PharmaShots’ Key Highlights of Second Quarter 2019

PharmaShots’ Key Highlights of Second Quarter 2019

The second quarter of 2019 has ended with major acquisitions in pharma and biotech industry. Moving with the latest acquisition of Allergan for $63B by AbbVie focusing on to generate revenue with addition of Allergan’s medical aesthetics and ophthalmology portfolio. Prior to that, Pfizer acquired Array Biopharma for $11.4B to expand its oncology portfolio. Some global companies presented data at ASCO and EULAR 2019 for instance Celltrion presented results of CT-P13 SC (infliximab, biosimilar) for Rheumatoid Arthritis. IBM Watson created a buzz in oncology segment with the presentation of real-world data based on Artificial Intelligence at ASCO 2019. Our team at PharmaShots has summarized and complied the insights of Q2’19.

1.NuVasive Reported Results of Cohere Porous PEEK Implants for Degenerative Cervical Disc

Date – April 23, 2019

Product – Cohere Porous PEEK

The study involved assessing of Cohere Porous PEEK vs structural allograft/smooth PEEK in 167 patients with degenerative cervical disc underwent anterior cervical discectomy and fusion (ACDF). The study resulted in clinical improvement relative to preoperative (pre-op) scores, @postoperative (post-op) improvements in NDI scores and pain by 6wks. vs 3mos., improvement over baseline by 2wks. vs 6wks., improvement was maintained up to 1yr. Cohere Porous PEEK is manufactured through extrusion process providing 3D porous architecture and is designed to promote bone growth while maintaining the biomechanical and imaging properties of PEEK.

2.   Eli Lilly to Sell Rights for its Two Antibiotics and a Manufacturing Facility to Eddingpharm in China for $375M

Date – April 23, 2019

Value – $75M, $300M

Eli Lilly received $75M upfront & $300M on the completion of the transaction. Eddingpharm got exclusive rights for Lilly’s two antibiotics, Ceclor and Vancocin and a manufacturing facility located in China producing Ceclor. The transaction is expected to close in H2’19/H1’20. Additionally, all the employees at the Ceclor’s manufacturing facility will continue to work with Eddingpharm. Lilly will provide ongoing services to Eddingpharm for continuity of product supply & smooth transition of the facility. Ceclor & Vancocin are anti-infectives therapies used to treat bacterial infections & penicillin-resistant Staphylococcus aureus respectively. In 2004, Eli Lilly licensed Vancocin to ViroPharma, Flynn Pharma and Aspen Pharmacare in the US, UK and Australia respectively.

3. Roche Launched Ventana HER2 Dual ISH CDx for the Identification of Breast and Gastric Cancer

Date – April 23, 2019

Products – Ventana HER2 Dual ISH CDx, Herceptin

Roche’s Ventana HER2 Dual ISH DNA Probe Cocktail assay is used to detect HER2 biomarker in breast and gastric cancer patients receiving Herceptin (trastuzumab). The approval of Ventana HER2 Dual ISH assay supported Roche’s personalized healthcare sector by providing techniques to diagnose breast and gastric cancer. The Ventana HER2 assay is fully automated on BenchMark IHC/ISH instruments providing results on the same day & can be read using light microscopy, launched in EU, the Middle East, Africa, Latin America & Asia Pacific with its expected regulatory submission to FDA.

4. Fulcrum Therapeutics Signed an Exclusive Worldwide License Agreement with GSK to Develop and Commercialize Losmapimod for Facioscapulohumeral Muscular Dystrophy

Date – April 24, 2019

Product – Losmapimod

GSK received shares of Fulcrum’s preferred stock, milestones & royalties on sales of losmapimod. Fulcrum got exclusive WW rights to develop & commercialize losmapimod with all patent rights. Fulcrum has conducted pre-clinical testing of losmapimod and identified it as a potent regulator of the DUX4 gene. In mid-2019, Fulcrum plans for the onset of P-IIb trial of losmapimod in patients with FSHD across multiple sites in the US and Europe. Losmapimod is a selective p38α/β mitogen-activated protein kinase (MAPK) inhibitor, evaluated in 3,500 candidates for multiple indications in 24 clinical studies.

5. Janssen Collaborated with Iktos for its Artificial Intelligence (AI) Technology

Date – April 30, 2019

Products – AI Technology, Makya

Janssen entered into an agreement to utilize Iktos’ AI (in silico drug design) technology for the enhancement of speed & efficacy of its small molecules discovery platform and will develop new therapies utilizing Iktos’ know-how in deep generative models applied to chemistry with its own AI expertise. Additionally, Iktos has also collaborated with other biopharma companies for its AI technology to expedite the design of compounds and planned to release its SaaS software Makya, a beta version for testing by customers in mid-2019. Iktos’ in silico drug design technology improves the drug discovery workflows by utilizing the existing data in designing molecules that are optimized in silico to meet the criteria of a small molecule discovery projects.

6. Medtronic Acquired Titan Spine for its Portfolio of Implants and nanoLock Surface Technology

Date – May 10, 2019

Product – NanoLock

Medtronic acquired Titan Spine, in all-stock transaction. The acquisition is completed on June 27, 2019. The focus of the acquisition is to bolster Medtronic’s Spine portfolio with the addition of Titan’s spine implant surface technology and surface-enhanced interbody implants, providing complete procedural solutions for surgeons and improving patient’s outcomes. Titan’s nano Lock is a surface technology enhancing micro and nano-scaled architecture thus improving the osteogenic response and has received FDA’s nano-clearance & Centers for Medicare & Medicaid Services (CMS) new technology designation.

7. Merck To Acquire Tilos Therapeutics for ~ $773M

Date – May 10, 2019

Value – $773M

Merck acquires Tilos Therapeutics, in all-stock transaction. Tilos Therapeutics has received upfront and contingent milestone payments, making the total deal value ~$773M. The focus of the acquisition is to strengthen Merck’s footprint with the addition of Tilos’ antibodies modulating TGFβ portfolio targeting cancer, fibrosis and autoimmune diseases. TGFβ is a cytokine secreted as a complex with the protein, latency-associated peptide (LAP). Tilos Therapeutics was founded by the collaboration of BI Venture Fund and Partners Innovation Fund.

8. UCB’s Nayzilam (midazolam) Received FDA’s Approval for the Treatment of Seizure Cluster in Epilepsy in the US

Date – May 21, 2019

Product – Nayzilam

The approval followed Study 1 consisting of two phases i.e., Test Dose Phase & Comparative Phase assessing Nayzilam (midazolam) vs PBO in 292 & 201 patients with intermittent, stereotypic episodes of frequent seizure activity aged ≥12yrs. respectively. Study 1 resulted in the termination of seizures within 10 min after the initial dose (80.6% vs 70.1%); absence of seizure recurrence b/w 10min & 6hrs. after the initial dose (58.2% vs 37.3%); an occurrence of seizures within 24hrs. after the initial blinded dose (37.3% vs 46.3%); longer time to next seizure than PBO. Nayzilam (midazolam) nasal spray CIV, designed as single-use treatment, allowing the non-healthcare professionals to administer the drug in patients actively seizing when and where a seizure cluster occurs, UCB acquired Nayzilam from Proximagen in Jun’18 for $370M.

9. OncoSec Reported Result of Keytruda + TAVO in P-II KEYNOTE-890 Study for Refractory Metastatic Triple Negative Breast Cancer

Date – May 23, 2019

Products – Keytruda, TAVO

The P-II KEYNOTE-890 study involved assessing of Keytruda (200mg, IV) + TAVO (tavokinogene telseplasmid) in 25 patients with heavily pretreated, CT/radiotherapy refractory mTNBC who failed an average of 3.5 prior lines of CT. The P-II KEYNOTE-890 study resulted:  @3mos. 20% + tumor reduction; two patients showed 66% tumor reduction including reduction of liver lesions; well tolerated. OncoSec’s TAVO (tavokinogene telseplasmid) is an immunotherapy platform, allowing the intratumoral delivery of IL-12 and Keytruda (pembrolizumab) is mAb targeting PD-1, blocking the interaction b/w PD-1 and its ligands, PD-L1 and PD-L2 thus activating T-lymphocytes affecting both tumor & healthy cells.

10. Roche and GE Healthcare Launched NAVIFY Tumor Board 2.0 for Personalized Treatment Decision in Cancer Care

Date – May 31, 2019

Products – NAVIFY Tumor Board 2.0

The NAVIFY Tumor Board 2.0 with medical imaging capabilities brings a personalized treatment in patients with cancer with its initial availability in the US & Canada. The tumor board enabled radiologists to upload their patient records to the same dashboard where the patient’s previous treatment details were stored, helping the clinicians to have a quick review of all relevant files and to choose the best treatment for each cancer patient. The NAVIFY tumor board is a web-based cancer care team workflow tool, presented data in a dashboard and standardizes processes to encourage collaboration on patient treatment decisions.

11. AstraZeneca and Merck Reported Results of Lynparza (olaparib) in P-III SOLO3 Study for Platinum-Sensitive Relapsed Germline BRCA-mutated Advanced Ovarian Cancer #ASCO2019

Date – June 04, 2019

Product– Lynparza

The P-III SOLO3 study involved assessing of Lynparza (300mg, bid) vs CT (paclitaxel/topotecan /pegylated liposomal doxorubicin/gemcitabine) in 266 patients in a ratio (2:1) with 2L+ platinum-sensitive relapsed BRCA1/2-mutated (gBRCAm) advanced ovarian cancer. The P-III SOLO3 study resulted in improvement in ORR (72.2% vs 51.4%); PFS (13.4 mos. vs 9.2mos.); safe & tolerable, presented at ASCO 2019. Lynparza is a PARP inhibitor, targeted for DNA damage response (DDR) pathway deficiencies, including BRCA mutations and has received approval in 64 & 38 countries as a maintenance treatment of platinum-sensitive relapsed ovarian cancer & 1L gBRCAm HER2- metastatic breast cancer respectively.

12. IBM Watson Health Reported Real-World Progress of AI in Oncology in #ASCO2019

Date – June 05, 2019

Product – AI-Technology

IBM Watson has presented 22 new scientific studies showing progress in clinical studies of cancer using AI-Technology with informed decisions based on curated scientific evidences, insights and information which are unidentified manually and further leading to QoL. The presented data included: Watson For Oncology lead to 13.6% changes in informs clinical decision reviewed by multidisciplinary tumor board; Watson For Genomics Surfaces resulted in new insights for oncologists to treat hematological malignancies; Watson For Oncology improved cancer patient confidence. Additionally, IBM Watson reported to identify automatically, high-quality and relevant scientific publications with the help of machine learning on words from abstracts of papers cited at three expert resources: NCCN, NCI-PDQ, and Hemonc.org further resulted in 93% accuracy, 95% sensitivity, and 91% specificity of treatment.

13. STADA to Acquire GSK’s OTC Portfolio for the Expansion of its Consumer Health Business in Europe

Date – June 07, 2019

Products – Oilatum, Eurax, Savlon, Ceridal, Tixylix and Polytar

STADA acquires GSK’s six brands containing five skincare/topical application and one pediatric cough remedy namely Oilatum, Eurax, Savlon Antiseptic Cream, Ceridal, Tixylix and Polytar. The transaction is expected to close in Aug 2019. The focus of the acquisition is to strengthen and expand STADA’s Consumer Health business in European Healthcare markets. Additionally, the manufacturing of five skin care products will be transferred to Thornton & Ross (STADA acquired Thornton & Ross) having portfolio and expertise for same. Polytar is a coal-tar based dandruff shampoo, marketed as a Tarmed in Spain and Portugal. Eurax is a topical itch relief cream marketed in France, Italy and Norway including UK, Ireland and Hong Kong.

14. Celltrion Reported Results of CT-P13 SC (infliximab, biosimilar) in a Clinical Study for Rheumatoid Arthritis #EULAR2019

Date – June 13, 2019

Product– CT-P13, Infliximab Biosimilar

The study involved assessing of CT-P13 SC (90mg/120mg/180mg) vs CT-P13 IV (3mg/kg)  in 50 patients in ratio (1:1:1:1) with RA, followed by a P-I/III study assessing CT-P13 SC (120mg, q2w) vs CT-P13 IV in 362 patients in ratio (1:1) with RA for 30wks. Collective results demonstrated @54wks. efficacy is comparable; DAS28 (CRP) and ACR20 are comparable in all cohorts; CT-P13 SC is non-inferior to CT-P13 IV, @22wks. similar ACR response, @6wk. SC 120mg safety is comparable to an IV dose. CT-P13 is a mAb, currently being evaluated in an additional 5yrs. study for RA and ankylosing spondylitis and has received approval in the US (marketed as Inflectra) in Apr’16, in Europe (marketed as Remsima) in Sept’13, additionally in other 89+ countries.

15. Pfizer to Acquire Array Biopharma for ~$11.4B

Date – June 17, 2019

Value – $48/share, $11.42B  

Pfizer to acquire Array Biopharma in all-stock transaction for $48/share making the total deal value ~11.4B, with its expected completion in H2’19. The focus of the acquisition is to bolster Pfizer’s oncology portfolio with the addition of Array’s combined therapy of Braftovi (encorafenib) and Mektovi (binimetinib) indicated for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma. Braftovi and Mektovi are BRAF/MEK inhibitors, being evaluated in P-III BEACON study as a triple combination therapy (braftovi + mektovi + cetuximab) in patients with BRAF-mutant mCRC with its expected regulatory submission in the US in H2’19.

16. AbbVie to Acquire Allergan for $63B  

Date – June 25, 2019

Value – $63B

AbbVie to acquire Allergan in cash & stock transaction making the total deal value $63B, based on the closing price of AbbVie’s common stock of $78.45 on June 24, 2019. The transaction represented a 45% premium to the closing price of shares of Allergan on June 24, 2019. Allergan shareholders to receive 0.8660 shares in AbbVie and $120.30 in cash for each share in Allergan for a total consideration of $188.24/share of Allergan. The focus of the acquisition is to expand AbbVie’s revenue base with the addition of Allergan’s medical aesthetics and ophthalmology portfolio. Post-acquisition AbbVie’s shareholder will own ~83% of AbbVie and Allergan’s shareholders will own ~17% of AbbVie on a fully diluted basis. The transaction is expected to close in H1’20.