The first quarter of 2019 has marked with major events in the pharma & biotech industries. We have gathered the key highlights of the quarter, which was starting with the blockbuster news, where Celgene had acquired BMS for $74B. Moving to the next news, acquisition of Loxo Oncology for $8B, in addition to Spark Therapeutics’ acquisition by Roche for $4.3B. Some major approvals also caught the eyes of industry executives, for example Novartis’ Mayzent FDA approval for SPMS, the Breakthrough Therapy designation for Paige.AI’s Artificial Intelligence in Pathology. The industry was also shocked by the sudden resignation of the US FDA Chief Scott Gottlieb who disagreed the growing use of e-cigarettes/methanol and vaping devices in teens. PharmaShots has summarized the key events and news as below:

1.Bristol-Myers Squibb (BMS) to Acquire Celgene for $74B

Date -January 03, 2019

Value -$74B, $50/share, 54% premium

BMS acquires Celgene, in all stock transaction for $74B. Celgene to receive $50/share, 1 BMS share and 1 Contingent Value Right (CVR) of $9 cash as regulatory milestone for each future approval of Celgene’s three drugs candidates ozanimod, liso-cel, bb2121. Celgene has received premium value of 54% on its last day closing share price making it $102.43/share. The focus of the acquisition is to expand its portfolio in Oncology, Immunology and Inflammation and Cardiovascular Disease. The transaction is expected to close in Q3’19. Ozanimod is a P-III candidate indicated for relapsing multiple sclerosis and ulcerative colitis with its expected approval in 31 Dec,2020. Lisocabtagene maraleucel (JCAR01, liso-cel) is a CD19-directed CAR T candidate indicated for r/r B cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B, and mantle cell lymphoma with expected approval in 31 Dec,2020.

2. Eli Lilly to Acquire Loxo Oncology for $8B

Date - January 07, 2019

Value - $8B, $235/share

Eli Lily acquires Loxo Oncology, in all stock transaction for $8B. Loxo to receive $235/share in cash making $8B as total deal value, including premium based on its last day closing share price value. The focus of the acquisition is to utilize Loxo’s approved oncology portfolio for patients with genomically defined cancers. The acquisition is expected to close in Q1’19. Vitrakvi is an oral TRK inhibitor developed in collaboration with Bayer, targeted for specific genetic abnormality and has also received FDA approval. LOXO-292 is an oral RET inhibitor indicated for targeting cancers with alterations to the rearranged during transfection (RET) kinase. LOXO-305 & LOXO-195 is an oral P-I/II BTK & TRK inhibitor respectively. 

3. Novo Nordisk Signs Non -Exclusive Agreement with Abbott for its FreeStyle Libre Mobile App

Date - February 20, 2019

Product - FreeStyle Libre Mobile App

The companies entered into an agreement to assess insulin dose data from Novo Nordisk’ pre-filled insulin pen connected to digital health tool attached with Abbott’s FreeStyle Libre system (FreeStyle LibreLink mobile app and LibreView cloud-based system). The focus of an agreement is to advance management techniques for diabetes with the combination of the two technologies CGM & connected insulin pen, enabling healthcare professionals to monitor glucose and insulin data. In H1’17, Novo signed a collaboration with Glooko for its platform connected to insulin pens for uploading data by any means of communication-capable Android phone. Abbott's FreeStyle Libre system uses sensors allowing the monitor glucose levels in real-time with eight-hour glucose history & change in glucose level.

4. Merck to Acquire Immune Design for its Technologies for $300M

Date - February 21, 2019

Value - $300M, $5.85/share

Merck acquires Immune Design, in all stock transaction for $5.85/share in cash making total deal value ~ $300M. The transaction is expected to close in Q2’19. The focus of the agreement is to develop and commercialize immune vaccines using Immune Design’s in vivo technologies i.e GLAAS and ZVex against cancer and infectious diseases. GLA Adjuvant Systems (GLAAS) is an in vivo Glucopyranosyl Lipid A (GLA) based platform that binds TLR4 receptor activating DCs to produce cytokines and chemokines activating Th1-type immune response. ZVex is a delivery system designed for developing T-Cells targeting tumor cells. 

5. Roche to Acquire Spark Therapeutics for $4.3B

Date - February 25, 2019

Value - $4.3B, $114.50 /share in cash

Roche acquires Spark Therapeutics, in all stock transaction for $114.50 /share in cash, making the total deal value $4.3B. Spark to receive premium of 122% based on its last day closing share price value i.e 22 February 2019. The focus of the acquisition is to expand Roche’s footprints in genetic disorders including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases. Spark therapeutics’ portfolio includes SPK-8011 & SPK-8016 for hemophilia A, SPK-9001 for haemophilia B, SPK-3006 for Pompe disease, SPK-1001 for CLN2 disease and Luxturna (voretigene neparvovec-rzyl) approved for confirmed biallelic RPE65 mutation-associated retinal dystrophy. The transaction is expected to close in the Q2’19.

6. Paige.AI Receives FDA’s Breakthrough Designation for its Artificial Intelligence in Pathology

Date - March 07, 2019

Product - Fuch Technology

FDA grants BT designation to Paige.AI to develop AI in computational pathology for the diagnosis and treatment of cancer including prostate cancer. The FDA’s BT designation is granted for technologies that provide effective diagnosis and treatment for life-threatening diseases. Paige.AI is based on Fuch’s technology, works with the de-identified dataset to develop AI portfolio targeting multiple cancer across the world.

7. Fujifilm to Acquire Biogen’s Danish Biologics Manufacturing Facility for $890M

Date - March 12, 2019

Value - $890M

Fujifilm acquires Biogen’s subsidiary having the production capacity of 90,000L biologics, in all-stock transaction for $890M. The acquisition is expected to be complete in H2’19. The focus of the acquisition is to expand Fujifilm’s bio CDMO business. It will provide Biogen a tax relaxation. As a part of transaction Biogen also signs a service agreement with Fujifilm to develop products for Biogen including Tysabri. Biogen to develop a new manufacturing facility in Solothurn, Switzerland by H2’20 after the closing of this transaction.

8. Biogen and Eisai Terminate P-III ENGAGE and EMERGE Study for Alzheimer’s Disease

Date - March 22, 2019

Product -Aducanumab

The termination is based on P-III EMERGE and ENGAGE study results assessing Aducanumab vs PBO in ~ 3,200 patients with mild cognitive impairment due to Alzheimer’s disease and dementia across the world. The termination is due to its inability to meet 1EPs resulted in the loss of ~$18B to Biogen. Biogen also terminates P-II EVOLVE study of Aducanumab and the long-term extension of PRIME leads to falling in Biogen’s stock price up to 28%. Aducanumab (BIIB037) is a mAb evaluated for the treatment of Alzheimer’s disease. On Oct,2017 Biogen & Eisai collaborated for the development & commercialization of aducanumab globally.

9. Lupin and YL Biologics’ Etanercept Biosimilar (YLB113) Receive PMDA’s Approval for Moderate-to-Severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA) in Japan

Date - March 26, 2019

Products - YLB113, Etanercept Biosimilar

The approval is based on global P-III trial results assessing etanercept biosimilar (YLB113) vs Enbrel in 500 patients with RA across 11 countries including Japan, EU, and India evaluating its efficacy and safety. In Mar,2018 Lupin ad YLB filled NDA based on the above study results to Pharmaceutical and Medical Devices Agency (PMDA) in Japan. YLB113 is a biosimilar of Amgen’s Enbrel, targeted globally for severe autoimmune disorders including RA & JIA. Lupin also has two oncology biosimilars Lupifil (filgrastim) and Lupifil-P (peg-filgrastim).

10. Novartis’ Mayzent (siponimod) Receives FDA’s Approval for Patients with Secondary Progressive Multiple Sclerosis (SPMS)

Date - March 27, 2019

Product - Mayzent

The approval is based on P-III EXPAND study results assessing Mayzent vs PBO in 1,651 patients with SPMS from 31 countries aged 48yrs.The P-III study results: reduction in risk of three-month & six-month confirmed disability progression (CDP) 21% & 26%, 33% reduction with relapse activity in the two years, 55% reduction in annualized relapse rate (ARR), limited increase of T2 lesion volume by ~80, 89% free from gadolinium-enhancing lesions. Mayzent (siponimod) is a sphingosine 1-phosphate receptor modulator binds to S1P1 and S1P5 receptors and is approved for relapsing forms of MS, including SPMS with active disease, relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS).

11. Apple Launches its Watch Series 4 Enabled with ECG App and Irregular Rhythm Notification in Europe and Hong Kong

Date – March 28, 2019

Product - Apple Watch Series 4

The ECG app on Apple Watch Series 4 is evaluated in 600 patients resulted in 98.3% sensitivity in classifying AFib, 99.6% specificity in classifying sinus rhythm, 87.8% of recordings classified by the ECG app. The irregular rhythm notification function was assessed in the Apple Heart study enrolled with 400,000 candidates and demonstrated 0.5% irregular pulse notifications, identified heart rate irregularities with confirmed AFib. Watch Series 4 with OS 5.2 possess a health app with irregular rhythm notification enables customers to produce ECG on demand & check user’s heart rhythm using the optical heart sensor, available in 19 EU countries and has received FDA’s De Novo clearance in the US.

12.  AstraZeneca Signs a Worldwide Development and Commercialization Agreement with Daiichi Sankyo for $6.9B

Date - March 29, 2019

Value - $1.35B Upfront, $5.55B Milestone, $6.9B

Daiichi Sankyo to receive $1.35B upfront, $5.55B as regulatory & commercial milestones making the total deal value $6.9B. AstraZeneca to get WW co-development and co-commercialization rights for Daiichi’s trastuzumab deruxtecan (Ex- Japan) with equal cost & profit sharing. The focus of the collaboration is to develop trastuzumab deruxtecan for HER2+ breast and gastric cancer with the expansion of AstraZeneca’s Oncology portfolio. Trastuzumab deruxtecan (DS-8201) is ADC designed to deliver CT to cancer cells and has received FDA’s BT designation & MHLW’s Sakigake designation for HER2+ advanced or m-breast cancer & HER2-positive advanced gastric or gastroesophageal junction respectively with its expected FDA filling in Q2’19.