Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Report: Molecular imaging market valued at $5B; future of PET looks bright
Written by Editorial Staff March 4, 2010
The molecular imaging market is currently valued at approximately $5 billion, with half of the revenue being generated in North America alone, according to a market research report from Espicom Business Intelligence.
The report included the range of fields within molecular imaging (MI) market, including: chemistry, cell biology, disease modeling, target discovery, imaging, clinical research and data processing.
“Presently, most molecular imaging research and development focuses on clinical applications in cancer, cardiovascular and neurological diseases,” the report stated. Moreover, companies are also focusing on translation research, the report said. Imaging small animals can aid in assessing the effectiveness of therapeutic technologies, such as directed drug therapies and radiation therapy and companies are developing and marketing small animal, pre-clinical MI systems with the goal of translating this technology into human applications in the future.
“Additionally, MI technologies will be more readily adopted as clinical evidence establishes its benefits, new technological innovations are brought to the market, and as reimbursement increases,” the report predicts.
Despite this, the outlook for the nuclear imaging industry is highly uncertain with continued questions about future funding and reform, as well as the unresolved matters surrounding the supply of SPECT radiopharmaceuticals and 36 percent reimbursement cut for cardiac myocardial SPECT imaging procedures by the Centers for Medicare & Medicaid Services (CMS).
The outlook for the use of PET products is far more positive, according to the market analysis. “Not only has there been an increase in the number of PET procedures being undertaken due to the lack of SPECT radiopharmaceutical availability, demand for PET is also rising as a result of the CMS decision in 2009 to expand reimbursement coverage for the use of FDG-PET in several new cancers, and to increase reimbursement rates for cardiac myocardial perfusion PET imaging by 20 percent.”
All of the major imaging systems companies reported more positive results for the fourth quarter of 2009, with orders either increasing or falling at a much slower rate than seen earlier in the year. While there continues to be weakness in the U.S., declines in this market are lessening. However, the main growth is coming from other regions of the world in emerging markets such as India and China, said the report.
Despite some short-term factors that are likely to impact growth in the MI market, there are strong opportunities in this area. The increasing incidence of cancer, cardiovascular and neurological diseases means that demand for faster and more accurate diagnosis, as well as drug development and pre-clinical study efforts, will continue to accelerate in the coming years, the report predicted.
Last updated on March 9, 2010 at 1:04 pm EST
http://www.healthimaging.com/index.php?option=com_articles&view=article&id=21045
Bull Market Intact for Biggest U.S. Equity Managers (Update1)
http://www.bloomberg.com/apps/news?pid=20601087&sid=aDsaK_JarQw0&pos=4
Positron Sells Its PET Scanner To Manhattan Based Gramercy Cardiac Diagnostic Services - Quick Facts
(RTTNews) - Wednesday, Positron Corp. (POSC.OB) announced the sale and installation of its PET scanner to Manhattan based, Gramercy Cardiac Diagnostic Services, owned by prominent New York City cardiologist, Dr. Peter Rentrop.
Positron is a molecular imaging company focused on Nuclear Cardiology. Positron utilizes its proprietary product line to provide unique solutions to the Nuclear Medicine community ranging from imaging to radiopharmaceutical distribution.
For comments and feedback: contact editorial@rttnews.com
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201001201041rttraderusequity_0997&title=positron-sells-its-pet-scanner-to-manhattan-based-gramercy-cardiac-diagnostic-services---quick-facts#ixzz0n79JppLz
http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201001201041rttraderusequity_0997&title=positron-sells-its-pet-scanner-to-manhattan-based-gramercy-cardiac-diagnostic-services---quick-facts
Major news wires are picking up POSC
http://www.upi.com/finance/?GUID=12941248&Page=MediaViewer&Ticker=COV
http://finance.bnet.com/bnet/news/read?GUID=12940656
Coffee? This is a Jack with a beer back day!
Penny stock company will run if partner turns out to be Covidien
New York, NY - In the last two weeks, there have been all kinds of rumors and speculation surrounding Positron Corporation (OTCBB: POSC) and a potential partnership with a "big NYSE traded company." Those rumors may finally be made official today.
Most analysts believe that yet-to-be announced partner to be Covidien (NYSE: COV), the multi-billion dollar, worldwide leader and healthcare industry distributor whose shares trade in the fifty-dollar range on a daily basis. The site which is most often credited for breaking the news about the potential marriage between the penny stock pick and the profitble big board player, has also reported on a number of initiatives which could turn out to be very profitable for the company.
POSC's perfectly timed position as the undisputed leader in Cardio PET imaging already makes the company attractive to investors, but its revolutionary Pharm-Assist® automated radiopharmaceutical distribution device seems to be what is driving most of the radio pharma industry interest to the company.
"Our machine is not only a very attractive option for patients and doctors, but also to many of the current companies and drug manufacturers who deal in the cardiac and oncology imaging space," CEO Pat Rooney said in a recent interview. "Instead of taking on the expense of opening up a brick and mortar location for $3+ million and being worried about the expensive overhead and personnel costs of selling radiopharmaceuticals, we can install this inexpensive, automated device that is compliant with all the U.S. rules and regulations for safety and exposure issues. It works well in emergency rooms, in cardiology offices, etc. There are many benefits to it, including the fact that it saves a great deal of money, gas, and time. In addition, if you're trying to get a dose and you're the 10th person in line ordering, you may not get the dose. With our system, you're guaranteed to get a dose."
The fact that the company has chosen the Nasdaq Marketsite as a lauching platform for today's annouoncements tells us that the news must be pretty significant. Otherwise, a simple press release would have been enough. It also tells us that the new conference could turn out to be a better-late-than-never coming out party for the 27 year old company.
Shifting market conditions in the lucrative Cardiac Pet Scan sector are evident and difficult to dismiss.
"The standard of care throughout history has been SPECT technology, but really it's inferior to our PET technology," explained Rooney. "The financial reimbursement for these services from places like CMS, Medicare and Medicaid have just increased PET Reimbursement and decreased SPECT reimbursement."
A worldwide shortage of Molybdenum - a necessary isotope used for SPECT imaging is also driving more customers to Positron according to the CEO. During the last three months alone, requests for proposals at Positron have increased three-fold.
In the wild-west-like world of over the counter stocks, Marketmakers and shorts have kept POSC shares down but it may be difficult for them to continue doing so after today's news conference. That is especially true if it turns out that partnership and all it's rumored details are real and substantive.
Sentiment : Strong Buy
I take it as" Do not hold after 10:00 AM. Wednesday, (Im in Nevada)
Shares Likely To Trade Higher On Tuesday
Just a reminder that the anticipated press conference for Positron Corporation, (OTCBB:POSC) will take place in two days- on Wednesday.
As is the case with these forward looking news conferences, shares will likely trade higher tomorrow. Be cautious, however, about holding the shares after the press conference starts on Wednesday afternoon. As is also the usual case with these types of trades, there is usually a "sell on news" mentality that takes hold of the stock. So, this is a good trade with another day left of trading before the press conference.
As we reported here first, POSC discuss new initiatives and partnerships and recent highlights including their Frost & Sullivan 2010 North American New Product Innovation Award for their Attrius PET Scanner.
When: May 5, 2010, 1:00 pm EDT
Where: NASDAQ MarketSite, 4 Times Square, New York, NY
This item is being released to subscribers first. It will be released later this afternoon to our general readership.
GET TRADE ALERTS FAST!
From Yahoo Board
Friends, and new investors. One last time I will try and briefly capture why Positron has a bright future both in the very near term and mid/long term:
* They have the only FDA approved PET Scanner, which, due to the reimbursement policies under Obama administration, gives PET scanners the upperhand and makes them the new standard in the industry.
* Obviously, we are only a couple of business days away from finding out the partnership and alliance deals which are entered into to increase sales of PET scanner exponentially. These scanners are about $1M each.
* Positron is the only player right now in a multibillion dollar, untapped market worldwide.
Just the above should be enough to expect good things from this company in terms of PPS (and thus, profit for us investors).
Just a couple of quick notes: Positron has been around for over 2 decades, and yes, they do not have a strong balance sheet neither have they been able to generate huge revenues. But, they have not gone bankrupt, have they? It is only very seldom that a small guy like Positron will have a product that is a game changer in a specific segment of the medical device industry, and be able to thrive on her own. Do not be fooled by statements referencing last quarters or last years earnings - Positron is signing partnership deals because they have tried to do it all on their own, and did not succeed. With partnerships, and wide networks/experienced sales people, they will be able sell a lot of these machines.
Also keep in mind the revenue from PharmAssist, tech support, parts etc agreements. Keep in mind how much more confidence those potential customers will have in this product in terms of reliability & post-purchase support if they know that the product is backed by multibillion $ companies.
The list can go on and on, but i doubt it is necessary. There is enough potential here for all of us to make decent profits.
""company will be profitable this year, he sees it becoming much more profitable next year and so on- year over year- going forward""
Patrick G. Rooney, the Chariman of the Board of Positron Corporation (OTC:POSC.OB) - a molecular imaging company focused on Nuclear Cardiology- has confirmed in an exclusive interview with BioMedReports that while his company will be profitable this year, he sees it becoming much more profitable next year and so on- year over year- going forward
Special Report coming on Friday
After telling investors, "We believe Positron's (OTCBB:POSC) dose dispensing device will revolutionize the way radiopharmaceuticals are compounded and distributed in the US and around the world." BiomedReports will feature a fully press-released special report and interview on the subject with Positron's CEO, Patrick Rooney this Friday.
BiomedReports today has learned that not only one, but multiple big board companies may have apparently taken great interest in POSC's Nuclear Pharm-Assist® technology and that some may have already inked deals involving the platform with the company.
While everyone has been focused on POSC's bright future as the leader and single buggest provider of Cardiac PET technology products, this morning Positron's CEO Patrick G. Rooney surprised investors by telling them that the company's radiopharmaceuticals business may be getting more attention going forward as well. "While most in the industry already know that PET is the future of nuclear cardiology, we fully expect that an equal to greater amount of revenue and profits will be generated by our new proprietary automated radiopharmaceutical device as it is used in both the cardiac and oncology sectors."
Developing...
" we fully expect that an equal to greater amount of revenue and profits will be generated by our new proprietary automated radiopharmaceutical device
We believe Positron's dose dispensing device will revolutionize the way radiopharmaceuticals are compounded and distributed in the US and around the world. Positron's products, services and position in the marketplace provide an economical, efficient and regulatory compliant solution in the multibillion dollar per year radiopharmaceutical consumables industry," said Positron's CEO Patrick G. Rooney. "While most in the industry already know that PET is the future of nuclear cardiology, "We believe Positron's dose dispensing device will revolutionize the way radiopharmaceuticals are compounded and distributed in the US and around the world. Positron's products, services and position in the marketplace provide an economical, efficient and regulatory compliant solution in the multibillion dollar per year radiopharmaceutical consumables industry," said Positron's CEO Patrick G. Rooney.
""U.S. where the market opportunities call for four to six thousand machines""
BiomedReports: How else has this affected your company and the future prospects of business?
On the PET side, we are now working on some significant strategic alliances which we will talk about. For example, one of our new markets that has very few PET systems in it is the Canadian market. We look to be selling a significant amount of systems in Canada. With a population of 38 million plus, that is a large market for us to be expanding into.
Compared to the United States, it’s a smaller market, but what’s nice is that we are the only dedicated cardiac PET manufacturer in the world, so the expansion opportunities will continue. We plan on being a leader in the market place not only here in the U.S. (where the market opportunities call for four to six thousand machines), but also outside the U.S. There will be an announcement shortly that will impact those markets opportunities for us in a substantial way.
It was in one of the articles that Biomeds posted.
The PET unit also has a lower radiation dose.
PRICE OF POSITRON Attrius PET Camera/Scanner
Orders are 100 and counting.
http://www.dotmed.com/listing/773309?utm_source=base&utm_medium=search&utm_campaign=Base
Insmed Inc. Welcomes Studies Linking IGFBP-3 to Prevention of Blindness in Premature Infants
BusinessWire 9:15 am June 26, 2007
RICHMOND, Va.--(BUSINESS WIRE)--
Insmed Incorporated (Nasdaq:INSM), a biopharmaceutical companyfocused on the development and approval of drugs for the treatment ofmetabolic diseases with unmet medical needs, today noted thepublication of promising results of research from three universitiesregarding the potential role of insulin-like growth factor bindingprotein-3 (IGFBP-3) in the prevention of blindness among prematureinfants.
IGFBP-3 is a key component of Insmed's lead drug candidate,IPLEX(TM), which has been approved by the U.S. Food and DrugAdministration for the treatment of a severe growth disorder and iscurrently being studied as a treatment for myotonic musculardystrophy, HIV-associated adipose redistribution syndrome andretinopathy of prematurity (ROP). IPLEX(TM) is the combination ofIGFBP-3 with recombinant human insulin-like growth factor 1 (IGF-I).
The new study results, published in the June 19 issue of theProceedings of the National Academy of Sciences, focus on the actionof IGFBP-3 in promoting normal tissue growth and preventing ROP.Researchers at the University of Florida reported that mice treatedwith IGFBP-3 showed closer-to-normal growth of retinal vasculaturethan mice without IGFBP-3 in similar high-oxygen conditions.Researchers at Harvard Medical School and the University of Goteborgin Sweden reported similar results.
In addition, Harvard Medical School researchers, in collaborationwith researchers at the University of Goteborg, reported results of aclinical study showing IGFBP-3 levels in infants with ROP were lowerthan those of healthy babies. The researchers said these resultssuggest that IGFBP-3, acting independently of IGF-I, helps preventoxygen-induced loss of blood-vessels and helps promote vascularre-growth.
Insmed Chairman and CEO Geoffrey Allan, Ph.D., commented: "Thesestudies by researchers at three distinguished universities mark animportant scientific milestone in Insmed's development of IPLEX(TM) asa treatment for ROP. They suggest that IGFBP-3, once thought only toregulate IGF-I, actually plays a broader role in human development andin the growth or regeneration of human tissues. Not only is thisdiscovery important in the fight against ROP, but it also suggestspromising avenues for research into the treatment of other conditionsassociated with ischemia and vascular damage."
About IPLEX(TM) and ROP
IPLEX(TM) is currently in the first phase of clinical developmentfor the treatment of ROP, a disease that affects an estimated 14,000to 16,000 premature infants each year. ROP impedes the development ofthe small blood vessels in the back of the eye, leading to blindnessin severe cases. A Phase I clinical study investigating IPLEX(TM) as atreatment for ROP is underway at the University of Goteborg, incollaboration with scientists at the Harvard Medical School. Tenpatients will be enrolled with the objective of the study being todetermine the dose of IPLEX(TM) required to increase serum IGF-Ilevels into the normal physiological range. This study is expected tobe completed by the end of 2007.
About Insmed
Insmed is a biopharmaceutical company focused on the developmentand approval of drugs for the treatment of metabolic diseases withunmet medical needs. For more information, please visitwww.insmed.com. To be added to Insmed's investor lists, please contactHaris Tajyar at htajyar@irintl.com or at 818-382-9702.
Forward Looking Statements
This release contains forward-looking statements which are madepursuant to provisions of Section 21E of the Securities Exchange Actof 1934. Investors are cautioned that such statements in this release,including statements relating to planned clinical study design,regulatory and business strategies, plans and objectives of managementand growth opportunities for existing or proposed products, constituteforward-looking statements which involve risks and uncertainties thatcould cause actual results to differ materially from those anticipatedby the forward-looking statements. The risks and uncertaintiesinclude, without limitation, risks that product candidates may fail inthe clinic or may not be successfully marketed or manufactured, theCompany may lack financial resources to complete development ofproduct candidates, the FDA may interpret the results of studiesdifferently than the Company, competing products may be moresuccessful, demand for new pharmaceutical products may decrease, thebiopharmaceutical industry may experience negative market trends andother risks and challenges detailed in the Company's filings with theU.S. Securities and Exchange Commission, including the Company'sQuarterly Report on Form 10-Q for the quarter ended March 31, 2007.Readers are cautioned not to place undue reliance on anyforward-looking statements which speak only as of the date of thisrelease. The Company undertakes no obligation to publicly release theresults of any revisions to these forward-looking statements that maybe made to reflect events or circumstances that occur after the dateof this release or to reflect the occurrence of unanticipated events.
Source: Insmed
Antares Pharma Inc.
(AMEX: AIS)
Antares Pharma Inc. (AMEX: AIS)
We are initiating coverage of Antares Pharma Inc. with a BUY rating and a price target of $3.00. At a market cap of $59 million, we believe Antares represents an under-recognized, under-valued, and misunderstood opportunity. Antares is a specialty pharma company built around two primary drug delivery technologies. Their ATD transdermal gel platform and their injectable devices. They are developing internal products, and they collaborate with companies to enhance a current product, or develop a new drug.
The ATD Gel technology is used in several products. Elestrin (Estradiol ATD gel) was approved by the FDA in December 2006 for treatment of menopausal symptoms. Libi-Gel (testosterone ATD gel) started Phase III trials in December 2006 for female sexual dysfunction. Anturol (oxybutynin ATD gel) has already successfully completed Phase II testing.
Injectable devices; Antares features a disposable mini-needle product line and a reusable needle-free device for use in specialty and generic pharmaceutical products. In 2005 and 2006 they signed three deals with TEVA Pharmaceutical Industries Ltd. (TEVA) using these devices. Importantly, we believe these deals represent significant value for the company which is currently unrealized in their valuation. Potential entry into the biogenerics market is another key future value driver for the Company which represents upside to our estimates.
We anticipate several important catalysts driving Antares valuation during the next 12 months. These events include: 1) Advancement of Anturol into pivotal clinical trials for incontinence; 2) Approval of first product under the TEVA deal; 3) Receipt of significant milestones relating to Elestrin; and 4) Increased revenue with decreased operating losses, indicating Antares is achieving a sustainable business.
http://www.pzk.com/index.cfm
Some seem to think we are headed down this road.
http://www.iimagazine.com/Article.aspx?ArticleID=1041370
Changewave alliance report
From this weeks alliance report on hot tickets...#(3) Insmed Positioning for Biologics Market
"While Insmed (INSM) recently settled with competitors Tercica and Genentech, there appears to be a new story is in the making. Insmed Therapeutic Proteins (ITP) - their manufacturing facility in Boulder, CO - is capable of producing a host of biologics. CEO Geoffrey Allan has testified before Congress on the need to authorize the FDA to move forward with the processes to bring generic biologics to U.S. approval.
"The patents on currently marketed biologics are expiring, and by 2010, the door will be open to a $12 billion market. Insmed has indicated they are currently developing several such proteins and expect to find a partner for the generic biologic market. Congress is opening the door to generic biologics and Insmed stands as one of only a few capable firms ready to participate."
Cash flow positive within a year?
From apenny4em Yahoo Board
Here is something that Dr Allan didn't, and wouldn't say.
Despite exiting short stature, Insmed's revenue from cost recovery/sales DOUBLED quarter over quarter, from $502,000 to $1,100,000.
Insmed's quarterly burn rate would appear to be around $4,500,000.
IF revenues do not increase, Insmed has enough operating cash to see them through to the end of Q3 2008 (possibly Q4 2008).
But what if off-label revenues continue to ramp at the present rate?
We haven't had a full quarter's worth of revenue from the ALS trials in Italy.
Insmed are on track to initiate formal Phase II trials for both MMD and HARS by the end of this year. With HARS alone there are estimated to be 250,000 patients USA/Europe, and for 100,000 of those Iplex is the ONLY long-term treatment available.
Cash at present, say 27m at 4.5m per quarter gives us 6 quarters (from mid-May).
As the revenues continue to ramp, the burn rate will decrease. By the end of Q2, we could be be looking at 24.5m at 3.5m per quarter, giving us 7 further quarters. And so on.
For those who thought that the latest shelf-sale was a desparate measure, perhaps you should think again.
Even without an opt-in, and even without a biotech partnership, I believe that Insmed now has enough cash to see them through to Cash Flow Positive.
Press Release Source: Insmed Inc.
Insmed Inc. Releases Investor Fact Sheet with Updates on Drug Development Progress
Wednesday April 25, 9:01 am ET
Insmed Incorporated (NASDAQ:INSM - News) is a biopharmaceutical company engaged in the development and approval of drugs to treat patients with metabolic diseases that currently have limited or no treatment options.
Our lead drug, IPLEX(TM), is a complex composed of recombinant human insulin-like growth factor I and insulin-like growth factor binding protein-3.
Insmed is presently moving forward on two very specific pathways. We are continuing the development of IPLEX(TM) for additional clinical indications while concurrently studying the emerging generic biologic market, recognizing the potential opportunities that exist in this sector.
Headquartered in Richmond, Virginia, Insmed maintains a state-of the-art FDA-approved commercial biologic manufacturing facility, Insmed Therapeutic Proteins, in Boulder, Colorado.
The IPLEX(TM) Pipeline - Targeted Research
IPLEX(TM) is currently being studied as a treatment for several serious medical conditions, Myotonic Muscular Dystrophy (MMD); Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease; HIV-Associated Adipose Redistribution Syndrome (HARS); and retinopathy of prematurity (ROP). Cumulatively, these disorders affect more than 100,000 patients in the United States, and an equal number in the European Union, representing potential markets that could be measured in the hundreds of millions of dollars.
Myotonic Muscular Dystrophy Research
MMD is the most common form of adult muscular dystrophy, affecting 1 in 8,000 individuals in the United States. Approximately 40,000 Americans are diagnosed with the disease, and close to 60,000 people in the European Union also suffer from this life-threatening disorder. Patients with MMD develop progressive muscle wasting and weakness, cardiovascular problems and digestive complications. In extreme cases patients eventually become totally disabled and typically die from respiratory or cardiac failure. At present there is no treatment to halt or reverse the progression of MMD.
IPLEX(TM) is being investigated in an ongoing open label Phase II clinical study at the University of Rochester School of Medicine, with funding provided by the Muscular Dystrophy Association and the National Institutes of Health. The objective of the Phase II study is to examine the safety, tolerability and initial efficacy of a once-daily, subcutaneous injection of IPLEX(TM) in patients with MMD.
We expect initial data from the first of these trials to be available in the second quarter of 2007 and presented at a scientific meeting in the third quarter of 2007. We currently plan to initiate an expanded Phase II trial, with a larger number of participants, by the end of 2007 and enter Phase III clinical trials in early 2009.
Italy Requests IPLEX(TM) for ALS Patients
In January 2007, Insmed announced that the Italian Ministry of Health had requested IPLEX(TM) for Italian patients suffering from ALS. This life-threatening neuromuscular disease strikes adults in mid-life. In Italy approximately 1,000 new cases of ALS are diagnosed every year.
In cooperation with Cephalon, which holds the patent for IGF-1in the European Union, Insmed is currently supplying IPLEX(TM) on a cost recovery basis to these Italian patients under an Expanded Access Program. Data collected through the Expanded Access Program in Italy will be used to design future ALS clinical development studies with IPLEX(TM).
IPLEX(TM) for HARS
IPLEX(TM) is being explored as a possible therapy for HARS. An estimated 80,000 HIV patients in the United States have HARS, according to published reports. This disorder is marked by abnormal metabolism including both central fat accumulation (visceral adiposity and buffalo hump) with or without fat loss in the limbs. These features have increased markedly with the advent of highly active antiretroviral therapy (HAART) for HIV. Recent studies performed in subjects on HAART suggest nearly 50% of these individuals develop the morphologic features characteristic of this syndrome.
Preliminary data from a Phase II open-label clinical study is currently being analyzed. The study, directed by Morris Schambelan, M.D., a professor of medicine at University of California San Francisco and Chief of Endocrinology and Director of the General Clinical Research Center at San Francisco General Hospital, is designed to evaluate the safety and efficacy of 12 weeks of IPLEX(TM) treatment in subjects with HARS. The primary objective of the study is to determine the effects of IPLEX(TM) on visceral fat distribution, insulin sensitivity and glucose and lipid metabolism. We expect initial data from this trial to be available in 2007, with additional Phase II trials planned to begin in the first half of 2008 and Phase III trials planned to initiate in 2009.
IPLEX(TM) for Retinopathy of Prematurity
IPLEX(TM) is currently in the first phase of clinical development for the treatment of ROP. This disease, which affects an estimated 14,000 to 16,000 premature infants each year, impedes the development of the small blood vessels in the back of the eye leading to blindness in the majority of cases. A Phase I clinical study investigating IPLEX(TM) as a treatment for ROP has been initiated at the University of Gothenburg in Sweden, in collaboration with scientists at the Harvard Medical School in the United States.
Ten patients are being enrolled sequentially, with each subsequent patient receiving a higher dose of IPLEX(TM). The objective of the study is to determine the dose of IPLEX(TM) required to increase serum IGF-1 levels into the normal physiological range. Results of this study are currently expected by the end of 2007, at which point a timeline for future clinical development will be determined.
Beyond IPLEX(TM): Oncology Compounds
Insmed has two oncology compounds, rhIGFBP-3 and INSM-18, in development. Both hold promising potential treatments for a variety of cancers. Preclinical models show that one or both treatments interact with the IGF-1 system to reduce tumor growth in models of breast, prostate, lung, colorectal and head and neck cancers.
RhIGFBP-3 has demonstrated preclinical efficacy in numerous cancer indications, including breast, prostate, liver, ovarian and colon. Additionally, several lines of recent evidence, from various cell systems, have suggested that rhIGFBP-3 may play a more active, IGF-1-independent role in growth regulation of cancer cells, binding specifically with high affinity to the surface of various cell types and directly inhibiting monolayer growth of these cells in an IGF-1-independent manner. Also recent independent studies have demonstrated that when IGFBP-3 is used in combination with other cancer therapies it can accentuate and even synergize the efficacy of standard cancer therapies. We have an ongoing open label Phase I clinical study with rhIGFBP-3 which is a dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of a single intravenous dose of rhIGFBP-3. The primary goal of this 30-patient study is to identify the appropriate dose of rhIGFBP-3 for a planned Phase II clinical trial in breast cancer patients.
INSM-18 is an orally available, small molecule, tyrosine kinase inhibitor. It has demonstrated dual inhibition of the IGF-1 and HER2 receptors. Two single-dose Phase I clinical studies in healthy volunteers have previously been completed with this drug candidate. In both studies, the drug was safe and well-tolerated. Additionally, a Phase I-II dose escalation clinical study designed to define the maximum tolerated dose of INSM-18 in patients with relapsed prostate cancer has been completed at the University of California, San Francisco. This study consisted of a 28-day treatment period at each dose level to investigate the effect of INSM-18 on levels of prostate specific antigen (PSA). An analysis of the data collected from the study is currently being conducted, and the results will be used to design further Phase II clinical studies.
Manufacturing Edge
Our state-of-the-art manufacturing facility, Insmed Therapeutic Proteins (ITP), is FDA-inspected and approved. Located in the biotechnology hub of Boulder, Colorado, we believe ITP is a significant technological asset for Insmed. Given its advanced protein manufacturing capability, combined with a skilled work force, we believe we are well placed to leverage our protein development and manufacturing expertise in a number of new ventures, either through acquisitions or partnering.
As pending legislation is paving the way for affordable and safe alternatives to existing biologics that will soon be coming off patent, we believe our ITP facility and the inherent expertise developed at the site positions Insmed for the potential development of generic biologics
Insmed Chairman and CEO Dr. Geoffrey Allan testified at the United States House of Representatives Oversight and Government Reform Committee with respect to generic biologics on March 16, 2007, stating, "Insmed has developed significant intellectual capital focused towards protein characterization and purification. We have invested in building the facilities required to manufacture quality recombinant proteins. The combination of our proprietary protein platform with a biogeneric protein platform meets our goal to sustain innovation along with the ability to provide safe and affordable drugs to address a growing economic issue."
Insmed has an ongoing development program in the biogeneric area. We are currently at an early stage in developing five protein products which collectively could potentially represent several billion dollars of sales in the United States market. We intend to seek a partner to undertake the commercialization of these protein products.
Insmed Corporate Information
Insmed Incorporated
8720 Stony Point Parkway
Richmond, Virginia 23235
TRCA: Downgraded - JAGNote by Friedman, Billings, Ramsey & Co., Inc
TRCA: Downgraded - The firm noted Tercica reported its 4Q and gave guidance for 2007 that was significantly below consensus. With the Insmed litigation over, TRCA shares will trade on Increlex sales, and a meaningful pickup in sales seems unlikely until approval in the non-severe market, now expected in 2009. Increlex sales in 4Q were roughly $700,000, an uptick from 3Q, but probably not enough to exceed new guidance of $7-8M in 2007; consensus had been around $20M. We lowered our 2007-2012 Increlex sales estimates by 40-50%; even 2007`s guidance looks aggressive to us. With only $41M in 2008 revenues, and breakeven not until 2011 (in our model), TRCA`s $270M market cap is expensive. We are downgrading Tercica to Underperform and lowering our price target to $4 (from $6).
Philip J. Youngs new job
April 3, 2007
SAN FRANCISCO, April 3, 2007 /PRNewswire-FirstCall via COMTEX News Network/ --
Osteologix Inc. (OTC Bulletin Board: OLGX) announced today that it has appointed Philip J. Young as President and Chief Executive Officer, effective May 1, 2007. Mr. Young most recently was Chief Business Officer, Executive Vice President of Insmed, Inc. Previously he has served as an industry consultant and as an executive with several small and medium sized biotechnology companies, including as Chief Executive Officer.
"Phil has the ideal experience and capabilities to lead Osteologix forward through a very exciting time for the Company," stated Klaus Eldrup-Jorgensen, Chairman of the Osteologix board of directors. "He has experience leading small, entrepreneurial organizations through rapid phases of growth, has extensive experience working with Wall Street and has twice previously served as President or Chief Executive Officer of biopharmaceutical companies."
"I am very excited to join Osteologix," said Mr. Young. "There is a critical need for improved treatments for osteoporosis. I believe our lead product, NB S101, has tremendous potential to take a significant share of the multi-billion dollar market for therapies that treat this disease. If approved for commercial sale in the United States, NB S101 would be the first therapy to simultaneously induce new bone formation while also preventing bone loss. I am looking forward to leading the advancement of Osteologix and overseeing the continued development of NB S101."
Reporting to Mr. Young will be Stephan Christgau, Chief Operating Officer, and Matthew M. Loar, Chief Financial Officer. Dr. Christgau will continue to lead all of the company's research and development, including the on-going phase II clinical trial, from the company's Copenhagen office. Mr. Loar will continue to lead all financial, administrative and corporate matters from the company's San Francisco office.
"With Phil in place, we have an outstanding team to advance our potential treatment for osteoporosis," stated Christian Hansen, founder of Osteologix and partner in Nordic Biotech K/S, the largest stockholder of Osteologix. "We are nearing full enrollment in our current phase II clinical trial of NB S101, and I am very pleased to say that the study is progressing on-schedule."
Effective April 3, 2007, Charles J. Casamento, who was the company's previous Chief Executive Officer and President from October 18, 2004 through April 3, 2007, has resigned from the Company to pursue other opportunities. Mr. Casamento has agreed to provide consulting services to the company during a three-month transition period. Mr. Casamento will remain on the board of directors but will not stand for re-election at the company's annual meeting of stockholders.
"For the two and a half years that Chuck was CEO, Osteologix progressed from a company with pre-clinical operations through the completion of a phase I human clinical trial, and into our first phase II program. He has taken a previously private company headquartered in Europe into the U.S. and has successfully accessed U.S. capital markets with our becoming a public company through a merger transaction with a public shell. I would like to thank him for his contributions, effective leadership during his tenure and a job well done," concluded Dr. Eldrup-Jorgensen.
Latest CEUnterberg report.. PART 1, 2, 3
Through the litigation settlement with Tercica, Insmed has announced that it has
fulfilled its cash needs through 4Q:07. We note that by 2H:07, the company will
have IPLEX data in the HARS and MMD indications which we believe will drive
investor interest.
Additionally, following the announcement of the settlement, Insmed made
significant expense cuts. Given the lack of a marketable drug for the foreseeable
future, Insmed has laid off its entire sales and marketing force. In total, company
management expects that it will have achieved approximately $22MM in cost
savings. The company has guided operating losses to the range of $25-28MM
for 2007.
We believe the settlement solves many issues for both companies. Insmed was
faced with owing a 15-20% royalty on future sales of IPLEX, in addition to a
$7.5MM upfront payment, as well as the possibility, however small, of an
injunction against it. With no need to dedicate further resources to the marketing
of IPLEX for the small short stature indication, and with the elimination of the
$7.5MM upfront payment, Insmed is now in a better position to allocate
resources towards additional indications, which we have long held offer a
more alluring investment opportunity.
We continue to expect data from the phase II HARS trial for IPLEX in
2Q:07. We have long recommended that investors seeking to garner substantial
long term returns from INSM investments focus on opportunities for IPLEX
beyond its initial indication, rather than hyperanalyze what will likely turn out to
be a modestly sized initial opportunity particularly in light of the trial verdict.
With the legal overhang now lifted, we continue to highlight Insmed’s HARS trial.
One of the advantages of IPLEX for this indication is inclusion of patients with
insulin resistance in the trial who may have previously been excluded from
enrollment in other lipodystriphy trials. IPLEX has the unique ability to be used
in those patients who are insulin resistant thereby opening up a variety of new
indications for it including myotonic muscular dystrophy and HIV lipodystrophy.
Company management indicated during the conference call that it expects to
conduct a larger phase II HARS trial prior to moving into phase III. They
expect the phase II trial to be a randomized, placebo-controlled trial in 150-200
patients looking at IPLEX in possibly 2 doses with 40-60 patients in each arm.
The trial will likely look at measures such as visceral adiposity as well as glucose
control. Following positive data from the larger phase II trial, the company
anticipates it may be able to move into phase III trials by 2009.
We also point out that the positive phase III data in its HIV lipodystrophy drug,
TH9507, was highly accretive to Theratechnologies’ market valuation. We
believe IPLEX has the potential to be used in a wider population given that unlike
TH9507, IPLEX can be used in insulin resistant patients.
By way of background on the Theratechnologies program, the phase III trial for
TH9507 enrolled 412 patients in 43 centers in the United States and Canada. The
study examined the safety and efficacy of a daily administration of 2 milligrams of
TH9507 for a period of 26 weeks and long-term safety over 52 weeks. The
primary endpoint is a reduction of visceral adipose tissue, or VAT, which is a risk
factor for cardiovascular disease and type 2 diabetes.
By applying a 6-7x multiple to our 2012 revenue
forecast of $75MM and discounting back at a rate
20% per annum, we arrive at a fair value for INSM
shares of $2.
Risks for Insmed include the inability to successfully
develop and commercialize pipeline products
indications. We also note that INSM is a cash-burn
story and will need to raise additional funds down
line.
Fourth Quarter Results & Highlights
Insmed reported 4Q:06 revenues of $502,000 beating our estimate of $350,000 and
missing Consensus estimate of $600,000. INSM reported a loss of $0.21 per share
missing Consensus and our forecasts of a loss of $0.13 per share. Notably, R&D
expenses increased to $9.42MM compared to our forecast of $7.5MM.
Figure 1: INSM 4Q:06 Reported Earnings
4Q:06E CEUT 4Q:06E Consensus 4Q:06 ACTUAL
Total Revenues $0.35MM $0.60MM $0.50MM
COGS $0.11MM $0.84MM
R&D $5.50MM $4.25MM
SG&A $7.50MM $9.42MM
EPS ($0.13) ($0.13) ($0.21)
Source: C.E. Unterberg, Towbin, Company Reports, FirstCall
Trimming Back Expenses
We believe the settlement solves many issues for both companies. Insmed was faced
with owing a 15-20% royalty on future sales of IPLEX, in addition to a $7.5MM upfront
payment, as well as the possibility, however small, of an injunction against it. With no
need to dedicate further resources to the marketing of IPLEX for the small short stature
indication, and with the elimination of the $7.5MM upfront payment, Insmed is now in
better position to allocate resources towards additional indications, which we have long
held offer a more alluring investment opportunity.
We continue to expect data from the phase II HARS trial for IPLEX in 2Q:07. We have
long recommended that investors seeking to garner substantial long term returns from
INSM investments focus on opportunities for IPLEX beyond its initial indication, rather
than hyperanalyze what will likely turn out to be a modestly sized initial opportunity
particularly in light of the trial verdict. With the legal overhang now lifted, we continue
to highlight Insmed’s HARS trial. One of the advantages of IPLEX for this indication is
inclusion of patients with insulin resistance in the trial who may have previously been
excluded from enrollment in other lipodystriphy trials. IPLEX has the unique ability to
be used in those patients who are insulin resistant thereby opening up a variety of new
indications for it including myotonic muscular dystrophy and HIV lipodystrophy.
Company management indicated during the conference call that it expects to conduct
larger phase II HARS trial prior to moving into phase III. They expect the phase II trial
to be a randomized, placebo-controlled trial in 150-200 patients looking at IPLEX in
possibly 2 doses with 40-60 patients in each arm. The trial will likely look at measures
such as visceral adiposity as well as glucose control. Following positive data from the
larger phase II trial, the company anticipates it may be able to move into phase III trials
by 2009.
We also point out that the positive phase III data in its HIV lipodystrophy drug, TH9507,
was highly accretive to Theratechnologies’ market valuation. We believe IPLEX has the
potential to be used in a wider population given that unlike TH9507, IPLEX can be used
in insulin resistant patients.
By way of background on the Theratechnologies program, the phase III trial for TH9507
enrolled 412 patients in 43 centers in the United States and Canada. The study examined
the safety and efficacy of a daily administration of 2 milligrams of TH9507 for a period
of 26 weeks and long-term safety over 52 weeks. The primary endpoint is a reduction of
visceral adipose tissue, or VAT, which is a risk factor for cardiovascular disease and type 2 diabetes
Valuation
By applying a 6-7x multiple to our 2012 revenue forecast of $75MM and discounting
back at a rate of 20% per annum, we arrive at a fair value for INSM shares of $2.
Investment Risks
Risks for Insmed include the inability to successfully develop and commercialize pipeline
products and indications. We also note that INSM is a cash-burn story and will need to
raise additional funds down the line.
Figure 2: Insmed Upcoming Events
Timing Product Event
2Q:07 IPLEX - HIV Lipodystrophy Topline Phase II Data
2Q:07 IPLEX - MMD Phase II topline data
2H:07 IPLEX - HIV Lipodystrophy Initiate Phase IIb trial
2009 IPLEX - HIV Lipodystrophy Initiate Phase III trial
CE Unterberg Towbin UPGRADE
http://www.briefing.com/GeneralContent/Active/Investor/TickerSearch/TickerSearchInvestor.aspx
BLOOMBERG VIDEO ON NAKED SHORTING
A bumpy ride going foward for TRCA
A Second Look: Tercica Inc.
Thursday March 8, 4:13 pm ET
Shares of Tercica Fall Following Previous Sharp Gains on Heels of Legal Settlement
NEW YORK (AP) -- Shares of drug maker Tercica Inc. reversed course Thursday, after marking big gains a day prior on news of a legal settlement with rival drug maker Insmed Inc.
The stock fell 57 cents, or 9.7 percent, to close at $5.31 on the Nasdaq Stock Market. Shares gained 20 percent on Wednesday and have traded in a 52-week range of $2.92 to $7.94.
ADVERTISEMENT
Insmed, as part of the settlement with Tercica and Genentech Inc., agreed to stop marketing Iplex, which treats growth disorders. That company had been sued over patent issues for its marketing of the drug.
Friedman, Billings, Ramsey analyst Jim Reddoch downgraded Tercica to "Market Perform" from "Outperform" and moved the price target to $6 from $7, saying the removal of the Iplex issue amounted to a positive, but only for the short term. Now Tercica must look to Increlex, also a growth hormone deficiency treatment, as the next driver for its shares.
"The current market opportunity -- the severe population -- looks limiting, and there is risk that Increlex misses Wall Street revenue estimates," Reddoch wrote in a note to investors.
Iplex's absence from the market should add between $1 million and $2 million in annual sales to Increlex's $2 million to $3 million in annual sales, he estimated. The risk is that Increlex misses Wall Street revenue estimates which ramp up to $24 million in 2007, he said. Tercica said it expects Increlex revenue of about $7 million to $8 million in 2007.
"""""He lowered U.S. sales estimates for the next six years, citing the difficulty the drug has had moving from the market for severe patients into non-severe patients. Also, the company expects to operate at a loss into 2010, he said.""""""""&q uot;"
From yahoo board
I am not going to give all my reasons why this settlement is good for INSM, but I will share some of my thoughts. Insmed is now licensed from DNA to go after HARS, MMD, ALS, and others. The opt-in clause is a partnership endorsement from DNA. I am not going to comment on TRCA's opt-in option because TRCA own future is uncertain. Guys, wake up, IPLEX is still available for all other indications other than Short Stature. Think of it this way, Insmed traded the Short Stature market for DNA's endorsement and licensing for all other indications. How much would you value Insmed if it were a new BioTech with license and partnership clause from DNA, add to that an approved superior FDA drug with known safety record. I have said it before and I will say it again that Short Stature is not where the meat is especially when TRCA is fighting for the same patients. Short Stature would never have sustained the company nor prevented further dilutions. With this new agreement, DNA can finance all the promising indications and market them too (opt-in my ass, they are in). I personally think INSM is finally in the right track. Litigation is behind us now once and for all, we lost Short Stature but we won a license and partnership from DNA. Talk to any analyst, INSM can easily be worth $300M-500M with its current standing.
BigTex
Insmed, Tercica Settle Patent Suit Over Growth-Drug (Update3)
By Joel Rosenblatt
March 6 (Bloomberg) -- Insmed Inc. will stop selling its lone product, a medication that spurs growth in abnormally short children, as part of a settlement of a patent-infringement suit it lost at trial to rival Tercica Inc.
Insmed will be able to sell Iplex for other purposes not related to short stature if it pays royalties to Tercica and patent owner Genentech Inc. Tercica said the former adversaries will work with doctors to find other treatments for children using Iplex, including a possible switch to Tercica's Increlex.
The agreement comes three months after a federal jury in Oakland, California, said Insmed infringed patents controlled by Tercica and owned by Genentech Inc. The settlement relieves both companies of the cost of fighting an appeal that Insmed had promised to file, said Matthew Osborne, an analyst at Lazard Capital Markets in New York.
``It's a positive event for both companies because they can spend their resources developing these compounds for more indications for other diseases,'' Osborne said in an interview before the settlement was announced.
Insmed shares declined 28 percent over two days in December after the Oakland jury found the Richmond, Virginia-based company infringed Tercica's patents. The jury ruled Insmed should pay Tercica $7.5 million for past sales of Iplex, plus royalties of 15 percent to 20 percent. Under terms of the settlement, Insmed won't pay the damages.
Protect Patients
Analysts had predicted that U.S. Judge Claudia Wilkin wouldn't have granted a court ruling that Tercica and Genentech sought blocking sales of Iplex. In its arguments against the injunction, Insmed submitted letters from doctors urging Wilkin to refuse the request to protect patients taking Iplex, which requires half as many injections as Tercica's Increlex.
Insmed spokeswoman Jody LoMenzo declined to comment on potential reactions from patients taking Iplex and doctors who prefer it to Increlex.
The settlement permits Tercica and Genentech to invest in Insmed's development of Iplex for other diseases, with Insmed earning 50 percent of profit after development costs, the statement said.
Both Iplex and Increlex are given to children whose growth is stunted by the lack of a protein called insulin-like growth factor, which is created in the liver. In countries outside the U.S., Insmed can sell Iplex if it pays royalties between 4 and 15 percent to Tercica, Genentech and Ipsen SA, a French family- controlled drugmaker, according to the statement.
Validity Upheld
The jury in December found that Insmed infringed two patents and it also upheld the validity of the manufacturing patent that Wilkin had already found to be infringed. Tercica licenses the patents from Genentech, the world's second-biggest biotechnology company behind Amgen Inc. The jury found Insmed's infringement willful, allowing Wilkin to as much as triple any damage award.
Tercica Chief Executive Officer John Scarlett and Insmed CEO Geoffrey Allan said in a joint statement that the settlement ``allows Tercica to focus its efforts in the short-stature market and allows Insmed, in cooperation with Tercica and Genentech, to focus its Iplex development.''
Insmed shares rose 10 cents, or 6.9 percent, to $1.55 in Nasdaq Stock Market composite trading. Tercica, based in Brisbane, California, rose 4 cents to $4.88.
Genentech, based in South San Francisco, California, rose 62 cents to $82.28 in New York Stock Exchange composite trading.
The case is Genentech Inc. v. Insmed Inc., 04cv5429, U.S. District Court, Northern District of California (Oakland).
To contact the reporter on this story: Joel Rosenblatt in Oakland federal court at jrosenblatt@blooomberg.net
Last Updated: March 6, 2007 21:02 EST
New York Times article on INSM settlement
[Blocked Ads][Blocked Ads][Blocked Ads]
--------------------------------------------------------------------------------
March 7, 2007
To Settle Suit, Maker Agrees to Withdraw Growth Drug
By ANDREW POLLACK
A drug to spur growth in extremely short children will be removed from the market to settle patent infringement charges, the companies involved in the dispute announced last night.
The settlement will resolve all litigation between Tercica and Insmed, two small biotechnology companies that sell competing drugs to treat an extremely rare condition, a deficiency of a hormone called insulinlike growth factor-1.
A jury found that Insmed, based near Richmond, Va., infringed patents held by Genentech and licensed to Tercica, which is based in Brisbane, Calif. Genentech and Tercica had been seeking a court order to halt Insmed’s sales.
To protect its sales, Insmed had argued that its drug, Iplex, was superior to Tercica’s drug, Increlex, because it required only one injection a day instead of two.
Some doctors had also urged the court to keep Iplex available, arguing that it was not only more convenient but possibly safer as well. Other doctors had written that Iplex held promise as a treatment for various other diseases.
But in the settlement, Insmed agreed to stop selling Iplex in the United States as a treatment for growth deficiencies and to withdraw an application to have the drug approved for such use in Europe, according to a joint press release issued by Tercica and Insmed last night.
In exchange, Insmed will have the right to develop Iplex as a treatment for certain other diseases that may be more lucrative to treat than the childhood growth deficiency, like severe insulin resistance, myotonic muscular dystrophy and the side effects of drugs to treat H.I.V.
Genentech and Tercica will have the right to take part in those programs or to receive royalties from Insmed. Genentech and Tercica also agreed to waive the damages of at least $7.5 million they were awarded by the jury for Insmed’s infringement.
The children in the United States now getting Iplex — more than 100 — will shift to Tercica’s drug Increlex or seek other options.
“That’s really sad,” said Kelly Mullins of Palm Bay, Fla., whose 8-year-old son, Salem Khalfan, has been receiving Iplex. Ms. Mullins said she was not sure whether she would put Salem on Increlex.
“It’s hard enough giving a kid one shot a day,” she said.
Insmed to Discuss Litigation Settlement with Tercica
BusinessWire 11:24 pm March 6, 2007
Insmed to Discuss Litigation Settlement with Tercica
Pharmaceutical Writers/Business Editors
RICHMOND, Va.--(BUSINESS WIRE)--March 6, 2007--Insmed (NASDAQ:INSM) announced that it will host a conference call on Wednesday, March 7 at 11:00 a.m. (ET) to discuss the litigation settlement with Genentech and Tercica, and other business details.
Among participants on the call will be Geoffrey Allan, Ph.D., president and CEO of Insmed and Kevin Tully, Executive Vice President and CFO.
Interested investors can listen to the call over the Internet from Insmed's investor relations website at www.insmed.com or by dialing (888) 802-2225 (domestic) or (913) 312-1268 (international).
A telephonic replay of the call will be available for two weeks, by dialling (888) 203-1112 (domestic) or (719) 457-0820 (international). The passcode # is 4396908.
A web replay of the call will be available through the corporate website.
About Insmed
Got in at $2.83.
Looking good on todays news. Check out this link.
http://www.wrhambrecht.com/research/biotech/avrx.html
Good luck.
Sheepherder 1976 posted (from YMB):
"INSM keeps all current cash (saving itself $7.5M)
~ INSM's all litigation expenses are done;
~ INSM has ability to manufacture it's product;
~ INSM could even potentially manufacture for Tercica;
~ INSM still has ALS EU monies coming in;
~ INSM still has potential U.S. & EU IPLEX patients 160,000 for HARS;
~ INSM still has potential U.S. & EU IPLEX patients 97,000 for MMD;
~ INSM still has potential U.S. & EU IPLEX patients 44,000 for Severe Burns;
~ INSM still has potential U.S. & EU IPLEX patients 80,000 for ALS;
~ INSM still has potential U.S. & EU IPLEX patients 2,000 for Severe Insulin Resistance;
~ INSM still has potential U.S. & EU IPLEX patients 2,000,000 for US only Severe Diabetes;
~ INSM will get "milestone" payments on "opt-in" by TRCA or DNA;
~ INSM may already have "Phase III-enabling" clinical data on one or more of the above;
~ INSM has BP3;
~ INSM has INS-18; and
~ INSM has Phillip Young and Dr. Attie, the latter of whom's success rate is amazing.
The true longs in INSM were never here for Primary IGF-1 Deficiency. This has been discussed many times by many here.
Watch as INSM starts generating the PR to show Phase II trial results. They've been waiting for this to be over and now it is. Relief is my reaction. Now I'll wait and watch as INSM continues to execute as it has very well since it began pursuing IPLEX. Don't discount either the chance of a Pfizer deal on INSM-18 Pfizer and Insmed are investigating small molecule cancer, and "INSM-18 from Insmed and the University of California San Francisco is a dual inhibitor of IGF-1R and Her2/neu and is the ONLY clinical stage IGF-1R small molecule antagonist (phase I/II in prostate cancer)."
check out this link about Carl Bruno
http://translate.google.com/translate?u=www.carlobruno.it&langpair=it%7Cen&hl=en&ie=UTF-...
Got this in the mail today
http://www.smallcapfortunes.com/upbs/upbsextra.html
Good day today!
Let's keep it up.
Growth Drug Is Caught Up in Patent Fight
http://www.nytimes.com/2007/02/17/business/17patent.html?pagewanted=1&_r=2&adxnnl=0&adxn...
By ANDREW POLLACK
Published: February 17, 2007
Skip to next paragraph
Gregg Matthews for The New York Times
Ian Jackson, left, is 16 months older than his neighbor Salem Khalfan, 8.
Salem Khalfan is nearly 9 years old but only a little over three feet tall. His mother says he has grown a couple of inches in the last five months, though, since he began taking a new drug to replace a hormone his body lacks.
But his mother, Kelly Mullins, is worried that the drug, called Iplex, may be taken off the market.
The manufacturer of Iplex, a company called Insmed, has been found to infringe patents licensed by Tercica, the maker of a rival drug. Tercica is now trying to get a federal judge to ban sales of Iplex. Although Tercica’s drug will be available, it requires two injections a day instead of one. And some doctors say it may be less safe.
Insmed has submitted to the court letters from more than 20 doctors from around the world urging that Iplex continue to be made available. The letters say Iplex might be useful in treating not only growth deficiency, but also Lou Gehrig’s disease, burns, eye diseases, adult muscular dystrophy and the side effects of H.I.V. medications.
A hearing in Federal District Court in Oakland, Calif., at which Judge Claudia Wilken was to consider the fate of Iplex had been scheduled for yesterday but was postponed at the last minute. That suggests that the parties may be working out a settlement, although the companies and lawyers involved declined to comment.
The number of patients potentially affected would be small. Only about 6,000 children in this country have the growth factor deficiency for which the drugs are approved and only a few hundred are now using either of the drugs. But the two products are potentially lucrative for their makers, selling for $20,000 to $40,000 a year.
Patent lawyers said it would be highly unusual for a drug to be taken off the market for patent infringement because judges, in considering any sort of injunction request, must consider the public interest, not just those of the parties involved.
In the case of drug distribution, monetary damages would generally be a court’s preferred remedy.
But there is a precedent. A product for improving bone marrow transplantation was removed from the market in the late 1990s after an equivalent product from the patent-holding company became available.
The case stems from a long-running and bitter dispute between Insmed, a publicly traded company based in Richmond, Va., and Tercica, based in Brisbane, Calif., and also publicly traded. Both sell drugs that were approved in 2005 to treat extremely short children who are deficient in a hormone called insulinlike growth factor one, or IGF-1.
In December a jury ruled that Insmed had infringed patents that are owned by Genentech and licensed to Tercica and ordered Insmed to pay $7.5 million, plus royalties. On one of three patents in dispute, the jury found the infringement to be willful.
In seeking an injunction against further sales of Iplex, Tercica and Genentech have proposed to the court that Insmed be allowed to continue providing Iplex to patients who were using it before the jury decision on Dec. 6.
But all new patients since then, they say, could be adequately treated with Tercica’s own drug, Increlex.
The companies argue that Insmed’s patent infringement causes harm to Tercica, which built its entire business around the Genentech patents.
They say that Genentech, as was its right, refused to license the patent rights to Insmed over a period of 10 years. But they say Insmed continued to develop its drug in a calculated gamble that even if the company were found to have infringed on the patents, it would have to pay only monetary damages.
“Insmed knew this day would come and ignored or squandered many opportunities to avoid it,” Genentech and Tercica said in a filing in support of the injunction. They said that allowing Insmed to continue selling Iplex would just be “rewarding Insmed’s illegal misconduct.”
Insmed counters that if it cannot add patients it may go out of business, meaning it could no longer supply even existing patients. It also argues that its drug has advantages over Tercica’s.
Some doctors agree. “Definitely having to give a child a shot once a day instead of twice a day is a huge advantage,” said Dr. Emily C. Walvoord, an assistant clinical professor at Indiana University, who wrote a letter to the court in support of Insmed.
Some doctors also say that Insmed’s drug may carry a lower risk of hypoglycemia — low blood sugar that can cause convulsions or loss of consciousness — than Tercica’s.
The letters in support of Iplex by Insmed also note that it is being tested for various other uses.
For instance, Dr. Lois Smith, an associate professor of pediatric ophthalmology at Harvard Medical School, is testing whether Iplex could prevent the eye disease retinopathy, which can occur in premature babies.
1 2 Next Page »
Next Article in Business (9 of 21) »
(Page 2 of 2)
If Iplex were taken off the market, it “would put all premature infants at risk and our study at risk,” Dr. Smith said in a letter in support of Iplex. “This work has the potential to prevent blindness in the ever-growing number of premature infants.”
Tercica is testing its drug for a less extreme form of IGF-1 deficiency but has not revealed what other diseases it is exploring, said Fredrik Wiklund, senior director of investor relations for the company.
Studies aimed at winning approval of drugs are exempt under federal law from patent infringement. So Insmed’s studies could theoretically continue even if an injunction were granted — although the new uses might also eventually be blocked by the patents if they reached the market.
As for Insmed’s contention that it might go out of business, Tercica and Genentech said that if the new uses were truly promising, Insmed would be able to raise money from investors. Shares of Insmed rose 17 percent, to $1.18, in regular trading. Shares of Tercica fell 5 cents, to $5.51.
Both drugs contain IGF-1, the missing growth factor, that is made in genetically engineered bacteria. And both drugs appear to spur growth to about the same degree. But while Tercica’s drug consists of only IGF-1, Insmed’s consists of IGF-1 that is bound to another protein called BP-3.
Because IGF-1 is often bound to BP-3 in the bloodstream, Insmed argues that its drug more closely matches the natural condition and enables IGF-1 to last longer in the bloodstream. That is what allows for the once-a-day dosing.
But Tercica’s drug has been studied in more patients and for a longer period of time. It also does not have to be thawed before use like Iplex does.
Dr. Mitchell E. Geffner, a professor of pediatrics at the University of Southern California, said the advantages of Iplex were “more theoretical than real,” and that it would probably not make a difference to patients if they had to switch to Tercica’s drug.
Ms. Mullins, who lives in Palm Bay, Fla., said she might not want to put Salem on the Tercica drug if the side effects like hypoglycemia are worse. “I’d rather he be short than have bad side effects,” she said.
He had not tried Tercica’s Increlex or other drugs before starting on the Iplex. Ms. Mullins said her insurer, Aetna, was completely covering the cost of the drug, at about $27,000 a year at Salem’s dosage.
Joyce Schrock of Winter Park, Fla., whose 11-year-old son, Logan, is using Iplex, was more angry. “We just feel like it’s an answered prayer, and now we think the door’s being slammed in our face again,” Ms. Schrock said.
Dr. Paul Desrosiers, who treats both Salem and Logan and is medical director for pediatric endocrinology at Arnold Palmer Children’s Hospital in Orlando, said if Iplex were not available he would put patients on Increlex. While they would complain about the extra injection, he said, “Would it kill them? No.”
Dr. Desrosiers, who has been an adviser to Tercica but favors Insmed’s drug, said he wished the dispute would go away. “I wish they wouldn’t eat each other, whoever wins,” he said.
« Previous Page1 2
Next Article in Business (9 of 21) »