Asia Deal Watch: Zogenix Partners Japanese Rights To Pediatric Epilepsy Therapy To Nippon Shinyaku

Nippon Shinyaku obtains rights to sell Dravet and Lennox-Gastaut syndrome drug Fintepla in its home market. Sun Pharma increases its ownership stake in Russia’s PJSC Biosintez.

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

Zogenix Licenses Lead Candidate To Nippon Shinyaku In Japan

Rare disease specialist Zogenix Inc. disclosed on March 19 an exclusive distribution agreement with Nippon Shinyaku Co. Ltd. for the commercialization in Japan of its lead product candidate, Fintepla (ZX008, fenfluramine). Zogenix is developing the drug internationally for the treatment of Dravet syndrome and Lennox-Gastaut syndrome (LGS), two rare and often fatal childhood-onset epileptic encephalopathies.

Nippon Shinyaku will receive exclusive commercial rights in Japan in exchange for payments to Zogenix totaling $20m, a major portion of which was paid at signing and the remainder of which will be paid over the next two years. Zogenix will also be eligible for future regulatory and sales-based milestone payments and will supply product to Nippon Shinyaku on a tiered transfer price based on Zogenix’s manufacturing costs, as well as the annual net sales of Fintepla in Japan.

Zogenix retains responsibility for completing its global clinical programs for the drug, including those already underway to support Zogenix’s planned approval submissions in Japan for Dravet syndrome and LGS. (Also see "Zogenix' ZX008 Emerges As Strong Contender In Rare Epilepsy" - Scrip, 12 Jul, 2018.)

A rolling new drug application (NDA) submission for Fintepla has been made in the US for Dravet syndrome, for which the product is also awaiting EU approval. (Also see "Keeping Track: CDER Approves Its First Two Novel Agents Of 2019" - Pink Sheet, 10 Feb, 2019.) Zogenix anticipates a decision on approval could be reached in Europe in the first quarter of 2020, and expects to hear from the US FDA shortly regarding the filing status of its NDA.

Japan’s Takeda Pharmaceutical Co. Ltd. separately is partnered with Ovid Therapeutics Inc. on a first-in-class CH24H inhibitor for Dravet syndrome and other rare forms of pediatric epilepsy. (Also see "Takeda/Ovid Broaden Pioneering CH24H Inhibitor To Rare Epilepsies" - Scrip, 19 Jul, 2018.)

Sun Shores Up Holding In Russian Firm

Sun Pharmaceutical Industries Ltd. has increased its holding in the Russian company PJSC Biosintez, fortifying its presence in a market that is keen to boost localization efforts for pharmaceuticals. The Indian pharma said its subsidiary in the Netherlands acquired a further 33,958 shares (30,221 ordinary shares and 3,737 preferred shares) equivalent to 11.86% of PJSC Biosintez on March 12 under a mandatory tender offer requirement.

“Post the purchase, Sun Pharma (Netherlands) BY's current shareholding in the target entity (Biosintez) has increased from 85.10% to 96.96%,” Sun informed said March 13. The shares were acquired for about $3.2m.

The tender offer follows the 2016 acquisition of Biosintez by Sun at an equity consideration of $24m; India’s top-ranked drug firm, at the time, said that it also will assume debt of about $36m as part of the transaction. (Also see "Sun Acquires Russian Firm Amid Localization Push" - Scrip, 23 Nov, 2016.) Sun’s interest in Biosintez comes against a backdrop of efforts by Russia to pare its dependence on overseas imports and encourage local manufacturing.

Incorporated in 1959, Biosintez manufactures and markets pharmaceutical products used in the hospital segment, with a presence in Russia and Commonwealth of Independent States (CIS) countries. It produces a range of dosage forms including pharmaceuticals for injections, blood substitutes, blood preservatives, ampules, tablets, ointment, creams, gels, suppositories and active pharmaceutical ingredients. The company’s sales have dipped over the recent past, with turnover at RUB2,373m ($36.9m) in April 2017-March 2018, compared to RUB2,922m (2016-17) and RUB3,154m (2015-16).

OliX Inks AMD License With Thea Open Innovation

OliX Pharmaceuticals Inc. reached a license agreement March 18 with Thea Open Innovation, a unit of France’s ophthalmology specialist Laboratoires THEA SAS, for the rights to OLX301A, an investigative drug for dry and wet age-related macular degeneration (AMD), in Europe, the Middle East and Africa for KRW80.7bn ($76.8m).

OliX will receive an upfront payment of €2m ($2.3m) and could earn milestone payments of €43.5m, plus double-digit royalties. It can also receive an additional €17.5m on new ocular disease therapy development under the agreement. The deal also includes the option for the two sides to jointly develop new ocular disease therapies.

OliX will retain OLX301A’s rights in the American and Asian regions, which could be out-licensed to global pharmas going forward. The South Korean firm uses its proprietary technology to address problems with small interfering RNA (siRNA) therapeutics. The company's cell-penetrating asymmetric siRNA (cp-asiRNA) technology is designed to offer a solution for the intracellular delivery of asiRNA with minimized adverse effects.

OliX CEO Dong Ki Lee said the agreement with Thea validates his company’s technology, which will now be used to address other ocular diseases. OLX301A has gained strong attention from potential partners despite being a preclinical asset, he added, and OliX intends to seek other partnerships for the therapy, including for US rights. Filing of an investigational new drug (IND) application at the US FDA is planned for later this year.

The first Asian company to enter clinical development with proprietary RNAi drug development technology, OliX is progressing 15 pipeline candidates for indications including idiopathic pulmonary fibrosis, skin scarring, neuropathic pain and liver fibrosis. SC100141 Its most advanced candidate is for hypertrophic scar therapy.

Astellas Taps NapaJen For Therapeutic Oligonucleotide Research

Drug delivery specialty firm NapaJen Pharma Inc. said on March 18 that it entered into a research collaboration with Astellas Pharma Inc. for the discovery and development of novel oligonucleotide therapeutics. Burlingame, Calif.-based NapaJen will receive an undisclosed upfront payment and research funding, and will be eligible for payments associated with the achievement of key research milestones.

The companies will jointly collaborate on the discovery and creation of novel oligonucleotide drug candidates utilizing novel delivery technology developed by NapaJen, which will be responsible for providing its Japanese partner with a therapeutic complex combining the novel oligonucleotide with NapaJen’s proprietary schizophyllan delivery vehicle for further development.

NapaJen’s proprietary immune cell-targeted delivery platform is designed to overcome limitations for the delivery of oligonucleotide-based therapeutics to target cells, such as high instability, low bioavailability and poor cellular uptake, and to reduce off-target effects. The delivery vehicle is built upon schizophyllan, a beta-glucan that specifically binds to Dectin-1, a cell-surface receptor expressed on antigen-presenting immune cells such as dendritic cells and macrophages.

By complexing oligonucleotides with schizophyllan, the platform enables selective delivery of oligonucleotides to cells playing key roles in regulating immune responses, NapaJen says. The biotech is looking at areas including autoimmune disease, cancer, transplantation and vaccines through collaborative work with industry and academia. Its lead therapeutic candidate, NJA-730, is a siRNA drug targeting CD40 in a Phase I study in healthy volunteers with potential for development in graft-versus-host disease.

Ono, twoXAR Sign Discovery Collaboration In Neurologic Disease

Ono Pharmaceutical Co. Ltd. and artificial intelligence (AI)-driven biotech twoXAR Inc. announced a drug discovery and research collaboration March 18 that will seek novel therapies to address unmet medical needs in an undisclosed neurological disease. Specific terms of the deal were not revealed, but twoXAR will get research and licensing fees from Ono, and can earn development and sales milestone fees.

The agreement specifies that twoXAR will deploy its proprietary AI technology to identify lead compounds using a novel mechanism of action for further optimization as drug candidates by the Japanese pharma. Also, according to a statement, twoXAR’s responsibilities under the partnership include “predict[ing] a set of hypotheses which suggest the efficacy and safety of such lead compounds for the therapy.” The two companies will select compounds from the discoveries for further validation.

Ono gets global development and commercialization rights to drug candidates derived from the research. The agreement is twoXAR’s second research tie-up with a Japanese company, following a 2017 glaucoma-focused partnership with Santen Pharmaceutical Co. Ltd. [See Deal]

Ocumension Gains Chinese Rights To Nicox’s Conjunctivitis Formulation

France-based ophthalmic specialist Nicox SA and Chinese firm Ocumension Therapeutics announced on March 15 an exclusive agreement for the development and commercialization of Nicox's Zerviate (cetirizine topical ophthalmic solution; AC-170), 0.24% for allergic conjunctivitis in mainland China, Hong Kong, Macau and Taiwan. The two also recently entered into a collaboration for the development and commercialization of Nicox’s NCX 470 for patients with glaucoma or ocular hypertension in the same territories. [See Deal]

Ophthalmology-focused Ocumension, supported by health care investment fund 6 Dimensions Capital (itself formed by the merger of WuXi Healthcare Ventures and Frontline BioVentures), will receive exclusive development and commercialization rights in the territories, while Nicox could earn development and sales milestone fees of up €17m ($19.3m), together with sales royalties of 5%-9%.

Ocumension expects it will need to conduct additional clinical studies for the regulatory approval of Zerviate in China. All development activities will be overseen by a joint development committee, with Ocumension responsible for undertaking all the activities at its own cost.

Zerviate is the first and only topical ocular formulation of the oral antihistamine (H1 receptor antagonist) cetirizine, for the treatment of ocular itching associated with allergic conjunctivitis. The product is already approved in the US, where a commercial launch is planned this summer by the exclusive licensee for that market, Eyevance Pharmaceuticals LLC. [See Deal] Nicox says it is also planning further international collaborations.

NCX 470 is being developed for intraocular pressure-lowering, and is based on Nicox’s proprietary NO-donating research platform.

SRL To Provide Chugai’s Cancer Genomic Profiling Product

Miraca Holdings Inc. subsidiary SRL Inc. and Chugai Pharmaceutical Co. Ltd. announced on March 19 a business partnership in Japan for FoundationOne CDx Cancer Genome Profile, an analysis program for gene mutation already marketed by Chugai. SRL, the largest commercial clinical laboratory in Japan, will provide commissioned testing services using the profile for medical institutions.

The diagnostic tool comprises a gene mutation analysis program (for use in cancer genome profiling) and a somatic gene mutation analysis program (for use in assessing anticancer drug indications). It allows comprehensive genomic and mutation status profiling of cancer-related genes for solid tumors from a single tissue sample, along with the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements.

It also identifies genomic signatures including microsatellite instability and tumor mutational burden (biomarkers reported to predict the efficacy of cancer immunotherapies), using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens. This allows it to be used as a comprehensive companion diagnostic to identify responders to a broad range of Japanese-approved molecular-targeted therapies, including erlotinib, osimertinib, trastuzumab and alectinib.

In March 2018, Chugai started to market in Japan products (including the Profile) developed by molecular information company Foundation Medicine Inc., which provides comprehensive genomic profiling testing aimed at improving access to personalized oncology care in Japan. Both Chugai and Foundation Medicine are subsidiaries of Roche.

Commercial terms of the new arrangement with SRL were not disclosed.

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

(Also see "Abbott Builds Its Digital Reach In India" - Scrip, 19 Mar, 2019.)

Abbott Laboratories Inc.’s new digital initiative in India, which already has 2,000 physicians and 1,000 patients on board, aims to provide services and information to improve health outcomes. Gamification concepts and an offline component such as a learning program for physicians are also part of the new offering.