Sat, Sep 09, 2017 - Page 12 News List

Lotus to challenge drug patent claims

By Ted Chen  /  Staff reporter

Lotus Pharmaceuticals Co (美時化學製藥) yesterday announced that it would challenge the patent rights claims of the developer of a hematological malignancies drug, as it seeks to launch a generic version of the same drug.

The company has teamed up with US-based Alvogen Inc to launch an abbreviated new drug application (ANDA) for a generic version of Revlimid (lenalidomide) to the US Food and Drug Administration (FDA), it said in a statement.

The company said that it is seeking regulatory approval to market lenalidomide in 2.5mg, 5mg, 10mg, 20mg and 25mg doses.

Its application included a Paragraph IV certification with respect to the patents listed in the US FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, it added.

However, the drug’s original developer, US-based Celgene Corp, has filed a lawsuit in the US District Court of New Jersey.

The lawsuit was filed under the provisions of the Hatch-Waxman Act, which may delay Lotus’ ANDA approval for up to 30 months, the Taiwanese company said.

The delay could begin from the date the plaintiffs received notice of Lotus’ ANDA filing or until final resolution of the matter before the court, depending on whichever occurs first, the company said, adding that the terms are subject to any other exclusivities.

The Orange Book serves as a source of public information for state health agencies and healthcare providers regarding ongoing evaluations of generic drugs that perform similarly to branded innovator drugs in the hopes that they can contain rising healthcare costs.

It also lists the patents protecting the innovator drugs, with regulations stipulating that generic drugs may not be launched until after the expiration of the patents listed in the Orange Book.

The Paragraph IV filing by Lotus is aimed at gaining certifications that the patents claimed by Celgene are invalid or unenforceable, which allows generic drugs to be launched before the patent’s expiration under the US’ Hatch-Waxman Act.

Unlike new drug applications, ANDAs are not required to include preclinical and clinical trial data to establish safety and effectiveness, and approval is given once an applicant demonstrates that their product performs similarly to the innovator product and delivers the same amount of active ingredients into the bloodstream at the same rate of absorption.

Sales of Revlimid in the US last year totaled about U$4.4 billion, according to data from Celgene, Lotus Pharmaceuticals said, adding that market research firm Statista Inc has projected that lenalidomide would be the world’s top cancer drug by 2020.

Lotus chairman Andrew Lin (林群) expressed confidence in the company’s Paragraph IV challenge and outlined plans to market lenalidomide as a global product.

The company has also completed filings in Europe and several countries in Asia, Lin added.

The company posted a net loss of NT$37 million (US$1.23 million) in the first half of this year, compared with net income of NT$81 million a year ago. Losses per share were NT$0.16 in the first half.

Cumulative revenue in the first seven months totaled NT$3.55 billion, up 1.75 percent from a year ago, company data showed.

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