Global Pharma Briefs: News from Asia and the USBy
A roundup of developments and latest news from India (Aurobindo, Biocon), Japan (Kyowa Kirin), Singapore and South Korea (Ministry of Food and Drug Safety), United States (AstraZeneca, Recro Pharma, Horizon Pharma)
FDA Approves Biocon’s Application for New Manufacturing Facility
The US Food and Drug Administration (FDA) has approved Biocon’s new biologics manufacturing facility in Bengaluru, India to manufacture the drug substance for a biosimilar of pegfilgrastim, which is based on Amgen’s blockbuster drug, Neulasta. The license is for pegfilgrastim drug substance to be manufactured at Biocon’s new biologics manufacturing facility in Bengaluru, India. The FDA conducted an inspection of the facility from September 10-19, 2019.
This additional approval of its new manufacturing facility will enable Biocon Biologics, a subsidiary of Biocon and Mylan, to scale up capacity multi-fold and address growing market opportunities in the US and other global markets. Biocon and Mylan are partnered for the development and commercialization of specified biosimilars. Biocon Biologics, through its partner Mylan, has commercialized three of its co-developed biosimilars for developed markets in US, Canada, European Union and Australia.
Fulphila (pegfilgrastim-jmdb), a biosimilar of pegfilgrastim, co-developed by Biocon and Mylan, was the first biosimilar of pegfilgrastim to be approved in the US and was commercially launched in July 2018. Fulphila is also approved in EU, Australia and Canada.
FDA Issues Form 483 to Aurobindo’s API Mfg Facility in India
The US Food and Drug Administration (FDA) has issued a Form 483 to Aurobindo for its Unit V, API Manufacturing facility at Pashamylaram, Hyderabad, India and Unit VIII, API Manufacturing facility at Gaddapotharam, Hyderabad, India. The Form 483 was issued following inspections on October 21-28, 2019 and October 21-25, 2019.
The Form 483 cited four observations for each facility. Aurobindo believes these observations are related to procedural improvements and none of the observations are related to data integrity.
Aurobindo says with respect to Unit IV, a formulation manufacturing facility at Pashamylaram, Hyderabad, India, the inspection is still in progress.
Kyowa Kirin To Reorganize Quality Assurance Functions
Kyowa Kirin, a Japanese drug discovery company, has announced it will change its quality assurance and pharmacovigilance functions, effective January 1, 2020, as stated in a November 26, 2019 announcement.
The organizational changes are that a Quality Division and Pharmacovigilance (PV) Division will be newly established and report directly to the President and CEO. A Quality Assurance Department and Regulatory Audit Department will be established within the Quality Division. A PV Business Management Department, PV Operations Department, and PV Medical Department will be established within the Pharmacovigilance Division.
Kyowa Kirin says the purpose of the organizational changes are to clarify the roles and responsibilities by operating as independent organizations, pursue maintenance and improvement of the quality of pharmaceuticals, and pursue the proper use of pharmaceuticals and the safety of patients.
Source: Kyowa Kirin
South Korea and Singapore Agree to Collaborate for GMP in Pharmaceuticals
South Korea’s Ministry of Food and Drug Safety has signed a memorandum of understanding with Singapore’s Health Science Authority to collaborate on GMPs.
The two countries say this memorandum of understanding aims to bring the two together in terms of GMP regulations, and both have agreed to exchange information on inspections. They agreed to hold joint workshops, share knowledge and experiences on GMP, and share information of unqualified medicines and recalled products as well as manufacturing sites and inspections.
The two countries also plan in the future to conclude the GMP Mutual Recognition Agreement, which will help Korean pharmaceutical companies advance into Association of Southeast Asian Nations members.
Source: Health Science Authority
AstraZeneca Divests Rights to Antipsychotic Drug to Chephlapharm for $41 Million
AstraZeneca has agreed to sell the commercial rights to its anti-psychotic medicines, Seroquel (quetiapine fumarate immediate-release) and Seroquel XR (quetiapine fumarate extended- release), to Cheplapharm Arzneimittel GmbH, a German pharmaceutical company, for $41 million.
Seroquel and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in the US and Canada. AstraZeneca has agreed to sell the commercial rights in the US and Canada to Cheplapharm.
Cheplapharm will make an upfront payment of $35 million to AstraZeneca and may also make future sales-contingent payments of up to $6 million. In 2018, Seroquel generated sales of $36 million in the markets covered by this agreement while Seroquel XR generated sales of $79 million. As there were no closing conditions to the divestment, the agreement became effective upon signing.
AstraZeneca will continue to manufacture and supply Seroquel and Seroquel XR to Cheplapharm during a transition period.
Horizon Therapeutics Opens New Formulation and Process Development R&D Facility
Horizon Therapeutics, a Dublin, Ireland-headquartered company, has opened a new formulation and process development facility in South San Francisco, California. The 20,000-square-foot facility features laboratory space that will enable formulation and process development for manufacturing as well as bioanalytical method development and other research and development functions.
Horizon plans to add new positions in bioanalysis, clinical research, pharmacology, manufacturing and business development during the next year.
Source: Horizon Therapeutics
Recro Pharma’s Baudax Bio Launches as New Pharmaceutical Company
Baudax Bio has launched as an independent, publicly traded Pennsylvania-based pharmaceutical company focused on advancing non-opioid analgesics and other products for hospitals and other acute care settings. Baudax launches with $19 million in funding from Recro Pharma, its former parent company and a Georgia-based formulations CDMO, and holds the rights to a pipeline of pharmaceutical assets.
On November 13, 2019, Recro announced that its board of directors approved the separation of Baudax Bio and Recro and declared a dividend distribution of one share of Baudax Bio common stock for every two- and one-half shares of Recro common stock held as of the close of business on November 15, 2019, the record date for the distribution.
Baudax holds exclusive global rights to IV meloxicam, a post-Phase III non-opioid analgesic developed for moderate to severe pain. If approved, IV meloxicam will be a new IV non-opioid option for the management of moderate to severe pain. Baudax also holds global rights to two neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs which were licensed from Cornell University in 2017. Baudax holds rights to intranasal dexmedetomidine (Dex-In), a non-opioid alpha-2 adrenergic agonist being developed for possible uses in pain or sedation.
Baudax has appointed Gerri Henwood as Chief Executive Officer (CEO), who brings over three decades of senior leadership experience in biopharmaceuticals, healthcare and life sciences, including as Founder, President and CEO of both Recro Pharma and Auxilium Pharmaceuticals.