Chemical entities SHINE in the top 10 fastest-growing drugs of 2016

Global pharmaceutical companies are increasingly focusing on the development of new biologics. In fact, in 2016, nine out of the top 15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder what the future holds for manufacturers specializing in drugs that originate from chemical synthesis.

This week, PharmaCompass continued its analysis of the top pharma drugs by sales to evaluate the drugs that registered large sales growth in 2016.

Please note that these are not the top-selling drugs, but are the top 10 drugs that registered the maximum growth in global sales over 2015.

Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis.

Here’s a list of drugs that witnessed the largest sales growth in 2016:

1. Opdivo (nivolumab) – Bristol-Myers Squibb

2016 sales: US$ 3,774 million

2015 sales: US$ 942 million

Sales growth: US$ 2,832 million

First approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer.

With a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth of any single drug in 2016. However, Bristol-Myers Squibb received a nasty surprise last year when Opdivo did not demonstrate the desired slowdown in the progress of advanced lung cancer in a trial, as compared to conventional chemotherapy.

While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million.

2. Humira (adalimumab) – AbbVie

2016 sales: US$ 16,078 million

2015 sales: US$ 14,012 million

Sales growth: US$ 2,066 million

Abbvie’s Humira (adalimumab) juggernaut continued as it not only remained the best-selling drug in the world, but also added another US$ 2 billion to its 2015 sales by generating record sales of US $16.078 billion in 2016.

Last year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.

3. Epclusa (sofosbuvir and velpatasvir) – Gilead

2016 sales: US$ 1,752 million (new launch)

Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead’s other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion.

4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie

2016 sales: US$ 3,083 million

2015 sales: US$ 1,443 million

Sales growth: US$ 1,640 million

Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally.

5. Eliquis (apixaban) – Bristol-Myers Squibb / Pfizer

2016 sales: US$ 3,342 million

2015 sales: US$ 1,860 million

Sales growth: US$ 1,483 million

Although apixaban was the third-to-market novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its class based on total prescriptions. Rivaroxaban’s total 2016 sales were US$ 5.392 billion.

While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban.

6. Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) — Gilead

2016 sales: US$ 1,484 million

2015 sales: US$ 45 million

Sales growth: US$ 1,439 million

Genvoya has been the most successful HIV treatment launch since the introduction of Atripla (the first single-tablet regimen launched a decade ago). Gilead is the dominant HIV player in the US market and has the top three most-prescribed HIV regimens in the US.

Genvoya adds Tenofovir Alafenamide (TAF) to already known treatments. TAF based drugs have demonstrated a better safety profile. They would also allow Gilead to maintain its dominance in the HIV market.

7. Ibrance (palbociclib) — Pfizer

2016 sales: US$ 2,135 million

2015 sales: US$ 723 million

Sales growth: US$ 1,412 million

Discovered in Pfizer laboratories and approved by the US FDA in February 2015, Ibrance is used in combination with Letrozole as a first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.

8. Triumeq (abacavir, dolutegravir, lamivudine) – GlaxoSmithKline

2016 sales:US$ 2,151 million

2015 sales: US$ 905 million

Sales growth: US$ 1,246 million

GlaxoSmithKline’s HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine.

9. Revlimid (lenalidomide) – Celgene

2016 sales: US$ 6,974 million

2015 sales: US$ 5,801 million

Sales growth: US$ 1,173 million

Celgene’s Revlimid (lenalidomide) — a thalidomide-derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene’s total sales of US$ 11.229 billion.

10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer

2016 sales: US$ 5,392 million

2015 sales: US$ 4,255 million

Sales growth: US$ 1,137 million

Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the class lead in indications.

Xarelto recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the blood thinner in preventing major adverse cardiac events (MACE).

The trial was stopped a year early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE (which includes cardiovascular death, myocardial infarction and stroke) reached its pre-specified criteria for superiority over aspirin.

Our view

In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that over the coming five years the industry should continue to receive 40 to 45 new drug approvals every year.

A quarter of all the drugs in late-stage development are now focused on oncology. The rate of oncology drug development has hit such a rapid pace that new drugs are superseding old ones in a matter of a few years.

It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore.

 

Article credit: https://www.pharmacompass.com/radio-compass-blog/chemical-entities-shine-in-the-top-10-fastest-growing-drugs-of-2016

Carfilzomib Shines in Studies of Patients with Relapsed Myeloma

carfilzomibCarfilzomib shined in pharmaceutical headlines recently with encouraging study data being shared in June 2015. Known as the brand name anticancer therapy Kyprolis, which is marketed by Onyx, the Carfilzomib injection proved to be superior to a Bortezomib-Dexamethasone combination treatment in patients with refractory multiple myeloma. Carfilzomib is an effectual single-agent therapy and proteasome inhibitor which in studies doubled progression free survival time in patients suffering from relapsed multiple myeloma. When compared to a combination therapy of Bortezomib and Dexamethasone, a higher dose of Carfilzomib then currently approved elicited an average progression free survival time of 18.7 months versus 9.4 months, respectively. Being that the standard best in care therapy for patients with unresectable multiple myeloma is currently Bortezomib and Dexamethasone, this new information regarding Carfilzomib efficacy offers new hope for the many patients who seek longer and better quality progression free survival time.

Myeloma AgeThe FDA approved dosage of Carfilzomib is 20 milligrams on days one and two of the first cycle, followed by a dosage of 27 milligrams daily thereafter to be infused in a two to ten minute time frame. Data from phase a first-ever phase III randomized study compared Carfilzomib with the standard therapy of Bortezomib, with both groups of patients also receiving Dexamethasone. In total 929 patients were dosed with Carfilzomib 20/56 mg/m2 via a 30 minute infusion or Bortezomib 1.3 mg/m2, via a subcutaneous injection or intravenously. All patients also received 20 milligrams daily of Dexamethasone. The patient population who were dosed with Carfilzomib regimen had it administered in 28-day cycles versus a 21-day cycle of treatment for the patients who were given Bortezomib. Roughly 15 percent of the patients enrolled in this study were older than age 75, but the average age for all of the participants was 65 years of age. A 47 percent reduction in hazard for disease progression or mortality was established for patients who were administered Carfilzomib and Dexamethasone, with twice as many participants achieving a complete response as compared the Bortezomib patient group. While grade 3 adverse events did occur with patients in both study groups, the most frequently reported side effects included fatigue, diarrhea, dyspnea and pyrexia.

LGM Pharma can assist clients as a supplier/distributor of the API Carfilzomib, CAS # 868540-17-4 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Gemcitabine and Cisplatin Continue as Successful Therapy for Patients with NSCLC

Gemcitabine and Cisplatin

Patients with non-small cell lung cancer, also known as NSCLC, are anxiously awaiting a decision from the FDA’s Oncologic Drugs Advisory Committee regarding Eli Lilly’s introduction of Necitumumab to the already formidable Gemcitabine and Cisplatin combination. Both Gemcitabine and Cisplatin are currently the first line-treatment for patients diagnosed with NSCLC, and the addition of Necitumumab looks to be a promising happening on the horizon. Not only was the addition of Necitumumab to the Gemcitabine and Cisplatin pair tolerable in studies, overall survival rates significantly improved with the new trio of treatments.

Results from the successful phase III clinical trial which combined Gemcitabine, Cisplatin and Necitumumab have been encouraging. Approximately 1,093 patients were enrolled in this landmark study, which demonstrated a median overall survival time of 11.5 months for patients treated with all three drugs. Compared to patients who were dosed with Gemcitabine and Cisplatin only, there was a definite improvement in overall survival rates- 11.5 months versus 9.9 months, respectively. The aforementioned study, coined SQUIRE, included 184 investigative sites in 26 countries. All of the patients in the study had stage IV squamous NSCLC and were admitted to the study, regardless of their EGFR mutation status. A 3-week schedule is most often administered when dosing both Gemcitabine and Cisplatin, and this was the case in the SQUIRE study. Of the 1,093 patients, 545 patients were randomized to receive Gemcitabine and Cisplatin plus Necitumumab and 548 patients were dosed Gemcitabine and Cisplatin only. Exactly 800 milligrams of Necitumumab was administered to patients on day 1 and 8 every 3 weeks. In both groups Gemcitabine was dosed at 1250 mg/m2 on days 1 and 8 and 75 mg/m2 of Cisplatin was given on day 1 only. Patients were balanced in both of the study arms, with statistical data revealing an average participant age of 62, with 84 percent of patients being of the Caucasian ethnicity and 91 percent of people being smokers. More information will be presented in September 2015 at the 16th World Conference on Lung Cancer.

As the most commonly diagnosed form of lung cancer NSCLC accounts for roughly 85 percent of all lung cancer patients. The squamous form of NSCLC is less common, and effects less patients, but is much more difficult to treat effectively. Unfortunately the majority of patients are diagnosed with squamous NSCLC when the disease has progressed extensively, leaving an average five year survival rate of less than five percent. Further R&D is needed using the effectual Gemcitabine and Cisplatin products.

LGM Pharma can assist clients as a supplier/distributor of the APIs Gemcitabine, CAS # 95058-81-4 and Cisplatin CAS #15663-27-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

Sonidegib FDA Approved as Once Daily Treatment for Locally Advanced Basal Cell Carcinoma

Sonidegib FDA Approved for Locally Advanced Basal Cell CarcinomaOn July 24, 2015 the FDA approved Sonidegib, marketed by Novartis AG as the once daily pill Odomzoa for the treatment of locally advanced basal cell carcinoma. Specifically for patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.

Sonidegib, also known as the compound LDE225, had recently captured the attention of the pharmaceutical and medical industry worldwide, due to extremely successful study data. Conducted by Novartis, the reports from a Phase 2 study have shown Sonidegib to be a top-notch drug, eradicating basal cell carcinoma in a number of patients. Dispensed as an oral treatment for patients suffering from advanced basal cell carcinoma, the study results easily met the primary endpoint, garnishing an objective response rate within six months’ time. The objective response was based on the criteria of the complete absence of advanced basal cell carcinoma, and clinically sizable tumor shrinkage. The pharmaceutical industry was poised for an earlier than planned FDA application from Novartis, based on these incredible Phase 2 results.

smoothendAs an effectual drug that inhibits a receptor coined smoothened, that regulates the hedgehog signaling pathway, Sonidegib efficiently and safely blocks tumor growth. With basal cell carcinoma accounting for over 80 percent of non-melanoma cancers, treatments for advanced stages of this form of skin cancer are urgently needed. The advent of an easy to dispense oral treatment to fight this now common cancer worldwide offers hope for a greater number of patients. Around the world there is a 10 percent incident increase of basal cell carcinoma every year, which is likely due to an aging population and greater exposure to dangerous ultraviolet rays. Basal Cell Carcinoma does not often metastasize, but more advanced cases of this regularly seen disease are manifesting. The exciting data gleaned from Novartis’s study of Sonidegib showcasing patients who achieved complete remission is nothing short of miraculous.

LGM Pharma provides Sonidegib CAS# 956697-53-3, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Caspofungin Therapy Aids ALL Patients with Invasive Fungal Disease

caspofunginExciting news was shared in the January 2015 issue of Mycoses, with clinical data revealing that the use of Caspofungin to treat invasive fungal disease in leukemia patients was both positive and responsive. Adult patients who were diagnosed with acute lymphoblastic leukemia attained relief from their suspected fungal disease after the clinical use of Caspofungin. As an effectual member of the echinocandin drug class Caspofungin is often used in patients who have not responded to prior antifungal treatments. Caspofungin has, however, proved to be widely effective for treating an array of serious fungal infections, particularly in immunocompromised patients such as the patient population aforementioned. The administration of Caspofungin is done intravenously, with a typical dosage being dispensed slowly over a one hour period. Side effects can sometimes include nausea, diarrhea, and headache and skin flushing.

The risk of invasive and life-threatening fungal disease is specifically common in patients with acute lymphoblastic leukemia (ALL). This patient group will be at a greater risk for this virulent fungal disease typically after either a hematopoietic stem cell transplantation or cytotoxic chemotherapy. Data gleaned from the study shared in Mycoses showed that when patients with ALL who received Caspofungin empirically attained treatment that was deemed therapeutically effective. Nine medical centers in Germany participated in the ALL/Caspofungin data analysis, with information being collected between 2006 and 2012. Therapy duration of at least 8 days of treatment with Caspofungin in these patients with suspected invasive fungal disease proved that 95 percent of patients attained efficacy, including those patients who were considered critically ill.

LGM Pharma can assist clients as a supplier/distributor of the API Caspofungin, CAS #162808-62-0 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.