Syneos Health Consulting BioPharma BD Newsletter
2019 | Full Year & H2 Analysis Newsletter Content . H2 Deal Summary . H2 Global & US Deals 2019 has been a year of high value low volume exits and partnerships. Deal activity may be continuing a decline, as H2 faced a decrease in both deal value and volume when compared . H2 Ex-US Deals to H1. The IPO window also seemed to be slightly wavering as the second half of 2019 . 2019 Deal Summary observed a decrease in volume and value of public exits. A 50% decrease in global . H2 US IPOs collaboration in H2 compared to H1 may signal that companies are favoring full ownership . H2 FDA Approvals vs partnering their capabilities. On the regulatory side, a spike in FDA approvals through . Q1 ‘20 PDUFA Dates the second half of 2019 lead to 35 novel products and 33 generics launches. H2 Deal Summary1
HIGHLIGHTS . Novartis agreed to a $9.7 billion deal to buy The Medicines Company for access to their next-generation heart drug inclisiran. The takeover represents a big bet on the cholesterol drug to outperform competitor products sold by Amgen and Regeneron. . Galapagos and Gilead have agreed a ten-year multi-billion dollar collaboration to create a ‘global R&D leader’ based in EU and engaged in developing and commercializing breakthrough therapies. Analysts bill this tie-up as one of the largest biotech deals ever in the EU with an upfront payment of $3.95 billion. . Amgen buys rights to the psoriasis drug Otezla from Celgene for $13.4 billion, allowing BMS to move forward with its Celgene merger.
H2 2019 # of Deals Tot. Deal Avg. Deal Value No. of Deals Avg. Upfront YoY Growth % Summary disclosed Value ($M) ($M) With upfront Payments H2 2019 v. finances of payments ($M) H2 2018 total Tot. Deal Value
Mergers & 13 of 27 26,311 2,024 12 1,814 40% Acquisitions
Partnerships 37 of 164 20,847 563 29 140 48%
Asset Purchases 10 of 21 19,687 1,969 7 2,561 264%
Deals by Geography (H2 2019)
WW -- | 26 | 2
NA EU 4 | 2 | 4 7 | 1 | 2
APAC 2 | 8 | 2
Legend: M&A Partnerships Asset Purchases 1
Note: M&As deals used the buyers HQ country. Partnerships deals listed through the licensing territory. Asset Purchases deals used either the HQ country or the licensing territory. H2 2019 Deal Summary1
Value & No. of Deals by Quarter Value of Deals ($M) Q3 2018 – Q4 2019 No. of Deals
46 Deals 120,000 $112,393M 80 110,000 29 Deals 70 100,000 $96,351M 60 90,000 80,000 50 56 Deals 29 Deals 40 $37,559M 40,000 75 Deals 31 Deals $37,086M $29,758M 30 30,000 $26,821M 20 20,000 10,000 10 0 0 Q3 ‘18 Q4 ‘18 Q1 ‘19 Q2 ‘19 Q3 ‘19 Q4 ‘19
Value & No. of Deals by Therapeutic Area H2 2019 Value of Deals ($M) No. of Deals 22 Deals $19,917M 20,000 22 3 Deals 20 $16,695M 18 15,000 16 14 2 Deals $9,789M 12 10,000 10 8 4 Deal 2 Deals 6 5,000 $4,439M 8 Deal $3,535M $3,048M 3 Deal 2 Deal 4 2 Deals 2 Deals $1,840M $1,502M $1,386M 2 Deals 1 Deal 1 Deal 4 Deals 1 Deal $963M $850M $750M $720M $715M $625M 1 Deal 2 $73M 0 0 Onc Auto Cardio Endo/Meta Muscu Neuro Pulmonary Gastro Infectious Hepatic Hema Derma Resp Ophth Otologic Genito
Value & No. of Deals by Development Phase Value of Deals ($M) H2 2019 No. of Deals 10 Deals 35,000 $32,209M 14 30,000 12 25,000 10 20,000 8 15,000 6 6 Deals 11 Deals 10,000 13 Deals 10 Deals 4 $6,832M $7,215M 4 Deals $6,591M 5 Deals 5,612 $4,436M 3,932 5,000 1 Deal 2 $20M 0 0 Marketed Registration Phase III Phase II Phase I Preclinical Research Undisclosed
Legend: M&A Partnerships Asset Purchases Deal Count 2
Note: Therapeutic count was determined by the largest drug in the pipeline or the focus drug of the deal. The graph only includes deals with disclosed financing. The development phase was determined by the development phase at the time deal sign of the biopharma products only. H2 2019 Global & US Deals1
Top 5 Mergers & Acquisitions
Tot. Deal Upfront Buyer Seller Summary Value ($M) Payment ($M)
Novartis acquired The Medicines Company, adding inclisiran 9,700 9,700 to their portfolio, a cholesterol-lowering therapy
Astellas Pharma acquired Audentes to broaden its genetic 3,000 3,000 medicine and gene therapy business
Exact Sciences completed its acquisition of Genomic Health, 2,800 2,800 creating a leading global cancer diagnostics company
Merck acquired ArQule to further diversify its oncology 2,700 2,700 pipeline with expansion into hematological malignancies
Sanofi acquired Synthorx bolstering its immuno-oncology 2,500 2,500 pipeline
DEAL HIGHLIGHT2 Novartis successfully completes acquisition of the Medicines Company, adding a potentially first-in-class, investigational cholesterol-lowering therapy inclisiran The Medicines Company submitted the New Drug Application for inclisiran to the FDA in December 2019; comprehensive Phase III inclisiran program showed potent and durable reduction of >50% in LDL-C on top of standard of care, with an excellent safety profile Inlcisiran leverages significant synergies with Novartis’ existing global cardiovascular commercial capabilities
Top 5 Partnerships
Tot. Deal Upfront Buyer Seller TA Phase Leading Asset Value ($M) Payment ($M)
5,100 3,950 Inflammation Phase III Filgotinib
Endocrine / 2,099 20 Preclinical SLN500 Metabolic
Endocrine/ AKCEA- 1,550 250 Phase II Metabolic ANGPTL3-LRx
1,251 51 Pulmonary Phase I BBT-877
1,226 26 Gastrointestinal Research Undisclosed
DEAL HIGHLIGHT3 Gilead and Galapagos enter into transformative research and development collaboration Gilead gains access to Galapagos’ differentiated drug discovery platform and current and future pipeline outside of Europe The investment enables Galapagos to expand and accelerate research and clinical programs Galapagos gains broader commercialization role for Filgotinib in Europe and agrees to share equally in future development costs
3 H2 2019 Global & US Deals1
Asset Purchases
Tot. Deal Upfront Buyer Seller Phase Asset Value ($M) Payment ($M)
Otezla: treatment for certain types of psoriasis 13,400 13,400 Marketed and psoriatic arthritis
Bermekimab: treatment of atopic dermatitis and 750 750 Phase II hidradenitis suppurativa
FX301: potential first-in-class therapy aimed to 128 3 Preclinical provide post operative pain relief
ALT-801: novel therapy to treat the underlying 93 -- Preclinical metabolic dysfunction that leads to NASH
DEAL HIGHLIGHT4 Amgen to acquire Otezla for $13.4 B in cash, or approximately $11.2 B net of anticipated future cash tax benefits The acquisition of Otezla offers a unique opportunity for Amgen to provide patients an innovative oral therapy for psoriasis and psoriatic arthritis that fits squarely within their portfolio and complements their Anbrel and Amgevita brands Celgene planned a strategic agreement to allow Amgen to purchase its blockbuster psoriasis product, Otezla, to sweeten Celgene’s case to antitrust officials as it seeks approval for the merger with BMS; as BMS has a competing psoriasis drug in development, BMS-986165, a TYK2 inhibitor
H2 2019 Ex-US Deals1
Highlighted Deals
Tot. Deal Buyer Seller Deal Summary Geography Value ($M)
Zambon is acquiring Sofinnova Partners portfolio 557 (parent company Breath Therapeutics) which EU specializes in respiratory diseases
Boehringer Ingelheim acquires AMAL Therapeutics,
Mergers & Mergers 367 significantly enriching its cancer immunology portfolio EU Acquisition with novel cancer products
Amgen enters into strategic collaboration with 3,950 APAC BeiGene to expand oncology presence in China
Astellas enters into a partnership with Frequency to 625 develop Frequency’s lead candidate – sensorineural APAC / EU
Partnership hearing loss regenerative therapeutics
Roivant agreed to sell ownership of five of its Vant 3,000 companies (Myovant, Urovant, Enzvant, Altavant, and APAC / EU Spirovant) to Sumitomo Dainippon
Asset Bavarian Nordic buys vaccines against rabies
1,066 (Rabipur) and tick-borne encephalitis (Encepur) from EU Purchases GlaxoSmithKline
4 Full Year 2019 Deal Summary
Top Dealmakers of 2019
No. of Tot. Deal Company Deals Value ($M) The biopharmaceutical sector has experienced continued volatility as a combination of economic and 6 353,687 regulatory factors drive change across the landscape. Despite uncertainty around the global economy, 2019 11 88,910 was a banner year in terms of total deal value for the biopharmaceutical landscape. M&As led the way with 6 74,000 several deals surpassing the billion-dollar threshold, however robust activity was seen across all deal types. We expect the 2020 deal landscape to increase in deal 10 63,510 volume and decrease in value, driven mainly by smaller biotech companies. 21 17,866
Mergers & Acquisitions Partnerships & Asset Purchases
51 211,140 3,984 180 461,688 2,496 Disclosed Deal $ Tot. Deal Value $M Avg. Deal Value $M Disclosed Deal $ Tot. Deal Value $M Avg. Deal Value $M
Bristol-Myers Squibb acquired Celgene to create a premier innovative biopharma company10 Highly complementary portfolios with leading franchise in Oncology, Immunology and Inflammation, and Cardiovascular disease Significantly expands BMS Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential Registrational trial opportunities and early-stage pipeline position combined company for sustained leadership underpinned by cutting-edge technologies and discovery platforms Deal completed after Celgene sold Otezla to Amgen, addressing US Federal Trade Commission concerns
AstraZeneca and Daiichi Sankyo entered into a collaboration for novel HER2-targeting antibody- drug conjugate11 Companies to accelerate and expand development of trastuzumab deruxtecan across breast and other cancers, with the potential to redefine standard of care The collaboration is aligned with AstraZeneca’s science-led strategy in Oncology, which is based on four key scientific platforms: tumor drivers & resistance, DNA damage response, ImmunoOncology, and ADCs Funding via an equity placement of approximately $3.5 billion
Novartis acquired Xiidra, expanding front-of-eye portfolio and strengthening leadership in eye care12 Xiidra 5% fits strategically within industry-leading $4.6 billion Novartis ophthalmic pharmaceutical portfolio, laying groundwork for front-of-the-eye pipeline products currently in development Xiidra is the first and only prescription treatment approved for both signs and symptoms of dry eye disease with a mechanism of action that targets inflammation Deal terms include a $3.4 billion upfront payment with potential milestone payments of up to $1.9 billion 5 H2 2019 US IPOs1
Ticker Amount Lead Product Date Company Therapeutic Area (NASDAQ) Raised ($M) Status Complete
Mirum Pharmaceuticals Inc. MIRM 75 Hepatic Phase II Jul 17
Fulcrum Therapeutics Inc. FULC 72 Neurology Preclinical Jul 17
Satsuma Pharmaceuticals Inc. STSA 91 Neurology Phase III Sep 12
SpringWorks Therapeutics Inc. SWTX 186 Oncology Phase III Sep 12
IGM Biosciences Inc. IGMS 201 Oncology Preclinical Sep 17
Frequency Therapeutics Inc. FREQ 89 Otology Phase II Oct 02
Viela Bio Inc. VIE 173 Inflammation Phase III Oct 02
Vir Biotechnology Inc. VIR 143 Infectious Phase II Oct 10
TFF Pharmaceuticals Inc. TFFP 24 Cardiovascular Preclinical Oct 24
Phathom Pharmaceuticals Inc. PHAT 209 Gastrointestinal Phase III Oct 24
Cabaletta Bio Inc. CABA 80 Autoimmune IND Oct 25
RAPT Therapeutics Inc. RAPT 41 Oncology Phase II Oct 30
Oyster Point Pharma Inc. OYST 92 Ophthalmic Phase III Oct 30
Galera Therapeutics Inc. GRTX 65 Oncology Phase III Nov 06
89bio Inc. ETNB 98 Hepatic Phase I Nov 12
CNS Pharmaceuticals Inc. CNSP 10 Oncology Preclinical Nov 13
Monopar Therapeutics Inc. MNPR 10 Oncology Phase II Dec 18
Value & No. of IPOs by Quarter Q3 2018 – Q4 2019 Value of IPOS ($M) No. of IPOs 11 IPOs 2,500 $1,065M 20 19 IPOs 2,000 $1,767M 1,767 15
1,500 11 IPOs 12 IPOS $1,855M $1,033M 10 1,000 5 IPOs $625M 5 500
0 0 Q3 ’18 Q4 ’18 Q1 ’19 Q2 ’19 Q3 ’19 Q4 ’19
Legend: Amount Raised No. Financing Data
6 H2 2019 FDA Approvals
Approval Novel Drugs6 Generic Name, Company, and Indication Date
selinexor | Karyopharm Jul 03 . Relapsed or refractory multiple myeloma
imipenem, cilastatin, and relebactam | Merck & Co. Jul 16 . Complicated urinary tract and complicated intra-abdominal infections
ferric maltol | Shield Therapeutics Jul 25 . Iron deficiency anemia
darolutamide | Bayer and Orion Corp. Jul 30 . Non-metastatic castration resistant prostate cancer
pexidartinib | Daiichi Sankyo Aug 02 . Symptomatic tenosynovial giant cell tumor
pitolisant | Bioproject Aug 14 . Excessive daytime sleepiness in adult patients with narcolepsy
entrectinib | Genentech Inc. Aug 15 . Metastatic non-small cell lung cancer
fedratinib | Impact Biomedicines Inc. Aug 16 . Intermediate-2 or high-risk primary or secondary myelofibrosis
upadacitinib | Abbvie Inc. Aug 16 . Moderately to severely active rheumatoid arthritis
lefamulin | Nabriva Therapeutics Inc. Aug 19 . Community-acquired bacterial pneumonia
istradefylline | Kyowa Kirin Aug 27 . Parkinson’s disease experiencing “off” episodes
tenapanor | Ardelyx Inc. Sep 12 . Irritable bowel syndrome with constipation
trifarotene | Galderma Sep 04 . Topical treatment of acne vulgaris in patients 9 and older
brolucizumab-dbll | Novartis Sep 07 . Wet age-related macular degeneration
lasmiditan | Eli Lilly & Co. Oct 11 . Acute treatment of migraine with or without aura
elexacaftor/ivacaftor/tezacaftor | Vertex Pharmaceuticals Oct 21 . Common gene mutation that causes cystic fibrosis
air polymer-type A | ExEm Foam Inc. Nov 07 . Diagnostic agent used to assess fallopian tube patency in women with infertility
luspatercept-aamt | Bristol-Myers Squibb and Acceleron Nov 08 . Anemia in adult patients with beta thalassemia who require red blood cell transfusions
zanubrutinib | BeiGene Nov 14 . Mantle cell lymphoma
cefiderocol | Shionogi Inc. Nov 14 . Complicated urinary tract infections who have limited to no alternative treatment options
7 H2 2019 FDA Approvals
Approval Novel Drugs6 Generic Name, Company, and Indication Date
crizanlizumab-tmca | Novartis Nov 15 . Painful complication of sickle cell disease
givosiran | Alnylam Pharmaceuticals Nov 20 . Acute hepatic porphyria
cenobamate | SK Life Science Nov 21 . Treat partial onset seizures
voxelotor | Global Blood Therapeutics Nov 25 . Sickle cell disease
golodirsen | Sarepta Therapeutics Dec 12 . Duchenne muscular dystrophy
enfortumab vedotin-ejfv | Agensys and Seattle Genetics Dec 18 . Refractory bladder cancer
brilliant blue G Ophthalmic solution | Dutch Ophthalmic Research Center Dec 20 . Dye used in eye surgery
lumateperone tasylate | Intra-Cellular Therapies Dec 20 . Schizophrenia
lemborexant | Eisai Dec 20 . Insomnia
fam-trastuzumab-deruxtecan-nxki | Daiichi Sankyo Dec 20 . Metastatic breast cancer
ubrogepant | Allergan plc Dec 23 . Acute treatment of migraine with or without aura
Approval Biosimilar7 Generic Name, Company, and Indication Date
rituximab-pvvr | Pfizer . Non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with Jul 23 polyangiitis
adalimumab-bwwd | Samsung Bioepis . Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Jul 23 crohn’s disease, ulcerative colitis, and plaque psoriasis
pegfilgrastim-bmez | Sandoz Nov 05 . Decrease the incidence of infection in patients with non-myeloid malignancies
adalimumab-afzb | Pfizer Nov 18 . Psoriatic arthritis
infliximab-axxq | Amgen Dec 06 . Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis
8 H2 2019 FDA Approvals
Approval First Generic8 Company and Indication Brand Product Date
Mylan, Alembic, Sun febuxostat Jul 01 Tablet . Chronic management of hyperuricemia
phenylephrine / Lupin Limited ketorolac Jul 01 . Preventing intraoperative miosis and reducing postoperative pain Intraocular solution
Dr. Reddy’s Laboratories Limited carboprost tromethamine Jul 02 Injection . Aborting pregnancy between the 13th and 20th week
Pharmalucene Inc. technetium tc99m Jul 12 Kit . diagnosis of renal failure, urinary tract obstruction, and calculi
Accord Healthcare Inc. daptomycin Jul 12 Injection . Complicated skin and skin structure infections
icatibant Teva Pharmaceuticals Jul 15 Injection . Acute attacks of hereditary angioedema
Teva, Alembic, Alkem, Sciegen, MSN, Dr. Reddy’s, Amneal, Rising, pregabalin InvaGen Jul 19 Capsule . Management of neuropathic pain
morphine sulfate Upsher-Smith Laboratories Jul 22 Tablet . Management of acute and chronic pain
halcinonide Mylan Pharmaceuticals Aug 12 Cream . Releif of inflammatory dermatoses
tafluprost ophthalmic Micro Labs Limited Aug 12 Solution . Reducing elevated intraocular pressure
triamterene Agnitio Inc Aug 19 Capsule . Edema associated with congestive heart failure
sapropterin Par Pharmaceuticals Aug 20 Powder . Reduction of blood phenylalanine levels
posaconazole Sinotherapeutics Inc. Aug 21 Tablet . Prophylaxis of invasive aspergillus and candida infections
nitisinone Notivium Pharma Aug 26 Capsule . Hereditary tyrosinemia type 1
nabumetone Nexgen Pharma Aug 30 Tablet . Relief of signs and symptoms of osteoarthritis and rheumatoid arthritis
fosaprepitant Mylan Pharmaceuticals Sep 05 Injection . Prevention of acute and delayed nausea and vomiting
carfilzomib Dr. Reddy’s Laboratories Sep 09 Injection . Relapsed or refractory multiple myeloma
ivermectin Teva Pharmaceuticals Sep 13 Cream . Inflammatory lesions of rosacea
vilazodone Teva Pharma Sep 30 Tablet . Major depressive disorder
digoxin Novitium Pharma Oct 04 Oral . Atrial fibrillation and heart failure
GE Healthcare gadoterate meglumine . Magnetic resonance imaging to detect areas with disruption of the Nov 01 Injection blood
9 H2 2019 FDA Approvals
Approval First Generic8 Company and Indication Brand Product Date
mesalamine Mylan Pharmaceuticals Nov 01 Capsule . Maintenance of remission of ulcerative colitis
deferasirox MSN Pharma, Alembic Pharma, Zydus Pharma, Teva Pharma, Actavis Nov 20 Tablets . Chronic iron overload due to blood transfusions
sucralfate Amneal Pharma Dec 02 Oral . Short-term treatment of active duodenal ulcer
fingolimod HEC Pharm Co, Biocon Limited, Sun Pharma Dec 04 Capsule . Relapsing forms of multiple sclerosis
Par Pharmaceutical, Teva Pharma . Advanced hormone receptor-positive, HER2-negative breast cancer in everolimus postmenopausal women; advanced renal cell carcinoma; renal Dec 09 Tablet angiomyolipoma and tuberous sclerosis complex; progressive neuroendocrine tumors of pancreatic origin
etonogestrel and ethinyl Amneal Pharmaceutical estradiol Dec 11 . Prevent pregnancy Vaginal ring
Watson Laboratories alvimopan . Accelerate time to upper and lower gastrointestinal recovery following Dec 19 Capsule partial large or small bowel resection surgery with primary anastomosis
e5 Pharma diazoxide . Management of hypoglycemia due to hyperinsulinism associated with Dec 20 Suspension Proglycem certain conditions
Micro Labs Limited, Mylan apixaban . Reduce the risk of stroke and systemic embolism in patients with Dec 23 Tablet nonvalvular atrial fibrillation; for the prophylaxis of deep vein thrombosis
Par Pharmaceutical penicillamine . Wilson’s disease, cystinuria, and in patients with severe active Dec 23 Tablet Depen rheumatoid arthritis
ziprasidone mesylate Gland Pharma Limited Dec 26 Injection . Acute treatment of agitation in schizophrenic patients
Sawai USA mirabegron . Overactive bladder with symptoms of urge urinary incontinence, Dec 27 Tablet urgency, and urinary frequency
No. of Drug Approvals by Quarter No. of Approvals
70
60 21 Novel 18 Novel 1 Biosimilar 4 Biosimilar 14 Novel 50 25 Generic 17 Novel 23 Generic 2 Biosimilar 7 Novel 3 Biosimilar 19 Generic 40 3 Biosimilar 14 Generic 7 Novel 20 Generic 30 2 Biosimilar 45% 12 Generic 51% 20 5% 9% 10 50% 40% 0 Q3 ’18 Q4 ’18 Q1 ’19 Q2 ’19 Q3 ’19 Q4 ’19
Legend: 10 Novel Biosimilar First Generic Q1 2020 FDA PDUFA Dates9
Estimated PDUFA Company Name Drug Name Indication Date Review
Aimmune Therapeutics AR101 Peanut Allergy Jan 31
Agile Therapeutics Twirla Contraceptive patch Feb 16
Merck & Co. Keytruda 6-week dosing for melanoma Feb 18
Baudax Bio IV melaxicam Acute pain following bunionectomy surgery Feb 20
Hyperlipidemia whose LDL-C is not adequately Esperion Therapeutics Bempedoic acid Feb 21 controlled with low-and moderate-dose statins
Bempedoic acid / Esperion Therapeutics Hypercholesterolemia Feb 26 ezetimibe
Bristol-Myers Squibb Opdivo & Yervoy Previously treated hepatocellular carcinoma Mar 10 Priority
Eton Pharma EM-105 Lennox-Gastaut syndrome, epilepsy Mar 17
Ozanimod – Bristol-Myers Squibb Relapsing multiple sclerosis Mar 25 RADIANCE
Zogenix Fintepla Dravet syndrome Mar 25 Priority
Heron Therapeutics HTX-011 Post operative pain Mar 26
RIZAPORT (RHB- Intelgenx Techs Migraine Mar 26 103)
Rockwell Medical IV Triferic Anemia Mar 28
Imfinzi + AstraZeneca Small cell lung cancer Mar 29 Priority tremelimumab
11 Authors
Neel Patel Katya Magonova Senior Managing Director Senior Engagement Manager [email protected] [email protected]
David Tannin Nick Milazzo Andrew Okimura Senior Consultant Associate Consultant Associate Consultant [email protected] [email protected] [email protected]
Sources
1. https://bciq.biocentury.com/deal/all-deals/insights 2. https://www.novartis.com/news/media-releases/novartis-successfully-completes-acquisition-medicines-company-adding-potentially- first-class-investigational-cholesterol-lowering-therapy-inclisiran 3. https://www.gilead.com/news-and-press/press-room/press-releases/2019/7/gilead-and-galapagos-enter-into-transformative-research- and-development-collaboration 4. https://www.amgen.com/media/news-releases/2019/08/amgen-to-acquire-otezla-for-134-billion-in-cash-or-approximately-112-billion- net-of-anticipated-future-cash-tax-benefits/ 5. https://www.genengnews.com/news/astellas-frequency-therapeutics-partner-to-develop-hearing-loss-drug/ 6. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm629491.htm 7. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologic applications/biosimilars/ucm580432.htm 8. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugandbiologicapprovalreports/andage nericdrugapprovals/default.htm 9. https://www.biopharmcatalyst.com/calendars/fda-calendar 10. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-acquire-celgene-create-premier-innovative 11. https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-and-daiichi-sankyo-enter-collaboration-for-novel-her-2- targeting-antibody-drug-conjugate.html 12. https://www.novartis.com/news/media-releases/novartis-acquire-xiidra-expanding-front-eye-portfolio-and-strengthening-leadership-eye- care
Note: Mergers & Acquisition deals include: Full Acquisition, Majority Acquisition, Acquisition Option, Merger. Mergers & Acquisition asset types include: Company, Pharmaceutical Product, Facility. Partnership deals include: Development and Commercialization License, Collaborative Research and Product License Option, Equity Stake and License Option, Product License Option, Partnership with Company Acquisition Option, Joint Venture / Consortium, Sales Marketing and Co-Promotion, Cross License. Partnerships assets include: Company, Pharmaceutical Product, Facility. Asset Purchases deals include: Business Unit or Division Purchase, Product Pipeline or Platform Purchase. Asset Purchases assets include: Business Unit or Division Purchase, Company, Pharmaceutical Product Deal Values have been rounded to the nearest million
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