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Wednesday, September 5, 2018

Cuomo: Crystal Run could have ‘admitted to a crime’


Gov. Andrew Cuomo’s campaign has generally refused to answer questions about an ongoing federal investigation into Crystal Run Healthcare, which has given $400,000 in campaign donations to the governor and received an extraordinary $25.4 million in state grants.
In a meeting with the Times Union editorial board on Tuesday, Cuomo did answer a question his campaign has evaded for weeks: Crystal Run officials, the governor said, have not approached him about any potential legal problems with their donations.
By contrast, U.S. Rep. Sean Patrick Maloney — currently running for the Democratic nomination for state attorney general — has publicly stated that Crystal Run approached him about irregularities with more than $35,000 in donations its made to the congressman.
“Well, then,” Cuomo said of Crystal Run’s disclosure to Maloney, “they admitted to a crime.”
“Which is sort of incredible for me to believe as a former prosecutor and an attorney general,” Cuomo said. “Why somebody would call up and say to a congressman, ‘I committed a felony. Just thought you should know.’ Especially since nobody’s been charged. I mean, who would make that phone call?”
Maloney’s decision to turn over Crystal Run’s legally problematic donations to the U.S. Treasury has put Cuomo – who has refused calls to return any portion of his own Crystal Run donations – in the position of having to rationalize that stance.
On Tuesday, Cuomo theorized that Maloney’s statements about Crystal Run admitting legal troubles were not accurate.
“How much do you want to bet,” he said, “the Crystal Run people never called Maloney and said that?”
In response to Cuomo’s comments, Maloney’s office on Tuesday provided the Times Union with a letter from a Crystal Run attorney that disclosed issues with the company’s donations but insisted they were inadvertent.
Listen to Cuomo discuss Crystal Run in a meeting with the Times Union’s editorial board:

No one from Crystal Run has been charged with any wrongdoing.
Following a series of Times Union articles last year, the Manhattan U.S. Attorney’s office and FBI are investigating Crystal Run over its manner of giving to Cuomo. The investigation has also brought allegations of pay-to-play behavior from the governor’s electoral challengers this year: The company in 2016 landed $25.4 million in state grants for projects it was already building without taxpayer subsidies.
Cuomo maintains the prodigious campaign giving of Crystal Run and other donors – totaling $49 million for his current reelection bid – has never impacted state policy decisions.
The ongoing criminal investigation of Crystal Run is examining whether its officials were reimbursed by company bonuses for a flurry of $25,000 donations they made to Cuomo’s campaign in 2013. If that occurred, it would be a potential violation of state election law.
On Tuesday, Maloney’s office provided more information about how it came to return the Crystal Run-connected donations.
The Orange County-based company this spring asked Maloney to give back some of its officials’ past campaign donations to the congressman. In response, Maloney’s office asked for more information.
In April 2018, an outside counsel for Crystal Run, David Frulla of the firm Kelley Drye, wrote a letter to an attorney for Maloney.
“Upon review, Kelley Drye determined it was appropriate to request the enumerated refunds, but have no reason to believe that Maloney for Congress was privy to any of the information or actions that caused the refund request,” Frulla said in the letter. “Crystal Run has made a sua sponte” – or voluntary – “submission to the Federal Election Commission regarding this matter.”
“Further, we requested the refunds because our review found that (Crystal Run), and its officers, partners, and employees, did not fully or accurately understand campaign finance law and regulations applicable to partnerships,” the lawyer wrote. “Any resulting failure to comply with the applicable law or regulations was, accordingly, inadvertent.”
Maloney’s office has also said that Crystal Run acknowledged the donations were “incorrectly attributed” in campaign filings.
A Crystal Run spokesman did not respond to a request for comment on Tuesday.
Cuomo, meanwhile, has declined to heed calls from his political opponents, actress and Democratic primary opponent Cythnia Nixon and Republican Marc Molinaro, that he also return Crystal Run’s money.
The governor stated again on Tuesday that he would return the company’s money if legal wrongdoing was found.
“The Crystal Run situation is this,” Cuomo said. “Two years ago, I don’t know which office started an investigation on a doctor as a ‘straw donor.’ Our contribution form, on our website, says ‘Do not do straw donors.'”
“That was two years ago,” Cuomo said, noting he had heard little since. “As soon as there is a finding that somebody did something wrong, I will return the contributions.”
Over a two-day period in October 2013, Crystal Run officials, doctors or their spouses gave Cuomo 10 donations of $25,000 apiece. The donations came during a Cuomo fundraiser, though the governor’s campaign has repeatedly refused to discuss its location and details such as whether it was an exclusive Crystal Run event.
Of the 10 Crystal Run donors to Cuomo, seven had not made a donation in a New York election in at least a decade.
On Tuesday, Cuomo stated for the first time that Crystal Run officials threw a fundraiser for him in 2013. He also said it was not unusual for so many people, who had not given in New York elections before, to give him the 10 identical $25,000 checks.
“If you do a fundraiser for me, you’re going to go to your neighbors and your friends and say, ‘Do me a favor — Andrew Cuomo’s a good guy, he’s a friend of mine, come over and contribute,'” Cuomo said. “Yeah, so the company did a fundraiser.”
Cuomo also addressed the fact that Crystal Run was granted $25.4 million in 2016 by the state Department of Health to build two health care facilities — in Monroe, Orange County, and West Nyack, Rockland County — that it was already constructing without taxpayer subsidies.
Cuomo said the agency’s decisions in handing out $1.2 billion in health care capital funds grants statewide had been made by civil service employees.
“It’s done on objective criteria, pursuant to a 2014 law. And that’s how the program works,” Cuomo said. “I haven’t gotten into it well enough. But there is no suggestion that they got the grant from Health because of the contribution.
“The only suggestion is this guy was a straw donor,” Cuomo said of the investigation. “That was two years ago.”
The Times Union first wrote about the Crystal Run donations to Cuomo in February 2017, about 18 months ago.
On Tuesday, the Times Union reported that for the two projects, Crystal Run had attempted to get taxpayer reimbursement of the $25 million in grants for a number questionable expenses, from artwork and “mood music” systems to plastic flowers for a lobby. While the Cuomo administration has not repaid the company for those purchases, it did reimburse Crystal Run — one of New York’s fastest-growing private medical firms — for $6 million, including $1.2 million in corporate office furniture.
“Not another a dime of taxpayer money should go from the Cuomo administration to Crystal Run while the FBI and Orange County are investigating this,” said Molinaro, the Dutchess County executive, in a statement responding to the story. “And, Gov. Cuomo: You won’t have enough money in your campaign arsenal in November to explain away the dirty $400,000 you’re holding. Mark my words: New Yorkers have had enough.”
Cuomo campaign spokeswoman Abbey Collins responded that “Trump mini-me Marc Molinaro should look in the mirror. He’s taking a page from Trump’s playbook by taking contributions from business with local contracts, doling out tax breaks in return, and handing out favors to his friends and family.”
At the Times Union, Cuomo said Maloney had only returned the more than $35,000 because he is currently running in the heated Democratic primary for state attorney general, the state’s top law enforcement job.
“I think it was just a political decision,” Cuomo said. “It was a PR decision.”
“There’s been no charge,” Cuomo added. “And also, straw donor cases are also sort of an open-and-shut case. It’s ‘Dr. Smith, you gave $25,000 to Sean Patrick Maloney. Did the company reimburse you?’ That’s it. And, ‘Is there a check that goes to you for the $25,000?'”
“This has been two years! If they have that case, that’s the case,” he said.

12 more patients dosed, Bluebird boosts strong profile for gene therapy


  • Fresh data on Bluebird Bio’s Lenti-D reinforced the encouraging efficacy and safety profile the gene therapy demonstrated in the clinic last year, adding support to regulatory filings planned for 2019.
  • Bluebird is testing Lenti-D in boys with a rare metabolic disorder called cerebral adrenoleukodystrophy, or CALD. Last year, early results from the Phase 2/3 STARBEAM trial showed 15 of 17 patients treated with the therapy were alive and free of major functional disabilities (MFDs) after two years. As of April 25, an additional 12 boys were given Lenti-D, none of whom experienced MFDs by a median follow-up of 4.2 months, the company said in a Wednesday statement.
  • STARBEAM’s primary safety endpoint is the proportion of patients with grade 2 or higher acute graft-versus-host disease (GvHD) or chronic GvHD two years after treatment. None of the 29 patients on Lenti-D have experienced such diseases as of April 25, though there have been three adverse events potentially related to treatment with the therapy, including a grade 3 case of bladder inflammation caused by a virus.

Bluebird has a few busy years ahead. The Massachusetts-based biotech expects to file three therapies, including Lenti-D, for approval by the end of 2019. And by 2022, the aim is to have at least two products on the market.
In a Sept. 5 statement, Bluebird said it reached agreements with the Food and Drug Administration and the European Medicines Agency on regulatory pathways for Lenti-D. Meeting STARBEAM’s primary endpoints — MFD-free survival for efficacy, GvHD occurrence for safety — will be key to any approval decisions.
While proponents of gene therapy often tout it as an ultra-effective, one-time remedy for difficult-to-treat diseases, regulators have held some apprehension, particularly when it comes to safety. The FDA halted 27 gene therapy trials in 2003, for instance, after leukemia-like symptoms arose in two children enrolled in a gene therapy study. More recently, investors have been spooked by safety too. Spark Therapeutics lost around $1 billion in its market capitalization earlier this year as data on its hemophilia gene therapy raised some safety concerns.
“Even when there may be uncertainty about some questions, we need to make certain we assure patient safety and adequately characterize the potential risks and demonstrated benefits of these products,” FDA Commissioner Scott Gottlieb said in a July statement on new agency guidance for gene therapies.
To the point on safety, Bluebird is running an observational study that looks at outcomes of boys 17 and younger who have CALD and received allogeneic hematopoietic stem cell transplants (HSCTs). The biotech intends to compare data from that study with STARBEAM’s safety results.
In that study, 34% of the 41 patients who received allogeneic HSCTs experienced grade 2 or higher acute GvHD or chronic GvHD.
What’s more, it’s also conducting a long-term safety and efficacy follow-up study for STARBEAM participants treated with Lenti-D.
Bluebird said Lenti-D’s safety profile has so far been consistent with certain conditioning therapies used to suppress the immune system before allogeneic HSCTs.
“Data from the Phase 2/3 Starbeam study suggest that Lenti-D, which utilizes a child’s own cells and does not require a matched donor, may be a potential treatment for CALD,” Paul Gissen, a consultant in pediatric metabolic diseases at London’s Great Ormond Street Hospital and an investigator in the STARBEAM study, said in the Sept. 5 statement.

Chi-Med wins landmark cancer drug approval in China


  • London-listed drugmaker Hutchinson China MediTech has won the first unconditional approval from Chinese regulators of a cancer medicine both discovered and developed in China, marking a milestone for the country’s emerging biotech sector.
  • Better known as Chi-Med, the company on Wednesday said its drug, a VEGF inhibitor called fruquintinib, is now cleared to treat metastatic colorectal cancer in patients who have failed two other systemic therapies.
  • Fruquintinib’s approval is a tangible sign of the progress made by a new crop of Chinese biotech companies that aim to invent novel therapies and shift away from the country’s historical role as a manufacturer of raw pharmaceutical ingredients.

Chi-Med began work on what would become fruquintinib in 2007, pushing the compound into clinical testing four years later. That decade-plus of drug development has now paid off, with an approval that puts the drugmaker at the forefront of China’s biotech scene.
Clinical progress from biotechs like Chi-Med, coupled with sweeping regulatory reforms and the recent opening of Hong Kong’s stock exchange to pre-revenue biotech companies, has fueled a surge of interest in Chinese drug development.
Historically, China’s contribution to drug supply chains has been the active pharmaceutical ingredients that make up foreign-made medicines. Chi-Med and its Chinese biotech peers, on the other hand, hope to take their place alongside U.S. and European companies in developing new drugs.
It’s clear why drugmakers are interested in introducing more branded drugs in China. The country is the second-largest market for drugs globally, trailing only the U.S. in overall size.
Fruquintinib’s approval was backed up by a Phase 3 study, published in JAMA earlier this year, that showed the drug improved median overall survival versus placebo by nearly three months in 416 colorectal cancer patients whose tumors had grown after prior treatment with two chemotherapies.
The National Medical Products Administration of China approved fruquintinib roughly a year after granting the drug priority review status.
“What that illustrates is that Chinese companies now are conducting science and developing drugs in a way that meets the height of global standards,” said Brad Loncar, head of Loncar Investments, in an interview with BioPharma Dive. “I think that this is a sign of things to come.”
That optimism is tempered, however, by continued concerns over production quality among Chinese manufacturers. A recent vaccine scandal and global recalls of a heart drug made by a Chinese drugmaker indicate that, even as biotech companies push forward, the broader industry still lags in meeting global standards.
Under a 2013 collaboration deal with Chi-Med, Eli Lilly will launch fruquintinib in China under the brand name Elunate.
Studies of the drug in gastric and lung cancer are ongoing and, in December of last year, Chi-Med initiated a Phase 1 trial in the U.S.
Beyond fruquintinib, Chi-Med hopes to win approval of two other cancer drugs within the next three years.
Other Chinese biotechs are making strides in drug development as well. Beigene recently filed for Chinese approval of its anti-PD-1 cancer immunotherapy tislelizumab and Jiangsu Hengrui Medicine won a conditional approval for its breast cancer drug pyrotinib.
At the same time, Chinese regulators have ramped up the pace of approvals of foreign-made drugs, particularly in cancer. Just in the past few months, Merck & Co., Bristol-Myers Squibb, Roche and AstraZeneca have all secured OKs for key drugs, including the immuno-oncology stars Opdivo (nivolumab) and Keytruda (pembrolizumab).

More Bad News About Benzos


Hello. I’m Dr Arefa Cassoobhoy, a practicing internist, Medscape advisor, and senior medical director for WebMD. Welcome to Medscape Morning Report, our 1-minute news story for primary care.
Benzodiazepines are in the news again—this time, not for the increased risk for falls and fractures that can come with their use.
A case-control study was conducted in Finland among community-dwelling adults who had been diagnosed with Alzheimer disease. Benzodiazepines and related Z drug use was associated with a modestly increased risk for Alzheimer disease. No real differences were seen for the drug subcategories. This included short-, medium-, and long-acting benzodiazepines, as well as zolpidem, zaleplon, and eszopiclone.
The analysis showed that 5.7% of dementia cases among adults using benzodiazepines were due to the drugs. Even this small increased risk could be significant because they are widely prescribed to elderly adults, often long term. The drugs are given to treat prodromal and neuropsychiatric symptoms of dementia like insomnia and anxiety.
The authors concluded that benzodiazepines and Z drugs should be avoided when possible, given their adverse-event profile. For patients who you would like to wean off benzodiazepines, deprescribing can be tough and take a long time. Guidelines are now available to help you with the process.

Bovie Medical initiated at Piper Jaffray


Bovie Medical resumed with an Overweight at Piper Jaffray. Piper Jaffray analyst Matt O’Brien resumed Bovie Medical with an Overweight rating and a price target of $8 after the company’s business update call today regarding the completed divestiture of its core franchise, saying the company now intends to invest the proceeds in its J-Plasma sales channel. O’Brien notes that this is a “correct” strategic decision in spite of the uncertainty regarding the company’s financials in the coming quarters, adding that revenue growth will likely be “considerable” in 2019 and 2020. The analyst recommends that risk-tolerant investors begin to accumulate positions in the stock.

Embattled blood-testing firm Theranos to dissolve


Theranos Inc, the once-celebrated Silicon Valley blood-testing firm, is about to dissolve itself months after top executives were indicted for defrauding investors, the Wall Street Journal reported on Wednesday.
The move follows a failed attempt by Theranos to sell itself, during which it reached out to more than 80 potential buyers through Jefferies Group, the Journal reported, citing an email to shareholders from Chief Executive David Taylor.
“Unfortunately, none of those leads has materialized into a transaction. We are now out of time,” Taylor wrote in the letter, a copy of which was published by the WSJ.

The firm will attempt to pay unsecured creditors its remaining cash in the coming months, the Journal reported, adding that big name investors had lost about $1 billion.
Neither Taylor nor representatives for Palo Alto, California-based Theranos immediately responded to Reuters’ requests for comment.
Theranos founder Elizabeth Holmes, who started the company when she was 19, was celebrated as a rising Silicon Valley star until it became clear that many of the claims about the company’s supposedly revolutionary blood test were bogus.
In June this year, Holmes and former Theranos president Ramesh “Sunny” Balwani were indicted on charges that they engaged in schemes to defraud investors, doctors and patients.
They used advertising and solicitations to encourage doctors and patients to use Theranos’s blood testing laboratory services despite knowing the company could not produce accurate and reliable results consistently, prosecutors had said.
Theranos was in default under its credit facility with Fortress Investment Group, Taylor said in the letter.
He said the company was attempting to reach an agreement with Fortress to give it ownership of Theranos’ patents but leaving its remaining cash of about $5 million for distribution to other unsecured creditors.
Besides Fortress, Theranos owes at least $60 million to unsecured creditors, Taylor said. “Because the company’s cash is not nearly sufficient to pay all of its creditors in full, there will be no distributions to shareholders,” he added.
The company aims to seek board and shareholder consent for the Fortress settlement and corporate dissolution later this week and proceed with the actions starting Monday, Taylor said.

Westlake Bio Unveils $320M Fund to Put Los Angeles on the Biotech Map


Los Angeles has long been in San Francisco’s shadow when it comes to life sciences investment. But a new venture capital firm led by industry veterans is trying to cast the City of Angels in a new light.
Westlake Village BioPartners is launching today with $320 million in committed capital. The Los Angeles-based firm is led by managing directors Beth Seidenberg, a former general partner at venture capital firm Kleiner Perkins, and Sean Harper, the outgoing executive vice president of research and development at Amgen (NASDAQ: AMGN). Harper will start with Westlake in January after retiring from Amgen. Scott Ryles, chief operating officer of Kleiner Perkins, is joining Westlake as its COO.
Seidenberg shares Amgen ties with Harper. Before joining Menlo Park, CA-based Kleiner Perkins in 2005, she was Amgen’s chief medical officer. Kleiner Perkins invests in both technology and life sciences, and although there is growing overlap between the two fields, Seidenberg says she’ll have more opportunities at Westlake.
“At Kleiner Perkins, the amount of capital I would have to focus on life sciences was less than what I thought a dedicated life sciences fund would be able to have,” she says.
Westlake will invest primarily in pharmaceutical and biotech companies, but the firm will be open to other technologies with medical applications, says Seidenberg. Most investments will be in early-stage startups. Seidenberg adds that Westlake will incubate some technologies with seed money before committing to a full Series A round of financing. Westlake has already started talking with entrepreneurs, though Seidenberg declined to discuss additional details such as the therapeutic areas of potential investments.
The Los Angeles area attracts a fair amount of venture capital—it was the nation’s fifth largest market from 2006 to 2016, according to Pitchbook—but most of the investment is in is in high tech.
Harper says Westlake can play a role in boosting the L.A. life sciences sector. UCLA and CalTech are already churning out biotech innovations, and large pharmaceutical companies such as Thousand Oaks, CA-based Amgen and Allergan (NYSE: AGN), which has a large presence in Irvine, CA, have helped broaden the pool of life science workers throughout the region.
“The thing that’s really been missing in terms of sparking a really vibrant ecosystem like you see in Boston and San Francisco is having a dedicated life sciences venture group that knows what it’s doing from a scientific and technical perspective,” Harper says.
Harper has lived in Southern California for 16 years. For Seidenberg, Westlake represents a homecoming, though she points out that she never really left. For the past 13 years, she’s been commuting to the Bay Area from her L.A. home. She says that many of the L.A.-area biotech entrepreneurs are like her: industry veterans who are returning to Southern California from other parts of the country to try something new.
“This is the golden age of biotech,” Seidenberg says. “The opportunities for biotech investing, having been in this industry for nearly 30 years, are better than I’ve ever seen.”