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hamelinclara

Generic companies facing some of the same issues as big pharma (part 1) - Medical Progr... - 0 views

www.medicalprogresstoday.com/...ssues-as-big-pharma-part-1.php

pharma generic Bio

shared by hamelinclara on 15 Jan 13 - No Cached
  • But now the drugs in the headlines are generics. As the industry has grown and matured, it's faced greater scrutiny from regulatory agencies. Now it faces many of the same setbacks that plague their branded brethren.
  • Lipitor, Plavix, Lexapro and Seroquel
  • these same manufacturers are facing a patent cliff of their own
  • ...2 more annotations...
  • generics have been plagued by high-profile manufacturing and quality issues that have raised questions about the sector's safety and ultimate viability.
  • The market is increasingly complex for generic manufacturers, and business-as-usual isn't going to cut it. In my next post, I'll describe another critical issue facing these drugmakers and their relationship with regulatory agencies: moving into the new space of biologics.
hamelinclara

20 hospitals with inspiring social media strategies | Articles | Home - 0 views

www.prdaily.com/...ial_media_strategie_10655.aspx

hospital social_media

shared by hamelinclara on 22 Apr 13 - No Cached
  • 1. Mayo Clinic The Mayo Clinic has long been an online resource for medical information, with a website that offers advice and expertise from more than 3,300 medical professionals for free, so it’s not at all surprising that the medical group has been successful in social media
  • Doctors were able to share and connect with readers and patients through a first-hand account of relief efforts performed after the 2010 Haiti earthquake.
  • Massachusetts General Hospital recognizes this, and did something amazing when researchers from the Emergency Department worked together to create an iPhone app designed to help users find the closest emergency room to their area anywhere in the U.S. The app was promoted using hospital social media outlets, creating a YouTube video that bloggers could embed in their stories, also providing for opportunities to tweet the video and share it on Facebook. With the help of social media, the hospital’s app was able to stand out in the sea of apps available for the iPhone.
  • ...17 more annotations...
  • During the Ft. Hood shooting crisis, one of the hospitals treating victims, Scott & White, took it upon themselves to share updates with the community. Employee Steven Widman offered updates on emergency room access, hospital operation status, and more, also updating with Red Cross news and sharing communications with reporters. The crisis pushed Scott & White’s communications to the forefront of social media, increasing their Twitter followers by 78 percent in only three days, turning Scott & White Healthcare into a Twitter "trending topic," and ranking the hospital’s YouTube channel among the most viewed non-profit channels during the crisis. Both people who were affected and those who were tuned in from afar were able to get real-time updates, thanks to the efforts of Widman and the ability of social media to share information.
  • Nebraska Medical Center has created an incredible YouTube presence, one so successful, that as 360 Digital Influence points out, they’ve had an increase in requests for one surgery in particular. It’s all thanks to a patient who shared her cancer experience on YouTube, which led to so many requests for the surgery she had to treat her rare carcinoid cancer that NMC had to open a monthly clinic for the condition. The medical center encourages patients to share their experience, and even makes use of QR codes to share videos of physicians introducing themselves to potential patients.
  • Connecting with patients and community members is great, but what if you could use social media to do something really amazing, like raise more than $1 million for a new children’s hospital? UCSF did just that, taking on a social media fundraising contest named Challenge for the Children. About 165,000 people blew past the hospital’s initial $100,000 fundraising goal thanks to social media channels including Facebook and Twitter. Much of the campaign’s success ($805,554 worth) was thanks to the Facebook game FarmVille, which allowed players to purchase virtual candy cane seeds that sent 100 percent of the profits to the challenge. This amazingly successful challenge paved the way for a new children’s hospital in Mission Bay, set for completion in 2014, and the top two teams will be honored with the naming of a dedicated space in the hospital.
  • t’s so important to be relevant to the topic at hand in social media, and getting off course can turn off would-be fans. But WakeMed Health & Hospitals in Raleigh, North Carolina made a smart move in April 2011, sharing a time-lapse video shot from the hospital’s helipad that showed a tornado as it passed through the area. Although the tornado is a non-medical story not directly related to the hospital’s mission, hospitals are a vital part of any community, and in sharing this video, WakeMed further cemented itself as a valuable resource for the Raleigh area. Med City News praised WakeMed for the video, pointing it out as one of the top blog entries for the medical group. As WakeMed spokeswoman Heather Monackey shares, they’ve found success in social media because they "just pay attention to what’s going on."
  • Hospitals are using social media to connect internally, in addition to community building. At Texas Health Resources, social media tools make it possible for physicians and other health professionals to engage with each other and take advantage of useful tools. Using social media, Texas Health Resources promotes the adoption of electronic health records, and integrates the use of the private microblogging site Yammer to share internal messages, how-to videos, and more. Project managers and physicians use social media tools like Yammer to come together, collaborate, and communicate effectively over a large hospital system.
  • ealth care social media isn’t just about attracting patients and building community, at least not for Geisinger Health System in Danville, Pennsylvania. The health system typically turned to ads in medical journals and direct mail to recruit gastroenterologists, but when they had trouble getting enough responses, associate vice president of marketing Cathy Connolley turned to social media to recruit their physicians. With the help of a recruitment marketing firm, Geisinger created a social media physician recruitment campaign, creating a convenient and cost-effective way to communicate with physicians, and an easy way to direct gastroenterologists to their Facebook page. As Connolley reports, "that tactic outpaced our direct mail approach and our email blasts."
  • Live-tweeting brain surgery just sounds like crazy talk, but Henry Ford Hospital near Detroit made it work. While performing surgery on a 47-year-old man, doctors discussed the procedure with more than 1,900 people, and even uploaded video of the surgery to YouTube. Things seem to go to the next level when the answer to Twitter’s "What are you doing?" question is brain surgery. The hospital earned praise and attention from ABC News, and showed off just how well they can make use of social media. In addition to Twitter brain surgeries, Henry Ford Hospital makes use of news feeds, Flickr, and blogging to reach patients and the general community.
  • Scripps makes it a point to connect with patients and customers through the use of social media. In an interview with Found In Cache, Scripps director of web technology Marc Needham shared that the hospital typically spends its social media time on customer service. In fact, Scripps developed a new position of Electronic Customer Service Representative, specifically created to reach out to patients through social media and respond to online reviews. Needham pointed out that Scripps believes it’s important to have a good handle on their online brand perception, and left unchecked, "unaddressed complaints fester and lead to online reputation rot." Scripps has found success in this pursuit, but Needham says they haven’t quite defined their social media approach just yet, and they’re still experimenting with a variety of different sites, including Wikipedia, YouTube, Flickr, Facebook, and LinkedIn. Scripps tends to use different sites for different purposes, like Facebook for recruitment and LinkedIn for employee connections.
  • hildren’s Hospital Boston has a wildly popular Facebook page. A Facebook page alone isn’t quite enough to be truly impressive these days, but Children’s Hospital Boston really stands out, not just for its half a million plus fans, but really for its top-notch content. Their landing page has information people really want to read, and an encouraging atmosphere that gets patients and fans to open up and share their stories. This high level of engagement is truly inspiring, and offers a great lesson for any Facebook Page owner. Through photos of the week, Children’s Hospital Boston highlights families and patients, who in turn spread the word to their friends and family on Facebook, bringing fans and patients to the Facebook Page to interact. But, as Ignite Social Media points out, Children’s Hospital Boston does so much more than Facebook, effectively managing a Twitter feed and YouTube video collection as well.
  • arasota Memorial Hospital understands the value to building better relationships through social media. In an interview with The Side Note, the hospital’s market research manager Shawn Halls shared how it came to begin using social media as an important tool. After growth and more than three years of use, Sarasota Memorial now sees Twitter and other sites as an important part of their communications strategy, using social media as a way for the community to directly communicate with the hospital. The hospital encourages patients to direct message their Twitter account, and has even been able to connect patient family members with resources like local florists through the site. Like other hospitals, Sarasota Memorial also has plans to share surgery via Twitter, specifically a brain mapping procedure where the patient is awake.
  • Social media is great for spreading news, but it’s also a useful tool for correcting misinformation as well. The Greater Baltimore Medical Center knows that fact all too well, as in August 2010, a Baltimore TV station incorrectly reported that the hospital had been invaded by an armed robber. GBMC media relations manager Michael Schwartzberg was able to act quickly to correct the mistake, sending out a swift collection of tweets that set the story straight for the public and concerned citizens. With active social media accounts already in place, the foundation for sharing information was set and easy to take advantage of, something that the hospital utilizes frequently. Schwartzberg reports that in addition to media relations and customer service, GBMC uses social media as a valuable way to share crisis communication, much like their fake armed robber, H1N1 updates, and if need be, disaster reporting.
  • Just like GBMC, Inova Health found value in Twitter’s ability to set incorrect information straight. Inova uses a security system designed to prevent the theft of babies from maternity wards, and as hospital personnel ran a test of the system, a visitor heard it and mistakenly believed that there was a lost baby. That same visitor then tweeted about the non-incident. Director of digital communications and marketing Chris Boyer had wisely set up social media monitoring services, and quickly spotted the tweet within just minutes of posting. After calling to confirm that there was not actually a problem, Boyer was able to immediately respond on Twitter and share the hard facts of the story, helping to preserve the hospital’s reputation before things got really crazy. Inova Health’s story shows just how important it is to use tools that can help you monitor and stay on top of your social media presence.
  • Living organ donation is an amazing gift and process, and Children’s Medical Center was able to share a special family’s story through Twitter. As a Texas firefighter donated his kidney to his three-year-old son, the Twitterverse was able to follow along with their successful story from start to finish, shared by none other than the mom and wife. With nearly 85,000 people on the waiting list for a kidney, Children’s Medical Center media relations manager Jessica Newell hopes that "twittering from this surgery will help raise awareness for organ donation, as well as living organ donation."
  • Twitter and social media in general can be a scary thing for hospitals, opening up issues of liability and uncomfortable situations. But at least at the University at Buffalo School of Medicine and Biomedical Sciences, doctors and professors recognize Twitter as an incredibly valuable tool for learning and training. Dr. Philip L. Glick shares his insight: "[A] lot of the training consists of passing on information, lessons learned, and wisdom to the next generation. Twitter allows us to dramatically scale up our ability to do this. When I post something on Twitter, all the pediatric surgeons, trainees and colleagues in the country and the world can see it instantly." In addition to small updates, University at Buffalo uses social media to share audio and video of procedures, breaking them down into small pieces that offer opportunities for sharing and teaching. 18. St. Luke’s Cedar Rapids
  • Anxious groups of families and friends sit in hospital waiting rooms across the country, hoping to hear updates and news that their loved one is doing well. Some will find out about things as they go along, some simply when procedures are over. The level of information shared largely depends on the capacity and availability of the team of medical professionals at work. With Twitter, the time and energy necessary to share updates with loved ones is significantly decreased, and small, frequent updates can be shared in just moments, creating an opportunity for hospitals to better inform worried waiting rooms as things go along. At St. Luke’s Cedar Rapids, one family was able to enjoy this incredible level of customer service, as their 70-year-old mother Monna Cleary underwent a hysterectomy and uterine prolapse surgery. Cleary had given her OK for the hospital to share a play-by-play of her operation, and hospital spokeswoman Sarah Corizzo shared more than 300 tweets, allowing the family to follow along, and informing the general public. Corizzo answered questions, and fascinated nearly 700 people who followed along with the surgery. Hospital spokeswoman Laura Rainey pointed out that live-tweeting is a "more gentle" way to inform patients and consumers, allowing them to follow what’s going on without shocking visuals. Cleary’s son Joe and his siblings appreciated the opportunity, pointing out that "it made the time go by," and they enjoyed having real-time information and staying informed while in the waiting room.
  • haring information during a crisis is vital, even when you don’t have a lot of time or resources to do it. So when more than 50 people had to go to hospitals for treatment following a chemical fume exposure at a trash disposal station, Southcoast Hospital turned its Twitter account into a "crisis communication portal," sharing status updates for more than a week. Updates included status on admitted, discharged, and treated patients during the spill, and helpful information and links that kept the public and concerned loved ones constantly updated during the situation.
  • Hospitals are full of stories that the community is interested in, with people overcoming great odds and going on to live healthier lives. At Barnes-Jewish Hospital, a 23-year-old heart transplant patient Megan Moss attracted lots of local interest, thanks to updates from the Barnes-Jewish Hospital blog, Touching Base. Additionally, Megan’s dad shared constant updates through his own blog. Moss’s story attracted so much attention, that one weekend, she got 75 emails through the hospital’s website with well wishes from friends, family, and strangers alike. Through numerous updates and even a video interview with the hospital’s director of heart transplant, both Moss and Barnes-Jewish got much deserved attention within the community.
hamelinclara

International Research - Brazil - Research and Trends - PMMI - 0 views

www.pmmi.org/...ResearchDetail.cfm

brazil sumup

shared by hamelinclara on 16 Apr 13 - No Cached
  • PHARMACEUTICAL INDUSTRY ANALYSIS Brazil has the 11th largest pharmaceutical market globally with annual sales topping US$17bn. Brazil launched a major 10-year biotechnology initiative in 2007 that provides incentives for private-sector R&D and production. There are some 550 pharmaceutical firms in Brazil. Of the top ten companies by sales in 2008, the first six are all foreign multinational drug makers. Sanofi-Aventis (US$1,229mn in sales) and Novartis (US$1,116mn) are clear leaders, followed by Roche (US$735mn), Pfizer (US$666mn) AstraZeneca (US$584mn) and Eli Lilly (US$545mn). Local firms Aché (US$456mn), EMS Sigma Pharma (US$445mn), Eurofarma (US$424mn) and Biosintética (US$382mn) fill the remaining spots. While this shows the strength of innovation for foreign drugmakers, the presence of five local firms highlights strong competition, as well as the growing use of generic drugs in Brazil. Other leading local producers include Aché/Biosintética, Medley and Libbs. From 2009-2014 BMI forecasts a CAGR of 11.63% for patented drug market in US dollar terms. The projected continuation of sales expansions is one of the key reasons that multinational research-based drugmakers continue to invest in Brazil despite generic competition having eroded some market potential since their inception in 2000. Industry association PróGenéricos has estimated that generics will account for 30% of the market by 2010. Investment reportedly totaled around US$400mn between 1999 and 2006, illustrating not only an expansion of capacity, but also the repositioning of product lines in favor of genuine generics. SOURCE: Business Monitor International
hamelinclara

China bypasses Big Pharma patents, authorizes low-cost generic drug manufacturing - 0 views

www.naturalnews.com/_China_Big_Pharma_patents.html

shared by hamelinclara on 29 Nov 12 - No Cached
  • The Chinese government has officially amended its patent laws to allow drug companies to reproduce generic, low-cost versions of expensive
  • China is considering further strengthening its legal framework, so as to make use of legal space to produce generic drugs
hamelinclara

How Big Pharma Gets Bigger, And What Little Pharma Can Do About It - Seeking Alpha - 0 views

seekingalpha.com/...-little-pharma-can-do-about-it

pharma 2013 Biotechnologies costs

shared by hamelinclara on 13 Feb 13 - No Cached
  • Most of these costs, writes the author Avik Roy, have to do with one specific aspect of the pipeline - phase III
  • Overall, Phase III trials now represent about 40 percent of pharmaceutical companies' R&D expenditures.
  • Phase III trials have become bigger, more complicated, more restrictive, and more time consuming as the years pass. Why should this be so? Is medical technology really getting all that more complicated that progressively more restrictive phase III trials are the only thing standing between global health and a renegade pharmaceutical industry intent on poisoning the human race with wildly experimental drugs?
  • ...4 more annotations...
  • two primary reasons
  • While bureaucrats get a thrill regulating, Big Pharma encourages it. Think about it this way.
  • Three of the most generous also happen to have the most pipeline drugs in phase III this year: Novartis (NVS), Roche (RHHBY.OB), and Sanofi-Aventis (SNY).
  • Let's start with Novartis. Novartis' last dividend was a very generous $2.48 per share annually. That's 4.6% per share since last dividend, and totals over $6B in dividends, which was an impressive 62% of its 2012 income. It spent close to $7B (page 50) in research and development costs in 2012, with around 20 drugs (pages 32-35) currently in phase III trials. No small cap would be able to afford such largesse, but that number is only 12% of its annual revenue. With government keeping out competition and subsidizing consumption, Novartis is sailing the corporatist sweet spot. At least it is nominally returning the favor to its shareholders with a dividend large enough to offset the risk of holding a stock that is near its all-time highs.Roche comes up right behind Novartis with 19 drugs in the pipeline at the all-expensive Phase III. It spent a similar amount of money on R&D as Novartis did at a hefty $8B, which was about 17% of its 2011 revenue. RHHBY is at a similar juncture as NVS. Nearing all-time highs and sailing in the same protected sweet spot. At a $1.84 dividend it is also quite generous with its shareholders, totaling 4.27% per share annually, a total amount of $6.355B forked over to shareholders, which totals just under 60% of its 2012 income, just shy of Novartis'.
hamelinclara

Global Pharma Intelligence: Brazil's EMS laboratories to sell drugs in Turkey - 0 views

www.pharmaintellect.com/...aboratories-to-sell-drugs.html

brazil turkey exportation

shared by hamelinclara on 16 Apr 13 - No Cached
  • hamelinclara on 16 Apr 13
     
    "Brazil's EMS laboratories to sell drugs in Turkey inShare EMS, one of Brazil's largest generic drugs manufacturer, will soon export pharmaceutical products to Turkey. The company recently obtained the good manufacturing practices certificate from Turkey thus marking a symbolic step in the EMS process of international business expansion.  EMS plans to market their specialty products comprising of highly complex medications such as immunosuppressants"
hamelinclara

Aché - 0 views

www.ache.com.br/...biosintetica.shtml

aché biosintética brazil

shared by hamelinclara on 16 Apr 13 - No Cached
  • In 2005, Aché acquired Biosintética Farmacêutica. This acquisition is part of Aché?s strategic plan, which was established in 2004, which aims for, amongst other things, sustained growth, leadership of the domestic market, greater capacity for investment in innovation, and strengthening of the product portfolio. The complementary portfolio and cultural similarities of the two companies were the main factors that led to the acquisition of Biosintética. With this integration, Aché now had 250 therapeutic alternatives and the company moved into new segments such as the cardiovascular area and generic medicines, and the expanded its portfolio in the central nervous system, dermatology, respiratory, oncology and generic medicine areas. Why not visit the Genéricos Biosintética website? - www.genericosbiosintetica.com.br
hamelinclara

DALLAS, Feb. 8. 2013: Pharmaceutical Market & Biotechnology Industry 2013 Outlook in Ne... - 0 views

www.heraldonline.com/...ical-market-biotechnology.html

biotechnology pharmaceutical

shared by hamelinclara on 13 Feb 13 - No Cached
  • Key Topics Covered Value Based Pricing- Strength of Innovation Vs Fiscal Pressures Major therapy areas to shape up pharma business going forward Europe – Regulatory Pressures and Increasing Pro Generic Stance Will US fall to Pricing Pressures? Emerging Markets and their importance in Growth of Large Cap Pharma Global Pharma -Drugs Losing Patent Protection By 2017 Impact of patent expiry in w.r.t. 2012 total revenue thru 2017 Global Pharma Research Pipeline (PhII And PhIII)- 2013 Global Pharma Milestones in 2013 Roche: Breast Cancer Franchise And Actemra To Drive Near Term Growth, And Multiple Blockbusters In Pipeline To Take Care Of Long Term Growth GlaxoSmithKline: Next Generation Bronchodilators, Melanoma, Hiv And Emerging Market To Lead The Way While Regulatory Overhang In Respiratory And EU Pricing Pressure Persist Bristol-Myers Squibb: Pressures To Dominate In The Near Term, Pipeline Will Take Longer To Deliver AstraZeneca: 2013 Will Be A Transition Year And AZN May Have To Take Some Bold Initiatives Eli Lilly: Late Stage Pipeline Fickle And Risky Merck: News-flow from Mega-trial on MRK's cardiology Franchise would reshape Merck's Growth Prospects Novartis: Back on a Growth Trajectory Novo Nordisk: Hemophilia Franchise and Thrice Weekly Degludec – The Future Drivers Pfizer: M&A Only Can Drive Further Upside In The Near Term Sanofi: Solid Base Business, But Upside From Pipeline Will Take Longer To Come About Global Pharma Sector Industry Tables
  • provides valuations and an in depth analyses of biotech companies, their launched drug portfolio and promising drug candidates in the pipeline.
hamelinclara

Is Pinterest the Risk-Free Social Channel for Pharma? - 0 views

blog.pharmexec.com/...free-social-channel-for-pharma

pinterest

shared by hamelinclara on 14 Jul 13 - No Cached
  • hamelinclara on 14 Jul 13
     
    "I recently came across a blog post headlining Pinterest as the "safest place" for medical marketers to start with social media. All too aware that there are many Pharma marketers out there still a little shy of social, it was a must read. Launched just three years ago, Pinterest has enjoyed phenomenal expansion of its user base, posting growth of 1,000 percent in 2012. As of June 2013 it had more than 48 million users, generating 2.5 billion page views a month. With a demographic skewed heavily towards 25 to 34 year-old women, half of them with children, the potential for marketers seems real. If you're not sure exactly what Pinterest is, imagine a huge virtual pinboard where users display pictures they like. Users can pin up their own images, but mostly they pin images from other people's websites or re-pin images previously posted on Pinterest - 80 percent of the images on Pinterest have been re-pinned, or shared, within the network. It's this re-pinning that makes Pinterest interesting for brands - the opportunity to harness the viral power of social sharing is enormous. In a recent adoption rates study, social media analytics firm Simply Measured reported that 69 percent of the Interbrand top 100 brands are on Pinterest."
hamelinclara

Why Big Pharma Won't Get Its Piece Of The $1.2 Trillion Global Drug Market - Forbes - 0 views

www.forbes.com/...-while-big-pharma-treads-water

shared by hamelinclara on 29 Nov 12 - No Cached
  • he United States will command a smaller piece of the pie while still being the largest single drug market. I
  • The U.S. still spends more per capita on medicine than any other nation
  • As per-capita income increases, say, from $500 to $5,000, a medicine’s cost as a percent of that income drops by an order of magnitude
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  • In these markets, the reports says, 65% of about $360 million in sales will be from generics.
hamelinclara

Pharmaceuticals: Companies will focus on external partnerships to improve productivity ... - 0 views

cen.acs.org/...cus-external-partnerships.html

phara 2012 2013

shared by hamelinclara on 20 Jan 13 - No Cached
  • If the buzzword for the pharmaceutical industry in 2012 was “patent cliff,” the key theme for 2013 is “partnership.”
  • maller R&D organizations and budgets, drug companies are putting more emphasis on working relationships with biotech firms or with academia
  • collaboration
  • ...4 more annotations...
  • pharmaceutical leader for the consulting firm Ernst & Young.
  • Patrick Flochel
  • While trying to make their own research efforts more productive, companies are filling gaps in their drug pipelines through acquisitions.
  • n exception may be AstraZeneca, which lost its patent for the antipsychotic drug Seroquel and was hit hard by generics competition. “AstraZeneca is in a pretty dire situation,” Latwis says.
hamelinclara

PharmTech Talk » Pharma's Reputation in Decline - 0 views

blog.pharmtech.com/...2%80%99s-reputation-in-decline

reputation pharma

shared by hamelinclara on 17 Jan 13 - No Cached
  • Respondents indicated several reasons for the overall decline: inappropriate marketing of drugs perceived lack of transparency, especially in reporting results from clinical trials some drug prices are still unaffordable to many patients and payers, giving the general impression that profit comes before patients.
  • Drug development is expensive; far more expensive than many average patients and consumers will ever understand
  •   patient-centredness, patient information, patient safety, useful products, transparency and integrity, so these represent good areas for companies seeking to boost their reputation to scrutinise.
hamelinclara

Pressure mounts to end US pharma pay-for-delay deals - FRANCE 24 - 0 views

www.france24.com/...-end-us-pharma-pay-delay-deals

shared by hamelinclara on 20 Jan 13 - No Cached
  • US senators are introducing legislation to end pay-off deals that keep generic drugs off shelves and give pharmaceutical giants market exclusivity that costs consumers billions of dollars per year.
  • pay-for-delay" agreements
hamelinclara

The search for blockbuster drugs - McKinsey Quarterly - Health Care - Pharmaceuticals - 1 views

www.mckinseyquarterly.com/rch_for_blockbuster_drugs_1474

blockbuster drugs Pharma

shared by hamelinclara on 09 Jan 13 - No Cached
  • "me-too" compounds,
  • heir efficacy, or comparative effectiveness in treating a specific disease
  • safety, including issues such as side effects and drug interactions
  • ...10 more annotations...
  • the breadth of their approved uses
  • convenience, including longer-lasting formulas and easier application
  • highly effective,
  • costly and inconclusive.
  • By contrast, many companies have had more success with efforts to improve the safety of products or to get them approved for use in treating additional diseases. Examples are Pfizer's Neurontin, a successful antiepilepsy medication driven predominantly by perceptions of safety differences, and the company's Celebrex, a Cox-2 inhibitor that reduces pain and inflammation and is thought to be easier on the stomach than aspirin. The breadth of approved uses for drugs can also be a significant source of differentiation. We found that nearly two-thirds of those in competitive therapeutic areas, such as depression and allergies, went on to receive regulatory approval for a broader range of treatments after they came on the market (Exhibit 2). Eli Lilly's Prozac, for example, was launched in 1987 to treat depression but has since been approved for use in a range of conditions. Today, drugs entering these competitive areas often need to have a similarly broad range of regulatory endorsements at the time of their launch, thereby raising the bar for compounds in development
  • pharmaceutical companies might rethink their strategies for clinical trials
  • oo many companies commit a disproportionate amount of their time and money to discovering first-in-class compounds when best-in-class opportunities might yield higher returns
  • Second, efficacy shouldn't be pursued at the expense of other sources of differentiation; claims of safety, pharmacokinetics (that is, dosing), and convenience may be as desirable and more clinically attainable
  • one meaningful point of differentiation and scuttle drugs that have even a single subpar attribute.

  • Of the recent blockbusters we analyzed, 59 percent were superior to the competition in only one area, while just 14 percent were superior in two, and no drug was the leader in three or more (Exhibit 3). While some of the remaining 27 percent were distinctive at launch, they are now comparable to their competitors in all significant dimensions but continue to be marketed more effectively. Yet drugs with even a single subpar attribute were generally commercial failures.1

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    These

hamelinclara

Trius: In An About Face, Congress Is Helping Biotech Companies That Are Developing Anti... - 0 views

seekingalpha.com/...hat-are-developing-antibiotics

trius pharma US

shared by hamelinclara on 15 Jan 13 - No Cached
  • The implications for Trius (TSRX) and other leading biotechnology companies involved in antibiotics development are profound.
  • ost large pharmaceutical and biotechnology firms have avoided antibiotics for much of the past two decades in large part due to the intrusion of Congress into the regulatory process
  • The most visible sign of this shift in attitude came from Congress with the passage of the Generating Antibiotics Incentives Now Act or GAIN which became effective on October 1, 2012. This was intended to spur development of new antibiotics through streamlining a regulatory process which has been oppressive for much of the last decade. Responding to the prompting of Congress, I expect the FDA to approach regulatory approval of new antibiotics with the same sense of urgency as drugs for cancer. The end result will be quicker approval of new drugs and new indications for existing antibiotics.
  • ...3 more annotations...
  • Antibiotics were major drivers of sales growth for the pharmaceutical industry in the 1970s, 1980s and early 1990s which caught the attention of the industry's many critics. A consensus developed among politicians, consumer groups and payors that there was no need for new antibiotics as most bacteria were susceptible to existing products. They saw new antibiotics as offering no advantages over existing drugs even though they were priced many times higher. Faced with this hostile environment, drug companies began to de-emphasize antibiotic research and focus on trendy new areas like depression, cholesterol lowering, gastrointestinal reflux disease, etc.
  • Adding to the move away from antibiotic development was considerable scrutiny about side effects that the industry came under in the early part of the 2000s. A major catalyst for this was the Vioxx side effect issues that caused Merck (MRK) to withdraw this anti-inflammatory drug from the market in 2004
  • ooking beyond the GAIN Act, infectious disease experts, FDA and industry are working on proposals for a new restricted approval pathway that would speed the development of new antibacterial drugs and could address some of the economic disincentives that have driven most pharma companies out of the space. A drug's safety and effectiveness would be studied in substantially smaller, more rapid, and less expensive clinical trials, like those typically used to support Orphan Drug approvals. They would be narrowly indicated for use in small, well-defined populations of patients for whom the drugs' benefits have been shown to outweigh their risks. It would slash the number of patients required to gain approval from about 1,400 for the typical antibiotic indication to 100 or less, cut development time in half, and reduce regulatory uncertainty
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