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Today's Top Stories
1. Biotechs choose Celgene, Novo Nordisk over pharma giants as preferred partners
2. Buyout buzz: Biopharma players staying focused on bolt-on deals
3. Payer risk outrivals regulatory jitters as biggest biotech hurdle
4. Medicines Co. spikes after anticlotting drug impresses in second run at PhIII
5. Baxter preps BLA on successful end to PhIII hemophilia drug study
Also Noted: Spotlight On... Novartis CEO pay cited as Swiss weigh limits to exec compensation
Teva expands work on women's health; Evotec AG collaborates with Yale; and much more...
![]() Teva CEO says job cuts are small part of efficiency plans
Teva Pharmaceuticals ($TEVA) CEO Jeremy Levin is determined to convince investors that the drugmaker is on the upswing these days. With some refocusing and restructuring, the generics giant can find a new path to the glories of yesteryear, Levin contended at the J.P. Morgan Healthcare Conference. And that restructuring--i.e., cost-cutting--won't require a major hit to payroll, he said. Read more >>
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There's no part of the business more in need of metamorphosis than R&D, and no one more convinced of it than pharma's movers and shakers.
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> Clinical Project Manager - Cambridge, MA or Oxford, UK - Summit plc > Specialist, Patient Support Job - Berkeley Heights, NJ, US – Celgene Corporation > Sr. QC Analyst – 2nd or 3rd Shift Job - Phoenix, AZ, US – Celgene Corporation > Director, Strategic Marketing Job - Warren Township, NJ, US – Celgene Corporation > QC Analyst – 2nd or 3rd Shift Job - Phoenix, AZ, US – Celgene Corporation > Clinical Lab Scientist - Permanent Job - Menlo Park, CA, USA – Yoh > Scientist Job - Cambridge, MA, USA – Yoh > Associate Scientist Job - Sellersville, PA, USA - Yoh > Clinical Statisticians - Permanent Job - King of Prussia, PA, USA – Yoh > Clinical Data Manager/Senior Clinical Data Manager - Waltham, MA – TESARO > Senior Clinical Trial Manager - Waltham, MA – TESARO > Vice President, Major Gifts – White Plains, NY – The Leukemia & Lymphoma Society > Vice President, Constituent Experience – White Plains, NY – The Leukemia & Lymphoma Society
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Today's Top News
Big Pharma companies love to hear it when new industry surveys put them at the top of the industry heap as a go-to source for new licensing deals. But a new Boston Consulting Group (BCG) review found that smaller companies--specifically, Celgene ( $CELG) and Novo Nordisk ( $NVO)--now sometimes jump ahead of giants such as Merck ( $MRK), Roche ( $RHHBY) and GlaxoSmithKline ( $GSK) as the industry's preferred partner of choice.
The allure of the Big Pharma companies has long been understood to center around deep pockets, powerhouse R&D efforts and long experience with the regulatory acts and commercialization. But BCG's new survey, unveiled at the J.P. Morgan Healthcare Conference, concludes that many of the traditional attractions of the giants have lost their luster, essentially getting "commoditized" along the way.
Those smaller companies are breaking out of the pack based on their increasing flexibility on deal terms and a better reputation for their executive teams. Novo Nordisk ranked second in the tally of all attributes, while Celgene came in on top for its "positive impression among core companies." That ranking might also have something to do with Celgene's willingness to put its cash where its mouth is.
But it wasn't all bad news for the pharma giants, either. GSK ranked high and Roche got the highest score on all partnering attributes. Merck was nominated most frequently for top partner, and AstraZeneca ( $AZN), long a laggard in this survey, also finished in the top group of performers.
These changes in rankings, though, come as the top 10 pharma companies account for a shrinking percentage of deals. They now account for a minority number of pacts, says BCG, while licensing transactions overall remains steady.
- here's the study from BCG
Related Articles: Smaller drugmakers beat Big Pharma in partnering popularity contest Celgene chief aims to double sales to $12B by 2017 Celgene chief Hugin wows J.P. Morgan with blockbuster plans for 2013 Celgene wraps $500M deal to partner with Sutro on next-gen ADCs |
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The buyout buzz in San Francisco this week has focused consistently on Big Pharma's hefty appetite for the kind of bolt-on deals that can boost product lines and pipelines. But there's hardly a hint of any interest in the kind of mega-mergers that redefined the industry's landscape a few years ago. And the newly spun-off AbbVie ( $ABBV) wasn't about to change the careful pace at J.P. Morgan.
"We are not really in a situation where we need to go and do a big deal," CFO Bill Chase told Reuters. "It doesn't seem to us to be a prudent way to use our cash."
What does seem sensible, he added to the wire service, were some more licensing pacts and what he termed "tuck-in acquisitions," which can be loosely translated as a bolt-on buy. Any deals AbbVie may do will have to sync with the pipeline. Newly spun off after its split with Abbott ( $ABT), the pharma company says it has 10 late-stage drugs and a similar number in mid-stage development.
AbbVie's big product is Humira, which loses patent protection in 2016. Now it's looking to a promising hepatitis C drug along with other experimental products to take its place as the $10 billion therapy takes on less expensive biosimilars in a few years. There's no sign that AbbVie's newly independent executive crew is anywhere close to hitting the panic button.
Vertex ( $VRTX), one of AbbVie's rivals in the race to develop a next-gen hep C drug, was just as eager to put a damper on any speculation that it was hunting for a big buyout.
"Our priority is to develop our medicines," CEO Jeffrey Leiden told Bloomberg. "If we see appropriately priced deals, we'd consider them; those usually end in 'millions,' not 'billions.'"
- here's the article from Reuters - here's the Bloomberg report
Commentary: E&Y: As Big Pharma falters, Big Biotech helps fill a $100B M&A firepower "gap" | Expect bold moves in the biopharma industry in 2013
Special Report: The top M&A dealmakers in biopharma
Related Articles: AbbVie is pharma's first birth of the new year Is Big Pharma on the verge of a buying spree? Biotech buyout buzz swells as industry's dealmakers flock to J.P. Morgan confab Pharma M&A takes nosedive, except in China |
Another trend we're hearing a lot about at the J.P. Morgan confab this year is the increasingly aggressive role that payers are playing when it comes to the growing number of pricey therapies coming out of the industry pipeline. Earlier in the week the California Biomedical Industry Report from BayBio and PwC noted that the biotech execs they surveyed in the state signaled growing fears that reimbursement rather than regulatory approvals loomed as the most worrisome barrier to their business. And today PwC's Health Research Institute stepped up with a new study on the top issues in healthcare, hitting many of the same chords.
"Pharmaceuticals and medical devices play a pivotal role in health outcomes," notes PwC in its new report. "But the path from lab to bedside is often long, arduous, and expensive. And now the final hurdle is not regulatory approval; it's reimbursement."
Clearing the hurdle now requires some careful added attention in the clinic, says the big consulting firm. The best developers will start early at pairing new drugs with diagnostics, a theme likely to be music to the ears of big outfits like Roche ( $RHHBY). And the payers want to see some hard data on comparative effectiveness with rival therapies as they seek out the most cost-effective solutions. After an approval, insurers are also looking to pharma to monitor costs as they shift from simply paying for a prescribed therapy and start reimbursing based on outcomes.
"Getting FDA approval is now one step in the process," says Gail Maderis, the CEO of BayBio, according to a report from Xconomy. "We're seeing a shift in concern from the FDA to insurance coverage. From a company's very early days, corporate partners and venture capitalists now want to know that if a product gets to the market, will it be reimbursed?"
- check out the report - here's the Xconomy story
Related Articles: PwC sees golden era for pharmas that dump the junk, innovate
What's killing biopharma's R&D success rate? |
The Medicines Company got a big boost out of the news that its second attempt to make a great impression in a Phase III trial for its anticlotting drug cangrelor worked out as planned. More than three years ago the Parsippany, NJ-based biotech ( $MDCO) had to suspend a Phase III study of the drug after concluding that it wasn't performing any better than Plavix. But a second take with a large patient population produced a positive result, with investigators claiming a top-line success in hitting the "primary composite efficacy endpoint" for a reduced risk of death, heart attack and stent thrombosis.
The developer now says it's preparing to take the data to the FDA and the EMA later this year in search of an approval. The actual data from the study, which enrolled 10,900 hospitalized patients, is being held back for a scientific meeting.
"The PHOENIX trial was designed with careful consideration of the prior studies to determine whether cangrelor is associated with improved ischemic outcomes compared with the usual treatment of oral clopidogrel [Plavix]," said Stanford investigator Dr. Robert A. Harrington in a press release. "We are grateful to the many investigators around the world who enabled rapid enrollment and the collection of high quality data. We are pleased that the trial delivered such clear results."
Jefferies' Biren Amin has estimated the drug could hit peak sales of $370 million if it can pass muster with regulators. And the turnaround cheered investors, who pushed shares up more than 12% after the news hit. The drug, an intravenous small molecule antiplatelet agent, is designed to thwart the kind of platelet accrual that can trigger blood clots.
"We believe that fast acting and rapidly reversible cangrelor may have an important role to play both in patients undergoing [percutaneous coronary intervention] and in patients who need to discontinue oral P2Y12 inhibitors prior to surgery," said Medicines Co. CEO Clive Meanwell in a release.
- here's the press release - read the AP report
Related Articles: The Medicines Co. abandons blood-loss drug over safety risk Medicines Co. shares plunge on cangrelor trial failure
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Baxter International ( $BAX) reports that its pivotal Phase III study comparing routine preventive use versus on-demand treatment using its anti-inhibitor coagulant complex FEIBA NF for hemophilia passed with flying colors, setting up plans to file for an approval soon.
Routine prophylaxis of the therapy led to a 72.5% reduction in the annual bleed rate among hemophiliacs in the late-stage trial, Baxter noted, adding that it is prepping a biologics license application to be filed in the first quarter of this year.
"Treatment with FEIBA NF resulted in a significant reduction in annual bleed rate of all types of bleeds in the prophylaxis arm as compared to the on-demand arm," said lead investigator Dr. Sandra Antunes. "Three of the 17 intent to treat patients (17.6 %) in the prophylaxis arm did not experience any bleeding episodes during the study, and this is very significant for hemophilia patients with inhibitors."
Baxter says that up to one in three hemophiliacs develop an inhibitor to a product used to treat or prevent bleeding episodes. The presence of an inhibitor makes response to treatment more challenging, and patients with inhibitors have an increased risk of developing complications such as joint damage.
The most commonly reported adverse reactions in the study were hypersensitivity, dizziness, headache, rash, hypotension and hepatitis B surface antibody positive laboratory test result, investigators noted. A temporary spike in hepatitis B surface antibodies was seen, but none of the patients exhibited any sign or symptom of hepatitis B infection.
"One of the greatest remaining challenges in the management of hemophilia is the development of inhibitors, which can lead to more difficult-to-control and sometimes life-threatening bleeding. The FEIBA NF prophylaxis study demonstrates Baxter's dedication to providing treatment options to the hemophilia community, including effective inhibitor management," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business.
- here's the press release
Related Articles: Baxter posts Q3 growth, but device sales slide Biogen streak lives on with upbeat PhIII results for hemophilia A therapy Baxter inks supply deal for key blood-derived meds Baxter to erect $1B plasma plant |
Also Noted
The Swiss are up in arms over executive pay again and, once again, Novartis ( $NVS) executives are key exhibits in their case. This time, a fair-pay initiative will go up for nationwide vote, giving citizens the chance to weigh in on executive compensation. As Swiss Info reports, Novartis' lowest-paid employee would have to work 266 years to earn the $17.1 million (15.7 million Swiss francs) that CEO Joe Jimenez earned in 2011. That's the largest wage gap reported by the trade union Travail Suisse in an annual survey. In third place was Novartis Chairman Daniel Vasella, whose 2011 compensation was 229 times the lowest-paid employee's salary, the union says. Report
![]() @FierceBiotech: Buyout buzz: Biopharma players staying focused on bolt-on deals. Report | Follow @FierceBiotech
![]() @JohnCFierce: Medicines Co. spikes after anti-clotting drug impresses in second run at PhIII. Story | Follow @JohnCFierce
> Teva Pharmaceuticals ( $TEVA) says it plans to boost its work on women's health beyond fertility. Story
> Germany's Evotec AG says it will collaborate with investigators at Yale in the search for new drugs that target metabolic diseases, CNS, immunological diseases and cancer. Release
> GlaxoSmithKline ( $GSK) and Theravance ( $THRX) have filed the LAMA/LABA combo UMEC/VI for approval in Europe. Story
> Onconova Therapeutics has struck a discovery deal with GVK BIO, an Indian CRO, in the hunt for new cancer drugs. Release
Medical Device News
![]() @FierceMedDev: Samsung med device sales spike in 2012. Item | Follow @FierceMedDev
![]() @MarkHFierce: Abbott is beginning a bioresorbable stent trial in the U.S. Big news for the company and its stent rivals alike. More | Follow @MarkHFierce
![]() @DamianFierce: $LIFE is teaming up with Boston Children's Hospital to develop genomics-based diagnostics. News | Follow @DamianFierce
> LabCorp inks companion diagnostic deal with Verastem. News
> JPM: U.S., EU regulators to consider GE's Alzheimer's imaging agent. Story
Pharma News
![]() @FiercePharma: Will Bausch + Lomb choose IPO over a sale to pharma? Related Q: Can Warburg Pincus get its $10B+ asking price? More | Follow @FiercePharma
![]() @EricPFierce: COO Perez says Cubist well positioned in new hospital-centric payer world. "The world has turned and we are Cinderella now." | Follow @EricPFierce
![]() @AlisonBFierce: Altravax landed $1.2M from NIAID to advance its dengue vaccine and hepatitis therapeutic. More | Follow @AlisonBFierce
> AbbVie CFO sees no need for big acquisition. Report
> Swiss insurer jumps into legal fight over Bayer's Yasmin. News
> Teva CEO says job cuts are small part of efficiency plans. Story
Drug Delivery News
> Alnylam prepares for U.K. Phase I and plans for the future. Article
> Agile snags $15M loan to push pipeline products forward. News
> FDA approves EMD Serono-Pfizer's Rebif auto-injector. Item
> FDA grants orphan label to eye cancer chemo-delivery combo. Story
Biomarkers News
> Biomarkers could tag chemo heart risk. Item
> Stem cell factor could improve ovarian cancer prognosis. Article
> Crescendo Bioscience deploys $28M Series D to market RA Dx biomarker test. News
> New target could improve treatment of deadly pancreatic cancer. Story
And Finally… A new poll summary finds strong public support for federally assisted biomedical research. Release
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> The Basics of Biotech 101, 102 & 301 - Individual Session: $129, Full Series: $299
This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Download now.
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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
> 20th Molecular Med Tri-Conference - February 11-15 - San Francisco, CA
Join Us in San Francisco for the 20th Molecular Med Tri-Conference. 3000+ Attendees, 450+ Speakers, 14 Conference Tracks, 60+ Posters. Register by January 11th for final registration savings!
> 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.
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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.
> 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
Yoh has a direct hire opportunity for a Clinical Lab Scientist to join our client in Menlo Park, CA. Under the direction of Technical and General Supervisors, this position will perform laboratory procedures across a broad range of assays and in accordance with standards established in the Clinical Laboratory Improvement Amendments (CLIA). Current California State Clinical Laboratory Scientist License required... Learn more.
> Scientist Job - Cambridge, MA, USA – Yoh
Yoh has a six month contract opportunity for a Scientist to join our client in Cambridge, MA. This is a temporary / contract position for 6 months with a preferred starting date in Feb 2013. The selected candidate will work in a team responsible for the physicochemical and biophysical characterization of protein therapeutics, in particular monoclonal antibodies. Bachelor's degree required, Master's degree preferred in Biochemistry, Analytical Chemistry, or a similar life science field... Learn more.
> Associate Scientist Job - Sellersville, PA, USA - Yoh
Yoh has a contract opportunity for an Associate Scientist to join our client in Sellersville, PA. Job Responsibilities include to conduct laboratory activities required for microbiological environmental monitoring and quality control of culture media. Education Required: A degree in Microbiology, Biology (or related) Life Sciences... Learn more.
> 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.
> Clinical Data Manager/Senior Clinical Data Manager - Waltham, MA – TESARO
Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients. This position will be responsible for providing data management expertise while working within Electronic Data Capture (EDC) environment for oncology clinical trials. The successful candidate will provide support for form design, specification review and effectively manage all aspects of the clinical trial data management process... Learn more.
> Senior Clinical Trial Manager - Waltham, MA – TESARO
Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients. The Senior Clinical Trial Manager will lead the forecasting, planning and manage the implementation of the clinical operational plans in alignment with the company's strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice. Demonstrated knowledge of FDA/EMA/GCP/ICH guidelines... 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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