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Following its partnership with Dicerna, the German pharma signs a second NASH deal with MiNA and inks three cancer-related transactions, including divestitures. Also, Amgen buys out Kirin’s half of their joint venture for $780m.






Boehringer Follows Dicerna NASH Deal With MiNA Tie-Up



Following its Nov. 2 collaboration with RNA-interference specialist Dicerna Pharmaceuticals go after a difficult-to-reach target in non-alcoholic steatohepatitis (NASH), Boehringer Ingelheim GMBH doubled down on both the disease and RNA approach with a second NASH deal. The family-owned German firm unveiled an agreement with MiNA Therapeutics Ltd. on Nov. 8 to focus on up to three undisclosed targets in fibrotic liver disease.



Like the Dicerna pact (see roundup below), this one with UK RNA-activation specialist MiNA references fibrotic liver disease in general, but the primary disease focus is NASH, a burgeoning global unmet medical need that has drawn development and deal-making from dozens of companies in recent years. (Also see "Genfit May Be Gaining An Edge In NASH Race" - Scrip, 26 Oct, 2017.)



BI said the partnership with MiNA will leverage the latter’s small activating RNA (saRNA) platform technology to prevent disease progression by restoring normal cell and organ function. The saRNA technology has the potential to activate transcription of specific genes that can up-regulate proteins of therapeutic potential.



Specifically, the collaboration will seek to identify targets to restore the metabolic function of hepatocytes and prevent fibrotic tissue formation in NASH patients, BI said. The pharma hopes the work will enable it to design, profile and develop novel compounds for NASH, including potential combination therapy partners for its other NASH candidates.



Total remuneration to MiNA under the deal could reach €307m (about $356m) and royalties on product sales. The total includes an undisclosed upfront payment and R&D cost reimbursement as well as potential research, development and regulatory milestone fees.



Also on Nov. 8, BI announced a collaboration with US imaging biotech CellSight Technologies to develop a technology to monitor anti-tumor T-cell activation. The agreement centers on developing PET-imaging tracer VisAcT (([18F]fluoro-arabinofuranosylguanine [18F]F-AraG) as a non-invasive way to determine T-cell activation changes in patients treated with cancer immunotherapies.



A clinical trial using the tracer to evaluate the benefit of anti-PD-1 therapy in patients with squamous cell head and neck cancer is underway, CellSight noted. The two companies initially connected via the US National Cancer Institute’s Small Business Innovations Research (SBIR) program.



In recent days, BI also announced a pair of agreements to out-license cancer candidates to other companies (see below).



China’s iPharma In-Licenses FAK Inhibitor From BI


Start-up iPharma (H.K.) Ltd. signed its second immunotherapy licensing deal with Boehringer on Nov. 2, which granted it exclusive worldwide rights to manufacture, develop and commercialize BI 853520, a focal adhesion kinase inhibitor (FAKi). [See Deal]



Without disclosing detailed financial terms, iPharma will pay Boehringer an upfront fee and future milestone and royalty payments. The biotech plans to initiate Phase I/II trials in 2018 in combination with immune checkpoint inhibitors and/or potentially with other therapies. A Phase I trial of BI 853520 has been completed in multiple solid tumors, including advanced pancreatic adenocarcinoma, platinum-resistant ovarian cancer, esophageal cancer and soft-tissue sarcoma.



iPharma is advancing a pipeline consisting of novel molecules for the treatment of cancers and other indications. It entered into a licensing deal on Aug. 25 with Germany's Mologen AG for the DNA-based immunomodulator lefitolimod (MGN1703), a toll-like receptor 9 (TLR9) agonist to treat cancer-related diseases that is in Phase III for metastatic colorectal cancer and Phase II for small-cell lung cancer. [See Deal]



iPharma is a joint venture formed by I-Bridge Capital of China and Israel's BioLineRx Ltd. in August 2016. [See Deal] The company’s CEO Binhui Ni previously served as the head of external innovation and partnering, strategy and business development for the Asia Pacific at Sanofi.



Xynomic Obtains Exclusive Rights To BI's RAF Inhibitor For Solid Tumors


Boehringer on Oct. 31 licensed Xynomic Pharmaceuticals Inc. exclusive rights to its solid tumor candidate BI882370, an elective RAF inhibitor that uniquely binds to the DFG-out conformation (currently being explored to treat solid tumors in animal models). The compound inhibited proliferation of BRAF mutant melanoma cell lines with 100x higher potency than vemurafenib and also is proving to be superior to vemurafenib in treating colorectal cancer, Xynomic said.



The purchase will complement Xynomic's existing pipeline, which already includes abexinostat, an HDAC inhibitor entering Phase III trials for non-Hodgkin's lymphoma and renal cell carcinoma that it acquired in February from an undisclosed partner. [See Deal] Around the same time Xynomic also gained rights to the preclinical acetyl CoA transferase inhibitor avasimibe for solid tumors from Purdue Pharma LP affiliate Resarci Therapeutics LLC. [See Deal]



Founded in 2016, Xynomic has been focused on acquiring assets to fill its pipeline and this third purchase is much larger than the others, with the company agreeing to pay a total of $502m in upfront and milestone fees as well as royalties to BI.



Amgen Pays $780m For Kirin's 50% Stake In JV


Amgen Inc. and Kirin Holdings Co. Ltd.'s Kirin-Amgen joint venture is becoming a wholly owned Amgen subsidiary following the JV's redemption of Kirin's shares. The Kirin-Amgen 50-50 joint venture was formed in 1984 to fund the global development of Amgen's anemia drug Epogen(epoetin alfa).



The JV eventually got rights to other Amgen products: Neupogen (filgrastim) and Neulasta(pegfilgrastim) for neutropenia, Aranesp (darbepoetin alfa) for anemia, Nplate (romiplostim) for thrombocytopenic purpura, and brodalumab for psoriasis and psoriatic arthritis. Kirin-Amgen holds the intellectual property for each of the products and, in exchange for royalty rights, licensed Kyowa Hakko Kirin Co. Ltd. marketing rights in certain Asian countries, while Amgen's rights extend to other territories. [See Deal]



Amgen will pay Kirin $780m for its 50% stake and up to $30m in sales-based earn-outs under the agreement announced Oct. 30. Amgen will own the product rights and remaining cash held by Kirin-Amgen when the transaction closes. However, the licensing agreements between Kirin-Amgen and Kyowa Hakko Kirin in certain Asian territories will remain in place.



Boryung Licenses PharmaMar's Marine-Derived Cancer Candidate


PharmaMar SA has reached a licensing agreement with Boryung Pharmaceuticals Co. Ltd. to commercialize the marine-derived anticancer drug Zepsyre (lurbinectedin), if approved, in South Korea. PharmaMar will receive an undisclosed upfront payment and be eligible for additional remunerations upon achieving regulatory and sales milestones under the agreement announced Nov. 7. The Spanish firm will retain exclusive production rights and will sell the product to the South Korean pharma for commercial use, if approved.



Zepsyre is undergoing late-stage clinical development for platinum-resistant ovarian cancer and for small-cell lung cancer. After results obtained in BRCA2-associated metastatic breast cancer and endometrial cancer clinical trials, PharmaMar also plans to start a pivotal Phase III study in each of those indications.



According to Luis Mora, managing director of PharmaMar's oncology business unit, “this is our second strategic agreement with Boryung Pharm and we are very pleased with our business partner. This new agreement will allow Zepsyre to reach the Korean market, if approved, in the hands of one of the leading companies in the field of oncology in this country."



"Zepsyre may provide new therapies in various types of solid tumors, including a platinum-resistant ovarian cancer, BRCA2-associated metastatic breast cancer and small cell lung cancer. We look forward to making these new therapies available in South Korea, if approved,” Boryung Pharm CEO Tae-Hong Choi said.



Sumitomo Dainippon Gets Asian Rights To Poxel's Imeglimin


Poxel SA licensed Sumitomo Dainippon Pharma Co. Ltd. rights on Oct. 30 to develop and commercialize its Phase II type 2 diabetes candidate imeglimin in 13 Asian markets: Japan, China, South Korea, Taiwan, Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, Myanmar, Cambodia and Laos.



In Japan, both parties will jointly develop imeglimin in Phase III trials and Sumitomo will fund associated costs and commercialize the product there. Sumitomo is solely responsible for development and commercialization in all other licensed Asian territories. Poxel receives $42m up front and could earn up to $24m for development milestones as well as $233m for achieving sales milestones and escalating double-digit royalties.



Imeglimin is an oral candidate in Phase II development as both a monotherapy and combination therapy for type 2 diabetes. The compound has demonstrated its ability to decrease mitochondrial respiration and is targeted to the muscle, liver and pancreas to inhibit gluconeogenesis, increase muscle glucose uptake and restore normal insulin secretion via a glucose-dependent mechanism. This unique mechanism of action has the potential to prevent endothelial and diastolic dysfunction and offer a protective effect on beta-cell survival and function.



Poxel says it chose Sumitomo as a partner because of its strong Asian presence and proven success in developing and commercializing diabetes therapies.



AstraZeneca Signs Over Japanese Zomig Rights To Sawai


AstraZeneca PLC granted Upsher-Smith Laboratories Inc. parent Sawai Pharmaceutical Co. Ltd.exclusive rights on Oct. 30 to manufacture and market its migraine drug Zomig (zolmitriptan) in Japan. The deal follows an agreement earlier this year through which Grunenthal GMBH acquired global (ex-Japan) rights to the product when AstraZeneca decided that migraine and cluster headaches fell outside of the big pharma’s core areas of focus. [See Deal] Sawai will manufacture and sell Zomig tablets 2.5 mg and Zomig RM (rapid melt) beginning in mid-2018.



Aviragen, Vaxart Merge With Focus On Viral Infection Prophylaxis


Public antivirals developer Aviragen Therapeutics Inc. and closely held vaccines maker Vaxart Inc.are merging. The combined firm will retain the Vaxart name and trade on the NASDAQ with Vaxart's CEO continuing in his position, under an agreement announced Oct. 30.



Post-transaction, Vaxart's shareholders will hold a 60% stake and Aviragen the remaining 40%. The exchange ratio was determined by valuing Aviragen at $60m and Vaxart at $90m based on their financial and clinical assets. The combined entity's cash position is expected to be approximately $30m.



The company will focus on creating oral therapies and prophylactics for viral infections. Aviragen brings to the table BTA074 for HPV-associated condyloma, vapendavir for rhinovirus and BTA585 (enzaplatovir) for respiratory syncytial virus – all in Phase II. It also has rights to two influenza candidates – Inavir (laninamivir octanoate) from Daiichi Sankyo Co. Ltd., and Relenza (zanamivir). Vaxart offers a technology for delivery of a wide range of oral vaccines. It has vaccine candidates in Phase II for influenza, Phase Ib for norovirus (VXA-G1.1) and preclinical studies for RSV. Vaxart also has a preclinical therapeutic for human papilloma virus.



Because Vaxart's vaccines are delivered in tablet form, they are easier to administer than injectable vaccines, are more shelf-stable and offer enhanced patient acceptance. In addition, they are designed to generate broad and durable immune responses, including toll cell and T-cell responses, which may enhance protection against certain infectious diseases for which no vaccines currently exist.



Medicure Gets US Rights To Carmel’s Prexxartan


Carmel Biosciences Inc. licensed Medicure Inc. exclusive rights Oct. 31 to commercialize and manufacture the cardiovascular therapy Prexxartan (valsartan) in the US and its territories.



The deal term is seven years with the possibility for extension. Carmel receives a $100,000 upfront payment, $400,000 upon FDA approval, plus sales milestone fees and royalties. Prexxartan is an oral solution for individuals unable to swallow valsartan tablets, indicated for hypertension in heart failure patients and to reduce the risk of cardiovascular death in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction. The drug has been granted tentative FDA approval, with the official approval expected to come by the end of 2017. Medicure plans to launch Prexxartan before the end of the first quarter of 2018.



You can read more about deals that have been covered in depth by Scrip in recent days below:





You can read more about deals that have been covered in depth by Scrip in recent days below:

(Also see "Sanofi Expands MS Portfolio With BTK Inhibitor From Principia" - Scrip, 9 Nov, 2017.)

The French pharma adds the Phase I candidate to itsLemtradafollow-on for multiple sclerosis development, whilePrincipia BioPharma Inc.will use $40m in upfront cash to advance its orphan disease strategy.

(Also see "Steady M&A Flow Lifts Fosun" - Scrip, 9 Nov, 2017.)

Continuing with its dual strategy driven by innovation and internationalization,Fosun International Ltd.recently announced two acquisitions on the trot. The deals separately tap into growth opportunities in new biologic products and build on Fosun’s presence in Africa.

(Also see "Ono Bulks Up MAb R&D With Second Swiss Biotech Deal" - Scrip, 9 Nov, 2017.)

Human-derived monoclonal antibodies targeted against neurodegenerative diseases is the subject of a deal between Japan'sOno Pharmaceutical Co. Ltd.and Zurich-based biotechNeurimmune Holdings AG.

(Also see "Dermira Ends UCB Cimzia Psoriasis Pact To Focus On Its Own Pipeline" - Scrip, 8 Nov, 2017.)

As it ends its pact withUCB Group,Dermira Inc.says it needs to focus on its own top assets and couldn't simultaneously launchCimziain psoriasis.

(Also see "Valeant Returns $1bn Female Libido Drug For Free" - Scrip, 7 Nov, 2017.)

At first glance, giving backAddyito the original owners for next to nothing looks like a complete disaster, but investors are relieved debt-riddenValeant Pharmaceuticals International Inc.has managed to offload another asset.

(Also see "M&A Buzz In Korea: CJ HealthCare On the Block" - Scrip, 6 Nov, 2017.)

CJ Group plans to sell its health care affiliate, in what could potentially emerge as the first major M&A deal involving a South Korean pharma firm in recent years. Although the company has not ruled out the option of an initial public offering as an alternative, the possible sale reflects the changing dynamics in the Korean pharma industry.

(Also see "No Smoke Without Fire: Unichem Divests Domestic Business To Torrent" - Scrip, 3 Nov, 2017.)

Two years after denying sell-off plans,Unichem Laboratories divesting its branded business in India and Nepal to peerTorrent Pharmaceuticals Ltd.for around $558m. The deal catapults Torrent to the top league on the domestic market and also sets the tone for potential consolidation in the Indian pharma space at more realistic valuations.

(Also see "Dong-A Mulls Fresh Options After Allergan Ends Evogliptin Deal" - Scrip, 3 Nov, 2017.)

WithAllergan PLChanding back the global development and sales rights of evogliptin as a NASH therapy toDong-A Pharmaceutical Co. Ltd., the South Korean firm is now considering an alternative business model around the DPP-4 inhibitor.

(Also see "Cardinal China Sell-Off Deal Advances" - Scrip, 3 Nov, 2017.)

The potential acquisition ofCardinal Health Inc.’s China business byShanghai Pharmaceuticals Holding Co. Ltd.could have significant strategic implications for the state-owned suitor, but it’s probably still “hard to assume” how the transaction may finally pan out. Expectations around the deal value are still in excess of $1bn, investor sources tellScrip.

(Also see "With Dicerna's NASH Asset, Boehringer Found What It Was Looking For" - Scrip, 2 Nov, 2017.)

In eyeing NASH, Dicerna and Boehringer Ingelheim both zeroed in on the same target, considered inaccessible to traditional modalities. Their new deal gives BI an RNAi approach, joining its Phase II anti-inflammatory candidate for NASH.

(Also see "Takeda's Deal Flurry Set To Wane" - Scrip, 2 Nov, 2017.)

Takeda Pharmaceutical Co. Ltd.'s reorganization and the focusing of its R&D on specialty medicines in three sectors is shifting to the next stage, with products moving through its pipeline; the company has lifted its financial outlook at the six-month stage, but is wary of the emergence of US generic competition toVelcadelater this year.

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