AZ News from the Street 2015

Dr Reddy's product is also in the shape of a pill. It comes in a bottle. It is swallowed and metabolized.

Dr. Reddy has no right to make a product that is pill-shaped, bottled and metabolized and the creator of this product should sue! (Kidding aside, there should be a stiff penalty for lawsuits like this paid by the entity filing them.)

 

They don't hope to actually win, just to delay six more months or so. The shark fin project still lives apparently.

 

AstraZeneca's potential $3 billion cancer pill wins early approval
By Ben Hirschler 45 minutes ago

• LONDON (Reuters) - A new lung cancer pill from AstraZeneca <AZN.L>, designed for patients whose disease has worsened after treatment with other therapies, won early U.S. approval on Friday, in a boost for the British drugmaker.
  
  Tagrisso, also known as AZD9291, is one of several cancer medicines AstraZeneca hopes will rebuild its sales following patent losses on older drugs. During its defense against a takeover attempt by Pfizer <PFE.N> last year, the firm forecast the drug could eventually sell as much as $3 billion a year.
  
  Industry analysts are more cautious about sales in the next few years, with consensus expectations pointing to revenue of $1.1 billion in 2020, according to Thomson Reuters Cortellis.
  
  The U.S. Food and Drug Administration (FDA) approved the once-daily tablet to treat a sub-set of patients with advanced non-small cell lung cancer earlier than analysts had expected: the official date for a decision was February 2016.
  
  A spokeswoman said AstraZeneca would make Tagrisso available to eligible U.S. patients as soon as possible and its price would be "comparable to other oral cancer therapies".
  
  Like a rival product in development at Clovis Oncology <CLVS.O>, Tagrisso targets a genetic mutation, known as T790M, that helps tumors evade current lung cancer pills.
  
  The FDA also approved a new companion diagnostic test for use with Tagrisso, made by Roche <ROG.VX>, to detect this mutation.
  
  Tagrisso's path to market has been unusually fast, taking just over 2-1/2 years from the start of clinical trials to approval in the world's top drugs market. That pace reflects an accelerated approval process at the FDA and AstraZeneca's determination to push development as fast as possible.
  
  In fighting off Pfizer's approach last year, Chief Executive Pascal Soriot had warned that the new cancer pill's progress could be disrupted by the distraction of a mega-merger.
  
  Mizuho Securities analyst Eric Criscuolo said the speedy FDA decision suggested a similarly early approval of Clovis' rival drug rociletinib, whose official FDA decision date is at the end of March. "Rociletinib could be right behind," he said in a note.
  
  AstraZeneca shares rose 0.5 percent in a weaker European stock market, while Clovis was up 1 percent on Nasdaq.
  
  In two clinical trials, 57 and 61 percent of patients experienced a complete or partial reduction in their tumor size, with the most common side effects being diarrhea and skin and fingernail problems.
  
  The green light for Tagrisso follows AstraZeneca's recent launch of Lynparza for ovarian cancer, taking the company closer to its goal of bringing six new cancer treatments to market by 2020.

 

Here is the reality of AZ; AZN is the worst performing Pharma stock in the exchange down 54% since April 2014 and under performing the market average by 55%. Oh but only if we had accepted the Pfizer offer at 84$ per share. Unanimously, the dumbest business decision in decades.

 

Taking this a step or two forward:

When a stock gets cut in half it takes a double to get back to even.
A double is a BIG deal.
If you take a penny and double it 30 times you have over $1,000,000.00.

Gargantuan fail. The stock will fall further and the street knows it: Sell now.

 

It's over $5,000,000.00 dumbass!

https://sites.google.com/site/teambarsite/ourexcitement

 

Competitor with an AZ drug hits a hurdle:

Clovis More Than Halves on FDA Hurdle
By Chris Lange November 16, 2015 10:40 am EST

Clovis Oncology Inc. (NASDAQ: CLVS) was leading the bears in Monday’s trading session on news that its lung cancer drug may be delayed. This was announced in the company’s most recent update on rociletinib.


The company announced that during its regularly scheduled Mid-Cycle Communication Meeting held last week with the U.S. Food and Drug Administration (FDA), the agency requested additional clinical data for use in the efficacy analysis for both the 500 mg and 625 mg BID dose patient groups for rociletinib. The company will provide this information in a major amendment to the FDA by close of business Monday.

The current confirmed response rate in the 500 mg group is 28%, and 34% in the 170 patients in the 625 mg dose group, with an encouraging duration of response in both doses. The most frequent reasons that patients’ responses were not confirmed in a subsequent scan were due to progression, often due to brain metastasis, and due to subsequent scans not demonstrating tumor shrinkage greater than 30%.

 

More on Clovis vs. AZ:

Clovis Oncology Falls 73 Percent After FDA Asks for More Data on Cancer Drug
November 16, 2015 — 8:38 AM EST Updated on November 16, 2015 — 10:01 AM EST

Clovis Oncology Inc. may have to wait longer for U.S. regulatory approval of its lung cancer drug rociletinib after the Food and Drug Administration requested more clinical information on the treatment. The shares plummeted.

The company plans to provide the data from its human trials of the drug by the close of business Monday, according to a statement. Clovis’s initial application for approval included early data on the effectiveness of the drug, including some patients who had an unconfirmed response to the treatment. In follow-up testing, a lower number of patients than expected had their response confirmed, Clovis said.

Clovis shares dropped 73 percent to $27.24 at 9:41 a.m. in New York, wiping out more than two years’ worth of gains.

As of June 30, Clovis was the biggest holding of Partner Fund Management, the drugmaker’s second-biggest shareholder with a 7.1 percent stake, according to data compiled by Bloomberg. It was also the second-biggest holding of Palo Alto Investors, with a 6.3 percent stake. Clovis’s top shareholder is Fidelity Investments, through its collection of funds.

The delay gives a boost to Clovis rival AstraZeneca Plc, whose lung cancer pill Tagrisso was approved early by the FDA last week. AstraZeneca shares rose 3.6 percent to 4,242 pence in London.

In an analysis of 79 patients on a 500-milligram dose of rociletinib, 28 percent have a confirmed response to the drug, Clovis said. A separate group of 170 patients on a 625-milligram dose has a 34 percent response rate. The duration of responses at both doses is "encouraging," the company said.

 

AZ issues bonds to pay for ZS Pharma Aquisition:

Details of AstraZeneca’s issue

AstraZeneca (AZN) is a global biopharmaceutical company. It issued A2/A rated high-grade bonds worth $6.0 billion via five parts:

• $400 million in three-year FRNs (floating-rate notes) issued at three-month LIBOR + 53 basis points
• $1.0 billion in 1.75% three-year notes issued at a spread of 55 basis points over similar-maturity Treasuries
• $1.6 billion in 2.38% five-year notes issued at a spread of 75 basis points over similar-maturity Treasuries
• $2.0 billion in 3.38% ten-year notes issued at a spread of 115 basis points over similar-maturity Treasuries
• $1.0 billion in 4.38% 30-year bonds issued at a spread of 135 basis points over similar-maturity Treasuries

AstraZeneca will use the proceeds of the issue to fund the acquisition of ZS Pharma (ZSPH).

 

Interesting! Who is loaning money to AZ, who is stupid enough to buy these bonds? What's the collateral I wonder -- Crestor?

 

You do realize the stock split don't you dumbass?
Currently trading around 34 (equates to 68 pre-split) so please try to explain your math.

Also, the 84 you mention (actually it was 82) was a run up based on the PFE offer. AZN traded around 64 previous to the buyout offer so the sky isn't falling quite as fast as you would lead one to believe. Good effort, however.

 

These bonds pay fairly well by today's zero interest rate environment standards.
As to who is paying? The stockholders of course. The bond holders are always first in line. The collateral is AZ itself

 

The public is expected to buy the bonds. The interest rate they sell at depends on the free market.

 

It is going to take a good bond salesman to get a good price for this issue. Imagine the pitch:

Hey this company is proven [to ruin every product launch] and has a deep pipeline of new products [but they've been making that claim ad nauseum for the last decade an d produced only one new product that the EU would not even issue patent protection for]. They are making solid profits [though profits are declining sharply and every revenue producer is approaching patent expiry] and are well run [overstaffed with lunch servers living the 1/2 day lie].

Trust me on this one and you can't go wrong. [You will lose every dime you invest here but you might get one or two interest payments while you're waiting.]

 

Yes, the interest rates are set to attract enough buyers. The "public" rarely buys such bonds directly, they are mostly sold to bond funds and to broker/dealers for secondary market sales. There is no true liquid market for the direct buying and selling of bonds by individuals like there is for stocks.

 

Gout Drug News:

Lesinurad’s Clinical Trials Demonstrate Strong Efficacy for Gout
By Margaret Patrick 17 hours ago

• 
  FDA Approval of Lesinurad Could Buoy AstraZeneca's Portfolio
  
  Clinical trials
  The FDA (U.S. Food and Drug Administration) is expected to announce its decision related to the approval of AstraZeneca’s (AZN) lesinurad (or LESU200) by December 29, 2015. This approval will be based on data obtained from two Phase 3 clinical trials of lesinurad, CLEAR 1 and CLEAR 2. These clinical trials evaluated the efficacy of lesinurad in combination with allopurinol (or allo), a xanthine oxidase (or XO) inhibitor, for gout patients.
  
  AstraZeneca has also conducted a Phase 3 clinical trial called CRYSTAL. In this trial, AstraZeneca evaluated the use of lesinurad in combination with febuxostat.
• 
  Clinical trial results
  The above diagram shows the results of the CLEAR 1 and CLEAR 2 studies published by AstraZeneca on August 13, 2014. Both CLEAR 1 and CLEAR 2 were randomized, double-blind, placebo-controlled trials that tested the efficacy of dosage samples of 200-mg (milligram) and 400-mg lesinurad, respectively.
  
  According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, “Gout is one of the most painful forms of arthritis. It occurs when too much uric acid builds up in the body.” The primary endpoint or goal of the CLEAR 1 and CLEAR 2 trials was the percentage of test patients achieving uric acid levels less than 6 mg per deciliter of blood after six months of therapy.
  
  MedicineNet explains randomized clinical trials as those “in which the participants are assigned randomly (by chance alone) to different treatments.” According to MedicineNet, a double-blinded study is defined as a “medical study in which both the subjects participating and the researchers are unaware of when the experimental medication or procedure has been given. Double-blinded studies are often used when initial studies shows [sic] particular promise.”
  
  ClinicalTrials.gov defines a placebo (or PBO) as “a substance that does not contain active ingredients and is made to be physically indistinguishable (that is, it looks and tastes identical) from the actual drug being studied.” In a placebo-controlled study, patients receiving the new treatment are compared with those who receive a placebo.
  
  Trial results
  When compared to patients receiving PBO or allo, patients on LESU200 and allo therapy managed to reach a primary endpoint at a substantially higher percentage of patients witnessing reduced serum uric acid levels. If approved, lesinurad will be competition to other major companies developing gout drugs such as Regeneron (REGN), Novartis (NVS), and Celgene (CELG).
  
  In addition to strong efficacy, the adverse event (or AE) profile of lenisurad 200-mg therapy combined with allo was similar to that witnessed when allo alone was administered to patients. However, renal-related adverse events and an increase in serum creatinine levels were found when lenisurad 400-mg combined with allo therapy was tested.
  
  So based on a risk-benefit analysis, 200-mg lenisurad has been recommended for patients with gout who could not substantially reduce their serum uric acid levels using XO (xanthine oxidase) inhibitors.

 

The FDA hates AZ. If they don't screw us then our leadership will fuck it up just like all of the other recent launches.

 

AstraZeneca confirms interest in a possible $5B purchase
Dec 14, 2015, 9:17am EST Updated Dec 14, 2015, 9:30am EST

AstraZeneca confirmed Monday morning that it is "exploring potential strategic options" with Acerta Pharma BV.

Acerta is a privately held biopharmaceutical company with offices in California and The Netherlands. Its lead product is an experimental blood cancer drug, called acalabrutinib, which is in late-stage clinical testing.

Such an acquisition would boost AstraZeneca’s pipeline of new drug candidates targeting cancer, a key therapeutic category for the global pharmaceutical manufacturer.

The purchase for Acerta could top $5 billion, according to a Wall Street Journal report.

AstraZeneca (NYSE: AZN), in its statement, said, “There can be no certainty that any transaction will ultimately be entered into, or as to the terms of any transaction.”

 

AstraZeneca spending hundreds of millions in China, blueprints new R&D hub
December 16, 2015 | By John Carroll

AstraZeneca ($AZN) is building a new global R&D hub in Shanghai while lining up a closer manufacturing relationship with the fast-growing WuXi AppTec and hiring dozens of scientists to accelerate development of new drugs for China.

AstraZeneca is following up on an earlier deal with WuXi AppTec, an international CRO and manufacturing powerhouse led by Ge Li, to develop MEDI5117. Eyeing a shorter route to China's big pharma market, AstraZeneca is looking to cut years out of the approval process as it maps a global strategy for its new drug launches. And it's budgeting hundreds of millions of dollars to make its move in China.

A number of pharma giants have jumped into the Chinese market in the last 5 years, building local operations to help position their products with China's regulatory groups. Investing in China is considered a key step toward gaining access to the big pharma market. One of those pioneers, GlaxoSmithKline ($GSK), has been struggling to overcome a bribery scandal that recently engulfed its local sales force.

Working with a Chinese partner like WuXi may help avoid similar setbacks for AstraZeneca as it develops drugs specifically for the Chinese.

To accomplish that, AstraZeneca is hiring up to 50 scientists for facilities in Shanghai and Wuxi City, following a plan to create a single unit to work on both small molecules and biologics. AstraZeneca also struck an option deal to buy out WuXi AppTec's manufacturing operations in Wuxi City for $100 million.

Under CEO Pascal Soriot, AstraZeneca has been building a $500 million headquarters and research center in Cambridge, U.K., while reorganizing the company's development infrastructure by refocusing and downsizing in the U.K. and Sweden, its other big R&D hub. The company was recently awarded an accelerated approval for the cancer drug AZD9291.

Mark Mallon, EVP for international at AstraZeneca, says the plan will make the pharma giant "the first multinational biopharmaceutical company to create a dedicated R&D platform and manufacturing capabilities in China for local development from research through to commercialization."

 

SPEND THAT MONEY FRENCHI!
http://www.pharmatimes.com/Article/15-12-17/AZ_announces_4-billion_deal_for_majority_stake_in_Acerta.aspx