Abbvie HCV DRUG Viekira Pak clinical results comparable to Gilead

In the 2015 annual meeting of the American Association for Study of Liver Diseases (AASLD), the Abbvie announced the latest clinical data hepatitis C VIEKIRA PAK of new drugs, drug treatment with or without cirrhosis in chronic hepatitis C virus gene type 1 infected patients 12 weeks cure rate of 95%! This further strengthened confirmed previous clinical data. It expects peak annual sales will reach $ 3 billion, will become a star Gilead hepatitis C drug Harvoni powerful competitors.
Viekira Pak has received FDA approval to market in December 2014, is the first to qualify for breakthrough drugs FDA accelerated approval of new drugs. Viekira Pak contains three new drugs - Ombitasvir, Paritaprevir and Dasabuvir, which together inhibit the growth of HCV. The drugs also contain ritonavir, which is a previously approved drug, which is used to increase blood levels of Paritaprevir. Viekira Pak may or may not be used with ribavirin, but this medication is not recommended for patients with liver does not work properly (decompensated cirrhosis) is used.
3b TOPAZ-II clinical study of cure data from ongoing research aimed at long-term therapeutic gene 1a and 1b adult chronic hepatitis C virus infection. 95% (n = 586/615) of patients in the 12 to 24 weeks after treatment had a sustained viral response, reaching the key secondary clinical endpoints.
TOPAZ-II is a single-group, open-label, 3b multi-center clinical study for the evaluation of treatment with ribavirin (+/-), cirrhosis (+/-), initial treatment or interferon (pegIFN / RBV) therapy Chronic hepatitis C genotype 1 infection who had 12 or 24 weeks of treatment. The clinical study is accompanied by up to 5 years of follow-up survey after treatment negative rate.
Trial included 615 cases of patients, 115 cases (19%) patients with cirrhosis and 500 cases (81%) patients without cirrhosis. 1, clinical treatment, the patient virus corresponding failure accounted for 0.8% (5/615), 1.9% (n = 11/590) of patients relapse. 1% (n = 6/615) of patients discontinued treatment because of side effects. 4% (n = 25/615) experienced a serious adverse event. Because 20/474 (4.2%) of the patients after injection of ribavirin emergence of hemoglobin decrease, so in 30/474 (6.3%) patients because of anemia and reduction of ribavirin dosage. The most commonly reported adverse events were fatigue, nausea, headache, itching and insomnia, accounting for 10% of patients.
This year's annual meeting of the American Association for Study of Liver Diseases described as fruitful, including Gilead (Gilead), Merck (Merck & Co), Bristol-Myers Squibb (BMS), including pharmaceutical giants have announced the latest development in meeting their hepatitis C drugs Advances in clinical results are excellent (Related reading: Bristol DRUG Daklinza 12 weeks of treatment of hepatitis C with advanced fibrosis 3 hepatitis C cure rate of 100). With the entry of other pharmaceutical companies, the competition in the field of HCV treatment will become more intense, I believe the price will gradually decline hepatitis C drugs, which the majority of patients with hepatitis C is a very good thing.

Sales dismal female Viagra Addyi, why it is far better than the best-selling men's Viagra?

After the female Viagra Addyi international pharmaceutical company acquired by rand (Valeant Pharmaceuticals, VRX), with sales unsatisfactory, it has only a few weeks out of 227 prescriptions. In this little blue Viagra pills respected today, so why such a small pink pill extent sought so low?
Addyi (generic name fluoride legislation serine class) obtained at the end of the third quarter of FDA-approved for the treatment of HSDD, officially listed on October 17. HSDD is that female hypoactive sexual dysfunction, clinical manifestations of long-term frigidity, lack of sexual fantasies, low libido, low sexual involvement, affect their status and marital relationships. Gynecologists Ohio State University Wexner Medical Center, said Jonathan Schaffir, HSDD small patient population. The physicians who participated in the clinical trial Addyi, he said he was exposed to the patient never consulted Addyi.
Addyi as female sexual dysfunction drugs, often and male sexual dysfunction drugs Viagra (Viagra) for comparison. However, the latter in the first week of sale, prescription volume to more than 500,000. Total sales in 2014, male sexual dysfunction drugs Viagra (sildenafil) and Eli Lilly's Cialis (tadalafil, trade name Cialis) is close to $ 4 billion. In addition to the significant differences in sales above Viagra and Addyi is also a great difference in the mechanism of action and onset time. Viagra's role is to improve sexual performance, and Addyi for improving libido. Viagra can be taken as needed, immediate action; and Addyi need to be taken daily, and for taking four weeks after the order has improved in the "exotic" on.
Before marketing authorization, Addyi repeatedly been rejected FDA. When early in 2010, Addyi also belong Boehringer Inge John, it was rejected once. Sprout took over the company in 2011, Addyi listing application by the FDA in 2013 also returned. 2015, FDA only through the listing application of the drug. However, serious side effects of the drug are also "black box warning" appears in the manual. Addyi may cause severe hypotension, or even shock the patient. Alcohol can increase the blood pressure decrease. Apart from a small number of patients and severe side effects than, the price is too high it is one of the factors affecting sales.
Addyi spending about $ 800 a month. After the acquisition of Sprout company, Valeant companies to improve the practice of drug prices blamed. Some insurers frankly, because the price is too high, they are not listed in the Addyi within the insurance coverage, or just include it in a higher amount of the policy. Sprout told Bloomberg that a patient assisted project is expected to start the company plans to price controls will Addyi about $ 200 a month.
After Addyi approved for marketing, Sprout says Sprout certified pharmacists need to be issued after the drug and conduct patient education, tell the patient to use the drug risks and side effects, especially severe hypotension when sharing with alcohol. So far, Sprout has been issued for this drug may 5600 physicians, gynecologists and about 1% general practitioners were trained.
After Addyi obtain FDA clearance to market, Valeant company through the acquisition of Sprout will Addyi bag. When announcing the transaction, Valeant current CEO Michael Pearson said: "This acquisition, so that Valeant has a unique and important female drugs." Sprout CEO Cindy Whitehead said, Valeant has a mature sales force, women around the world have the ability to have the opportunity to spend Addyi.

Danish anti-cancer drugs by the US government approved

Danish biopharmaceutical company Genmab newly developed anti-cancer drugs Darzalex approved by the US Food and Drug Administration. The drug is mainly suitable for repeated treatment ineffective bone marrow cancer, has been approved for use in the case of the three treatment ineffective. Currently, the company and its partners are applying the drug used in the initial treatment. The drug is eligible for US government-approved news boosted Genmab company fiscal year 2015 performance expectations, the company is now forecast sales this year at around 1.1 billion Danish kroner, compared with the previous increase of 300 million Danish kroner, operating profit is expected at 6.25-7 billion Danish between the krone, and it had expected to 3.25-4 billion Danish kroner.

( Bolise Co., Ltd. www.chemicalspharm.com ) 

Hui Rui Aier build on the acquisition breakup fee for consultations or record high

Pfizer is working with Al build (Allergan) on the break-up fee of about 2-3 per cent of $ 150 billion in potential acquisitions of consultations, the proportion consistent with other transactions.
If Pfizer to abandon the acquisition, it will be built in Al breakup fee paid above ratio, which indicates that the combined Pfizer believe regulatory risk facing yet reached the degree of endangering the survival of the transaction, although the US Treasury plans to tighten corporate tax upside this week The regulation, which is a key part of the acquisition plan.
Since the transaction itself will be one of the largest ever merger, therefore breakup fee will continue to be one of the highest on record.
Break-up fee is developed according to the size of the target company, one of the sources said Pfizer - Al build breakup fee of proportion compared with similar transactions may be at a lower level.
Previously the highest is Verizon (45.76,0.38,0.84%) Communication (Verizon Communications) 100 亿 dollar and Vodafone (33.71,0.13,0.39%) (Vodafone) reached the break-up fee, 2013 Verizon Communication intends to 1,300 billion acquisition of Vodafone's 45 percent stake in Verizon Wireless held.
The highest amount paid so far is the $ 4 billion breakup fee, in 2011 the American Telephone and Telegraph (33.62,0.08,0.24%) Company (AT & T) with $ 39 billion acquisition of T-Mobile US Inc's plan because of opposition from regulators failed to achieve.
The source warned that the break fee and Pfizer - Al build other aspects of the acquisition has not been finalized, the two sides still waiting for the Ministry of Finance announced that the latest provisions relating to tax inverted. Since the matter confidential, the sources requested anonymity.
Pfizer and Al build both declined to comment.
Reuters quoted sources reported Wednesday, Pfizer opened a price of $ 370-380 per share, plans to acquire El build. Al built the stock is currently trading at around $ 300, suggesting that investors are still worried about the prospect of acquisition. Al built fell 2.82 percent on Thursday, reported $ 302.05

( Bolise Co., Ltd. www.chemicalspharm.com )

Baxalta hemophilia product line Adds a new member

FDA recently announced the approval of a long-term Baxalta hemophilia A therapy Adynovate market, which is Baxalta since its predecessor company Baxter split out another good news in the field of blood diseases. This therapy is currently selling the drug Advate Baxalta company's long-term upgrade, while the latter is the world's best-selling class of drugs currently coagulation factor XIII.
Prior Baxalta to Adynovate (BAX855) high hopes that this product will help the company to further consolidate its market position in hemophilia, and with Biogen company launched similar products in the same stage last year. It is understood that patients receiving treatment Adynovate only need two injections a week, it can achieve normal blood coagulation promote wound effect.
However, Baxalta want a monopoly would not be easy in the hemophilia market. In addition to their old rival Biogen, Bayer similar products BAY 81-8973 is currently also awaiting FDA approval. In addition, Novo Nordisk also has a similar product is in phase III clinical study.
However, for Baxalta is another big positive is the Adynovate approved the acquisition will help the company resist the pressure Shire. As we all know, after Baxter split, Shire proposed acquisition Baxalta company's offer, the entire acquisition price has reached as much as $ 30 billion. However, just do not want to live on their own Baxalta apparently so quickly by other companies incorporated, company CEO Ludwig Hantson has repeatedly publicly turned down the acquisition. Shire's order to break even read like, Hantson also proposed a ambitious product development program and I hope that by 2020 the company launched 20 new products to market, so the company's annual sales to as much as $ 8.5 billion.

Merck $ 17 billion acquisition of Sigma

German pharmaceutical and chemical giant Merck (Merck KGaA) today announced the successful completion of the $ 17 billion cash acquisition of the world's largest manufacturer of chemical reagents - United States Sigma-Aldrich (Sigma-Aldrich, hereinafter referred to as Sigma), which also marked the history of this ultra-large-scale chemical industry acquisitions last week to get the European Commission (EC) for final approval after finally came to an end perfectly, consuming a total of 1 year and 2 months. The acquisition is aimed at strengthening the Merck subsidiary Merck Millipore (Merck Millipore) of laboratory supplies business, and will expand the global coverage Merck Millipore and improve presence in North America and the fast-growing Asian markets. With the completion of the acquisition, Merck will have nearly 50,000 employees in 67 countries, 72 production sites.
To ensure a smooth integration, Merck has made the appropriate adjustments in the integration of the planning of new business areas: across the globe, these new services will be the name of Merck (Merck) operations; and in the United States and Canada, these new services will be secret BSH management Sigma (MilliporeSigma) operations.
The acquisition Simga, also marks Merck "Metamorphosis 2018 Tour" milestone will be its three major business transformation platform for sustainable growth: health care, life sciences, high-performance materials.
The two sides reached last September of a definitive acquisition agreement, Merck will be $ 17 billion cash acquisition of Sigma, making it worth $ 130 billion in the global life sciences industry's leading companies, will be able to global life science customers, providing a sets attractive mature brand and an efficient supply chain, it can support up to more than 30 million products supply. In laboratory & academia business, combined with the Merck Millipore and Sigma existing life science businesses, Merck will provide a wide range of complementary products in the laboratory chemicals, biological agents, reagents aspects. In the pharmaceutical and biopharmaceutical aspects, Sigma will form with Merck Millipore's existing products and the ability to add.
It is worth mentioning that the acquisition of Sigma also the history of the biggest takeover Merck. The largest was in 2007 before trading to $ 13.3 billion acquisition of Switzerland's largest biotechnology company - Serono (Serono), the acquisition of the pharmaceutical industry in Europe to create a new giant, is positioned as the pharmaceutical industry giants . However, Merck Serono frustrated after several years of research and development of new drugs, has not been introduced blockbuster products, it has been in trouble. After 2010, Merck cost $ 6 billion acquisition of US laboratory equipment and chemicals manufacturers - Millipore (Millipore), to accelerate the company's transformation.
Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical and organic chemical products and kits are widely used, with operations in 36 countries, institutions and regions. Merck Group is focused on innovative pharmaceutical, life science and cutting-edge functional materials technology, with 154 offices in 67 countries and regions. Both with offices in China or joint venture.

EU approves expanded indications Kalydeco orphan drug price

The European Commission (EC) has approved the expansion of orphan drug Kalydeco (ivacaftor) indications, for carrying the cystic fibrosis transmembrane conductance regulator (CFTR) 9 种 gated one mutation (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R) of 2-5-year-old cystic fibrosis (CF) in pediatric patients, as well as carrying the R117H mutation of 18 years and older adult CF patients. Previously, Kalydeco been approved for the EU to carry nine kinds gated one mutation in CF patients 6 years and older. In Europe, about 125 cases of children 2-5 years old CF patients carry mutations in one of the gated above nine kinds, about 350 cases of adult CF patients carrying the R117H mutation. It is worth mentioning that, Kalydeco quite expensive, priced up to $ 300,000 / person / year, which means that the approval of this expanded indication, will add nearly $ 140 million in revenue annually Vertex.
Kalydeco expand pediatric indication is based on an open-label Phase III clinical trials 24 weeks, the study looked at the weight-based dosing regimens new formula safe for children 2-5 years old patients (50mg or 75mg twice daily) and pharmacokinetics. To meet this age group needs of pediatric patients, Vertex has developed a new weight-based Kalydeco oral granular formulations (50mg and 75mg), patients may be unable to swallow tablets, the drug can be mixed with food or liquid to medicine. Kalydeco expand adult indication is based on positive data from a Phase III study in 69 cases carrying the R117H mutation in adult CF patients conducted.
In many countries, Kalydeco were granted orphan drug status, the drug is the first targeted therapy for cystic fibrosis (CF) the underlying cause, can make the patient the defective CFTR protein function properly, the drug in 2012 It was first eligible for FDA and EU approval for the treatment of CFTR gene has at least one copy of the G551D mutation in 6 years and older with cystic fibrosis (CF) patients. After, Kalydeco indications continue to be expanded, but also for the Vertex company a big moneymaker.