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Friday, December 20, 2019

U.S. Continues Crackdown on Chinese Research Funding Nondisclosure

The U.S. Government is increasing the measures it is taking to counter what it sees as a growing threat to scientific intellectual property from China. On Thursday, the government fined the Michigan-based Van Andel Research Institute (VARI) $5.5 million to resolve claims the institute made false allegations related to grants from China it received.
The Department of Justice said the Van Andel Research Institute (VARI) violated the False Claims Act by submitting federal grant applications and progress reports to the National Institutes of Health (NIH) that failed to disclose Chinese government grants that funded two VARI researchers. Also, the settlement resolves allegations that in a Dec. 21, 2018 letter, “VARI made certain factual representations to NIH with deliberate ignorance or reckless disregard for the truth regarding the Chinese grants,” the government said.
The government has been closely monitoring researchers with ties to China, either through funding or heritage. A 2017 report issued by the FBI noted that that intellectual-property theft by China costs the U.S. as much as $600 billion annually. Last year, two Chinese scientists pled guilty to stealing intellectual property from GlaxoSmithKline. Those trade secrets were going to be part of the foundation for setting up a company in China called Renopharma. This year, researchers at Emory University and at MD Anderson were terminated following the revelation of potential undisclosed funding ties with the government of China.
In the case of VARI, the government said the National Institutes of Health requires grant recipients to disclose all financial resources, including other research grants. During the term of a grant, NIH also requires recipient institutions to disclose whether certain aspects of federally-funded research will be, or have been, performed outside of the United States, the DOJ said.
According to the government between Jan. 1, 2012 and Aug. 31, 2019, VARI received NIH grants for two researchers. The researchers, Huaqiang Xu and Jiyan Ma, served as principal investigators on several NIH grants in genetics and neuroscience research, The Wall Street Journal reported. The two researchers received over $3 million in NIH funding.
The government alleged that when VARI, an independent research institute in Grand Rapids, Mich., applied for the NIH grants, it did not disclose any foreign research funding for those researchers or any foreign components of their NIH-sponsored research. However, the government said that both researchers received research funding from Chinese sources while VARI was applying for and receiving NIH funds on their behalf. Some of the Chinese funds came from the Thousand Talents Plan in China, which provides funding for scientists willing to conduct scientific research on behalf of the government. Many of the western researchers who receive the Thousand Talents funding end up relocating to China to work for a period of time. Earlier this year the Chinese government tamped down promotion of the Thousand Talents plan as western fears mounted over concerns of intellectual property theft.
The Department of Justice argued that VARI should have disclosed the relationship with the Chinese sources in its application. One of the grant recipients 1 held a directorship at a Shanghai-based research institute—a collaboration between VARI and the Shanghai Institute of Materia Medica. The government claimed that rather than confirming and disclosing the information to the NIH, VARI removed references to those grants from the proposed funding attributions in its press release.
The $5.5 million settlement with VARI came one day after the Moffitt Cancer Center in Tampa, Fla., fired its chief executive officer and a director for allegedly violating conflict-of-interest rules through their work in China, the Wall Street Journal reported. According to a statement from the Cancer Center, a review focused on its team members’ participation in China’s Thousand Talents Program. There is no indication Moffitt research was compromised or patient care affected, the cancer center said.
“Going forward, this will not damage the future of our research or the care of our patients. We will continue to be careful stewards of the public money entrusted to us for cancer research,” Moffitt said in its statement.

Bristol Gets Euro OK for Revlimid Combination for Follicular Lymphoma

Bristol-Myers Squibb Co. (BMY) said the European Commission approved a new indication for Revlimid, in combination with rituximab (anti-CD20 antibody), for adult patients with previously treated follicular lymphoma.
FL is a subtype of indolent, but incurable, non-Hodgkin lymphoma which is associated with immune system dysfunction.
The approval was based primarily on results from the phase 3 Augment study, which evaluated the combination versus rituximab plus placebo. In the study, treatment with the combination demonstrated a statistically significant improvement in the primary endpoint of median progression-free survival, Bristol-Myers said.

AstraZeneca Sells Rights to Two Cancer Medicines for $181 Million Up Front

AstraZeneca PLC (AZN.LN) said Friday that it is selling the rights to two cancer medicines that have lost their patent protection for an upfront payment of $181 million, plus up to $17 million in royalties.
The British drug maker said it divested the rights to Arimidex and Casodex in a number of European, African and other countries to Juvise Pharmaceuticals. U.S. rights to the drugs were already sold in the U.S. previously.
The transaction is part of a broader strategy of exiting mature medicines in order to allocate more financial resources to develop drugs in the research pipeline, Dave Fredrickson, executive vice president of the oncology business, said.

Health Insurance Innovations down 14% on shift to Medicare segment

Health Insurance Innovations (HIIQ -13.6%) is down on modestly higher volume on the heels of its strategy update. CEO Gavin Southwell says the company will prioritize its buildout into the Medicare space, but cautions that the shift may lead to the exit of “certain carrier and distribution relationships” in the individual and family plan (IFP) arena.
In the meantime, the company will focus on maximizing cash flows in the IFP business while enhancing its e-commerce capabilities. Mr. Southwell expects its existing IFP book to generate ~$170M in net cash flow, mostly in 2020.

NewLink Genetics up 33% on FDA nod for Merck Ebola vaccine

NewLink Genetics (NLNK +32.9%) is up on more than an 8x surge in volume in response to the FDA’s approval of Merck’s Ebola vaccine Ervebo.
The company out-licensed the rights to the vaccine, known as rVSV-ZEBOV at the time, to Merck in 2014.

Aravive launches mid-stage study of AVB-500 in kidney disorder

Enrollment is underway in a Phase 2 clinical trial evaluating Aravive’s (ARAV -2.6%) lead candidate AVB-500 in patients with IgA nephropathy, also known as Berger’s disease, characterized by the gradual buildup of immunoglobulin A (IgA) in the kidneys which leads to inflammation and comprised organ function.
Primary endpoints of the 24-subject study include safety and a range of efficacy measures. The estimated primary completion date is December 2020.
The company says AVB-500 is an ultra-high affinity decoy protein that suppresses fibrosis (scarring) and cancer cell proliferation by capturing and binding to a protein called GAS6, overexpressed in Berger’s disease and ovarian cancer.

Lexicon Pharma’s Zynquista successful in late-stage T2D study

A Phase 3 clinical trial, SOTA-EMPA, evaluating Lexicon Pharmaceuticals’ (NASDAQ:LXRX) Zynquista (sotagliflozin) in patients with type 2 diabetes (T2D) met the primary endpoint demonstrating its superiority versus placebo in lowering HbA1C levels at week 26.
A secondary endpoint of non-inferiority to empagliflozin was also met.
No new safety signals were reported.
SOTA-EMPA, conducted by former licensee Sanofi, is the fourth of nine core late-stage studies in the sotagliflozin T2D program.
Complete results will be submitted for presentation at future medical conferences.
Shares up 16% premarket on robust volume.
Update: Shares have reversed, down 6%, apparently due to its failure to demonstrate superiority over Eli Lilly’s (LLY +1.7%) Jardiance (empagliflozin).