Deal Watch: Gilead And Spring Bank Set Second Trial Collaboration In HBV

Analyst speculates that Gilead could move to acquire Spring Bank if combo trial yields promising data for functional cure of hepatitis B. Eisai in-licenses PARP inhibitor with potential in breast cancer from Oncology Venture, while Sunovion out-licenses three corticosteroid products to Covis.

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.

Gilead Will Fund Second HBV Combo Study Using Spring Bank Immunomodulator

Building upon a relationship begun in November 2015 to test Spring Bank Pharmaceuticals Inc.'s novel, selective immunomodulator SB 9200 in tandem with Viread (tenofovir disoproxil fumarate) as a potential curative regimen for hepatitis B, the biotech and Gilead Sciences Inc. announced a second tie-up July 10 to study SB 9200 paired with Viread successor Vemlidy (tenofovir alafenamide).

No financial terms were disclosed, but a key difference is that Gilead is financing this Phase II combination study, whereas it merely provided clinical trial supply of Viread free-of-charge to the previous combo trial (ACHIEVE), which Spring Bank is conducting and funding. [See Deal]

In May, the Hopkinton, Mass.-based firm reported that interim data from a monotherapy cohort of the Phase IIa ACHIEVE study showed a statistically significant reduction in hepatitis B DNA compared to placebo. In a secondary endpoint measuring reduction of HBV surface antigen (HBsAg), five of 16 (31%) of treatment-arm subjects saw a 0.5 log10 reduction compared to zero patients in the control arm. All patients from that cohort now have crossed over to a portion of the study in which they will receive Viread daily for 12 weeks.

In a July 10 note, JMP Securities analyst Liisa Bayko called the agreement an "incremental positive" for Spring Bank that could accelerate development of SB 9200 as a therapeutic backbone for combination therapy offering a functional cure of chronic HBV infection. The Spring Bank molecule activates hepatic retinoic acid-inducible gene 1 (RIG-1) and offers the potential to provide a functional cure of HBV in tandem with direct-acting antiviral therapy by providing immune modulation on a persistent basis, the company says.

"We believe the fact that Gilead is willing to fund and run the new combination trial of SB 9200 plus Vemlidy suggests the industry leader's increased interest in Spring Bank's immunomodulatory approach, especially when Gilead's own immunomodulators, such as the therapeutic vaccine and TLR7 agonist, both disappointed, and think that good data could set up for a longer arrangement such as an acquisition given Gilead's commitment to HBV," Bayko wrote.

Spring Bank Chief Medical Officer Nezam Afdhal said he hopes the combination of SB 9200 and Vemlidy will demonstrate synergy in reducing HBsAg. Offering a better safety profile and greater potency than tenofovir disoproxil fumarate, tenofovir alafenamide is the backbone agent in several fixed-dose combination products Gilead is using to revitalize its HIV franchise, and it plans for the new formulation to provide a similar boost in HBV. (Also see "Gilead HIV Sales Getting Boost From Switches To TAF-Based Combos" - Scrip, 2 Nov, 2016.)

Eisai Licenses Breast Cancer Candidate From Oncology Venture

Oncology Venture APS has signed an exclusive global license agreement with Eisai Co. Ltd. for E7449, the latter company’s PARP inhibitor now known as 2X-121, which will be developed by 2X Oncology Inc., a spinout of Oncology Venture. The developer plans to initiate Phase II trials for the drug later this year as a treatment for metastatic breast cancer.

Under the agreement announced July 7, Oncology Ventures will develop and commercialize 2X-121 and will work with 2X Oncology to consolidate plans for the impending Phase II trial, which will use the company's Drug Response Predictor (DRP) technology. Positive data from this trial would enable 2X Oncology to move the product into a pivotal Phase II study in 2018. Financial terms were not disclosed.

2X-121 is a targeted inhibitor of poly ADP ribose polymerase (PARP), an enzyme which plays a role in DNA damage repair in cancer cells. 2X Oncology's DRP technology creates a precise mRNA-based companion diagnostic for each compound, making it easier to identify patients who are more likely to respond and benefit from treatment.

Last month, Eisai mentioned that along with neurology, it is making oncology a key area and said that its short-term focus will be to expand the reach of its marketed oral multi-kinase inhibitor Lenvima (lenvatinib). Lenvima is already approved for refractory thyroid cancer and last year it was approved in combination with everolimus for advanced renal cell carcinoma as second line therapy, marketed in the US as Kisplyx. (Also see "Eisai Predicts "Mayhem" For Kisplyx After NICE Finally Okays Halaven" - Pink Sheet, 11 Nov, 2016.)

Sunovion Divests Three Respiratory Brands To Covis

Reflecting a strategic decision to focus more specifically on chronic obstructive pulmonary disease in the respiratory therapy space, Sunovion Pharmaceuticals Inc. agreed July 13 to divest three branded corticosteroid products to Switzerland's Covis Pharma SARL. No financial terms were disclosed for the transaction, under which Covis said it will ship product immediately upon closing and work with Sunovion to ensure uninterrupted access for patients.

Covis will obtain three ciclesonide products under the agreement – Alvesco inhalation aerosol, Omnaris nasal spray and Zetonna nasal aerosol. The first is approved to treat asthma, the latter two are approved for allergic rhinitis.

A division of Japan's Sumitomo Dainippon Pharma Co. Ltd., Sunovion believes it offers the broadest COPD therapy portfolio in the US, with handheld and nebulized treatment options, including Brovana (arformoterol tartrate), Arcapta Neohaler (indacaterol), Seebri Neohaler (glycopyrrolate) and the combination LAMA/LABA product Utibron Neohaler (indacaterol/glycopyrrolate). Sunovion licensed US rights to the latter three products from Novartis AG last December. [See Deal]

Shield Seals Agreement With Switzerland's Ewopharma

UK-based Shield Therapeutics and Switzerland's Ewopharma AG have sealed an exclusive sale, supply, distribution and marketing agreement for Shield's lead product Feraccru (ferric maltol), which is approved for the treatment of iron deficiency anemia (IDA).

The exact terms of the deal, announced July 6, have not been disclosed, although Shield will receive an upfront free and is also set to get milestone payments, depending on regulatory and commercial achievements. Shield will continue managing regulatory matters related to Feraccru's initial marketing authorization and planned future label expansions, supply products and will also provide product training and support. Ewopharma will oversee the pricing, reimbursement and distribution.

Feraccru was initially approved in February 2016 for the treatment of adult inflammatory bowel disease (IBD) patients with IDA and is the first oral iron therapy to be approved for the treatment of IDA in these patients.

In an interview with Scrip earlier this year Carl Sterritt, CEO and founder of Shield, dubbed Feraccru as the "backbone" of the company's whole franchise and talked about plans to expand the product's label further. (Also see "Shield Pilots Ironclad Specialty Future With Feraccru" - Scrip, 15 Feb, 2017.)

A Shield spokesperson explained that it is running Phase III studies with Feraccru, and positive data could support broader commercialization in Europe and an NDA filing in the US. Data from the two trials, AEGIS-CKD and AEGIS-H2H, are expected in the fourth quarter of 2017 and the first quarter of 2018.

Cytovia Grants Latin American Ceplene Rights To Pint Pharma

Cytovia Inc., the oncology division of Immune Pharmaceuticals Inc., has granted Pint Pharma GMBH rights to market and distribute Ceplene (histamine dihydrochloride) for acute myeloid leukemia in Latin America, including Argentina, Brazil, Chile, Colombia and Mexico. [See Deal] Under the transaction announced July 11, Pint also agreed to make a $4m equity investment in Cytovia.

Ceplene is the only drug approved in 30 European countries and Israel as a maintenance therapy for AML. The drug originated at EpiCept, which granted Meda AB rights in Europe and Asia in 2010. [See Deal] In 2012, EpiCept and Immune Pharmaceuticals merged, with the combined entity keeping the IP name. [See Deal] In June, IP repurchased all Ceplene rights with the intention of Cytovia selling the drug throughout Europe, Latin America and Asia. (IP intends on transferring its oncology operations to Cytovia, and is looking into spinning it off into an independent company.)

Cytovia now grants Pint rights for Latin America. Pint plans to immediately commence regulatory activities to get Ceplene approved in Latin America and on the market. Other cancer therapies in Pint’s portfolio include Iclusig (ponatinib) for chronic myeloid leukemia and Philadelphia-positive (Ph+) ALL; Beleodaq (belinostat) for peripheral T-cell lymphoma; and Gliadel Wafer (carmustine implant) for high-grade glioma and recurrent glioblastoma multiforme.

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

(Also see "Without J&J, Capricor Plans To Advance Progenitor Cell Therapy In DMD" - Scrip, 11 Jul, 2017.)	Capricor Therapeutics Inc. says it will move forward with knowledge and expertise gained through its failed partnership with Johnson & Johnson. The California biotech hopes to re-partner CAP-1002 for cardiovascular indications, while continuing the candidate’s DMD development itself.
(Also see "Provenge To Drive Sanpower Growth And Wider China Cell Therapy Market?" - Scrip, 12 Jul, 2017.)	China will provide a rising market potential for Sanpower’s newly acquired Dendreon Corp. and its Provenge product for prostate cancer, as part of the Chinese firm’s broader strategy. The deal could also have an impact on the regulatory climate for cellular immunotherapies in China.
(Also see "Flu Vax Giant Sanofi Defends Corner With $650m Protein Sciences Buy" - Scrip, 11 Jul, 2017.)	In agreeing on a $650m+ deal to acquire privately owned Protein Sciences Corp., Sanofiis defending its market dominance in influenza vaccinations by adding an approved non-egg based product. The purchase may also help it defend its position in the section of the market targeting elderly patients, since its current trivalent offering is threatened by a rival quadrivalent product from Seqirus.
(Also see "Try, Try Again: Bain And Cinven File Fresh Bid For Stada" - Scrip, 11 Jul, 2017.)	Stada Arzneimittel AG is likely to approve a second takeover bid from equity groups Bain and Cinven soon, at a new price of €66.25 per share; an offer cleared by Germany's stock market authorities despite a ban in the country on repeat acquisition bids within 12 months.