"The Pink Sheet" :: Biopharma Regulatory and Business Analysis

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 28 May 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

FDA’s TV Ad Review Is Unconstitutional, PhRMA Says, Or Maybe Should Be A Reg

m.berman-gorvine@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

A draft guidance that outlines six categories of drug ads FDA wants submitted for prior review is a violation of advertisers’ free speech rights, the industry group argues. Other comments float a storyboard compromise.

PCORI Grant Process Begins, But Challenge Of Involving Nontraditional Researchers Remains

g.twachtman@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The Patient-Centered Outcomes Research Institute approved its priorities and research agenda May 21, and revealed funding amounts for clinical comparative research the following day. But, as the board of governors’ discussion showed, one of PCORI’s biggest challenges remains how to bring in nontraditional researchers to help give its research a uniquely patient-centered focus.

Not A “Cookbook”: PCORI Board Prepares For Release Of Research Methodology Report

g.twachtman@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The Patient-Centered Outcomes Research Institute will develop a multifaceted plan to solicit meaningful feedback on its forthcoming methodology committee report, including setting appropriate expectations for the document, members of the PCORI board said during a May 21 meeting.

Biosimilars, Year One: FDA Estimates 2 Applications, 1,720 Hours Of Work

b.sandburg@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

The agency’s expectation is that there will be a limited number of biosimilar applications, but the applicants will need as much time as traditional BLA sponsors to prepare their submissions.

Migraine Snapshot: Despite Significant Generic Presence, MAP, Allergan, Others See Big Market Potential

j.haas@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

After a 20-year hiatus, the market for acute and chronic migraine is set to expand with the introduction of Allergan’s Botox and of novel formulations of triptans and alternative therapies.

Xarelto Review Sparks Debate Over Feasibility Of A Three-Drug ACS Regimen

s.sutter@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

While the focus of the Cardiovascular and Renal Drugs Advisory Committee’s meeting was on rivaroxaban’s use in treating acute coronary syndromes, some panelists questioned the wisdom of adding an antithrombin to current dual-antiplatelet therapy standard of care. The lack of data on rivaroxaban’s use with the two newest antiplatelet agents, prasugrel and ticagrelor, also could prove problematic from a labeling perspective due to theoretical concerns about increased bleeding.

FDA’s ANDA Approvals

Mon, 28 May 2012 00:00:00 -0400

Generic drug approvals and tentative approvals for late May.

Deals Of The Week: NewDrugs4BadBugs Initiative, GSK/Auxilium, DaVita/Healthcare Partners

Mon, 28 May 2012 00:00:00 -0400

[Each week, “The Pink Sheet” presents commentary on some of the week’s most interesting business deals, contributed by the editors of the IN VIVO blog.] High on the New York Times list of bestsellers (in the hardcover advice & miscellaneous category) this spring has been the book “Innovation: Create Far From Home, Win Everywhere.” It’s authored by two well-known Dartmouth business school professors, Vijay Govindarajan and Chris Trimble, and tracks how innovation originating in emerging markets is finding its way into the broader global business world. That is a topic incre...

Biosimilars: Exclusivity Guidance Possible; Head-To-Head Comparison Studies Sinking In

b.sandburg@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

FDA’s Denise Esposito says that in many cases the agency will require biosimilar sponsors to conduct head-to-head comparison studies with the reference product.

PDUFA Reaches Approval Altitude; Can House Maintain Senate Speed?

d.gingery@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

After about a week of debate, the Senate overwhelmingly passes its FDA user fee package, with only track and trace to be finalized. House members are scheduled to begin floor debate after Memorial Day in the hopes of sending the bill to President Obama before July 4.

PDUFA Cost Offset In House Focuses On FDA Petition Review, Not REMS

c.dombrowski@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Faced with a CBO estimate that H.R. 5651 will increase federal spending in fiscal years 2013 through 2022, the House Energy and Commerce Committee applies a section that speeds FDA decisions on some petitions to biosimilars. This contrasts with the Senate bill, which allows FDA to require brand companies to sell products covered by limited distribution systems to generic firms.

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

s.sutter@elsevier.com — Mon, 28 May 2012 00:00:00 -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.

Value-Based Pricing's Slow Progress In U.K. Worries Industry

j.davis@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

With eighteen months until the start of a new drug pricing scheme, the slow progress and lack of detail on the U.K.'s value-based pricing (VBP) approach worries industry and suggests transitional arrangements may be necessary.

Precision Medicine Will Be In Action At ASCO

s.haley@elsevier.com — Mon, 28 May 2012 00:00:00 -0400

Though the tracks and sessions are still named largely for organs and other phenotypic descriptions of cancer, the notion of basing treatments on the molecular drivers of a tumor alone is pervasive at this year’s meeting of the American Society of Clinical Oncology, June 1-5 in Chicago.

"Opportunities and Challenges in the Indian Biopharmaceutical Market" Special Report

Mon, 21 May 2012 00:00:00 -0400

If you are interested in expanding your healthcare company, India is a market full of potential, both for developing biopharmaceuticals and pharmaceuticals, and for manufacturing them. The competitive market, availability of raw materials, and continually growing local market are all factors that contribute to the great opportunities available in India.

Medivation Battles UCLA Over Rights To Prostate Cancer Compound

b.sandburg@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

UCLA researchers secretly developed a compound almost identical to Medivation’s MDV3100 (enzalutamide), a breach of contract suit claims. The company expects to launch MDV3100 later this year.

Biosimilar Suffix Naming Idea Trips On Dispensing Problem

d.gingery@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

American Pharmacists Association tells FDA during biosimilar guidance hearing that using suffixes to create unique names will be problematic. FDA may be leaning toward the unique names, saying published literature indicates adequate safety tracking is not possible without them.

Bad News/Good News For Cholesterol: Another Strike Against HDL, But Support For Stricter LDL Targets

e.hayes@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

A large genetic analysis published in the Lancet suggests that drugs that raise HDL may not reduce cardiovascular risk, creating more bad news for a field still reeling from the failure of Roche’s dalcetrapib. But another study calls for much wider use of LDL-lowering drugs, even in patients with low cardiovascular risk.

Two Indications, One REMS: FDA Panel Debates Restricted Access For Truvada In PrEP

s.sutter@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.

Medicare CED Could Support, Benefit From Surveillance Systems Like FDA’s Sentinel – McClellan

c.kelly@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

At a May 16 Medicare Evidence Development and Coverage Advisory Committee meeting, former CMS and FDA Chief Mark McClellan advocated salvaging Medicare’s little-used coverage with evidence development policy for medical products.

PDUFA V Focus On Speeding FDA Drug Reviews May Be Unfounded, Study Concludes

b.sandburg@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

A New England Journal of Medicine study found that FDA is faster in reviewing novel therapeutics than regulatory agencies in Europe and Canada.

“Next Phase” For CED Should Focus On Treatments That Lower Cost, MEDCAC Told

c.kelly@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

The next iteration of CMS’ Medicare coverage with evidence development policy should limit application of the reimbursement tool to treatments that can lower overall health care spending, Center for Medical Technology Policy CEO Sean Tunis told the Medicare advisory committee.

FDA’s ANDA Approvals

Mon, 21 May 2012 00:00:00 -0400

Generic drug approvals and tentative approvals for mid-May.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 21 May 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Recent Round Of Obesity Reviews Suggests CV Safety Standards Have Come Into Focus

c.dombrowski@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

The advisory committee on Arena Pharmaceuticals’ lorcaserin continues to bring into focus what FDA and its expert advisers expect in terms of cardiovascular safety assessment for weight-loss drugs, possibly signaling a new consensus and the end of years of confusion.

Post Biocon, Pfizer Pushes Forward On Biosimilar MABs

w.diller@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

Biosimilars pioneers face a steep learning curve and multiple surprises, as shown by Pfizer’s recent and expensive backtrack on its deal with India’s Biocon. But Pfizer says the setback has reaffirmed its strategy as it pushes ahead on its own with a monoclonal antibody program, led by a biosimilar rituximab.

Behavioral Considerations Abound In FDA Review Of Truvada For PrEP

s.sutter@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

The potential dangers associated with medication non-adherence, failure to obtain regular HIV testing and “risk compensation” were cited by critics as reasons not to approve Truvada for pre-exposure prophylaxis. Although Gilead’s proposed REMS targets these behaviors, it remains to be seen whether such risk management efforts will have an impact.

Plavix Takes A Final Bow, But Will It Go Gracefully?

j.merrill@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

Generic versions of Bristol-Myers Squibb/Sanofi’s blockbuster clot-buster clopidogrel launched in the U.S. May 17, but the companies are helping some patients continue on the brand by covering the high out-of-pocket costs.

R&D For Diseases Of Developing Countries Could Be Driven By Pooled Funds

b.sandburg@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

WHO committee backs use of pooled funds to finance R&D, nixes priority review vouchers and finds no need for data exclusivity. Novartis’ Paul Herrling, a committee member, notes that governments would be responsible for R&D costs.

Novartis Typhoid Vaccine Seeks Partner After Securing Clinical Trial Site

b.sandburg@elsevier.com — Mon, 21 May 2012 00:00:00 -0400

Phase II study is ongoing in Pakistan, a year after Novartis convinced the Pakistani government to lift its ban on clinical trials. Antimalarials with a different mechanism of action than Coartem are in Phase I and II trials.

Deals of the Week: GSK Working On Three Deals, Agilent/Dako

Mon, 21 May 2012 00:00:00 -0400

GlaxoSmithKline tries to turn partnerships into acquisitions with varying results, as one company accepts a buy-out while another adopts a poison-pill strategy.

Webinar: Perspectives on FDA's New DTC TV Pre-Review Program and Other Hot DTC Topics

Mon, 14 May 2012 00:00:00 -0400

In March 2012, FDA's Office of Prescription Drug Promotion (OPDP) issued a Draft Guidance outlining the contours of the agency's new DTC Television Advertising Pre-Dissemination Review Program established under the Food and Drug Administration Amendments Act of 2007. During this webinar, Former FDA Associate Chief Counsel, and Principal at Arnold I.

Truvada PrEP REMS Needs More Work, FDA Panel Says

s.sutter@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

In a marathon meeting, the Antiviral Drugs Advisory Committee endorses use of Gilead’s emtricitabine/tenofovir fixed-dose combination for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection, but some committee members say Gilead’s REMS needs more “teeth,” including a linkage between a documented negative HIV test and access to the drug.

Weighty Issues: GW Obesity Outcomes Project Tests Model For Patient Input In Drug Development

michael.mccaughan@previsionpolicy.com — Mon, 14 May 2012 00:00:00 -0400

A stakeholder project on obesity treatment outcomes will complete its work this summer, setting the stage for FDA to rethink efficacy endpoints for weight loss drug development. The closed-door project is happening in parallel with public advisory committee discussions on pending applications and safety standards.

Asia Spotlight: SciClone China CEO Mark Lotter On The Changing Commercial Landscape

Mon, 14 May 2012 00:00:00 -0400

Considered one of the top commercial minds in China, the former AstraZeneca exec and founder of NovaMed discusses how to build a sustainable commercial model in a rapidly changing China, touching on everything from retaining talent to surviving China’s latest round of price cuts.

Another Arcalyst Trial May Be Regeneron’s Best Path To Approval In Gout

d.gingery@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Recommending against approval, FDA’s Arthritis Advisory Committee says there is not enough data for Regeneron’s gout therapy and suggests that chronic and refractory populations should be studied.

ESRD Market Snapshot: The Price Has To Be Right

j.merrill@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

The market for kidney disease drugs is under pressure from Medicare cost containment policies. However, there is still room for new drugs – if they can demonstrate a cost-savings benefit.

FDA’s ANDA Approvals

Mon, 14 May 2012 00:00:00 -0400

Generic drug approvals for late April and early May.

Linking EHRs To Cancer Registries Good In Theory, But Difficult In Practice, ASCO Says

g.twachtman@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

The American Society of Clinical Oncology offers support for the notion of using electronic health records to help provide information to cancer registries, but is critical of CMS’ approach as outlined in the stage 2 meaningful use proposed rule.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 14 May 2012 00:00:00 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Will Pharmacovigilance Be Enough To Address Questions About Pfizer’s Tofacitinib?

m.berman-gorvine@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Definitive data on structural damage measurement can be collected post-market, FDA’s Arthritis Advisory Committee said in voting to support approval. But the panel and FDA were both troubled by uncertainties over the safety profile, especially because the rheumatoid arthritis therapy would be for chronic use.

Lorcaserin Makes It Past Panel On The Strength Of Effect In Some Patients

c.dombrowski@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

The Endocrinologic and Metabolic Drugs Advisory Committee votes 18-4, with one abstention, in favor of lorcaserin for long-term treatment of overweight and obese individuals.

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns

s.sutter@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early.

PDUFA Scrubbing: How The House User Fee Bill Got So Agreeably Clean

n.hobbs@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Profound reforms to FDA’s mission were set aside, but industry seems poised for several big wins, including (probably) additional antibiotic exclusivity and even a national track and trace standard.

Janssen Builds A Pulmonary Pipeline: An Interview With Sue Dillon

m.goodman@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Citing high unmet medical need and significant commercial opportunity, Janssen Research & Development has dived into pulmonary therapeutics. TA head of immunology Sue Dillon discusses the rationale, the indications and the therapeutic approaches the company is taking.

Dalcetrapib Failure Raises Yet More Questions On Value Of Tinkering With HDL Cholesterol

e.hayes@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Termination of the development program for dalcetrapib creates more doubt about the class of CETP inhibitors, long viewed with ambivalence. But important differences in how the drug works compared to rivals leaves room for some to hold out hope for CETP inhibition and the HDL hypothesis in general.

Couples Therapy: Challenges In Companion Dx-Biopharma Relationships Noted By VC

c.kelly@elsevier.com — Mon, 14 May 2012 00:00:00 -0400

Companion diagnostic firms facing skeptical partners in big pharma need to focus on ways of establishing the value of their test to payers and patients, Third Rock Ventures’ Mark Levin advised the Personalized Medicine Coalition.

Deals Of The Week: GSK/HGSI, Daiichi Sankyo/Coherus

Mon, 14 May 2012 00:00:00 -0400

GSK/Human Genome story takes a sharp turn, but does the big pharma’s hostile bid expose greater interest in cardiovascular drug darapladib than it is admitting?

Boehringer Ingelheim Shrugs Off Patent Cliff, Returns To Sales Growth

j.davis@elsevier.com — Mon, 07 May 2012 00:00:00 -0400

Germany's Boehringer Ingelheim returns to sales growth and looks to Phase III hepatitis C and oncology products to provide long-term growth.