Global Pharma Briefs: News from Asia, Europe and the USBy
A roundup of developments and latest news from China (WuXi Biologics), India (Biocon), UK (AstraZeneca), US (Krystal Biotech).
WuXi Biologics Provides Update on Activities Relating to Coronavirus in China
WuXi Biologics, a contract biologics manufacturer based in Wuxi, China, provided an update to its activities relating to the coronavirus (2019-nCoV) infection in China.
WuXi Biologics says it does not operate in Wuhan, China and does not have major suppliers from Wuhan and that supplies for labs and manufacturing are not likely to be affected. WuXi Biologics emphasized that it is working to ensure that the quality of the products from its manufacturing is not affected by the outbreak. It says it does not expect to see any negative impact of this outbreak on its operations.
“WuXi Biologics is closely monitoring the coronavirus outbreak and is complying with guidance from the relevant authorities,” said the company in a January 29, 2020 statement. “Our management team is working vigilantly to execute our Business Continuity Plan to mitigate any potential risk.”
In addition, on an operational basis, the company outlined its activities to support development and manufacturing of biopharmaceutical companies’ potential treatments of the virus. It says it has mobilized a large team to develop and manufacture multiple neutralizing antibodies to potentially treat the coronavirus infection. WuXi Vaccines, a subsidiary of WuXi Biologics dedicated to vaccines, is also in discussions on the manufacturing of multiple novel vaccines.
WuXi Biologics has established a research and development team of more than 100 people to develop and manufacture multiple neutralizing antibodies for 2019-nCoV. As of January 29, 2020, the first batch of antibody is expected to be produced in two months and be ready for preclinical toxicology studies and initial human clinical studies. Large-scale manufacturing will be initiated following the studies at the company’s four GMP facilities with single-batch bioreactor capacity ranging from 2,000 to 12,000 liters. A single batch at this scale combined is expected to treat up to 80,000 patients.
FDA Cites Biocon’s Small-Molecule API Plant in India
Biocon, a Bangalore, India-based biopharmaceutical company, reports that the US Food and Drug Administration (FDA) has conducted a pre-approval inspection and GMP inspection of Biocon’s small molecules active pharmaceutical ingredients (API) manufacturing facility in Bangalore (Bengaluru), India and issued a Form 483 with five observations. The inspection took place January 20, 2020 to January 24, 2020.
Biocon says it will respond to the FDA with a corrective and preventive action plan.
AstraZeneca Divests Hypertension Medicines to UK Atnahs Pharma
AstraZeneca has agreed to sell the global commercial rights for five established hypertension medicines to UK-based Atnahs Pharma, a developer and marketer of established medicines. The medicines, used primarily to treat hypertension, have lost their patent protection globally.
The medicines include: Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination). AstraZeneca says it will continue to manufacture and supply Inderal, Tenormin, Tenoretic, Zestril and Zestoretic to Atnahs during a transition period.
Atnahs will make an upfront payment of $350 million to AstraZeneca. AstraZeneca may also receive future sales-contingent payments of up to $40 million between 2020 and 2022.
In 2018, Inderal, Tenormin, Tenoretic, Zestril and Zestoretic generated annual sales of $132 million in the markets covered by this agreement.
The agreement excludes the rights in the US and India, which were previously divested, and in Japan, which will be retained by AstraZeneca. The divestment is expected to be complete in the first quarter of 2020, subject to customary closing conditions and regulatory clearances.
Krystal Biotech Breaks Ground on Gene-Therapy Mfg Facility in Pennsylvania
Krystal Biotech, a gene-therapy company developing medicines to treat rare diseases, has broken ground on its second commercial gene-therapy manufacturing facility in Findlay Township, Pennsylvania. The Findlay-based cGMP facility, named ASTRA, will have the capacity to produce commercial gene therapies.
The ASTRA facility is being designed as a cGMP manufacturing facility that will allow the in-house incorporation of raw material preparation, excipient manufacturing, testing, packaging, labeling and distribution to incorporate all components of the supply chain from starting materials to the patient.
The ASTRA facility will initially be used as a commercial backup facility for B-VEC (previously KB103), which is being developed for the treatment of dystrophic epidermolysis bullosa, a rare skin disorder, as well as for producing investigational and commercial material for the company’s pipeline products. The 100,000-square-foot facility will be built out and validated over the next 12 to 15 months. Opening the ASTRA facility will create about 75 new jobs in western Pennsylvania, with the potential to create upwards of 200 new jobs when at full capacity, according to Krystal Biotech.
Source: Krystal Biotech