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Briefing IPO report... Zoetis (ZTS) Fundamental Grade: B
Zoetis (ZTS), the world's largest animal health business and a spin-off from Pfizer (PFE), is set to price its 86.1 million share IPO next week in the $22-25 range. Based on the mid-point of that range, Zoetis is expected to have a market cap of around $11.8 billion and it should raise around $2 billion before fees.
The IPO will be entirely made up entirely of Class A shares. After the offering, Pfizer will hold zero Class A shares but will have 413.9 million Class B shares. Both classes of shares will have identical rights and voting power on all matters submitted to stockholder vote, other than the election of directors where B shares will have 10x the voting power. ZTS expects to pay a quarterly dividend of $0.065 per share which computes to an annual yield of approximately 1.1%. JP Morgan, BofA Merrill and Morgan Stanley are the lead underwriters.
What They Do
Zoetis, formerly known as Pfizer Animal Health, is a supplier of animal health medicines and vaccines for both livestock (66% of revenue) and companion animals (34%). Its products are sold in more than 120 countries across eight core species and five major product categories. To get a sense of how large Zoetis is, consider that its products account for about one-fourth of all animal health medicine approvals made by the FDA and one-fifth of all animal health vaccine approvals granted by the USDA.
Its sales breakdown by geography is as follows: US (41%), Europe/Africa/Middle East (25%), Canada/Latin America (18%), Asia/Pacific (16%). A big part of Zoetis’ growth strategy is to further penetrate emerging markets. Based on its diverse product portfolio and regional/local focus, ZTS believes it has further opportunities to expand in emerging markets by reaching new customers, by introducing more products and by supporting the adoption of more sophisticated medicines and vaccines. Furthermore, Zoetis believes that the consolidation of livestock producers in certain emerging markets will drive adoption of Zoetis’ products.
Animal health industry
Livestock health and production are essential to meeting the growing demand for animal protein of a global population that is increasing its standard of living, particularly in many emerging markets. Also, livestock health is critical to assuring a safe food supply by reducing the outbreak of infectious diseases. The cost to livestock producers of medicines and vaccines is small relative to other costs such as feed. And these products help protect producers' investments by treating and preventing diseases in herds and flocks before they become widespread, thus improving economic outcomes for producers. As a result, demand for animal health products has typically been more stable than demand for other production inputs. As for the companion animal market, growth is being driven by increases in disposable income, higher rates of pet ownership, companion animals living longer etc.
There are significant differences between the animal health medicines and vaccines and human health businesses. For example, R&D is faster, less expensive and more predictable. R&D for animal health generally requires fewer clinical studies, fewer test subjects and is conducted directly in the target species. As a result, decisions on efficacy and safety can be made more quickly. Another difference is that generic competition in the animal health industry is less than in human health. The reasons for this include the smaller average market size of each product, the importance of direct distribution and the primarily self-pay nature of the business.
Financials
Taking a quick look at the financials, the company is profitable with strong margins. For the nine months ended September 30, revenue came in at $3.16 billion, which was up about 2% YoY. While the top line growth is pretty modest, Zoetis posted pre-tax margin of 21.9% when you back out restructuring charges, which is quite strong. Probably the main negative is the balance sheet. On a pro forma basis, Zoetis will have long term debt of $3.64 billion vs. shareholders equity of just $1.1 billion for a LT-debt-to-cap of 77% which is quite levered.
Conclusion and Briefing.com Grade: B
In sum, there are a number of positives with this IPO. Zoetis is the largest player in the animal health space, they are geographically diverse with a strong position in emerging markets and they have very strong margins. On the flip side, they have a lot of debt and the top line growth is pretty modest. Also, this is a huge company with a large offering size so we’d be surprised to see it pop one way or the other.
Read more: http://www.briefing.com/DisplayArticle/Article.aspx?ArticleId=NS20130123083724TheNextBigThing#ixzz2Jexv62Ih
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KaloBios prices upsized deal at $8, at low end of the range
1/31/13
KaloBios Pharmaceuticals, which is developing monoclonal antibodies to treat respiratory diseases and cancer, raised $70 million by offering 8.8 million shares (500,000 more than expected) at $8, the low end of the revised range of $8 to $9. The company will command a market value of $191 million and an enterprise value of $103 million. KaloBios Pharmaceuticals will begin trading on Thursday on the NASDAQ under the symbol KBIO. Leerink Swann was the sole bookrunner on the deal.
ANTH - does this rationale warrant a $40M raise?...
Anthera’s Lupus Drug Gets A Second Chance After Clinical Trial Disaster
11.09.2012 · by Brian L. Wilson
Shareholders of Anthera Pharmaceuticals (NADSAQ: ANTH) have been in for a volatile November.
After very gradual downward movement throughout the month of October, we saw shares jump over 20% throughout November 1st and 2nd. This bullish move was attributed to press release on November 1st that announced a clinical trial data presentation of the finished PEARL-SC study that was scheduled for the 2012 annual meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (or ACR/ARHP) – scheduled for November 10-14th. The organized phase IIb results, which were already publicly available months ago, will still be able to garner some extra (and much needed) attention for Anthera’s blisibimod in the treatment of systemic lupus erythematosus.
Considering that Anthera only has one clinical program (the blisbimod program for lupus), it’s clear that any news on this lone drug will be a big mover of the stock. This was made very apparent on June 27th, when we saw a monstrous 70% drop from $2.75/share to about $.81/share after the initial release of the PEARL-SC phase IIb clinical trial data.
Although blisibimod did show some favorable results, the primary endpoint that was based on the “SLE responder index” for the pooled blisbimod dosage groups was not met. Although the safety data that was collected implied that blisbimod is very well tolerated, with no major imbalances in the patients’ serological (serum) measurements, the market is quick to label any clinical trial that fails to meet its primary efficacy endpoint as a disaster. Anthera was basically left for dead and dismissed due to the headline announcements.
Although there’s no doubt that the PEARL-SC trial was technically a failure due to the statistically measurements that we use to gauge clinical trial data, it’s apparent that healthcare regulators did see some potential in blisbimod. I’ll now explain why all is not lost for Anthera’s lupus drug, despite what the market seems to think.
As confirmed in the press release that initially unveiled the data for PEARL-SC, the EMA (European Medicines Agency) gave Anthera confirmation that the drug could move into phase III clinical trials based on designs that were submitted to bring blisbimod towards a MAA (Marketing Authorization Application.) Months later, specifically in this September 17th press release, we saw that the FDA decided to extent Anthera the same courtesy, which will allow Anthera to proceed in the United States as well. Belisbimod, initially left for dead by the market, is basically getting a second chance.
Anthera can use the results from the PEARL-SC study to refine their phase III trial for blisbimod too, which improves the chances for its success later on. According to company statements, the company now knows more about selecting an appropriately large patient population and on selecting a good endpoint that can prove the drug’s efficacy. PEARL-SC had a total of 547 patients with SLE, and were randomized into three blisbimod dosage arms and a placebo arm. Improvement was measured using SELENA-SLEDAI, which is a universal scale that is used to measure the existence (or lack of) lupus symptoms.
What was especially interesting were the results for patients that were part of the SRI-8 category. The SRI categories were made to further organize patients – specifically by the improvement in there SELENA-SLEDAI scores. Patients that were in SRI-5 (those who didn’t do as well) underperformed SRI-8 (the best performers) by a very significant margin. According to the company’s own analysis, this means that those who respond to blisbimod’s mechanism see especially positive results.
“ In fact, the SRI-8 data, representing an improvement in SELENA-SLEDAI of eight points or greater achieves statistical significance at multiple time points including at 24 weeks. Due to the consistently better effects at higher thresholds, it appears that if a blisibimod patient responds, they respond very well” said Dr. Colin Hislop – Anthera’s Senior Vice President and Chief Medical Officer.
After we got more results on the PEARL-SC trial, it became a bit more obvious that the trial’s failure was also due to some misunderstanding of how blisbimod affects lupus patients. Blisbimod works specifically through the BAFF (B-cell Activating Factor) pathway, which is associated with a variety of autoimmune diseases including lupus. The causes of Systemic Lupus Erythematosus (or SLE) isn’t fully understood, but it seems that the patients that are majorly affected by BAFF can see major benefit by taking blisbimod.
It seems that the market still hasn’t forgive blisbimod for the PEARL-SC results, although it can be argued that the results were ultimately successful for Anthera’s long-term strategy. Not only did the phase IIb results allow the drug to continue onto phase III development in both the EU and the United States, but it provided some valuable data on the efficacy of the drug that will help the company prove its efficacy with “statistically correct measurements” later on. If you believe that Anthera was fairly valued prior to June 28th, the company is a deep value play that will require a bit of patience.
http://www.bio-wire.com/archives/287
Anthera Pharmaceuticals Announces Completion of Public Offering of Common Stock
Press Release: Anthera Pharmaceuticals, Inc. – 3 hours ago
HAYWARD, Calif., Jan. 30, 2013 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (ANTH) today announced that it has completed the previously announced underwritten public offering of 60,606,061 shares of its common stock, offered at a price of $0.66 per share. In addition, Anthera has granted the underwriters a 30-day option to purchase up to an additional 9,090,909 shares. The gross proceeds to the Company from the sale of shares in this offering, before deducting customary underwriting discounts and commissions, were $40.0 million. Anthera intends to use the net proceeds from this offering for general corporate purposes.
Jefferies & Company, Inc. is acting as sole book-running manager in the offering and Leerink Swann LLC is acting as co-manager. Trout Capital LLC has acted as an advisor to the Company.
The securities described above were offered by the Company pursuant to a shelf registration statement previously filed with, and declared effective by, the Securities and Exchange Commission (the "SEC"). A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC's website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Jefferies & Company, Inc., Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, or by telephone at 877-547-6340, or by email at Prospectus_Department@Jefferies.com.
MDGN starts HCV trial using an implantable Biopump for sustained production and delivery of INFa from patient's own dermal tissue...
Phase I/II Study in Hepatitis C Expected to Provide Gateway to Hepatitis B and D
MISGAV, Israel & SAN FRANCISCO --(BUSINESS WIRE)-- Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the "Company"), the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announced today that the first patient has been enrolled in a Phase I/II clinical trial with the Company's INFRADURE(TM) Biopump(TM) for the treatment of hepatitis C. This is the first clinical trial of INFRADURE, a subcutaneous autologous skin tissue implant for the continuous production and delivery of interferon-alpha (INFa) being developed by Medgenics to treat hepatitis B, C and D, aimed at replacing months of weekly injections of INFa, along with their serious side effects.
The Phase I/II dose-escalation study is being initiated at the Tel Aviv Sourasky Medical Center in Israel , with additional sites in Israel expected to join the study. The study is enrolling patients with hepatitis C of genotypes 2 and 3, who would normally receive weekly injections of pegylated INFa together with a daily dose of the oral antiviral drug ribavirin These patients will receive a single implantation of INFRADURE Biopumps in place of the weekly injections, together with daily ribavirin. The study is designed to show safety and tolerability of INFRADURE through the continuous delivery of INFa into the patient's circulation and to determine effective dose levels that suppress serum levels of hepatitis C virus. Medgenics believes that the results of this study will assist in developing and calibrating INFRADURE for use in additional types of viral hepatitis, as well as other indications.
INFRADURE is aimed at replacing injections of INFa to address a global market of over 500 million patients suffering from various forms of hepatitis. This proof of concept study will test INFRADURE's approach of continuous production of INFa from the patient's own dermal tissue. The INFRADURE treatment will be similar whether used in hepatitis C, hepatitis B, the most widespread form of hepatitis, or hepatitis D, a rare and highly aggressive form of the viral disease.
The current standard of care for treating hepatitis C involves weekly injections of pegylated INFa plus daily ribavirin. These weekly injections can be associated with high concentrations or spikes of INFa in patients, as well as significant side effects. These side effects pose considerable problems with patient compliance, as reflected in a therapy discontinuation rate of over 25%. INFa injections are also the primary treatment for hepatitis D and are often used in hepatitis B, where they pose similar problems. INFRADURE aims to address compliance and tolerability by providing sustained levels of INFa within the effective range for a sustained period from a single treatment, while avoiding high concentrations that are seen immediately following injections.
INFRADURE is the second product based on the Company's Biopump tissue-based platform to reach clinical trials in patients. INFRADURE employs the same approach as the Company's EPODURE(TM) implant producing erythropoietin, which reported months of safe and sustained treatment of anemia from a single treatment in a Phase I/II study in patients with chronic kidney disease, replacing frequent erythropoietin injections.
About Hepatitis
Hepatitis is an inflammation of the liver and refers to a group of viral infections that affect that organ. The most common types are hepatitis A, hepatitis B and hepatitis C. Viral hepatitis is the leading cause of liver cancer and the most common reason for liver transplantation. Hepatitis B affects more than 350 million people worldwide and approximately 1.3 million in the U.S. Hepatitis D, an aggressive form of hepatitis, affects approximately 15-20 million people worldwide, and is estimated to afflict tens of thousands in the U.S. Hepatitis C affects an estimated 180 million people worldwide and over 3 million in the U.S.
About Medgenics
Medgenics is developing and commercializing Biopump(TM), a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own tissue for the treatment of a range of chronic diseases including anemia, hepatitis and hemophilia, among others. For more information, visit the Company's website at www.medgenics.com.
AbbVie CEO Says Humira Will Blunt $1B Hit To Lipid Franchise
Comment Now Follow Comments
The former proprietary drug business of Abbott Laboratories (ABT), now split off into AbbVie (ABBV), expects to continue to benefit from the robust growth of its Humira biologic for myriad autoimmune diseases.
For better or worse, the sure bet for AbbVie remains Humira with the company’s lipid franchise, which includes the cholesterol treatments Niaspan and Tricor, losing market share with generics entering the market. AbbVie said such treatments for the prevention of heart disease will lose more than $1.2 billion in sales this year.
But AbbVie’s management team said its new company is still off to a good start thanks to Humira, which is used as a treatment for everything from rheumatoid arthritis and psoriasis to Crohn’s disease. Humira sales jumped 23 percent to $2.7 billion in the fourth quarter.
“Humira will continue to drive cash flow growth for many years to come,” AbbVie chairman and chief executive officer Rick Gonzalez told Wall Street analysts and investors this morning on an hour-long conference call – the company’s first with analysts and investors following its split off from Abbott. “There’s not a better asset in the pharmaceutical industry than Humira.”
For the first time, AbbVie issued full-year 2013 adjusted earnings-per-share guidance of $3.03 to $3.13, which was in line with analysts’ estimates of $3.08.
Many Wall Street analysts and investors worry about Humira with one observer on this morning’s call calling the drug both a “blessing and a curse.” Humira, which faces its first patent expirations in 2016, accounts for half of AbbVie’s revenue and 70 percent of company profits.
Meanwhile, Humira is already in a competitive market against similar biologics made by Amgen (AMGN) and Johnson & Johnson (JNJ) as well as the new rheumatoid arthritis drug Xeljanz, which is sold by Pfizer (PFE).
Gonzalez said Humira is still unknown in many parts of the word and will benefit from “further geographic penetration” with the company forecasting low double-digit percentage growth this year. Humira is also poised to launch several new indications, including four in late-stage development such as pediatric Crohn’s disease.
Stemline Therapeutics Is First Biotech IPO of 2013
By Peter Winter
BioWorld Insight Editor
Despite the positive reception that the Street afforded Intercept Pharmaceuticals Inc. and Kythera Biopharmaceuticals Inc., which each priced their initial public offerings (IPOs) at the top end of their ranges on the same day back in October, the bullish response to those two biotech offerings was not, it turned out to be, a harbinger for others to quickly follow suit.
After a gap of three months, New York-based Stemline Therapeutics Inc. became the first biotech IPO to launch in the new year. The company priced its IPO of 3.3 million shares of common stock at $10 per share, at the low end of its range of $10 to $12. It did, however increase the number of shares on offer by 1 million – a significant jump from the revised terms set for its offering. (See BioWorld Today, Jan. 11, 2013.)
Stemline granted the underwriters a 45-day option to purchase up to 497,647 additional shares of common stock to cover overallotments, if any.
Stemline, which will trade on Nasdaq under the symbol "STML," also became the second company to price an IPO that is focusing on therapies that target cancer stem cells, which typically comprise about 1 percent to 5 percent of a tumor but give rise to 95 percent or more of tumor cells known as the "tumor bulk."
Exactly one year ago, Verastem Inc., of Cambridge, Mass., priced a $55 million IPO, selling 5.5 million shares of its common stock at $10 per share. (See BioWorld Today, Jan. 30, 2012.)
Verastem is developing small-molecule inhibitors of signaling pathways that are critical to cancer stem cell survival and proliferation, including focal adhesion kinase (FAK), PI3K/mTOR and Wnt.
The company also recently in-licensed exclusive worldwide rights from Pfizer Inc. to VS-6063, an FAK inhibitor that has completed a Phase I study in advanced solid tumors. VS-6063 is expected to enter a Phase II mesothelioma study in mid-2013.
Among Stemline's lead drug candidates are SL-401, a biologic drug conjugate that targets the interleukin-3 receptor, and SL-701 , a synthetic peptide vaccine initially targeting pediatric and adult brain cancer, both of which, the company reported, have demonstrated single-agent clinical activity in Phase I/II studies in advanced cancer patients.
In December, Stemline released data from two studies of SL-401 in acute myeloid leukemia (AML) and other hematologic malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), and preclinical activity against Hodgkin's lymphoma. Updated clinical trial results for SL-401 suggested the therapy was well tolerated at clinically active doses and showed single-agent antitumor activity in heavily pretreated patients with AML as well as in patients with high-risk myelodysplastic syndrome and relapsed/refractory BPDCN. A single cycle of SL-401 demonstrated single-agent activity in patients with relapsed or refractory AML, including two durable complete responses of eight months and greater than 25 months duration, respectively, and multiple additional cases of leukemia blast reductions. (See BioWorld Today, Dec. 10, 2012.)
SL-401 is being advanced into a pivotal Phase IIb trial in patients with BPDCN and a registration-directed Phase IIb study in patients with advanced AML.
Stemline's second clinical-stage therapeutic, SL-701, has demonstrated single-agent activity, including durable complete responses and partial responses in adult patients with refractory or recurrent glioblastoma and pediatric patients with malignant glioma, as well as an overall survival benefit in adult patients with refractory or recurrent glioblastoma compared with historical data.
Stemline got off to a flying start on its first day of trading closing at $11.80, up an impressive 18 percent, or $1.80.
AbbVie (ABBV)'s Reliance on Humira: a Long-Term Problem?
1/29/2013 8:23:09 AM
Recently, Abbott Laboratories broke itself up into two parts: Abbott, a diversified medical products company and AbbVie, a research based pharmaceutical company. The jewel of the new pharma company is Humira, an antibody that blocks a mediator known as TNF-alpha and is an important treatment for rheumatoid arthritis (RA) as well as other immunological disorders. It is also now the world’s top selling drug with 2012 sales estimated to be in excess of $9 billion.But Humira is not just a small jewel for AbbVie – it’s the Hope diamond. This was spelled out in a FirstWord Pharma article entitled: “Spotlight on: On the back of 4Q results, AbbVie and Novartis demonstrate contrasting routes towards growth. In a stunning graph, it projected that in 2016, 60% of AbbVie’s revenues will be coming solely from Humira sales. This is in contrast to the rest of the industry, where it is rare that a company generates as much as 20% of its sales from one product. Theoretically, this should be a cause for alarm. Based on Abbott’s “Information Statement” filed with the Securities and Exchange Commission, the US composition of matter patent for Humira is expected to expire in December 2016 and in the majority of Europe by April 2018. Ordinarily, this is a major problem as sales drop precipitously once a product has generic competition. However, Humira is a biological product and generic versions of biologics like antibodies have been slow to market due to difficulties in manufacturing exact copies of the drug. (This contrasts with the situation with traditional small molecule drugs where chemical synthetic processes are straightforward in manufacturing.) However, this situation is changing. The Biologics Price Competition and Innovation Act, passed on 3/23/10 as part of the Affordable Care Act, creates a framework for the approval of generic versions of biologics (called “biosimilars”). A similar framework already exists in Europe. Furthermore, there are novel new RA drugs being approved, such as Pfizer’s Xaljenz, that will be competitors to Humira. Given this scenario, it is hard to imagine that by 2017, Humira will be a source of revenue growth for AbbVie. In fact, it is entirely possible that sales will be eroding significantly.
http://www.biospace.com/news_story.aspx?StoryID=285962&full=1
4 out of 20 were abnormal... Pinpoint identified the problems and they were resolved.
Researchers from Maimonides Medical Center Report on Findings in Gastroenterology
GastroenterologyNewsRx.com
By a News Reporter-Staff News Editor at Gastroenterology Week -- New research on Gastroenterology is the subject of a report. According to news originating from Brooklyn, New York, by NewsRx correspondents, research stated, "Aim Anastomotic dehiscence is a devastating complication. Inadequate blood supply is felt to be the prevailing cause."
Our news journalists obtained a quote from the research from Maimonides Medical Center, "This study describes the use of near infrared imaging to evaluate transanally anastomotic tissue perfusion following low anterior resection.Twenty patients undergoing low anterior resection for benign and malignant disease were studied. After completing the anastomosis, indocyanine green (ICG) was injected via a peripheral intravenous catheter. An endoscopic near infrared imaging system (Pinpoint, Novadaq, Canada) was then used transanally to visualize mucosal perfusion of the colon, rectum and the anastomotic staple line. All patients underwent a technically successful ICG angiogram. The angiogram was abnormal in four patients. Two of these had a protective loop ileostomy and showed no sign of anastomotic breakdown. The other two patients were found on CT scan to have a peri-anastomotic collection consistent with anastomotic leakage. Both were managed conservatively with resolution. This study confirms that transanal ICG angiography is feasible and provides imaging of mucosal and anastomotic blood flow."
According to the news editors, the research concluded: "The technique warrants further study in a larger group of patients to assess its ability to identify defects in tissue perfusion that may lead to anastomotic breakdown."
For more information on this research see: Intra-operative transanal near infrared imaging of colorectal anastomotic perfusion: a feasibility study. Colorectal Disease, 2013;15(1):91-6. (Wiley-Blackwell - www.wiley.com/; Colorectal Disease - onlinelibrary.wiley.com/journal/10.1111/(ISSN)1463-1318)
The news correspondents report that additional information may be obtained from D.A. Sherwinter, Maimonides Medical Center, Division of Minimally Invasive Surgery, Brooklyn, New York, United States (see also Gastroenterology).
http://www.equities.com/news/headline-story?dt=2013-01-16&val=933057&cat=hcare
I am a former investor in NAVB... I am not short. However if you have a position in NAVB you should be aware there is another company not mentioned on this board that uses the fluorescent dye ICG (indocyanine green) and a near infrared laser to identify SLN's...
Dr. Rossi is testing a novel technique for sentinel node mapping in a study comparing the detection of metastatic disease to routine lymphadenectomy, a more invasive surgical procedure in which the lymph nodes are removed and a sample of tissue is checked under a microscope for signs of cancer.
The fluorescing dye indocyanine green, or ICG, is injected into study participants in the cervix or endometrium before their cancer staging surgery. Dr. Rossi then uses an endoscope -- a thin, tube-like instrument used to look at tissues inside the body -- and a robotic camera that is capable of detecting the dye. The dye clearly identifies the nodes that receive drainage of cancer cells from the tumor.
“By using this technique, we only have to remove the sentinel nodes. Therefore, there is less cutting and potentially fewer complications,” said Dr. Rossi, who is the principal investigator for the IU study. “And we hope this technique will lead to an increased detection of cancer and save lives.”
http://www.healthcanal.com/cancers/35608-physician-researcher-testing-novel-surgical-technique-for-uterine-cervical-cancer-patients.html
The company is Novadaq (NVDQ)...they are also working on fluorescent imaging agents to identify tumor margins and nerves. They have a partnership with Intuitive Surgical (since 2011) and their FireFly device was installed on more than half of DaVinci's shipped last Q.
From ISRG's 3Q CC...
“Before the start of a surgery, imagine a patient being painlessly injected with multiple imaging molecules, each of which will go to its own sweet spot, to light up nerves in one color, perfusion of blood vessels in another color and cancer cells in yet a third color,” he adds.
“This would serve as a physiologically and anatomically enriched roadmap for a surgeon, who could then provide specific treatments for all of the disease processes afflicting a patient with the added confidence of image guidance. It would be like a GPS system inside a patient, telling a surgeon where to go and where not to go. This would be a game changer for surgery.”
NVDQ has partnerships with KCI/Lifecell and Maquet as well...
http://biotuesdays.com/2012/10/16/novadaq-highlights-game-changer-for-the-or/
KaloBios plans early test of 2013 market for biotech IPOs
January 28, 2013 | By John Carroll
Last year ended on a modestly upbeat note for biotech investors after a string of fairly successful IPOs in the life sciences industry allowed some venture groups to manage an exit after several years of lean pickings on the stock market. Now the industry will be paying keen attention to the first round of biotech IPOs in 2013 to see if the market window is finally opening up to money-losing drug developers. And investors' appetite will be tested early on by a classic developer with plenty of risk and losses to offer.
KaloBios has priced its long-anticipated IPO at $12 to $14 a share, looking to reap up to $62 million on the high end. That's not a huge amount by IPO standards, but KaloBios is still in Phase II with its lead assets--"new and improved" antibodies for respiratory disease and cancer. KaloBios CEO David Pritchard has been evangelizing the biotech's work on antibodies for several years, boasting that its better engineered brands that bind to targets better make a natural second-gen approach to the field.
"We believe that antibodies produced with our Humaneered technology offer important clinical and economic advantages over antibodies generated by other methods, including enhanced binding activity to target epitopes and minimal immunogenicity (undesired immune response), making our antibodies potentially more suitable for chronic treatment," says KaloBios in its S1 filing with the SEC. The San Francisco Business Times reported on the IPO late last week.
Whether KaloBios can make a good enough case to sell 3.8 million shares in its range, avoiding the hair cut that became standard after the market crisis of 2008, is yet to be seen. A success here, though, would likely inspire more such IPOs. And there are a number of drug developers who would love to do it.
MPM, Sofinnova Ventures of Menlo Park, CA, and Alloy Ventures are KaloBios' top three shareholders. The company was picked as a Fierce 15 company back in 2009 and is partnered with Sanofi.
S1
http://www.fiercebiotech.com/story/kalobios-plans-early-test-2013-market-biotech-ipos/2013-01-28
Anything For A Buck: Jim Letourneau Looks To Canadian Biotech for Opportunity
January 18th, 2013 by The Life Sciences Report
Submitted by The Life Sciences Report as part of our contributors program.
This interview was conducted by Daniel Levy of The Life Sciences Report (1/17/13)
To avoid some of the “dysfunctional excess” of the energy and mining sectors, Jim Letourneau, self-described contrarian and founder and editor of the Big Picture Speculator, turns to investing in biotech. His focus is on Canadian companies, which he believes perform on a par with companies in the United States. In this interview with The Life Sciences Report, Letourneau describes what he looks for in a biotech investment and names some of his favorite companies.
TLSR: Let’s move on to another company.
JL: Resverlogix Corp. (RVX:TSX) is developing RVX-208 as a first-in-class small molecule inhibitor of BET bromodomains for the clinical reversal of atherosclerosis. This company has had a long ride. In early 2007 the share price was almost $30. A few years later, when I learned about this stock, I found it trading in the $2?3 per share range. I saw Resverlogix as a great opportunity. Nothing had gone wrong with its science?what had gone wrong was the expectation that it would be an acquisition target. When that did not happen, the company needed to raise money, and investors lost patience. Since I started following this stock, I’ve seen the share price bounce from $3 to $7.50, and back down.
Currently, RVX-208 is being evaluated in phase 2 clinical trials. The therapy acts by stimulating gene transcription of ApoA-1 via an epigenetic mechanism. ApoA-1 has been documented to trigger atherosclerotic plaque regression by increasing functional high-density lipoproteins. The clinical trials are monitored using ultrasound to measure changes in arterial diameter and arterial wall thickness. That’s the main story that got me interested in this company. The exciting thing is that these BET inhibitors are relevant to cancer and diabetes, in addition to cardiovascular disease. This is a hot field.
TLSR: It is also very new. Control over the machinery behind cancer and other diseases has been very difficult to tackle. It seems much easier to go after specific cancer-related enzymes.
JL: Yes, it is new. You know you have something really interesting when you have positive data and not too many comparables. Resverlogix is busily patenting its science to build an intellectual property fence around the proteins it has been working on.
TLSR: One of the things that I find very frustrating in biotech is that if a number of companies are working on similar targets and they all fail, the one company that has a chance to succeed will never get funded.
JL: That is true. Resverlogix is suffering a bit from that. The big failure of Pfizer’s torcetrapib in 2006, after an outlay of ~$800 million ($800M), created a “nuclear winter” for cholesterol drugs. It’s the herd approach. Money tends to move away from research in certain areas at the worst possible times. In practice, the best time to find out what might have a chance of working is after some failures have demonstrated what doesn’t work.
http://www.trefis.com/stock/ymi/articles/163878/anything-for-a-buck-jim-letourneau-looks-to-canadian-biotech-for-opportunity/2013-01-18
Biotech Showcase 2013 presentation...
http://www.media-server.com/m/p/u8377oqj
I've been holding for a few months... just noticed the big pop today. No news that I could find..anything up?
Threshold Pharma: Digging into supporting data of study 404; Th-302 hopeful in other cancers- Maxim Group (4.90 -0.24)
Maxim Group notes that they believe the 1.8-month survival benefit reported by Abraxane's phase III trial may have benefited THLD's stock. However, the positive data may not correlate with TH-302's possibility of improving overall survival in pancreatic cancer. Instead, the value of TH-302, in their view, is supported by its own data. Their checks show that THLD is sponsoring TH-302 in three phase I trials. They believe preliminary efficacy and toxicity data from these indications may provide additional support to the stock.
Read more: http://www.briefing.com/InPlayEq/InPlay/InPlayDual.htm#ixzz2IuSugNq5
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Firefly mentions from ISRG conf call...
In imaging, we submitted a 510(k) application to expand indications for our Firefly Fluorescence imaging system to use in biliary imaging. We believe this will have application for use in imaging in the common bile duct during Cholecystectomy, and we’ll complement the use of Single-Site.
The year-over-year increase in I&A was driven by procedure growth of approximately 25%, sales of new instrument and accessory products, including Single-Site, Vessel Sealer and Firefly and higher stocking orders associated with higher system unit sales.
Instrument and accessory revenue realized per procedure including initial stocking orders was approximately $2,050 per procedure, which is higher than the $1,980 realized in the fourth quarter of 2011, and the third quarter of 2012. The sequential year-over-year increases were driven by higher new product sales, including Vessel Sealers, Single-Site kit, and Firefly kits.
ASPs include all da Vinci models, all simulators, and Firefly when configure with the systems and exclude upgrades. Fourth quarter ASP's benefited from the favorable mix of dual console systems, Firefly enabled systems, and direct sales to Europe. ASPs will fluctuate quarter-to-quarter based on product, customer, and trade-in mix as well as foreign exchange rates on direct sales to international customers.
We sold 150 simulators during the quarter, mostly in conjunction with new system sales compared with 123 last year and 87 last quarter. We sold 32 dual console systems compared with 29 last year and 20 last quarter. 52 of our fourth quarter 2012 system sales involve trade-in comprised of 40 da Vinci S and 12 standard models. 50 of our fourth quarter 2011 sales all trade-in, and 34 of our third 2012 sales all trade-in.
Our recently launched Vessel Sealer product continues to pick up clinical momentum with most of the interest coming from colorectal, advanced general and GYN clinicians. The customer adoption for both da Vinci Simulator and Firefly continues to expand, with 115 customers purchasing a da Vinci Simulator and 88 customers purchasing Firefly systems, as part of their da Vinci purchase this quarter.
Lawrence S. Keusch – Raymond James Financial
Got it and then just two other quick ones, just relative to the 510 clearance that you guys are anticipating for Firefly in biliary, could you talk about how important that is to proceed the option of Single-Site Chole. It seems to me that obviously we can reduce kind of bile duct injuries that would be a positive with that technology. And then separately, I think last quarter you provided some feel for kind of in the U.S. what procedures grew if you were to adjust for the declines in prostatectomy. I was wondering if you can help us with that in the fourth quarter.
Gary S. Guthart
Just speaking to the first one, the 510(k) submission for Firefly biliary imaging that has just been submitted this quarter, so in terms of when we expect clearance, no end point to tell you about yet. We do think that biliary imaging in real time is interesting and meaningful for Cholecystectomy for the reason that you indicated that a common bile duct injury is a serious complication, and we think that Firefly can augment the white light imaging and be a complement to cholangiography, so that’s the intend. We‘ve just started that conversation with FDA and as it proceeds in we have something more material to share we will. With regard to the break outs on kind of the adjustments and the procedure mix, I’ll turn to Aleks.
Rick A. Wise – Stifel, Nicolaus & Co., Inc.
Okay. Japan, just again, I think you said a significant demand, with the da Vinci Si approval on hand, is this going to be an incremental driver or we’re going to see more upgrades maybe in 2013, getting help or bring that for us? Thank you.
Gary S. Guthart
I think there are really two things to say with regard to Si approval in Japan. The first one is we’re excited about the approval in large part, because it allows us to bring the Japan with follow-on clearances, a set of technologies that we think have really made a down set in the rest of the world and things like Single-Site and Firefly and thus assuming to counsel and simulate or a bunch of things that we invest on the SI system side. So we’re excited about that. I think structurally though in the longer term, the Japanese market penetration will be based by additional procedure reimbursement and so near-term it’s a great thing to get in the hands of Japanese customer. We need to continue to work on reimbursements beyond Prostatectomy and we will continue to do so.
Toronto, Ontario — January 24, 2013 – Novadaq® Technologies Inc. (“Novadaq” or the “Company”) (NASDAQ: NVDQ, TSX: NDQ,), a developer of clinically-relevant fluorescence imaging solutions for use in surgical procedures, will announce its fourth quarter and full year 2012 financial results before the market opening on Thursday, February 7, 2013.
Novadaq is pleased to invite all interested parties to participate in a conference call, on February 7 at 8:30 a.m. Eastern Time, during which the results will be discussed.
Those wishing to access the live conference call by telephone should dial 1-877-407-8031 (within Canada and the United States) or 1-201-689-8031 (international callers) several minutes prior to the beginning of the call.
A telephonic replay of the conference call will be made available until midnight on March 7, 2013 and can be accessed by dialing 1-877-660-6853 (within Canada and the United States) or 1-201-612-7415 (international callers) and entering the conference identification number 408022 when prompted. The call will also be archived for 90 days on the Company’s website at http://www.novadaq.com under the “Events” tab in the Investors section, and a replay of the call will be available for download to a portable audio player or computer, as an MP3 or podcast file, at the same location on Novadaq’s website.
The Future of Antibiotics and Resistance
Brad Spellberg, M.D., John G. Bartlett, M.D., and David N. Gilbert, M.D.
N Engl J Med 2013; 368:299-302January 24, 2013DOI:
In its recent annual report on global risks, the World Economic Forum (WEF) concluded that “arguably the greatest risk . . . to human health comes in the form of antibiotic-resistant bacteria. We live in a bacterial world where we will never be able to stay ahead of the mutation curve. A test of our resilience is how far behind the curve we allow ourselves to fall.”1
Traditional practices in infection control, antibiotic stewardship, and new antibiotic development are cornerstones of society's approach to combating resistance and must be continued. But the WEF report underscores the facts that antibiotic resistance and the collapse of the antibiotic research-and-development pipeline continue to worsen despite our ongoing efforts on all these fronts. If we're to develop countermeasures that have lasting effects, new ideas that complement traditional approaches will be needed.
New ideas are often based on the recognition of old truths. Prokaryotes (bacteria) “invented” antibiotics billions of years ago, and resistance is primarily the result of bacterial adaptation to eons of antibiotic exposure. What are the fundamental implications of this reality? First, in addition to antibiotics' curative power, their use naturally selects for preexisting resistant populations of bacteria in nature. Second, it is not just “inappropriate” antibiotic use that selects for resistance. Rather, the speed with which resistance spreads is driven by microbial exposure to all antibiotics, whether appropriately prescribed or not. Thus, even if all inappropriate antibiotic use were eliminated, antibiotic-resistant infections would still occur (albeit at lower frequency).
Third, after billions of years of evolution, microbes have most likely invented antibiotics against every biochemical target that can be attacked — and, of necessity, developed resistance mechanisms to protect all those biochemical targets. Indeed, widespread antibiotic resistance was recently discovered among bacteria found in underground caves that had been geologically isolated from the surface of the planet for 4 million years.2 Remarkably, resistance was found even to synthetic antibiotics that did not exist on earth until the 20th century. These results underscore a critical reality: antibiotic resistance already exists, widely disseminated in nature, to drugs we have not yet invented.
Thus, from the microbial perspective, all antibiotic targets are “old” targets. Yet since the early 1930s, when Gerhard Domagk and colleagues discovered that chemical red dyes (the sulfonamides) can kill bacteria, the singular arc of antibiotic research and development has been to discover “new” targets to attack in order to kill the microbes. This strategy has saved countless lives. Ironically, it has also driven the resistance that threatens the very miracle of antibiotics. Ultimately, over centuries or millennia of selective pressure, we will run out of targets, and resistance mechanisms will become so prevalent as to preclude effective clinical deployment of antibiotics.
Promising future strategies to combat resistance can be divided into five categories, each of which requires additional societal investment in basic and applied research and policy activities (see table
New Interventions to Address the Antibiotic-Resistance Crisis.
). These interventions aim to prevent infections from occurring in the first place, to encourage new economic models that spur investment in anti-infective treatments, to slow the spread of resistance in order to prolong the useful lives of antibiotics, to discover new ways to directly attack microbes in a manner that does not drive resistance, or to alter host–microbe interactions in order to modify disease without directly attacking microbes.
Infection prevention eliminates the need to use antibiotics. Traditional infection-prevention efforts must be buttressed by new technologies that can more effectively disinfect environmental surfaces, people, and food. We also need technology that enables intensive health care without requiring the implantation of foreign materials such as plastic or metal (e.g., improved drug delivery by means of the gut, skin, or respiratory mucosa to replace intravenous therapy and regenerative-tissue technology that obviates the need for prosthetic implants). Improvements in population health and health care delivery systems can reduce admissions to hospitals and skilled nursing facilities, thereby reducing infections. Finally, new vaccines hold great promise for preventing antibiotic-resistant infections.
Despite preventive efforts, though, infections will always occur, and we will always need safe and effective therapy for them. The collapse of the antibiotic research-and-development pipeline is the result of both economic and regulatory barriers. The solution is better alignment of economic and regulatory approaches to antibiotic development.3 For example, public–private partnerships could align the research-and-development focus of industry with unmet medical needs. Also, a new regulatory approach, such as the Limited Population Antibiotic Drug (LPAD) proposal from the Infectious Diseases Society of America, could allow drugs to be approved on the basis of small, relatively inexpensive clinical superiority trials focused on lethal infections caused by highly resistant pathogens.3 The antibiotic would receive a very narrow label, helping to protect against overuse. Thus, the LPAD would simultaneously empower antibiotic stewardship and provide economic incentives for investment by reducing the cost of clinical trials and creating the conditions for a pricing premium.
In a 1945 interview with the New York Times, Alexander Fleming called for stopping the overuse of penicillin in order to slow the development of resistance. Nearly 65 years later, in 2009, more than 3 million kg of antibiotics were administered to human patients in the United States alone; in 2010, a staggering 13 million kg were administered to animals. The majority of the animal antibiotic use was meant to promote the growth of livestock. We cannot confront resistance unless we stop exposing the environment to massive quantities of antibiotics and their resulting selective pressure. Promising but untapped strategies for slowing resistance include transparent, public reporting of data on antibiotic use across medical centers and individual providers to enable national benchmarking and reimbursement modification, development and use of rapid diagnostic and biomarker tests that empower providers to withhold antibiotics from patients who don't have bacterial infections and shorten antibiotic courses for those who do, elimination of antibiotic use for the promotion of growth in animals, bioengineering efforts to degrade antibiotics in sewage so as to avoid environmental contamination and selection for resistance, and conducting of studies to determine the shortest effective course of therapy for common infections.
A more innovative form of stewardship is the development of therapies that do not drive resistance. For example, the infusion of monoclonal antibodies (a modern advance on serum therapy, which is more than a century old) or white cells that attack microbes holds promise for treating infections. Finally, what if we were able to treat infections without seeking to kill the microbe? Casadevall and Pirofski's damage-response framework of microbial pathogenesis underscores the concept that clinical signs, symptoms, and outcomes of infection result as much, or more, from the host response to the microbe as from a direct effect of the microbe itself.4 Thus, we should be able to treat infections by attacking host targets rather than microbial targets. Indeed, recent preclinical research demonstrates that we can successfully deploy therapies that either moderate the inflammatory response to infection or that limit microbial growth by blocking access to host resources without attempting to kill microbes. For example, an antibiotic of a novel class (LpxC inhibitors), which blocks synthesis of gram-negative lipopolysaccharide, could not kill Acinetobacter baumannii but prevented the microbe from causing disease in vivo.5 Other examples include antiinflammatory monoclonal antibodies, probiotics to compete with microbial growth, and sequestration of host nutrients (e.g., iron) to create a resource-limited environment in which microbes cannot reproduce. Such strategies require clinical validation but have the potential to reduce resistance when pursued in concert with traditional antibiotic therapy.
The converging crises of increasing resistance and collapse of antibiotic research and development are the predictable results of policies and processes we have used to deal with infections for 75 years. If we want a long-term solution, the answer is not incremental tweaking of these policies and processes. Novel approaches, based on a reconceptualization of the nature of resistance, disease, and prevention, are needed.
http://www.nejm.org/doi/full/10.1056/NEJMp1215093?query=TOC
Black Silicon Can Lead To More Efficient Solar Cells, New Breakthrough Shows
January 22, 2013Nathan
A significant breakthrough has been made in the light absorption and surface passivation abilities of silicon nano-structures (such as black silicon) by researchers at Aalto University in Finland.
The improvements were made by the application of an atomic layer coating, which works to improve light absorption and to make it more resistant to impurities (improved surface passivation).
The researchers think that big improvements in solar cell efficiency will be possible because of this work, as it addresses two of the main problems with black silicon: poor surface passivation, and limited light absorption.
“This method provides extremely good surface passivation. Simultaneously, it reduces the reflectance further at all wavelengths. These results are very promising considering the use of black silicon (b-Si) surfaces on solar cells to increase the efficiency to completely new levels,” said Päivikki Repo, a researcher at Aalto University.
Black Silicon solar cells are an exciting technology, as they allow the absorption of infrared light in addition to the visible spectrum. Eventually, they should lead to ultra-high-efficiency solar cells, and they have been experiencing a lot of progress in that regard recently. Just back in October, a new efficiency record was set that was nearly double what the previous record was.
This research was recently published in the Journal of Photovoltaics.
Clean Technica (http://s.tt/1yMn5)
Read more at http://cleantechnica.com/2013/01/22/black-silicon-can-lead-to-more-efficient-solar-cells-new-breakthrough-shows/#w5Cm5fdujl87ZKVm.99
Roth ups TearLab price target to $7
January 22, 2013 by Jennifer Poland · Leave a Comment
Roth Capital Partners has raised its price target on “buy-rated” TearLab (NASDAQ:TEAR; TSX:TLB) to $7 from $5, saying market awareness of TearLab is on the rise and TearLab system placements are expected to be strong in 2013. The stock closed at $5.48 on Monday.
“Our valuation analysis now centers on our revenue projection for fiscal 2015 [of $46-million], when we anticipate TearLab will have broader private pay coverage,” writes analyst Matt Dolan.
TearLab has first-mover advantage with its point-of-care diagnostic platform for the diagnosis of dry eye disease using tear film Osmolarity.
With CMS reimbursement, CLIA-waiver, and inclusion in AAO’s Preferred Practice Patterns, “we believe the company’s sales pitch is becoming more straightforward, focusing on the technology’s strong clinical and economic argument as opposed to the logistical obstacles it faced in the past,” Mr. Dolan said. He figures the company will steadily increase its sales force this year with an ultimate target of 40 territories in 4 regions.
As new systems are installed, he expects revenue growth to materialize when sites begin integrating tear Osmolarity testing into practice protocols and re-order test cards.
“Our current utilization projections are conservative, considering we only reach 1,500 cards per system in 2015, which represents the low end of TearLab’s sales utilization program,” Mr. Dolan said. “Management has previously stated that most new customers are choosing the higher, 2,400 cards per year minimum contracts. In our view, this is a good guide, although some high volume practices may skew this average over time under the recently introduced Master’s program.”
A cure for cancer? This ‘big data’ startup says it can deliver
January 16, 2013 3:13 PM
Christina Farr
‘Big data’ is one of the most over-used buzzwords in the startup vernacular, and founders rarely have the goods to back it up. So you’ll understand that I was intrigued — but highly skeptical — when an email with the subject line “using data to cure cancer” popped into my inbox.
But Ayasdi, a startup that closed $10 million in venture funding today, doesn’t just talk the talk. Stanford researchers have been baking the complex algorithms behind Ayasdi (its quirky name means “to seek,” in Cherokee) for over a decade, with the goal of unlocking the hidden value in human genetic data.
In 2008, the founders, Gurjeet Singh, Dr. Gunnar Carlsson, and Harlan Sexton, decided to commercialize the technology. With the government stepping up its funding for science, they were able to pull in $3.5 million in grants from DARPA, the department of defense agency responsible for building new technology for the military, and the National Science Foundation. The result? A synthesis of machine learning technology and topological data analysis (TDA) that has impressed a score of Silicon Valley investors. Rather than typing in search-style queries, the tools allow for automated discovery of information.
As Dr. Carlsson explained in an interview, “The idea is to answer questions that you didn’t know to ask.”
This year, the 30-person team of engineers will expand its marketing and sales efforts with funding from Khosla Ventures, Floodgate, Data Collective’s Matt Ocko, serial entrepreneur, Steve Blank, and more. Storied investor Vinod Khosla, who rocked the medical world with the statement that 80 percent of doctors would be replaced by machines, said Ayasdi’s “machine powered intelligence” has the potential to unearth “previously unattainable insights that will help solve some of our most pressing global, social, and economic issues.”
Eric Schadt, Director of the Institute for Genomics and Multiscale Biology, has a team of researchers using the technology to identify the genetic predispositions of many diseases, including cancer, which they hope will help them “glean new insights that will lead to breakthrough drug therapies.”
Related: In the burgeoning field of genomics, entrepreneurs aim to deliver more personalized treatments for life-threatening diseases.
Ayasdi is working with the nation’s top hospitals and medical researchers to uncover more targeted treatments for disease. Singh, the company’s CEO, told me that hospitals and big pharmas are routinely pulling data from public sources — medical researchers are required to publish their data – and combine it with private data to yield new insights.
A data visualization depicting 14 variants of breast cancer
The data isn’t anything new — it’s the technology that has evolved. “We have automated the discovery of knowledge from data,” said Singh in a phone interview. “We were able to discover a new type of breast cancer without asking questions.”
Singh was referring to a recent breakthrough where Ayasdi mapped 14 variants of breast cancer. Using data collected during a 15 year period, and studied by thousands of scientists, the algorithms discovered a sub-group of patients that have a higher chance of survival based on their genetic profile. If a patient falls into this sub-group, it is unlikely that they will require chemotherapy.
Ocko witnessed this medical breakthrough first-hand in the minutes before he opened his check book. “The massive deficit that corporations and governments face as the amount of data gets exponentially larger is not more intelligence, it’s insights and intuition,” he explained by phone. The data-focused investor said the company’s ability to provide human analysts with “intuition from vast amounts of data in very short periods of time” is virtually unprecedented. I
n another recent partnership, with Mount Sinai Medical Center, Ayasdi was used to point to targeted treatment options for E. coli sufferers. E. coli affects more than 265,000 people in the U.S. every year, and millions around the world. It is known in the medical community for developing resistance to many drugs, and doctors are never 100 percent sure if a treatment will work or not. Mount Sinai is using Ayasdi to analyze the entire E. coli genome sequence, which includes more than 1 million DNA variants. This will further our understanding of why some types of E. coli develop resistance to antibiotics and how we can combat the spread of the bacteria.
Singh, a former researcher at Stanford, told me that the company has secured 20 customers in the oil and gas, government, pharmaceutical, and healthcare sectors. Big name customers include Merck, the Food and Drug Administration, and the U.S. Department of Agriculture.
Read more at http://venturebeat.com/2013/01/16/ayasdi/#SgZbEqt0OfFHoSGf.99
Medical research news feeds added - suggestions for additional feeds welcome...
http://www.biotechinvestorsnetwork.com/#!medical-research/c1p0e
medical device news feeds also added...
http://www.biotechinvestorsnetwork.com/#!medical-device-news/czj8
The Evolution, and Revolution, of Flu Vaccines
Search Consumer Updates
An FDA laboratory worker injects an influenza virus into an egg, where it will grow before being harvested—one of the many complex steps involved in creating a traditional flu vaccine. Get this photo on Flickr.
The flu vaccine that you get at your doctor's office or pharmacy is the work of highly skilled microbiologists, epidemiologists, physicians and other public health experts too numerous to mention. It also likely required a hen and a rooster monitored by a veterinarian inside a henhouse that met biosecurity requirements.
Sound complicated? It is. The manufacturing of flu vaccines is a highly-orchestrated and complex process.
Vaccine manufacturers each year use millions of fertilized eggs as a culture to grow influenza viruses that, after numerous steps requiring about six months of expert work, become that season's flu vaccine. And while this tried-and-true method will continue to provide safe and effective vaccines for the foreseeable future, flu vaccines using new, more advanced technologies are arriving on the scene. Some don't require eggs at all.
The Food and Drug Administration (FDA) and its parent, the U.S. Department of Health and Human Services, have long encouraged the development of new technologies for producing flu vaccines. For example, cell culture technology is used to make vaccines to prevent other infectious diseases, and FDA has been working for a number of years, both on the research and regulatory fronts, to facilitate this for flu vaccines. A major push for cell-based flu vaccines occurred in 2006 as part of a plan to be ready in case of a world-wide epidemic.
In 2010, FDA issued final guidance to assist manufacturers working to develop safe and effective viral vaccines that grow in specially prepared cell lines. In the last two months, FDA has approved two new flu vaccines that, instead of using eggs to grow the influenza virus, use cell lines from either a mammal or insects.
"This is an important advance that will supplement current egg-based vaccines," said Jerry P. Weir, Ph.D., director of the Division of Viral Products in FDA's Center for Biologics Evaluation and Research. "The more manufacturing alternatives there are available, the better we can respond to public health emergencies in a timely manner."
Although egg-based production remains vital, cell technology has some advantages. Unlike eggs, cells can be frozen for later use to grow large volumes of cells. That advantage offers the potential for faster start-up of the vaccine manufacturing process for any unexpected need. This would also be critical if egg supplies were compromised. In addition, some flu virus strains don't grow that well in eggs at first and may grow better and faster in cells, helping speed vaccine production and availability. Moreover, alternatives to egg-based products provide an option for people with egg allergies.
The Making of the Vaccine
The job of producing a new vaccine for the next flu season starts well before the current flu season ends. For FDA, it's a year-round initiative.
The composition of vaccines for other diseases can stay the same year after year. But because influenza viruses are constantly evolving, and the viruses that circulate among people often change from one year to another, new flu vaccine needs to be made every year. To that end, scientists around the world collect samples to identify which flu strains are most likely to be circulating in the next flu season.
In February—well before a new flu season begins—FDA recommends the different strains of influenza viruses that should be included in vaccines that are going to be produced for the upcoming U.S. flu season starting in the fall.
Both traditional and new manufacturing methods for FDA-approved vaccines require high-tech processes and manufacturing facilities that have been inspected by FDA. Typically, seed viruses are produced and then distributed to manufacturers.
In egg based manufacturing, each virus strain is injected into eggs. The eggs are incubated for several days to allow the virus to multiply. The virus-loaded fluid from the egg is then harvested and undergoes purification. Manufacturers and the FDA test for potency and safety, using a type of test developed and calibrated by FDA.
Eventually, the strains are mixed together to formulate the vaccine into standard dosages. The product is then put into containers such as vials, syringes and, for the nasal vaccine, sprayers.
Each vaccine undergoes quality control tests, including testing for sterility. Manufacturers submit the results of their testing, along with sample vials from each lot to FDA for "lot release." FDA releases lots and the manufacturers begin shipping vaccine throughout the United States for use by the public.
Influenza vaccine works mainly by triggering the immune system to produce antibodies that help the body to fight off the infection.
New Vaccines Approved
The first flu vaccine to use cell-based rather than egg-based technologies, Flucelvax, was approved by FDA in November 2012 for use in people ages 18 and older. The manufacturing process for Flucelvax is similar to the egg-based production method, but the virus strains included in the vaccine are grown in cells of mammalian origin instead of eggs.
A second flu vaccine that is manufactured using another new technology was approved on January 16, 2013 for use in people 18 through 49 years of age. Called Flublok, it does not require the use of actual influenza viruses and eggs are not used at any point in the manufacturing process.
Flublok uses an influenza virus protein that is made by genetically modifying a virus that infects insect cells to produce the flu vaccine protein. The protein, as in other flu vaccines, then triggers the immune system of the person receiving the vaccine to make protective antibodies.
Similar technology, Weir noted, has been used successfully before in other licensed vaccines, such as the vaccines used to prevent cervical cancer. Finding a safe and effective way to use the technology to prevent influenza "represents a breakthrough," said Weir. "It provides another important option to fight a disease associated with the deaths of thousands in the United States every year."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
The Evolution, and Revolution, of Flu Vaccines
Search Consumer Updates
An FDA laboratory worker injects an influenza virus into an egg, where it will grow before being harvested—one of the many complex steps involved in creating a traditional flu vaccine. Get this photo on Flickr.
The flu vaccine that you get at your doctor's office or pharmacy is the work of highly skilled microbiologists, epidemiologists, physicians and other public health experts too numerous to mention. It also likely required a hen and a rooster monitored by a veterinarian inside a henhouse that met biosecurity requirements.
Sound complicated? It is. The manufacturing of flu vaccines is a highly-orchestrated and complex process.
Vaccine manufacturers each year use millions of fertilized eggs as a culture to grow influenza viruses that, after numerous steps requiring about six months of expert work, become that season's flu vaccine. And while this tried-and-true method will continue to provide safe and effective vaccines for the foreseeable future, flu vaccines using new, more advanced technologies are arriving on the scene. Some don't require eggs at all.
The Food and Drug Administration (FDA) and its parent, the U.S. Department of Health and Human Services, have long encouraged the development of new technologies for producing flu vaccines. For example, cell culture technology is used to make vaccines to prevent other infectious diseases, and FDA has been working for a number of years, both on the research and regulatory fronts, to facilitate this for flu vaccines. A major push for cell-based flu vaccines occurred in 2006 as part of a plan to be ready in case of a world-wide epidemic.
In 2010, FDA issued final guidance to assist manufacturers working to develop safe and effective viral vaccines that grow in specially prepared cell lines. In the last two months, FDA has approved two new flu vaccines that, instead of using eggs to grow the influenza virus, use cell lines from either a mammal or insects.
"This is an important advance that will supplement current egg-based vaccines," said Jerry P. Weir, Ph.D., director of the Division of Viral Products in FDA's Center for Biologics Evaluation and Research. "The more manufacturing alternatives there are available, the better we can respond to public health emergencies in a timely manner."
Although egg-based production remains vital, cell technology has some advantages. Unlike eggs, cells can be frozen for later use to grow large volumes of cells. That advantage offers the potential for faster start-up of the vaccine manufacturing process for any unexpected need. This would also be critical if egg supplies were compromised. In addition, some flu virus strains don't grow that well in eggs at first and may grow better and faster in cells, helping speed vaccine production and availability. Moreover, alternatives to egg-based products provide an option for people with egg allergies.
The Making of the Vaccine
The job of producing a new vaccine for the next flu season starts well before the current flu season ends. For FDA, it's a year-round initiative.
The composition of vaccines for other diseases can stay the same year after year. But because influenza viruses are constantly evolving, and the viruses that circulate among people often change from one year to another, new flu vaccine needs to be made every year. To that end, scientists around the world collect samples to identify which flu strains are most likely to be circulating in the next flu season.
In February—well before a new flu season begins—FDA recommends the different strains of influenza viruses that should be included in vaccines that are going to be produced for the upcoming U.S. flu season starting in the fall.
Both traditional and new manufacturing methods for FDA-approved vaccines require high-tech processes and manufacturing facilities that have been inspected by FDA. Typically, seed viruses are produced and then distributed to manufacturers.
In egg based manufacturing, each virus strain is injected into eggs. The eggs are incubated for several days to allow the virus to multiply. The virus-loaded fluid from the egg is then harvested and undergoes purification. Manufacturers and the FDA test for potency and safety, using a type of test developed and calibrated by FDA.
Eventually, the strains are mixed together to formulate the vaccine into standard dosages. The product is then put into containers such as vials, syringes and, for the nasal vaccine, sprayers.
Each vaccine undergoes quality control tests, including testing for sterility. Manufacturers submit the results of their testing, along with sample vials from each lot to FDA for "lot release." FDA releases lots and the manufacturers begin shipping vaccine throughout the United States for use by the public.
Influenza vaccine works mainly by triggering the immune system to produce antibodies that help the body to fight off the infection.
New Vaccines Approved
The first flu vaccine to use cell-based rather than egg-based technologies, Flucelvax, was approved by FDA in November 2012 for use in people ages 18 and older. The manufacturing process for Flucelvax is similar to the egg-based production method, but the virus strains included in the vaccine are grown in cells of mammalian origin instead of eggs.
A second flu vaccine that is manufactured using another new technology was approved on January 16, 2013 for use in people 18 through 49 years of age. Called Flublok, it does not require the use of actual influenza viruses and eggs are not used at any point in the manufacturing process.
Flublok uses an influenza virus protein that is made by genetically modifying a virus that infects insect cells to produce the flu vaccine protein. The protein, as in other flu vaccines, then triggers the immune system of the person receiving the vaccine to make protective antibodies.
Similar technology, Weir noted, has been used successfully before in other licensed vaccines, such as the vaccines used to prevent cervical cancer. Finding a safe and effective way to use the technology to prevent influenza "represents a breakthrough," said Weir. "It provides another important option to fight a disease associated with the deaths of thousands in the United States every year."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
January 18, 2013
Quantum Dots Get Commercial Debut in More Colorful Sony TVs
Technology from QD Vision replaces the conventional backlight in LCDs, allowing for purer colors.
By Kevin Bullis on January 11, 2013
Why It Matters
TV makers hope improved display quality will boost sales.
Color boost: You can’t tell, if you’re looking at this on a conventional display, but the colors in Sony’s new quantum-dot TV are stunning.
Sony is using nanoscale particles called quantum dots to significantly improve the color of some of its high-end Bravia televisions. It showed off the technology, which increases the range of colors that an LCD television can display by about 50 percent, at the Consumer Electronics Show in Las Vegas this week. This marks the first time that quantum dots—which for a long time have fascinated researchers because of their unusual electronic and optical properties—have been used in a mass-produced consumer electronics product.
Quantum dots emit very specific wavelengths of light. And the precise colors they emit can be tuned by changing their size. Sony is incorporating technology from QD Vision, which has been working to commercialize advances made at MIT over a decade ago. Originally, the company aimed to make quantum dot displays that are similar to OLED displays—the quantum dots would form the pixels of the display, and would be turned on and off by applying electrical current via a transistor. Although QD Vision has developed prototypes of these displays, they’ve been difficult to make reliably in large sizes (see “This Display Is a Quantum Leap”).
The product that’s finally coming to market is far different. Sony’s new television is a modified LCD TV. In LCD televisions, each pixel is illuminated from behind by a white backlight, and different colors are created by changing the amount of light allowed to pass through three different filters—one red, one green, and one blue. LCDs originally used fluorescent bulbs as the backlight, but now most use LEDs (marketers call these products LED LCDs). QD Vision uses quantum dots to enhance the LED backlight.
While sleeker and sharper than their bulky CRT predecessors, LCD displays can’t produce the full range of color that CRTs could. The problem is the filters. They’re not very selective—the red filter might allow some of the orange part of the spectrum through, for example. And when the impure reds and greens mix, they produce washed-out colors.
“Any blade of grass has colors you can’t see on your display,” says Seth Coe-Sullivan, chief technology officer of QD Vision. His company takes advantage of the optical properties of quantum dots to allow LCDs to display the same range of colors as the best old CRT displays—and close to the range of colors produced by expensive OLED displays (see “Would You Pay $8,000 for a TV?”). (Other qualities, such as contrast, won’t be quite as good as OLEDs.)
QD Vision’s technology eliminates the white backlight. It starts with a conventional blue LED, which produces pure blue light. But that blue light also stimulates two kinds of quantum dots that emit pure green and pure red. With this approach, the only wavelength that passes through the red filter is the pure red emitted by the red quantum dots.
Sony hasn’t announced prices for the new displays yet. But Coe-Sullivan says they will be priced in the range of current LCD TVs, not OLED televisions, which are far more expensive. The models that use QD Vision’s technology will carry the brand “Triluminos.”
The new technology is a hit with some industry watchers (one publication named the new Sony KD-65X9000A, one of the TVs to feature the quantum dots, “Best in Show” at CES). Sony is pairing the quantum dot backlighting with other innovations, such as 3-D and and ultra-high 4K resolution, which it hopes will boost sales. Sales of TVs have been flagging.
Other quantum dot displays are in the works. For example, last year Nanosys announced it would have a quantum dot backlight product in a notebook in 2013, but it hasn’t disclosed the specific product (see “Quantum Dots Give Notebooks a New Glow”).
http://www.technologyreview.com/news/509801/quantum-dots-get-commercial-debut-in-more-colorful-sony-tvs/?utm_campaign=newsletters&utm_source=newsletter-weekly-business&utm_medium=email&utm_content=20130118
Viagra as Weight Loss Drug? Potency Pill Melts Fat
Researchers have discovered that Viagra can also be used for a more surprising purpose: to fight obesity.
BY MAKINI BRICE | JAN 17, 2013 04:27 PM EST
Sildenafil - better known by its brand name Viagra - has been used to treat erectile dysfunction for a long time. However, researchers have also discovered that Viagra can also be used for a more surprising purpose: to fight obesity. Researchers from the University of Bonn and the Max Planck Institute for Heart and Lung Research in Germany have found out how, and the findings may have profound implications for the 500 million people in the world who are overweight or obese.
Researchers discovered that mice that were given sildenafil were resistant to obesity, even when fed a high-fat diet. In the study, they gave mice the drug and studied its effect on their fat cells. They found that the drug converts white fat cells - often found in humans' "problem areas" and which can cause inflammation and chronic diseases - into beige fat cells. "Beige fat cells burn the energy from ingested food and convert it to heat," study author Dr. Alexander Pfeiffer explained in a statement. It also melts fat, which makes it a powerful ally against obesity.
Researchers also found that sildenafil had another powerful trick. White fat cells may become "stuffed", accumulating lipids that make them bigger and cause them to release hormones and inflammation. That inflammation can make people more prone to deadly chronic diseases and other conditions, like heart attacks, strokes and cancer. Taking sildenafil prevented mice's white fat cells from beginning that slippery slope, indicating that even white fat cell production was healthier.
The study may have important implications for the half a billion people who are overweight or obese, but researchers do not suggest taking Viagra to prevent obesity just yet. Studies have only been conducted on mice, so further studies need to be performed in order to create suitable drugs for humans.
The study was published in the Journal of the Federation of American Societies for Experimental Biology.
Read more at http://www.medicaldaily.com/articles/13938/20130117/viagra-weight-loss-drug-potency-pill-melts.htm#a8ODUGJt3yHr2LFS.99
Needham conference presentation...
http://wsw.com/webcast/needham55/register.aspx?conf=needham55&page=nvdq&url=http%3A//wsw.com/webcast/needham55/nvdq/
ONTY obtained the license for sabutoclax in Sept 2011...
Drug Targets Hard-To-Reach Leukemia Stem Cells Responsible for Relapses
snip...
An emerging class of drugs called tyrosine kinase inhibitors (TKI) -- such as imitinib (Gleevec), gifitinib (Iressa) and sunitinib (Sutent) -- has become a popular anti-cancer treatment. However, current TKIs are not 100 percent effective. In cases of CML, for example, some LSCs tucked protectively within bone marrow elude destruction, develop resistance to therapy, self-renew and eventually cause the leukemia to dramatically return.
Of clinical importance, they noted that sabutoclax, which suppresses all BCL2 anti-apoptotic proteins, renders these marrow-dwelling blast crisis LSCs sensitive -- and more susceptible -- to TKI-based therapeutics at doses that do not harm normal progenitor cells.
"Our findings show that pan-BCL2 inhibition will be critical for the eradication of cancer stem cells in CML and that there is an essential link between cancer stem cell dormancy, pro-survival BCL2 isoform expression and therapeutic resistance," Jamieson said. "By using a novel pan-BCL2 inhibitor, we may be able to prevent therapeutic resistance by sensitizing malignant stem cell clones to TKIs."
The findings may have implications for treating solid tumor cancers, such as colon, prostate, breast, and brain cancers, noted Daniel J. Goff, the study's first author. "With many of these tumor types being shown to harbor cancer stem cells, it raises the question of whether BCL2 family expression as well as isoform-switching may be crucial for the maintenance of cancer stem cells in these diseases as well," he said. "If so, they may also be candidates for treatment with a BCL2 inhibitor like sabutoclax."
http://www.biotechinvestorsnetwork.com/#!feature-1/cqf5
ONTY obtained the license for sabutoclax in Sept 2011...
Drug Targets Hard-To-Reach Leukemia Stem Cells Responsible for Relapses
snip...
An emerging class of drugs called tyrosine kinase inhibitors (TKI) -- such as imitinib (Gleevec), gifitinib (Iressa) and sunitinib (Sutent) -- has become a popular anti-cancer treatment. However, current TKIs are not 100 percent effective. In cases of CML, for example, some LSCs tucked protectively within bone marrow elude destruction, develop resistance to therapy, self-renew and eventually cause the leukemia to dramatically return.
Of clinical importance, they noted that sabutoclax, which suppresses all BCL2 anti-apoptotic proteins, renders these marrow-dwelling blast crisis LSCs sensitive -- and more susceptible -- to TKI-based therapeutics at doses that do not harm normal progenitor cells.
"Our findings show that pan-BCL2 inhibition will be critical for the eradication of cancer stem cells in CML and that there is an essential link between cancer stem cell dormancy, pro-survival BCL2 isoform expression and therapeutic resistance," Jamieson said. "By using a novel pan-BCL2 inhibitor, we may be able to prevent therapeutic resistance by sensitizing malignant stem cell clones to TKIs."
The findings may have implications for treating solid tumor cancers, such as colon, prostate, breast, and brain cancers, noted Daniel J. Goff, the study's first author. "With many of these tumor types being shown to harbor cancer stem cells, it raises the question of whether BCL2 family expression as well as isoform-switching may be crucial for the maintenance of cancer stem cells in these diseases as well," he said. "If so, they may also be candidates for treatment with a BCL2 inhibitor like sabutoclax."
http://www.biotechinvestorsnetwork.com/#!feature-1/cqf5
David Grainger @sciencescanner
Chance finding of v elevated cholescytokinin (CCK) in patient with parasitic worms reveals weight loss mechanism:
http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1003122
David Grainger @sciencescanner
CD4+ T cells induce CCK production by l-cells in the gut during enteritis, leading to loss of appetite, hypophagy and weight loss...
David Grainger @sciencescanner
… with altered leptin levels feeding back to modulate the immune system and improve the rate of clearance of the worms. Fascinating
David Grainger @sciencescanner
Suggests CCK receptor agonists may have important new roles in obesity AND immunomodulation. Was that the sound of a starters gun?
Vivus target lowered to $21 at MLV & Co on slower initial sales ramp of Qsymia; longer-term outlook remains strong (13.72)
MLV & Co lowers their VVUS tgt to $21 from $40 following recent discussions with management on the progress of, and near-term plans for, the ongoing launch of Qsymia (phentermine and topiramate) for the treatment of obesity
Read more: http://www.briefing.com/InPlayEq/InPlay/InPlayDual.htm#ixzz2IKiCSRfR
More on Metformin and Cancer (and Alzheimer's)
Posted by Derek Lowe
Metformin: what a weird compound it is. Very small, very polar, the sort of thing you'd probably cross off your list of screening hits. But it's been taken by untold millions of diabetics (and made untold billions of dollars in the process), because it really does reduce glucose levels. It does so though mechanisms that are still the subject of vigorous debate and which (I might add) were completely unknown when the drug was approved. (I keep running into people who think that mechanism-of-action is some sort of FDA requirement, but it most certainly is not. Not saying that it wouldn't help, but what the regulatory agencies want are efficacy and safety. As they should).
And evidence has been piling up that the compound does many other things besides. The situation is murky. There was a report in 2009 that suggested that it might exacerbate the pathology of Alzheimer's. But last summer there was a rodent study that showed (in obese mice) that the compound seemed to improve neurogenerative effects seen in the hippocampus. (Whether this operates in animals, or humans, who are not metabolically impaired is an open question, although metformin is right in the middle of the whole "Type III diabetes" debate about Alzheimer's, which I'm going to cover in another post at some point soon). Meanwhile, human studies (in the large populations taking the drug) are not saying one way or another just yet. This British analysis suggested that there might be an association, but it's not for sure.
Then there's oncology. In 2010 I wrote about the evidence linking metformin use with lower incidence of some types of cancer, and one proposal for the mechanism. Now another paper is out suggesting that the compound works in this regard through modifying the inflammatory cascade. (Note that James Watson also highlighted this lab's previous work in his recent paper, blogged about here). The summary:
. . .Taken together, our observations suggest that metformin inhibits the inflammatory pathway necessary for transformation and CSC formation. To link our results with previous work on metformin in the diabetic context, we speculate that metformin may block a metabolic stress response that stimulates the inflammatory pathway associated with a wide variety of cancers. . .
. . .We suspect that this glucose- and metabolism-mediated pathway operates in many different cell types, and hence might explain why metformin reduces incidence of different human cancers and why the combination of metformin and chemotherapy is effective on many cell types in the xenograft context. While this pathway is hypothetical and has not been described in molecular terms, our results suggest that components in this pathway might be potential targets for cancer therapy.
The pathway referred to is through Src and IkappaB (of the NF-kB pathway), among others; the paper goes into more detail for those who are interested. There's a lot of stuff going on in the clinic with metformin added to different chemotherapy regimes, and I very much look forward to seeing the results. On the molecular level, I'd agree with the statement above - there's a lot to dig into here. The whole intersection of metabolism and cancer is a very large, very complex (and very tricky) area, but you'd have to think that there's a lot of really useful stuff to be found in it.
Comments (9) + TrackBacks (0) | Category: Cancer | Diabetes and Obesity
AbbVie, Abbott Spinoff, Starts Life Near Top of Pharma Industry’s Dividend-Yield Heap
Congratulations: If you held shares in AbbVie (ABBV) on Tuesday, you'll be getting 40 cents for each of them in about a month. If you don't, there's still time to sign on for next quarter's dividend — which, at $1.60 a year and a 4.6% dividend yield, is one of the best on offer in the pharmaceutical industry.
Only GlaxoSmithKline (GSK) offers a better dividend yield in that crowd, at about 5.2%, and AbbVie's yield puts it in the company of such well-known dividend payers as Duke Energy (DUK), at a 4.6% dividend yield and Verizon (VZ), at 4.9%. Other major pharmaceutical companies offer no more than 4.1%, at Bristol-Myers Squibb (BMY), to as little as 1.7%, for Abbott Labs (ABT).
AbbVie, of course, is the newly hatched offspring of Abbott Labs, spun off on Jan. 2; it announced the inaugural dividend two days later. That means there isn't much history to draw on when deciding how attractive that dividend really is.
There is this, though: Added up across all 1.6 billion AbbVie shares, that dividend should cost just under $2.6 billion. We figure that works out to an estimated payout ratio of 0.51 -- in other words, a little over half of AbbVie's net income is likely to go to paying its dividend this year. (We're assuming its reported Sept. 30 results, at net income of $3.74 billion, will amount to roughly three-quarters of the company's full-year profit.)
By all accounts, AbbVie is a strong cash generator. Abbott sent it into the world with it a portfolio of established drugs that includes Humira, a blockbuster drug for rheumatoid arthritis, psoriasis and Crohn's disease. Humira also provides nearly half of AbbVie's sales (and more of its profits): $6.59 billion of $13.2 billion in total sales in the nine months ended Sept. 30.
The bottom line: AbbVie seems to be promising to funnel much of its profits from Humira to shareholders in the form of dividends. That would leave the rest of its portfolio to fund growth.
But the rest of the fledgling company's business currently comes from a collection of less notable drugs, some of which lose patent protection starting this year, including three cardiovascular drugs that make up roughly 12% of AbbVie's total sales.
Morningstar pharma analyst Damien Conover estimates that AbbVie will lose nearly $2 billion in sales over the next couple years from those three drugs. (Humira could face generic competition starting in 2017, but Conover and other analysts think they won't capture much market share initially. Recreating biologics such as Humira is more difficult and costly than making a generic of a chemical compound.)
Should some of the drugs in AbbVie's pipeline take off — and analysts like the prospects of its Hepatitis C drugs, likely to launch starting in 2015 — the dividend coverage would remain just fine.
But absent some hefty pipeline successes or smart acquisitions, AbbVie's tidy dividend, in hindsight, would look more like a warning than an enticement.
Theo Francis, a contributing editor at YCharts, has specialized in digging into corporate disclosures, including for The Wall Street Journal, BusinessWeek, Bloomberg News and footnoted.com. He currently runs Disclosure Matters, an independent research and training firm in Washington, D.C. He can be reached at editor@ycharts.com.
ABBV new high... http://www.biotechinvestorsnetwork.com/#!new-highs/c23h2
A Big Year for Novel Drugs Approvals
What was your top Biopharma highlight for 2012? If it wasn’t the stellar move in the AMEX Biotech Index (up 42%), or the reauthorization of PDUFA, then perhaps it was the decade high for innovative drugs approvals. We would need to go back to the 1990s to find a year with as many FDA approvals for novel drugs as we had in 2012. Adding to the positive trend in numbers, up 29% from the robust 31 approvals in 2011, a number of last year’s approvals came earlier than expected. Vertex’s Kalydeco and Ariad’s Iclusig, for example, both came three months ahead of their respective PDUFA dates. Over 50% of the approvals had FDA Priority review or Orphan designations.
The top three therapeutic areas (cancer, cardiovascular, and metabolic) accounted for 60% of novel drug approvals. The majority of approvals (70%) were small molecule New Drug Applications (NDAs) approved through FDA’s Center for Drug Evaluation and Research (CDER).
On the biologics front, it was not antibodies that stole the show last year, but rather therapeutic enzymes and synthetic peptides. Among the enzymes approved was Jetrea, a recombinant protease from Belgium-based Thrombogenics (EBR:THR) that can be used to treat vision distortions. Protalix (PLX) and Pfizer (PFE) brought forward the first enzyme derived from plant cells. This recombinant enzyme, now branded as Elelyso, can now be used to treat adult Type 1 Gaucher Disease. Another recombinant enzyme, a carboxypeptidase named Voraxaze from BTG International (LON:BTG), was approved for lowering methotrexate levels in patients undergoing chemotherapy.
The first FDA approval of a synthetic peptide for respiratory distress syndrome (RDS) in premature infants was granted to Discovery Labs for Surfaxin. In the first half of 2012, the media and Wall Street spotlight focused on peptides heading into competitive markets: Amylin’s (now BMY) Bydureon, a long acting GLP-1 agonist for Type 2 Diabetes and Affymax’s (AFFY) Omontys, a long acting erythropoiesis-stimulating agent (ESA) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis. Omontys was AFFY’s first drug approval. Ironwood also had a first approval with a peptide compound, Linzess, for irritable bowel syndrome with constipation (IBS-C) and chronic constipation. Late in the year, Gattex, a degradation resistant GLP-2 peptide analog from NPS was approved.
Only two new monoclonal antibodies were approved in 2012 – Genentech’s (Roche’s) Perjeta, a new anti-Her-2 antibody that blocks dimerization, and Human Genome Sciences’ (GSK’s) Abthrax Mab for Anthrax.
Orphan and rare diseases also took the stage in 2012, with 15 molecules approved under the FDA’s Orphan designation. Late in December, small biotech Aegerion (AEGR) won its first FDA approval for Juxtapid to treat HoFH (homozygous familial hypercholesterolemia, a rare genetic disorder that causes unmanageable cholesterol levels. It was Vertex (VRTX) that kicked off the year for the rare disease space with Kalydeco, used for a specific mutation in Cystic Fibrosis patients. The rare occurrence of multi-drug resistant tuberculosis can now be treated with Jannsen’s (JNJ‘s) approved Sirturo. Novartis (NVS) also added to the orphan portfolio with a somatostatin analog (Signifor) for Cushing’s Disease patients unable to undergo pituitary surgery or whose surgeries were not successful.
For novel Biologic License Applications, (BLA filings), more came through CDER (Center of Drug Evaluation and Research) than through CBER (Center of Biologics Evaluation and Research). Although only 17% of approvals were via the BLA route, four of these came through CDER as most small peptides and Mabs qualify for NDA filing.
Looking to hear more about the launch of these new products? CEOs from public companies with 2012 FDA approvals, such as Gilead (GILD), Onyx (ONXX), Affymax (AFFY), Exelexis (EXEL), Arena (ARNA), and Protalix (PLX), will be presenting at the upcoming BIO CEO Conference February 11-12th in New York. As the world’s largest independent conference focused on publicly traded biotechs, it is the essential event for scouting 2013’s Phase III catalysts and NDA/BLA filers.
Methodology: We analyze each approval from the FDA and count only drugs that are approved for the first time (first indication). Unlike other counting methods for new approvals, we do not include imaging agents (such as last year’s Amyvid, Choline 11, and Prepopik), and avoid double counting (for example, Zaltrap for colon cancer is excluded, as the same molecule (aflibercept) was approved for wet macular degeneration in 2011). CBER approved a few cord blood products in 2012, where only the first such product was counted as they are nearly identical in composition.
Orphan Drugs & Value Propositions: Randy Explains
Make a comment
By Ed Silverman // January 17th, 2013 // 11:16 am
Earlier this month, NPS Pharmaceuticals announced that the price for its Gattex treatment for short-bowel syndrome would cost $295,000 a year, roughly three times what Wall Street had expected. This marked the fourth time in the past year that an orphan drug was approved and the price per patient was set at more than $200,000 annually. The move highlighted a growing debate about the calculations used for developing new medications designed for small patient populations and the ability of the healthcare system to afford these treatments and accommodate patients. We spoke with Randy Vogenberg, a principal at the Bentelligence consulting firm, which specializes in benefits consulting and strategic decision making, about the implications for drug makers and payers…
Pharmalot: Why are we seeing this kind of pricing?
Vogenberg: I think part of the reason is that we’re dealing with smaller patient populations than in the past and that’s the typical situation. There are hundreds instead of however many tens of thousands of patients and then we’re spreading cost among a smaller group. So unit costs rise dramatically. And there’s a Catch 22 around pricing – which is a little unique around specialty (drugs). You have a smaller number (of patients) and charging a higher price, so there’s a higher percentage of patients who can’t afford it. This means there’s greater need for unrestricted grants and patient assistant programs. So as a company, you end up paying more for your own product than in the older, traditional marketplace.
more...
http://www.biotechinvestorsnetwork.com/#!featured-article/c17ob
Orphan Drugs & Value Propositions: Randy Explains
Make a comment
By Ed Silverman // January 17th, 2013 // 11:16 am
Earlier this month, NPS Pharmaceuticals announced that the price for its Gattex treatment for short-bowel syndrome would cost $295,000 a year, roughly three times what Wall Street had expected. This marked the fourth time in the past year that an orphan drug was approved and the price per patient was set at more than $200,000 annually. The move highlighted a growing debate about the calculations used for developing new medications designed for small patient populations and the ability of the healthcare system to afford these treatments and accommodate patients. We spoke with Randy Vogenberg, a principal at the Bentelligence consulting firm, which specializes in benefits consulting and strategic decision making, about the implications for drug makers and payers…
Pharmalot: Why are we seeing this kind of pricing?
Vogenberg: I think part of the reason is that we’re dealing with smaller patient populations than in the past and that’s the typical situation. There are hundreds instead of however many tens of thousands of patients and then we’re spreading cost among a smaller group. So unit costs rise dramatically. And there’s a Catch 22 around pricing – which is a little unique around specialty (drugs). You have a smaller number (of patients) and charging a higher price, so there’s a higher percentage of patients who can’t afford it. This means there’s greater need for unrestricted grants and patient assistant programs. So as a company, you end up paying more for your own product than in the older, traditional marketplace.
more...
http://www.biotechinvestorsnetwork.com/#!featured-article/c17ob
Orphan Drugs & Value Propositions: Randy Explains
Make a comment
By Ed Silverman // January 17th, 2013 // 11:16 am
Earlier this month, NPS Pharmaceuticals announced that the price for its Gattex treatment for short-bowel syndrome would cost $295,000 a year, roughly three times what Wall Street had expected. This marked the fourth time in the past year that an orphan drug was approved and the price per patient was set at more than $200,000 annually. The move highlighted a growing debate about the calculations used for developing new medications designed for small patient populations and the ability of the healthcare system to afford these treatments and accommodate patients. We spoke with Randy Vogenberg, a principal at the Bentelligence consulting firm, which specializes in benefits consulting and strategic decision making, about the implications for drug makers and payers…
Pharmalot: Why are we seeing this kind of pricing?
Vogenberg: I think part of the reason is that we’re dealing with smaller patient populations than in the past and that’s the typical situation. There are hundreds instead of however many tens of thousands of patients and then we’re spreading cost among a smaller group. So unit costs rise dramatically. And there’s a Catch 22 around pricing – which is a little unique around specialty (drugs). You have a smaller number (of patients) and charging a higher price, so there’s a higher percentage of patients who can’t afford it. This means there’s greater need for unrestricted grants and patient assistant programs. So as a company, you end up paying more for your own product than in the older, traditional marketplace.
more...
http://www.biotechinvestorsnetwork.com/#!featured-article/c17ob
Citron Research short piece on ISRG... Has the Halo Been Broken...
http://www.citronresearch.com/wp-content/uploads/2012/12/isrg-final1.pdf
8K filed...
The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern.
Our auditors, Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global, have indicated in their report on our financial statements for the fiscal years ended December 31, 2010 and 2011 that there exist conditions that raise substantial doubt about our ability to continue as a going concern due to recurring losses and the lack of working capital. We also expect to receive such a report for the fiscal year ended December 31, 2012. Early-stage biotechnical companies often receive such a report, as our continued operations are dependent on our ability to raise additional capital until revenues are available and received. A “going concern” opinion could impair our ability to finance our operations through the sale of debt or equity securities. Our ability to continue as a going concern will depend on our ability to obtain additional financing when necessary, which is not certain. If we are unable to achieve these goals, our business would be jeopardized and we may not be able to continue. If we ceased operations, it is likely that all of our investors would lose their investment.
We will need substantial additional capital for the continued development of our product candidates and for our long-term operations.
As of December 31, 2012, our cash and cash equivalents were approximately $6.4 million. Our present and future capital requirements depend on many factors, including:
· the level of patient recruitment in the phase IIa study of EPODURE in Israel, which will be commencing in the near term, as well as the anticipated clinical trials of INFRADURE in Israel, and the continuing results of such trials;
· the level of preparations for our anticipated phase IIb study of EPODURE in the United States;
· the level of research and development investment required to develop our first product candidates, and maintain and improve the Biopump Platform Technology;
· changes in product development plans needed to address any difficulties that may arise in manufacturing, preclinical activities, clinical studies or commercialization;
· our ability and willingness to enter into new agreements with strategic partners, and the terms of these agreements;
· our success rate in preclinical and clinical efforts associated with milestones and royalties;
· the costs of recruiting and retaining qualified personnel;
· the time and costs involved in obtaining regulatory approvals; and
· the costs of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights.
We will require significant amounts of additional capital in the future, and such capital may not be available when we need it on terms that we find favorable, if at all. We may seek to raise these funds through public or private equity offerings, debt financings, credit facilities, or partnering or other corporate collaborations and licensing arrangements. If adequate funds are not available or are not available on acceptable terms, our ability to fund our operations, take advantage of opportunities, develop products and technologies, and otherwise respond to competitive pressures could be significantly delayed or limited, and we may need to downsize or halt our operations.
We have significant severance liabilities and may not be able to satisfy such obligations.
Our balance sheet as of September 30, 2012 includes a net liability of approximately $1.31 million representing severance payments required under Israeli law and contractual obligations in excess of severance covered by our current insurance policies that would be due if our employees left under circumstances that triggered payment of severance. Of such amount, approximately $0.59 million represents amounts that would be payable to our President and Chief Executive Officer if his employment with us terminated.
Our liability for severance pay is calculated pursuant to the Israeli severance pay law based on the most recent salary for the employees multiplied by the number of years of employment, as of the balance sheet date. Under law, employees are entitled to one month salary (based on the average of the employee’s last three months’ salary) for each year of employment or a portion thereof. Accordingly, our unfunded severance liability increases upon any increase in an employee’s salary. In addition, several employees are entitled to additional severance compensation in accordance with the terms of their respective employment agreements. Our liability for all of our employees is fully provided by an accrual and is mainly funded by monthly deposits with insurance policies. The value of these policies is recorded as an asset in our balance sheet. Our net liability for severance payments is due to additional months of severance provided under our agreements with certain employees and to any shortfall in our deposited amounts caused by increases in salary.
The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to Israeli severance pay law or labor agreements. The value of the deposited funds is based on the cash surrender value of these policies and includes profits or losses as appropriate.
We are still in the process of clinical trials and do not have a commercialized product and may never be able to commercialize our product candidates.
We have completed a phase I/II clinical trial with respect to our EPODURE Biopump in pre-dialysis patients and are conducting a phase IIa study in dialysis patients in Israel and preparing for a phase II study in dialysis patients in the United States. We have not commenced clinical trials for our INFRADURE Biopump or any other Biopump application. Only a small number of research and development programs ultimately result in commercially successful drugs and drug delivery systems. Potential products that appear to be promising at early stages of development may not reach the market for a number of reasons, including:
· failure to obtain approvals for large-scale clinical trials;
· difficulties related to large-scale manufacturing;
· lack of familiarity of health care providers and patients;
· low market acceptance as a result of lower demonstrated clinical safety or efficacy compared to other products or other potential disadvantages relative to alternative treatment methods;
· inability to obtain favorable coverage determinations from health plans and third-party payers;
· insufficient or unfavorable levels of reimbursement from government or third-party payers;
· infringement on proprietary rights of others for which we (or our licensees, if any) have not received licenses;
· incompatibility with other therapeutic products;
· potential advantages of alternative treatment methods;
· ineffective marketing and distribution support;
· lack of cost-effectiveness; or
· timing of market introduction of competitive products.
If any of these potential problems occurs, we may never successfully commercialize our Biopump Platform Technology. If we are unable to develop commercially viable products, our business, results of operations and financial condition will be materially and adversely affected.
Our Biopump Platform Technology is still being developed and has not been tested on a large scale, and, therefore, we do not know all of the possible side effects and may not be able to commercialize our technology as planned.
The Biopump Platform Technology has not been tested on a large scale, and is still in an early stage of development. Although we and our advisors believe that the results in patients treated to date have demonstrated proof of concept and shown safety and efficacy of our technology so far in its first application, and although we are encouraged by the FDA clearance to proceed with a Phase IIb anemia study with EPODURE in dialysis patients, this does not constitute confirmation or approval of the safety and efficacy of our technology, nor have we received such from any regulatory authority. To date, although we have produced thousands of Biopumps in the laboratory, we have administered Biopumps to only a relatively small number of patients. We are in the early stages of developing the most efficient and effective methods to implant Biopumps so as to attain sustained performance once in the patient and thereby produce the desired therapeutic effect for extended periods of time. While we have attained a number of positive results in our first clinical application, there is significant variability between patients. These and other aspects of the implementation and use of the Biopump Platform Technology are not yet fully developed or proven, and disappointing results and problems could delay or prevent their completion. Even if the Biopump Platform Technology works well in one indication, it could have disappointing results in others. If so, the development could be stalled or even blocked in one or more indications. Potential risks associated with the use of the Biopump Platform Technology are the development of an immune response to the vector or the encoded protein product, local inflammatory response to the implanted tissue or associated with the insertion of the Biopump in the surrounding tissue, autoimmunity to the endogenous protein product or potential overdose of protein due to difficulties in managing the continuous supply in the patient in accordance with patient need. Risk for immunogenic reaction to the vector is based on clinical studies using first general adenoviral vectors that contain a full complement of viral proteins. We currently use a gutless adenoviral vector in all our development activities and our current trial to eliminate the risk of immune rejection of the Biopumps prepared with viral vector particles. While these gutless adenoviral vectors do not include genes for viral proteins, the risk for somehow re-establishing expression of viral proteins cannot be ruled out.
The basis for the risks described above is currently only theoretical since these effects have not been seen in the small number of patients that have received a Biopump in our EPODURE clinical trials or in preclinical safety studies performed in mice. However, the possible side effects and full efficacy and safety of the technology need to be tested in a substantial number of patients to verify this. Our previous safety tests were only carried out on a small number of patients and therefore any conclusions may not be representative of either a larger multi-centric test or the commercial version of the technology in the general population. In addition, the full impact of the technology, and its many possible variations, on the body is, as yet, unknown. Although no side effects attributed to the Biopump Platform Technology were found to date in our EPODURE clinical trials, other than minor bruising at the implantation site, the possibility cannot be ruled out that serious side effects might be borne out by further trials, and if so, this could have serious implications on the viability of the technology and our business.
Although the Biopump Platform Technology aims to minimize the residual number of viral vector particles and their proteins introduced into a body, there is a chance that the cumulative effect of Biopump reimplantation could result in an eventual buildup of viral proteins and an immunogenic reaction against the Biopumps preventing further implantations, which could question the viability of the technology.
Severe side effects or complications in trials, or post-approval, could result in financial claims and losses against us, damage our reputation, and increase our expenses and reduce our assets. In addition, our product candidates may not gain commercial acceptance or ever be commercialized.
We are completely dependent upon the successful development of our Biopump Platform Technology. If we fail to successfully complete its development and commercialization or enter into licensing or partnership agreements, we will not generate operating revenues.
All of our efforts are focused on the development of our Biopump Platform Technology. There is no guarantee that we will succeed in developing products based on our Biopump Platform Technology. If we or any partner(s) or collaborator(s) that we may enter into a relationship with are unable to consummate the production of Biopumps to provide the sustained protein therapy to treat various chronic diseases in a safe, stable, commercial end-product form, we will be unable to generate any revenues. There is no certainty as to our success, whether within a given time frame or at all. Any delays in our schedule for clinical trials, regulatory approvals or other stages in the development of our product are likely to cause us additional expense, and may even prevent the successful finalization of any or all of our product candidates. Delays in the timing for development of our technology may also have a material adverse effect on our business, financial condition and results of operations due to the possible absence of financing sources for our operations during such additional periods of time.
Clinical trials involve lengthy and expensive processes with uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial results.
We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials, which would cause us or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from completed or ongoing clinical trials. We estimate that clinical trials involving various applications of our Biopump Platform Technology will continue for several years; however, such trials may also take significantly longer to complete and may cost more money that we expect. Failure can occur at any stage of testing, and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of the current, or a future, more advanced, version of our Biopump Platform Technology, including but not limited to:
· delays in obtaining regulatory approvals to commence a clinical trial;
· failure or inability to recruit qualified investigators;
· slower than anticipated patient recruitment and enrollment;
· negative or inconclusive results from clinical trials;
· unforeseen safety issues;
· an inability to monitor patients adequately during or after treatment; and
· problems with investigator or patient compliance with the trial protocols.
A number of companies in the medical device, biotechnology, and biopharmaceutical industries, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials. Despite the successful results reported in early clinical trials regarding our EPODURE Biopump, we do not know whether any clinical trials we or our clinical partners may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our product candidate for the treatment of chronic kidney disease or other indications. If later-stage clinical trials involving EPODURE Biopump do not produce favorable results, our ability to obtain regulatory approval may be adversely impacted, which will have a material adverse effect on our business, financial condition and results of operations.