By Seth Yakatan
In case you thought we were kidding about how horrible August was for biotech, check out what "TheStreet" said: Except for penny stocks, no biotech company did worse than NantKwest, the cancer immunotherapy project of health care billionaire Patrick Soon-Shiong. The market’s been a nasty place for Nantworks since its record-setting IPO at $25 per share in late July. The stock closed Monday at $17.12 — a 44% loss for the month of August. Sorento Therapeutics in which Soon-Shiong owns a large stake, fell 39% during August. Another billionaire, R.J. Kirk who invested in Intrexon and Ziopharm saw his holdings drop 32% and 35% during the month, respectively. Phil Frost’s Opko Health dropped 42%. These stocks underperformed the iShares Nasdaq Biotechnology ETF benchmark, which lost 11% during August.
Among all U.S.-listed biotech stocks regardless of market cap, only 68 companies managed to end August with higher stock prices, while 267 biotech stocks lost ground, according to FinViz.com. ARTICLE LINK: http://bit.ly/1MRcgIrhttp://
Valeant, which is currently under government scrutiny, has suffered a free fall in its stock price, but recently posted 36% growth on Monday. The Canadian drugmaker recorded third-quarter EPS of $2.74. Its revenue moved upward by 36% year-over-year, hitting $2.79 billion, partly thanks to recent acquisition Salix, which delivered $461 million— almost 50% more than the $300 million Valeant had forecast. Evercore ISI analyst Umer Raffat noted that in the U.S., 19% of Valeant’s branded prescription product growth was driven by volume increases, compared with 15% from price increases.
Those price increases have lawmakers demanding information, particularly in light of a couple of large increases. Last week, Valeant revealed that it had received subpoenas from the U.S. Attorney’s Office for the District of Massachusetts and from the U.S. Attorney’s Office for the Southern District of New York, requesting materials related to its pricing decisions. It’s CEO has maintained that Valeant has done this 56 times this year alone.
ARTICLE LINK: http://bit.ly/1LW3o4p
Watch this space…..
Pfizer CEO: Drug-pricing snafu isn't pharma's fault. It's insurers and their poor coverage: Pfizer’s CEO, Ian Read, told Forbes that it is an insurance problem. In his Forbes interview, Read cites cost-benefit analyses showing that Lipitor and other statin meds cost $305 billion between 1987 and 2008, but generated $1.3 trillion in economic benefits, preventing heart attacks and strokes, and their costs to the healthcare system. Oncologists’ complaints about the rising cost of cancer treatment are similarly misplaced, Read figures. Some high-profile cancer doctors have been vocal about expensive drugs, including one MD Anderson oncologist who’s taken to social media to generate public protest. Memorial Sloan Kettering’s cost-effectiveness expert Peter Bach has written newspaper op-eds and gone on the interview circuit to lament the $100,000-plus costs of new-generation cancer meds. More formally, the American Society of Clinical Oncology and, just this week, the National Cancer Center Network have decided to add pricing data to their assessments of individual cancer drugs. Bach and his team devised an online calculator to assess the cost-effectiveness of various treatments, allowing users to choose from among a variety of criteria. ARTICLE LINK: - see the Forbes interview
On another note, The National Comprehensive Cancer Network, an influential cancer group, is set to roll out its first set of "affordability" ratings on cancer drugs, while also presenting its first set of “evidence blocks” including cost information on oncology drugs which includes a focus on chronic myelogenous leukemia (CML) and multiple myeloma. Drugs from Bristol-Myers Squibb, Novartis, Johnson & Johnson and Celgene among others, were assessed on efficacy, safety and affordability. ARTICLE LINK: http://bit.ly/1GvEMmr
Preclinical research often hypes cancer drugs: Researchers at McGill say that the preclinical research field is badly skewed, favoring the publication of positive results in a way that has helped inspire more poorly designed studies for new therapies—studies which often can’t be reproduced later. And they used Sutent (sunitinib) as a case study. “Only a fraction of drugs that show promise in animals end up proving safe and effective in humans,” says lead researcher Dr. Jonathan Kimmelman, who directs the STREAM (Studies in Translation, Ethics and Medicine) research group. “An important reason is because studies in animals are often not well designed, and because positive results have a higher chance of being published. They end up skewing what we think we know about the potential of a drug.” ARTICLE LINK: http://bit.ly/1k7ua2m
Nobel Prize winner in medicine 2015: Many of the world’s most terrible diseases have started to disappear. Yet the threat isn’t over. In many parts of the developing world, public health workers are working hard to contain the spread of many of these illnesses — primarily by increasing peoples’ access to the shots and pills taken for granted in the Western World. Three scientists who were awarded the Nobel Prize on Monday are credited with coming up with drugs that have ”radically changed [that] situation.” They are Avermectin, a new drug whose derivative, Ivermectin, has slashed the incidence of two horrific infections caused by parasites, and Artemisinin, a drug that has dramatically reduced the death rates from Malaria, a life-threatening disease also caused by parasites. ARTICLE LINK: http://www.businessinsider.com/nobel-prize-winner-in-medicine-2015-2015-10
Andrew Robb: Australia and US close to drug patent compromise for TPP deal: The trade minister, Andrew Robb, has said Australia and the United States are within striking distance of a deal on the monopoly period for biologics medicines which could seal the Trans Pacific Partnership (TPP). Robb was speaking in Atlanta at the current round of negotiations for the TPP, which if signed would create a preferential trade zone between 12 countries covering 40% of the world’s economy. At issue is the monopoly period secured by pharmaceutical companies in the Australian market for “next generation” drugs known as biologics, before cheaper generic drugs can be produced. Under the current arrangements in Australia, US pharmaceutical companies have a five-year monopoly period to protect intellectual property for clinical data. For the TPP, the US has proposed an eight-year monopoly period which includes five years of data exclusivity plus an additional three years of “pharmacovigilance” which would in effect keep cheaper versions off the market for eight years. Australia, New Zealand and Chile have consistently opposed the move. Robb has consistently maintained the five-year cap on data exclusivity, telling US negotiators that the period was effectively closer to six or seven years due to the approval processes required. ARTICLE LINK: http://www.theguardian.com/australia-news/2015/oct/04/andrew-robb-australia-and-us-close-to-drug-patent-compromise-for-tpp-deal
For those of you looking at biotech and high tech crossovers, check out these Sensors You Can Swallow Could Be Made of Nutrients and Powered by Stomach Acid. The future of ingestible sensors could be a cross between silicon-based circuitry and biodegradable materials, with batteries made of nutrients, running on stomach juices. Ingestible sensors could provide a gut check for early signs on bacterial infection, look for symptoms of gastrointestinal disorders such as Crohn’s Disease, monitor uptake of medications, and even study the microbiome living inside people. Researchers are working on devices made from biocompatible materials such as gelatin and indigo. ARTICLE LINK: http://bit.ly/1Wg3jm8
AstraZeneca embraces crowdsourcing in a mix-and-match cancer R&D contest: AstraZeneca is releasing preclinical test results on roughly 11,500 potential combinations of drugs pitted against certain tumor types, matching them with cancer genomic data courtesy of the Sanger Institute and inviting research teams to dive in in search of winning cocktails. Through Sage Bionetworks’ DREAM Challenge program, scientists can sign up, download the data and get to work on ferreting out combinations, and the contest’s organizers plan to submit the best ideas for publication in Nature Biotechnology, according to Reuters. AstraZeneca’s embrace of crowdsourcing in precompetitive research follows a trend of open-access R&D among some of the world’s largest drugmakers, including Johnson & Johnson and GlaxoSmithKline. This week, Boehringer Ingelheim partnered with Germany’s BioMed X Innovation Center on a crowdsourced effort to find new approaches to treating COPD. ARTICLE LINK: http://bit.ly/1MqhL6B
Editor's Note: Seth Yakatan is currently serving as Vice-President of Business Development for Invion, Ltd. (ASX:IVX). Seth has been professionally involved in the biotechnology industry for over 15 years through his work with Katan Associates.
Invion is a clinical-stage drug development company focused on the development of treatments for major market opportunities in inflammatory diseases including asthma, chronic bronchitis and lupus.
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