Kristin Brooks, Contract Pharma12.23.19
According to MarketWatch, drug manufacturers have spent a record $342 billion on Mergers & Acquisitions in 2019. Addressing legacy losses for the industry’s largest players has driven recent M&A. Efforts to diversify have largely involved immuno-oncology and orphan drug assets.
The broader trend in the industry for big pharma has been to acquire assets, which has proven successful in the past. For example, Keytruda, which was acquired through Merck’s $41 billion acquisition of Schering-Plough in 2009, has since generated $103 billion in revenue since it was approved by the FDA in 2014, according to EvaluatePharma.
The following represent some of the largest M&A deals in the pharma and biopharma industry this past year.
Bristol-Myers Squibb, Celgene Ink $74B Merger
In January, Bristol-Myers Squibb entered into a definitive merger agreement to acquire Celgene in a cash and stock transaction valued at approximately $74 billion. BMS shareholders are expected to own approximately 69 percent of the company, and Celgene shareholders are expected to own approximately 31 percent. The transaction creates a leading specialty biopharma company in the areas of cancer, inflammatory and immunologic disease and cardiovascular disease.
The merger creates oncology franchises in both solid tumors and hematologic malignancies with Opdivo and Yervoy as well as Revlimid and Pomalyst; a top five immunology and inflammation franchise with Orencia and Otezla; and the number one cardiovascular franchise led by Eliquis. The combined company will have nine products with more than $1 billion in annual sales and significant potential for growth in the core disease areas of oncology, immunology and inflammation and cardiovascular disease. Near-term launch opportunities include six expected product launches: two in immunology and inflammation, TYK2 and ozanimod; and four in hematology, luspatercept, liso-cel (JCAR017), bb2121 and fedratinib.
AbbVie to Buy Allergan for $63B
In June, AbbVie struck a deal to buy Botox-maker, and the biggest name in medical aesthetics, Allergan, for roughly $63 billion. It’s doing so to diversify a portfolio that includes the world’s best-selling drug, Humira, which will soon face generic competition. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women's health, eye care and virology.
Pfizer to Acquire Array BioPharma for $11.4B
In June, Pfizer entered into a definitive merger agreement to acquire Array BioPharma, a commercial stage biopharma company focused on targeted small molecules to treat cancer and other diseases, in a transaction valued at approximately $11.4 billion. Array's portfolio includes the approved combined use of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for the treatment of BRAF mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is currently being investigated in more than 30 clinical trials across several solid tumor indications, including the Phase III trial in BRAF-mutant metastatic colorectal cancer (mCRC).
Roche to Acquire InterMune in $8.3B
In August, Roche entered into a definitive merger agreement to acquire InterMune for $8.3 billion in cash. The acquisition broadens Roche’s respiratory portfolio globally with InterMune's lead drug pirfenidone, approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada, and is under regulatory review in the U.S. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs.
Amgen Acquires Rights to Celgene’s Otezla
In August, Amgen entered into an agreement with Celgene Corp., in connection with its previously announced merger with Bristol-Myers Squibb, to acquire worldwide rights to Otezla (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and certain related assets and liabilities, for $13.4 billion in cash. Amgen believes that the acquisition is a strong strategic fit with its inflammation franchise offering a differentiated, oral therapy, along with Otezla’s sales growth potential over the next five years. Sales of Otezla in 2018 were $1.6 billion.
Lilly to Acquire Loxo Oncology
In January, Eli Lilly and Co. entered a definitive agreement to acquire Loxo Oncology for approximately $8 billion in cash. Loxo Oncology is a biopharmaceutical company focused on the development and commercialization of highly selective medicines for genomically defined cancers.
The acquisition is latest in a series of transactions Lilly has conducted to expand its cancer treatment efforts with externally sourced opportunities for first-in-class therapies. Loxo Oncology is developing a pipeline of targeted medicines focused on cancers that are uniquely dependent on single gene abnormalities that can be detected by genomic testing.
Loxo’s portfolio of approved and investigational medicines include:
Roche to Acquire Spark Therapeutics for $4.3B
In February, Roche entered into a definitive merger agreement to acquire Spark Therapeutics in a cash transaction valued at approximately $4.3 billion. Spark Therapeutics discovers and develops gene therapies for genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Spark’s lead clinical asset is SPK-8011, is a novel gene therapy for the treatment of hemophilia A, currently in Phase III development. Spark also has SPK-8016 in a phase 1/2 trial aimed at addressing the hemophilia A inhibitor population. LUXTURNA is a one-time gene therapy indicated for the treatment of biallelic RPE65 mutation-associated retinal dystrophy.
Spark Therapeutics' additional clinical assets include: SPK-9001, an investigational gene therapy for the potential treatment of hemophilia B in Phase III and SPK-7001 for choroideremia in Phase 1/2. The company is also developing SPK-3006 for Pompe disease and SPK-1001 for CLN2 disease (a form of Batten disease) which are expected to be ready for clinical development in 2019, as well as additional preclinical programs for Huntington's disease and Stargardt disease.
Novartis to Acquire The Medicines Company for $9.7B
In November, Novartis entered an agreement to acquire The Medicines Company, a U.S.-based biopharmaceutical company, for $9.7 billion. The deal bolsters Novartis’ cardiovascular drug portfolio with the addition of inclisiran.
The Medicines Company recently unveiled data from its clinical program consisting of three Phase III trials (ORION-9, 10 and 11) for inclisiran involving over 3,600 high-risk patients with ASCVD and FH. In all trials, inclisiran demonstrated potent and durable LDL-C reduction with an excellent safety and tolerability profile. Furthermore, inclisiran’s potentially first-in-class, twice-yearly dosing schedule allows administration during patients’ routine visits to their healthcare professionals and will likely contribute to improved patient adherence and sustained, lower LDL-C levels. The Medicines Company expects to file regulatory submissions in the U.S. in 4Q19 and in Europe in 1Q20.
Mylan and Upjohn Join Forces as Viatris
In August, Mylan and Pfizer entered an agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company called Viatris. Mylan brings a diverse portfolio across many geographies and key therapeutic areas, such as central nervous system and anesthesia, infectious disease and cardiovascular, as well as a robust pipeline, high-quality manufacturing and supply chain excellence. Upjohn brings iconic brands, such as Lipitor, Celebrex and Viagra, and commercialization capabilities, including leadership positions in China and other emerging markets.
The transaction will allow the new company to expand the geographic reach of Mylan’s existing product portfolio and future pipeline, including significant investments that have been made across complex generics and biosimilars, into new growth markets where Upjohn has existing sales infrastructure and local market expertise.
The broader trend in the industry for big pharma has been to acquire assets, which has proven successful in the past. For example, Keytruda, which was acquired through Merck’s $41 billion acquisition of Schering-Plough in 2009, has since generated $103 billion in revenue since it was approved by the FDA in 2014, according to EvaluatePharma.
The following represent some of the largest M&A deals in the pharma and biopharma industry this past year.
Bristol-Myers Squibb, Celgene Ink $74B Merger
In January, Bristol-Myers Squibb entered into a definitive merger agreement to acquire Celgene in a cash and stock transaction valued at approximately $74 billion. BMS shareholders are expected to own approximately 69 percent of the company, and Celgene shareholders are expected to own approximately 31 percent. The transaction creates a leading specialty biopharma company in the areas of cancer, inflammatory and immunologic disease and cardiovascular disease.
The merger creates oncology franchises in both solid tumors and hematologic malignancies with Opdivo and Yervoy as well as Revlimid and Pomalyst; a top five immunology and inflammation franchise with Orencia and Otezla; and the number one cardiovascular franchise led by Eliquis. The combined company will have nine products with more than $1 billion in annual sales and significant potential for growth in the core disease areas of oncology, immunology and inflammation and cardiovascular disease. Near-term launch opportunities include six expected product launches: two in immunology and inflammation, TYK2 and ozanimod; and four in hematology, luspatercept, liso-cel (JCAR017), bb2121 and fedratinib.
AbbVie to Buy Allergan for $63B
In June, AbbVie struck a deal to buy Botox-maker, and the biggest name in medical aesthetics, Allergan, for roughly $63 billion. It’s doing so to diversify a portfolio that includes the world’s best-selling drug, Humira, which will soon face generic competition. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women's health, eye care and virology.
Pfizer to Acquire Array BioPharma for $11.4B
In June, Pfizer entered into a definitive merger agreement to acquire Array BioPharma, a commercial stage biopharma company focused on targeted small molecules to treat cancer and other diseases, in a transaction valued at approximately $11.4 billion. Array's portfolio includes the approved combined use of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for the treatment of BRAF mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is currently being investigated in more than 30 clinical trials across several solid tumor indications, including the Phase III trial in BRAF-mutant metastatic colorectal cancer (mCRC).
Roche to Acquire InterMune in $8.3B
In August, Roche entered into a definitive merger agreement to acquire InterMune for $8.3 billion in cash. The acquisition broadens Roche’s respiratory portfolio globally with InterMune's lead drug pirfenidone, approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada, and is under regulatory review in the U.S. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs.
Amgen Acquires Rights to Celgene’s Otezla
In August, Amgen entered into an agreement with Celgene Corp., in connection with its previously announced merger with Bristol-Myers Squibb, to acquire worldwide rights to Otezla (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and certain related assets and liabilities, for $13.4 billion in cash. Amgen believes that the acquisition is a strong strategic fit with its inflammation franchise offering a differentiated, oral therapy, along with Otezla’s sales growth potential over the next five years. Sales of Otezla in 2018 were $1.6 billion.
Lilly to Acquire Loxo Oncology
In January, Eli Lilly and Co. entered a definitive agreement to acquire Loxo Oncology for approximately $8 billion in cash. Loxo Oncology is a biopharmaceutical company focused on the development and commercialization of highly selective medicines for genomically defined cancers.
The acquisition is latest in a series of transactions Lilly has conducted to expand its cancer treatment efforts with externally sourced opportunities for first-in-class therapies. Loxo Oncology is developing a pipeline of targeted medicines focused on cancers that are uniquely dependent on single gene abnormalities that can be detected by genomic testing.
Loxo’s portfolio of approved and investigational medicines include:
- LOXO-292, a first-in-class oral RET inhibitor that has been granted Breakthrough Therapy designation by the FDA for three cancer indications, with an initial potential launch in 2020.
- LOXO-305, an oral BTK inhibitor designed to address acquired resistance to currently available BTK inhibitors. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas.
- Vitrakvi, a first-in-class oral TRK inhibitor developed and commercialized in collaboration with Bayer that was recently approved by the FDA. Vitrakvi is the first treatment that targets a specific genetic abnormality to receive a tumor-agnostic indication at the time of initial FDA approval.
- LOXO-195, a follow-on TRK inhibitor also being studied by Loxo Oncology and Bayer for acquired resistance to TRK inhibition, with a potential launch in 2022.
Roche to Acquire Spark Therapeutics for $4.3B
In February, Roche entered into a definitive merger agreement to acquire Spark Therapeutics in a cash transaction valued at approximately $4.3 billion. Spark Therapeutics discovers and develops gene therapies for genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Spark’s lead clinical asset is SPK-8011, is a novel gene therapy for the treatment of hemophilia A, currently in Phase III development. Spark also has SPK-8016 in a phase 1/2 trial aimed at addressing the hemophilia A inhibitor population. LUXTURNA is a one-time gene therapy indicated for the treatment of biallelic RPE65 mutation-associated retinal dystrophy.
Spark Therapeutics' additional clinical assets include: SPK-9001, an investigational gene therapy for the potential treatment of hemophilia B in Phase III and SPK-7001 for choroideremia in Phase 1/2. The company is also developing SPK-3006 for Pompe disease and SPK-1001 for CLN2 disease (a form of Batten disease) which are expected to be ready for clinical development in 2019, as well as additional preclinical programs for Huntington's disease and Stargardt disease.
Novartis to Acquire The Medicines Company for $9.7B
In November, Novartis entered an agreement to acquire The Medicines Company, a U.S.-based biopharmaceutical company, for $9.7 billion. The deal bolsters Novartis’ cardiovascular drug portfolio with the addition of inclisiran.
The Medicines Company recently unveiled data from its clinical program consisting of three Phase III trials (ORION-9, 10 and 11) for inclisiran involving over 3,600 high-risk patients with ASCVD and FH. In all trials, inclisiran demonstrated potent and durable LDL-C reduction with an excellent safety and tolerability profile. Furthermore, inclisiran’s potentially first-in-class, twice-yearly dosing schedule allows administration during patients’ routine visits to their healthcare professionals and will likely contribute to improved patient adherence and sustained, lower LDL-C levels. The Medicines Company expects to file regulatory submissions in the U.S. in 4Q19 and in Europe in 1Q20.
Mylan and Upjohn Join Forces as Viatris
In August, Mylan and Pfizer entered an agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company called Viatris. Mylan brings a diverse portfolio across many geographies and key therapeutic areas, such as central nervous system and anesthesia, infectious disease and cardiovascular, as well as a robust pipeline, high-quality manufacturing and supply chain excellence. Upjohn brings iconic brands, such as Lipitor, Celebrex and Viagra, and commercialization capabilities, including leadership positions in China and other emerging markets.
The transaction will allow the new company to expand the geographic reach of Mylan’s existing product portfolio and future pipeline, including significant investments that have been made across complex generics and biosimilars, into new growth markets where Upjohn has existing sales infrastructure and local market expertise.
