Friday, August 17, 2012

Deals of the Week Ponders PatientsLikeMe and Empowerment

Next-wave patient-based research pioneer PatientsLikeMe (PLM) struck an alliance with Merck on August 13th to “evaluate the impact of psoriasis on patients and to inform a novel approach to improving outcomes.”

Dr. Sachin H. Jain, chief medical information and innovation officer at Merck looks to the collaboration to help it “establish and apply innovative solutions that improve disease management and enhance the patient experience.” In other words the Big Pharma is tapping into PLM’s network to gather patient-reported data it can use to tweak and tailor its psoriasis clinical strategy – one hopes to the eventual benefit of patients – but the announcement fell short on concrete terms and goals.

PLM’s model consists of organizing patients into online disease communities where they can share information about how their disease affects them, how they are treating it, the outcome of treatment, etc. The company, founded in 2004, is based on a sophisticated IT platform that, according to one of its founders, Jamie Heywood, aims to convert patients’ stories into structured information that is “computable, to change the way medicine is done and delivered.”

According to PLM’s website, it is backed by an interesting syndicate consisting of a “mission-based” investment group, technology-focused seed capital investors, and traditional private equity.  PLM’s main source of revenue is the sale of aggregate and annonymized patient information to industry, primarily drug firms. PLM lists many partners on its website, including Novartis, Abbott, Biogen Idec, Sanofi, and numerous disease associations.

PLM is totally plugged into the reigning zeitgeist of openness, sharing, connectivity, and community. Think Facebook, social networks, precompetitive consortia and collectives, open source programming – these are all cousins to PLM, although their business or operational models may differ. In a commercial context, the flipside of this zeitgeist, particularly in the world of consumer data, is crowdsourcing off the harvested information and selling it to end users. As for PLM, the company is refreshingly candid about its business model: “We take the information patients like you share about your experience with the disease and sell it to our partners (i.e., companies that are developing or selling products to patients).”

Is the information gathered and sold better – in terms of granularity, nuance, accuracy, actionability – than what can be provided through traditional means, including field and panel market research, patient diarization, etc? Do the patient communities offer more in the way of education and solace than patient groups organized by disease associations or that spontaneously assemble online?

In a video on PLM’s website, Jamie Heywood outlines the grand goal of PLM: “Everyone learns from the experience of everyone else on every meaningful variable that can affect the [health] outcome in real time across the whole medical system.” We applaud the sentiment, but wonder if it can be achieved.

And where does this leave the patient?  PLM offers no way to measure its own outcomes on patient health and happiness, or on R&D innovation, or disease management or the delivery of care. How can we know that PLM is moving the needle with respect to these lofty ends?

The patient empowerment promised by PLM and others is truly a worthy goal. But only getting downstream of the results of collaborations like this will tell us if we are really getting there. For now, we can take you, dear reader, through this week's installment of...

AstraZeneca/Regulus, Biogen Idec/Regulus: Regulus Therapeutics snagged another Big Pharma partner on Aug. 14 when it announced its agreement with AstraZeneca PLC to discover, develop, and commercialize microRNA therapeutics based on three targets for oncology, cardiovascular, and metabolic disorders. Under the deal with AstraZeneca, the Carlsbad, Calif.-based biotech will identify and prepare the pre-clinical compounds for human trials and AstraZeneca will handle clinical development and commercialization. AstraZeneca is paying $28 million up-front and is also making an undisclosed equity investment. Regulus also has the potential to receive undisclosed pre-clinical, clinical and commercialization milestones. The program will begin with Regulus’ microRNA-33, which is in pre-clinical development for treatment of atherosclerosis, a hardening of the arteries due to buildup of fat and cholesterol. The drug reduced arterial plaque size by more than 35% in pre-clinical animal models. The other two targets were not identified by the companies. Regulus added to the news flow with another announcement that it would team up with Biogen Idec to develop microRNA-based biomarkers for multiple sclerosis. Biogen will make an undisclosed upfront cash payment and equity investment in the company, as well as potential milestone payments. Biogen is hoping that Regulus will be able to help it identify the optimal patients in clinical trials, as well as in use with companion diagnostics, and to monitor disease progression and relapse. – Lisa LaMotta

Elan Corporation/Neotope: In a move that polishes Elan up for a sale after the Phase III failure of bapineuzumab, the Irish drug maker announced plans Aug. 13 to spin-out its Neotope Biosciences drug discovery business into an independent company. The news came just days after Elan’s development partners, Pfizer Inc. and Johnson & Johnson, discontinued almost all of the bapineuzumab research programs after two Phase III failures in Alzheimer’s disease. Elan developed bapineuzumab and the disappointing news leaves the company solely dependent on the multiple sclerosis drug Tysabri (natalizumab), partnered with Biogen Idec Inc., to generate revenue. One of the more appealing exits for Elan shareholders now could be the sale of the company, with the most obvious acquirer being Biogen Idec. By spinning out Neotope, Elan reduces operating expenses and positions the company as a more attractive takeout target for an acquirer interested in the Tysabri revenue stream. After, Elan will be a “focused business” that will generate immediate profits, with its primary being Tysabri, but the business will also own ELND005, a Phase II/Phase IIb ready asset in development for neuropsychiatry indications targeting non-amyloid pathologies, and the continued interest in the J&J partnership, which includes bapineuzumab. The spinout of discovery research would reduce Elan’s operating expenses by $103 million to $300 million post the transaction. Net income would be in excess of $250 million, and the company is targeting earnings per share of $1 by 2015, the firm said. Neotope Biosciences PLC will focus on discovery-stage research with a focus on transforming science into clinical stage assets. The unit mainly develops antibodies to tackle disease related to misfolded proteins, including chronic degenerative diseases. Chief Scientific Officer Dale Schenk will be the CEO. Elan plans to finance the start-up with $120 million to $130 million in capital and will retain a 14% to 18% minority equity position in the company. - Jessica Merrill

Merck/Arrowhead: Nanomedicine company Arrowhead Research Corp. has found a research partner for one of the programs it obtained in April when it acquired Alvos Therapeutics. A Merck & Co. subsidiary will evaluate a monoclonal antibody discovered using the human-derived peptide targeting program now owned by Arrowhead, according to an Aug. 14 announcement. Financial terms weren't disclosed, although the company said Merck will pay for the evaluation. It was not immediately clear what rights, if any, Merck obtained to the compound, nor what compensation Arrowhead would receive if the compound is developed further and commercialized. Spun out of the University of Texas' MD Anderson cancer research center, Alvos developed technology that generated peptides that target tumor cells or other tissues specifically. Arrowhead paid $2.13 million in stock up-front to acquire Alvos in April, although milestone payments could add $23.5 million to that deal. Arrowhead said it is currently evaluating additional programs derived from the platform in oncology and other therapeutic areas, and will assess them for partnering or internal development. - Paul Bonanos

Pfizer/AstraZeneca: Pfizer shows once again in the consumer health care products space that it will put its money where its mouth is, acquiring from AstraZeneca global OTC rights for Nexium and gaining right of first refusal on OTC rights for Rhinocort Aqua. The firms Aug. 13 said Pfizer will make an upfront payment of $250 million to AstraZeneca for to market a potential 20mg version of the proton pump inhibitor Nexium (esomeprazole), currently available only by prescription and indicated to treat the symptoms of gastroesophageal reflux disease. AstraZeneca, which is eligible to receive milestone and royalty payments from Pfizer based on product launches and sales, in June filed a marketing authorization application for an OTC Nexium tablet with the European Medicines Agency and expects in the first half of 2013 to file a new drug application with FDA for an OTC Nexium in delayed release capsules. If approved, Pfizer anticipates commercializing the product in the U.S. beginning in 2014 with launches in other markets to follow. While an OTC Nexium would enter a crowded nonprescription PPI market, an OTC Rhinocort Aqua could be a first-in-class U.S. switch as all pharmaceutical therapies for non-infectious rhinitis currently remain Rx only. The product is a pump spray containing the glucocorticosteroid budesonide, with a local anti-inflammatory effect. Both agreements underscore Pfizer’s commitment to keeping and growing its consumer health care products business, largely acquired in its takeover of Wyeth in 2009, rather than divesting the business. The firm this year launched an online health and wellness self-assessment tool,, to help drive sales for its vitamins and dietary supplements business, led by the Centrum line added in the Wyeth deal, and acquired Alacer Corp., maker of Emergen-C vitamin C powdered drink mixes.--Malcolm Spicer

Epic Sciences/Undisclosed Partners: Epic Sciences, a cancer diagnostic company located in San Diego, announced Aug. 15 that it has signed collaborations with six major pharmaceutical companies, including two of the top four multi-national pharmas. The company works to develop circulating tumor cell (CTC) technology for companion diagnostics to help predict later-stage cancer outcomes. Epic said its collaborations include 12 clinical trials in over 40 distinct projects. "By using Epic to molecularly characterize CTCs, our pharmaceutical partners are looking to improve the success rate, decrease the cost, and expedite commercial launch of their targeted therapies,” said Epic president and CEO David Nelson in a statement.
Epic was spun out of Scripps Research Institute in 2008 and completed a Series A in March 2011, but did not reveal the amount that was brought in or its investors. -LL

Michael Goodman wrote about PatientsLikeMe this week.Close up of 'Empowerment' in Lincoln, UK from flickr user Lincolnian under creative commons.

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