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EyesOn BioPharma Business Development Activities
BioPharma dealmaking is still going strong this summer. We're highlighting a few companies that caught our EyesOn team attention. Check out details on the Roche + Hanmi, Leo Pharma + Tanabe, and the SK BioPharma + Biohaven deals.
By paying $190 million up front for a clinical-stage UCN2 (urocortin-2) analogue from South Korea’s Hanmi Pharm, Roche has advanced its obesity approach into unprecedented territory.
Eli Lilly investigated the mechanism in a heart failure medication that was discontinued back in 2019. For decades, scientists have known that UCN2 can theoretically lower rates of muscle atrophy, and Roche is placing a wager that Hanmi’s medication, known as HM17321, would be able to fulfill this promise.
Roche’s Genentech division has obtained the worldwide rights to HM17321, with the exception of South Korea, in exchange for a $190 million upfront price and the possibility of up to 2.3 billion in development, regulatory, and commercial milestone payments. Hanmi is eligible for tiered royalties on sales as well.
One of the main objectives of the next generation of obesity treatments is to reduce weight without sacrificing muscle mass. Emugrobart, an anti-latent myostatin-sweeping antibody intended to boost muscle growth and currently undertaking a phase 2 study in conjunction with Lilly’s Mounjaro, is Roche’s own contender for this award.
According to Hanmi, HM17321’s non-incretin mechanism of action could make it a first-in-class treatment that simultaneously promotes weight loss and maintains lean body mass.
The Korean biotech noted that although current GLP-1 based incretin treatments have shown significant weight loss, they are linked to a decrease in lean body mass.
According to the company, the paradigm for treating obesity is changing from just losing weight to enhancing body composition and re-establishing metabolic health.
The company is thrilled that the international market has acknowledged the unique scientific mechanism and development potential of HM17321.
Roche intends to investigate the potential of HM17321 to treat obesity as well as related disorders like type 2 diabetes and cardiovascular diseases.
According to the firms, preclinical testing of HM17321 alone and in conjunction with GLP-1-based medicines has already been associated with weight loss. Since then, Hanmi has included obese people and healthy volunteers in a phase 1 trial of HM17321. Before Genentech takes over for phase 2 development and beyond, the biotech will finish this study.
According to the business, Roche and Genentech will pursue a unique strategy to specifically reduce fat content while increasing both muscle mass and muscle function by licensing this next-generation investigational medicine with first-in-class potential from Hanmi.
Last year, Roche increased their obesity goals, including the audacious objective of ranking among the top three businesses in the weight loss industry. One of the goals of the plan was to bring the dual GLP-1/GIP receptor enicepatide to market by 2030.
Roche is developing a portfolio intended to address the various needs of individuals with obesity and related health issues thanks to its expanding cardiometabolic pipeline and strong diagnostic capabilities.
Hanmi has been busy this year, purchasing Canadian cancer firm Aptiose Biosciences and granting Lilly a 475 million upfront licence for a phase 2-stage GLP-2 agonist that may be used to treat short bowel syndrome.
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In keeping with its goal of bolstering its pipeline in 2026, Leo Pharma signed a $435 million contract with Tanabe Pharma for a medication for a rare skin condition that is seeking FDA approval.
Dersimelagon is an oral melanocortin-1 receptor agonist used to treat X-linked protoporphyria (XLP) and erythropoietic protoporphyria (EPP). When exposed to the sun and occasionally specific artificial light, the two uncommon hereditary disorders result in severe and excruciating skin reactions.
Dersimelagon is intended to cause the skin to produce melanin by activating melanocortin-1. According to the business, this in turn increases pigmentation in a manner similar to a protective shield, allowing patients to spend time outside.
Tanabe will receive up to $435 million in total upfront and near-term milestone payments in exchange for the global rights to dersimelagon. Although the companies did not provide a thorough financial breakdown, there may be more milestone payments and tiered royalties in the future.
Tanabe began the year by announcing a phase 3 victory for dersimelagon in both EPP and XLP. Later, they clarified that the medication has considerably extended the time-to-first prodromal symptoms, like burning, tingling, itching, or stinging, from exposure to sunlight of over 30 minutes at Week 16. The pharmaceutical company with its headquarters in Japan submitted the medication to the FDA for clearance in June based on that study.
Leo found Dersimelagon to be an alluring reward, and according to CEO Christophe Bourdon, the Danish dermatologist is searching for other acquisitions. Adbry, a medication for eczema, Enstilar foam for plaque psoriasis, and Spevigo, a medication for pustular psoriasis, are among the company’s commercial offerings.
However, the only FDA-approved medicine for EPP is sold by Australia’s Clinuvel Pharmaceuticals, therefore Leo did not yet have a treatment. The melanin-stimulating mode of action of that therapy, known as Scenesse, is comparable to that of dersimelagon. However, dersimelagon can be taken orally, whereas Scenesse necessitates an implant under the skin every eight weeks.
According to Bourdon, “every dermatologist is familiar with the Leo brand, and what we are currently doing with Dersimelagon is really strengthening the innovation pipeline and hope to bring the asset that will completely transform the life of patients.”
In his search for novel treatments, Leo paid Boehringer Ingelheim $105 million up front for Spevigo last year and $50 million four months ago for Replay and its preclinical gene therapy platform for the uncommon skin condition dystrophic epidermolysis bullosa.
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By investing $350 million up front to expedite the release of Biohaven’s Kv7 ion channel activator, SK Biopharmaceuticals enhanced its epilepsy portfolio.
In a phase 2/3 trial of patients with focal epilepsy, Biohaven is currently assessing the daily oral medication known as opakalim or BHV-7000. Later this year, a topline readout is anticipated.
Instead of waiting for the results, SK has decided to give both Opakalim and Biohaven’s Kv7 platform the upfront money and an additional $50 million next year for the global licence. In addition to those immediate payouts, Biohaven will be eligible for up to $150 million in development and regulatory milestone payments, as well as a portion of the royalties in the event that opakalim is commercialised.
As part of the agreement, SK will also assume responsibility for specific Kv7 platform milestones that Biohaven owes Knopp Biosciences, the drug’s original developer. Due to these commitments, which total $245 million, SK may potentially have to pay out a total of $795 million in connection with the agreement.
When the FDA approved Xcopri in 2019 as a therapy for partial-onset seizures, SK entered the epilepsy arena. Through its U.S. affiliate SK Life Science, the South Korean biopharma hopes to introduce opakalim in the United States as early as 2029.
According to Donghoon Lee, CEO of SK, the business has a thorough understanding of what it takes to provide patients with a unique CNS medication because of its experience moving Xcopri from clinical development to worldwide distribution.
With a mechanism and tolerability profile that potentially expand our capacity to serve patients who might benefit from additional treatment alternatives, the business views pakalim as a very complementary addition to our epilepsy portfolio. Through NDA submission and beyond, the company anticipates a tight, supportive cooperation with the Biohaven team.
According to Biohaven CEO Vlad Coric, M.D., SK’s well-established experience in epilepsy development and commercialisation provides opakalim with the quickest and most reliable route to patients globally, should it be approved.
In order to maximise the long-term revenue potential of this innovative mechanism, the business formed a relationship with a top strategic partner in epilepsy rather than establishing a commercial organization of its own for opakalim. Additionally, this agreement preserves significant long-term upside for Biohaven’s shareholders while providing $400 million in short-term, non-dilutive capital.
Opakalim will face competition from Xenon Pharmaceuticals’ oral Kv7 ion channel activator azetukalner, which is now conducting a late-stage research trial for generalised epilepsy and has already successfully completed a phase 3 seizure trial earlier this year.
In contrast to previous experimental Kv7 activators, Biohaven has been highlighting opakalim’s capacity to selectively activate the Kv7.2/7.3 heteromeric channels while missing GABA receptor action.
According to the company’s announcement, opakalim is intended to provide significant efficacy without the problematic side effects on the central nervous system, such as drowsiness and lightheadedness, that are connected to a lot of antiseizure medications.
An analysis from an open-label extension study of patients with persistent focal epilepsy revealed that 54% of participants who received 75 mg of opakalim once daily achieved a 50% or greater reduction in seizure frequency over six months of treatment, according to the Connecticut-based biopharmaceutical company’s May R&D Day.
Additionally, the business stated at the time that compared to other approved or experimental antiseizure medications, the candidate had shown a significantly lower incidence of nervous system adverse effects.
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