Asia Deal Watch: Vibegron’s Vagabond Journey Continues With Eisai Acquiring Partial Asian Rights

Kyorin, Eisai build on earlier OAB deal to team on vibegron. Plus deals involving Piramal/Hemmo, ImmuneOncia/3D Medicines, Kyowa Kirin/Cerecor, Simcere/Kazia, Nippon Shinyaku/Menarini, Tarsus/LianBio

Source: Alamy

Scrip regularly covers business development and deal-making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Biomedtracker.

Eisai To Sell Kyorin’s OAB Agent In Four Asian Countries

Kyorin Pharmaceutical Co., Ltd. licensed exclusive marketing rights in four countries overactive bladder drug vibegron to Eisai Co., Ltd. on 31 March. The agreement confers those rights in Thailand, the Philippines, Malaysia and Brunei; Eisai also will be responsible for submitting local approval applications. Terms of the deal were not disclosed.

Rights to vibegron – approved by the US Food and Drug Administration under the brand name Gemtesa for OAB on 23 December – have changed hands in a series of deals in the past decade, flowing from a US big pharma to a Roivant Sciences subsidiary, which then was acquired by a Japanese major, Sumitomo Dainippon Pharma Co., Ltd. (Also see "Sumitovant Keeping Sumitomo Dainippon-Acquired Roivant Companies On Track" - Scrip, 29 Jan, 2020.)

Kyorin obtained Japanese rights to vibegron in 2014 from Merck & Co., Inc.; those rights then expanded to all of Asia in a 2017 amendment to the agreement. (Also see "Kyorin Licenses Merck’s OAB Drug Vibegron For Japan" - Scrip, 29 Jul, 2014.) Acquired by Urovant Sciences, Inc. from Merck & Co. in 2017, vibegron is a novel, beta3 adrenergic receptor agonist administered once daily to improve the symptoms of urgency, urinary frequency and urge urinary incontinence associated with OAB. (Also see "Deal Watch: Merck KGAA, Pfizer, eFFECTOR Agree To PD-L1/MNK Combo Study In CRC" - Scrip, 27 Jun, 2017.)

Urovant now is part of Sumitovant Biopharma Ltd. under a 2019 deal; Sumitovant acquired all outstanding shares in Urovant in December 2020. (Also see "Deal Watch: Lilly Finds New Partners For Genetic Disorders, Protein Degradation" - Scrip, 25 Nov, 2020.) Last October, Urovant inked an agreement with another Sumitomo Dainippon unit, Sunovion Pharmaceuticals Inc., to assist with commercialization of vibegron. (Also see "Deal Watch: Roche Partners With Dyno On AAV-Delivered Gene Therapies" - Scrip, 14 Oct, 2020.)

Previously, Eisai and Kyorin signed a license agreement in 2009 for the development and marketing in Asia of Uritos (imidafenacin), an earlier OAB therapy discovered and developed by Kyorin, which Eisai still sells in Thailand, the Philippines, Indonesia and Myanmar. (Also see "Eisai Obtains Rights To Overactive Bladder Agent Uritos In 13 Asian Countries" - Scrip, 1 Oct, 2009.)

Piramal Snaps Up Peptide API Manufacturer

The Piramal Group continued its activity on deal street on 31 March, buying local pure-play synthetic peptide active pharmaceutical ingredients (APIs) manufacturer Hemmo Pharmaceuticals  (Also see "Piramal Snaps Up Peptide API Specialist Hemmo" - Generics Bulletin, 6 Apr, 2021.) The diversified Piramal had earlier outlined its ambitions for inorganic growth following a capital raise last year from Carlyle, which saw the private equity group snap up 20% of Piramal’s pharma business for close to $500m. (Also see "Carlyle's 20% Stake Gives Piramal Pharma 'War Chest' For Growth" - Scrip, 28 Jun, 2020.) (Also see "Piramal To Plant A Flag In North America" - Generics Bulletin, 23 Jun, 2020.)

The latest transaction will see Piramal Pharma acquire a 100% stake in Hemmo for an upfront consideration of INR7.75bn ($106m) and earnouts linked to achievement of milestones. The deal expands the suite of offerings of Piramal Pharma Solutions (PPS), the group’s contract development and manufacturing organization, adding peptide API development and manufacturing capabilities, an area with growing significance in the oncology and metabolic therapy segments. The global peptide API market is estimated to be valued at $2bn and growing at 6%-8% annually.

Piramal said it also sees scope for synergy towards integrated projects – for instance where products developed and manufactured by Hemmo are being used by existing customers elsewhere in Piramal’s network. Savings on capital/operating expenditures and general and administrative expenses are expected to accrue by integrating business functions.

Mumbai-headquartered Hemmo is one of India’s largest manufacturers of synthetic peptides with more than three decades of experience; it brings 250 employees to Piramal, including more than 60 quality assurance personnel. Its portfolio includes over 30 APIs including generic peptides, peptide NCEs and assets in in clinical development. Hemmo’s manufacturing facility in Turbhe, India has been inspected and “deemed compliant” by US, EU and Asian regulatory agencies, the company said.

Despite the pandemic, Hemmo reported a 20% increase in revenue during the first 11 months of fiscal year 2021 versus the full prior fiscal year. Piramal said it expects the business’s revenue to grow three times or more in the next few years.

ImmuneOncia, 3D Medicines Ink $470m IO License Agreement

South Korea’s ImmuneOncia Therapeutics, Inc. and China’s 3D Medicines Co., Ltd. announced an exclusive license agreement on 30 March for the development, manufacture and commercialization of IMC-002, ImmuneOncia's monoclonal antibody against CD47. ImmuneOncia is a joint venture of Yuhan Corporation and Sorrento Therapeutics, Inc. launched in 2016. (Also see "ImmuneOncia: A PD-L1 Latecomer Hoping To Break Into The Market" - Scrip, 16 Nov, 2017.)

IMC-002 is a fully human IgG4 monoclonal antibody designed to block the CD47–SIRPα interaction in order to promote the phagocytosis of cancer cells by macrophages. According to non-clinical results, the antibody binds to human CD47 with an optimal affinity that maximizes efficacy without binding to red blood cells or causing anemia, an issue often seen with other CD47-blocking agents in development.

The agreement includes uses of IMC-002 for oncology indications as monotherapy or a combination agent in greater China (mainland China, Hong Kong, Macau and Taiwan). ImmuneOncia retains rights to IMC-002 in the rest of the world including the US, EU and Japan. 3D Medicines will make an upfront payment of $8m, and ImmuneOncia can realize up to $462.5m in development and commercial milestones, plus tiered royalties up to double-digits on annual net sales of IMC-002 in greater China.

3D Medicines plans to file an investigational new drug (IND) application to China’s NMPA this year, the companies said. "We believe that IMC-002, used in combination with existing standard of care therapeutics or envafolimab, an innovative subcutaneous PD-L1 antibody which we have just filed for marketing approval in China, could alter the treatment paradigm across various tumor types," 3D Medicines CEO John Gong said in a statement.

Kyowa Kirin, Cerecor Expand LIGHT Antibody Collaboration

Japan’s Kyowa Kirin Co., Ltd. has expanded its collaboration with Cerecor, Inc. subsidiary Aevi Genomic Medicine, Inc. by conferring exclusive worldwide rights to develop, manufacture and commercialize a potential first-in-class fully human anti-LIGHT monoclonal antibody, CERC-002, created by Kyowa Kirin and the La Jolla Institute for Allergy & Immunology in the US. Cerecor and Aevi merged in 2019 with a focus on rare pediatric indications. (Also see "Deal Watch: AstraZeneca Continues Divestments By Offloading US/Canada Seroquel Rights" - Scrip, 6 Dec, 2019.)

Kyowa Kirin initially signed an option agreement with Cerecor in mid-2016 for the clinical development and commercialization of the antibody for severe pediatric onset inflammatory bowel disease and certain other rare and orphan pediatric indications, with options in North America and Europe. (Also see "Deals Shaping the Medical Industry, October 2016" - In Vivo, 9 Oct, 2016.) The Japanese firms subsequently granted additional option rights to Cerecor for worldwide development, manufacturing and marketing rights for COVID-19 ARDS in May 2020.

Under the new agreement, announced on 29 March, Kyowa Kirin will license to Aevi exclusive global rights to CERC-002 for all indications, while holding an option on rights in Japan. Kyowa Kirin will receive an undisclosed upfront payment from Cerecor and is eligible for development and commercial milestones, plus sales-based royalties.

CERC-002 is a fully human anti-LIGHT or tumor necrosis factor superfamily member 14 (TNFSF14) antibody, in development for pediatric-onset Crohn’s disease and cytokine storm induced COVID-19-related acute respiratory distress syndrome. Cerecor has also developed a related serum/plasma-free LIGHT assay in collaboration with Myriad RBM.

LIGHT is homologous to lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on T lymphocytes. It has been shown to play a key role in the immune response to viral pneumonia and in regulating immune responses in the lung and gut, according to Cerecor.

Simcere Picks Up Kazia’s Paxalisib In China-Plus Area

On 29 March, oncology-focused Kazia Therapeutics Limited announced a licensing agreement with China’s Simcere Pharmaceutical Group to develop and commercialize Kazia's paxalisib in China plus other territories. Paxalisib is a brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway and is currently in six additional studies in other forms of brain cancer beyond glioblastoma.

Kazia will receive $11m up front, comprising $7m in cash and a $4m equity investment, priced at a 20% premium to recent trading. It also could earn contingent milestone payments of up to $281m for glioblastoma, with further milestones payable for indications beyond this, plus mid-teen percentage sales royalties.

Simcere will be responsible for development, registration and commercialization activities in mainland China, Hong Kong, Macau and Taiwan, while Kazia will continue to conduct the ongoing pivotal GBM AGILE study, including at sites in China.

Nippon Shinyaku Licenses Menarini’s Tagraxofusp For Japan

Menarini Group announced on 29 March an exclusive license for the development and commercialization of Elzonris (tagraxofusp) in Japan with Nippon Shinyaku Co., Ltd. No financial terms were disclosed.

The CD-123-targeting drug, originally developed by Stemline Therapeutics, Inc. (now part of the Menarini), is already approved in the US and EU for blastic plasmacytoid dendritic cell neoplasm, a rare aggressive hematologic malignancy that typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. (Also see "Menarini Seals Stemline Merger" - Scrip, 11 Jun, 2020.) Tagraxofusp is also being evaluated in clinical trials for additional indications including chronic myelomonocytic leukemia, myelofibrosis and acute myeloid leukemia, with others planned.

Tarsus Joins With LianBio For Anti-Mite Ophthalmic In Greater China

Tarsus Pharmaceuticals Inc. unveiled a deal with China’s LianBio on 29 March for the development and commercialization of TP-03 (lotilaner ophthalmic solution) in mainland China, Hong Kong, Taiwan and Macau. The first-in-class therapeutic, Tarsus’ lead candidate, is in development for the treatment two ophthalmic indications, Demodex blepharitis and Meibomian gland disease.

Shanghai-based LianBio gets exclusive rights in return for $15m upfront, plus up to $185m in development and commercialization milestones. Earnouts could include $10m by 30 June 2021 and $45m over the next 12 months for anticipated near-term clinical milestones, the companies said. Tarsus will also be eligible for tiered, low double-digit sales royalties and obtain a minority equity stake in LianBio Ophthalmology, to vest upon the achievement of certain development and commercialization milestones.

TP-03 is a non-competitive antagonist of insect and arachnid GABA-Cl channels and is used to kill the Demodex mites responsible for many cases of the two inflammatory and irritation disorders. Tarsus has already completed four Phase II trials in Demodex blepharitis, which met their endpoints, and is now conducting a pivotal Phase IIb/III trial.

The companies noted that there are more than 100 million estimated Demodex blepharitis and Meibomian gland disease patients in China.

ST Pharm Licenses In Genevant Technology For COVID-19 mRNA Vaccine

ST Pharm said on 8 April it had reached a non-exclusive license agreement with Genevant Sciences to bring in lipid nanoparticle (LNP) drug delivery technology which is needed in the development and commercialization of a COVID-19 mRNA vaccine candidate.

Under the agreement, ST Pharm, an affiliate of South Korea’s Dong-A Socio Holdings, has acquired the rights to directly develop and manufacture the vaccine using Genevant’s LNP technology in 12 countries, including South Korea and Japan. In return, US-based Genevant will receive up to $133.8m, including upfront and milestone payments.

ST Pharm is the only Korean firm to have secured 5’-Capping and LNP drug delivery technology, which are core platforms for mRNA synthesis and antibody generation. It has completed a patent filing in South Korea and is preparing to file for global patents for the vaccine.

In addition, it is preparing to raise capacity at its GMP facilities specifically for the mass manufacturing of mRNA. If construction is completed in the first half of this year, it would be able to manufacture 2.4 million doses annually of mRNA substance based on Pfizer Inc./BioNTech SE’s COVID-19 vaccine Comirnaty (tozinameran).

Stay tuned for the next edition of Deal Watch. You can read more about other Asia deals that have been covered in depth by Scrip and Generics Bulletin in recent days below:

(Also see "India’s Big Eight Make Digital Leap With Two Acquisitions" - Scrip, 6 Apr, 2021.)	In an unprecedented move, eight of India’s top pharma companies, including Sun Pharma, Cipla, Torrent and Lupin, have set up a common vehicle for digitization initiatives. Having acquired local market research firm AIOCD AWACS and B2B platform Pharmarack, it's possible a similar move could extend to other services.
(Also see "GSK Sells Indian Site To Hetero Labs" - Generics Bulletin, 1 Apr, 2021.)	GSK has sold its Vemgal manufacturing plant to Indian company Hetero Labs. GSK’s decision came after the recall of ranitidine products made in India.
(Also see "Yposkesi Acquisition Fuels SK's Global Push Into Biologics Manufacturing" - Scrip, 1 Apr, 2021.)	South Korean conglomerate SK Group continues its cross-border acquisitions of contract manufacturers, this time of French biologics specialist Yposkesi, marking a new push into the gene and cell therapy sector as it looks to become a global leader in the production of both innovative chemical drugs and biologics.