PharmaShots’ Key Highlights of Fourth Quarter 2019

1. Pfizer Launched its Zirabev (biosimilar, bevacizumab) in the US by the year end 2019

Date – Oct 01, 2019

Product – Zirabev (biosimilar, bevacizumab)

  • The biosimilar was launched in the US on Dec 31, 2019 following the settlement between Genentech and Pfizer granting all global rights of the product to the Pfizer. In Sept 2019, Genentech and Pfizer signed a joint stipulation of dismissal in their patent litigation case and voluntarily dismissed all the claims and counterclaims of April 2019 complaint
  • Genentech alleged that Pfizer had not produced all necessary information concerning Avastin, and claimed that the biosimilar would infringe 23 of its patents
  • Zirabev (bevacizumab-bvzr) is a mAb inhibits formation of new blood cells (angiogenesis) approved by the US FDA in Jun’2019 for MCC, unresectable/LA/recurrent or mnon-sq NSCLC, recurrent glioblastoma, mRCC, and persistent, recurrent or metastatic cervical cancer and also received EC’s approval in Feb’2019

2. Alvogen and Pfenex’s PF708 (biosimilar, teriparatide) Received FDA’s Approval for the Treatment of Osteoporosis

Date – Oct 07, 2019

Product – PF708 (biosimilar, teriparatide)

  • The US FDA has granted approval to PF708, a biosimilar of Eli Lilly’s Forteo (teriparatide injection) under the 505(b)(2) regulatory pathway for the treatment of osteoporosis in certain patients at high risk for fracture
  • Pfenex will receive a $2.5M milestone from Alvogen on its approval in the US. The PF708 is the first approved product of Pfenex, validating Pfenex Expression Technology platform and enhances patient’s access to a cost-effective alternative to Forteo
  • Pfenex is conducting a comparative human factors study between PF708 and Forteo, evaluating the therapeutic equivalence of both the therapies with its anticipated submission by the end of Oct’19

3. Allergan Launched Three REFRESH RELIEVA Lubricant Eye Drops Expanding its REFRESH Portfolio 

Date – Oct 08, 2019

Products – REFRESH RELIEVA, REFRESH RELIEVA PF

  • Allergan launched three new OTC REFRESH RELIEVA products: REFRESH RELIEVA, REFRESH RELIEVA PF multidose and REFRESH RELIEVA for contacts to relieve discomfort due to eye dryness and to prevent irritation
  • The launch of three unique options to treat patients with dry, irritated eyes and contact lens dryness expands Allergan’s artificial tear, REFRESH portfolio. REFRESH RELIEVA products demonstrated improvement in symptoms of eye dryness with a low incidence of blur upon installation in 70% of patients
  • REFRESH RELIEVA lubricant eye drops are available in three formulations: preserved, preservative-free and a formula for contact lens wearers, formulated with CMC, hyaluronic acid, glycerin and HydroCell technology

4. Samsung Bioepis Reported Real-World Data of Benepali (biosimilar, etanercept) in Patients with Psoriasis at EADV 2019

Date – Oct 09, 2019

Product – Benepali (biosimilar, etanercept)

  • The study enrolled BADBIR-registered patient treated with Benepali from Jan 01, 2016 to Sept 01, 2018. BADBIR is a UK and Ireland observational study assessing long-term safety of biologic treatments for psoriasis while Samsung Bioepis participated in it since May 2016
  • The mean disease duration was 22.6 yrs., PASI and DLQI scores 11.6 and 13.1 respectively, median treatment period 14.1 months. In 48 patients with PASI score at baseline and 6 mos. PASI < 10 (N=20, mean PASI 3.2) no increment after 6 mos. and PASI ≥ 10 (N=28, mean PASI 15.7) reduced after 6 mos. (mean PASI 5.0)
  • Benepali (biosimilar, etanercept) referencing Enbrel is an anti-TNF biosimilar approved by EC in Jan 2016, for moderate to severe RA, JIA, PsA, axSpA  (ankylosing spondylitis and non-radiographic axial spondyloarthritis), and plaque psoriasis and is available in 25 countries in EU plus most prescribed across France, Germany, Italy, Spain, and the UK combined

5. Sartorius Acquired Danaher’s Life Science Portfolio for $750M

Date – Sept 11, 2019

Product – FortéBio, Chromatography Hardware and Resins

  • The life science portfolio to be acquired includes label-free biomolecular characterization (FortéBio), chromatography hardware and resins, and microcarriers (SoloHill) businesses. The proposed transaction follows Danaher’s GE Biopharma business and related regulatory approval.
  • The transaction is expected to be completed in Q1’20 and will strengthen Sartorius’ presence in bio-analytics and bioprocessing segments with the acquisition of Danaher’s life science platform businesses.
  • Danaher’s FortéBio comprises protein analysis instruments, biosensors and reagents, used in drug discovery while its SoloHill includes microcarrier technology and particle validation standards used in cell culture and other bioprocesses

6. Pfizer and OPKO Reported Results of Somatrogon in P-III Study for Children with Growth Hormone Deficiency

Date – Oct 22, 2019

Products – Somatrogon, Genotropin 

  • The P-III study involved assessing of Somatrogon (qw) vs Genotropin (somatropin,qd) for injection, in 224 pre-pubertal, treatment-naive children in a ratio (1:1) with growth hormone deficiency across 20 countries
  • The P-III study resulted in meeting its 1EPs of non-inferiority to somatropin with respect to height velocity at 12 mos. of treatment, least-square mean (10.12 vs 9.78 cm/year), 2EPs: treatment difference (0.33), higher change in height standard deviation scores @6 & 12mos., higher change in height velocity, well-tolerated
  • Somatrogon is an investigational long-acting human GH one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic hCG at the N terminus and two copies at the C-terminus and has received FDA & EMA’s ODD to treat children and adults with GHD

7. Takeda Acquired Exclusive Worldwide License Rights for COUR’s CNP-101 to Treat Celiac Disease

Date – Oct 22, 2019

Product – CNP-101/TAK-101

  • COUR to receive ~$420M milestone and royalties on sales of licensed products. Takeda exercised its option to acquire the exclusive global license to develop and commercialize TAK-101/CNP-101 following P-IIa proof-of-concept placebo-controlled study
  • In Dec’2015, Takeda and COUR collaborated to develop therapies for celiac disease, provided Takeda an exclusive option to acquire a WW license to the developed program and an option to collaborate up to three additional TIMP compounds
  • CNP-101/TAK-101 is an investigational immune modifying nanoparticle designed to induce tolerance to gluten in patients with celiac disease. The P-IIa POC study results demonstrated mean change from baseline in IFN-γ ELISpotSFUs (2.10 vs 17.57), protection from intestinal mucosal damage with deterioration (0.18 vs 0.63)

8. WHO Signed MoU with IGBA for Promoting the Access to Biosimilars and Generics

Date – Oct 24, 2019

Product – N/A

  • The memorandum of understanding signed between WHO and International Generic and Biosimilar Medicines Association to facilitates the approval of generics and biosimilars thus reduces the burden of clinical trials for biosimilars and increases the access to drugs
  • The WHO’s efforts to increase the access to Biosimilar includes List of International Comparators, providing information on reference products that can be used in clinical studies and its prequalification program, assessing the quality, safety, and efficacy of medicinal products
  • The independent study by McKinsey estimated that WHO prequalification saves the world up to $590M/year. Additionally, WHO provides Biowaiver List which describes generic medicines that are eligible for a waiver from studies

9. Novartis Reported Results of Cosentyx (secukinumab) in Head to Head P-III EXCEED Study for Psoriatic Arthritis

Date – Nov 01, 2019

Products – Cosentyx (secukinumab), Humira (adalimumab)

  • The P-III EXCEED study involved assessing Cosentyx (300mg) vs Humira (adalimumab, 40 mg) in 800+ biologic-naïve patients with PsA for 52wks.
  • The P-III EXCEED results: Cosentyx narrowly missed statistical significance for superiority in ACR 20 but showed significant advantages in PsA specific endpoints, observed in a pre-specified sensitivity analysis, no new safety signals were observed
  • Cosentyx is a mAb, selectively targeting IL-17A and is indicated to treat mod. to sev. plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy, for patients with active psoriatic arthritis and active ankylosing spondylitis

10. Biogen Signed an Exclusive Commercialization Agreement with Samsung Bioepis to Expand its Biosimilars Portfolio

Date – Nov 07, 2019

Products – Benepali (etanercept), Flixabi (infliximab), Imraldi (adalimumab), Remicade (infliximab)

  • Samsung Bioepis received $100M up front, up to $210M development, regulatory and commercial milestones and will be responsible for the development and supply of both the products. Biogen got exclusive commercialization rights for two ophthalmology biosimilars, SB11 referencing Lucentis and SB15 referencing Eylea in the US, Canada, Europe, Japan and Australia
  • Additionally, Biogen got exclusive right to commercialize anti-TNF portfolio including Benepali (etanercept), Flixabi (infliximab) & Imraldi (adalimumab) in exchange for royalties on sales in China and acquired an option for extending its existing commercial agreement with Samsung Bioepis for anti-TNF portfolio in EU
  • The transaction is expected to be closed in Q4’19. Benapali, Flixabi & Imraldi are the biosimilars referencing Enbrel, Remicade & Humira indicated to treat RA, PsA, axSpA and other autoimmune diseases respectively

11. Bluebird Bio Collaborated with Forty Seven to Evaluate Antibody Conditioning Regimen in Combination with Autologous Lentiviral Vector Hematopoietic Stem Cell Gene Therapy  

Date – Nov 12, 2019

Products – FSI-174, Magrolimab

  • The collaboration leads to evaluation of Forty Seven’s FSI-174 + magrolimab in combination with Bluebird’s ex vivo lentiviral vector hematopoietic stem cell (LVV HSC) gene therapy platform
  • The focus of the collaboration was to develop gene therapy with reduced toxicity and will initially target diseases having the potential to be corrected with transplantation of autologous gene-modified blood-forming stem cells
  • FSI-174 is mAb targeting cKIT while magrolimab is a mAb targeting CD47, currently being evaluated in P-II clinical study to treat cancer and other indications including myelodysplastic syndrome, acute myeloid leukemia, diffuse large B cell lymphoma and follicular lymphoma

12. Mylan and Pfizer Named Viatris as the New Company for Mylan-Upjohn’s Combination

Date – Nov 13, 2019

Product – N/A

  • The name Viatris symbolizes the new company’s goal of providing a path- “VIA’ —to three ”TRIS”—core goals: expanding access to medicines, leading by innovating to meet patient needs and being a trusted partner for the healthcare community worldwide
  • Viatris to bring together Upjohn’s position in China and emerging markets with Mylan’s presence in the US and Europe, allowing the new company to have expanded geographic reach for its portfolio and future pipeline
  • The new name, Viatris will be effective upon closing of the combination, which is expected to occur in H2’20. The two companies will continue to operate as independent, separate organizations until close

13. Merck Acquired Calporta Therapeutics for ~$576M  

Date – Nov 14, 2019    

Product – N/A

  • Merck acquired Calporta, in the all-cash transaction making a total deal value ~$576M including an up front and contingent milestone payments
  • The focus of the collaboration is to gain a preclinical portfolio of small-molecule TRPML1 agonists which are being evaluated for lysosomal storage and neurodegenerative disorders, including Alzheimer’s and Parkinson’s disease
  • Avalon Ventures and GSK launched Calporta in 2015 as part of their collaborative effort to found up to 10 biotech companies. TRPML1 is a lysosomal ion channel, by activating it signaling with small molecules could re-establish lysosomal processes and restore cellular function

14. Pfizer Collaborated with Centogene to Access its Rare Disease Data

Date – Nov 14, 2019

Product- N/A

  • Centogene received up front and will be eligible for additional research payments for any future collaboration. Pfizer to get access to Centogene’s data repository, which may be used to discover and validate new therapies targeting rare diseases
  • The companies will work together in mining the data repository and jointly agree for any research project to substantiate the results of data mining. Pfizer along with international data privacy regulations will manage, protect & share individual-level data from the repository
  • Centogene’s rare disease data repository includes relevant structured and unstructured patient data, including clinical information; health records; and genetic, transcriptomic, proteomic, and metabolomic data

15. Novartis Collaborated with Biofourmis To Offer Digital Therapeutics for Managing Heart Failures

Date – Nov 19, 2019

Product – BiovitalsHF

  • Novartis will access Biofourmis’ lead digital therapeutics, BiovitalsHF to manage patients with heart failure across Asia, with a potential plan to expand it globally
  • The focus of the collaboration is to improve clinical outcomes utilizing Biofourmis’ BiovitalsHF along with Biovitals Analytics Engine to identify early signs of HF exacerbations, enabling early interventions in patients with HF with a reduced ejection fraction
  • Additionally, Biofourmis acquired Biovotion including its Everion biosensor, combining Biovotion’s wearables with Biofourmis’ digital therapeutics platform and its AI-driven predictive analytics to offer the most comprehensive digital therapeutics solution for the patients

16. Novartis Acquired The Medicines Company for $9.7B

Date – Nov 25, 2019

Product – Inclisiran

  • Novartis acquired The Medicine Company in all-cash transaction for $85/share at a 24% 1-day premium, making fully diluted equity value as $7.7B and a total deal value as $9.7B. The transaction is expected to be closed in Q1’20 
  • The acquisition will expand Novartis’ global footprints with the addition of Inclisiran in cardiovascular portfolio, thus enable Novartis to leverage its commercial capabilities globally
  • The Medicine Company’s Inclisiran is first-in-class siRNA inhibitor targeting PCSK9, currently being evaluated in P-III (ORION-9, 10 and 11) studies for patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH), demonstrating potent and durable LDL-C reduction with its expected regulatory submission in the US in Q4’19 and in the EU in Q1’20

17. Gene Techno Science Signed an Agreement with Kishi Kasei to Co-Develop Biosimilar of Aflibercept

Date – Dec 03, 2019

Product- Aflibercept

  • GTS and Kishi Kasei will jointly develop biosimilar of Aflibercept and will form a manufacturing process for the drug substance utilizing high-yield protein-producing cell lines, which were jointly developed by GTS and Fuso Pharmaceutical
  • The collaboration focusses to secure a future revenue base via commercialization of biosimilar of Aflibercept and to gain market share in ophthalmologic diseases
  • The companies will partner with others to jointly promote drug development, non-clinical studies, clinical studies, manufacturing and approvals, sales, etc. and create a business structure for commercialization of the product

18. GE Healthcare Signed an Agreement with Affidea to Deploy Digital Imaging Technologies

Date – Dec 03, 2019

Product – Clariscan

  • GE Healthcare will install 200+ new equipment including 60 new MRIs, 50 ultrasound devices, 40 CT scanners, and 30 X-rays machines in the next 3 yrs. in Affidea’s network of centers across EU and will pay $100M to Affidea
  • Additionally, Affidea expands its collaboration with GE Healthcare in pharmaceutical diagnostics in all its geographies, to include its Clariscan to be used in MRI exams
  • The companies will combine their clinical education, lean and leadership development expertise utilizing digital technologies with the goal to support doctors and HCPs to benefit patients by leveraging data analytics as the new way of orchestrating patient care and improving their experience

 19. Sanofi Acquired Synthorx for $2.5B

Date – Dec 09, 2019

Product – THOR-707

  • Sanofi acquired Synthrox in all-cash transactions at $68/share, making a total deal value $2.5B with a premium of 172% to Synthorx’s closing price on December 6, 2019. The transaction is expected to be completed in Q1’20
  • The focus of the acquisition is to foster Sanofi’s immuno-oncology (IO) pipeline with the addition of Synthorx’s THOR-707. Additionally, Synthorx’s Expanded Genetic Alphabet platform is expected to display synergistic effect with Sanofi’s platforms including Nanobody technology, enabling it to develop novel therapies for oncology and other therapeutic areas
  • Synthorx’s THOR-707 is a variant of IL-2, being evaluated for multiple solid tumors as monothx or in combination with immune checkpoint inhibitors. Sanofi expects THOR-707 to shown therapeutic activity when combined with its pre/-clinical oncology assets including PD-1, CD-38, and molecules modulating effector T-cells and NK cells and pursue it as a foundation of future IO-IO combinations

20. Merck Acquired ArQule for $2.7B

Date – Dec 09, 2019    

Product – ARQ 531   

  • Merck acquired Arqule in all-cash transactions at $20/share, making a total deal value $2.7B. The transaction is expected to be completed in Q1’20
  • The focus of the acquisition is to bolster Merck’s oncology pipeline with the addition of ArQule’s lead investigational candidate, ARQ 531, a precision therapy to treat hematological malignancies
  • ArQule’s ARQ 531 (PO) is a novel BTK inhibitor, currently being evaluated in P-II dose-expansion study for the treatment of B-cell malignancies and has demonstrated safety and anti-tumor activity for the treatment of patients with r/r CLL and Richter’s Transformation in its early studies