Deal Watch: Emergent Strikes Again, Acquiring Adapt And Its Opioid Overdose Drug For $635m

Following its purchase of PaxVax earlier this month, Emergent is taking on Narcan nasal spray for opioid overdose as part of its acquisition of Adapt. Also-busy Evotec teams up with Centogene in rare genetic disease and Novo in diabetes/obesity.

Scrip regularly covers business development and deal-making in the biopharmaceutical industry. Below is a roundup of some of the most noteworthy recent transactions. Deal Watch is supported by deal intelligence from Strategic Transactions.

Emergent Calls Narcan Part Of “Only-In-Class” Public Safety Product Strategy

Furthering what it calls its strategy around “only-in-class” medical countermeasures, Emergent BioSolutions Inc. agreed to pay $635m up front on Aug. 28 to acquire Adapt Pharma Ltd. and its Narcan (naloxone HCl) nasal spray product, approved by the US FDA in 2015 to treat known or suspected opioid overdoses. The Maryland-based firm will pay $575m in cash for Adapt along with stock worth $60m, while the acquired company can earn up to $100m more through 2022 in commercial milestones.

On Aug. 9, Emergent paid $270m in cash for PaxVax Inc. and its two commercial vaccine products, Vaxchora, which is the only FDA-approved vaccine for cholera, and Vivotif, an oral vaccine against typhoid fever that is approved in 27 countries. (Also see "Deal Watch, Focus On Acquisitions: Emergent Acquires PaxVax, Pair Of Commercialized Vaccines" - Scrip, 14 Aug, 2018.)

Narcan nasal spray obtained FDA approval in November 2015 and has been commercially available since 2016. (Also see "After Competitor's Narcan Approval, Addiction Fighter Indivior Plans New US, China Launches" - Scrip, 20 Nov, 2015.) Emergent thinks Narcan will bring it between $200m-$220m in incremental revenue in 2019.

Along with Narcan, Emergent also picks up a developmental pipeline of new treatment and delivery options for naloxone and will bring on approximately 50 Adapt employees based in the US, Canada and Ireland. It anticipates leveraging its experience in both government and commercial markets with the Adapt team’s experience in marketing Narcan to state and local governments.

“Adding this important, life-saving product to our portfolio of preparedness solutions allows us to apply our experience gained from two decades of partnering with the US government to safeguard public health against biological and chemical threats,” Emergent CEO Daniel Abdun-Nabi said in a statement. The US Centers for Disease Control and Prevention estimate that approximately 42,000 US citizens died from opioid overdoses in 2016.

Combined with the PaxVax transaction, Emergent said it is on track to meet or exceed its goal of reaching $1bn in annual revenues in 2020.

Evotec, Centogene Team Up On Discovery In Rare Genetic Disorders

Evotec AG and Centogene AG, a rare disease genetic testing company, have created a global collaboration for joint drug discovery projects, developing compounds to treat rare genetic diseases. The companies initiated the collaboration Aug. 27 to develop a high-throughput platform for testing novel small molecules in rare hereditary metabolic diseases. Financial details of the deal were undisclosed.

“The identification and development of innovative small molecules to treat rare, hereditary conditions is particularly challenging because of the absence of adequate cellular models and the general lack of specific biomarkers to monitor the different diseases,” explained Arndt Rolfs, Centogene CEO. “With this innovative collaboration between Evotec and Centogene, we can accelerate the development of new drugs.”

Evotec will use its induced pluripotent stem cell (iPSC) platform added to Centogene’s detailed genotype-phenotype data, which enables rapid biomarker development using patient primary cells.

Evotec’s Chief Scientific Officer Cord Dohrmann called the partnership “a perfect match between highly complementary platforms and companies with the potential to open a new chapter in the translatability of preclinical discovery efforts into clinic benefits.”

Evotec, Novo Nordisk Pact Focused On Diabetes, Obesity

Prior to the Centogene partnership, Evotec announced Aug. 23 that it and Novo Nordisk AS will combine resources to discover and develop small molecule therapeutics aimed at diabetes and obesity as well as associated co-morbidities, such as nonalcoholic steatohepatitis (NASH), cardiovascular disease and diabetic kidney disease.

Evotec will initially use its ligand-based drug discovery technology to select safe and efficacious candidates. Once preclinical compounds are identified, Novo Nordisk will use Evotec’s INDiGo platform to move them into the clinic. INDiGo can accelerate early-stage candidates into clinic trials by reducing time from nomination to regulatory submission in 52 weeks or less, according to Evotec.

Evotec chose Novo Nordisk as a partner because of the firm’s expertise in the diabetes and obesity space. Financial terms of the agreement were not disclosed.

Urovant Licenses OAB Gene Therapy From Ion Channel Innovations

Roivant Sciences GMBH affiliate Urovant Sciences Ltd. licensed worldwide development and commercial rights Aug. 28 to a novel gene therapy candidate for overactive bladder (OAB) from Ion Channel Innovations. Deal terms were not disclosed.

Known as hMaxi-K, the gene therapy has completed a pair of Phase I studies, including a 13-patient, Phase Ib trial in which an intravesical formulation of the drug demonstrated dose-dependent improvements in urinary urgency and frequency, with statistical significance achieved in a high-dose cohort, Urovant said.

One of 10 “Vant” subsidiaries launched by Roivant, Urovant initiated a Phase III study of its OAB candidate vibegron this past April. (Also see "Pipeline Watch: Phase III Starts With Murepavadin, CSL112 And Vibegron" - Scrip, 4 Apr, 2018.) The company plans to discuss plans for Phase II investigation of hMaxi-K with the FDA in the hopes of launching a study in 2019 as treatment for OAB patients who have not respond to other drug therapies.

Novartis Offloads Rare Disease Candidate To LifeMax

Privately held LifeMax Laboratories agreed Aug. 27 to license development, manufacturing and commercial rights to BPR277, a Phase I candidate for the rare dermatologic disease Netherton syndrome, from Novartis AG for undisclosed terms, including an upfront payment, potential development and regulatory milestones, and sales royalties if the drug reaches market.

An autosomal recessive monogenic disease also known as congenital ichthyosis, the disease is caused by mutations of the SPINK5 gene and can affect patients’ skin, hair and immune systems. Current therapeutic options only address symptoms and are said to offer unproven efficacy with a poor side effect profile, the Palo Alto, Calif.-based firm said.

BPR277 is a topical, small molecule kallikrein-related peptidase 7 (LKL7) inhibitor. Biomedtracker lists four clinical candidates for congenital ichthyosis, including Aldeyra Therapeutics Inc.’s Phase III aldehyde trap candidate NS2, also a topical compound.

Sobi Licenses HLH Candidate Emapalumab From Novimmune

NovImmune SA granted Swedish Orphan Biovitrum AB (Sobi) exclusive global rights Aug. 23 to emapalumab, an interferon gamma antagonist awaiting approval for primary hemophagocytic lymphohitiocytosis (HLH). Under terms of the license, Sobi gains exclusive rights to the compound and is responsible for all future development and commercialization costs.

It paid CHF50m ($50m) up front and could hand over an additional CHF400m in payments over the next eight years. Sobi also signed a non-binding letter of intent to acquire all assets relating to emapalumab, and gained options to license two other preclinical Novimmune candidates--NI1801 (solid tumors) and NI1701 (blood cancers including ALL, NHL and B-cell malignancies).

HLH is a rare disease of extreme immune activation that causes white blood cells such as histiocytes and lymphocytes to attack other blood cells. The abnormal cells collect in the liver and spleen, causing enlargement and other symptoms including swollen lymph nodes, jaundice, lung and digestive issues, as well as neurological problems. Current treatment for the disease includes administration of immuno-chemotherapeutics to control the immune reaction; there is no approved drug for HLH.

Novimmune filed for approval of emapalumab in the US, where the candidate received orphan drug designation, breakthrough designation, and rare pediatric disease designation. Filings in Europe (where it has also received orphan designation) are expected later this year. Studies in secondary HLH and hematopoietic stem cell transplant are also planned.

LEO Pharma Gets Global Rights For JWP's Novel Atopic Dermatitis Drug

South Korea's JW Pharmaceutical Corp. and Denmark-based Leo Pharma AS have signed a global licensing agreement for the former’s novel atopic dermatitis drug candidate, JW1601, in a deal worth up to $402m plus sales royalties, said the two companies on Aug. 24.

LEO Pharma, a global leader in medical dermatology, gets exclusive rights to develop and commercialize JW1601 globally excluding Korea where JWP will maintain its exclusivity. JWP will receive $17m as an upfront fee and can earn development and sales milestones of up to $385m. Apart from the milestone payments, JWP will receive up to a two-digit royalty based on net sales.

JW1601 is a new molecular entity developed by C&C Research Laboratories, a R&D affiliate of JWP. In May 2017, JWP acquired the global exclusive rights to develop and commercialize JW1601 and plans to submit an IND for a Phase I clinical trial within this year.

JW1601 employs a dual mechanism of action that blocks the activation and migration of the immune cells that cause atopic dermatitis by selectively acting on the histamine H4 receptor and inhibiting the histamine signaling that causes itching. The drug is expected to show good efficacy because it has both anti-pruritic and anti-inflammatory effects, whereas the competing substances only show efficacy against inflammation. Also, it is expected to demonstrate a good safety profile due to its high selectivity towards H4 receptor.

Dong-A, Takara Reach Oncolytic Virus License Agreement

Dong-A ST Co. Ltd. has reached an agreement with Takara Bio Inc. for exclusive development and sales of the oncolytic virus canerpaturev (C-REV) in South Korea, the two companies announced Aug. 23.

Under the agreement, Dong-A ST will conduct clinical development and sell C-REV in South Korea after obtaining regulatory approval for manufacture and sales. Takara Bio holds a right to manufacture C-REV and supply Dong-A with the products under certain financial condition. Takara Bio will receive upfront and milestone payments totaling up to Y300m (about $2.7m) plus running royalties on net sales from Dong-A.

Canerpaturev is an attenuated strain of the herpes simplex virus (HSV-1) and exhibits antitumor activity when inserted into a cancerous region. Takara previously signed an exclusive licensing agreement for domestic co-development and exclusive sales of the oncolytic virus C-REV with Otsuka Pharmaceutical Co. Ltd. in December 2016. [See Deal]

With the aim of early commercialization, Takara is advancing the clinical development of gene therapies utilizing oncolytic virus and engineered T-cells in Japan and overseas. The Japanese firm plans to apply for application of C-REV targeting melanoma for fiscal year 2019 in Japan. It is also progressing development of C-REV targeting pancreatic cancer.

Amgen Inc. received the first approval for an oncolytic virus therapeutic in 2015, Imlygic (talimogene laherparepvec) for intralesional treatment of melanoma.

In line with C-REV's development in Japan, Dong-A plans to obtain regulatory approval and sell the product in South Korea for melanoma and pancreatic cancer.

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

(Also see "GSK Puts Tail End Brands On The Block In India" - Scrip, 29 Aug, 2018.)	GlaxoSmithKline PLC is believed to be keen to divest close to a dozen tail-end brands across therapy groups including anti-infectives and dermatology in India as it tweaks its portfolio to focus on sustained profitable growth.
(Also see "Bluebird Casts Wide Partnering Net To Keep Advancing Cell Therapy" - Scrip, 28 Aug, 2018.)	bluebird bio Inc. has been an active deal maker as it looks to add tools, targets and technological capabilities to its R&D engine. A pair of August TCR-focused deals, including the latest with Gritstone Oncology, continue that strategy.
(Also see "Roche Pact Is Affirmation Of Affimed Technology " - Scrip, 28 Aug, 2018.)	Beware the hype but a deal with one of the big oncology players that involves $96m upfront and potentially $5.0bn in milestones is a decent validation for Affimed NV’s technology platform.
(Also see "GBT Picks Up Inclacumab From Roche's Bargain Bin" - Scrip, 24 Aug, 2018.)	Five years after Roche presented positive Phase II data on inclacumab as a treatment for patients with acute coronary syndromes, the drug has been snapped up by Global Blood Therapeutics Inc. for a tiny upfront fee to be developed for sickle cell disease.
(Also see "Sierra Believes It Can Do Better Than Gilead With JAK Inhibitor Momelotinib" - Scrip, 23 Aug, 2018.)	With many on the executive team who worked on the drug previously, Sierra Oncology Inc. thinks the stalled Phase III compound could be differentiated from Jakafi and others in the myelofibrosis space based on anemia benefit.