CMS has placed Cologuard from Exact Sciences Corp. (NASDAQ:EXAS) on the agenda of a July 16 meeting to discuss 2016 payment levels for clinical tests. The action follows a campaign by hedge fund Cable Car Capital to persuade CMS to narrow its coverage and reduce reimbursement levels for the non-invasive DNA screening test for colorectal cancer. Cable Car holds a short position in Exact Sciences.
In October, CMS issued its final National Coverage Determination (NCD) for Cologuard, which established national coverage for the test once every three years for asymptomatic beneficiaries aged 50-85 who are at average risk of developing colorectal cancer. CMS's 2015 reimbursement rate for Cologuard is $492.72 per test.
Cologuard was the first product to undergo a pilot parallel assessment by CMS and FDA (see BioCentury Extra, Oct. 9, 2014).
In a September 2014 letter to CMS, Cable Car Capital portfolio manager Jacob Ma-Weaver said the NCD should be modified to lengthen the screening interval and cover only beneficiaries aged 50-75, the age range recommended for screening by the U.S. Preventive Services Task Force. In a second letter to the agency in October 2014, Ma-Weaver urged CMS to reconsider the reimbursement rate for Cologuard, arguing that any reimbursement above a range of $80-$191 "should require a very compelling justification."
Exact Sciences spokesperson J.P. Fielder said the company is "very confident in the value of Cologuard," but declined further comment.
FDA approved Cologuard in August 2014. The product uses a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene.
In December, UnitedHealth Group Inc. (NYSE:UNH) instituted a medical policy that concluded evidence is insufficient to support the diagnostic accuracy of fecal DNA tests including Cologuard to screen for colorectal cancer in asymptomatic, average-risk patients (see Biocentury Extra, Dec. 1, 2014).
Anastasios Belesis filed suit against Kadmon Corp. LLC (New York, N.Y.), Samuel Waksal and Steven Gordon in the U.S. District Court for the Southern District of New York alleging breach of contract. The former founder and CEO of now-defunct brokerage firm John Thomas Financial Inc. and a former managing member of ATB Holding Co. LLC alleges that Waksal did not meet the terms of a stock purchase agreement with ATB to trade 1,000 Class B units of Kadmon, convertible to 1 million Kadmon shares, in exchange for $1.
According to the suit, Gordon subsequently proposed and failed to follow through on an agreement in which Belesis would renounce his interest in Kadmon and claims against Waksal in exchange for $15 million. Belesis alleged the agreement was designed to "avoid mandatory disclosure to investors" and "evade Waksal's lifetime bar from participation as an officer or director of any publicly traded company."
Waksal is Kadmon's founder, chairman and chief of innovation, science and strategy and Gordon is the company's EVP, general counsel and chief administrative, compliance and legal officer.
Belesis is seeking a jury trial and an order for the defendants to issue 1 million Kadmon shares or $15 million.
Waksal was permanently barred from acting as an officer or director of any public company in a 2005 settlement with the SEC (see BioCentury Extra, Jan. 19, 2005).
Last September, Kadmon signaled an interest in preparing for an IPO by naming Harlan Waksal CEO in place of Samuel Waksal (see BioCentury Extra, Oct. 6, 2014).
In January, the Financial Industry Regulatory Authority (FINRA) expelled John Thomas Financial and barred Belesis from the securities industry for trading ahead of customers' orders, record keeping violations, violating just and equitable principles of trade, and providing false testimony.
Juno Therapeutics Inc. (NASDAQ:JUNO) gained $7.03 (15%) to $53.33 on Tuesday after post-market news Monday that it formed a 10-year collaboration with Celgene Corp. (NASDAQ:CELG) to develop immunotherapies for cancer and autoimmune diseases. Juno will receive $150.2 million in upfront cash plus $849.8 million through the sale to Celgene of 9.1 million newly issued Juno shares at $93, a 100% premium over Juno's Monday close (see BioCentury Extra, June 29).
Merck & Co. Inc. (NYSE:MRK) and the Sanofi Pasteur S.A. vaccines unit of Sanofi (Euronext:SAN; NYSE:SNY) hired David Khougazian as president of their Sanofi Pasteur MSD joint venture. Khougazian was Sanofi's CEO chief of staff.
Oncology company Tesaro Inc. (NASDAQ:TSRO) hired Jeffrey Hanke as CSO and EVP of R&D. Hanke was SVP of research and global head of biotherapeutics at Boehringer Ingelheim GmbH (Ingelheim, Germany).
Vaccine developer Vaccibody A/S (Oslo, Norway) hired Martin Bonde as CEO, effective Aug. 10. Bonde was CEO at EpiTherapeutics ApS, which Gilead Sciences Inc (NASDAQ:GILD) acquired.
Rare-disease play Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) named Gary Ingenito CMO. Ingenito was head of regulatory affairs for biosimilars in North America at Boehringer Ingelheim.
Antibody company Abcam plc (LSE:ABC) hired Suzanne Smith as chief legal officer. Smith was executive director of legal at Actavis plc, now known as Allergan plc (NYSE:AGN).
Structural biology company Proteros biostructures GmbH (Martinsreid, Germany) named Torsten Hoffmann CSO, a newly created position. Hoffmann was CSO at Zealand Pharma A/S (CSE:ZEAL).
Cancer play Idera Pharmaceuticals Inc. (NASDAQ:IDRA) hired Mark Casey as SVP and general counsel. Casey was chief administrative officer, SVP and general counsel at Hologic Inc. (NASDAQ:HOLX).
Evotec AG (Xetra:EVT) said sembragiline (RG1577; EVT 302) missed the primary endpoint in a Phase IIb trial to treat moderately severe Alzheimer's disease. In the MAyflOwer RoAD study conducted by Evotec partner Roche (SIX:ROG; OTCQX:RHHBY), sembragiline failed to significantly improve scores on a cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog11) after 52 weeks.
Roche spokesperson Stepan Kracala told BioCentury the company will analyze additional data from the trial, but declined to say when the company will decide next steps for sembragiline.
Roche paid Evotec $10 million up front in 2011 for exclusive, worldwide rights to the reversible monoamine oxidase type B (MAO-B) inhibitor (see BioCentury Extra, Sept. 6, 2011).
Evotec, which made the announcement after market close, was unchanged at EUR 3.55 on Tuesday.
Roche (SIX:ROG; OTCQX:RHHBY) said ocrelizumab met the primary endpoints of reducing annualized relapse rates (ARR) in two identically designed Phase III studies, OPERA I and OPERA II, to treat relapsing multiple sclerosis (MS). The trials compared the intravenous second-generation humanized mAb against CD20 vs. Rebif interferon beta-1a, a standard-of-care treatment, in a total of 1,656 patients.
Ocrelizumab also significantly reduced progression of clinical disability, as measured by the Expanded Disability Status Scale, and the number of brain lesions compared with Rebif. Roche said it will present data from the studies at an upcoming medical congress.
The company plans to submit marketing applications for ocrelizumab in the U.S. and EU in 1Q16. The company also expects data this year from ORATORIO, a Phase III study of ocrelizumab to treat progressive MS.
Biogen Inc. (NASDAQ:BIIB) is eligible for tiered royalties on sales of ocrelizumab under a deal the parties amended in 2010 (see BioCentury Extra, Oct. 21, 2010). Merck KGaA markets Rebif.
Healthcare information technology company Allscripts Healthcare Solutions Inc. (NASDAQ:MDRX) invested $200 million for a 10% stake in NantHealth, a health care IT subsidiary of Patrick Soon-Shiong's NantWorks LLC (Los Angeles, Calif.).
Soon-Shiong's investment vehicle NantCapital invested $100 million in Allscripts.
Allscripts and NantHealth partnered in 2015 to develop IT infrastructure for personalized cancer care, including NantHealth's molecular diagnostics.
Samsung Bioepis Co. Ltd., a JV between Biogen Inc. (NASDAQ:BIIB) and Samsung Group (Seoul, South Korea), said it is considering an IPO of undisclosed size on NASDAQ. Spokesperson Jamyung Cha told BioCentury the company has not yet set a timeline for the offering.
Samsung Bioepis is developing a pipeline of biosimilars, including several under a partnership with Merck & Co. Inc. (NYSE:MRK). EMA is reviewing an MAA for SB4, the partners' biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN) and Pfizer Inc. (NYSE:PFE). Samsung Bioepis submitted an MAA to EMA in March for SB2, the partners' biosimilar of Remicade infliximab from Merck and Johnson & Johnson (NYSE:JNJ).
Sanaria Inc. (Rockville, Md.) said the government of Equatorial Guinea, Marathon Oil Corp. (NYSE:MRO), Noble Energy Inc. (NYSE:NBL) and Atlantic Methanol Production Co. LLC (Bioko, Equatorial Guinea) will invest $48.5 million to fund development of its PfSPZ Vaccine. The government of Equatorial Guinea will provide $36.8 million of the funding.
Sanaria said it began a clinical trial earlier this year of the sporozoite vaccine containing a weakened form of Plasmodium falciparum. It plans to conduct additional trials in 2016, and a Phase III study in 2017-18.
Robert Califf received about $25,000 for consulting for five pharma companies in 2014 prior to his appointment as FDA deputy commissioner for medical products and tobacco, according to a physician payments database CMS released Tuesday. According to the database, Califf contributed all of the fees to third parties. In financial disclosure sections of published papers, Califf has reported that he donated all income from consulting activities to not-for-profit organizations.
Califf consulted in 2014 for Amgen Inc. (NASDAQ:AMGN), Daiichi Sankyo Co. Ltd. (Tokyo:4568), Roche (SIX:ROG; OTCQX:RHHBY), Merck & Co. Inc. (NYSE:MRK) and Sanofi (Euronext:SAN; NYSE:SNY). Califf also received about $4,000 in reimbursement for travel expenses from the five companies in 2014.
Califf has already made public financial disclosure statements covering the period 2010-14 that include consulting for at least 36 companies and organizations, research grants and contracts from 10 pharma companies, and equity holdings. Califf divested equity in two biotechs prior to joining FDA (see BioCentury, Feb. 2, 2015).
In a statement, FDA said Tuesday that "prior to joining the FDA, Califf went through a comprehensive screening process for conflicts of interest, working closely with HHS and FDA ethics staff, including legal counsel. As part of that process, HHS/FDA officials identified Califf's potential conflicts and put in place measures to ensure that he is recused from matters that would give rise to conflicts or appearance of conflicts."
In a submission to the White House Office of Management and Budget (OMB), FDA estimated it expects to receive five biosimilar product applications and two interchangeable product applications or supplements per year. The agency also said it plans to issue a draft guidance this year addressing biosimilar interchangeability entitled "Considerations in Demonstrating Interchangeability to a Reference Product."
FDA issued draft guidance last month on biosimilars; however, the document did not settle key issues on interchangeability (see BioCentury Extra, May 12).
In April, nine Senators urged FDA to release all final guidances on biosimilars, specifically requesting answers from the agency on non-proprietary naming and interchangeability (see BioCentury Extra, April 30).
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