external elements are sparing no effort to attend the meetings and every effort will be made to prevent unauthorized persons from attending the deliberations of the health basket committee."