Asterias gains on recommendation to continue cancer immunotherapy study

Shares of Asterias Biotherapeutics Inc (NYSEAMERICAN:AST) soared Wednesday after the biotech said a safety review committee has recommended continuation of a study for its cancer immunotherapy product, AST-VAC2.

Asterias Biotherapeutics stock jumped nearly 16% to US$1.79 on the news.

“Based on its review of all available study data after five doses in the first patient, the Safety Review Committee`s recommendation to continue the trial without modification reaffirms our belief that AST-VAC2 is safe and well-tolerated,” said Edward Wirth, chief medical officer at Asterias Biotherapeutics. “The committee concluded that the trial can proceed as planned per protocol an important step as we continue the clinical development of AST-VAC2.”

The Safety Review Committee reviewed all the data generated for the first patient in Arm A (advanced disease), who by the time of the review had received five weekly doses of 10 million AST-VAC2 cells. As specified in the AST-VAC2 clinical trial protocol, the committee meets on a dosing-driven basis to review safety and tolerability data from the ongoing trial.

AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. The AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase and, through this mechanism, target tumor cells.

The initial clinical trial is being funded by Cancer Research UK and will examine the safety and tolerability of AST-VAC2 in non-small cell lung cancer (NSCLC) as the study`s primary endpoints.

NSCLC is one of two major types of lung cancer that can affect smokers and nonsmokers.

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Unitedhealth Makes Payout Faster, Easier to Employees in Med, Supplemental Plans

• Industry-first program by UnitedHealthcare helps employees initiate their claims under accident, critical illness and hospital indemnity protection plans

Employees enrolled in UnitedHealthcare accident, critical illness or hospital indemnity protection plans can now receive benefit payouts faster and easier through UnitedHealthcare’s industry-first Supplemental Health Benefit Assist Program.

Here’s a look at how UnitedHealthcare’s industry-first Benefit Assist program makes it faster and easier for eligible plan participants to receive payouts after a qualifying critical illness diagnosis, hospital stay or serious accident (Graphic: UnitedHealthcare).

Benefit Assistfeatures a team of UnitedHealthcare Benefit Assistants who contact via phone or email an eligible plan participant following a qualifying critical illness diagnosis, hospital stay or serious accident. The Benefit Assistants help the patient kick-start the claim process soon after the related medical diagnosis or treatment to facilitate a faster payout so that the patient can focus on healing and getting well.

Often people enrolled in supplemental plans wait weeks or months to start the related claim, or neglect to do so entirely, thus delaying or missing a cash benefit that can help pay out-of-pocket expenses or cover lost income. Payouts under UnitedHealthcare supplemental plan coverage can reach $5,000 or more under accident and hospital indemnity plans; critical illness coverage can reach up to $40,000.

“Almost two-thirds of employees have less than $1,000 on hand to pay out-of-pocket expenses related to an unexpected accident, hospital stay or serious illness. Benefit Assist helps employees receive benefit payouts faster and more efficiently, giving employees peace-of-mind and allowing them to worry less about their finances and focus more on healing and getting healthy,” said Tom Wiffler, CEO, UnitedHealthcare Specialty Benefits.

The Supplemental Health Benefit Assist Program is available to companies nationwide with 250 or more employees enrolled in both UnitedHealthcare medical and supplemental health plans, including accident, critical illness or hospital indemnity coverage.

This resource highlights the value to companies and their employees of combining medical and ancillary health benefits, including supplemental health, vision, dental and other financial protection coverage, through a single health plan. More employers are offering supplemental benefit plans as a way to add financial certainty for employees, especially with more than 80 percent of employers now offering consumer-directed health plans. To learn more about the value of integrating medical and specialty benefits, click here.

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Zogenix gains on Phase 3 results

Zogenix, Inc. (NASDAQ: ZGNX) shares rose sharply Thursday, after the company disclosed top-line results from second Pivotal Phase 3 trial of ZX008 in dravet syndrome. The company reported that the trial met primary endpoint.

The company, based in Emeryville, California, is a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today reported positive top-line results from its second confirmatory Phase 3 study for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of children and young adults with Dravet syndrome.

The study results, which are consistent with those reported in Study 1, Zogenix’s first pivotal Phase 3 study, successfully met the primary endpoint and all key secondary endpoints, demonstrating that ZX008, at a dose of 0.5 mg/kg/day (maximum 20 mg/day), is superior to placebo when added to a stiripentol regimen.

Patients taking ZX008 achieved a 54.7% greater reduction in mean monthly convulsive seizures compared to placebo. The median reduction in monthly convulsive seizure frequency was 62.7% in the ZX008 group compared to 1.2% in placebo patients.

Said Professor Rima Nabbout “These impressive study results show the significant impact the addition of ZX008 made in reducing the burden of convulsive seizures for patients who are not adequately controlled using stiripentol, the standard of care for the treatment of Dravet syndrome in Europe.”

Zogenix is dedicated to developing therapies for people living with severe central nervous system disorders who have limited or no treatment options.

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U.S. trade under a cloud, China opens to Indian pharma

China is preparing to give swift regulatory approvals to India-manufactured drugs, the head of an Indian export promotion group said, as Beijing looks for new commercial partners ahead of what could be a protracted trade war with the United States.

Indian firms are looking to fill gaps in Chinese demand for generic drugs, software, sugar and some varieties of rice, trade officials in New Delhi said.

“We do feel that China is receptive at this time and it’s all about making prices competitive,” said a government official involved in the effort to promote trade with China. The official declined to be identified since he is not authorised to speak to the media.

No concrete deals have been signed but the outlook for pharmaceutical sales from India is positive, according to officials from both nations.

India dominates the world’s generic drugs market, exporting $17.3 billion (13.10 billion pounds) of drugs in the 2017/18 (April-March) year, including to the United States and the EU. But only 1 percent of that went to China, the world’s second-largest market for pharmaceuticals, industry data shows.

Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil), which falls under India’s trade ministry, told Reuters in an interview that Indian firms could expect to win licences to export to China within six months of application.

“We understand internally that Chinese authorities have issued instructions that EU-approved Indian suppliers should be granted the industrial drug licence in an expeditious manner so they can enter the Chinese market within six months,” Dua said.

Many Indian drug-makers are already selling to the European Union. The EU is already one of India’s key export markets for medicines, and accounted for about 15 percent of overall drug exports in 2016/17, according to Pharmexcil.

Swift regulatory approvals in China would allow Indian companies to boost revenue at a time when pricing scrutiny and regulatory troubles have hurt U.S. sales.

Some of India’s largest drugmakers, Sun Pharmaceutical Industries and Lupin Ltd as well as Aurobindo Pharma Ltd, have been trying for years to expand in the massive Chinese market, which is second only to the United States.

Details of Chinese moves to open up its heavily regulated pharmaceuticals sector have not been previously reported.

The China Food and Drug Administration (CFDA) did not respond to a Reuters’ request for comment.

But Chinese Foreign Ministry spokeswoman Hua Chunying said this week that China was moving forward on giving greater market access to Indian drug makers.

“China and India are witnessing a growth in pharmaceutical trade, and the two sides are in sound communication on opening the Chinese market to drugs from India and conducting dialogue and co-operation between the two sides’ pharmaceutical industries,” Hua told a regular news conference on Monday.

“The relevant departments have formulated specific measures on promoting China-India pharmaceutical trade cooperation and granting greater access to drugs from India. We believe that stronger pharmaceutical trade co-operation will contribute to the well being of the people in our two countries.”

PENDING CLEARANCE

In May, China exempted import tariffs on 28 drugs, including all cancer drugs, a move that would help India reduce its trade imbalance with China, Luo Zhaohui, the Chinese ambassador to India said.

China has been touting greater access to cancer drugs and pushing to lower prices in a bid to soothe a major social issue in the country, where traditionally many patients with serious illness have had to pay out of their pocket for cutting-edge drugs or have had to buy medicines through unapproved grey market channels.

China also lags far behind in terms of drug approvals versus developed markets.

The issue was highlighted in a recent film that went viral in China which echoed the U.S. “Dallas Buyers Club” about a Chinese cancer patient who had helped others getting unapproved cancer drugs at lower prices shipped in from India.

About 250 product applications from Indian drug firms are pending before the CFDA, some of them for years, an Indian trade ministry official said.

Bilateral trade between the two Asian nations touched $89.6 billion in 2017/18 with the trade deficit widening to $62.9 billion in China’s favour, an over nine-fold increase over the last decade.

The two sides are discussing ways to increase Indian sales of farm products, including sugar and some varieties of rice, to China.

India is also trying to persuade China to give access to its cost-competitive software service firms that have dominated global markets. Some of these firms are pitching for ‘smart’ manufacturing projects in the central city of Wuhan and two other provinces in the healthcare and automotive sector.

But it is in the drugs sector that India is hoping to make the first dent, according to officials and a government document.

China has agreed to train Indian pharmaceutical executives to help them gain a swifter entry into the Chinese market, a government document seen by Reuters on efforts to improve trade with China showed. The training is planned for next month.

India’s Pharmexcil and the China Chamber of Commerce for Import and Export of Medicines and Health Products will shortly sign an agreement to ease clearance processes and help Indian companies find Chinese partners, according to the document.

Dua and the Indian trade ministry official said China will soon open a desk at its embassy in New Delhi to facilitate Indian drug makers.

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Akebia target upped by Piper

Piper incrementally positive on Akebia shares, ups target to $22. Piper Jaffray analyst Christopher Raymond is incrementally positive on shares of Akebia Therapeutics after new nephrologist survey data indicated that Auryxia “has not just turned a corner, but is really on quite a roll, both in terms of the drug’s perception and its market share dynamics.” With the stock down 4% since before last month’s merger announcement with Keryx (KERX), Raymond sees a “significant opportunity” to own Akebia before the drug’s near-term share gains and the “real potential of a nephrology powerhouse with both Auryxia and vadadustat, become more apparent.” He raised his price target for the shares to $22 from $20 and keeps an Overweight rating on the name

https://bit.ly/2NbeBpr

Mylan priced Amgen biosimilar at 33% discount, says Jefferies

Jefferies analyst Michael Yee says Mylan (MYL) priced its biosimilar to Amgen’s Neulasta at a 33% discount to the gross price of branded Neulasta. While the discount is slightly more than initial expectations of 10%-20%, the key is knowing what level of rebating Mylan will be offering to hospitals, Yee tells investors in a research note. The analyst admits, however, that Mylan’s Fulphila price “indeed undercuts” Amgen. He keeps a Buy rating on Amgen shares with a $200 price target.

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Pfenex gets milestone from Merck with Phase 3 start for vax

Pfenex (PFNX) announced the receipt of a milestone payment from Merck (MRK) associated with the initiation of the first Phase 3 clinical study of, an investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. Under the agreement, signed in 2007, Pfenex is eligible to receive annual fees, milestone payments, and a tiered royalty based on net sales for all products developed by Merck that use the Pfenex Expression Technology platform.

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