Nusinersen
Top drugs and pharmaceutical companies of 2019 by revenues
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

Impressions: 54752

https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

#PharmaFlow by PHARMACOMPASS
29 Apr 2020
Top Biotech and Pharma Deals in April 2018
Insofar as pharma M&As are concerned, 2018 is turning out to be a milestone year with more than US$ 170 billion invested in the first quarter alone. While March saw a steep climb in deal values with the Cigna-Express Scripts US$ 67 billion acquisition, April remained significant for Novartis’ renewed interests in gene therapy — the Swiss pharma giant acquired AveXis, a clinical-stage gene therapy company, for US$ 8.7 billion. Novartis retains focus on gene therapy with US$ 8.7 billion AveXis buyout   In a bid to secure its leadership position in gene therapy, Novartis struck a deal to acquire Illinois-based AveXis, a clinical-stage gene therapy company working to develop treatments of rare and life-threatening neurological genetic diseases. AveXis’ lead pipeline candidate is a neurology-targeted treatment based on virus-mediated gene therapy — AVXS-101. It has the potential to be the first one-time gene replacement therapy for spinal muscular atrophy (SMA), a disease which results in early death or lifelong disability with considerable healthcare costs.  “What was remarkable and what we consider transformative – and frankly all the experts in the SMA field also feel the same – is that we had 100 percent survival of the children at 13.6 months of age, and 100 percent survival of the children at 20 months of age,” Sukumar Nagendran, the chief medical officer of AveXis said in an interview with SMA News Today. Click here to view the major deals in April 2018 (FREE Excel version available) In addition, AVXS-101 has attained the Breakthrough Therapy Designation in the US and the Sakigake Designation in Japan. Moreover, this therapy, which is currently in Clinical Phase 3 development, also has access into the PRIority MEdicines (PRIME) scheme in the EU.Novartis CEO Vas Narasimhan said recently the patient population for SMA was 23,500 people in established markets. A filing with the US Food and Drug Administration (FDA) for AVXS-101 is expected in the second half of 2018 and approval and launch in the US is expected in 2019. Click here to view the major deals in April 2018 (FREE Excel version available) P&G acquires Merck KGaA’s consumer healthcare business   Proctor & Gamble, one of the world’s largest personal care goods manufacturer, announced in mid-April that it has agreed to buy Merck KGaA’s consumer health unit for US$ 4 billion (€3.4 billion). This was just weeks after GlaxoSmithKline announced its buyout of Novartis’ consumer healthcare joint venture for US$ 13 billion. Priced at US$ 4.2 billion, the deal enables P&G to expand its successful consumer healthcare business by adding a fast-growing portfolio of differentiated, physician-supported brands across a broad geographic footprint. P&G now has better access to the Asian and Latin American markets, and an enhanced product portfolio that includes vitamin brands like Femibion, Neurobion and Seven Seas. It also provides P&G with leadership in consumer healthcare, complementing its existing portfolio that includes brands like Vicks, Metamucil, Pepto-Bismol, Crest and Oral-B. According to Reuters, the purchase price for Merck’s business suggests the German consumer healthcare conglomerate climbed down from price demands of as much as US$ 4.71 billion (€4 billion), which may have deterred initial suitors such as Nestle. Click here to view the major deals in April 2018 (FREE Excel version available) Ionis is flush with cash as it bags deals with Biogen and AstraZeneca   Carlsbad, California-based drug maker, Ionis Pharmaceuticals, which successfully brought Spinraza (nusinersen) to clinic, earned US$ 1 billion in cash from Biogen as the two companies expanded their research collaboration on neurological diseases. Biogen announced in April this year that the transaction builds upon the collaboration that produced Spinraza as well as two antisense drug candidates currently in the clinic, with the potential to advance up to seven more drug candidates to the clinic within the next two years. Biogen’s announcement came less than two weeks after AstraZeneca paid Ionis a US$ 30 million license fee for its potential treatment for nonalcoholic steatohepatitis (NASH) where the inhibition target is undisclosed. Click here to view the major deals in April 2018 (FREE Excel version available) Ionis stands to receive up to US$ 300 million in additional development and regulatory milestone payments, as well as tiered royalties from sales of the drug.Speaking about the development, Brett P. Monia, CEO and senior vice president of Antisense Drug Discovery at Ionis Pharmaceuticals said: “AstraZeneca has played a strategic role in advancing this program forward by providing both preclinical and development expertise in NASH that has contributed to the rapid advance of this drug into development. We look forward to AstraZeneca moving this program swiftly into clinical testing and ultimately to the market.”  Click here to view the major deals in April 2018 (FREE Excel version available) Rise in immuno-oncology deals   Shire announced it was selling its oncology business to French company Servier for US$ 2.4 billion, whilst Takeda said it was considering an acquisition bid for Shire. Servier has obtained the rights to Shire’s presently marketed chemotherapy agent, Oncaspar, and pancreatic cancer treatment, Onivyde. Additionally, Shire’s pipeline of immuno-oncology assets (including Calaspargase Pegol under priority review) are all part of the offerings that were made during the divestment to Servier.  For Servier, the acquisition of Shire’s oncology franchise enables it to establish a stronger “commercial presence in the US as well as the ex-US territories where Servier is already present,” Olivier Laureau, President of the Servier Group, said. Two dedicated cancer immunotherapy companies — Allogene Therapeutics and Cellectis — together announced a joint asset contribution agreement involving select allogeneic CAR-T programs from Pfizer’s oncology portfolio for a massive US$ 2.8 billion. This deal also landed Allogene US$ 300 million in funding and Pfizer a 25 percent stake in the company. Click here to view the major deals in April 2018 (FREE Excel version available) The immune-oncology collaboration provides Allogene exclusive rights to develop 16 preclinical assets including UCART19 — a CAR T-cell product jointly developed by Servier and Pfizer that Pfizer had earlier licensed from Cellectis and Servier.     Cellectis’ CAR-T platform provides an allogeneic approach of using engineered T-cells from healthy donors, which makes T-cell therapy more accessible to cancer patients. This is distinct from autologous approaches that require the patient’s own T-cells for targeting tumor cells.  Early last month, Boehringer Ingelheim and OSE Immunotherapeutics entered into an immuno-oncology collaboration to develop OSE-172 — a novel antibody targeting myeloid lineage cells.  Click here to view the major deals in April 2018 (FREE Excel version available) While this highlights Boehringer Ingelheim’s strategy to strengthen its core pillar of cancer immunology, Paris-based OSE stands to receive approximately US$ 1.2 billion (€1.1 billion) upon reaching pre-specified development, commercialization and sales milestones, plus royalties on worldwide net sales. Our view   Deals by major pharmaceutical companies during the month of April continued to be driven by their focus on gene therapy and immuno-oncology. While companies like Novartis, Biogen, AstraZeneca and Boehringer-Ingelheim are betting big on drugs that are still in development, others like Proctor & Gamble, Servier and Takeda have chosen to acquire proven assets that will immediately contribute to their sales. All eyes are set on Pfizer, which is exploring a sale of its consumer healthcare business. However, the pharma major has seen potential suitors drop out and during an earnings call a few weeks ago, its chairman Ian Read ruled out a transformative deal. “I don’t see that we need a transformative deal or see one at an appropriate value,” Read had said. Even if the Pfizer deal does not prove to be transformative, the M&A deals in the first few months of 2018 surely indicate that the world of pharmaceuticals is transforming at a fast pace. Click here to view the major deals in April 2018 (FREE Excel version available)  

Impressions: 3242

https://www.pharmacompass.com/radio-compass-blog/top-biotech-and-pharma-deals-in-april-2018

#PharmaFlow by PHARMACOMPASS
17 May 2018