Trump tells FDA to fund itself fully through industry fees; Astra's CEO dumps Teva offer

Trump tells FDA to fund itself fully through industry fees; Astra’s CEO dumps Teva offer

This week, Phispers brings you lots of regulatory news from the US, where the Trump administration has instructed FDA to fund itself entirely through industry fees; and the agency’s chief has pledged to accelerate generic reviews through two new policies. This was yet another bad week for Teva, as it faced charges in Europe, lost a patent battle in the US to Takeda, and AstraZeneca’s CEO reportedly tossed away an offer to head it. Plus, there is news on AstraZeneca’s investment in China and Novartis’ CAR-T cell therapy for cancer.

Teva’s woes continue: Faces EC charges; loses patent battle; and Soriot drops offer

Teva’s troubles continued unabated. First, Pascal Soriot, the chief executive of AstraZeneca, who was rumored to be the next head of the Israeli drugmaker, decided not to leave AstraZeneca. He is reportedly forgoing an offer of a US$ 20 million bonus, and a chance to reorganize Teva, the world’s largest generic drug company.

Last week, the UK-based drug firm confirmed that Soriot would be presenting AstraZeneca’s second-quarter earnings, on July 27. Rumors of Soriot’s likely appointment were floated by an Israeli financial website. Teva is likely to announce the name of its new CEO within a month, Chaim Hurvitz, a member of Teva’s founding family, said.

Second, the European Commission (EC) charged Teva of doing an illegal deal with Cephalon to delay selling a cheaper generic version of Cephalon’s sleep disorder drug. In the past, the EU regulator has charged scores of other companies as well, including Denmark’s Lundbeck, USA’s Johnson & Johnson and France’s Servier. According to the regulator, the pay-for-delay deals cost European consumers billions of euros.

Third, the Israeli pharma biggie lost a patent battle in the US appeals court to Takeda Pharmaceutical. The court said a patent on Takeda's cancer treatment — Velcade — is valid, pushing back the date when generic drug makers, including Teva and Mylan, will be allowed to launch lower-cost versions of the drug in the US.

AZ invests US$ 79 million in Australia to cater to China’s demand for asthma drug

Air pollution is choking people in the big cities of China, raising demand for AstraZeneca’s asthma medicine — Pulmicort respules. As a result, the British pharmaceutical giant announced an investment of US$ 79.27 million (AUD $100 million) last week at its Sydney site which manufactures the treatment.

The announcement was made in London on July 13, at a meeting between AstraZeneca CEO Pascal Soriot and Australia’s Prime Minister Malcolm Turnbull.

AstraZeneca will add three production lines to the existing eight at its Sydney site, each with a capacity to produce over 70 million units of Pulmicort respules in a year. The company will bolster exports from the site to over US$ 1.9 billion (AUD 2.4 billion) in the next four years, with a further goal of doubling respules production to 1 billion by 2025.

“The demand for this asthma product, particularly for children in China, is immense and we see that trend continuing,” Mark Morgan, manufacturing director of AstraZeneca Australia, said.

Although labor costs are lower in China, the manufacturing technology “is difficult to replicate,” Morgan added. Over 50 percent of Pulmicort’s worldwide sales come from China. And its demand increased by 18 percent — from US$ 485 million in 2015 to US$ 570 million in 2016.

White House tells FDA to fund itself via industry fees; FDA scouts for top talent

In the US last week, the House of Representatives passed the bill that reauthorizes US Food and Drug Administration (FDA) to levy user fees. Soon after that, the White House reiterated its earlier call to amend the agreements so that the FDA is entirely funded by the medical products industries.

In a statement, the White House said: “The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs… In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.”

Last week’s statement said President Trump is “concerned with certain other provisions in the bill, such as those providing additional market exclusivity to manufacturers, which could make exclusivity unpredictable and decrease competition.”

Meanwhile, the FDA Commissioner Scott Gottlieb is embarking on a talent hunt to recruit new staffers for the Prescription Drug User Fee Act (PDUFA)-related positions in the drugs and biologics programs.

“To take on this new effort, we’re establishing a dedicated group of full-time staff with the responsibility to ensure that we reliably and predictably identify, recruit, and efficiently hire the scientific personnel the Agency needs,” Gottlieb said in his blog.

Novartis’ CAR-T cell therapy unanimously recommended for approval by FDA

The US FDA’s advisory committee has unanimously (10:0) recommended Novartis’ CAR-T cell therapy — CTL019 (tisagenlecleucel) — for approval to treat pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).

CAR-T is short for chimeric antigen receptor T cell (CAR-T) therapy. In the US, ALL is the most common childhood cancer.

This therapy is an immunotherapy approach to treat cancer, also considered the “fifth pillar” (after surgery, chemotherapy, radiation and targeted therapies like imatinib and trastuzumab) of cancer treatment. This approach, called adoptive cell transfer (ACT), uses engineered immune cells to generate remarkable responses in patients with advanced cancer.

In several early stage trials, when ACT was tested in patients with advanced ALL (with few treatment options left before these patients), many reported a complete disappearance of the cancer. And these patients remained cancer free for extended periods. Therefore, Novartis’ CTL019 assumes tremendous importance.

Meanwhile, the FDA advisory committee also unanimously recommended Biocon/Mylan’s and Amgen’s biosimilars for approval. The two recommendations imply a double whammy for Roche, with its drugs Avastin and Herceptin poised to get impacted by these biosimilars.

The FDA’s Oncologic Drugs Advisory Committee (ODOC) voted 16-0 in favor of Milan’s proposed Herceptin biosimilar to treat HER2-positive breast cancer, both for patients after surgery and for metastatic disease. The ODOC also voted 17-0 to recommend FDA approval for Amgen’s ABP 215, an Avastin biosimilar, in each of the approved indications for the reference medication. The uses include metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.

Concord Biotech faces GMP concerns; FDA warning letters to firms in India, Italy

Ahmedabad-based Concord Biotech, a research and development-driven biotech firm that makes fermentation-based APIs, was placed on Health Canada’s Inspection Tracker due to “general GMP observations” shared by a regulatory partner. While no details of the observations were divulged, Health Canada did not mention any data integrity concerns and is “continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner).”

The FDA also issued a warning letter to Tubilux Pharma SpA in Italy over concerns arising from an inspection conducted in December 2016. The investigators raised concerns over turbulent airflow on an aseptic processing line which “poses a significant contamination hazard” to the product. Limitations in Tubilux’s “current equipment and process design” also posed “a significant hazard” in the aseptic processing operation.

The warning letter also highlights that some of the products manufactured at Tubilux were not tested for particulates prior to release. During the inspection, FDA “observed repeated instances of high particle count alarms during production”.

Tubilux specializes in manufacturing various types of products used in ophthalmic applications.

A September 2016, FDA inspection at Vista Pharmaceuticals in India highlighted concerns over the sale of isoxsuprine hydrochloride USP, 20 mg tablets, by the firm. Although isoxsuprine hydrochloride is sold in the US, the drug is not approved in the Orange Book. The firm had also not validated the manufacturing process for isoxsuprine hydrochloride USP, 20 mg tablets.

The warning letter also mentions that during the walk through of the firm’s manufacturing areas, FDA investigators observed that the equipment was in a state of disrepair. “Specifically, our investigators saw holes and corrosion in three pieces of equipment,” the letter noted.

FDA chief pledges to accelerate generic reviews through two new policies

This week, the US FDA Commissioner, Scott Gottlieb, made an announcement that by the end of 2017, the American drug regulator will issue two new documents to improve the review process for generic drugs.

These documents are meant to streamline the submission and review of abbreviated new drug applications (ANDAs) under the FDA’s drug competition action plan.

The first document is a planned internal manual of policies and procedures (MAPP) — titled “Good ANDA Assessment Practices”. It will look to reduce “unnecessary” and “duplicative” procedures from FDA’s reviews to make them more efficient.

However, the document will not alter any of the review goals the FDA agreed to as part of the negotiations to reauthorize the GDUFA.

For applications that aren’t approved, MAPP will instruct reviewers to detail what needs to be fixed in the complete response letter (CRL), and provide follow up with sponsors over phone if the reasons in the letter are unclear, Gottlieb said.

The second document will be a guidance on “Good ANDA Submission Practices”. It will be added to the Center for Drug Evaluation and Research’s ‘to-do list’ for the year, which already includes 13 other new and revised draft guidances for generic drugs.

According to Gottlieb, this guidance will detail common issues found in ANDA submissions and give sponsors advice on how to avoid those issues before submitting an application.

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