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Tuesday, October 30, 2018

4 Former Genentech Employees Indicted on Theft of Trade Secrets

Four former Genentech employees have been indicted by a federal grand jury for the alleged theft of company trade secrets in order to help a company set up in Taiwan develop drugs similar to those made by the Roche subsidiary.
The grand jury indicted Xanthe Lam, Allen Lam, Hohn Chan and James Quach for stealing trade secrets, the Department of Justice announced Monday. The announcement was first reported by ARS Technica. Xanthe Lam worked at Genentech as a principal scientist from 1986 until 2017, according to the press release. Allen Lam, Xanthe’s husband, as well as Chan and Quach were all former employees who became consultants for JHL Biotech, Inc., the company established in Taiwan. According to the Department of Justice, JHL develops biosimilar treatments. The four are alleged to have conspired to steal information related to four Genentech drugs, Pulmozyme, Rituxan, Herceptin and Avastin, and provide that information to JHL. According to the indictment, Xanthe Lam, who was terminated by Genentech last year, gathered confidential clinical data about the drugs and sent them to her husband and the other two conspirators. They, in turn, sent the information to JHL Biotech. The indictment also said that while employed at Genentech, Xanthe Lam secretly consulted with the Taiwan-based company.
The indictment also alleges that Xanthe Lam gave Quach access to her work computer to gain access to Genentech’s secure document repository in order to steal proprietary manufacturing secrets.
Founded in 2012, JHL Biotech develops biosimilar drugs primarily for marketing in China.
Genentech told The San Francisco Chronicle that it was cooperating with the federal government on the investigation and had also reported information to the government about the four former employees.
“Dishonest and illegal actions such as these threaten scientific innovation, obstruct fair competition, and undermine the hard work of our employees and people throughout the industry who act with integrity and in the best interests of patients every day,” Genentech told the Chronicle in a statement.
Lam’s attorney defended his client. He told the Chronicle that Lam was not working for a competing company and “never realized a penny out of this supposed conspiracy.” The attorney, William Osterhaudt, went on to say that the charges were being “driven by Genentech” over concerns about biosimilar—manufacturing companies that “are able to produce wonder drugs, on which the patent has run out, at a lower cost,” the Chronicle reported.
Xanthe Lam faces multiple charges, including conspiracy to commit theft of trade secrets and theft of trade secrets. Two of the charges carry 10-year sentences and $250,000 fines each. The other two carry five-year prison sentences and $250,000 fines each.
Allen Lam faces charges of conspiracy to commit theft of trade secrets and theft of trade secrets. Both carry 10-year sentences and $250,000 fines. Chan also faces the same charges.
Quach faces charges of conspiracy to commit computer fraud and abuse and computer fraud and abuse. Each of those charges come with five years of imprisonment and $250,000 in fines.
The four are expected in court later this week.
Following the report of the indictment, Genentech sent BioSpace a note that not only included the statement provided to the Chronicle, but also included notice that the South San Francisco-based company filed a civil complaint in U.S. District Court for the Northern District of California against the indicted individuals, as well as Taiwan-based JHL. Included in that indictment is JHL co-Chairman and Chief Executive Officer Racho Jordanov and Chief Operating Officer Rose Lin.
Genentech noted that Chan had been employed by JHL and that he and other company employees, including Jordanov and Lin “solicited and accepted Genentech trade secrets and other confidential and proprietary information from both Xanthe and Allen Lam.”

82% Mortality Cut, 56% Rehospitalization Cut on Daxor Guided Heart Therapy

Controlled Study of BVA-100 Published in The Journal of the American College of Cardiology – Heart Failure Showed 86 Percent Reduction in One-Year Mortality
Daxor Corporation (NYSE MKT: DXR), an innovative medical instrumentation and biotechnology company focused on blood volume measurement today announces the publication of new data in the Journal of the American College of Cardiology – Heart Failure showing statistically significantly reduced 30-day readmission and 30-day and 1-year mortality rates in patients who received individualized treatment for acute heart failure guided by blood volume measurement with the BVA-100 blood volume analyzer, compared to propensity-matched controls.
“This is a landmark study for Daxor as it provides peer review validation in a leading cardiology journal of the value of our technology and its potential to improve heart failure outcomes. Heart failure represents one of the largest areas of healthcare spending and one of the most significant treatment challenges for approximately 6 million US patients, which is expected to double as the population ages,” commented Michael Feldschuh, CEO of Daxor. “The BVA-100 provides a simple, rapid, inexpensive, non-invasive, and most importantly, objective measurement of volume status and composition. This precision enables individualization of treatment and significantly better outcomes for patients.”
Treatment guided by the BVA-100 blood volume analyzer resulted in a statistically significant decrease in rehospitalization (12.2 percent vs. 27.7 percent, p<0.001), 30-day mortality (2.0 percent vs. 11.1 percent, p<0.001) and 365-day mortality (4.9 percent vs. 35.5. percent, p<0.001), compared to a propensity score control. Further, an analysis of 30-day readmission by diagnosis showed fewer heart failure readmissions (6.1 percent vs. 20.2 percent, p<0.001) and fewer cardiac non-heart failure admissions (1.6 percent vs. 3.9 percent, p<0.001).
“The results of this outcome study demonstrate without question that accurate blood volume measurement substantially improves the physician’s ability to prescribe decongestion therapy that will result in significantly better outcomes in acute heart failure, particularly with regard to rehospitalization and mortality,” said John E. Strobeck, M.D., Ph.D., Director, Heart-Lung Consultants, Inc., Hawthorne, NJ and lead author of the study. “These results clearly show that BVA measurement has a one-to-one relationship in achieving meaningful improvements in clinical and resource-use outcomes in patients hospitalized for acute heart failure.”
Total blood volume, red blood cell volume and plasma volume were measured using Daxor’s BVA-100, an I-131 labeled albumin indicator dilution technique that is unique to the BVA-100. Patients were assigned a decongestion and treatment strategy based on the BVA-100 measurement. Propensity score control matching was derived from CMS data matching 10:1 for demographics, comorbidity and year of treatment.

Amgen beats earnings views, raises guidance


Shares of Amgen Inc. AMGN, +0.47% rose 2% in the extended session Tuesday after the pharma giant reported third-quarter profits and sales above Wall Street expectations and revised up its guidance for the year. Amgen said it earned $1.86 billion, or $2.86 a share, in the quarter, compared with $2.02 billion, or $2.76 a share, in the year-ago quarter. Adjusted for one-time items, Amgen earned $2.39 billion, or $3.69 a share, compared with $3.27 a share a year ago. Revenue increased 2% to $5.9 billion, from $5.8 billion a year ago. Analysts polled by FactSet had expected Amgen to report adjusted earnings of $3.45 a share on sales of $5.8 billion. Amgen said it expects full-year 2018 sales between $23.2 billion and $23.5 billion, up from a previous guidance of sales between $22.5 billion and $23.2 billion. Adjusted per-share earnings are seen between $14 a share and $14.25 a share for the year, compared with expectations of non-GAAP EPS between $13.30 and $14. Shares of Amgen ended the regular trading session up 0.5%.

Clovis Oncology hit on wider quarterly loss, sales miss


Shares of Clovis Oncology Inc. CLVS, -20.11% tanked more than 22% in the extended session Tuesday after the Boulder, Colo.,-based biopharma company reported a wider-than-expected third-quarter loss and quarterly sales missed expectations. Clovis said it lost $89.9 million, or $1.71 a share, in the quarter, compared with a loss of $61 million, or $1.24 a share, in the third quarter of 2017. Revenue rose to $23 million from $17 million a year ago. Analysts polled by FactSet had expected a loss of $1.59 a share on sales of $30 million for the quarter. Clovis shares ended the regular trading day down 0.5%.

Sanofi announces FDA priority review granted for dengue vaccine


The FDA has accepted a biologics license application for Sanofi Pasteur’s dengue vaccine. The dengue vaccine candidate has been granted priority review by the FDA as it would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need. The FDA set a Prescription Drug User Fee Act action date of May 1. Dengue is endemic in the U.S. territories of Puerto Rico and the US Virgin Islands. In 2010, Puerto Rico experienced the largest outbreak when more than 12,000 cases were confirmed. Incidence remained high in subsequent years, particularly in 2012 and 2013. Dengue represents a health and economic burden in Puerto Rico with total annual associated costs reaching an estimated $160.2M. The vaccine, known as Dengvaxia in countries where it is approved, remains the only vaccine available for the prevention of dengue. The European Commission is expected to grant marketing authorization for Dengvaxia in December.
https://thefly.com/landingPageNews.php?id=2813983

Nasdaq Halts Avista Healthcare Public Acquisition Corp.


The Nasdaq Stock Market® (Nasdaq:NDAQ) announced that trading was halted today in Avista Healthcare Public Acquisition Corp. (Nasdaq: AHPA, AHPAU, AHPAW) at 17:05:35 Eastern Time for “additional information requested” from the company at a last sale price of $10.15, $10.36 and $0.21 respectively.
Trading will remain halted until Avista Healthcare Public Acquisition Corp. has fully satisfied Nasdaq’s request for additional information.

NextGen Healthcare sees FY19 EPS 70c-74c vs. prior 70c-78c


Consensus 75c. Lowers FY18 revenue outlook to $525M-$535M from $532M-$548M. Consensus $541.61M.