Welcome to this week’s FiercePharmaAsia report. WuXi AppTec acquired HD Biosciences, while preparing an IPO for its biologics subsidiary. Mezzion is suing Dr. Reddy's for an alleged plant problems cover-up, which cost it a drug approval. Eisai's liver cancer med Lenvima reported positive data in phase 3, moving toward a showdown with Bayer's Nexavar. A culprit in China’s multimillion-dollar illegal vaccine sales scandal was sentenced to 19 years in prison. Sun Pharma is hoping to unload New Jersey plants for $100 million in a manufacturing consolidation. Hetero Labs' and Eisai's Maryland plants were cited in FDA 483 forms.
1. WuXi AppTec acquires HD Biosciences, prepares IPO for biologics subsidiary
Chinese CRO giant WuXi AppTec just filed a draft listing application for its biologics unit at the Hong Kong Stock Exchange, about a year after the entire company was taken off the New York Stock Exchange by management. It also built further on its core business by acquiring Shanghai-based preclinical CRO HD Biosciences.
2. Mezzion sues Dr. Reddy's for fraud, citing plant problems that cost it a drug approval
South Korea’s Mezzion has brought a lawsuit against Dr. Reddy’s for fraud, seeking millions of dollars in damages. Mezzion said that the Indian company presented itself as compliant with FDA regulations, while its misconduct “was the sole reason given by the FDA” to deny approval of Mezzion's NDA for udenafil for the treatment of erectile dysfunction.
3. Eisai's Lenvima moves toward Nexavar showdown with phase 3 liver cancer win
Japanese pharma Eisai announced positive phase 3 data for its liver cancer med Lenvima, posing a direct threat to Bayer’s Nexavar, the only FDA-approved first-line treatment for hepatocellular carcinoma, the most common type of the disease. But Bayer has Stivarga lining up as a potential second-line HCC therapy, which has earned the FDA’s “priority” tag.
4. China’s illegal vaccine sales culprit gets 19 years in prison
Pang Hongwei, the leader in the mother-and-daughter illegal vaccine sales ring in China, was sentenced to 19 years in prison for illegal business practices. The court in the city of Jinan found she improperly stored the vaccines, and earned about 75 million Chinese yuan ($11 million) from selling them illegally. Her daughter, who provided financial assistance in the crime, received 6 years in prison.
5. Sun looks to unload Ohm Labs New Jersey plants in manufacturing consolidation
Sources say Sun Pharma is looking to sell New Jersey labs for about $100 million as part of a manufacturing consolidation. The Indian drugmaker got the solid-dose, prescription and OTC manufacturing facilities in its 2015 buyout of Ranbaxy Laboratories, but now seems them as non-essential to its businesses.
6. Hetero Labs plant hit with Form 483 for suspicious shredding of documents
India’s Hetero Labs, which launched biosimilars of top cancer drugs Avastin and Rituximab in India was hit by an FDA Form 483. Video footage showed workers at a formulations manufacturing plant in Jadcherla shredding manufacturing and packaging documents at 1 a.m. in the morning four days before an FDA inspection.
7. FDA delivers Form 483 to Eisai plant in U.S.
A plant of Eisai’s in Baltimore, MD, received an FDA Form 483 with five observations for quality issues and data record keeping. The Japanese drugmaker has been revamping operations in the face of generic competition.