BioPharm International - February 2020

BioPharm-Outsourcing eBook

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30 BioPharm International eBook February 2020 Although the companies have been in collaboration since 2018, the partnership only became public in December 2019 after Rocket Pharma published positive preliminary data from a Phase I/II trial of the drug, according to a Lonza press release. Clinical manufact ur ing of the therapy will take place at Lonza's Houston, TX and Netherlands cGMP manufacturing sites. The agreement also involves analytical assays and development services. " We a re f i r m bel ievers a nd supporters of the science developed by Roc ket Pha r ma. O u r c lose collaboration with this team started over two years ago and has enabled the delivery of life-saving treatments to young patients left with no other options," said Alberto Santagostino, senior vice president, head of Cell and Gene Technologies, Lonza Pharma & Biotech, in the press release. In September 2019, Catalent entered into a long-term commercial supply agreement with Minerva N e u r o s c i e n c e s , a Wa l t h a m , M A - b a s e d b i o p h a r m a c e u t i c a l c o m p a n y f o c u s e d o n t h e development of therapies to treat cent ra l ner vous system (C NS) disorders (8). The collaborations will center on roluperidone (MIN- 101), an investigational compound under development by Minerva, for the treatment of negative symptoms of schizophrenia. If its successful in Phase III clinical trials, the drug will be the first treatment approved to treat symptoms of schizophrenia in the United States, according to the companies. Additionally, Catalent announced on Feb. 11, 2020 that it has signed an agreement with Cambridge, MA-based therapeutics company, Zumutor Biologics, to manufacture Zumutor's lead candidate, ZM008, a monoclonal antibody for the treatment of solid tumors (9). Samsung Biologics announced a long-term agreement with Ichnos Sc iences, a Pa ra mus, N J-based biotech company, in November 2019 for the manufact uring of dr ug substance for ISB 830, an anti-OX40 monoclonal antibody in development as a potent ia l treatment for moderate-to-severe atopic dermatitis (10). Through the agreement, Samsung will provide f le x ible b u si ne s s te r m s wh i le offering full regulatory support and improved batch release from small to large scale, according to Samsung. "We are extremely proud to advance our ongoing relationship with Ichnos and truly appreciate the trust they have placed in Samsung Biologics to ensure delivery of high quality ISB 830 drug supply for clinical studies and for potential future commercial supply," said Dr. Tae Han Kim, CEO of Samsung Biologics, in a press release. "Client satisfaction is our highest priority, and we look forward to generating future value for Ichnos via our continued collaboration." On Jan. 9, 2020, WuXi Biologics a n d A l m i r a l l , a s k i n - h e a l t h focused pharmaceutical company, announced that they have signed a strategic collaboration agreement that gives Almirall access to WuXi Biolog ics' propr ietar y antibody platforms, including WuXiBody, to develop bispecific antibodies for dermatological diseases (11). Under their agreement, WuXi Biologics will receive an upfront payment as well as development, r e g u l a t o r y, a n d c o m m e r c i a l m i le s tone p ay me nt s for e ac h bispecific antibody generated from this platform. The company will also be entitled to royalties based on global sales generated by these projects. Almirall will develop the therapeutics under license and will maintain ownership for medical use of the resulting components. REFERENCES 1. Catalent, "Catalent To Acquire Leading Cell Therapy Company MaSTherCell Global for $315 Million, Creating an Industry-Leading Cell & Gene Therapy Platform," Press Release, Feb. 3, 2020. 2. Catalent, "Catalent Completes Purchase of Biologics Fill-Finish and Oral Solid Dose Facility in Anagni, Italy," Press Release, Jan. 7, 2020. 3. Catalent, "Catalent To Open New Clinical Supply Facility in San Diego," Press Release, Sept. 5, 2019. 4. The Discovery Labs, "The Center for Breakthrough Medicines is Building the World's Largest Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) to Launch in King of Prussia, PA," Press Release, Jan. 23, 2020. 5. Lonza, "Lonza's Ibex Solutions to Support Genmab's Growing Clinical Portfolio," Press Release, Oct. 14, 2019. 6. Lonza, "Lonza Partners with Cryoport and Strengthens its 'Vein-to-vein' Delivery Network in Cell & Gene Therapy," Press Release, Nov. 5, 2019. 7. Lonza, "Lonza Supporting Rocket Pharma with Clinical Manufacturing of RP-L201 for the Treatment of Leukocyte Adhesion Deficiency-I," Press Release, Jan. 28, 2020. 8. Catalent, "Catalent and Minerva Neurosciences Enter Commercial Supply Agreement for Schizophrenia Drug Roluperidone," Press Release, Sept. 24, 2019. 9. Catalent, "Catalent and Zumutor Biologics Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors," Press Release, Feb. 11, 2020. 10. Samsung Biologics, "Samsung Biologics and Ichnos Sciences Announce Agreement for Manufacture of ISB 830," Press Release, Nov. 5, 2019. 11. WuXi Biologics, "Almirall and WuXi Biologics Sign Strategic Collaboration Agreement for Multiple Bispecific Antibodies Targeting Dermatology Diseases," Press Release, Jan. 9, 2020 BP Outsourcing Resources Operations Aji Bio-Pharma Services ..................................13 Catalent .............................................................17 Eurofins ...............................................................7 Patheon .............................................................25 Ad Index COMPANY PAGE

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