Expert answer:College Freshman Medical Chemistry

Expert answer:You must find at least one internet source about a recent (post 2014) development in nanotechnology and also answer the following questions.What do medicinal chemists do and where do they work?Why isn’t preventing cancer a priority in drug development?What are some of the drugs to watch in 2016? What diseases do this drugs target? (Additional reading attached)Who is the “Drugs to watch” report written for?What are some problems with drug development?What are drug company R&D divisions doing to overhaul current models?What are some risks to drug companies doing R&D?Please answer the questions for 280-350 words. That means the answer does not need to be specifically overall. Thank you for your help.
drugs_to_watch_2016.pdf

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Drugs to Watch 2016
Where the 2015
Drugs to Watch
Are Now
In January 2015, Thomson Reuters Cortellis
for Competitive Intelligence named 11 drugs
to watch that were predicted to enter the
market that year and make over US $1 billion
within 5 years.
The drugs ranked by highest sales forecasts for
2019 were: Bristol-Myers Squibb (BMS) and Ono
Pharmaceutical’s melanoma drug Opdivo (nivolumab);
Regeneron Pharmaceuticals and Sanofi’s Praluent
(alirocumab) for hypercholesterolemia; Novartis’
Entresto (LCZ-696; sacubitril and valsartan) for
chronic heart failure; Pfizer’s breast cancer drug
Ibrance (palbociclib); Vertex Pharmaceutical’s Orkambi
(lumacaftor plus ivacaftor) for cystic fibrosis; AbbVie’s
Viekira Pak (paritaprevir, ritonavir, ombitasvir and
dasabuvir) for hepatitis C virus (HCV) infection;
Amgen and Astellas Pharma’s hypercholesterolemia/
hyperlipidemia drug Repatha (evolocumab); Merck &
Co’s Gardasil 9 vaccine against human papillomavirus
(HPV) infection; Otsuka Pharmaceutical and Lundbeck’s
1
schizophrenia and depression drug
Rexulti (brexpiprazole); Sanofi’s Toujeo (new
formulation of insulin glargine) for diabetes; and
Novartis’ Cosentyx (secukinumab) for psoriasis and
psoriatic arthritis. All 11 drugs entered the market as
anticipated, and although the Cortellis Consensus sale
forecasts have fluctuated over the course of the year, all
of the drugs (with the exception of Gardasil 9, for which
forecasts were not available as of January 2016) are still
forecast to be $1 billion-plus blockbusters. An in-depth
discussion of the fortunes of the 2015 drugs to watch is
provided in the 2015—A Blockbuster year report.
Drugs to Watch 2016
Drugs to Watch
2016
There are seven emerging therapeutics that are
poised to enter the market in 2016 and achieve
blockbuster sales status by 2020. The majority
are anticipated to yield annual revenues of $1
billion to $2 billion, although two are set to
exceed this.
In the $2 billion-plus annual revenue bracket
are drugs treating chronic liver disease and HIV-1
infection. Ranked by highest sales forecasts for
2020, the potential blockbuster drugs are Intercept
Pharmaceuticals and Sumitomo Dainippon Pharma’s
obeticholic acid ($2.621 billion) for chronic liver disease;
Gilead Sciences and Japan Tobacco’s anti-HIV-1 infection
combination emtricitabine + tenofovir alafenamide
(F/TAF; $2.006 billion); Gilead Sciences and Janssen
R&D’s tenofovir alafenamide + emtricitabine + rilpivirine
(R/F/TAF; $1.572 billion) also for HIV-1 infection;
Merck & Co’s anti-HCV infection drug MK-5172A
(grazoprevir + elbasvir; $1.537 billion); Abbvie’s
chronic lymphocytic leukemia (CLL) agent venetoclax
($1.477 billion); ACADIA Pharmaceuticals’ Nuplazid
(pimavanserin; $1.409 billion) for Parkinson’s disease
psychosis (PDP); and Nippon Shinyaku Co and Actelion’s
Uptravi (selexipag; $1.268 billion) for pulmonary arterial
hypertension (PAH). A summary of the drugs to watch
in 2016 and their associated forecast sales data are
provided in Table 1 and Figure 1.
Thomson Reuters
Trends
Key trends in the pharmaceutical industry for 2016
and beyond, as exemplified by several of the potential
blockbuster drugs described herein, are the increasing
focus on rare diseases, the continued development
of more convenient fixed-dose combination (FDC)
regimens, and access to medicines and affordability.
With declining R&D productivity, the pharmaceutical
industry is increasingly turning to treatments for
rare diseases, also referred to as orphan diseases,
which are generally classified as affecting fewer than
200,000 people in the US and no more than 5 in
10,000 people in the EU. There are approximately
7,000 ‘rare’ diseases and disorders that affect around
350,000,000 individuals globally. Both Intercept/
Sumitomo Dainippon Pharma and AbbVie are aiming
to enter the orphan market in 2016 with their candidate
potential blockbusters drugs obeticholic acid (OCA) and
venetoclax, respectively.
2
Table 1: 2016 Drugs to Watch Forecast Sales Rankings
Ranking
(by highest sales
forecasts for 2020)
Drug
Disease
Chronic liver
diseases,
primarily primary
biliary cirrhosis
Pharmaceutical
Company
2020
Forecast Sales
Intercept Pharmaceuticals
and Sumitomo Dainippon
Pharma
2.621
(US $ billions)
1
Obeticholic acid
2
Emtricitabine +
HIV-1 infection
tenofovir alafenamide
(F/TAF)
Gilead Sciences and Japan
Tobacco
2.006
3
Tenofovir
alafenamide +
emtricitabine +
rilpivirine (R/F/TAF)
HIV-1 infection
Gilead Sciences and Janssen
R&D
1.572
4
MK-5172A
(grazoprevir +
elbasvir)
HCV infection
Merck & Co
1.537
5
Venetoclax
Chronic lymphocytic
leukemia
Abbvie
1.477
6
Nuplazid
(pimavanserin)
Parkinson’s disease
psychosis
ACADIA Pharmaceuticals
1.409
7
Uptravi (selexipag)
Pulmonary arterial
hypertension
Nippon Shinyaku Co and
Actelion
1.268
Analysis based on data accessed on January 08, 2016
Source: Thomson Reuters Cortellis
Traditionally, the development of orphan drugs has not
been an area of focus for the pharmaceutical industry,
given the limited number of patient populations for
each disease and the challenges caused by the often
scant knowledge regarding cause, pathophysiology and
epidemiology. However, this trend has been changing
steadily as the revenue potential of orphan drugs
becomes more evident.
In 2015, the FDA approved more orphan drugs for rare
diseases than any previous year: 21 (47%) of the novel
drugs approved by the FDA in 2015 were classified as
orphan drugs, compared with 17 (41%) in 2014, 9 (33%)
in 2013, 13 (33%) in 2012 and 11 (37%) in 2011. This shift
has been stimulated by a range of commercial drivers,
including reduced timelines for clinical development
and a higher probability of approval, a longer period of
marketing exclusivity, tax credits and user fee waivers,
premium pricing, faster uptake and lower marketing
costs. It is anticipated that such incentives will continue
to promote the shift toward a drug development
business model that incorporates orphan diseases.
3
Gilead’s FDC products, such as the TDF/TAF-based
products described in this article, have allowed the
company to gain significant shares in the HCV and
HIV markets. Such products are becoming increasingly
important in the management of complex diseases,
such as HIV infection, diabetes and cardiovascular
disease. FDCs can also confer a range of advantages
to both the developing company and patient. These
products can provide lifecycle extension strategies
and product differentiation, as well as increased efficacy
with the added benefit of reduced pill burden to improve
patient convenience and compliance. The FDA has
further incentivized the development of FDC products
by making them eligible to five years of market-based
exclusivity upon regulatory approval. Prior to October
2014, such products were ineligible for this protection.
Drugs to Watch 2016
Figure 1: 2016 Drugs to Watch Forecast Sales (US $ Millions)
3000
Obeticholic acid
Emtricitabine + tenofovir alafenamide (F/TAF)
Tenofovir alafenamide + emtricitabine + rilpivirine (R/F/TAF)
MK-5172A (grazoprevir + elbasvir)
Venetoclax
Nuplazid (pimavanserin)
Uptravi (selexipag)
Sales US $ Millions
2500
2000
1500
1000
500
0
2014
2015
2016
2017
2018
2019
2020
Year: actual sales data in 2014; forecast sales data from 2015
Source: Thomson Reuters Cortellis
Price Fixing
The growing conflict between access to drugs
and affordability is also likely to intensify in 2016.
A congressional committee is investigating the high
prices of innovative new branded therapeutics in the
US. As that nation’s presidential election looms, the
increased political focus on drug pricing is expected
to continue.
Several companies have come under fire regarding
their pricing strategies, most notably Gilead, which has
experienced intense scrutiny for the pricing of its HCV
treatments Sovaldi and Harvoni. The growing conflict
between access to medicines and affordability is not
only seen in the US. It is a worldwide issue, with
Europe’s health agencies struggling to pay for
expensive new drugs.
One new initiative that Novartis is testing with its
heart failure drug Entresto is a success-driven pricing
model, where the price is set based on an assumption
that the number of hospital admissions and therefore
Thomson Reuters
treatment costs will fall below a certain level. It will be
interesting to see if other companies follow suit. Such
drives to improve value for money, as well as to increase
affordability and access, may impact potential sales
revenues of new drugs entering the market in 2016.
This year may also witness the first and only drug to be
approved in the US for PDP and the first new treatment
for primary biliary cirrhosis (PBC) to reach the market in
more than two decades.
Obeticholic Acid for
Chronic Liver Disease
Intercept and Asian licensee Sumitomo Dainippon
Pharma are developing the farnesoid X receptor agonist
OCA for the potential oral treatment of chronic liver
diseases. A rolling NDA submission was initiated in
December 2014 for PBC in patients with inadequate
response to ursodeoxycholic acid (UDCA) or as
monotherapy in adults unable to tolerate UDCA.
4
A key trend in 2016, as
exemplified by the potential
blockbuster drugs, is the
continued development of more
convenient fixed-dose, all-oral
regimens for HCV and HIV.
In August 2015, the NDA was granted Priority Review
with a Prescription Drug User Fee Act (PDUFA) date set
for February 29, 2016. However, in December 2015, the
FDA extended the PDUFA date by 3 months to May 29,
2016, following the submission of extra clinical data in
response to an FDA request. A marketing authorization
application (MAA) was accepted for review in Europe for
PBC in June 2015.
In PBC, clinically meaningful biochemical improvements
were seen in the phase III POISE study in patients not
responding to UDCA: 47% of patients had ALP levels
<1.67 times the upper limit of normal at 6 months and total bilirubin within normal limits within 12 months, versus 10% of placebo patients. However, PBC is a rare liver disease that results from autoimmune destruction of the bile ducts in the liver, and estimates of annual incidence and prevalence range from 2 to 24 cases per million and 19 to 240 cases per million, respectively. OCA has also demonstrated good efficacy in phase II studies in nonalcoholic steatohepatitis (NASH), and it is the larger NASH market that is anticipated to be the most lucrative. NASH is estimated to affect 2 to 3% of the population and the worldwide market is expected to expand rapidly due to an increasing incidence of predisposing factors, such as metabolic disease, obesity and insulin resistance. Currently, there is no approved treatment for NASH. The Breakthrough designation awarded to OCA for this indication raises the hope that the registration path for NASH will be possible without an outcomes trial. Intercept stated that the phase III REGENERATE study, which is scheduled to complete in 2021, will form the basis of regulatory filings for NASH. If approved, OCA could become the first new treatment for PBC in more than two decades. Forecasts predict sales of OCA of $29 million in 2016, rising to $2.621 billion in 2020. Competitor UDCA is the only drug currently approved for PBC and it is now generic. Potential longer-term competition for PBC comes from investigational agents GSK-2330672, A-4250, MBX-8025, NGM-282 and SHP-625. Genfit’s PPAR alpha and delta agonist GFT-505 (elafibranor) is in phase II studies and is expected to be OCA’s main near-term competitor in the oral NASH market. Gilead’s allosteric humanized mAb simtuzumab, which inhibits lysyl oxidase-like 2 (LOXL2), is an infusion that may also feature in the NASH market. Simtuzumab is in phase II development and may be useful in reversing the fibrosis associated with liver cirrhosis. Thomson Reuters Fixed-Dose Combinations for HIV Infection Gilead’s nucleoside reverse transcriptase inhibitor tenofovir alafenamide fumarate (TAF; GS-7340), a follow-on to the company’s tenofovir disoproxil fumarate (TDF), is currently being developed as a component of several FDC regimens, including the potential blockbuster regimens emtricitabine (a nucleoside reverse transcriptase inhibitor) + tenofovir alafenamide (F/TAF) and tenofovir alafenamide + emtricitabine + rilpivirine (a non-nucleoside reverse transcriptase inhibitor; R/F/TAF), for the potential treatment of HIV-1 infection. The F/TAF regimen was filed for US and EU approval in April and May 2015, respectively, for the treatment of HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents. A PDUFA date of April 07, 2016, has been set in the US. Regulatory filings in the US and EU for the R/F/TAF regimen were submitted in July and August 2015, respectively. A Priority Review voucher acquired from Knight Therapeutics was submitted along with the US filing to expedite the review and a PDUFA date of March 01, 2016, has been set. The filings for the F/TAF and R/F/TAF regimens are based on data from phase III clinical studies evaluating the safety and efficacy of the TAF-based regimen Genvoya (emtricitabine/cobicistat/elvitegravir/tenofovir alafenamide or E/C/F/TAF), which demonstrated non-inferior efficacy and improved renal and bone mineral density (BMD) measurements compared with the TDF-based regimen Stribild (comprising E/C/F/ TDF). Genvoya was effective in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Additionally, F/TAF also demonstrated non-inferior efficacy to the widely used E/TDF combination drug Truvada in a head-to-head phase III trial, but with less impact on BMD and renal parameters, highlighting its potential to become a safer replacement for Truvada. The improved longevity of HIV-infected patients and widening of the antiretroviral eligibility criteria are expanding the size of the already large HIV market, providing significant revenue-generating opportunities. Market-leader Gilead has a dominant position within the HIV market given its convenient, once-daily combination products with reduced pill burden, such as the TDFbased regimens Atripla (emtricitabine/efavirenz/TDF), Truvada, Stribild and Complera/Eviplera (emtricitabine/ 6 rilpivirine/TDF). In 2014, Atripla, Truvada, Stribild and Complera generated combined sales of $9.235 billion. However, expiry of patent coverage for TDF begins in July 2017 and Teva has entered into an agreement in principle to launch its generic version of the drug in December 2017. The entry of generic versions of TDF will make allgeneric regimens a possibility in the short term, and their availability will impact sales of Gilead’s four TDF-based regimens, with combined sales predicted to decrease to $8.589 billion in 2020. TAF has the potential to protect Gilead’s HIV franchise from generic TDF competition, as the patents covering TAF extend to 2025 in the US and 2027 in the EU. The company’s Genvoya was the first TAF-based regimen to enter the market in December 2015 and additional F/TAF-based regimens for HIV treatment are currently in development. If approved, the TAF-based regimens F/TAF and R/F/TAF will face competition from other TAF-based regimens as well as from GlaxoSmithKline/ViiV’s Triumeq, the first non-Gilead single-tablet regimen that has been helping to increase ViiV’s share of the HIV market since its launch in September 2014. Triumeq is expected to generate sales of $4.020 billion in 2020. Forecasts predict respective F/TAF and R/F/TAF sales of $320 million and $176 million in 2016, rising to $2.006 billion and $1.572 billion in 2020. MK-5172A for Hepatitis C Virus Infection Merck & Co’s MK-5172A is an oral fixed-dose tablet formulation of the pan-genomic NS3/4A inhibitor grazoprevir (MK-5172) and the NS5A inhibitor elbasvir (MK-8742). Cure rates of between 92% and 100% were seen in phase III trials, including in treatment-naïve and experienced patients, as well as in patients with compensated cirrhosis and those with advanced chronic kidney disease stage 4 or 5. MK-5172A received approval in the US in January 2016 for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin. Merck had previously received FDA Breakthrough Therapy designation for treating patients with chronic HCV genotype 1 infection in October 2013, although this designation was rescinded in January 2015 based on recent approval of treatments for HCV genotype 1 infection. 7 Merck experienced a further setback in December 2015 when the European Medical Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) stated that the MAA, which had previously been accepted for an accelerated assessment, would now be assessed under the standard process; a decision in the EU is expected in mid-2016 according to Merck. Interferon-free regimens are expected to become the standard of care as the elimination of side effects associated with interferon improves quality of life significantly. MK-5172A will face tough competition from recent interferon-free market entrants, including Gilead’s once-daily pill Harvoni (sofosbuvir/ledipasvir) and Abbvie’s twice-daily four pill offering Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets). However, Merck could experience some respite, as sales forecasts of Viekira Pak have been clipped by an FDA warning released in October 2015 highlighting a potential risk of serious liver injury for certain patients. Merck could therefore gain a competitive advantage over Viekira Pak if the company is able to position MK-5172A as a safer option. Nevertheless, gaining market share from Harvoni could be challenging, as Harvoni has first-to-market advantage and a best-in-class profile. Current forecasts predict 2020 sales of $9.335 billion for Harvoni versus $1.749 billion for Viekira Pak, while MK-5172A is anticipated to achieve sales of $636 million in 2016, rising to $1.537 billion in 2020. Both Gilead and Abbvie have come under intense scrutiny regarding the high price of these drugs, which were listed for around $90,000 per treatment course. Discounted pricing with pharmacybenefit managers, insurers and other payers has featured significantly in the competition between these two agents. An aggressive pricing strategy for MK-5172A versus the Gilead and AbbVie regimens could drive growth as competition intensifies within the market for interferon-free, all-oral regimens to treat HCV. Venetoclax for Chronic Lymphocytic Leukemia Second-generation BH3-mimetic venetoclax (ABT-199) is being developed by AbbVie, in collaboration with Genentech, as a potential oral treatment for cancer, primarily CLL. In September 2012, venetoclax received Orphan designation for the treatment of CLL and in May 2015 the FDA granted the agent Breakthrough Therapy designation for the treatment of patients with Drugs to Watch 2016 relapsed or refractory CLL with 17p deletion. An NDA was submitted to the FDA for venetoclax for relapsed or refractory CLL with 17p deletion in November 2015 and by December 2015, an MAA had also been filed in the EU. Venetoclax was one of the leading agents at the 2015 annual meeting of the American Society of Hematology, with over 40 presentations on the drug in multiple indications. Enthusiasm for venetoclax was generated, at least in part, by data reported from the pivotal phase II M13-982 trial in patients with relapsed/refractory CLL who have del17p. An overall response rate of 79.4% was observed, with 12-month progression-free survival and overall survival rates of 72.0 and 86.7%, respectively. The M13-982 trial formed the basis of the regulatory filings for venetoclax ... Purchase answer to see full attachment

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