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BioCentury Extra
As published Monday, January 26, 2015 6:28 PM PST

  • FDA names Duke's Califf as deputy commissioner

    FDA named Robert Califf as deputy commissioner for medical products and tobacco, positioning the Duke University physician as a likely successor to Commissioner Margaret Hamburg if she steps down before the end of the Obama administration.

    FDA said Califf will "provide executive leadership" for its centers for drugs, biologics, medical devices and tobacco, and will oversee the Office of Special Medical Programs in the Office of the Commissioner.

    Califf has taken a leave of absence as vice chancellor of clinical and translational research and other positions at the university's school of medicine.

    Califf was on a short list of FDA commissioner candidates in 2009, before Hamburg was appointed to the job. His ties to industry, including leading pharma-funded clinical trials and holding seats on corporate boards, would have made confirmation extremely difficult at the time, but are unlikely to be an impediment in the Republican-controlled Senate.

    On Monday, Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said Califf retired from its board, which he joined in 2012. Califf also served on the medical advisory board of Regado Biosciences Inc. (NASDAQ:RGDO) from 2009 until the board was dissolved as a result of the company's agreement this month to merge with Tobira Therapeutics Inc. (San Francisco, Calif.).

    Califf is also on the board of managers of the Biomarker Factory, a for-profit collaboration between Duke Medical Strategies, an affiliate of the university, and Laboratory Corp. of America Holdings (NYSE:LH). The Biomarker Factory and Duke told BioCentury they did not know if Califf will retain the position.

    FDA specified that Califf will manage initiatives addressing personalized medicine, Orphan drugs, pediatric science and the advisory committee system.

    Califf, one of the most prominent physician-researchers in the U.S., has led major initiatives concerning translational medicine; clinical, observational and comparative trials; and cardiology.

    Among Califf's projects is the Measurement to Understand the Reclassification of Disease of Cabarrus/Kannapolis (MURDOCK) Study, a longitudinal study of 50,000 residents of Kannapolis County N.C, which he discussed on BioCentury This Week television (see BioCentury This Week, Jan. 27, 2013).

  • Voucher puts alirocumab ahead in PCSK9 race

    FDA accepted and granted Priority Review to a BLA for Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY) to treat hypercholesterolemia.

    Praluent's PDUFA date is July 24, more than one month ahead of that of evolocumab (AMG 145) from Amgen Inc. (NASDAQ:AMGN). Both are human mAbs against proprotein convertase subtilisin/kexin type 9 (PCSK9). Evolocumab's PDUFA date is Aug. 27 (see BioCentury Extra, Nov. 10, 2014).

    Regeneron and Sanofi used a Priority Review voucher purchased from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to expedite Praluent's review (see BioCentury, Aug. 4, 2014).

    EMA accepted an MAA for Praluent earlier this month to treat hypercholesterolemia (see BioCentury Extra, Jan. 12).

    Regeneron and Sanofi are co-developing Praluent under a 2007 deal.

    Regeneron added $3.56 to $423.77 on Monday. Amgen lost $0.08 to $159.73.

  • FDA approves Symplmed's Prestalia combo for hypertension

    Symplmed Pharmaceuticals LLC (Cincinnati, Ohio) said FDA approved an NDA for Prestalia to treat hypertension. The company plans to launch the fixed-dose combination of perindopril arginine plus amlodipine besylate this quarter through its bpCareConnect program, which ships directly to patients who are members of the company's hypertension management program.

    The approval was based on results from the 837-patient Phase III PATH trial, in which the oral, once-daily angiotensin-converting enzyme (ACE) inhibitor plus calcium channel blocker produced significantly greater reductions in both seated DBP and SBP from baseline to week 6 compared to either perindopril or amlodipine alone. Prestalia is the first fixed-dose combination of these two medications approved in the U.S. It is indicated for use in patients whose blood pressure is not adequately controlled on monotherapy.

    Symplmed sublicensed U.S. rights to Prestalia from Xoma Corp. (NASDAQ:XOMA) in 2013 (see BioCentury, Sept. 30, 2013).

    Servier (Neuilly-sur-Seine, France), which developed the drug, markets a fixed-dose combination of the same two compounds outside the U.S. as Coveram.

  • Pharmas pitch in on GAVI initiative

    The Global Alliance for Vaccine Immunization (GAVI) announced commitments from private sector partners including Pfizer Inc. (NYSE:PFE), GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), the Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ), Sanofi (Euronext:SAN; NYSE:SNY), Merck & Co. Inc. (NYSE:MRK) and NewLink Genetics Corp. (NASDAQ:NLNK). GAVI hopes to raise $7.5 billion at a funding conference on Tuesday to deliver vaccines to GAVI-supported countries in 2016-20.

    Pfizer reduced the price of its Prevanar 13, a pneumococcal vaccine containing 13 serotypes, from $3.30 per dose to $3.10 per dose in a four-dose course of treatment. The price reduction will be extended to GAVI-supported and GAVI-graduated countries through 2025.

    GSK will continue to provide vaccines against pneumonia, diarrhea and cervical cancer at discounted GAVI prices to developing countries for a decade after they graduate from GAVI support. Janssen will make its pentavalent vaccine available at UNICEF prices to GAVI-graduated countries for five years. Sanofi will expand production and extend GAVI pricing to GAVI-graduated countries for its yellow fever vaccine through 2018.

    Merck and NewLink will provide their rVSV-EBOV Ebola vaccine to GAVI-supported countries at "the lowest possible access price."

    Indian companies Biological E. Ltd. (Hyderabad, India) and Panacea Biotec Ltd. (NSE:PANACEABIO) offered five-year price commitments to GAVI-graduated countries for their respective vaccine programs. The Serum Institute of India Ltd. (Pune, India) will provide discounts for its pentavalent vaccines, which the company said will save Gavi $50 million over two years.

  • CMS to discuss prognostic tests for cancer

    CMS's Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will meet on March 24 to discuss molecular pathology tests for the prognosis of colorectal, breast and non-small cell lung cancer (NSCLC). The committee will review existing evidence that CMS may use to determine coverage for prognostic tests for cancer.

    MEDCAC will consider colorectal cancer tests including the Oncotype DX colon cancer assay from Genomic Health Inc. (NASDAQ:GHDX) and testing for BRAF and K-Ras (KRAS) mutations, microsatellite instability and DNA mismatch repair protein Mlh1 (MLH1) promoter methylation. The committee will discuss breast cancer tests including MammaPrint from Agendia N.V. (Amsterdam, the Netherlands) and Genomic Health's Oncotype DX breast cancer assay, as well as NSCLC tests including those for anaplastic lymphoma kinase (ALK), EGFR and KRAS mutations.

    HHS's Agency for Healthcare Research and Quality (AHRQ) released a technology assessment in May 2014 that found "modest" evidence supporting the prognostic value of MammaPrint, the Oncotype DX breast cancer assay, KRAS mutation testing for lung cancer, and colorectal cancer tests including those for BRAF mutation, KRAS mutation and microsatellite instability. AHRQ evaluated various mutation tests from companies including Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN), Roche (SIX:ROG; OTCQX:RHHBY) and Illumina Inc. (NASDAQ:ILMN).

    The report found that the OncoType DX breast cancer assay led to changes in treatment decisions. However, the committee found no evidence to determine whether using the tests to estimate prognosis led to improved outcomes. The review was not focused on the Medicare population, though the reported noted that there was no evidence to suggest the prognostic value of the tests would be different for this population.

    On Monday, Genomic Health added $1.37 to $32.69 and Illumina rose $4.52 to $201.68. Qiagen gained $0.22 to $23.76 on NASDAQ and EUR 0.05 to EUR 21 on Xetra.

  • HHS's timeline for Medicare reimbursement reform

    HHS set an explicit timeline for moving Medicare payments away from the traditional fee-for-service model toward alternative models that pay providers based on the value and quality of the care they provide.

    HHS Secretary Sylvia Burwell published a perspective in the New England Journal of Medicine in which she said HHS intends to tie 30% of traditional fee-for-service payments to quality or value by YE16, and 50% by YE18, through alternative payment models such as Accountable Care Organizations (ACOs) or bundled payment arrangements. About 20% of Medicare's payments to providers are made through alternative payment models today, Burwell said.

    The department aims to have 85% of all traditional Medicare payments tied to quality or value by 2016, and 90% by 2018, via programs including the Hospital Value Based Purchasing and Hospital Readmissions Reduction Programs.

    CMS is already testing bundled payment models that include Medicare Part B drugs. In a white paper issued last year, the agency outlined plans for bundled payment models for cancer care that would include drugs (see BioCentury, Sept. 15, 2014).

    To help other organizations make the switch, Burwell said HHS has formed the Health Care Payment Learning and Action Network, which will work with private payers, state Medicaid programs, employers, consumers, providers and other partners. The network will hold its first meeting in March.

  • SCOTUS remands Shire, Actavis

    The U.S. Supreme Court granted a petition from Shire plc (LSE:SHP; NASDAQ:SHPG) and remanded to a lower court Shire's patent infringement suit against Actavis plc (NYSE:ACT), citing the high court's decision last week in Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) vs. the Sandoz International GmbH generics unit of Novartis AG (NYSE:NVS; SIX:NOVN).

    Shire asked SCOTUS to review whether the U.S. Court of Appeals for the Federal Circuit (CAFC) overreached by reviewing de novo certain questions of fact in the company's lawsuit against Actavis plc (NYSE:ACT) rather than deferring to the findings of the U.S. District Court for the Southern District of Florida.

    Shire alleges Actavis' ANDA for generic Lialda mesalamine -- originally submitted by Watson Pharmaceuticals Inc., which has merged with Actavis -- infringed on Shire's U.S. Patent No. 6,773,720, which expires in 2020. Shire received notice of Watson's ANDA for the ulcerative colitis drug in March 2012, and the district court ruled in Shire's favor in May 2013. In 2014, the CAFC reviewed the facts of the case and overturned the district court's ruling.

    On Monday, SCOTUS remanded the case back to the CAFC "for further consideration" in light of the Teva action.

    In last week's decision, the high court ruled the CAFC must defer fact finding to the district court unless there is evidence of "clear error" (see BioCentury Extra, Jan. 20).

    Lialda, a 5-aminosalicylate (5-ASA) mesalamine formulated using Multi-Matrix system (MMX) technology, contributed $449.1 million in sales in the nine months ended Sept. 30, 2014.

    Shire rose $4.54 to $220.57 on Monday.

  • FDA schedules patient-focused meeting on breast cancer

    FDA will hold a public meeting on April 2 to discuss breast cancer, its effects on daily life, and patients' perspectives on available therapies. The meeting is one of 20 under FDA's Patient-Focused Drug Development initiative.

  • Correction

    Syndax Pharmaceuticals Inc. (Waltham, Mass.) has exclusive, worldwide rights to entinostat except in Japan and Korea, where Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) holds rights. The Jan. 23 BioCentury Extra misstated the territories.

  • Market Entry Strategy and Planning with Campbell Alliance

    Find a commercialization partner, or go it alone? This decision involves not only strategic questions regarding a company's identity and core competencies, but also multiple value drivers that are easy to overlook. This article examines how a value-based approach can help companies position themselves to ensure their business plans contribute to a product's success and an improved return on investment. Download your copy now!

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