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Bristol-Myers Squibb and Samsung BioLogics Announce Biopharmaceutical Manufacturing Relationship

On July 29, 2023 Bristol-Myers Squibb Company (NYSE:BMY) and Samsung BioLogics reported the companies have entered into a 10-year agreement under which Samsung BioLogics will manufacture a commercial antibody cancer drug for Bristol-Myers Squibb at its recently completed plant in Songdo Incheon, South Korea (Press release, Bristol-Myers Squibb, JUL 29, 2013, View Source [SID1234635229]).

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Financial terms were not disclosed. Technology transfer and trial production will commence in July 2013 and commercial production will immediately begin following regulatory approvals.

"We are pleased to announce this strategic manufacturing relationship with Bristol-Myers Squibb and look forward to delivering best-in-class manufacturing services with the highest global quality standards," said Tae-Han Kim, president and CEO of Samsung BioLogics. "The relationship with Bristol-Myers Squibb represents the validation of our long-term commitment to the biopharmaceutical manufacturing industry."

"Our agreement with Samsung is an important part of our company’s overall manufacturing and supply strategy focused on creating long-term relationships with high quality manufacturing partners around the world," said Louis Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb. "This agreement increases our biologic manufacturing capacity to help ensure sufficient long-term supply of our commercial products."

Immunocore and Genentech enter strategic alliance

On 27 June 2013 Immunocore reported that it has entered into a research collaboration and licensing agreement with Genentech, a member of the Roche Group for the discovery and development of multiple novel cancer targets using Immunocore’s ImmTAC technology (Press release, Immunocore, JUL 27, 2013, View Source [SID1234518787]).

Under the terms of the agreement, Immunocore will receive an initiation fee of between $10 and $20 million per programme and is eligible to receive in excess of $300 million in development and commercial milestone payments for each target programme and significant tiered royalties.

(Press release, TNI BioTech, JUL 24, 2013, View Source [SID:1234507316])

Application Seeking Approval for Additional Indication for ATL, PTCL and CTCL of Mogamulizumab

On July 19, 2013 Kyowa Hakko Kirin reported that it has been filed an application to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval for additional indication for untreated CCR4-positive adult T-cell leukemia-lymphoma (ATL), relapsed CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO Injection 20 mg) (Press release , JUL 19, 2013, View Source [SID:1234500288]).

Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including ATL, PTCL and CTCL cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Clinical studies of Mogamulizumab in patients with untreated CCR4-positive ATL, relapsed CCR4-positive PTCL and CTCL in Japan met their primary endpoint, which allowed Kyowa Hakko Kirin to file an application. Mogamulizumab was also granted orphan drug designations for the treatment of CCR4-positive ATL in August 2010, PTCL and CTCL in March 2013 by the MHLW.
Mogamulizumab was launched in Japan with the brand name "POTELIGIO Injection 20 mg" on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL and is being investigated world-wide in a number of clinical studies for other potential indications.

Ipsen strengthens its neurology R&D capabilities with the acquisition of Syntaxin, a leader in recombinant botulinum toxin technology

On July 15, 2013 Ipsen (Euronext: IPN; ADR: IPSEY) reported the closing of the acquisition of Syntaxin, a UK-based private life sciences company specialized in botulinum toxin engineering (Press release, Ipsen, JUL 15, 2013, View Source [SID1234517245]). Under the terms of the agreement, Ipsen will pay €28 million upfront, as well as further contingent payments that could reach €130 million or more depending on the achievement of development and commercial milestones. Furthermore, Syntaxin’s shareholders will receive the greater part of additional downstream payments related to the company’s most advanced asset, currently in Phase II clinical trials.

The transaction fits into Ipsen’s strategy to reinforce its core technological platforms, peptides and toxins. Syntaxin has a wealth of experience in botulinum toxin biology, supported by an extensive patent portfolio – with 75 granted patents and over 130 patents pending.

Syntaxin and Ipsen started collaborating in 2010. A year later, they signed a global strategic partnership to explore the discovery and development of new compounds in the field of recombinant botulinum toxins. Syntaxin’s team has used its extensive expertise in the discovery of new therapeutic candidates while Ipsen applied its skills to pharmacological, preclinical and clinical assessment of the compounds. Prior to the transaction, Ipsen owned c.10% of Syntaxin’s capital on a fully diluted basis.

Marc de Garidel, Chairman and CEO of Ipsen stated: "We are very pleased to see Syntaxin become part of Ipsen. This is an important step in our ambition to become a global leader in targeted debilitating diseases. The acquisition of Syntaxin is a considerable addition to our neurology franchise and is fully aligned with our strategy of focus."

Syntaxin has a strong R&D portfolio which exploits the diversity of botulinum toxins, including recombinant botulinum toxins with improved designs and properties. The Company’s technology has been validated by the Phase II clinical trials of Syntaxin’s lead candidate. Dr Keith Foster and Dr John Chaddock, the co-founders of Syntaxin, will join Ipsen to help the Group build a highly differentiated and innovative toxin platform. Syntaxin’s recombinant toxin expertise and Ipsen’s know-how will be a powerful combination to release the full potential of the Targeted Secretion Inhibitors platform across Ipsen’s therapeutic areas of neurology, endocrinology and uro-oncology.

Ipsen expects to achieve full integration by the end of the year.

Ipsen has been supported on this transaction by Lazard Ltd, Freshfields Bruckhaus Deringer LLP, and Bristows LLP (for IP matters).