"The Pink Sheet" DAILY :: Key Developments Shaping the Biopharma Industry

Takeda Continues Emerging Market Emphasis With Acquisition Of Brazil’s Multilab

Fri, 25 May 2012 17:17:19 -0400

Already a player in Brazil, the Japanese pharma will improve its distribution network there thanks to Multilab’s relationships with regional wholesalers and small and mid-size pharmacies.

Vertex's Cystic Fibrosis Drug Kalydeco Given Green Light By EU's Scientific Advisory Panel

j.davis@elsevier.com — Fri, 25 May 2012 17:17:00 -0400

Vertex's cystic fibrosis product Kalydeco is one of five new molecular entities given a positive opinion by Europe's Committee for Medicinal Products for Human Use on May 25, which also included Almirall's novel COPD therapy aclidinium and Novo Nordisk's recombinant Factor XIII.

Cancer Imaging In Clear Cell Renal Carcinoma Gets ODAC Attention As Pipeline Fills

m.berman-gorvine@elsevier.com — Fri, 25 May 2012 15:00:00 -0400

FDA’s Oncologic Drugs Advisory Committee will examine the extent (if any) to which the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information. ASCO abstracts show considerable research interest in the area.

Sangart Completes Its Series G; Looks For Partner

l.lamotta@elsevier.com — Fri, 25 May 2012 14:34:04 -0400

Mid-stage biotech Sangart completes another round of financing and makes big plans for the future of its lead compound for treating tissues deprived of oxygen.

Korea FDA To Consider Substantial Reduction To IND Timeframe

p.chang@elsevier.com — Fri, 25 May 2012 14:00:00 -0400

As Korea competes with neighboring countries to be a regional clinical trial hub, KFDA weighs the advantages of slashing IND timelines from 30 days down to 14 days.

Teva’s New CEO Levin Urges “Fiscal, Strategic Discipline,” Reduces 2012 Guidance

w.diller@elsevier.com — Thu, 24 May 2012 22:18:52 -0400

In a hastily scheduled, between-quarters update, Teva takes down its 2012 guidance issued only five months ago. New CEO Jeremy Levin promises a full strategic rendering by year end, announces long-time Teva exec Allan Oberman as new head of U.S. generics and establishment of a global compliance committee.

Antibiotic Policy Solutions An Ocean Apart Between U.S., EU

l.lamotta@elsevier.com — Thu, 24 May 2012 17:47:02 -0400

Governments are taking on different initiatives to solve the problem of developing products to address worries about drug-resistant bacteria. The EU is helping to fund trials, while the U.S. is offer extended exclusivity.

Pfizer’s Vyndaqel Splits Advisory Committee; Now It Must Move FDA

m.berman-gorvine@elsevier.com — Thu, 24 May 2012 17:30:00 -0400

In mirror-image votes, FDA’s Peripheral and Central Nervous System Drugs Advisory Committee says that there is substantial evidence for surrogate endpoints but not for clinical endpoints for the drug to treat familial amyloid polyneuropathy.

Pfizer Mobile App Includes $4 Copay Card For Lipitor

s.steinke@elsevier.com — Thu, 24 May 2012 17:15:58 -0400

Pfizer introduces a tool that could help keep the brand in patients’ minds when a flood of generics becomes available in June.

Senate Passes User Fee Package With Ease

d.gingery@elsevier.com — Thu, 24 May 2012 17:00:00 -0400

Sanders casts the lone dissenting vote, saying it does not do enough to curb drug costs. Pay-for-delay and drug reimportation amendments fail.

FDA Biologics Sterility Testing Rule Finalized In Just 10 Months

m.berman-gorvine@elsevier.com — Thu, 24 May 2012 16:57:17 -0400

The goal is to streamline the sterility testing requirements manufacturers must fulfill while allowing them to use new methods, but FDA rejected most industry calls to make further changes.

Xarelto, Pradaxa Difficult To Separate After Positive NICE Final Guidance

f.kermani@elsevier.com — Wed, 23 May 2012 19:11:47 -0400

Bayer’s Xarelto has made it into the NHS in England after its NICE recommendation went unchallenged, prompting a head to head battle with Boehringer Ingelheim’s Pradaxa.

ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says

s.sutter@elsevier.com — Wed, 23 May 2012 18:58:06 -0400

Six of 11 members of the Cardiovascular and Renal Drugs Advisory Committee voted against rivaroxaban’s approval for acute coronary syndromes, saying concerns about missing data in the pivotal trial raised doubts about the efficacy results and could not support creating a new standard of care by adding the Factor Xa inhibitor to dual-antiplatelet therapy.

Pfizer Shuffle: Simmons Out, Brandicourt In At Emerging Markets And Established Products Unit

m.goodman@elsevier.com — Wed, 23 May 2012 17:49:51 -0400

David Simmons, head of established products and emerging markets at Pfizer, has jumped ship to lead global CRO PPD Inc. Olivier Brandicourt, currently head of primary care at the big pharma, will take Simmons’ place.

Senate Faces Amendment Gauntlet As User Fee Passage Nears

d.gingery@elsevier.com — Wed, 23 May 2012 17:30:00 -0400

Seventeen amendments will be considered and final passage could come May 24. Along with a ban on generic drug settlements is a proposal to allow members of Congress to observe FDA-industry user fee negotiations.

Autoimmune Drug Reactions To Get Further FDA Research After Ziagen Side Effect Findings

Wed, 23 May 2012 16:00:00 -0400

Carriers of the HLAB*57:01 allele who take Ziagen can come down with severe autoimmune reactions due to a mechanism traced by agency researchers.

FDA Execs Prefer Novel Switch Model Sans Intervention

d.schiff@elsevier.com — Wed, 23 May 2012 14:00:00 -0400

Leaders at FDA’s drug center appear more closely aligned with the OTC industry than with medical professionals’ groups on consumer access to innovative switches. CDER Director Woodcock says the clinical community has resisted switches – and been proven wrong – before.

Track And Trace Negotiations Continue As Senate Works To Cull Amendments

d.gingery@elsevier.com — Tue, 22 May 2012 22:50:29 -0400

Language in manager’s amendment is considered a placeholder, and a resolution could come when the Senate’s FDA user fee bill reaches the conference committee. But first, the bill needs to pass.

Opioid Prescriber Education Mandate Could Be Added To User Fee Bill

d.gingery@elsevier.com — Tue, 22 May 2012 22:04:24 -0400

Sen. Rockefeller introduces amendment that would require 16 hours of training every three years to maintain DEA registration.

Pfizer Vyndaqel Advisory Committee Pits Orphan Flexibility Vs. Data Shortcomings

m.berman-gorvine@elsevier.com — Tue, 22 May 2012 22:02:39 -0400

FDA finds much to question in a single pivotal trial of Pfizer’s orphan drug Vyndaqel (tafamidis meglumine) for familial amyloid polyneuropathy, but the ultra-orphan nature of the disease may outweigh those concerns.

Nexavar Expansion Plans Suffer Another Blow With Failed Phase III Lung Cancer Trial

e.hayes@elsevier.com — Tue, 22 May 2012 18:21:46 -0400

Failed MISSION trial closes a door for Bayer/Onyx’s Nexavar in non-small cell lung cancer. Meanwhile, follow-on regorafenib, also partnered by Bayer and Onyx, is poised for submission in the U.S. and Europe for metastatic colon cancer, with ASCO presentations ahead.

More Competition In Prostate Cancer? Medivation’s Enzalutamide Now With FDA

l.lamotta@elsevier.com — Tue, 22 May 2012 17:52:15 -0400

Medivation and Astellas have submitted their castration-resistant prostate cancer drug enzalutamide to FDA and hope to gain priority review for the long-anticipated therapy.

Chelsea’s Northera Plan: Expand Ongoing Study While Assuring Integrity Of Older Data

s.sutter@elsevier.com — Tue, 22 May 2012 17:10:55 -0400

Chelsea said it will address FDA’s “complete response” letter by modifying and enlarging an ongoing droxidopa clinical trial and submitting all patient source documentation from an ex-U.S. study site in the completed pivotal trial that the agency has called into question.

Is India Falling Behind Its Neighbors In Attracting Clinical Research?

j.berlin@elsevier.com — Tue, 22 May 2012 15:00:00 -0400

During the USA-India Chamber of Commerce biopharma summit, participants discussed the pros and cons of doing research in India, and pointed to key policy issues that must be resolved to spur more clinical trials.

Lot-Level Track And Trace System Outlined In Senate Manager’s Amendment To PDUFA Bill

n.hobbs@elsevier.com — Mon, 21 May 2012 23:00:00 -0400

But state law is not preempted in the new section of the user fee legislation, and implementation of a federal requirement is postponed until that issue is resolved. The compromise appears to offer only limited clarity for industry and regulators, but does seem to clear the way for Senate passage.

Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle

s.sutter@elsevier.com — Mon, 21 May 2012 22:23:51 -0400

FDA will ask its cardio-renal advisory committee whether missing data in J&J/Bayer’s ATLAS study affects the interpretability of rivaroxaban’s demonstrated efficacy in acute coronary syndromes. The panel also will be asked whether the agency should pre-specify clinical trial standards for data quality to reduce the problems associated with missing data in CV outcomes studies.

DaVita Shifts Its Business Model With HealthCare Partners Acquisition

l.lamotta@elsevier.com — Mon, 21 May 2012 18:35:49 -0400

Dialysis provider DaVita acquires one of the largest independent physician associations, HealthCare Partners, for $4.4 billion in cash and stock, as well as earn-outs.

P&G Spinout Spins Off Another Company, While Looking To Partner Mid-Stage Oral Anemia Candidate

j.haas@elsevier.com — Mon, 21 May 2012 18:03:53 -0400

Akebia will sell off, partner or possibly bring AKB-6548 – thought to be a safer erythropoietin stimulator than currently available injectables – through Phase III, while its spinout, Aerpio, will focus on clinical development of candidates for diabetic macular edema and inflammatory bowel disease.

Prosonix Extends Series B Financing, Plans Generic Fluticasone Filing

j.davis@elsevier.com — Mon, 21 May 2012 15:58:17 -0400

Prosonix receives an extra $9 million for its Series B round as it changes business strategy from contract research to the development of generic respiratory products, based on a novel particle-engineering technology for inhaled powders.

OraSure In-Home HIV Test’s Promise Outweighs Risks, Panel Concludes

rebecca.kern@elsevier.com — Mon, 21 May 2012 15:00:00 -0400

FDA’s Blood Products Advisory Committee endorses OraSure’s OraQuick in-home HIV test in a unanimous 17-0 vote on May 15. If approved, OraQuick would be the first-ever over-the-counter test for HIV that can be performed entirely in the home by untrained users.

User Fee Amendments In Senate Filed, But Track-And-Trace Remains Off The Map

d.gingery@elsevier.com — Fri, 18 May 2012 16:54:32 -0400

System standards could be included in the manager’s amendment, which was not complete May 18. A cloture vote could come late May 21, which would delay the start of floor debate.

FDA Performance Assessments Include Drug Review Clock Sometimes, GAO Says

s.sutter@elsevier.com — Fri, 18 May 2012 16:30:00 -0400

Government Accountability Office report finds that meeting PDUFA review goals is not an explicit element in CDER non-executive level employees’ performance plans. However, CDER Director Janet Woodcock’s performance plan includes an express reference to PDUFA performance goals, reflecting a “buck stops here” level of accountability.

Sign Of The Times: Late-Stage Cancer Vaccines On Display At ASCO

s.haley@elsevier.com — Fri, 18 May 2012 16:02:13 -0400

Vindicated by the approvals of Provenge and Yervoy, a host of therapeutic cancer vaccines is working through late-stage trials with the regulatory finish line in sight, and some of those companies will be presenting data at the American Society of Clinical Oncology meeting in Chicago June 1-5.

Osiris Prochymal Gets Green Light In Canada; FDA Filing Is Next

l.lamotta@elsevier.com — Fri, 18 May 2012 15:11:56 -0400

World’s first approval for a stem cell treatment is milestone for Maryland-based Osiris Therapeutics, but the product’s patient population is small and further studies are required.

Financings Of The Fortnight Parses Federal Funding For Roche/Genentech Alzheimer’s Candidate

Fri, 18 May 2012 14:26:28 -0400

Plus news on recent financing activity by Arena, OncoMed, Egalet and Dynavax.

BMS Dives Deeper Into China With First Discovery Partnership

t.sami@elsevier.com — Fri, 18 May 2012 14:00:00 -0400

BMS doubling down in China with discovery deal with Beijing’s Tsinghua University and plans to ramp up in diabetes and hepatitis.

Medication Adherence Improves With eRx Growth – Surescripts

g.twachtman@elsevier.com — Thu, 17 May 2012 17:59:02 -0400

With more than 50% of office-based physicians electronically prescribing, Surescripts is estimating that the benefit to the health care system from eRx could reach $240 billion over the next 10 years.

Ra Pharma Aims For Oral Peptide Drugs Using Synthetic Amino Acids

j.haas@elsevier.com — Thu, 17 May 2012 17:16:32 -0400

Just out of stealth mode, privately held biotech closes second tranche of $27 million Series A financing and announces first drug program will pursue an oral kallikrein inhibitor for prevention of hereditary angioedema.

Alkermes After Elan: A Slow Start But A Maturing Pipeline

l.lamotta@elsevier.com — Thu, 17 May 2012 17:06:17 -0400

As it continues its transformation into a drug development company, Alkermes says it is meeting its own expectations, but analysts are disappointed, at least in the short term.

Zithromax Cardiovascular Safety Label Revision May Resemble Levaquin

m.berman-gorvine@elsevier.com — Thu, 17 May 2012 16:56:49 -0400

FDA is reviewing a large study published in the New England Journal of Medicine, and strengthened warnings about cardiovascular risk may be on the way for all azithromycin products.

Value-Based Pricing Could Boost Global Applicability Of NICE Appraisals

j.davis@elsevier.com — Thu, 17 May 2012 16:00:41 -0400

Value-based pricing will start in the U.K. in January 2014 for newly launched products, with prices taking into account innovation and societal benefit as well as NICE's usual clinical and cost-effectiveness analysis, U.K. Health Secretary Andrew Lansley tells NICE's annual conference.

NICE Price: Zytiga On Track In England After Discount

f.kermani@elsevier.com — Thu, 17 May 2012 14:35:29 -0400

Janssen’s decision to offer the NHS a discount for its oral prostate cancer treatment Zytiga appears to have paid off, giving the drug a boost and head start over potential rivals in the EU.

User Fee Bill Reemerges In Senate With Minor Tweaks, But More Changes Expected

d.gingery@elsevier.com — Wed, 16 May 2012 23:30:00 -0400

The new bill includes a provision requiring FDA to consider foreign clinical trial data when making approval decisions and more patient participation in drug development meetings. A cloture vote could come as soon as May 17 with floor debate possibly beginning next week, Sen.

Antibiotic Exclusivity’s Latest Push: Distressing Resistance Data From The VA

m.berman-gorvine@elsevier.com — Wed, 16 May 2012 23:00:00 -0400

A Pew-funded study found growing use of “last-stand” antibiotics in VA hospitals as resistant pathogens spread. Researchers say the pending GAIN Act will help address some of the economics of convincing drug makers to invest in development of new antibiotics, but other financial – as well as regulatory and scientific challenges – will remain.

Small Companies Turning To CDER Ombudsman For Help With Drug Approvals

m.berman-gorvine@elsevier.com — Wed, 16 May 2012 22:26:25 -0400

While the CDER ombudsman dealt with far fewer complaints overall in 2011 than in 2010 due to administrative changes, smaller companies are increasingly asking for help in certain key areas of drug development.

Pfizer’s Biosimilar Program: A MAB Dash After Biocon Deal Ends

w.diller@elsevier.com — Wed, 16 May 2012 21:21:28 -0400

Following the breakup in March of its insulin biosimilars deal with Biocon, Pfizer confirms plans to develop monoclonal antibody biosimilars on its own, and has put its first candidate, rituximab, into Phase 1 testing.

Cardinal’s Dik Acquisition Aims To Grow Independent Pharmacy Ties, Generic Rx Sales

s.steinke@elsevier.com — Wed, 16 May 2012 16:53:07 -0400

Cardinal agrees to purchase regional distributor Dik Drug, bringing in business with about 500 independent retail pharmacies and high generic drug volume.

Regional Firms Must Compete With Multinationals At Home And Away

e.crawford@elsevier.com — Wed, 16 May 2012 14:00:00 -0400

Regional firms have to face multinationals coming into small and emerging markets, says an Alkaloid AD Skopje exec, but they need to venture into new markets themselves. While multinationals have the benefit of large budgets and proven strategies, smaller companies can more effectively identify and predict key local behavior.

Alzheimer’s Research To Be More Collaborative, Better Funded Under National Plan

a.lash@elsevier.com — Tue, 15 May 2012 19:16:43 -0400

Most of the additional money will help support two trials – one for insulin as a treatment and one for crenezumab as a preventative. The Obama administration formally launched its national Alzheimer’s plan in the midst of a two-day meeting that underscored how little researchers know about the disease.

Cornerstone Buys EKR Therapeutics To Expand Hospital Growth Strategy

j.merrill@elsevier.com — Tue, 15 May 2012 16:55:13 -0400

Cornerstone gains two commercial products for the acute-care hospital setting, Cardene and Retavase, with the acquisition of EKR Therapeutics for $125 million upfront and potential milestones.