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Today's Top Stories
1. New cancer drugs help spur drug approvals to 16-year high
2. Last-minute drive at FDA added 6 new drug approvals
3. AbbVie celebrates New Year's Day as a big new biopharma player
4. BGI clears hurdle in buyout of Complete Genomics
5. Cambridge market sizzles as biotech ditches the burbs
Also Noted: FGI Research
Spotlight On... Research groups relieved by last-minute deal to delay sequestration
Synergy reports PhIIb/III success for constipation drug; Warburg Pincus pays $195M for JHP; and much more...
 iPad app garners kudos for boosting lab productivity
BioData picked up a nod from The Scientist for its web application called Labguru. Named among the magazine's Top 10 Innovations of 2012, the app offers scientists the ability to manage their lab work on their desktop or iPad easily and inexpensively. Israel-based BioData announced the release of Labguru in December 2011 and offers a basic version of the app to individuals for free, enabling them to plan and track experiments, among other things. Read the story >>
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Today's Top News
A run-up of new drug approvals in the last two weeks of the year pushed the FDA's record to 39 new drug sanctions in 2012, almost twice the number approved just two years ago and the highest figure the agency has seen since 1996, when 53 new molecular entities crossed the finish line.
Regulatory OKs represent a crucial industry metric, underscoring whether an industry that spends tens of billions of dollars on R&D while racking up a terrible productivity rate over more than a decade can reform itself in time to counter the loss of tens of billions of dollars in revenue from old products now facing generic competition. Two years of encouraging improvement, though, aren't enough to satisfy some longtime industry observers who want to see whether these new drugs can live up to their peak sales estimates.
"The patent exposure will be less going forward, but where there is still a little bit of uncertainty is how much better the pipelines have become and how strong the recently approved products are," Damien Conover, Morningstar's director of pharmaceutical research, tells Reuters' Ben Hirschler.
Two big trends leap out of the numbers. One-third of these new drugs approved in the last 12 months are for cancer, underscoring the big investment being made in oncology as an improved understanding of the genetics involved in the disease is opening the door to new treatments--some of which are coming down the pipeline at a relatively rapid pace.
Another big trend: New drugs for rare diseases are also making their debut, underscoring the industry's eagerness to advance high-priced therapies for small patient populations as they follow a playbook written by pioneers like Genzyme.
The approvals we're seeing now are the result of strategic shifts at Big Pharma as well as biotech dating back 5FDA years or more, with some smaller companies like Ariad and Ironwood going all the way through to an approval without giving up primary marketing rights. And there could be some real momentum building up as developers start making smarter choices.
"The sheer number I think support the correctness in some of the strategy shift of the pharmaceutical companies over the last number of years," Rick Edmunds, a senior partner at Booz & Co., tells Bloomberg. The rate "implies pharma growth potential to 2015 and beyond."
- here's the Reuters story - read the Bloomberg report
Special Report: FDA approvals of 2011
Related Articles: Can Big Pharma sustain a swelling rate of new drug approvals? FDA matches most new drug approvals in years in 2012, but is it enough? Big Pharma earns mixed grades on late-stage drug development report card Science advisors lay out ambitious plan to double FDA approval rates
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By John Carroll and Ryan McBride
The push to a record rate of new drug approvals required a big fourth-quarter effort on the part of the FDA. In December the agency handed out 8 new drug OKs, and six of them came in the waning days of 2012, after FierceBiotech had begun its official publishing break for the holidays. Our readers who regularly check our website know that we kept up with the news online. But for everyone else, here's a roundup of the regulatory actions you may have missed:
- On the last day of 2012 the FDA OK'd Salix Pharmaceuticals' crofelemer for use in treating HIV-related diarrhea. The drug, to be marketed as Fulyzaq, is derived from the red sap of the Croton lechleri plant, making this the second botanical drug ever approved by the agency. Analysts don't expect the drug to be a big earner. A Bloomberg report in September noted that the average sales estimate for 2014 was only $33 million. But the agency notes that HIV/AIDS patients often suffer from diarrhea, forcing them to switch their treatments, making this a significant advance for that patient population. And Salix ($SLXP) has counted on Fulyzaq to broaden its product line. Story
- Another drug to barely make the end-of-year deadline was Johnson & Johnson's bedaquiline, the first new treatment for drug-resistant tuberculosis in four decades. The approval was based on midstage data after J&J ($JNJ) made its case that the urgent need for a new TB therapy warranted an OK ahead of Phase III results. J&J will sell the drug as Sirturo, part of a combination therapy that will now be available as a last-ditch treatment for patients who have failed standard remedies. The FDA handed out the accelerated approval based on rules that allow the agency to green-light a therapy on efficacy data based on a surrogate endpoint. Report
- The big approval in this last wave of regulatory nods was reserved for Eliquis, the clot buster from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE), which garnered the agency's stamp for use in certain patients with atrial fibrillation. Bristol and Pfizer--which have suffered from generic competition to the big-selling meds Plavix and Lipitor, respectively--have now won approval for the most lucrative use of the drug in the world's top healthcare market. The FDA sanctioned the bloodthinner for reducing risk of stroke and blood clots in patients with nonvalvular atrial fibrillation, saying that the drug shouldn't be used in patients with artificial heart valves or defective heart valves. Report
- Alexza Pharmaceuticals ($ALXA) won an early Christmas present when the FDA handed out a long-sought approval for an antipsychotic drug called Adasuve. Wasting no time, the company plans to push the inhaled med onto the U.S. market early in the first quarter of 2013. U.S. regulators stamped an approval of Alexza's inhaled version of the antipsychotic drug loxapine for adults struck with agitation linked to schizophrenia or bipolar disorder. The approval comes with warnings about serious adverse events such as potentially lethal bronchospasms and increased risk of death in elders with dementia-related psychosis. Report
- The FDA also approved Aegerion's ($AEGR) new drug for homozygous familial hypercholesterolemia on Christmas eve, clearing a path to begin commercialization as the biotech comes to a major turning point. Lomitapide will now hit the market as Juxtapid featuring a boxed warning about the distinct threat of liver toxicity. "We are excited that Juxtapid will become a new treatment option for patients with HoFH," said Marc Beer, the CEO at Aegerion. "The approval of our first product also marks an important corporate milestone for Aegerion and reflects our commitment to help patients in need." Story
- And near the end of the day on Dec. 21 the FDA stamped an approval on NPS Pharmaceuticals' ($NPSP) Gattex for treating patients with short bowel syndrome. The approval sets the stage for the U.S. launch of the company's lead drug. The sanctioning of Gattex isn't a big surprise. FDA advisers unanimously endorsed the drug, which helps patients with the syndrome reduce their dependence on IV feeding, for approval in October. And most of them backed the REMS plan from the company to monitor cancer and other risks associated with the therapy. Article
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The biopharma industry rang in the New Year with a big independent player to add to its roster. After 15 months of planning, AbbVie ( $ABBV) has split away from Abbott ( $ABT), complete with a pipeline of more than 20 mid- and late-stage therapies, $18 billion in revenue and a commercial operation that spans the globe.
AbbVie's biggest strength is also its biggest weakness. Its blockbuster drug is Humira, which earns about half of its revenue. Now the number one drug in the world by sales, Humira is expected to earn $10 billion this year, dominating the rheumatoid arthritis market. But the big money train will start to slow in 2016, when Humira loses patent protection and faces less-expensive knockoffs. The market for follow-on therapies isn't like the traditional generic market--which can blast revenue from traditional small molecule drugs in a matter of weeks--but AbbVie will have to look to its R&D group to provide new products for growth.
That's why in today's press release AbbVie is heralding its pipeline work. AbbVie has been a busy dealmaker in the past year, signing some big pacts with biotech companies. It's made headlines with a compelling hepatitis C program and is working in rheumatoid arthritis, psoriasis, multiple sclerosis, Alzheimer's disease, Parkinson's disease, spondyloarthropathies, multiple myeloma and endometriosis.
Conspicuously missing from that list is chronic kidney disease. In the lead-up to the corporate split Abbott committed close to a billion dollars in upfront payments and near-term cash to partner on Reata Pharmaceuticals' bardoxolone and a next-gen portfolio of CKD drugs. But the Phase III program was shuttered in October after the drug was linked to a higher rate of death. Since then, virtually nothing has been said about it.
- here's the press release
Related Articles: AbbVie shares fall in first day of 'when-issued' trading AbbVie to ring in 2013 as an independent drugmaker AbbVie raises $14.7B for spinoff in record bond issue
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BGI-Shenzhen nailed down U.S. government approval for its controversial buyout of Complete Genomics ( $GNOM), which would expand the Chinese sequencing powerhouse's technological capabilities in the competitive business of decoding DNA for medicine and agriculture. The company revealed the win over the weekend.
This might be an unwelcome development for Illumina ( $ILMN), the largest provider of DNA sequencers in the world. Illumina has hotly contested BGI's purchase of financially strapped Complete, offered to marginally top BGI's bid for its Mountain View, CA, competitor, and has hired lobbyists to drum up opposition to the BGI deal on Capitol Hill, as The New York Times reported.
As the Times' Andrew Pollack points out, Illumina has stoked concerns about potential--and what some interpret as unlikely--threats to U.S. national security as a result of the Chinese firm's takeover of Complete. And its fight against the deal strikes nationalistic tones, including keeping sequencing secrets in U.S. hands, which clash with the international spirit of the Human Genome Project to map the code of life.
BGI, formerly known as Beijing Genomics Institute, was an active player in the Human Genome Project. It's expanded in the U.S. and Europe with new offices and collaborations with Western pharma companies, top hospitals and academics. Yet the firm primarily acts as a service provider, relying on machines from Illumina and others to sequence genomes for customers.
A key to the Complete Genomics deal is that BGI would acquire technology for sequencing genomes, which could make the company less dependent on other companies for sequencing tech.
With the recent clearance from the Committee on Foreign Investment in the United States, the acquisition still needs an OK from the Federal Trade Commission, Pollack reported.
- here's the release - see the Times' article
Related Articles: China's BGI strikes deal to buy Complete Genomics for $117.6M Illumina gets dose of its own medicine, spurned by Complete Genomics Complete Genomics axes 55 staffers |
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| George Scangos, CEO of Biogen Idec |
The foibles of the country's real estate market are largely absent in biotech's boomtown. Like pioneers rushing for gold, biotech and pharma outfits have swept into Cambridge, MA, and dismissed the hefty property costs in search of talent and technology that could lead to lucrative new drugs.
In a New York Times article, Biogen Idec ( $BIIB) CEO George Scangos serves as a leading mover in the industry's rush to Cambridge. After Scangos took the top job at Biogen in 2010, he quickly jettisoned his predecessor's plan of keeping business folks and executives a half-hour outside Boston in Weston, MA, while R&D stayed in Cambridge. And now Biogen is planning to ditch its HQ in sleepy Weston for a new $500 million facility under construction in the biotech hotbed of Cambridge.
Of course, Scangos has plenty of company. As the Times reports, the biotech industry's growth is the leading factor in the whopping 3.4 million square feet of space at various stages of construction or planning in the city that sits across the Charles River from Boston.
Pfizer ( $PFE) has been moving research and hundreds of employees to Cambridge as it exits facilities in Groton, CT, Sandwich, U.K., and elsewhere. Novartis ( $NVS), which houses its global R&D operation in Cambridge, is erecting two major buildings there at a cost of $600 million. The list goes on.
In general the burbs outside Boston offer cheaper digs than the city. Yet biopharma isn't the insurance industry. It needs copious inventions to thrive. And the cost of real estate in Cambridge--which offers a smorgasbord of biotech talent and innovations--has become another cost of doing business for a bevy of biotech and pharma outfits.
"It's an amazing place to be," Scangos told the Times. "The intellectual firepower that is in Cambridge, between Harvard and MIT and the number of companies, is quite remarkable."
- check out the Times article
Related Articles: Bustling biotech pushes Cambridge, MA surge in VC deals, dollars Massachusetts plants seed for new biotech destination
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As a pharma or bio-pharma decision maker, we invite you to share your experience and opinions towards drug safety activities in your organization.
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Lawmakers have kicked the threat of sequestration down the road a bit, triggering some relief in the biomedical research community, which was staring down the sudden elimination of $2.5 billion in funding for the NIH. The NIH budget, the mother lode of money for basic and increasingly translational research work in the U.S., was to be slashed 8.2% unless Congress reached a deal. And every research organization in the country had been complaining loudly of the impact that would have on a research community which still sees itself as largely underfunded. The two-month delay in reaching a final deal, though, won't eliminate the threat. And the lingering fear of sequestration is spurring many of the same groups to continue their fight. "The (American Society of Hematology) will educate Congress about the value of biomedical research so that all members of the new 113th Congress understand that this is not the time to defund science and that discoveries made possible by investments in NIH generate incredible returns in the form of lives and jobs and importantly help secure America's position as a global economic force," ASH noted in a release.
Conversation on Twitter :
@FierceBiotech: Preclinical breast cancer finding could change tamoxifen use. Story | Follow @FierceBiotech
@JohnCFierce: It's official. 39 new drugs approved in 2012, highest since 1996. Big step in the right direction. More | Follow @JohnCFierce
@RyanMFierce: Qualcomm backs clinical trials software outfit in $12M round. News | Follow @RyanMFierce
> Shares of Synergy Pharmaceuticals ($SGYP) got a big boost today after the biotech announced that its Phase IIb/III study of an experimental therapy for chronic idiopathic constipation (CIC) hit its primary and key secondary endpoints. The developer held back the data for an upcoming scientific meeting but maintained that lead drug plecanatide significantly increased "the number of complete spontaneous bowel movements" along with impacting stool consistency, straining and time to first bowel movement in patients with CIC. The drug is being billed as a potential competitor to Ironwood's Linzess ( linaclotide). Shares were up 13% today in midmorning trading. Release
> Private equity player Warburg Pincus has stepped in to buy contract manufacturing company JHP Pharmaceuticals for $195 million. JHP manufactures injectable products for clinical trials as well as for commercial distribution. Release
> Vernalis says that it has achieved a third milestone in its drug discovery collaboration with H. Lundbeck, triggering payment of £0.75M. Release
> Takeda writes off its $1B obesity deal with Amylin. Article
> Infinity pays $15M to tailor its deal with Takeda. Story
> New Teva CEO dumps cancer drug pact with Proteologics. More
> Biogen Idec to offset tax burden for workers in same-sex relationships. More
> Omeros again falls short in PhIII trial with drug for knee surgery patients. More
Medical Device News
@FierceMedDev: Diabetes light Dx begins U.S. trial. Story | Follow @FierceMedDev
@MarkHFierce: Dune Medical won an FDA nod for a new tool designed to find cancerous tissue. The company is a rumored M&A target. Report | Follow @MarkHFierce
@DamianFierce: DJO Global scoops up Minnesota maker of heat-sensitive casts. More | Follow @DamianFierce
> FDA confronts Mindray over patient monitor quality control. News
> Quest Diagnostics slims down for the new year. Story
Pharma News
@FiercePharma: AbbVie is pharma's first birth of the new year. Story | Follow @FiercePharma
> Sun chief eyes more deals, European and otherwise. News
> Cancer meds now drugs of choice among counterfeiters . Article
CRO News
> India group wants change in clinical trial regs for children. Report
> WuXi, PRA plan to launch joint venture in China. News
> Chinese CRO ShangPharma looks to go private. Article
> goBalto rakes in $12M for cloud-based clinical development. Story
Biotech IT News
> Interview: Stanford's Butte on bridging gap from Big Data to biotech discoveries. Item
> iPad app garners kudos for boosting lab productivity. News
> Qualcomm backs clinical trials software outfit in $12M round. Story
Biotech Research News
> Preclinical breast cancer finding could change tamoxifen use. Item
> Enzyme inhibitor could be key to treating malaria. Report
> Scripps drug reduces, reverses fatty liver disease. News
> Chemo combo shows promise against glioblastoma. Article
> Stem cells step forward in ALS. Story
Drug Delivery News
> Radius, 3M update transdermal osteoporosis treatment agreement. News
> Arrowhead polymers boost siRNA delivery 500 times. Story
> Japan welcomes Neupro patch for restless legs and Parkinson's. Article
> QLT signs eye delivery tech option deal with former CEO. Report
> AstraZeneca hitches cancer drug hopes to CytImmune's nano-gold standard. Item
And Finally… Lean and mean may not win the longevity race after all. Reviewing group of studies covering close to 3 million people, investigators found that the pleasantly plump appear to have the lowest risk of death. Story
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> Life Sciences Ontario (LSO) Launches New Interactive Asset Map
LSO has launched the new Ontario Life Sciences Asset Map, an interactive directory and information platform profiling organizations across the province. Find out why Ontario is a global leader in life sciences by exploring the new Asset Map on our website at: www.lifesciencesontario.ca
> DCAT Week '13 - March 11-14 - New York, NY
DCAT Week is one of the largest gatherings for the pharmaceutical manufacturing and related industries. Download our brochure and learn more about DCAT's education programs, including two unique biologic programs focusing on drug delivery systems for the future and single use technologies.
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> Research: Key Findings: Pharmaceutical Diversification Trends 2012
Pharmaceutical companies are facing unprecedented pressures including revenue loss due to the patent cliff and growing healthcare cost containment measures introduced in most developed markets. As a result, they have been forced to reassess their strategies, with diversification beyond branded small molecule products and branded pharmaceuticals in general representing an obvious route. Download this report.
> Survey: Drug Safety Activities
As a pharma or bio-pharma decision maker, we invite you to share your experience and opinions towards drug safety activities in your organization. Click here to complete this survey. In appreciation of your time, the first 50 qualified respondents will receive a $5 Starbucks eCard.
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> Clinical Project Manager - Cambridge, MA or Oxford, UK - Summit plc
Summit is focused on the discovery and development of novel drug canddidates to treat areas of high unmet medical need. The Clinical Project Manager will be responsible for all aspects of Clinical Trials Management for the assigned project. Responsibilities include study design; selection and management of CRO's and clinical trial sites; and scheduling, review, analysis, and reporting of clinical trials. The successful candidates will be educated to degree level or equivalent in a relevant scientific field, with extensive experience in clinical development and a proven track record in clinical project leadership... Learn More.
> Medical Director/Senior Medical Director - Waltham, MA - TESARO
TESARO is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients. The Director/Senior Director will be responsible for developing the clinical trial strategy, designing clinical trials in consultation with expert clinicians in the medical community and colleagues at TESARO, helping to identify key sites for the studies, serving as a key strategic and medical point person during the conduct of the trials, monitoring safety of ongoing trials and leading efforts to analyze and present data from clinical studies. MD/PhD preferred... Learn more.
> Manager/Associate Director, Product Management - Cambridge, MA - bluebird bio
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. In this new role reporting to the VP Program Management and Commercial Development, this Product Manager will have the opportunity to help lead development of our content and communications activities that will ultimately lead to product launch. 5+ years of experience developing content in a Biotech/Pharmaceutical (FDA-regulated) environment required... Learn more.
> Specialist, Patient Support Job - Berkeley Heights, NJ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Patient Support Specialist will serve as dedicated point of contact for healthcare providers/patients for their reimbursement and access needs. The Specialist will help patients and healthcare providers navigate through patient support and reimbursement issues and partner with Commercial organization as needed to meet customer needs and develop patient access solutions. Bi-lingual, Spanish speaking preferred... Learn more.
> Sr. QC Analyst – 2nd or 3rd Shift Job - Phoenix, AZ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Senior Analyst performs and documents testing to support routine and non-routine analysis of utility, raw material, in-process, finished product, stability, customer complaint and validation protocol samples. Daily work hours may occasionally extend to up to 12 hrs. on an as-needed basis... Learn more.
> Director, Strategic Marketing Job - Warren Township, NJ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. This position has leadership of all indication and market research, product planning and commercial activities to guide Cell Therapy R&D at CCT, and is the primary contact point for liaison with Celgene on all aspects of pricing/reimbursement, strategic market access and commercial strategy. BS degree in science/engineering and MBA required... Learn more.
> QC Analyst – 2nd or 3rd Shift Job - Phoenix, AZ, US – Celgene Corporation
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Analyst performs and documents testing to support routine analysis of utility, raw material, in-process, finished product and stability samples. The incumbent assures individual compliance with the DEA and FDA regulations, cGMP's and applicable department programs, including training, documentation, standard operating procedures, and Abraxis policies and procedures. Performs shift work as assigned... Learn more.
> Clinical Lab Scientist - Permanent Job - Menlo Park, CA, USA – Yoh
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> Scientist Job - Cambridge, MA, USA – Yoh
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> Associate Scientist Job - Sellersville, PA, USA - Yoh
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> Clinical Statisticians - Permanent Job - King of Prussia, PA, USA – Yoh
Yoh has multiple direct hire opportunities for Statisticians in Clinical Research for our client based in the Philadelphia area. This position will conduct basic statistical analysis in support of clinical research studies as specified in statistical analysis plans, including statistical graphics. One to three (1-3) years of experience in the analysis of clinical data preferred... Learn more.
> Vice President, Major Gifts – White Plains, NY – The Leukemia & Lymphoma Society
This is an opportunity to become a part of a new and exciting team. Experience in fund raising with exceptional abilities to understand research advancements and communicate them and "out-of-the-box" thinking desired. The VP of Major Gifts will initiate the identification, cultivation, solicitation, and stewardship of prospects capable of making major gifts to LLS…Learn More.
> Vice President, Constituent Experience – White Plains, NY – The Leukemia & Lymphoma Society
VP of Stewardship is responsible for designing a program to steward a cadre of champions who engage in LLS's mission. They will create and execute over-arching stewardship strategy that deepens constituent's understand of LLS's work, design customized strategies for donors, advocates and patients, and help drive all constituents toward renewed/increased involvement…Learn More.
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