Medical network - March 16 for pharmaceutical companies, 2016 is an unusual year, because the FDA approved only 22 kinds of new drugs. The pharmaceutical industry in 2017 will do much better remains to be seen.
According to EP Vantage for 2017 is expected to or has the foresight of listed drugs, Roche (Roche) treatment of multiple sclerosis (MS) drugs Ocrevus is a new list of the most attractive, the drug is expected to break the market pattern from multiple aspects.
In the clinical trials of patients with primary progressive MS, than the current standard treatment curative effect of Ocrevus, namely Germany Merck (Merck KGaA) of interferon is better, and show other drugs do not have effect. This will cause pressure to other drugs, and the insurance company for drug firms price pressure.
In addition, analysts say if insurance company is not pressure, Sanofi (Sanofi) and regeneration yuan (Regeneron) Dupixent hot new drug for the treatment of allergic dermatitis, can also cause a big market.
It is worth noting that 2017 will be listed on the new drugs especially critical for several companies, because of some new drugs are these companies listed on the first products.
There are also some new drug or drug firms are not necessarily the field pioneer products, nervous but they can make the competition. Novartis (Novartis) ribociclib (Kisqali, formerly known as LEE011) will challenge in the field of 4/6 CDK inhibitors for the treatment of breast cancer Ibrance Pfizer (Pfizer); Novo Nordisk (Novo Nordisk) for a weekly glp-1 analogue semaglutide, will take over the company's blockbuster Victoza, with Lilly (Eli Lilly) of the same dosage every week Trulicity competition in the market. It is reported, semaglutide preliminary research data shows that it has an advantage in protecting cardiovascular function.
On March 14, the FDA approved novartis Kisqali associated with aromatase inhibitors for postmenopausal hormone receptor and human epidermal growth factor receptor 2 negative + / HER2 - (HR) of patients with advanced or metastatic breast cancer in women.
This year is expected to or drugs already on the market after 5 years sales top ten list
Ocrevus:
Lift the MS drug price reduction tide
Ocrevus is expected to be ahead of the 2017 new drugs for a reason, because MS areas are facing a big reshuffle.
The drug is the first show can delay the morbidity of the patients with primary progressive MS therapy, these patients 15% in patients with MS, this also is Ocrevus in February last year the FDA breakthrough treatments of reason.
At the same time, Ocrevus also performed for the treatment of recurrent ease type MS is extraordinary. Two Ⅲ period clinical research data can not only support the drug applications, also suggests that it would go beyond the Rebif of Germany's Merck.
Ocrevus originally had, in fact, may be approved in 2017 years ago, but last year in late December, roche has announced the Ocrevus production process was found to have a problem, the FDA will eventually audit from December 28, 2016, the deadline of delayed to March 28, 2017.
However, the come always. Analysts predict that Ocrevus listed will be advantageous to the insurance company for the whole market price pressure, MS after MS drugs under the prescription management policy has experienced a price cut.
Dupixent:
Pricing into focus
Analysts believe that sanofi and regeneration yuan dupilumab (trade name: Dupixent) is expected to be a success. In clinical trials dupilumab has made a lot of positive data, and as a result of allergic dermatitis has been a lack of reliable treatment option, so some analysts believe that dupilumab or permission to change the fate of many patients.
But concerns over Dupixent listed point is the price of the drug, and the insurance company how to view the pricing. In fact, sanofi and regeneration yuan is very clear, in recent years the pressure on prices from the insurance company, has hindered the certain chronic diseases promotion of new drugs. Both Praluent PCSK9 inhibitors, for example, because of its expensive "stressed out", the insurance company has led to some insurance companies even made a strict limits on the use of these drugs.
Sanofi and regeneration yuan pointed out that according to the FDA is currently in the review of the indications, estimates that only about 1.6 million patients with allergic dermatitis Dupixent treatments are available, and these patients account for only a small part of the huge eczema drug market, therefore the insurance company may accept their price.
At the same time, the two companies is also developing Dupixent other indications, such as asthma and other allergic diseases.
Semaglutide:
To reduce cardiovascular risk
Novo nordisk hopes to meet its diabetes drug semaglutide stick its daily dosing Victoza become the new blockbuster products at a time. However, it will faces competition from other glp-1 drugs, such as lilly Trulicity.
Because insurance companies have been pressuring the diabetes drug makers, asked for a discount, so the novo nordisk should provide a set of strong evidence to illustrate the efficacy of semaglutide, to make it in the fierce competition in the glp-1 analogues in the market place. To this end, the company plans to conduct more clinical trials, including head butt.
In fact, in clinical trials, semaglutide has shown its than some commonly used drugs have advantages, such as astrazeneca to once a week of glp-1 drugs Bydureon, small molecules of MSD Januvia DPP 4 inhibitors, as well as the basis of sanofi Lantus insulin.
In addition, the semaglutide has lower overall cardiovascular risk. The Sustain of 6 study released in September last year, according to the results of subcutaneous injection once a week, semaglutide can make the heart attack, stroke and cardiovascular disease had a 26% lower risk of death. At present, only the rest of the two types of diabetes drugs clinical data showed that have benefits for the cardiovascular system, namely Victoza and lilly/boehringer ingelheim Jardiance SGLT - 2 inhibitors.
Novo nordisk plan, once semaglutide approved by the public, is the complete test to continue to follow-up, to prove semaglutide instance can reduce cardiovascular risk supplement evidence. The company is recruiting subjects' study, to compare the curative effect of semaglutide and Jardiance.
Novo nordisk, meanwhile, also in the development of oral semaglutide, when successful, it will be the first oral glp-1 drugs.
Durvalumab:
Combination first-line therapy
Astrazeneca's durvalumab is going to be a fourth of the checkpoint inhibitors market products, but this does not mean that its not a competitive advantage.
With rival bristol-myers squibb, Merck and roche, astrazeneca is targeting the non-small cell lung cancer (NSCLC) drug market profits. Joint treatment, however, it has been developing tremelimumab durvalumab with another potential drugs (astrazeneca's a pill CTLA 4) combination to improve its curative effect in NSCLC. The company recently is to speed up the research, and strive to make the combination therapy of NSCLC first-line therapy, so perhaps or fill bristol-myers squibb Opdivo leave blank. Opdivo as single-agent first-line treatment trials failed last year.
But it postponed the astrazeneca NSCLC Ⅲ period clinical trial completion time, which means that the durvalumab may take some time to log in lung cancer drug market.
At the same time, with its rivals, astrazeneca is trying to remove barriers for durvalumab into other market. In February last year, the FDA granted durvalumab breakthrough in the treatment of metastatic urothelial bladder cancer has decided that it would compete with Tecentriq and Opdivo this market. The FDA has started to review Opdivo bladder cancer treatment application, it may be before durvalumab approved the indications. Astrazeneca is still hard for durvalumab apply for head and neck cancer indications, last November, because suddenly appeared in two clinical trials bleeding adverse events, astrazeneca had to give up durvalumab treatment of head and neck cancer submission plan early.
Niraparib:
Indications into competitive advantage
After Niraparib will become the Lynparza and Rubraca, a third PARP inhibitors anti-cancer drugs on the market. Tesaro company hopes to be approved for more niraparib indications, because clinical trial data show that not only for women with BRCA mutations niraparib cancer patients have surprise effect, also have the effect in patients with no gene mutation.
According to the clinical trial data, compared with placebo, niraparib with BRCA mutations of prolonged progression-free surial of patients with ovarian cancer by 15.5 months, and make no gene mutation women progression-free surial in patients with extended 5.4 months. In the BRCA mutations but there are other mutations in patients, niraparib also has positive effect, the patient's progression-free surial was 12.9 months, and the control group was 3.8 months, longer more than nine months.
Niraparib first indications will be ovarian cancer second-line therapy, at the same time Tesaro company is studying Niraparib curative effect in patients with untreated, in the hope of the drug is approved as the first-line therapy of ovarian cancer. Tesaro company also launched niraparib clinical research for the treatment of breast cancer.
If niraparib listed, astrazeneca Lynparza and Clovis tumor Rubraca will become a company's most important competitors. But if niraparib approved indications, so its use scope will be wider. At present, Rubraca like Lynparza, only approved for the treatment of cancer with BRCA mutations.
Baricitinib:
RA field competition is intense
In order to deal with "patent cliff" blow, lilly plans during the period of 2014 ~ 2023, achieve the aim of "launched 20 new drugs".
However, rheumatoid arthritis (RA) oral medicine baricitinib may not carry the girders. The drug will be followed by Pfizer Xeljanz entered the field of rheumatoid arthritis, and there is currently no Xeljanz sales analysts' forecasts. The first nine months of 2016, Xeljanz accumulative total sales of just $649 million, with the analysts' estimates of the drug in 2016 annual sales of $1.3 billion is far goal.
Baricitinib clinical trials have made a lot of positive data, a Ⅲ period clinical follow-up data showed that the drug in the prevention of progressive structural joint damage in radiology curative effect can be maintained at least 48 weeks.
RA field, meanwhile, many of the participants will make lilly future sales task more difficult. Glaxosmithkline and Johnson &johnson, sanofi and regeneration yuan, and gilead and Galapagos company RA drug has entered the stage of Ⅲ phase of clinical trial. Abbvie "blockbuster" Humira biological medicine could make similar baricitinib market outlook becomes more complex, although in baricitinib and Humira headon study found that the curative effect is better than the latter.
Kisqali:
Challenge Ibrance security hidden danger
Novartis Kisqali gaining momentum, will sell like hot cakes in the field of 4/6 CDK inhibitors to Pfizer's drugs Ibrance challenge. Although Kisqali some security problems for investors to worry, but EP analysts are optimistic about its future.
Kisqali made a strong in Ⅲ period clinical trial data, but compared with Ibrance, the drug safety issues of concern. Cause liver damage and, for example, arrhythmia, and have a case for sudden death.
Swiss bank Credit Suisse (Credit Suisse), an analyst at Vamil Divan that Kisqali security problems may make its market prospect is not as good as lilly abemaciclib. But novartis, head of global research and development department of Vas Narasimhan said that will arrange to use the oncologist Kisqali treatment monitoring, "the relatively regular monitoring is not an excessive burden."
Novartis's next step is to use Kisqali premenopausal women, in order to get real, key clinical data.
KTE - C19:
Be the first CAR - T listed products
Kite pharmaceutical is working with novartis race, hope that the lymphoma drug KTE - C19 became the market's first CAR - T therapy.
Although the Kite pharmaceutical in early December was submitted to the FDA KTE - C19 scroll new drug applications, it is used in the treatment of recurrent or refractory diffuse B cell non-hodgkin's lymphoma (NHL), but at the same time, novartis has also actively opened communication work with the FDA.
Last December, novartis announced its CAR - T therapy CTL019 new Ⅱ period clinical data, it is the drug for earlier in 2017 for the treatment of children or young adults with recurrent or refractory acute lymphoblastic leukemia (ALL) r/r. Kite company is expected to be completed at the end of the first quarter of 2017 submitted to the FDA's new drug application (BLA) biological products, and intends to KTE - C19 to the market in 2017.
Novartis plans this year to Europe and drug administration (EMA) to submit an application, because EMA has granted CTL019 brings into focus drugs (PRIME) approval plan, it will greatly save the time of review. Kite company KTE - C19, meanwhile, also won the PRIME qualifications, in 2017, and plans to submit application to the EMA. The two companies also hopes its new drugs can approved other blood system tumor indications in the coming years.
KTE - C19 expected sales in 2026 to $1.9 billion, but overall sales are likely to depend on its indications and similar competitive products could extend to the solid tumor. KTE - C19 sales will also be related to its price, some analysts expect that the price of the CAR - T therapy was about $300000 a course of treatment.
Ingrezza:
First TD drugs approved by FDA
If Ingrezza gain FDA "green light", it will be the first fda-approved for used in the treatment of tardive dyskinesia (TD) of drugs, but Neurocrine companies won't stop there.
In Ⅱ stage of clinical trials, Ingrezza used to treat with speech disorders and symptoms such as multiple twitch tourette syndrome, but the research recently met the bottleneck. Neurocrine in mid-january announced that in adult patients participating in a clinical study did not reach the main treatment of end point.
Next, Neurocrine is expected to be released at the end of march or early April Ingrezza treatment of infantile tourette syndrome clinical data, these data will be Ingrezza development important effect for the treatment of tourette syndrome.
Spinraza:
High prices lead controversy
In January of this year, the health and Ionis company cooperation development Spinraza listed won FDA approval. It became the market first treat spinal muscular atrophy (SMA) drugs, patients in the first year of the required expenses for medicine as much as $750000, for $375000 a year later.
Medicine as a treatment for a rare disease, Spinraza a year of treatment is beyond the scope of the drug standard fee, but in the current under the background of the public attention to drug prices high, high price tag immediately the controversial Spinraza. Analysts suspect that the public response to Spinraza price can make insurance company to put pressure on health, so as to strive for some discount.
Despite the debate, but analysts believe Spinraza will be the best health and Ionis the success of the company products. Leerink Partners analyst Geoffrey Porges increases the expected sales of the drug in 2020 to $2 billion, he expects to have 1700 patients for treatment. |
