Welcome to this week's FiercePharmaAsia report, which includes stories about Merck HPV vaccine Gardasil's approval in mainland China, Lupin's lackluster fourth-quarter performance in the U.S., CANbridge Life Sciences' $25 million series B and more.
Gardasil, the world’s second-best-selling vaccine, has been approved by China’s FDA and is ready to compete with GlaxoSmithKline’s Cervarix, the first HPV shot approved in mainland China. To help with the launch, Merck tapped a local vaccine-focused company, which is contracted to buy $166 million worth of the shot for the first year. Gardasil can protect against more types of HPV than Cervarix, but the approved age groups are different between the two.
2. Lupin plant problems weigh on Q4 results for Indian drugmaker
For the quarter ended March 31, Lupin’s revenues in North America fell 13% to about $293.4 million, regardless of a 24.4% sales increase worldwide. Although much of the hit in the area can be attributed to competition in the diabetes drugs realm, pricing pressure might also have contributed. Besides, the company’s planned launches in the U.S. were affected by manufacturing problems at its Goa plant.
3. China’s CANbridge Life Sciences gains $25M series B, plots new cancer trials
Beijing-based CANbridge Life Sciences secured $25 million in its series B round and plans to use the money to advance its two lead compounds in China. CAN008 and CAN107, both cancer immunotherapies, are meant to treat glioblastoma multiforme and esophageal squamous cell cancer, respectively. The company says it’s also planning additional transactions this year.
4. J&J fires off legal salvo to block Samsung's Remicade biosim launch
Johnson & Johnson’s Janssen is taking its Remicade patent lawsuit against Samsung Bioepis to federal court. The Big Pharma says Samsung is violating three patents with its biosimilar version of Remicade. J&J’s arthritis fighter had nearly $5 billion in U.S. sales last year. The company is trying to block the launch of the copy and is seeking damages.
5. Otsuka, Proteus refile for FDA approval of digital medicine
The FDA rejected the combination of Otsuka’s antipsychotic Abilify and Proteus’ ingestible sensor 13 months ago, asking for more evidence—including under real-world conditions—to prove the product’s safety and effectiveness. Now, the pair have refiled for FDA approval. Proteus’ technology, combined with pills, could help physicians monitor compliance.
6. Months after trial setbacks, Merck licenses Teijin Alzheimer’s candidate
Back in February, Merck ended a phase 2/3 trial of its Alzheimer’s disease med verubecestat after interim analysis boded ill for its future. Now, it has penned a new licensing deal with Tokyo’s Teijin Pharma for its investigational tau-targeting antibody candidate in Alzheimer’s. Merck gains exclusive worldwide rights to the candidate, while Teijin gets money and an option to copromote the med in Japan.
7. India's Granules is adding manufacturing and 102 jobs to its U.S. site
India’s Granules bought a U.S. R&D facility from Valeant in 2014, and will invest $35 million into its operations in Virginia. The plan is to add manufacturing space as well as 102 jobs to the 75 it now has at the site. The company is getting financial aid from a state jobs investment program to do that.
8. Nektar pens sweetened Takeda cancer drugs deal
Takeda signed a deal with Nektar Therapeutics to work together on combo cancer therapies with Nektar’s CD122-biased agonist NKTR-214, as well as five Takeda oncology compounds. They would explore the combos’ possibilities in preclinical tumor models of lymphoma, melanoma and colorectal cancer.
9. SPARC gets second CRL tied to Sun Pharma's troubled Halol plant
For the second time, the FDA has thwarted approval of a new drug from Sun Pharma’s novel drug development group SPARC. The problem? Its Halol plant. The FDA had actually approved the drug in March 2015, but as SPARC was still looking for marketing partners, the FDA revoked the approval, after it had uncovered problems at the Halol plant, where the API for the epilepsy drug was being made. They again pointed to unresolved problems at the Halol plant as the reason for not approving the drug.
10. China API plant slammed and banned by FDA for having no quality control in place
Changzhou Jintan Qianyao Raw Material Factory, a Chinese API maker, has been banned from shipping all products to the U.S. The FDA made the decision after it found that the company didn’t have any quality-related procedures in place. Of the 42 warning letters issued by the FDA’s Office of Manufacturing Quality in 2016, a third of them were issued to Chinese companies.