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Deal Watch: Lilly Takes Global Rights To Centrexion Non-Opioid Pain Candidate

Executive Summary

Lilly licenses non-opioid pain candidate from Centrexion. China’s Hansoh gets rights to inibelizumab from AstraZeneca spinout Viela for lead indication neuromyelitis optica as well as other autoimmune and blood cancer indications.

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

Lilly Pays $47.5m Up Front For Centrexion’s CNTX-0290

Eli Lilly & Co. agreed to pay $47.5m up front on 28 May to license exclusive worldwide rights to the Phase I chronic pain candidate CNTX-0290 from Centrexion Therapeutics Corp. The Indianapolis pharma indicated that it believes the early-stage, small molecule somatostatin receptor type 4 (SSTR4) agonist offers potential utility as a non-opioid therapy in multiple pain indications.

Centrexion can earn up to $575m in development and regulatory milestone payments under the deal. In addition, it could realize up to $375m in commercial milestones if CNTX-0290 reach market, along with tiered sales royalties ranging from the high single digits to low double digits. The two companies also agreed to discuss the possibility of co-promotion of the drug in US at a later date.

Led by former Pfizer Inc. CEO Jeffrey Kindler, Centrexion is focused primarily on lead candidate CNTX-4975, which is in Phase III for osteoarthritis and related pain and in Phase II for neuropathic pain. Data from a pair of ongoing Phase III trials with the synthetic capsaicin are expected in 2020. In a statement, Kindler said Lilly’s track record of clinical development and commercial success in the pain space make it the ideal company to take CNTX-0290 forward in development.

Hansoh Bets On Viela Candidate In Three-Drug NMOSD Race

AstraZeneca PLC spinout Viela Bio signed a potentially lucrative partnership on 28 May with China’s Hansoh Pharma, giving the latter rights in its home market to anti-CD19 therapy inibelizumab for the lead indication neuromyelitis optica spectrum disorder (NMOSD) plus other autoimmune and hematologic cancer indications. Earnouts were not broken down specifically but Viela can earn up to $220m in up-front cash along with milestones tied to development, regulatory and commercial achievements, along with sales royalties.

Viela CEO Bing Yao said in a statement that the agreement will strengthen his company’s ability to commercialize the drug globally, thanks to Hansoh’s commercial, regulatory and clinical development capabilities. Inibelizumab obtained breakthrough therapy designation from the FDA on 18 April for NMOSD, an indication with no approved drug therapy.

Viela hopes to file inibelizumab for US approval later this year. Hansoh said it will work to accelerate the therapy’s approval in China and will investigate its potential in combination therapy regimens, as well.

At the American Academy of Neurology meeting earlier in May, Viela reported that inibelizumab met primary and secondary endpoints in a Phase III study in NMOSD, demonstrating the potential of targeting CD19 to achieved sustained B-cell depletion as a therapeutic approach to the disease. Inibelizumab is one of three late-stage candidates for NMOSD, along with Alexion Pharmaceuticals Inc.’s complement inhibitor Soliris (eculizumab), which is under review at the FDA with a 28 June action date, while Chugai Pharmaceutical Co. Ltd. ’s anti-interleukin-6 receptor candidate is satralizumab in Phase III studies. (Also see "Viela Adds Momentum To Burgeoning NMOSD Market With Pivotal Inebilizumab Results" - Scrip, 3 Jan, 2019.)

Crown Acquires Xycrobe, Skin Microbiome Technologies

Dermatology-focused Crown Laboratories Inc. announced the acquisition of Xycrobe Therapeutics Inc. at undisclosed terms on 22 May. Crown says the buyout will increase its technological capabilities by adding both the scientific team from Xycrobe as well as the biotech’s skin microbiome technology platform, which can turn skin microbes into delivery vehicles for biotherapeutics.

The Xycrobe technology could offer better solutions for a host of dermatologic conditions, Crown notes, including therapies for inflammatory skin conditions that develop “good” bacterial strains for therapeutic purposes. The biotech’s platform enables creation of probiotic-like molecules that potentially can replace pathogenic bacterial flora with microbes that express skin-healthy properties. Under the agreement, Xycrobe founder and CEO Thomas Hitchcock becomes chief science officer at privately held Crown.

Shionogi Licenses Partial EU Rights For Rizmoic To Molteni

The European subsidiary of Japan’s Shionogi & Co. Ltd. licensed commercial rights in Italy and Poland on 22 May to opioid-induced constipation drug Rizmoic (naldemedine) to [Molteni Therapeutics SRL] at undisclosed terms. Previously, Shionogi licensed rights to the therapy to Sandoz in April in the UK, Germany and the Netherlands; that deal also gave the Novartis AG unit right of first-refusal to the drug “for certain other European markets.” (Also see "Sandoz Strikes Shionogi Partnership as Part of Pain Play" - Generics Bulletin, 11 Apr, 2019.)

Florence-based Molteni is focused on treatments for moderate-to-severe pain and addiction in Europe. Rizmoic obtained EU approval for the treatment of OIC in adult patients who previously used a laxative in February. (Also see "New EU Approvals" - Pink Sheet, 14 Mar, 2019.) Launched under the brand name Symproic in Japan and the US in 2017, the peripherally acting mu-opioid receptor antagonist is slated to launch in Italy and Poland in 2020.

Winhealth Obtains Chinese Rights Two Cumberland Products

Nashville-based Cumberland Pharmaceuticals Inc. out-licensed Chinese rights to a pair of drugs to Winhealth Pharma Group on 15 May under an agreement that assigns responsibility for regulatory approval of both injectable products in China to Winhealth. The products are Acetadote (acetylcysteine) to prevent or reduce liver damage resulting from acetaminophen overdose and Caldolor, an injectable formulation ibuprofen for hospital-based analgesia.

No specific financial terms were disclosed, but Cumberland will get both an upfront payment and potential milestones under the deal, along with royalties on sales if the projects are approved and reach market in China. Patents for both products have been issued in that country. The license rights cover Hong Kong and Macau in addition to mainland China.

Headquartered in Hong Kong, Winhealth says it currently markets 12 branded pharmaceutical products in China under license agreements with Boehringer Ingelheim GmbH, Novartis, Pfizer and Roche.

PharmaMar Nets €33m For Pharma Focus

Spain’s PharmaMar SA agreed on 23 May to sell its Zelnova business for €33.4m (about $37.3m). The divestment of the consumer chemicals unit is in line with the company’s strategy to focus on biopharmaceuticals. In September 2018, it sold another chemicals business, Xylazel, for €21.8m.

PharmaMar develops anticancer drugs of marine origin; its approved product Yondelis (trabectedin) – partnered with Johnson & Johnson – is a synthetic version of an agent found in the sea squirt and is used to treat soft tissue sarcoma, as well as relapsed ovarian cancer in some territories. (Also see "J&J's Yondelis Leads New Wave Of Sarcoma Drugs" - Scrip, 26 Oct, 2015.)

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

(Also see "Daiichi Denies OTC Business Sale But Would It Make Sense? " - Scrip, 27 May, 2019.)

Daiichi Sankyo Co. Ltd. denies report it is in negotiations to sell its OTC business, but might such a move actually align well with mid-term strategy?

(Also see "Santhera Shores Up Finances With Chiesi Deal for Raxone " - Scrip, 23 May, 2019.)

In a deal that could be worth CHF105m, the Swiss biotech has out-licensed Raxone to Chiesi Farmaceutici SPA for the rare eye disease LHON as it concentrates on the drug's filing for Duchenne muscular dystrophy.

(Also see "Lured By Its Discovery Platform And Pipeline, Amgen Bids For Nuevolution" - Scrip, 22 May, 2019.)

Amgen Inc. offered to buy its Scandinavian discovery partner for $166.8m to gain access to Nuevolution AS’ DNA-encoded drug discovery platform and nascent pipeline.

(Also see "Google's Verily Makes Clinical Trials Pitch With Big Pharma Pacts " - Scrip, 22 May, 2019.)

Verily Life Sciences LLC has kept a low profile since it was set up in 2015 but deals with Novartis, Otsuka Holdings Co. Ltd., Pfizer and Sanofi reveal the data management giant's ambitions to become a major player in the lucrative clinical studies space.

(Also see "Merck Buys Peloton On Eve Of IPO, Expands Kidney Cancer Portfolio" - Scrip, 21 May, 2019.)

Investors in Peloton Therapeutics Inc., which has the only clinical-stage HIF-2α inhibitor, will get back 3.5 times the $304m in venture capital invested in the firm via the $1.1bn that Merck & Co. Inc. is paying up front. With all $1.15bn in additional milestone fees, the return could grow to 7.2x.

 

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