Deal Watch: Themis Leverages Measles Vector Platform In Collaboration With Merck & Co.

In its first big pharma deal, Austrian biotech will develop experimental vaccines for Merck against an undisclosed target. Innovent licenses Chinese rights to Lilly diabetes candidate, while Novartis gets option to Iconic’s preclinical ophthalmology program.

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

Themis Partners With Merck On Measles Vector Platform

Merck & Co. Inc. has licensed Themis Bioscience GmbH’s measles vector-based platform for use in the development of its vaccine candidates. It is the Vienna-based private company’s first partnership with a major pharma firm.

Under the agreement unveiled on 22 August, Themis will develop vaccine candidates against an undisclosed disease target. Merck will provide research funding and make an equity investment in Themis, which also will be eligible to receive development and sales milestone payments up to $200m, plus royalties on approved products from the collaboration. No further financial details were disclosed.

Themis’s measles vector platform is based on research licensed from the Institut Pasteur in Paris. Themis explained the vaccination vector offers the ability to incorporate large recombinant genes coding for selected antigens into its genome. “The vaccine delivers the selected antigens directly to macrophages and dendritic cells – the most potent and effective antigen-presenting cells, thereby triggering a specific immune response to the selected antigens,” the firm said.

As it is a replicating vector, the vaccine continuously expresses antigens even after immunization, the company continued. “This results in a powerful, antigen-focused immune response, which is expected to confer long-term immunity.”

Themis also has developed an “efficient and robust” manufacturing process for its product candidates, and shown the potential of the platform with the completion of Phase II studies of a vaccine against chikungunya, MK-CHIK, which is poised to enter Phase III. It recently signed an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) that will give it access to up to $21m for the product’s development. (Also see "Finance Watch: Third Rock Raises $770m To Launch Up To 12 New Companies" - Scrip, 6 Jun, 2019.)

Last November, Themis shelved plans to list on the Euronext Amsterdam, citing adverse market conditions. (Also see "Finance Watch: Not Everyone Can Go Public, But Biopharma IPOs Are Using Multiple Markets" - Scrip, 15 Nov, 2018.)

Innovent Gets Chinese Rights To Lilly’s Oxyntomodulin Analog

Innovent Biologics Inc. licensed development and commercialization rights in China on 22 August to Eli Lilly & Co.’s Phase I oxyntomodulin peptide analog OXM3 (LY-3305677). No financial terms were disclosed for the deal involving the dual GLP-1 and glucagon receptor agonist, which Innovent said could be a potential best-in-class medicine for diabetes patients in China.

Innovent CEO Michael Yu said in a statement that the deal expands his firm’s therapeutic focus into diabetes, noting that China has the largest diabetes patient population of any country, estimated at 114m people. He added that OXM3 could address an unmet medical need in China, and that Innovent’s goals include offering “high-quality biopharmaceuticals that are affordable to ordinary people.”

As an analogue of the naturally occurring oxyntomodulin peptide, Innovent believes the drug will bind to activate both the GLP-1 and GCGR receptors with a long-acting effect enabling once-weekly injection. In early-stage development at Lilly, the compound has shown potential for weight loss and improved glycemic control, and the US pharma sees OXM3 as potentially offering a treatment option for obesity and non-alcoholic steatohepatitis as well as diabetes.

AstraZeneca Options Iconic’s Preclinical Antibody For AMD

AstraZeneca PLC has obtained options rights to acquire a preclinical antibody candidate from privately held Iconic Therapeutics Inc. that both companies believe offers the possibility to address the underlying causes of age-related macular degeneration (AMD). No financial terms were disclosed for the agreement announced on 22 August.

Novartis is making an upfront payment and an equity investment in the venture-backed South San Francisco biotech. The candidate ICON-4, now in investigational new drug (IND)-enabling studies, targets anti-tissue factor and is expected to enter the clinic in 2020. Iconic noted that tissue factor has early clinical validation as a target for both eye diseases and cancer.

Iconic believes ICON-4 can go beyond improving patients’ visual acuity and stop disease progression because tissue factor over-expression typically is seen in AMD. This approach may yield a therapy that offers greater efficacy and durability of effect than current AMD treatments, the company asserted.

Orexo, GAIA Team Up On Digital Therapy For Opioid Abuse

Uppsala, Sweden-based Orexo AB is teaming up with digital therapeutics leader GAIA AG to develop a new digital therapy for the treatment of opioid use disorder (OUD). Under the 20 August agreement, Orexo, which markets the OUD product Zubsolv, obtains exclusive global commercial rights to the new product and hopes to launch it in the US in 2022 if it gains approval.

Zubsolv is a mixture of buprenorphine and naloxone, which are commonly used to treat narcotic addiction. But treating OUD needs a holistic approach, including counseling and psychosocial support in addition to medication, and Orexo maintains that access and quality of counseling and psychosocial support remain the main barriers to successful treatment in many areas of the US. (Also see "Defusing US Opioid Crisis Offers Orexo "Strong Growth Potential" Says CEO " - Scrip, 10 Apr, 2019.)

The digital therapy should help with this, according to Orexo. The fully-automated DTx (Orexo project no. OXD-01) could augment existing treatment plans and will improve patients’ access to treatment and overall treatment outcomes, it said.

The project will use GAIA’s technology platform broca. Using an artificial intelligence (AI)-expert system, broca “engages users in highly individualized, simulated 1:1 interactions, guiding patients step-by-step towards specific goals and therapeutic targets.” The platform can be run on nearly all web-compatible devices, including virtual reality applications.

Orexo will be responsible for the clinical development, regulatory approval and commercialization of the product, with GAIA eligible for royalties, milestone payments and financial compensation during the development phase. Orexo said any increase in its operational expenses for 2019 was expected to be non-material, and that future expenses related to OXD-01 will be incorporated into Orexo’s overall cost guidance.

Bausch Sublicenses Leo Pharma Brodalumab Rights Outside Europe

Bausch Health Companies Inc.'s Ireland subsidiary sublicensed Leo Pharma AS's ex-European marketing rights on 13 August for Siliq (brodalumab) in moderate-to-severe psoriasis. Under a 2015 deal with AstraZeneca, Bausch holds the worldwide rights, excluding Asia (where it's marketed by Kyowa Hakko Kirin Co. Ltd. through its own 2015 partnership with AstraZeneca) and Europe (where Leo already has rights through a July 2016 alliance with AstraZeneca). [See Deal]

Through the 2016 deal, Leo gained a European license to brodalumab in dermatology indications, along with global rights to the atopic dermatitis therapy tralokinumab. In July 2017, Leo received marketing approval in Europe for brodalumab under the brand name Kyntheum.

In the current deal, Bausch will retain rights for the US and Canada. The additional territories give Leo the opportunity to address a significantly high unmet need in countries including Australia, Brazil, Egypt, Mexico, Russia and Saudi Arabia.

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

(Also see "Lupin Rationalizes Japan Operations, Sheds Injectables Business" - Scrip, 23 Aug, 2019.)	Lupin Pharmaceuticals Inc. sells Japanese injectables business, eight years after it made an acquisition in that segment there. The Indian firm now plans to concentrate on building a hybrid pharma model in the country.
(Also see "Genexine, ToolGen Merger Collapses Amid Stock Drops, But Collaboration Still Planned" - Scrip, 22 Aug, 2019.)	The planned merger between Genexine Inc. and ToolGen, which was poised to create a major Korean biotech entity, has collapsed amid recent generally weak investor sentiment over the sector. But the two sides will maintain their collaborations for new drug development going forward, with a focus on gene and cell therapies.
(Also see "Bayer Says $7.6bn Farewell To Animal Health As It Sells Unit To Elanco" - Scrip, 21 Aug, 2019.)	Bayer AG is relinquishing its Animal Health Unit to Elanco as the German major turns its focus more towards life sciences. The money received should help it pay down some Monsanto Co. debt, but there are antitrust concerns.
(Also see "Alvogen Advances Its Branded Offering Via Agreements" - Generics Bulletin, 21 Aug, 2019.)	By licensing Covis Pharma BV’s Alvesco ciclesonide inhaler in central and eastern Europe, as well as preparing to launch the Qysmia weight-loss brand for which it just obtained approval in Korea,Alvogen Inc. is expanding its portfolio of branded drugs.
(Also see "Advanz Has Six Deals In The Works As It Cuts Its Losses " - Generics Bulletin, 16 Aug, 2019.)	Advanz Pharma Corp.’s business development team is busy assessing potential deals as the recapitalized company works towards restoring profitability on an eroding revenues base.
(Also see "Glenmark On Course For Xolair Biosimilar Deal, US Capital Raise For Innovation" - Generics Bulletin, 22 Aug, 2019.)	Glenmark Pharmaceuticals Ltd. appears close to sewing up a deal for its biosimilar version of Novartis/Genentech Inc.'s Xolair amid the firm's ongoing focus on partnering out some key assets. It also expects to kick off plans to raise capital in the US for its innovation business in Q4 of fiscal 2019-20.