Insilico signs $200M AI drug discovery partnership with China’s CTFH

Shortly after publishing a paper demonstrating how its artificial intelligence programs could generate viable lead compounds in just a few weeks, Insilico Medicine has signed a dual-program discovery collaboration with Jiangsu Chia Tai Fenghai Pharmaceutical worth up to $200 million.
Focused on previously undruggable targets in triple-negative breast cancer, the deal includes an upfront payment along with potential milestones and sales-based royalties pegged to any eventual products.
“We are very pleased to establish the partnership with Insilico Medicine, entering the new era of AI-enabled drug development,” Wenyu Xia, general manager of the China-based pharma company, said in a statement. “We look forward to a long-term partnership with Insilico Medicine.”

The company is a joint venture between the Chia-Tai Group, also known as CP Pharmaceutical, and the Jiangsu Agriculture Reclamation Group. With its R&D, production and sales backgrounds, it has developed several finished dosages and active pharmaceutical ingredients spanning gastrointestinal, cardiovascular, respiratory, neuropsychological and oncology areas.

In early September, Insilico showed it could conceptualize 30,000 novel small molecules using its machine learning approach, narrow them down to six potential candidates for a fibrosis target and then test them preclinically in less than 50 days. The company’s paper was published in Nature Biotechnology.
Additionally, Insilico recently raised $37 million in a series B round to fuel more AI-based pharma partnerships from China-based Qiming Venture Partners alongside participation from Eight Roads, F-Prime Capital, Lilly Asia Ventures, Sinovation Ventures, Baidu Ventures, Deep Knowledge Ventures and more.
Insilico said it plans to use the proceeds to build out its senior management with biotech industry veterans to help drive collaborations in therapeutic programs covering cancer, immunology, fibrosis, nonalcoholic steatohepatitis and central nervous system conditions.

https://www.fiercebiotech.com/medtech/insilico-signs-200m-ai-drug-discovery-partnership-china-s-ctfh

Bayer forms drug discovery pact with Japan’s Riken Innovation

Bayer has entered into a drug discovery collaboration (PDF) with Riken Innovation. The agreement will give Bayer the chance to explore drug targets based on research at a leading Japanese scientific research institute.
Riken Innovation is a wholly owned subsidiary of the Japanese research institute from which it takes its name. The institute, called Riken, employs more than 3,000 researchers and has an annual budget of close to $900 million. Riken Innovation, which began operating last month, will work to bring the benefits of its parent organization’s research to the public by collaborating with industry.
Bayer is the first company to publicly sign up to work with Riken Innovation. The partners plan to use Riken research as the basis for joint explorations of potential drug targets and assessments of disease mechanisms. A road map is in place for drug targets that show promise.

“In cases where a path for novel drug target is identified for specific partnering opportunities, Riken Innovation will coordinate the advancement of the potential project,” the partners wrote in a joint statement.
Bayer’s Open Innovation Center in Osaka, Japan, will oversee the project, providing drug discovery capabilities to complement its new partner’s basic research. The collaboration opens up another front in Bayer’s efforts to connect with Japanese R&D organizations. Bayer already runs one of its CoLaborator startup collaboration centers out of the Japanese city of Kobe.
The Japanese facilities are part of a global network of sites Bayer hopes will form collaborations to boost its internal R&D group, which is adapting to a restructuring that axed 900 of its 8,000 workers.
For Riken, the partnership furthers its efforts to become a less insular organization. Last year, Riken opened an office in Belgium, in part to give its researchers opportunities to work with Europeans. Talking to Science Business at the time, Riken’s president Hiroshi Matsumoto said Japanese scientists are “inward looking,” adding that “this tendency has to change.”
https://www.fiercebiotech.com/biotech/bayer-forms-drug-discovery-pact-japan-s-riken-innovation

BioNTech cuts share offering and lowers proposed range to $15 to $16

BioNTech, a German biotech developing individualized immunotherapies for cancer, lowered the proposed deal size for its upcoming US IPO on Wednesday.

The Mainz, Germany-based company now plans to raise $155 million by offering 10 million ADSs at a price range of $15 to $16. The company had previously filed to offer 13.2 million shares at a range of $18 to $20. At the midpoint of the revised range, BioNTech will raise 38% less in proceeds than previously anticipated and would command a market value of $3.6 billion.
BioNTech was founded in 2008 and booked $149 million in revenue for the 12 months ended June 30, 2019. It plans to list on the Nasdaq under the symbol BNTX. J.P. Morgan, BofA Merrill Lynch, UBS Investment Bank, SVB Leerink, Canaccord Genuity, Bryan, Garnier & Co and Berenberg Bank are the joint bookrunners on the deal. It is expected to price on Wednesday, October 9, 2019.

Relevant Profile: BNTX

https://www.renaissancecapital.com/IPO-Center/News/65358/BioNTech-cuts-share-offering-and-lowers-proposed-range-to-$15-to-$16

Medical debt collectors barred from wiping out Californians’ bank accounts

A new California law signed by Gov. Gavin Newsom prohibits collection agencies from wiping out bank accounts to pay medical debts.
“People who are living paycheck to paycheck need the protection that this bill will provide to give them more financial security,” said Sen. Bob Wieckowski, who authored the legislation. “We do not want people living on the streets because debt collectors, who don’t have the greatest track record for accuracy, claim someone owes an old debt.”
Mr. Wieckowski says the legislation doesn’t erase debt, but “gives people the ability to pay rent, medical expenses and other daily costs while they pay down or contest the debt.”
Agencies will be required to leave $1,724 in a consumer’s bank account. Mr. Wieckowski said this amount is the lowest possible for a family of four to live in urban California, as determined by the state’s social services department.
Read the full text of the bill here.
https://www.beckershospitalreview.com/finance/medical-debt-collectors-barred-from-wiping-out-californians-bank-accounts.html

Ohio Senate passes bill to allow patients to learn hospital costs in advance

Ohioans would be able to learn the bottom-line cost of their scheduled hospital care — and their out-of-pocket share of the bill — in advance under a bill passed unanimously by the Ohio Senate on Wednesday.
Senate Bill 97, sponsored by Sen. Steve Huffman, R-Tipp City, would require hospitals to provide a “reasonable, good faith” cost estimate, or price range, of scheduled services at the advance request of patients beginning July 1, 2021.
The information must include an estimate of out-of-pocket costs and whether other costs, such as physician or anesthesiology services, will be billed separately. Hospitals also must warn patients if they are out of network with their health insurer to prevent so-called “surprise billing.” Patients must request cost estimates at least seven days in advance.
Hospitals also must provide a web site which contains the standard costs of common items and services, which also is required under federal law to allow consumers to price shop.
Senate President Larry Obhof, R-Medina, said the bill would give consumers a heads-up on potential costs to avoid financial surprises and could help control costs.
The bill, passed by a 32-0 vote, now advances to the House for consideration.
Lawmakers used the state budget to insert the hospital price transparency language and a provision requiring insurers to cover out-of-network care when provided at in-network facilities.
However, Republican Gov. Mike DeWine vetoed the provisions, calling them unworkable and duplicative of federal requirements. A separate bill addressing “surprise billing” accompanying out-of-network care at covered providers is undergoing hearings in the Senate.

The price disclosure mandate comes as health care costs continue to spiral. The Kaiser Family Foundation reports the average price of an in-patient surgery increased 30% over five years. And, employee health insurance premiums and deductibles for a family plan have increased 162% over the last 10 years, the foundation reported.
The Ohio Hospital Association supports the bill, saying a “competitive health care market and patient demand” has prompted hospitals and other health care providers to publicly post costs for common procedures and inform patients of their uninsured share of the price.
“What patients want to know is how much something is going to cost them out of their pocket,” Sean McGlone, lawyer for the hospital association, told a Senate committee.
As introduced, the bill would have required physicians, therapists, dentists, chiropractors, psychologists and others to also provide cost estimates, but that portion was dropped due to concerns over burdensome regulations on smaller practioners, which DeWine cited in his veto.
The General Assembly’s last attempt to improve cost transparency in 2015 died in the courts. After delaying its enactment, the Ohio Hospital Association and other health care providers obtained a state court injunction early this year, successfully arguing the bill violated the “one bill, one topic” section of the Ohio Constitution by not being passed as stand-alone legislation.
In other action, the Senate voted unanimously to approve Senate Bill 52, creating the Ohio Cyber Reserve as civilian IT volunteers under the Ohio National Guard to be called to duty in response to cyber attacks on state and local government computer systems and other infrastructure.
To increase election security against hacking and other threats, the bill makes Secretary of State Frank LaRose a member of Ohio’s Homeland Security Advisory Council. The legislation also requires county boards of election to audit the official results of general and primary elections, which now occur under directives from the secretary of state. The bill now goes to DeWine for his signature.
https://www.dispatch.com/news/20191009/senate-passes-bill-to-allow-patients-to-learn-hospital-costs-in-advance

Return of Vioxx: Can drug once deemed deadly relaunch to treat rare disease?

Since its recall in 2004, the pain drug Vioxx has been a symbol of pharmaceutical danger, starring in countless daytime legal advertisements explaining how you, or perhaps a loved one, might be entitled to millions in settlement dollars. But one company believes the infamous drug deserves a second chance, and is plotting to resurrect the former blockbuster as a treatment for a rare, incurable condition.
Vioxx’s days as a widely used treatment for arthritis and chronic pain came to an end when studies revealed that it roughly doubled patients’ risk of heart attack and stroke, leading to an estimated 60,000 deaths. It was a public health disaster, and it led to a congressional investigation, allegations of lapses at the Food and Drug Administration, and agreement by the manufacturer, Merck, to pay a nearly $5 billion settlement.
Now, Tremeau Pharmaceuticals, a private Massachusetts company, is developing a generic version of Vioxx as a treatment for severe joint pain in people with hemophilia, a side effect called hemophilic arthropathy. The company plans to begin a pivotal trial next year and, if the resulting data are positive, Tremeau will apply for FDA approval in hopes of bringing Vioxx back to market more than 15 years after Merck pulled it from shelves.

Experts say the drug’s cardiovascular issues are nothing to discount, but Vioxx’s deadly history isn’t doomed to repeat itself. The alarming number of heart attacks associated with the drug represent a small percentage of the millions of people who took it, driven in part by the fact that doctors prescribed liberally. Now that Vioxx’s relationship with cardiovascular danger is well-understood, they say, doctors could mitigate future problems by ensuring that patients at high risk don’t get it, and by consistently monitoring those who do.

While the Vioxx brand might be tarnished in the popular consciousness, the drug has a much different reputation in the hemophilia community. Before its recall, the drug was the off-label drug of choice to treat hemophilic arthropathy, which results from a buildup of blood in patients’ joints and leads to pain, inflammation, and tissue damage. Over-the-counter pain treatments like ibuprofen can lead to internal bleeding, making them inadvisable for patients with hemophilia.
Dr. Ellis Neufeld, clinical director of hematology at St. Jude Children’s Research Hospital in Memphis, said the recall of Vioxx, while certainly advisable given the safety concerns, robbed patients with hemophilia of an important treatment.
“That was a bad day,” Neufeld said. “We really lamented it. Vioxx was a good drug.”
In the years since, doctors have reached for steroids, physical therapy, and even opioids to treat the pain of hemophilic arthropathy. In severe cases, patients get their problematic joints replaced. But each solution comes with limitations. Steroids can only be used for a short time, and opioids come with serious risks of abuse.
“Vioxx certainly left a void in our arsenal,” said Dr. Catherine Broome, a hematologist at Georgetown University Hospital in Washington, D.C.
While physicians who spoke with STAT have no trouble seeing the medical utility of a Vioxx reboot, the business case is a little less clear.
There are only about 20,000 people in the U.S. with hemophilia, and, thanks to modern treatment, the percentage who develop hemophilic arthropathy has decreased over time, doctors said. Since the 1990s, physicians have been able to replace the missing proteins that prevent clotting in patients with hemophilia, minimizing the number of bleeds and thus reducing the incidence of hemophilic arthropathy.
“If you take what we dealt with in the early years in my career, the people I was taking care of then, they are all severely affected with hemophilic arthropathy,” said Broome, who has been treating hemophilia patients since 1985. “But if you look at young men in their 20s and 30s right now, you can’t tell them apart from you or me.”

On the horizon are one-time gene therapies that promise to free hemophilia patients from regular infusions of clotting protein. The most advanced of those therapies, a treatment for hemophilia A developed by BioMarin, could win FDA approval as early as next year. If its effects prove to last a lifetime, the number of people with hemophilic arthropathy would further wane.
That could mean Tremeau’s reanimated Vioxx would be a niche product at best, and it might explain the company’s delayed development.
In 2017, Tremeau told the Associated Press that it would need to raise $25 million to fund its pivotal trial. That same year, the company said it “gained agreement” with the FDA on the size, duration, and details of that trial. However, Tremeau has raised just $5.2 million since then and is yet to enroll a single patient.
In an email, a Tremeau representative said the company is “in active discussions with the FDA and the hemophilia community” and plans to start the trial some time in 2020. The company declined to answer questions about the cause of its delay and whether it has enough money to complete the study.
Despite the changing dynamics in hemophilia treatment, “hemophilic arthropathy isn’t going away,” said Dr. Christopher Walsh, a hematologist at Mount Sinai Hospital in New York City who has served as a paid adviser to Tremeau.
“There’s a definite need in this community for alternative pain medication that is not addictive,” Walsh said. “And Vioxx — hopefully, if they do the study — would be one of those drugs. But that remains to be seen.”

The return of Vioxx: Can a drug once deemed deadly be relaunched to treat rare disease?

Alibaba to stop sales of e-cigarette components in US

Chinese e-commerce firm Alibaba said on Wednesday it will stop selling e-cigarette components in the United States, amid growing regulatory scrutiny and reports of lung disease and some deaths linked to vaping.
The move follows announcements by Kroger Co and Walgreens Boots Alliance Inc this week that they would stop selling e-cigarettes at their stores, in line with a similar decision by Walmart.
Alibaba said it already had a long-standing policy in place to not sell complete e-cigarette products in the United States.

Vaping products have been linked to a mysterious lung illness that is reported to have led to 18 deaths as of last week, with the number of confirmed and probable cases of the condition exceeding 1,000, according to the U.S. Centers for Disease Control and Prevention.
Alibaba Group Holding Ltd said that listings for products such as box mods, vape pens, herbal vapors, heat not burn devices, and empty pod cartridges would not be displayed for users located in the United States.
While Juul Labs Inc dominates the North American market for pod e-cigarettes, many reports of death and injury in the United States have been tied to makeshift brands with no identifiable owner.

The most prominent, Dank Vapes, was linked to 24 patients with lung illness, according to a study from the New England Journal of Medicine. The products contained THC, the psychoactive ingredient in marijuana.
Prior to the suspension, buyers could easily purchase devices, component parts and packaging from sites like Alibaba or Amazon to make their own counterfeit vaping devices.
Amazon.com Inc took down vape paraphernalia in September, although it did not specify the exact products it removed.
https://www.reuters.com/article/us-alibaba-cigarettes/alibaba-to-stop-sales-of-e-cigarette-components-in-united-states-idUSKBN1WO0A3