This week in Phispers, we bring you the latest on Pfizer’s manufacturing woes, attributed largely to its much-touted US$ 17 billion acquisition of Hospira in 2015. Sun Pharma bagged FDA approval for its treatment for prostate cancer — Yonsa. The FDA brought out educational videos on biosimilars, while its commissioner discussed the agency’s policy plans for gene therapy. IQVIA released a report on how cancer treatments have been advancing at a rapid pace. J&J got hit by another jury verdict pertaining to asbestos in its baby powder. And in compliance news, FDA issued a warning letter to Chinese caffeine producer found with duplicate documents; and Allergan recalled birth control pills due to a packaging error.
Pfizer’s manufacturing woes continue, as Apotex recalls antibiotic made by Hospira
According to the FDA website, Apotex is voluntarily recalling 36 lots of Piperacillin and Tazobactam for Injection — USP 3.375 gram/vial and 4.5 gram/vial strengths. The antibiotic injections have been found to contain elevated levels of impurities that may result in decreased potency. According to the FDA, the decreased potency, in turn, could result in worsening of the infection and under extreme circumstances lead to serious morbidities.
Manufactured by Hospira, the product is distributed in the US market by Apotex Corp.
A recent article in Fortune puts the blame on Pfizer’s much-touted US$ 17 billion acquisition of Hospira in 2015 for turning the United States’ chronic drug shortage into a full-blown crisis.
According to the article, as of May 11 this year, Pfizer — which is the world’s largest maker of sterile injectable drugs — had 370 products that are depleted or in limited supply, 102 of which the company has indicated will not be available until 2019.
“The simple answer to why America currently has so many shortages of generic sterile injectable drugs: America’s leading manufacturer of generic sterile injectable drugs hasn’t been making them,” the article said.
Mylan’s flagship product EpiPen is also likely to face shortage if its manufacturing partner — Pfizer — does not resolve its problems in the United States. Mylan is putting pressure on Pfizer to do more to tackle shortages of this life-saving medicine.
Although Mylan owns the rights to the EpiPen, it subcontracts manufacturing of the auto-injector to Meridian Medical Technologies, a division of Pfizer.
However, Pfizer has struggled to meet demand for EpiPen and earlier this month, the US Food and Drug Administration (FDA) had put the medicine on its official shortages list.
In September last year, the FDA had issued a warning letter to Meridian Medical Technologies over serious component and product failures that had been associated with patient deaths.
Sun Pharma bags FDA nod for prostate cancer drug; signals trouble for J&J’s Zytiga
Sun will launch the drug in the US through its licensing partner Churchill Pharmaceuticals, which is also the original developer of the drug. Churchill is eligible for upfront fees, as well as milestone payments and royalties.
Earlier this year, Johnson & Johnson’s prostate cancer blockbuster — Zytiga — took an unexpected hit when a US court stripped away a key patent. This court order opened the prospects of generic launches of Zytiga later this year. And that’s something J&J is working hard to avoid.
Though Yonsa is not a generic, it is definitely a competitor for J&J’s Zytiga, a drug that generated sales of US$ 1.23 billion in the US in 2017.
Sun’s Yonsa contains the same active ingredient as Zytiga—abiraterone acetate. However, Yonsa’s formulation doesn’t step on J&J’s patents. Yonsa is approved in combination with methylprednisolone to treat patients with mCRPC. It can be takenwith or without food.
Zytiga is approved for use in combination with a different steroid — prednisone. J&J is expected to appeal that patent decision. Unless some suits get filed against Sun or Churchill, Yonsa should enter the market.
FDA releases five-part video on biosimilars; plans to encourage gene therapy
As part of a larger education and outreach effort, the FDA released a new five-part video series highlighting biosimilars and interchangeable products. The videos highlight key concepts about the development and approval of these products, as well as how state-of-the-art technologies and tools are used to demonstrate biosimilarity.
A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved reference product. So far, the agency has approved 10 biosimilars. Many of these biosimilars treat serious and life-threatening illnesses.
The number of FDA-approved biosimilar products continues to grow. “They’re just as safe and effective as their traditional counterparts, and they could provide enormous savings to consumers through product competition,” FDA Commissioner Scott Gottlieb said in the first video.
Last week, Gottlieb also discussed the agency’s policy plans for gene therapy at the annual board meeting of the Alliance for Regenerative Medicine. He spoke about FDA’s role in facilitating gene therapy, and also quoted an MIT study that predicts 40 FDA-approved gene therapy products by the end of 2022.
“FDA has more than 500 active investigational new drug applications involving gene therapy products,” Gottlieb said. “We’ve received more than one hundred such applications last year alone. This shows the intensity of scientific work going on in this field.”
Gottlieb said some gene therapies may qualify for the regenerative medicine advanced therapy (RMAT) designation — a status established by the 21st Century Cures Act that confers benefits of fast track and breakthrough designations. Developers may also apply for accelerated approval.
IQVIA’s Global Oncology Trends says cancer treatments advancing at rapid pace
Last week, Phispers had carried a report on how the US FDA had lashed out at IQVIA — a leading global provider of advanced analytics, technology solutions, and contract research services to the life sciences industry — as the agency had found mistakes in its opioid sales data.
This week, there is some positive news from IQVIA. According to a report prepared by IQVIA — Global Oncology Trends 2018 — cancer treatments have been advancing at an accelerated pace in recent years, offering notable improvements in clinical benefit to patients.
According to the report, 63 cancer drugs had been launched in the last five years. The continued rise and impact of immuno-oncology has been largely centered on the PD-1 and PD-L1 checkpoint inhibitors, which have broad efficacy across solid tumors and are used across 23 different tumor types. Of the 14 New Active Substance cancer therapeutics launched in 2017 alone, all of them were targeted therapies and 11 of them were granted Breakthrough Therapy designations by the FDA.
The report also talks of global spending on cancer medicines — which increased from US$ 96 billion in 2013 to US$ 133 billion globally in 2017. However, spending on cancer medicines is heavily concentrated on a handful of therapies, with the top 35 drugs accounting for 80 percent of total spending.
According to the report, the global market for oncology therapeutic medicines will reach as much as US$ 200 billion by 2022, averaging 10 to 13 percent growth over the next five years, with the US market reaching as much as US$ 100 billion by 2022, averaging 12 to 15 percent growth.
J&J hit by another ‘asbestos-in-talc’ cancer case; to pay millions in compensation
Its smell may still remind us of our childhood, but for Johnson & Johnson its baby powder has caused it much distress. For years, J&J has been battling some 6,000 cases that allege its baby powder caused ovarian cancer.
Recently, the litigations took a new focus with plaintiffs claiming the widely used powder causes mesothelioma due to alleged asbestos contamination. Mesothelioma is a rare and aggressive form of cancer that develops in the lining of the lungs, abdomen or heart. It has no known cure and is said to be caused by asbestos.
Last week, J&J and its talc suppliers were slapped a US$ 21.7 million jury verdict in a lawsuit by a 68-year old woman — Joanne Anderson — who said she developed mesothelioma after being exposed to asbestos in the company’s baby powder.
The verdict marked the second such trial loss for J&J. In April, a New Jersey state court jury had ordered J&J and its talc supplier, a unit of Imerys SA, to pay US$ 117 million to a man who alleged he developed mesothelioma due to asbestos exposure from J&J Baby Powder. An appeal is pending.
Of the US$ 21.7 million the jury awarded in compensatory damages, J&J was assigned 67 percent, with the rest distributed among other defendants.
J&J has denied its talc products contain asbestos or cause cancer, citing decades of testing by independent laboratories and scientists. But plaintiffs claim that asbestos and talc, which are closely linked minerals, are intermingled in the mining process, making it impossible to remove the carcinogenic substance.
The company and Imerys, as well as a local drugstore chain in the US, are also facing another mesothelioma trial in a South Carolina court.
FDA warning letter to Chinese caffeine producer found with duplicate documents
This week, the FDA posted a warning letter issued to Jilin Shulan Synthetic Pharmaceutical, a manufacturer of caffeine API in China. The letter reveals flagrant data-integrity violations.
During the November 2017 inspection, the FDA investigator uncovered dual sets of laboratory records in which one set of records included out-of-specification (OOS) results while the second set included results within specifications.
The firm’s quality department acknowledged this practice during the inspection and said it failed to investigate OOS deviations due to lack of cGMP knowledge on part of its staff.
The FDA investigator also discovered blank batch production records that were pre-signed by operators, partially-completed batch records, and batch records with data changes in pencil without any justification.
Moreover, the FDA investigator found two process batch records for the same operation — one record was partially filled out by one operator, while the second one was completed by a different operator.
In another case, the FDA investigator found a note in a batch record stating there had been a manufacturing process deviation for which the operator involved was to be fined 50 yuan (US$ 7.8). There was no formal deviation report documented in the GMP system.
At Jilin Shulan Synthetic, audit trails were enabled in their standalone analytical instruments like high-performance liquid chromatography systems, gas chromatography systems, and infrared radiation system. The FDA had placed the firm on import alert on March 1, 2018.
Allergan recalls birth control pill due to packaging error in the US
Allergan Plc issued a voluntary recall in the US market of its birth control pill — Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules). In its recall announcement, Allergan states it recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of Taytulla.
Taytulla is an oral contraceptive, available in a 28-count blister card pack that has 24 ‘active’ pink softgel capsules (with hormones) with ‘WC’ printed on the outer shell in white to be taken for 24 days, followed by four maroon softgel capsules (without hormones) also imprinted with ‘WC’ on one side to be taken for the next four days.
Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy.
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