Merck Pushes On With Failed Cancer Vaccine

Following in the path of other cancer vaccines that have already lived up to low expectations, Stimuvax has been revived to try again. Merck KGaA (MKGAY.PK) made the surprise announcement today that it would put the project, now called tecemotide, through another large phase III trial to try and replicate results that had emerged in a subgroup of the failed Start study.

That subgroup generated some intriguing data; at 800 patients strong investigators called it the largest clinical trial conducted in stage III non-small cell lung cancer patients in its own right, and the only one to demonstrate a significant survival benefit. A specific chemo-radiation regimen appears to have produced much stronger responses; Merck now needs to work out whether the presence of tecemotide contributed anything to the effect.

Concurrent advantages

Start tested tecemotide (also known as L-BLP25) in a maintenance setting, enrolling patients with unresectable, locally advanced stage III NSCLC who had stable disease after at least two cycles of platinum-based chemo-radiotherapy. They were then treated with either tecemotide or a placebo, to see if the immunotherapy would prolong survival. Five-year survival for patients with lung cancer at this stage is 10-25%.

The trial was an unequivocal failure overall – median overall survival was 25.6 months for patients in the tecemotide group compared with 22.3 months for those on placebo (p=0.123).

However the initial chemo-radiotherapy given as standard of care in this setting can vary, and Merck had stratified patients getting two different regimens – those who received chemotherapy and radiation concurrently, or those who received them sequentially.

Patients who received the therapies concurrently seemed to respond much more strongly to tecemotide, living 10 months longer than those in the placebo group – a post-hoc analysis revealed a median overall survival of 30.8 months compared with the placebo group’s 20.6 months (p=0.016).

This subgroup represented a big proportion of the total recruited – of the 1,239 patients enrolled into the study, 806 had received concurrent chemo-radiotherapy.

Hence the decision to run Start2, which will look almost identical to Start1, but enroll only patients who have received the concurrent regimen. The FDA has agreed a Special Protocol Assessment for the study, and Merck says it has received advice from the European Medicines Agency.

Explaining the response

Merck does not why this subgroup seemed to respond much more strongly to tecemotide.

Although the project is a MUC-1 antigen-specific immunotherapy, the pivotal studies have not recruited or stratified patients based on their MUC-1 status. A spokesman for Merck could not confirm whether this would be different in Start2, saying only that the company would be seeking to understand the immunological response and look for potential predictive biomarkers.

Charles Butts, a clinical investigator for the Start trial who presented the study at Asco earlier this year, put forward a couple of possible explanations at the time.

While chemotherapy and radiotherapy have long been considered immunosuppressive, it is now thought that in certain cases, and depending on how they are given, they can be immune-potentiating. It has been hypothesised that some chemotherapies and radiation given together produce a more inflammatory or immunogenic type of cell death and therefore might be more susceptible to an immune-mediated response, although this remains to be proven.

Dr Butts also said patient selection might be a simpler explanation. Those who get selected for sequential chemo-radiotherapy are not really being treated with curative intent, he said. It is widely believed that immunotherapies are likely to work better in relatively healthier patients, and those are the patients being given concurrent chemo-radiation.

Start2, which will recruit 1,000 patients, will be a big enough trial to determine whether tecemotide can indeed add anything to this chemo-radiotherapy regimen. Currently, there are no further options once patients stop responding to this treatment. So should tecemotide manage to replicate the Start1 finding, a 10-month prolongation of life would be considered a big step forward, particularly as it does not appear to add any toxicity or tolerability issues.

Although the subgroup on which this decision is based was large, many will still consider this a risky basis for further study. Some investors thought it was a risk worth taking: shares in Oncothyreon (ONTY), which licensed the drug to Merck and saw its valuation more than halve on news of the Start failure, were trading 22% higher this morning at $2.19; Merck KGaA stock was little changed. But, in the meantime, tecemotide will struggle to shake off the stain of past failure.

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Cancer Genetics: High-End Diagnostics For Personal Cancer Treatment

Original post, Bio-Wire (9/5/2013)

Editors' Note: This article covers a micro-cap stock. Please be aware of the risks associated with these stocks.

CGI: Overview

Cancer Genetics Inc. (NASDAQ: CGIX) is a rapidly growing genetics company that specializes in cancer diagnostics and the process of creating personalized cancer therapies for patients. The company's IP-protected products include proprietary FISH probes and a wide variety of CGH Microarrays that are designed to identify genetic mutations present in particular types of cancer cells.

The company is also developing next-generation DNA sequencing and offers diagnostic services from its headquarters in Rutherford, New Jersey. CGI clients include prestigious cancer centers like Memorial Sloan-Kettering, Mayo Clinic, the National Cancer Institute, Dana-Farber, Hackensack University Medical Center, The Cleveland Clinic and others.

CGIX Since IPO

Cancer Genetics announced its initial public offering of 600,000 shares priced at $10.00 apiece on April 4th, 2013, with the ticker "CGIX" on the OTC markets. The IPO was completed on April 10th, 2013, with a total of 690,000 shares sold (90,000 extra from overallotment). Proceeds from the IPO were $6.9 M prior to underwriting discounts and commissions. Shares of CGIX traded in the $7.00-17.00 range since April, and recently settled close to the $10.00 level after the recent 1.5 M share offering. CGIX was also uplisted to the NASDAQ on August 14th, 2013. (Source: MarketWatch)

(click to enlarge)

CGI: Financials

Recent uplisting to the NASDAQ, and the successful close of a 1.5 M share public offering (raising $15 M for the company) puts CGI at a much more comfortable position going forward.

Top-line growth for the company has been very strong, reflecting high demand for cancer diagnostics in recent years. In the first half of 2013, revenues were 54% higher than they were in the first half of 2012. Gross margins have also improved quite dramatically, reflecting the impact of higher sales.

The bulk of the company's revenue was derived from hospitals and clinics (including the names mentioned earlier), as well as insurance companies, Medicare and pharmaceutical companies. These revenues are generated from the sale of products used in clinical and research settings, and various services performed by the company's specialists.

The Role of Modern Cancer Diagnostics

Recent advances in biology have created a golden age for cancer research and development. FDA approvals for cancer drugs have surged in recent years, and institutional grants for cancer research are at an all-time high. Financial incentives have also encouraged a number of companies to pursue rare ("orphan") drug indications, many of which are cancer indications that were historically deemed "unattractive" by the pharmaceutical industry. Patients with late-stage disease have also done better due to an inflow of specialized drugs typically used after first and second line therapy.

In recent years there has also been an enormous effort to improve patient outcomes with early detection. It is often the case that a cancerous growth will start off simpler (and in a smaller area) and with fewer mutations in the tumor cells. If left untreated, malignant cells can breach membranes and spread to other areas of the body - sometimes developing new, harmful mutations in the process. Because of the progressive nature of the disease, early detection is usually the best weapon.

Until recent advancements in diagnostic technology, biopsies of malignant tissue would be examined under a microscope by a pathology lab in an attempt to predict the course of the disease. We now have very powerful tests that can not only identify the presence of important proteins in malignant tissue, but monitor the expression of specific oncogenes by cancer cells. To do this, mRNA is isolated from the cells and introduced to something known as a DNA microarray. This device maps the activity level of genes, and produces a simple color-coded map that allows researchers and physicians to interpret genomic activity of cancer cells on a very fundamental level.

Knowing more details about the genotype of a patient's malignancy allows physicians to employ highly personalized therapeutic regimens, which target the vulnerabilities of malignant cells much more effectively. With this we can also determine the course of each patient's malignancy more accurately, which allows oncologists to adjust the intensity of damaging treatments like chemotherapy.

Advanced cancer diagnostics will also reduce our current reliance on outdated phenotypic analysis of malignancies, which are less accurate and much more time intensive. In coming years, widespread adoption of new diagnostics is not only expected to improve patient survival rates, but to reduce the overall costs of cancer treatment.

CGI: Diagnostics Pipeline

Cancer Genetics produced two main kinds of diagnostic tools - fluorescent in situ hybridization ((FISH)) probes, and comparative genomic hybridization (CGH) arrays.

Fluorescent in situ hybridization

FISH is based on older technology that can identify and bind onto the location of certain DNA sequences on individual chromosomes. Fluorescent molecules are attached to the probes to reveal their exact location during analysis. When used clinically, FISH probes can quickly identify specific chromosomal abnormalities that are associated with certain cancers and other genetic disorders.

CGI developed and patented FISH probes for eight major types of hemotologic malignancies: Anaplastic Large Cell Lymphoma (ALCL), Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CML), Multiple Myeloma (MM), Myelodysplastic Syndromes (MDS) and Non-Hodgkin Lymphoma (NHL).

Four other FISH probes were developed for breast, cervical, colorectal and lung solid tumors. CGI also developed a novel probe for cervical cancer called FHACT, which looks for four specific chromosomal aberrations associated with Human Papillomavirus (HPV) and cervical cancer.

The FISH probes are manufactured outside of the US and distributed in Europe under CE marking, although the FISH probe portfolio is only cleared for use in research labs in the United States.

Comparative Genomic Hybridization (CGH) Arrays

CGH arrays are based on the fluorescent marking technique used with FISH probes, although they are much more sophisticated. Note that CGH arrays are not DNA microarrays because they specifically track the gain and loss of genetic material in a test sample of DNA relative to a reference sample. This allows for more accurate, in-depth analysis of the genotypic differences between the DNA of a tumor cell and healthy cell DNA.

CGI currently markets three CGH arrays which provide a highly detailed diagnostic profile for three types of blood cancers: Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL). The company also markets a test specifically designed to classify kidney cancers into one of three subtypes - clear cell, papillary and chromophobe renal cell carcinoma (RCC).

Recently presented data from a 322 specimen study performed by Dr. Kanti Rai and Dr. Nicholas Chiorazzi at North Shore LIJ showed that the Cancer Genetics MatBA® test for Chronic Lymphocytic Leukemia (and Small Lymphocytic Leukemia) was able to identify genomic abnormalities associated with "unfavorable" CLL/SLL outcomes that were missed by FISH probes (8% of total specimens). The CGH array was also able to differentiate between "favorable" and "intermediate" outcomes with statistical significance. In a clinical setting this would allow an oncologist to adjust a patient's therapy in accordance with his or her expected outcome.

Source: Cancer Genetics Inc.

Next-Generation DNA Sequencing

Cancer Genetics' technology pipeline includes DNA sequencing technology which would allow for genomic maps that display individual base pairs. These maps would allow geneticists to "see" a genotype with 1000x the resolution of DNA Microarrays, which paves the way for even more sophisticated interpretation of cancer cell genotypes and their likely outcomes.

Opportunity in Cancer Diagnostics

Although the cost of cancer diagnostics pale in comparison to the cost of novel therapies, genetic assays are being used more frequently due to their usefulness. Pharmacoeconomic benefit has also supported strong and growing demand for new and high-end tests.

Cancer Genetics is on track to process around 10,000 tests by the end of 2013, which should produce revenues of roughly $6 M for fiscal year 2013. Expected improvements in manufacturing efficiency should also improve the company's margins.

CGIX, at a market capitalization of $57 M at time of writing, is valued at approximately 10x its revenues. This is inexpensive if you factor in the company's trailing rate of sales growth, which has been faster than the industry average.

The company's CGH diagnostic products target blood and kidney cancer indications, which are currently more attractive than crowded indications like breast cancer.

Based on US statistics for blood cancers and costs for diagnostic products and servicing, about 40,000 newly diagnosed patients creates ~$40-50 M in opportunity for MatBA® in currently targeted indications. More potential is found in ex-US markets and in cancer patients that already have a diagnosis. The figure grows dramatically after including the market potential of other hematologic indications. In the US alone, the market opportunity for the newly diagnosed approaches $200 M.

UroGenRA for renal cell carcinoma classification also has huge potential and a ~$60 M opportunity on currently targeting indications. This figure grows dramatically when factoring in potential use in bladder and prostate cancers, which would bring the market size closer to $400 M.

The novel FISH probe for HPV mutation, FHACT , has an approximate $10 M US opportunity while targeting cervical cancer, although this could expand significantly with use in endometrial and ovarian cancers. $80 M is realistic given incidence of HPV-induced cancer.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Expectations For Eli Lilly's Lung Cancer Drug Rise, But Revenue Concerns Continue

Eli Lilly & Co. (LLY): Expectations For Eli Lilly's Lung Cancer Drug Rise, But Revenue Concerns Continue - Seeking Alpha (function(_,e,rr,s){_errs=[s];var c=_.onerror;_.onerror=function(){var a=arguments;_errs.push(a); c&&c.apply(this,a)};var b=function(){var c=e.createElement(rr),b=e.getElementsByTagName(rr)[0]; c.src="//beacon.errorception.com/"+s+".js";c.async=!0;b.parentNode.insertBefore(c,b)}; _.addEventListener?_.addEventListener("load",b,!1):_.attachEvent("onload",b)}) (window,document,"script","4ffae9d6f05d1da630000008"); if (SA.Data && SA.Data.Cache) { var adata = SA.Data.Cache.get('campaign_content'); }.market_currents_list li .ticker_date_left .mc_list_tickers a{font-weight: normal} var ms_slug = ''; var article_dashboards = '@investing-ideas@sectors@'; var article_sectors_themes = '@long-ideas@us@drug-manufacturers-major@healthcare@article@'; var ratings_hash={}; var ARTICLE_ID = 1667152; var ARTICLE_TYPE = "standard"; var ARTICLE_LOCK = ""; var author_slug = "a-john-hodge"; var pticker_for_ads = "lly"; var time_left; var lock_comments = false; var machine_cookie = readCookie('machine_cookie'); var middle_version = ABTest.identity%10; try { window.sessionStorage.setItem("/article/"+ARTICLE_ID, '1'); } catch (error) {}var mone_article_tags = "{bmy,mrk,lly};;;{healthcare};;;{long-ideas,us,drug-manufacturers-major,investing-ideas};;;{a-john-hodge}"var ord = Math.floor(Math.random()*1000000000);Seeking Alpha Seeking Alpha Portfolio App for iPad Finance (1) var ipadData; SeekingAlpha.Initializer.AddAfterLoad(function(){ if (SA.Utils.Env.isIPad && !/3/.test(SA.Data.Cookies.get("user_devices"))){ Mone.event("ipad_promotion_top","top_ipad_banner_large","ipad_promotion_displayed"); ipadData = new SA.Data.iPad(); ipadData.instanceName = "ipadData"; var responseHandler = new Object(); responseHandler.handleResponse = function(data){ if (!data.averageUserRating) return; var stars = data.averageUserRating Home | Portfolio | Market Currents | Investing Ideas | Dividends & Income | ETFs | Macro View | ALERTS | PRO   This article was sent to 7,235 people who get email alerts on  . Which cover: new articles | breaking news | earnings results | dividend announcements Get email alerts on   » This article was sent to 337,618 people who get the Investing Ideas newsletter. Get the Investing Ideas newsletter » Expectations For Eli Lilly's Lung Cancer Drug Rise, But Revenue Concerns Continue Aug 30 2013, 15:47 by: A John Hodge  |  about: LLY, includes: BMY, MRK BOOKMARKED / READ LATER Bookmarked

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Eli Lilly Co. (LLY), in desperate need of a blockbuster new drug, may have struck gold when its lung cancer drug, necitumumab (IMC-11F8), was shown to extend patient survival in a phase 3 study. Necitumumab has met its primary endpoint in improving overall survival in patients who received the drug in combination with gemcitabine and cisplatin as a first-line therapy for metastatic squamous non-small cell lung cancer (NSCLC) when compared with chemotherapy alone. Necitumumab is a fully human IgG1 monoclonal antibody designed to block the ligand binding site of the human epidermal growth factor receptor (EGFR), which is a target in several anti-cancer treatments because it sparks cancer progression, both by promoting angiogenesis, or the formation of new blood vessels for tumors, and by inhibiting apoptosis, or cell death.

Necitumumab: From The Ash Heap To Blockbuster Drug?

Lilly expects to submit necitumumab for approval to the Food and Drug Administration (FDA) by the end of the year and, if approved, it could be a great revenue source for the company. Globally, the non-small-cell lung cancer (NSCLC) drug market is expected to reach $6.9 billion in 2019 and climb to $7.9 billion in 2022. There are over 1.2 million new cases of lung cancer diagnosed every year and over 1 million lung cancer patients will die each year, and non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancers. The positive results from the drug came as a surprise according to Mark Schoenebaum, analyst with ISI Group LLC, since not so long ago analysts had given up on necitumumab, with "basically zero" expectations as the drug failed in a prior non-squamous lung cancer trial. Bristol Myers Squibb (BMY), Lilly's partner in the drug, even gave it up as the company terminated the collaboration in late 2012. Mr. Schoenebaum added however, "We really need to see the full data to understand risk/benefit."

While necitumumab could be a potent boost to Lilly's product portfolio, the drug could also bring a much-needed new therapy for NSCLC, a cancer that has been proven difficult to treat with the current drugs on the market, such as Genentech's Avastin, which directly target tumors, as opposed to more broadly active chemotherapy drugs. Richard Gaynor, vice president of product development and medical affairs for Lilly Oncology, said in a prepared statement, "If approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer." And it is quite conceivable that the drug will dominate the NSCLC market with sales expected to reach $1.75 billion by 2022.

But necitumumab is not without some possible stiff competition, as Merck (MRK) plans to initiate late-stage clinical trials of lambrolizumab in the third quarter of 2013 for both non-small cell lung cancer and advanced melanoma. Lambrolizumab, which received "breakthrough status" in late April by the FDA, is an investigational antibody therapy designed to disrupt the action of the immune checkpoint protein PD-1 and therefore inhibit the ability of some cancers to evade the body's immune system.

Generics Continue To Chip Away At Revenue

Eli Lilly will be in need of new successful drugs to market, as sales of its $4.99 billion blockbuster treatment to combat depression, Cymbalta, are expected to plummet when the company loses U.S. patent protection in December. Cymbalta accounted for 22% of the $22 billion in global product sales in 2012, and $1.5 billion in second quarter of 2013. When a blockbuster drug falls off patent it can be devastating to revenue, as witnessed with Zyprexa, Lilly's once best-selling schizophrenia treatment, which had $2.17 billion in domestic sales the year before its patent expired. However, after the drug came off patent the company sold a mere $360 million in the U.S. as 63% of its sales were gobbled up by generic competition. And Lilly will experience more revenue declines as some of the company's other drugs fall off patent, like its $2.4 billion mealtime insulin, Humalog, which expires in June 2014. And the company will also lose its $1 billion osteoporosis medication, Evista, which falls off patent in March of 2014.

Solid Pipeline May Bring Solid Revenues Down The Line

The future is not glum for Lilly, as the company has spent heavily on R&D over the past few years, with $5.28 billion on R&D in 2012, and has no less than 60 potential new drugs in testing, including three in regulatory review and ten in phase 3 trials. For example Lilly submitted empagliflozin for a new drug application (NDA) for the treatment of type 2 diabetes in adults. Empagliflozin is one of a new class of glucose-lowering drugs which work by increasing urinary glucose excretion with a consequent lowering of plasma glucose levels. The company expects to receive a decision by the end of the second quarter 2014.

Lilly's advanced gastric cancer drug, ramucirumab, showed promising results from its phase 3 trials as the drug showed the median overall survival was better in 238 patients who received ramucirumab than in the 117 patients who received placebo. Earlier this year, the company initiated a fast track review to the FDA. Lilly also submitted the drug for approval for breast cancer patients, which could be where the real revenue success for the drug would be found. According to a recent CitiGroup report, peak sales potential could exceed $3 billion.

Cost Cutting: A Leaner Lilly In The Works

Ely Lilly's management team feels confident that over the next few years it will be able to mitigate the negative revenue impact of its drugs' patent expirations with successful launches of its late stage portfolio. The company is also mitigating its lost revenue with a series of cost cuts by slashing jobs and raising prices on Cymbalta before the patent expires. And these cuts have helped as Lilly's second-quarter earnings are up with reported earnings of $1.21 billion while worldwide revenues rose 6% to $5.93 billion, beating Wall Street expectations of $5.82 billion. Lilly also raised its EPS guidance for the year, to earn between $4.28 and $4.38 per share for the year on revenues between $22.6 billion and $23.4 billion.

The cost cutting will continue according to Lilly's Senior Director of Global Corporate Communications Ed Sagebiel, "We continue to face the most significant challenges in our history." The company will suspend base pay increases for most of its employees next year till 2015. Plus the company will be reducing bonuses by 25% for 2014, and it won't be paid out till 2015. These cuts are expected to shave $400 million through 2016. In May the company announced that roughly 1,000 sales staffers would be laid off, which amounted to 40% of the U.S. salesforce.

Ely Lilly is a $50.09 billion market cap company. Year-over-year the stock is up just under 20%, however the stock's growth has slowed from its late April high of $58.40. The company still has a solid dividend with a yield of 3.74, and carries one of the lower P/E ratios of the major drug companies, at 11.67. And the company holds more than $4.6 billion in short-term liquidity.

Conclusion

Big Pharma is experiencing a glut of generics eating away at what were once their revenue cash cows. However there seems to be new cash cows working their way down the pipelines. Lilly too has been hit hard and will continue to be hit hard by the generics, though the company has done some much needed "belt tightening" to get it through the tough times. And CEO John Lechleiter is quite confident that these measures will get them through, as he commented in a prepared statement: "Continued operating and financial discipline, along with a maturing pipeline of potential new medicines, gives me great confidence in the company's ability to meet the challenges we face from upcoming patent expirations and to resume growth after 2014."

While Lilly may experience a rocky road for the next few quarters, for an excellent dividend stock and a patient investor, Eli Lilly, with its cost cutting measures and perhaps a few blockbuster drugs in the pipeline, should be a good long-term stock to have in one's portfolio.

Source: Expectations For Eli Lilly's Lung Cancer Drug Rise, But Revenue Concerns Continue

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Rexahn Regains Rights To Novel Cancer Drug As Teva Continues Its Pipeline Stumble

(Editors' Note: This article covers a micro-cap stock. Please be aware of the risks associated with these stocks.)

Teva Pharmaceutical Industries (TEVA), the powerful generic giant, has been experiencing trouble with its franchise. Sales are down to $9.8 billion from 10.1 billion in the first six months of 2013. Management has been reshuffled; late last year the CEO was asked to step down and a new man put in charge of generics. Teva's shot at branded pharmaceuticals reached a speed bump in July when a U.S. court invalidated a 2015 patent for big-seller Copaxone, inviting in generics as early as next year. Teva's stock price has not yet recovered. Competitors Mylan, Inc. (MYL) and Momenta Pharmaceuticals (MNTA) are developing similar drugs in a healthcare environment that favors the cheapest compounds that work, causing more pressure.

In the midst of problems, Teva made an unwise decision to relinquish an option to continue with a licensing plan for RX-3117, Rexahn Pharmaceutical's (RNN) unique cancer drug that kills tumor cells. Teva will give back to Rexahn all global rights to make and sell the DNA/RNA inhibitor for treating solid tumors. Teva, however, did fulfill a promise to put RX-3117 under FDA review as a new drug. Rexahn passed the FDA's examination and the drug is on its regulatory path. RX-3117 is a small molecule drug that has shown in studies to enter the bloodstream and cause a therapeutic effect in colon, lung, kidney and pancreas, in addition to overcoming chemotherapy drug resistance.

Teva's public reasoning for ending the work on RX-3117 was stated as a "misalignment" with the company's oncology strategy. Teva wants to focus on hematological cancers like chronic lymphocytic leukemia and non-Hodgkin's lymphoma. If I was a shareholder, I'd be less than happy given Teva's $6.8 billion purchase of Cephalon only two years ago, expressly for the purpose of launching into branded oncology products.

A look at Teva's recent past show fumbling efforts at drugs tried and failed. Last week, the company halted trials of Nuvigil, a me-too treatment for depression and bipolarism, after a Phase III yielded no effects better than placebo. In October 2012, another Phase III was suspended, this time for a generic version of $7 billion blood cancer drug Rituxan, made famous by Roche Holding AG (RHHBY.OB). Another slap in the face for shareholders - developing a biosimilar generic version of Rituxan was the ultimate goal of the joint venture Teva formed with privately-held Lonza four years ago; now competitive positioning will most likely be afforded to generic leader Sandoz.

Teva's bad luck with drug development away from generics came to light in December of last year, when it announced slashing certain oncology and cell therapy programs to the tune of $2 billion. Management themselves admitted acquisitions created a confused pipeline. Studies for lung cancer and a stem cell treatment for peripheral artery disease were cut. Unfortunately, the new focus became, in part, neurology, and we see where that has gotten the company so far. Shareholders are not out of the woods - Teva struck a $376 million deal with Xenon Pharmaceuticals late last year for rights to an ion channel blocker for pain, to bolster its new efforts.

Teva's star as an oncology player has fallen. I believe relinquishing its deal with Rexahn is an example of how it is failing to fill the gap void left by huge generic competition, decreased revenue, no strong branding, and management that looks increasingly incompetent. These problems in a company with a $32 billion market cap should give Teva investors pause and question the logic of terminating a license agreement with Rexahn, especially when it was only in April 2012 that Teva decided to expand its oncology pipeline with a $334 million investment in Mersana Therapeutics. Nine months later, a collaboration with another experimental cancer drug was halted, causing a $109 million write-down. This company appears to be on course to bankrupt its pipeline, lacking the brand differentiation it so desires, and years away from delivering top-line results to replace lost generic revenue.

Big Pharma needs an active pipeline of innovative drugs, not to mention blockbusters, something that has diminished with the mega-mergers of the 1990s. Partnering has long been viewed as key to a successful strategy to stay competitive. History, however, tells a different story filled with pharmaceutical missteps and squandered cash. Just in the last few years, GlaxoSmithKline plc (GSK) mysteriously halted a licensing agreement with Actelion Ltd. (ALIOF.PK) in the midst of Phase III for a new insomnia treatment and was strangely quiet about the reasons. Novartis AG (NVS) wrote off $230 million after shelving plans for what was proclaimed as a major advance in hepatitis C, developed by its then-licensing partner, Human Genome Sciences, after a minor disagreement with the FDA. Most surprising was Sanofi's (SNY) decision to terminate its deal with privately-held Metabolex during Phase II for a diabetes drug expected to be a breakthrough treatment, in spite of favorable data, and without any explanation to shareholders for their action.

With the mistake of returning the RX-3117 license to Rexahn, investors can now add Teva to the list.

I believe that for Rexahn, the return of the license can only be a benefit. Phased trials for RX-3117 will continue with a likely candidate being pancreatic cancer that is hard to treat and attracting the attention of major pharma companies like Merck & Co. (MRK) and Celgene Corp. (CELG). The global pancreatic cancer market is expected to rise to $1.2 billion within two years, and with unsatisfactory treatment options being studied among just a handful of competitors, other, more suitable partners could soon take an active interest in Rexahn and its revolutionary compound.

The foremost risk facing Rexahn is loss of a deep-pocketed partner; however, the company has $15.7 million in cash to bring the company through a number of clinical developments, and a prestigious partner in the University of Maryland for which it is developing RX-21101, a re-engineered form of Taxotere for solid tumors. Other more common risks are enrollment for clinical trials and FDA delays. So far, Rexahn appears to have a favorable, expedited relationship with the FDA as evidenced by its Orphan Drug status for several compound indications,

Rexahn has a platform for over a dozen drugs in targeted tumor therapy, representing billions of potential revenue dollars so that only a small percentage of market share would result in strong licensed sales for the company. Big pharmaceutical firms like Teva are proving that the cancer business is better served by younger, more dynamic companies, and in this light, I believe Rexahn will prevail as a leader in new cancer therapies.

Disclosure: I am long RNN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Breakthrough Breast Cancer seeking 'the best and the brightest'

Breakthrough Breast Cancer has a number of vacancies ranging from trainees to senior managers in various areas. Photograph: Breakthrough Breast Cancer

Tell us about Breakthrough Breast Cancer
Breakthrough Breast Cancer is a passionate, focused and energetic charity committed to achieving our vision of a world freed from breast cancer. First and foremost we're a research organisation, funding 25% of all breast cancer research in the UK, and this underpins every part of our work. Breakthrough's research is saving lives by helping improve early diagnosis, developing new treatments and working to ultimately prevent all types of breast cancer.

What is the focus of the Breakthrough Breast Cancer team?
Our research is the heart of what we do at Breakthrough, but the work that takes place outside the laboratory is equally important. Our work covers all aspects of breast cancer including patient advocacy, mass engagement, fundraising and working with policy makers to ensure breast cancer patients and their families get the best and most current, effective care possible.

We've got a huge challenge ahead of us, but we're fortunate to have a talented, driven team who not only enjoy what they do, but are also making a huge difference to the lives of the thousands of men and women affected by breast cancer in the UK.

Tell us a bit about your careers open day. Why are you doing it?
If we're going to make our vision of a world freed from breast cancer a reality, then we're going to need the best and the brightest. We currently have a number of vacancies across the organisation and we're inviting applications for a range of jobs, from trainees to senior managers, in fundraising, communications, marketing and business development. Our careers open day is an opportunity for prospective members of our team to come and meet us, learn about what we do and find out first-hand how we're making a real difference to the lives of people affected by breast cancer.

Is breast cancer just a women's issue?
Every year, 50,000 women and 400 men will be diagnosed with breast cancer, making it the most commonly diagnosed cancer in the UK. Everyone knows someone who's been affected by breast cancer, and the shock and grief that the disease causes affects individuals, their friends and their families. Breast cancer is everyone's problem, and Breakthrough is dedicated to uniting everybody affected by and working against the disease.

I'm not a scientist, how could I make an impact on breast cancer?
Our scientific research is important, but there are so many teams in Breakthrough fighting breast cancer on all fronts. Outside the lab our teams engage with policy makers, campaign for better breast awareness, produce health information, fundraise, and work with our many supporters with the aim of stopping women and men dying from breast cancer.

What are the opportunities over the next few years for Breakthrough Breast Cancer? And how will these prospective applicants contribute to Breakthrough's ongoing success?
Over the years we've had the benefit of experience and expertise from every professional sector, and moving forward we want to build on this, grow our workforce and get ever closer to achieving our goals. We are at an exciting stage of our development; we've just launched our new strategy and five new areas of focus for our work, so we're actively seeking the best of the best to make these ambitions a reality. Our careers open day is an opportunity for people to find out what we want to achieve, and let us know how they can help us do it.

What's it like to work in the charity sector?
Working in the charity sector is a rewarding experience; your work is making a difference to people's lives, and bringing about positive social change. At Breakthrough, we pride ourselves on using business methods to capitalise on every opportunity, and ensure every penny of our fundraisers' money goes towards achieving our ultimate aim of stopping women and men dying from breast cancer.

Why should people want to work for Breakthrough?
Our recent in-house opinion survey showed that over 80% of our people would recommend Breakthrough as an employer; we've got a great team working in a lively, engaging environment. There are great benefits, and our staff progression scheme allows our team members to grow and develop into their roles.

But beyond that, Breakthrough is a unique, special place to work. Being part of our team means you're making a genuine difference to the lives of people living with breast cancer. Breakthrough is a force for change, and everyone who works here takes us a step closer to achieving the vision that underpins all of our work, a world freed from breast cancer.

Catherine Devitt is director of people and organisation development at Breakthrough Breast Cancer

For more information about our benefits and vacancies please visit Breakthrough's careers page. If you would like to attend the careers open day please email openday@breakthrough.org.uk

This content is produced and funded by Breakthrough Breast Cancer

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Expectations For Eli Lilly's Lung Cancer Drug Rise, But Revenue Concerns Continue

Eli Lilly & Co. (LLY): Expectations For Eli Lilly's Lung Cancer Drug Rise, But Revenue Concerns Continue - Seeking Alpha (function(_,e,rr,s){_errs=[s];var c=_.onerror;_.onerror=function(){var a=arguments;_errs.push(a); c&&c.apply(this,a)};var b=function(){var c=e.createElement(rr),b=e.getElementsByTagName(rr)[0]; c.src="//beacon.errorception.com/"+s+".js";c.async=!0;b.parentNode.insertBefore(c,b)}; _.addEventListener?_.addEventListener("load",b,!1):_.attachEvent("onload",b)}) (window,document,"script","4ffae9d6f05d1da630000008"); if (SA.Data && SA.Data.Cache) { var adata = SA.Data.Cache.get('campaign_content'); }.market_currents_list li .ticker_date_left .mc_list_tickers a{font-weight: normal} var ms_slug = ''; var article_dashboards = '@investing-ideas@sectors@'; var article_sectors_themes = '@long-ideas@us@drug-manufacturers-major@healthcare@article@'; var ratings_hash={}; var ARTICLE_ID = 1667152; var ARTICLE_TYPE = "standard"; var ARTICLE_LOCK = ""; var author_slug = "a-john-hodge"; var pticker_for_ads = "lly"; var time_left; var lock_comments = false; var machine_cookie = readCookie('machine_cookie'); var middle_version = ABTest.identity%10; try { window.sessionStorage.setItem("/article/"+ARTICLE_ID, '1'); } catch (error) {}var mone_article_tags = "{bmy,mrk,lly};;;{healthcare};;;{long-ideas,us,drug-manufacturers-major,investing-ideas};;;{a-john-hodge}"var ord = Math.floor(Math.random()*1000000000);Seeking Alpha Seeking Alpha Portfolio App for iPad Finance (1) var ipadData; SeekingAlpha.Initializer.AddAfterLoad(function(){ if (SA.Utils.Env.isIPad && !/3/.test(SA.Data.Cookies.get("user_devices"))){ Mone.event("ipad_promotion_top","top_ipad_banner_large","ipad_promotion_displayed"); ipadData = new SA.Data.iPad(); ipadData.instanceName = "ipadData"; var responseHandler = new Object(); responseHandler.handleResponse = function(data){ if (!data.averageUserRating) return; var stars = data.averageUserRating Home | Portfolio | Market Currents | Investing Ideas | Dividends & Income | ETFs | Macro View | ALERTS | PRO   This article was sent to 7,224 people who get email alerts on  . Which cover: new articles | breaking news | earnings results | dividend announcements Get email alerts on   » This article was sent to 337,202 people who get the Investing Ideas newsletter. Get the Investing Ideas newsletter » Expectations For Eli Lilly's Lung Cancer Drug Rise, But Revenue Concerns Continue Aug 30 2013, 15:47 by: A John Hodge  |  about: LLY, includes: BMY, MRK BOOKMARKED / READ LATER Bookmarked

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Eli Lilly Co. (LLY), in desperate need of a blockbuster new drug, may have struck gold when its lung cancer drug, necitumumab (IMC-11F8), was shown to extend patient survival in a phase 3 study. Necitumumab has met its primary endpoint in improving overall survival in patients who received the drug in combination with gemcitabine and cisplatin as a first-line therapy for metastatic squamous non-small cell lung cancer (NSCLC) when compared with chemotherapy alone. Necitumumab is a fully human IgG1 monoclonal antibody designed to block the ligand binding site of the human epidermal growth factor receptor (EGFR), which is a target in several anti-cancer treatments because it sparks cancer progression, both by promoting angiogenesis, or the formation of new blood vessels for tumors, and by inhibiting apoptosis, or cell death.

Necitumumab: From The Ash Heap To Blockbuster Drug?

Lilly expects to submit necitumumab for approval to the Food and Drug Administration (FDA) by the end of the year and, if approved, it could be a great revenue source for the company. Globally, the non-small-cell lung cancer (NSCLC) drug market is expected to reach $6.9 billion in 2019 and climb to $7.9 billion in 2022. There are over 1.2 million new cases of lung cancer diagnosed every year and over 1 million lung cancer patients will die each year, and non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancers. The positive results from the drug came as a surprise according to Mark Schoenebaum, analyst with ISI Group LLC, since not so long ago analysts had given up on necitumumab, with "basically zero" expectations as the drug failed in a prior non-squamous lung cancer trial. Bristol Myers Squibb (BMY), Lilly's partner in the drug, even gave it up as the company terminated the collaboration in late 2012. Mr. Schoenebaum added however, "We really need to see the full data to understand risk/benefit."

While necitumumab could be a potent boost to Lilly's product portfolio, the drug could also bring a much-needed new therapy for NSCLC, a cancer that has been proven difficult to treat with the current drugs on the market, such as Genentech's Avastin, which directly target tumors, as opposed to more broadly active chemotherapy drugs. Richard Gaynor, vice president of product development and medical affairs for Lilly Oncology, said in a prepared statement, "If approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer." And it is quite conceivable that the drug will dominate the NSCLC market with sales expected to reach $1.75 billion by 2022.

But necitumumab is not without some possible stiff competition, as Merck (MRK) plans to initiate late-stage clinical trials of lambrolizumab in the third quarter of 2013 for both non-small cell lung cancer and advanced melanoma. Lambrolizumab, which received "breakthrough status" in late April by the FDA, is an investigational antibody therapy designed to disrupt the action of the immune checkpoint protein PD-1 and therefore inhibit the ability of some cancers to evade the body's immune system.

Generics Continue To Chip Away At Revenue

Eli Lilly will be in need of new successful drugs to market, as sales of its $4.99 billion blockbuster treatment to combat depression, Cymbalta, are expected to plummet when the company loses U.S. patent protection in December. Cymbalta accounted for 22% of the $22 billion in global product sales in 2012, and $1.5 billion in second quarter of 2013. When a blockbuster drug falls off patent it can be devastating to revenue, as witnessed with Zyprexa, Lilly's once best-selling schizophrenia treatment, which had $2.17 billion in domestic sales the year before its patent expired. However, after the drug came off patent the company sold a mere $360 million in the U.S. as 63% of its sales were gobbled up by generic competition. And Lilly will experience more revenue declines as some of the company's other drugs fall off patent, like its $2.4 billion mealtime insulin, Humalog, which expires in June 2014. And the company will also lose its $1 billion osteoporosis medication, Evista, which falls off patent in March of 2014.

Solid Pipeline May Bring Solid Revenues Down The Line

The future is not glum for Lilly, as the company has spent heavily on R&D over the past few years, with $5.28 billion on R&D in 2012, and has no less than 60 potential new drugs in testing, including three in regulatory review and ten in phase 3 trials. For example Lilly submitted empagliflozin for a new drug application (NDA) for the treatment of type 2 diabetes in adults. Empagliflozin is one of a new class of glucose-lowering drugs which work by increasing urinary glucose excretion with a consequent lowering of plasma glucose levels. The company expects to receive a decision by the end of the second quarter 2014.

Lilly's advanced gastric cancer drug, ramucirumab, showed promising results from its phase 3 trials as the drug showed the median overall survival was better in 238 patients who received ramucirumab than in the 117 patients who received placebo. Earlier this year, the company initiated a fast track review to the FDA. Lilly also submitted the drug for approval for breast cancer patients, which could be where the real revenue success for the drug would be found. According to a recent CitiGroup report, peak sales potential could exceed $3 billion.

Cost Cutting: A Leaner Lilly In The Works

Ely Lilly's management team feels confident that over the next few years it will be able to mitigate the negative revenue impact of its drugs' patent expirations with successful launches of its late stage portfolio. The company is also mitigating its lost revenue with a series of cost cuts by slashing jobs and raising prices on Cymbalta before the patent expires. And these cuts have helped as Lilly's second-quarter earnings are up with reported earnings of $1.21 billion while worldwide revenues rose 6% to $5.93 billion, beating Wall Street expectations of $5.82 billion. Lilly also raised its EPS guidance for the year, to earn between $4.28 and $4.38 per share for the year on revenues between $22.6 billion and $23.4 billion.

The cost cutting will continue according to Lilly's Senior Director of Global Corporate Communications Ed Sagebiel, "We continue to face the most significant challenges in our history." The company will suspend base pay increases for most of its employees next year till 2015. Plus the company will be reducing bonuses by 25% for 2014, and it won't be paid out till 2015. These cuts are expected to shave $400 million through 2016. In May the company announced that roughly 1,000 sales staffers would be laid off, which amounted to 40% of the U.S. salesforce.

Ely Lilly is a $50.09 billion market cap company. Year-over-year the stock is up just under 20%, however the stock's growth has slowed from its late April high of $58.40. The company still has a solid dividend with a yield of 3.74, and carries one of the lower P/E ratios of the major drug companies, at 11.67. And the company holds more than $4.6 billion in short-term liquidity.

Conclusion

Big Pharma is experiencing a glut of generics eating away at what were once their revenue cash cows. However there seems to be new cash cows working their way down the pipelines. Lilly too has been hit hard and will continue to be hit hard by the generics, though the company has done some much needed "belt tightening" to get it through the tough times. And CEO John Lechleiter is quite confident that these measures will get them through, as he commented in a prepared statement: "Continued operating and financial discipline, along with a maturing pipeline of potential new medicines, gives me great confidence in the company's ability to meet the challenges we face from upcoming patent expirations and to resume growth after 2014."

While Lilly may experience a rocky road for the next few quarters, for an excellent dividend stock and a patient investor, Eli Lilly, with its cost cutting measures and perhaps a few blockbuster drugs in the pipeline, should be a good long-term stock to have in one's portfolio.

Source: Expectations For Eli Lilly's Lung Cancer Drug Rise, But Revenue Concerns Continue

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Remove Bookmark new SA.Pages.Article.bookmark("_bottom"); var author_info_popup_timeout; About the author: A John Hodge John Hodge is an active trader who follows the technology/biotech sector specifically. I have been successfully trading stocks for the last 16 years and still thank those that pointed me in the direction of Qualcomm and Amgen many years ago. I believe research and timing is the key to long term... More A John Hodge Articles (40) Instablog (1) Comments (22) if (/stats viewer/.test(readCookie("user_perm"))) document.write("Earnings"); Profile 219 Followers 46 Following Follow.author_sidebar__follow_button_initiator('a-john-hodge') Send Message

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Amgen Enters The High-stakes Race Of Blood Cancer Drugs

In August Amgen (AMGN) acquired Onyx (ONXX) for $125 a share, or for a total of $9.7 billion net of Onyx's estimated cash holdings. Onyx's main drug, Kyprolis, approved last year in the U.S. for a rare blood cancer, may generate $3 billion in revenue by 2021, according to an estimate by Bloomberg.

Multiple myeloma is the second most common blood cancer and remains incurable despite advances in treatment options over the last decade. There remains a high unmet medical need for patients, as almost all will eventually relapse and become resistant to currently available therapies.

According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die yearly from the disease.

Amgen is already a force in cancer therapy and obviously it has further ambitions in the segment. But multiple myeloma is a fiercely contested field and Kyprolis faces a lot of rivals.

Kyprolis vs. Pomalyst

The FDA approved Onyx's Kyprolis in 2012 for treatment of patients with multiple myeloma who have received at least two prior therapies.

Celgene's (CELG) Pomalyst was approved in early 2013 for pretty much the same group of patients.

Pomalyst and Kyprolis do not represent a new class of drug. Kyprolis works like Johnson & Johnson (JNJ) and Takeda's (TKPHF.PK) Velcade, and Pomalyst works like thalidomide/Revlimid, also sold by Celgene.

Kyprolis inhibits the action of the proteasome, which is sort of a garbage disposal system for cells. For some reason, the inhibition somehow hurts cancerous cells more than healthy ones, and this is the same mechanism of action of Velcade, too.

Pomalyst is prescribed to patients who cannot be on thalidomide and/or Revlimid because of toxicities of these drugs, while Kyprolis is mainly used for patients who have pronounced neuropathy due to Velcade.

Pomalyst is an immunomodulator that has a similar labeling and neurotoxic profile as Kyprolis. A main difference is that Pomalyst is a pill and Kyprolis is injected.

In that respect Pomalyst maybe favored if the option is choosing an oral drug or making office visits two days every week for Kyprolis injections.

Pomalyst and Kyprolis are both approved for similar indications, but physicians may not consider them as competitors. Patients need both options, and the use of one does not preclude the use of the other. Eventually both drugs will be experimented with to move them up in the disease' cycle.

Combinations could also work. The response rate to Kyprolis when used by itself, is about 20 percent, but higher when combined with Revlimid and dexamethasone. Pomalyst appears to be more effective when combined with dexamethasone, and the expectation is that it will have more activity when combined with a proteasome inhibitor such as Velcade or Kyprolis.

Onyx also developing an oral compound: oprozomib, an innovative oral proteasome inhibitor in Phase 2 trials.

Competition

Amgen's acquisition of Onyx is not without risks.

The multiple myeloma market is competitive, led by Celgene, which sells the blockbuster Revlimid which together with thalidomide and Pomalyst serves the patient population at every stage of the disease.

There is also the issue of cost. If Kyprolis is approved for use earlier in the course of treatment, it is likely to be used in combination with another drug like Revlimid. That could create resistance in reimbursement, particularly in Europe. Kyprolis costs about $10,000 for a 28-day cycle at the recommended dose for a patient of average size and Revlimid costs $7,900 per 28-day period at the FDA-approved 21-out-of-28-day dosing.

Whether Kyprolis will manage to grow under Amgen's management is an open question. The company's oncology sales force has mixed results: sales of the bone cancer drug Xgeva rose by 85 percent last year according Amgen's 2012 10-K, but sales of older prostate-cancer drug Vectibix were largely flat year-over-year.

Success depends on a successful launch in Europe and the expansion of Kyprolis to a broader market. Right now, Kyprolis is approved as a third-line treatment, a sort of last-ditch effort for myeloma patients who've failed on two previous regimens.

Trials are under way to extend Kyprolis' indication and to support the European application.

Two trials, Clarion and Endeavor, will evaluate the combo of Kyprolis and Velcade. Clarion will test the pair, along with chemo and prednisone, in newly diagnosed patients who are ineligible for transplant.

Endeavor will assess survival in relapsed patients when the Kyprolis-Velcade duo is paired with dexamethasone. Both trials are currently enrolling patients. Clarion is expected to be completed in 2016, while Endeavor's completion date is 2015.

The two other late-stage trials, Focus and Aspire, seek to support Kyprolis's bid for approval in Europe in 2014.

Amgen's main competitor in multiple myeloma is the heavy weight of the segment, Celgene, especially the $4.3 billion a year Revlimid. But Amgen is strong in promotion, regulatory affairs and good in running trials.

Also, Onyx did a good job with Kyprolis' launch.

Kyprolis' market share increased to over 40 percent as a third-line treatment at the end of the second quarter, compared to 30 percent at the beginning of the year. The next agent had 20 percent share at the end of the second quarter. So at this point, Kyprolis appears to be established as the leading agent in third-line-plus multiple myeloma.

Kyprolis' share of second-line patients doubled to approximately 10 percent at the end of the second quarter. In this setting, the majority of patients had already received Revlimid, Velcade and dexamethasone in the front line.

Onyx also did a good job moving Kyprolis into the clinics. The drug was used in 2,400 clinics and hospitals, an increase of 300 in the second quarter. Depth of adoption, as measured by repeat ordering, also continues to increase as the drug continues to displace the use of older agents.

Europe represents the largest opportunity outside the U.S. and Onyx was getting ready for a launch there. Following approval, the plan is to establish operating affiliates in Germany, France, Italy, Spain and the United Kingdom and commercialize the drug in 12 markets.

A survey of blood-cancer specialists found that a high level of unmet need exists for therapies with a more favorable neurotoxic profile.

Against Velcade, a $2 billion proteasome inhibitor, Kyprolis is favorably positioned.

Peripheral neuropathy, a bad side effect, generally affects about 16 percent of resistant MM patients on an IV version of Velcade and 6 percent in patients on injections of the drug, versus 1 percent in a single-arm study with 266 patients treated with Kyprolis. The prescribing information for Kyprolis does not, in contrast to Velcade, contains a warning about the risk of peripheral neuropathy: pain, tingling, or loss of sensation in the extremities.

There are several new candidates to the field. Outstanding among them is the oral proteasome inhibitor ixazomib from Takeda/Millennium (MHCC.PK), which shows little peripheral neuropathy in early-stage clinical data.

Investors' summary

Amgen has consulted with the rating agencies ahead of the acquisition announcement and is expected to maintain its solid investment-grade credit rating. Fitch, however, revised its rating outlook downward to negative from stable.

Yet Fitch views the Onyx acquisition as a strategically sound move that will likely soften the blow of Amgen's patent expiry risks.

The Onyx acquisition will be financed with $8.1 billion in bank loans plus company cash for the balance. Investors found it strange that cash-rich Amgen needs to take out bank loans. Amgen reported cash and short-term investments of $22 billion at June 30, 2013. However, most of that money resides outside the U.S. and it would cost the company too much in taxes to repatriate it.

The loans will have a 5-year term and an average interest rate of 3-month LIBOR plus 104 basis points with current interest rates amounting to around 1.3 percent. Management expects the Onyx deal to deliver a return on capital well in excess of the cost of capital.

Following its launch in 2012, Kyprolis brought in $64 million by year-end, and by the end of the second quarter this year, it racked up another $125 million. It's expected to hit $2 billion to $2.4 billion in sales by 2019. Amgen's current leading cancer drug, Xgeva, brought in $748 million worldwide in 2012.

Amgen has 9 late-stage programs, which are expected to generate registration-enabling data by 2016. The 9 include 4 novel oncology compounds, specifically T-VEC and blinatumomab, as well as rilotumumab and trebananib.

The Onyx transaction could close as early as September 30, subject to a satisfactory outcome from the Hart-Scott-Rodino review and the tender offer, the primary conditions to closing.

No significant share repurchase activity should be expected in 2014 or 2015, but the overall plan remains intact to return, on average, 60 percent of net income to shareholders over the period 2011 to 2015.

Amgen has gotten to the point in its history where management feels that it has to take risks. Major risks. Buying back company stock by itself won't do it anymore, and neither will early stage developments, which can take forever to get to the market. An instant success is needed -- a product that is already on the market and selling well, possibly in cancer therapy -- no matter what the cost.

This, maybe, is the explanation behind the Onyx deal.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Breakthrough Breast Cancer seeking 'the best and the brightest'

Breakthrough Breast Cancer has a number of vacancies ranging from trainees to senior managers in various areas. Photograph: Breakthrough Breast Cancer

Tell us about Breakthrough Breast Cancer
Breakthrough Breast Cancer is a passionate, focused and energetic charity committed to achieving our vision of a world freed from breast cancer. First and foremost we're a research organisation, funding 25% of all breast cancer research in the UK, and this underpins every part of our work. Breakthrough's research is saving lives by helping improve early diagnosis, developing new treatments and working to ultimately prevent all types of breast cancer.

What is the focus of the Breakthrough Breast Cancer team?
Our research is the heart of what we do at Breakthrough, but the work that takes place outside the laboratory is equally important. Our work covers all aspects of breast cancer including patient advocacy, mass engagement, fundraising and working with policy makers to ensure breast cancer patients and their families get the best and most current, effective care possible.

We've got a huge challenge ahead of us, but we're fortunate to have a talented, driven team who not only enjoy what they do, but are also making a huge difference to the lives of the thousands of men and women affected by breast cancer in the UK.

Tell us a bit about your careers open day. Why are you doing it?
If we're going to make our vision of a world freed from breast cancer a reality, then we're going to need the best and the brightest. We currently have a number of vacancies across the organisation and we're inviting applications for a range of jobs, from trainees to senior managers, in fundraising, communications, marketing and business development. Our careers open day is an opportunity for prospective members of our team to come and meet us, learn about what we do and find out first-hand how we're making a real difference to the lives of people affected by breast cancer.

Is breast cancer just a women's issue?
Every year, 50,000 women and 400 men will be diagnosed with breast cancer, making it the most commonly diagnosed cancer in the UK. Everyone knows someone who's been affected by breast cancer, and the shock and grief that the disease causes affects individuals, their friends and their families. Breast cancer is everyone's problem, and Breakthrough is dedicated to uniting everybody affected by and working against the disease.

I'm not a scientist, how could I make an impact on breast cancer?
Our scientific research is important, but there are so many teams in Breakthrough fighting breast cancer on all fronts. Outside the lab our teams engage with policy makers, campaign for better breast awareness, produce health information, fundraise, and work with our many supporters with the aim of stopping women and men dying from breast cancer.

What are the opportunities over the next few years for Breakthrough Breast Cancer? And how will these prospective applicants contribute to Breakthrough's ongoing success?
Over the years we've had the benefit of experience and expertise from every professional sector, and moving forward we want to build on this, grow our workforce and get ever closer to achieving our goals. We are at an exciting stage of our development; we've just launched our new strategy and five new areas of focus for our work, so we're actively seeking the best of the best to make these ambitions a reality. Our careers open day is an opportunity for people to find out what we want to achieve, and let us know how they can help us do it.

What's it like to work in the charity sector?
Working in the charity sector is a rewarding experience; your work is making a difference to people's lives, and bringing about positive social change. At Breakthrough, we pride ourselves on using business methods to capitalise on every opportunity, and ensure every penny of our fundraisers' money goes towards achieving our ultimate aim of stopping women and men dying from breast cancer.

Why should people want to work for Breakthrough?
Our recent in-house opinion survey showed that over 80% of our people would recommend Breakthrough as an employer; we've got a great team working in a lively, engaging environment. There are great benefits, and our staff progression scheme allows our team members to grow and develop into their roles.

But beyond that, Breakthrough is a unique, special place to work. Being part of our team means you're making a genuine difference to the lives of people living with breast cancer. Breakthrough is a force for change, and everyone who works here takes us a step closer to achieving the vision that underpins all of our work, a world freed from breast cancer.

Catherine Devitt is director of people and organisation development at Breakthrough Breast Cancer

For more information about our benefits and vacancies please visit Breakthrough's careers page. If you would like to attend the careers open day please email openday@breakthrough.org.uk

This content is produced and funded by Breakthrough Breast Cancer

View the original article here

Breakthrough Breast Cancer seeking 'the best and the brightest'

Breakthrough Breast Cancer has a number of vacancies ranging from trainees to senior managers in various areas. Photograph: Breakthrough Breast Cancer

Tell us about Breakthrough Breast Cancer
Breakthrough Breast Cancer is a passionate, focused and energetic charity committed to achieving our vision of a world freed from breast cancer. First and foremost we're a research organisation, funding 25% of all breast cancer research in the UK, and this underpins every part of our work. Breakthrough's research is saving lives by helping improve early diagnosis, developing new treatments and working to ultimately prevent all types of breast cancer.

What is the focus of the Breakthrough Breast Cancer team?
Our research is the heart of what we do at Breakthrough, but the work that takes place outside the laboratory is equally important. Our work covers all aspects of breast cancer including patient advocacy, mass engagement, fundraising and working with policy makers to ensure breast cancer patients and their families get the best and most current, effective care possible.

We've got a huge challenge ahead of us, but we're fortunate to have a talented, driven team who not only enjoy what they do, but are also making a huge difference to the lives of the thousands of men and women affected by breast cancer in the UK.

Tell us a bit about your careers open day. Why are you doing it?
If we're going to make our vision of a world freed from breast cancer a reality, then we're going to need the best and the brightest. We currently have a number of vacancies across the organisation and we're inviting applications for a range of jobs, from trainees to senior managers, in fundraising, communications, marketing and business development. Our careers open day is an opportunity for prospective members of our team to come and meet us, learn about what we do and find out first-hand how we're making a real difference to the lives of people affected by breast cancer.

Is breast cancer just a women's issue?
Every year, 50,000 women and 400 men will be diagnosed with breast cancer, making it the most commonly diagnosed cancer in the UK. Everyone knows someone who's been affected by breast cancer, and the shock and grief that the disease causes affects individuals, their friends and their families. Breast cancer is everyone's problem, and Breakthrough is dedicated to uniting everybody affected by and working against the disease.

I'm not a scientist, how could I make an impact on breast cancer?
Our scientific research is important, but there are so many teams in Breakthrough fighting breast cancer on all fronts. Outside the lab our teams engage with policy makers, campaign for better breast awareness, produce health information, fundraise, and work with our many supporters with the aim of stopping women and men dying from breast cancer.

What are the opportunities over the next few years for Breakthrough Breast Cancer? And how will these prospective applicants contribute to Breakthrough's ongoing success?
Over the years we've had the benefit of experience and expertise from every professional sector, and moving forward we want to build on this, grow our workforce and get ever closer to achieving our goals. We are at an exciting stage of our development; we've just launched our new strategy and five new areas of focus for our work, so we're actively seeking the best of the best to make these ambitions a reality. Our careers open day is an opportunity for people to find out what we want to achieve, and let us know how they can help us do it.

What's it like to work in the charity sector?
Working in the charity sector is a rewarding experience; your work is making a difference to people's lives, and bringing about positive social change. At Breakthrough, we pride ourselves on using business methods to capitalise on every opportunity, and ensure every penny of our fundraisers' money goes towards achieving our ultimate aim of stopping women and men dying from breast cancer.

Why should people want to work for Breakthrough?
Our recent in-house opinion survey showed that over 80% of our people would recommend Breakthrough as an employer; we've got a great team working in a lively, engaging environment. There are great benefits, and our staff progression scheme allows our team members to grow and develop into their roles.

But beyond that, Breakthrough is a unique, special place to work. Being part of our team means you're making a genuine difference to the lives of people living with breast cancer. Breakthrough is a force for change, and everyone who works here takes us a step closer to achieving the vision that underpins all of our work, a world freed from breast cancer.

Catherine Devitt is director of people and organisation development at Breakthrough Breast Cancer

For more information about our benefits and vacancies please visit Breakthrough's careers page. If you would like to attend the careers open day please email openday@breakthrough.org.uk

This content is produced and funded by Breakthrough Breast Cancer

View the original article here

Long-term side-effects in testicular cancer could be reduced by chemotherapy before radiotherapy

Main Category: Cancer / Oncology
Also Included In: Radiology / Nuclear Medicine
Article Date: 20 Aug 2013 - 0:00 PDT Current ratings for:
Long-term side-effects in testicular cancer could be reduced by chemotherapy before radiotherapy

Giving men with testicular cancer a single dose of chemotherapy alongside radiotherapy could improve the effectiveness of treatment and reduce the risk of long-term side-effects, a new study reports. As many as 96% of men with testicular cancer now survive at least ten years from diagnosis (1), but more advanced forms need to be treated with combination chemotherapy - which can have serious long-term complications. Researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust have therefore been searching for new treatments that would reduce the risk of relapse after initial treatment and so spare as many men as possible from needing combination chemotherapy.

The new pilot study, published in the August issue of prestigious journal the Annals of Oncology, tested a new treatment in a pilot study of men with stage IIA and IIB testicular seminoma - where the cancer has spread to the lymph nodes in the abdomen.

The researchers showed that giving chemotherapy drug carboplatin before radiotherapy could reduce relapse rates compared with radiotherapy alone - cutting the numbers of men who would need follow-up treatment. It also allowed radiation doses to be reduced. The study was funded by The Institute of Cancer Research (ICR), the Bob Champion Cancer Trust and Cancer Research UK, as well as through the NIHR Biomedical Research Centre at The Royal Marsden and the ICR.

Researchers gave 51 men with stage IIA and IIB testicular seminoma a single cycle of carboplatin - a low toxicity form of chemotherapy - followed three to four weeks later by radiotherapy. Most of the men were aged below 50, over a range of 18-73 years.

Adding carboplatin to patients' treatment plans allowed doctors to give a lower dose of radiation over a smaller area of the body for most of the men in the study. Some 39 of the men in the study had their prescription of radiation reduced from the standard 35 Grays (Gy) of radiation to 30 Gy, delivered to a smaller area of the abdomen.

After an average of 4.5 years of follow-up, there were no relapses of the cancer compared with a relapse risk of 5-11% after radiotherapy alone. The side-effects from treatment were mild and only lasted a short time.

Dr Robert Huddart, Team Leader in the Division of Radiation and Imaging at the Institute of Cancer Research, London, and Consultant at The Royal Marsden, who led the study, said:

"The results of this study show great promise. Men who have this stage of testicular seminoma are normally treated with just radiotherapy, or in some countries with intensive combination chemotherapy, where several anticancer drugs are given at once. Relapse occurs in 5-11% of men after radiotherapy alone, and these recurrences have to be treated with combination chemotherapy, which is associated with a risk of serious long-term complications such as cardiovascular disease or second cancers.

"The aim of the study was to develop an effective non-toxic treatment with low risk of long-term treatment complications, and our findings suggest that a single cycle of carboplatin before radiotherapy may reduce the chances of cancer reappearing compared with radiotherapy alone. This will reduce the risk that these patients would need combination chemotherapy. Not only that, but by adding carboplatin to the therapy, the radiation dose and volume can be lowered."

As this was a small, single-centre study, the researchers are recommending the approach is evaluated more widely.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject.

(1) Cancer Research UK Testicular cancer survival statistics (2009). Accessed online 15 August 2013.

Neoadjuvant carboplatin before radiotherapy in stage IIA and IIB seminoma

Ann Oncol (2013) 24 (8): 2104-2107. doi: 10.1093/annonc/mdt148

Institute of Cancer Research

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Treatment-resistant lymphomas 'reprogrammed' to respond to cancer drugs

Main Category: Lymphoma / Leukemia / Myeloma
Article Date: 20 Aug 2013 - 0:00 PDT Current ratings for:
Treatment-resistant lymphomas 'reprogrammed' to respond to cancer drugs

A phase I clinical trial showed diffuse, large B-cell lymphomas (DLBCLs) resistant to chemotherapy can be reprogrammed to respond to treatment using the drug azacitidine, according to a study published in Cancer Discovery, a journal of the American Association for Cancer Research.

Patients whose lymphomas recur after initial chemotherapy are treated with a combination of approaches, including high-dose chemotherapy followed by a stem cell transplant. However, some patients have tumors that do not respond to these extensive second treatments, and many of these patients die within two years of diagnosis.

"When lymphomas are formed, they shut down the cellular programs that sense that something is wrong in the cells. Once these fail-safe mechanisms that trigger cell death are shut down, it becomes difficult to kill the tumor with chemotherapy," said Leandro Cerchietti, M.D., assistant professor at the Hematology and Oncology Division of Weill Cornell Medical College in New York. "Our study showed that using low concentrations of the DNA methyltransferase inhibitors decitabine or azacitidine, these fail-safe mechanisms can slowly be awakened to induce lymphoma cell death when chemotherapy is administered."

Cerchietti and colleagues conducted a phase I trial in patients with newly diagnosed DLBCL. Eleven of the 12 patients enrolled were more than 60 years old when diagnosed, which meant that they were at high risk for tumor recurrence after initial treatment. The patients were treated with azacitidine, in escalating doses, eight days prior to initiation of six cycles of standard chemotherapy. Side effects from pretreatment with azacitidine were minimal. Two patients who were treated with the maximum dose of azacitidine had dose-limiting toxicities.

Of the 12 patients, 11 had a complete response and 10 remained in complete remission for up to 28 months.

"We showed that aggressive lymphomas can be reprogramed to a more benign disease," said Cerchietti. "We think this work has the potential to change the standard of care for patients with aggressive lymphomas."

The researchers conducted the clinical trial based on the results of their extensive preclinical experiments to determine the mechanisms by which lymphomas evade chemotherapy drugs. They found that compared with normal cells, all DLBCLs possess a high degree of aberrant DNA methylation, a process which "silences" certain genes, causing resistance to treatment.

Using DLBCL cells and mice bearing human lymphoma xenografts, the researchers showed that DNA methyltransferase inhibitors are most effective if administered prior to chemotherapy, but not concurrently. They also found the gene SMAD1 to be silenced in the unresponsive tumors.

When the researchers looked for SMAD1 status in the biopsy specimens collected from patients enrolled in the phase I trial, they found that after treatment with azacitidine, there was a decrease in SMAD1 methylation and increase in SMAD1 protein, providing proof of principle.

Cerchietti and colleagues are currently conducting clinical trials with patients with lymphomas whose tumors failed to respond to standard therapies. They are in the process of conducting larger, multicenter trials to extend this treatment to other cancers as well.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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As many as 1 in 5 women don't believe their breast cancer risk

Main Category: Breast Cancer
Also Included In: Genetics;  Psychology / Psychiatry
Article Date: 19 Aug 2013 - 1:00 PDT
Current ratings for:
As many as 1 in 5 women don't believe their breast cancer risk

Despite taking a tailored risk assessment tool that factors in family history and personal habits, nearly 20 percent of women did not believe their breast cancer risk, according to a new study from the University of Michigan Comprehensive Cancer Center.

Most of the women who didn't believe their risk numbers said they did not feel it took into account their family history of cancer or their personal health habits. The tool did ask relevant questions about the individual's family and personal history.

"If people don't believe their risk numbers, it does not allow them to make informed medical decisions," says senior study author Angela Fagerlin, Ph.D., associate professor of internal medicine at the University of Michigan Medical School and a research scientist at the VA Ann Arbor Center for Clinical Management Research.

"Women who believe their risk is not high might skip chemoprevention strategies that could significantly reduce their risk. And women who think their risk should be higher could potentially undergo treatments that might not be medically appropriate, which can have long-term ramifications," she adds

The findings, published in Patient Education and Counseling, are part of a larger study looking at how to improve patients' understanding of risk information.

Some 690 women who were at above-average risk of developing breast cancer completed a web-based decision aid that included questions about age, ethnicity, personal history of breast cancer, and number of first-degree relatives who had had breast cancer. The women then were told their five-year risk of developing breast cancer and given information about prevention strategies.

After receiving this information, the women were asked to recall their risk of breast cancer within the next five years. If they answered incorrectly, they were asked why: they forgot, made a rounding error or disagreed with the number. The researchers found that 22 percent of women who misreported their risk said they disagreed with the numbers.

The most common reason women said they disagreed with their risk was that their family history made them either more or less likely to develop breast cancer. Many believed that because an aunt or father had cancer, it increased their risk. Only first-degree female relatives - mother, sister, daughter - impact a person's breast cancer risk. Others felt a lack of family history meant their cancer risk should be very low.

One-third of women cited a gut instinct that their risk numbers just seemed too high or too low.

"We've put so much fear in people about breast cancer so they feel at high risk," says lead study author Laura D. Scherer, Ph.D. "We found that many women assumed certain factors should impact their risk, like cancer history in distant or male relatives, but those factors don't put a woman at increased risk.

"We have a trend toward personalized medicine and individualized medicine, but if people don't believe their personalized risk numbers, they're not going to get the best medical care for them," says Scherer, who is now at the University of Missouri. She completed the research while at the University of Michigan.

Breast cancer statistics: 234,580 Americans will be diagnosed with breast cancer this year and 40,030 will die from the disease, according to the American Cancer Society

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our breast cancer section for the latest news on this subject.

Belief in numbers: When and why women disbelieve tailored breast cancer risk statistics, doi:10.1016/j.pec.2013.03.016

Additional authors: Peter A. Ubel, Duke University; Jennifer McClure, Group Health Research Institute; Sharon Hensley Alford, Henry Ford Health System; Lisa Holtzman, University of Michigan; Nicole Exe, University of Michigan

Patient Education and Counseling, Vol. 92, No. 2, pp. 253-259, August 2013

University of Michigan Health System

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