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Boston Scientific to Buy Full Control of Sadra Medical
http://www.bloomberg.com/news/2010-11-19/boston-scientific-to-buy-sadra-medical-for-386-million-to-get-heart-valve.html
By David Olmos and Elizabeth Lopatto - Nov 19, 2010
Boston Scientific Corp. said it agreed to acquire closely held Sadra Medical Inc. for as much as $386 million to compete in the $2.1 billion market for transcathether heart valves that don’t require open-heart surgery.
Boston Scientific Chief Executive Ray Elliott told investors earlier today the company’s “priority growth initiatives” would include products targeting asthma, diabetes, obesity and “structural heart” therapies. Sadra’s less- invasive valve system is a structural heart therapy.
Boston Scientific, the second-biggest maker of heart devices, faces an industrywide slowdown in its two biggest markets, heart-rhythm devices and cardiac stents used to open clogged arteries. The Natick, Massachusetts-based company will overhaul its product line, cut costs and seek to improve profitability over the next three years, hoping to double sales growth to 6 percent to 8 percent within five years, Elliott said at a meeting in New York to describe his long-term strategy.
“We have quietly, carefully put together a plan to drive growth,” Elliott said.
Boston Scientific rose 19 cents, or 2.9 percent, to $6.75, at 2:22 p.m. in New York Stock Exchange composite trading. The shares declined 22 percent in the 12 months through yesterday.
Deal Price
Boston Scientific, which owns 14 percent of Los Gatos, California-based Sadra, will pay $193 million upfront, with additional payments of as much as $193 million for certain milestones, the companies said in a statement. The company’s current stake reduces the deal cost from a potential $450 million.
The acquisition puts Boston Scientific in competition with heart-valve maker Edwards Lifesciences Corp., of Irvine, California, and Minneapolis-based Medtronic Inc., which paid $700 million to acquire CoreValve, another valve maker, in 2009. Boston Scientific “looked at” CoreValve prior to Medtronic’s acquisition, Elliott said.
“We didn’t feel that was the winning technology,” he said. “We feel the deal we did today was the winning technology.”
Seeking Acquisitions
Edwards’s new valve, which is implanted using a thin wire threaded through the arteries, reduced death rates in a study of patients too sick for open-heart surgery. Abbott Laboratories, based in Abbott Park, Illinois, and New Brunswick, New Jersey- based Johnson & Johnson, the world’s largest maker of health products, are among those seeking deals to enter the market for transcatheter valves, said Antoine Papiernik, managing partner at Sofinnova Partners in Paris, in a telephone interview. While the Edwards valve is cleared for sale in Europe, it hasn’t been approved for U.S. use.
If the ongoing medical trials of Edwards’ valve show it also works for less severely sick patients, the market for the new valves may reach $2.1 billion by 2015, said Larry Biegelsen, a Wells Fargo Securities analyst based in New York, in a note to investors.
The Sadra acquisition will lower Boston Scientific’s earnings by about 1 to 2 cents a year through 2013, then add to the company’s earnings, according to the statement.
Acquisitions will continue to be a part of the company’s growth strategy, Elliott said. It expects to end 2010 with $1.6 billion in cash and to generate $7 billion in cash flow in the next five years, he said.
Boston Scientific had $624 million in cash and short-term investments as of Sept. 30, according to data compiled by Bloomberg. Over the past five years, the company has announced nine pending or completed acquisitions, with an average size of $6.37 billion and an average premium of 9.7 percent. The biggest deal was the $25.2 billion purchase of Guidant Corp. in 2005.
Earnings Goals
The company’s goal is to deliver about $5 a share of increased per-share earnings during the next three years, Elliot said. The company hasn’t had a full-year profit since 2005.
Boston Scientific has 150 new products in its research pipeline, Elliott said. The company also sees “huge opportunity” to expand sales in emerging markets, including China and India, and will invest as much as $40 million through 2011 to develop those markets, Elliott said.
Compound annual sales growth should average about 6 percent through 2015, with half the growth coming from new markets, Elliott said.
“For the next two or three years, they are just going to have to grind it out with the business mix they have,” Phillip Nalbone, an analyst at Wedbush Securities in San Francisco said in a telephone interview before today’s meeting.
Boston Scientific will cap its research spending at $1 billion annually, while shifting about 30 percent of the budget to higher-growing product areas than its current businesses, Elliott said. The company also aims to reduce manufacturing costs and to trim about $200 million in “waste” from its research spending, he said.
I don't know the date of the above
Thanks, Clark for your comments on the issue.
A few more points on CT calcium scoring: first, the score depends on what you're looking at - spatial distribution of calcified plaque, overall amount of calcium, the calcium density or even higher order information concerning plaque location (not only a generalized burden of calcification). Second, it also depends on who you're looking at - age (specificity tends to decrease with advanced age), a/symptomatic, other risk factors like LDL-C etc. Overall, we are in agreement that the best thing to do is the non-radiative improved Framingham model. Like Dr. Rita Redberg (University of California, San Francisco) said last Aug.:
Before subjecting healthy men and women to a test with significant radiation—2 to 7 mSv or 100 chest roentgenograms—one must be able to tell patients that there is a benefit from having this test," Redberg argues. "With no known benefit, CACS fails this essential criterion, and the harm, including cancer risk from radiation, and incidental findings prevail.
It [CT calcium scoring] is actually quite common where I live. And it is in the process of being accepted by insurance companies.
Aetna considers calcium scoring medically necessary for diagnostic cardiac CT angiography to assess whether an adequate image of the coronary arteries can be obtained.
...Aetna considers calcium scoring (e.g., with ultrafast (electron beam) CT, spiral (helical) CT, and multislice CT) experimental and investigational for all other indications because the definitive value of calcium scoring for assessing coronary heart disease risk has not been established in the peer-reviewed published medical literature.
...there is no evidence so far to support using the results of EBCT in an asymptomatic patient to select a therapy or to guide referral to invasive investigations. The clinical role of EBCT is yet to be established in terms of screening for disease or risk assessment. Electron beam computed tomography is highly sensitive, but its specificity is low.
The USPSTF reaffirmed their position in 2009, stating that the evidence is insufficient to assess the balance of benefits and harms of using coronary artery calcification (CAC) score on electron-beam computed tomography (EBCT) to screen asymptomatic men and women with no history of CHD to prevent CHD events.
I think Lp-PLA2 was independent of CRP. A few readings when you have the time:
http://www.biomedsearch.com/attachments/00/17/31/94/17319459/vhrm0202-153.pdf
http://www.mdpi.com/1424-8247/3/5/1360/pdf
http://content.onlinejacc.org/cgi/content/full/51/9/913
A members of the statin family.
The CT scan is a more sensitive test than hs-CRP but in addition to the radiation issue, is more expensive and I believe it has a high false positive rate. Also, I remember reading that using both hs-CRP and Lp-PLA2 gives better diagnostic accuracy than either alone. So perhaps (you tell me if you know), this combined test might not be so far from the scan in terms of predicting of heart disease.
If I were at high-risk to CHD and showed evidence of pre-existing cardiovascular disease (but low to normal LDL-C), with or without other risk factors including age, obesity, hypertension, I would want to test for plasma hs-CRP and Lp-PLA2. If these are elevated, I would simply take the drug.
Of course the Reuters journalist dismissed the radiation, he is not going to get it :)
(I wouldn't either, not for this purpose that is)
The study is indeed interesting but do you see physicians sending patients for CT to test for Ca buildup? not likely, imo.
Xarelto vs Pradaxa one more point for the former is ROCKET-AF was a double blind trial whereas RELY was an open label one.
And a call for guideline changes:
This Medtronic-supported research is the first to show the significant lifesaving value of CRT-D for mildly symptomatic heart failure patients and builds upon the growing body of evidence calling for guideline changes,”
There are studies showing insults to the BBB in neuropsychiatric SLE (see #msg-56694303), but this is not likely in the case because patients with active central nervous system (CNS) lupus were excluded in the phase III benlysta trials.
Note that this review is on neuropsychiatric SLE (NPSLE) and looks at the increased immunoglobulin index, which suggested autoantibodies can be synthesized intrathecally within the brain. In NPSLE the BBB can be (at least transiently) damaged but it is still not clear if these antibodies passively diffuse from the peripheral blood or are synthesized by leukocytes inside.
..."we consider it unlikely that a targeted biologic is increasing suicidality in a patient population already known to be at increased risk."
Rib-X projects filing the radezolid NDA in 2015.
Yes, but it's is a next-generation quinolone and about a year behind, I think. Not partnered either is it?
Yes, the patents running till 2021 will probably not keep a generic Zyvox off the market. Teva is challenging the '792 patent that runs until Nov. 18, 2014 (May 18, 2015 including the pediatric extension). Pfizer filed suit against Teva early this year, in the U.S. District Court for the District of Delaware asserting the infringement of the basic patent, asking for an injunction. See here: http://patentdocs.typepad.com/files/pfizer-v-teva-2.pdf
I'm not following Trius but took a look and torezolid' efficacy (the 200mg dose from phase II in cSSSI/MRSA trial) does look better in comparison with data from Zyvox on clinical cure rates in the CE, ME and ITT groups, and seems to have a few advantages over Zyvox. In addition to those you've mentioned there's also the possibility for longer course (whereas Zyvox carries an irreversible occular toxicity risk when dosed more than 4 weeks and reversible thrombocytopenia when taken more than 2 weeks. It also has an increased rate of death with Gram-negative infections, so that's another angle in which TSRX may be able to differentiate torezolid in the future).
The US basic Zyvox patent, expires in 2015 (including the 6-month
pediatric exclusivity period), and another patent that expires in 2021. So, Zyvox patent would not expire until at least 2014 but Teva might win the case in court before.
Shlomo Yanai on ‘Low-Volume’ Copaxone
As you all are aware, our [inaudible] trial examined a lower-volume 0.5 mL injection of Copaxone, for which Teva submitted an FNDA. We have had recent communication with the FDA on this lower-volume product, and conclude that the clinical data to establish similar efficacy of this new concentration and the currently marketed product will be required for approval.
To support the approval of our FNDA, we have supplemented clinical trial data on our [fourth] study, which was designed to assess the efficacy, safety, and [inaudible] of glatiramer acetate in the same concentration. And I am pleased to update you that recently we received a notice of allowance on our patent related to our 0.5 mL product.
The funniest line is Bill Marth saying that he's a kibbutznik.
About 15% of the patients develop antibodies to the current commercially available recombinant human glucocerebrosidase, expressed in CHO cells. There were worries that prGCD being a plant-derived glycoproteins (since higher number of mannose residues may result in increased immunogenicity due to the presentation of nonmammalian glycans), might be associated with excessive immunogenicity effects or excessive neutralizing antibody formation, beyond that the standard rate seen for recombinant therapeutic proteins. But that was not the case with PLX's glucocerebrosidase. Also the antibodies found in the switchover trial were not neutralizing antibodies.
Yanai is also a Graduate of the U.S. National War College (NDU), maybe he learned a thing or two there as well.
What else about Teva’s Lovenox is different from Lupenox? My source says nothing.
I think the bottom line is - Teva's generic is different from Lupin's.
Just got an indirect (from an analyst who met Teva's CFO) reply. Before asking me more questions please bear in mind these facts:
I wasn't present, I'm translating from Hebrew and I'm going away in two days and need to organize my surroundings and pack :)
He knows about the "rumors".
Teva normally do not discuss its API suppliers or product sources.
About 40% of this generic product comes from out source.
He knows ItalFarmaco and its drug marketed in India by Lupin.
Teva's generic is different from Lupin's.
I have emailed two analysts and this is the reply from the 1st one. I'll try to post the other if I get it before I leave.
FRX/IRWD linaclotide in IBS-c positive results in another phase III:
http://www.reuters.com/article/idCNSGE6A00MQ20101101?rpc=44
Positive preliminary data from the first 15 patients that completed nine month of the switchover trial
http://maya.tase.co.il/bursa/report.asp?report_cd=585368-00&CompCd=1554&Type=Pdf
MRK/(more) problems:
Generic pressure on Cozaar/Hyzaar and Temodar generics could enter the market soon pending a decision from the Court of Appeals..
What I've been told (by an Israeli analyst who attended the meeting) Eyal Desheh said is they don't manufacture enoxaparin in-house but have a partner.
I've been told that Eyal Desheh (Teva's CFO) said that long time ago at meetings with Israeli analysts, so I guess others had to know as well.
Bayer said Xarelto had “comparable” safety and rates of bleeding versus the standard.
Telaprevir is clearly superior. Who will use Boceprevir? I suppose those who could not tolerate or failed telaprevir. Can't be a big market.
Just to note something known - boceprevir had a lower % of patients who could stop therapy early and also patients took boceprevir itself for 24 weeks minimum but telaprevir for 12 weeks.
Xarelto/ROCKET AF phase III trial results:
Bayer Blood Thinner Xarelto Matches Warfarin in Irregular-Heartbeat Trial
http://www.bloomberg.com/news/2010-10-31/bayer-s-xarelto-matches-warfarin-in-rocket-af-trial-update1-.html
By Naomi Kresge - Nov 1, 2010
Bayer AG’s blood thinner Xarelto matched the standard therapy at preventing blood clots in patients with an irregular heartbeat, results that may determine its success in a market worth as much as $14 billion a year.
Xarelto was as effective as warfarin, the standard treatment over the past half century, Leverkusen, Germany-based Bayer said yesterday in the first comparison between the two drugs. Xarelto had “comparable” safety and rates of bleeding versus the standard, Bayer said.
Boehringer Ingelheim GmbH last month beat Bayer and its partner Johnson & Johnson to market with the first warfarin replacement. Investors now want to know whether, like its competitor from Boehringer, Xarelto is better than, and not simply equal to the older treatment, Jack Scannell, a London- based analyst with Sanford C. Bernstein Ltd., said in a note to investors today. Bayer and J&J will present full results of the trial, called Rocket-AF, at the American Heart Association conference on Nov. 15.
“Bayer might be hiding good news,” Scannell said. He rates the shares “outperform.”
The stock rose as much as 3 percent in Frankfurt trading, the most in two months, and were up 1.43 euros, or 2.7 percent, to 55.05 euros at 9:23 a.m.
Market Estimate
The market for new blood thinners including Xarelto may surpass 10 billion euros ($14 billion) a year, and Xarelto sales may peak at more than 2 billion euros, Bayer Chief Executive Officer Marijn Dekkers estimated in a Bloomberg Television interview on Oct. 28. Pfizer Inc. and Bristol-Myers Squibb Co. are also working on a replacement for warfarin.
Xarelto matched standard treatments for clots in the lungs and legs in a study, Einstein-DVT, released in August. Medicines to prevent clots after knee surgery or in the lungs and legs are a small part of the blood-thinner market compared with drugs for people with an irregular heartbeat, Flemming Oernskov, head of the women’s health and general medicine unit at Bayer, said in an interview at the time.
Patients with an irregular heartbeat, or atrial fibrillation, face a risk of clots as blood pools in the upper chamber of their hearts. Doctors have relied on warfarin and aspirin to ward off the strokes that may result if a clot gets stuck in the artery to the brain.
J&J has said it will request U.S. regulatory approval next year to sell Xarelto for hip and knee surgery patients. The Food and Drug Administration didn’t approve the drug at its first review in May 2009, instead asking for more information.
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added ASH, ASCB
OCTOBER 2010
American Association for the Study of Liver Diseases - AASLD
Boston, MA
October 29-November 2, 2010
http://www.aasld.org/
American Society for Therapeutic Radiology and Oncology - ASTRO
San Diego, CA
October 31-November 4, 2010
http://www.astro.org/
NOVEMBER 2010
American Society of Human Genetics - ASHG
Washington, DC
November 2-6, 2010
http://www.ashg.org/
Society for Melanoma Research (International Melanoma Congress) - SMR
4-7 November
Sydney, Australia
http://www.melanoma2010.com/
American College of Rheumatology - ACR
Atlanta, GA
November 6-11, 2010
http://www.rheumatology.org/
American College of Allergy, Asthma & Immunology - ACAAI
Phoenix, AZ
November 11-16, 2010
http://www.acaai.org/Pages/default.aspx
Society of Neuroscience - SFN
San Diego, CA
November 13-10, 2010
http://www.sfn.org/
American Heart Association - AHA
Chicago, IL
November 13-17, 2010
http://aha-pda.com/presenter.jhtml?identifier=3064925
22nd EORTC-NCI-AACR symposium on “Molecular targets and Cancer Therapeutics”
Berlin, GERMANY
November 16-19, 2010
http://www.ecco-org.eu/Conferences-and-Events/EORTC-NCI-AACR-2010/page.aspx/1386
World Orphan Drug Congress
Nov 29-Dec 1
Geneva, Switzerland
http://www.terrapinn.com/2010/orphandrugs/programme.stm
DECEMBER 2010
American Society of Hematology - ASH
Orlando, FL
December 4-7, 2010
http://www.hematology.org/Meetings/Annual-Meeting/
American Society of Cell Biology - ASCB
Philadelphia, PA
December 11-15, 2010
http://www.ascb.org/meetings/
----
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting any new items in chronological order.
3. Near the top of the message, give a very brief description of your changes (e.g. “Edits: Added entry for AASLD”).
4. Post the updated calendar in a new message as a reply to the message with the old calendar.
There are about 2,300 patients on Shire's Replagal worldwide (approximately 80% of patients in EU) and that makes it the global market leader in Fabry.
Shire booked sales of $50M for Vpriv (velaglucerase for Gaucher) in Q3, a 71% growth over Q2. Currently treating about 1,000 patients.
From Dennis Crouch's Patently-O
US Government Argues in Court that Isolated Genes are Unpatentable
http://www.patentlyo.com/patent/2010/10/us-government-argues-in-court-that-isolated-genes-are-unpatentable.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+PatentlyO+%28Dennis+Crouch%27s+Patently-O%29
AMP v. Myriad (Fed. Cir. 2010)
In March, 2010, District Court Judge Robert Sweet held Myriad's gene patent claims invalid for failing to satisfy the subject matter eligibility requirements of 35 U.S.C. 101. The ruling was directed toward claims that cover particular isolated DNA molecules (genes) and processes of detecting and screening for those genes, but was written broadly enough to essentially invalidate all patents covering genes that were isolated from an organism.
Last month, I heard a rumor that Obama administration science and legal advisors outside of the USPTO supported Judge Sweet's ruling. At the time I disregarded that suggestion as unlikely. I was wrong. [Andy Pollack at the NYTimes has the scoop]
The US Department of Justice (DOJ) has now filed an amicus brief supporting the lower court decision — arguing that isolated genes are unpatentable because they improperly claim a product of naturer [Link to Brief]:
The district court correctly held . . . that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty, the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.
. . . .
Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology. Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.
. . . .
A product of nature is unpatentable because it is not the inventive work of humankind. That essential rule cannot be circumvented by drafting claims for the same natural product removed from its natural environment and proclaiming the result “pure.”
Several other amici have filed briefs:
* USA. File Attachment: Myriad.CAFC.Amicus.USA.pdf (191 KB)
* Intellectual Property Owners Association. File Attachment: Myriad.CAFC.Amicus.IPO.pdf (423 KB)
* Alnylam Phamaceuticals. File Attachment: Myriad.CAFC.Amicus.Alnylam.pdf (273 KB)
VRUS/more upside - perhaps when final data from RG7128 PROPEL study (AASLD abs of interim) and PSI-7977 phase IIb are out.
Regardless of the information from Dew's source, which I will try to inquire about after Teva will report 3Q10 next week, I think the answer to the question - can Teva's ANDA for generic Lovenox pass the high bar placed by Momenta, is - no. And if it takes few more years, as I suspect, Teva might withdrawal.