Dermavant Bags GSK Phase III-Ready Psoriasis Treatment in $330 Million Deal

Months after tapping GlaxoSmithKline dermatology division executive David Rubenstein as its new chief scientific officer, Vivek Ramaswamy’s Dermavant Sciences has returned to the pharma giant to acquire a Phase III-ready psoriasis treatment.

Unlike past moves where a Ramaswamy company has acquired cast-off drugs for pennies on the dollar, Dermavant ponied up $330 million for Tapinarof, a topical treatment for psoriasis and atopic dermatitis. Dermavant provided an initial payment of nearly $200 million to GSK for the medication. The remaining monies will be handed over to the U.K.-based company if future milestones are hit, according to a statement issued by GlaxoSmithKline.

Tapinarof is an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA). Dermavant Executive Chairperson Jackie Fouse, a Celgene alumnus, said Tapinarof will be the “cornerstone of Dermavant’s pipeline.” She said it has the potential to provide an important treatment option for millions of patients affected by psoriasis and atopic dermatitis.

With the acquisition of Tapinarof, Dermavant is taking aim at multiple companies who have already fielded drugs for these indications. Sanofi and Regeneron have the powerhouse atopic dermatitis treatment Dupixent on the market. AbbVie is eying a potential launch of 2019 for risankizumab, a drug that blew away its own blockbuster drug Humira and Johnson & Johnson’s Stelara in treating patients with moderate to severe chronic plaque psoriasis during Phase III trials.

The deal is expected to be finalized during the second half of this year, GSK said. Dermavant will have global rights to Tapinarof, except in China. Dermavant will acquire global rights to the preclinical topical backup program to Tapinarof and will assume responsibility for all development milestones owed to third parties. As part of the transaction, GSK, Roivant and Dermavant will enter into agreements for supply of the investigational medicine for the phase III program and commercial supply.

For GSK the deal is part of the company’s global strategy to divest assets that no longer fit with its strategic focus. John Lepore, head of GSK’s R&D pipeline, said the sale of Tapinarof is part of that model. In a statement, he noted that Tapinarof “has the potential to be a first-in-class therapy and a convenient, once-daily topical agent that postpones or potentially eliminates the need for systemic treatment” of the two dermatological indications.

“We are confident that Dermavant is well positioned to progress rapidly with the Tapinarof development program into phase III and registration,” Lepore said.

In a Phase IIb trial for the treatment of patients with plaque psoriasis, Tapinarof hit its primary endpoint of demonstrating clinically meaningful improvements. GSK said that 56 percent of patients in the Tapinarof 1 percent once-daily group, and 46 percent of patients in the Tapinarof 0.5 percent once-daily group, achieved 75 percent or greater improvement in Psoriasis Area and Severity Index scores (PASI 75) after 12 weeks of treatment, compared to 5 percent in the placebo once-daily group.

In atopic dermatitis, Tapinarof also fared well and achieved primary endpoints in a Phase IIb study.

This is the second big licensing deal for Dermavant in the past few months. In April the company also strengthened its pipeline by licensing RVT-504 (previously THVD-102), an investigational drug for the treatment of multi-focal hyperhidrosis. Dermavant licensed the treatment from TheraVida, which had mixed results in a previous Phase II trial.

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Novartis prevails in Gilenya patent challenge brought by Teva and Apotex

The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board wrote that petitioners Apotex, Teva (TEVA) and Sun Pharmaceutical failed to show, by a preponderance of the evidence, that claims 1-6 of U.S. Patent No. US 9,187,405 held by Novartis (NVS) related to its Gilenya are unpatentable, according to a decision dated July 11 that was posted to the USPTO site.

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Aurobindo Pharma gets USFDA nod for infection treatment drug

Drug firm Aurobindo Pharma has received final approval from the USFDA to manufacture and market Azithromycin tablets, used for the treatment of patients with mild to moderate infections, in the US market.

The approval has been granted in the strengths of 250 mg and 500 mg, and the product will be launched this month, Aurobindo Pharma said in a BSE filing.

The approved product is generic equivalent of Pfizer Inc`s Zithromax tablet, it added.

Quoting IQVIA sales data, the company said, the approved product has an estimated market size of USD 132 million for the 12 months ending May 2018.

Aurobindo Pharma currently has a total of 337 ANDA approvals (344 final approvals including 17 from Aurolife Pharma and 35 tentative approvals) from the US.

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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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