Search This Blog

Wednesday, August 1, 2018

FDA Approves Shionogi Liver Disease Med


Shionogi & Co., Ltd., based in Osaka, Japan and Florham Park, New Jersey, announced that the U.S. Food and Drug Administration (FDA) approved Mulpleta (lusutrombopag) for thrombocytopenia in adults with chronic liver disease who were about to have a medical procedure performed.
Mulpleta is a once-daily, oral medication that acts as a small molecule agonist on the thrombopoietin (TPO) receptor. It is part of a new class of drugs known as thrombopoietin receptor agonists (TPO-RA). They stimulate platelet production. Thrombocytopenia is often seen as a complication of CLD, occurring in up to 78 percent of patients with cirrhosis. Patients with CLD and thrombocytopenia are at increased risk of bleeding and require recurrent platelet transfusions, more ambulatory visits and inpatient hospital stays.
“Therapeutic options in this area are critically needed, as adult patients with chronic liver disease often require multiple procedures for various medical reasons,” said Nezam Afdhal,senior physician in Hepatology at Beth Israel Deaconess Medical Center and professor of Medicine at Harvard Medical School, in a statement. “I look forward to being able to offer this new oral treatment to patients, instead of relying solely on platelet transfusions.”
The FDA approval was based on safety and efficacy results from two Phase III clinical trials, L-PLUS 1 and L-PLUS 2.
In May, Durham, North Carolina-based Dova Pharmaceuticals announced the FDA had approved its Doptelet (avatrombopag) for thrombocytopenia in adults with CLD. It was the first TPO-RA approved in the U.S. for that indication.
“We are delighted FDA has approved Doptelet, which represents a significant milestone for Dova, physicians, and most importantly, patients,” said Alex Sapir, president and chief executive officer of Dova, in a statement in May. “Doptelet is the first orally administered treatment option for patients with CLD, allowing the majority of patients to avoid a platelet transfusion prior to a procedure by increasing platelet counts to the target level of greater or equal to 50,000 per microliter. Given our extensive preparations to date, we are positioned to launch Doptelet in June with our full complement of sales, marketing, and reimbursement support resources.”
Shionogi’s Mulpleta has been used in Japan since it was approved in September 2015 by the Ministry of Health, Labor and Welfare. The FDA had a PDUFA date of August 26 for the drug, but zipped it through approval almost a month early. In two studies, 78 percent and 65 percent of patients receiving the drug did not require transfusions ahead of medical procedures. The patients also didn’t require rescue therapy for bleeding within 7 days of the procedure.
“Patients with chronic liver disease and thrombocytopenia undergoing non-emergent invasive procedures currently have no approved medical treatment options except for platelet transfusions, therefore therapeutic options in this area are critically needed,” said Tsutae “Den” Nagata, Shionogi’s chief medical officer, in a statement last fall.
The drug has been validated by the European Medicines Agency (EMA) and is expected to be approved in the first half of 2019. It is expected to be available in the U.S. by early September 2018.

China’s Ascletis Debuted: Stocks Flat


Chinese biotech company Ascletis Pharma debuted on the Hong Kong stock exchange, rising as much as 6.4 percent, but ending the day where it started. Shares began trading at $14 (HK) and rose as high as $14.90 (HK) in early trading before returning by end of the trading day to $14. The listing was made under a new set of rules.
According to Reuters UK, “The rules, introduced in late April, are part of efforts to better compete with New York for listings. Currently, Nasdaq is the biggest center for biotech initial public offerings (IPOs), with $2.4 billion worth of such shares sold last year.”
Ascletis, based in Hangzhou, China, was founded in 2013 and has two drug candidates for the treatment of hepatitis C and one for HIV, which has finished a Phase IIa clinical trial. The company also has a liver cancer drug candidate, which has completed Phase I and Phase I extension clinical trials.
The new rules allow Chinese biotech companies to launch IPOs when they have not made a profit or brought in revenue yet—a condition that applies to most biotech companies, unlike typical tech companies. In biotech, an IPO is often launched to raise money to advance a product into clinical trials, particularly the more expensive Phase II and Phase III clinical trials.
After the new rules were put in place, more than 10 biotech companies, mostly Chinese, announced plans to list in Hong Kong. Some have also dropped plans to launch IPOs in the U.S. in favor of the Hong Kong exchange. Two companies that are planning to list in Hong Kong are Innovent Biologics and Shanghai Henlius Biotech.
Under the previous guidelines, the Hong Kong exchange’s biggest biotech IPOs were 3SBio,which raised $818 million in 2015 and WuXi Biologics Cayman, which raised $587 million in 2017.
There is currently an ongoing scandal in China over a biopharma company, Changsheng Bio-Technology, which is under investigation by Chinese regulators for allegedly falsifying data for several products. Shenzhen Stock Exchange has barred the company’s major shareholders and executives from selling stock and threatened to delist the company.
In November 2017, two batches of DPT vaccines made by Changsheng and the Wuhan Institute of Biological Products didn’t meet national standards. A July 2018 inspection found evidence of forged data related to the company’s manufacturing of about 113,000 rabies vaccines. At that time the State Drug Administration revoked the company’s license to produce the vaccine and initiated recalls. Vaccine production was suspended the next day and on July 17, the Jilin Food and Drug Administration fined the company 3.4 million yuan ($502,000 U.S.) over the DPT vaccines from the previous year.
Wu Jinzi, founder of Ascletis, was asked about the Changsheng scandal and said that quality was “the lifeline” of Ascletis. “We are going to make the best quality, most effective and the safest drugs for patients in China and the world,” he told Reuters.
In a country known for executing white collar criminals, that seems like a reasonable answer.

DexCom raises FY18 revenue view to about $925M from $850M-$860M


Consensus $862.25M

DaVita reports Q2 adjusted EPS $1.05, consensus 97c


Reports Q2 revenue $2.89B, consensus $2.88B.

PRA Health raises FY18 adj. EPS view to $4.13-$4.32 from $4.00-$4.15


Consensus $4.12. Sees FY18 revenue $2.87B-$2.92B, consensus $2.92B.

Express Scripts updates expected 2019 retention rate for the 2018 selling season

The Company is updating its expected 2019 retention rate for the 2018 selling season from a range of 96% to 98% to a range of 97.5% to 98.5%. “As clients benefit from better health outcomes and savings, they choose to remain our clients and adopt a greater number of Express Scripts’ product and service solutions. Put simply, we are having a strong selling season across both commercial and health plans and we now expect to grow core business adjusted claims by 2% to 3% in 2019,” said Wentworth. “Furthermore, client adoption of our new solutions, a key indicator of the relevance of our ongoing innovation, is meaningfully outperforming our expectations, with continued interest in, among others, our 90-day programs, Accredo specialty pharmacy, SafeGuardRx, Advanced Opioid Management and Advanced Utilization Management solutions.”

Herbalife Nutrition cuts FY18 adj. EPS view to $2.60-$2.80 from $5.05-$5.45


Consensus $2.73.