Breakthroughs in Pharma Industry in the last 12 months

Immunotherapy for Cancer Treatment

In an international trial conducted by various organizations, 945 patients with advanced Melanoma (a type of skin cancer) were treated using the drugs ipilimumab and nivolumab. The treatment was able to delay the advancement of the cancer cells for nearly a year in 58% of the cases, with tumors stable or shrinking for an average of 11.5 months, researchers found.

Prof. Roy Herbst, Chief of Medical Oncology at Yale Cancer Centre (USA), said that the treatment uses body’s immune system to attack cancerous cells and could potentially replace chemotherapy as the standard cancer treatment within five years.

“It is being seen as the third major breakthrough in cancer treatments: the first being chemotherapy, the second being targeted treatments and the third being immunotherapy,” said Colin White, Lead Analyst for Oncology at the research group Datamonitor Healthcare.

Ipilimumab was approved as an advanced melanoma treatment in the UK last year. The drug is given intravenously every three months and costs approximately USD 1,39,755 per year. Nivolumab is given every two weeks until it stops working. According to some estimates, the market for immuno-oncology drugs could be as big as USD 35 billion. There is a strong opportunity to profit from dedicated R&D in this arena.

A combination of these treatments also increases the likelihood of potentially severe side-effects, including fatigue, rash and diarrhea.

Entresto (TM) for Cardiovascular Diseases

Novartis’ new FDA approved medicine Entresto reduces the strain on the failing heart, and is prescribed for reducing the risk of cardiovascular death and heart failure. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.

In the pivotal PARADIGM-HF trial in 2014, Entresto was shown to reduce cardiovascular death by 20% as compared to standard ACE inhibitor treatment with enalapril, while cutting sudden deaths by 19%, death from any cause by 16% and hospitalization by 23%.

Entresto costs about USD 4,500 annually and was approved by the government in July 2015. Sales of Entresto totaled USD 21 million in 2015, a small portion for a drug company that had USD 49 billion in total revenue last year. The staggering point is that the total product sales touched USD 21 million in 5 months of launch. Novartis estimated peak global sales for the drug could reach USD 5 billion, while some wonder if its value-based contracts are a move to hit a larger patient base.

Most common side effects of Entresto include hypotension (low blood pressure), hyperkalemia (high blood potassium), cough, dizziness, and kidney (renal) failure.

Amgen Inc.’s Repatha (Evolocumab) for High Cholesterol

Evolocumab belongs to a new therapeutic class known as PCSK9 inhibitors. These inhibitors limit the liver’s ability to remove bad cholesterol (LDL – low density lipoprotein) from the blood.

Repatha’s USD 14,100 annual wholesale cost is way higher than the current standards of care for high LDL-cholesterol readings. By 2020, the sales of Repatha are expected to reach USD 2.3 billion,

Repatha is approved in the United States, Japan, Canada, Australia, Kuwait, in all 28 EU countries, as well as Norway, Iceland, and Liechtenstein. Applications in other countries are pending.

Common side effects with Repatha use include nasopharyngitis (common cold), upper respiratory tract infections, influenza, back pain, and injection site reactions like redness, pain or bruise. Allergic reactions, such as rash and hives, have been reported.

Ibrance (Palbociclib) for Breast Cancer

Cancer cells grow in uncontrolled fashion. Ibrance (FDA approved) is a cyclin-dependent kinase 4/6 inhibitor. A kinase is a type of protein in the body that helps control cell division. Ibrance works by interfering with the kinase and stopping cancer cells from dividing and growing. Ibrance is specifically indicated for use in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer as initial endocrine-based therapy for their metastatic disease.

Annual sales for cancer drug Ibrance, which was approved in the USA early last year, stood at USD 723 million for 2015. JP Morgan analysts suggested that the product will generate annual sales of up to USD 4 billion by 2020.

IBRANCE may cause serious side effects, including: Low white blood cell counts (neutropenia), serious or life-threatening infections and blood clots in the arteries of your lungs.

Rexulti (Brexpiprazole)for Schizophrenia

Co-developed by Otsuka and Lundbeck, Rexulti is now FDA approved for the adjunctive treatment of major depressive disorder and the treatment of schizophrenia.

Following the launch in the US in August 2015, Rexulti crossed USD 17 million for the year. The drug is expected to grow to approx. USD 750 million. Thesalesin USA grew 2.5% to USD 1.1 billion in the first quarter of 2015 and was the 11th biggest-selling drug in the world by global sales in July 2015.

Some of the side effects associated with the use of Rexulti may include, Akathisia (movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion) and weight gain.

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