CAMBRIDGE, Mass., Aug 10, 2020 (GLOBE NEWSWIRE via COMTEX) -- -- Interim Phase 2 Vivacity-MG results met primary endpoints, demonstrating nipocalimab was well-tolerated and achieved rapid and durable responses with significant correlation (p<0.0001) between IgG reduction and MG-ADL clinical benefit in MG; full data expected by Q4 2020 -
-- Nipocalimab receives rare pediatric disease designation by FDA for HDFN --
Momenta Pharmaceuticals, Inc. /zigman2/quotes/200094979/composite MNTA +0.03% , a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today reported its financial results for the second quarter ended June 30, 2020.
"Momenta has made meaningful progress advancing our novel drug portfolio for auto- and alloimmune diseases, including a substantial data update from our lead program, nipocalimab," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "In particular, we achieved proof of concept for nipocalimab, establishing a linear and highly statistically significant correlation between rapid and durable IgG reduction and efficacy in MG. We are preparing to engage with regulators on the design for a Phase 3 study in MG and look forward to reporting full results from Vivacity-MG in the fourth quarter of 2020, as we advance ongoing studies of nipocalimab in other indications.
Additionally, we were very pleased to receive rare pediatric disease designation for nipocalimab in hemolytic disease of the fetus and newborn (HDFN), which emphasizes the need for non-invasive, safe and effective treatment options for pregnant women with alloimmune diseases. Importantly, our data and FDA's action supports nipocalimab as a best-in-class investigational FcRn-inhibitor for dosing precision and flexibility and its utility across IgG-mediated diseases.
Lastly, with M254, we recently completed enrollment in Part B of our multi-part Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP) and look forward to sharing the study results later this quarter."
Second Quarter 2020 Highlights, Recent Events and Anticipated Upcoming Milestones
Novel Therapeutics Pipeline:
Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb) candidate
-- In June 2020, Momenta announced positive topline data from an interim analysis of Vivacity-MG, the Company's Phase 2 study of nipocalimab in generalized myasthenia gravis (gMG). The results demonstrated that nipocalimab induced a rapid and durable response in the myasthenia gravis activities of daily living score (MG-ADL) at all doses and met the study's primary efficacy endpoint, demonstrating a linear and highly statistically significant (p<0.0001) relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit. Nipocalimab was also observed to be well-tolerated, with no adverse events leading to discontinuation. The study is expected to be completed in the third quarter of 2020, and the Company plans to present the full 16-week data in the fourth quarter of 2020. Additionally, Momenta has begun preparations to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) before the end of 2020 and anticipates initiating a Phase 3 study in the first quarter of 2021.
-- Unity, Momenta's global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), continues to enroll patients at sites where they can be safely accommodated. FDA recently granted Rare Pediatric Disease Designation and Orphan Drug Designation for nipocalimab in HDFN.
-- Momenta continues to activate sites globally for the Energy Study, the Company's adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA). Patient enrollment was temporarily suspended due to the COVID-19 pandemic but is expected to resume in the fourth quarter 2020. Momenta has amended the study protocol to facilitate remote monitoring procedures.
M254 (hsIgG): a hypersialylated immunoglobulin candidate designed as a high potency alternative for intravenous immunoglobulin (IVIg)
-- Patient enrollment is complete in Part B of the Company's Phase 1 / 2 study in idiopathic thrombocytopenic purpura (ITP), which is evaluating M254 in a single ascending dose cohort of ITP patients, followed by 1,000 mg/kg of IVIg. The Company intends to release results from this study in the third quarter of 2020 and has initiated patient enrollment in Part C of the study.
-- The Company's planned Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected to initiate in 2021.
M230 (CSL730): a recombinant Fc multimer candidate being developed in collaboration with CSL
-- Momenta's collaboration partner, CSL, plans to introduce a subcutaneous formulation into the Phase 1 program later this year.
M267: a SIFbody candidate targeting CD38, designed to combine multiple Fc's with antibody fabs to optimally activate Fc, complement effector function and effectively deplete target cells.
-- IND-enabling studies are ongoing, and the Company expects to submit an IND for M267 in 2021.
Necuparanib (M402): The Company is currently exploring the utility of necuparanib (M402), a former novel oncology candidate, as a potential therapy for treating COVID-19. The Company has confirmed the ability of necuparanib (M402) to bind to the SARS-Cov2 spike protein and is assessing the potential to block viral infection of respiratory epithelial cells. As multiple respiratory viruses are believed to utilize binding to heparin sulfate glycoproteins on cells to facilitate infection, the Company is assessing the ability of necuparanib to block cell infection by other coronavirus and respiratory viruses. The Company anticipates completing the initial cell infection studies in the coming weeks.
GLATOPA(R) 20 mg and 40 mg: U.S. Food and Drug Administration (FDA) approved generic versions of COPAXONE 20 mg and 40 mg, developed and commercialized in collaboration with Sandoz
-- In the second quarter of 2020, Momenta recorded $6.6 million in product revenue from Sandoz's sales of GLATOPA products.
M710: a proposed biosimilar to EYLEA(R) (aflibercept) candidate being developed in collaboration with Mylan
-- Mylan continues its pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA. Mylan expects to target U.S. submission in 2021, while monitoring and navigating potential COVID-19 issues.
Second Quarter 2020 Financial Results
In the second quarter of 2020, the Company recorded $6.6 million in product revenue from Sandoz's sales of GLATOPA, compared to $3.3 million for the same period in 2019. The increase in product revenue from the prior year period was primarily due to higher net sales of GLATOPA, driven by volume increases.
Research and development revenue for the second quarter of 2020 was less than $0.1 million, compared to $1.8 million for the same period in 2019. The decrease in research and development revenue of $1.8 million, or 99%, was primarily due to lower reimbursement revenue for GLATOPA expenses and lower revenue recognized from Mylan's upfront payment associated with the biosimilar collaboration.
Total revenue for the second quarter of 2020 was $6.6 million compared to $5.2 million for the same period in 2019.
Research and development expenses for the second quarter of 2020 were $38.8 million, compared to $32.1 million for the same period in 2019. The increase of $6.7 million, or 21%, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254 and an increase in share-based compensation expense, offset in part by lower lease costs.
General and administrative expenses for the second quarter of 2020 were $25.3 million, compared with $46.6 million for the same period in 2019. The decrease of $21.3 million, or 46%, was primarily due to a payment of $21.0 million in June 2019 reflecting the Company's portion of a settlement payment; lower legal fees and lower depreciation and rent costs due to the modification to the Bent Street lease in 2019; partially offset by an increase in share-based compensation expense.
Other operating expenses in the second quarter of 2019 included a $42.9 million charge to be paid between the end of 2020 and 2022, related to Momenta's manufacturing agreement with GSK, the supplier of M923. Following the Company's decision to cease development activity relating to M923, Momenta incurred these charges for canceled manufacturing runs scheduled through 2020 and may not use manufacturing runs scheduled for 2021 and 2022.