=Amgen (AMGN) reported earnings on Thur 26 Oct 2017 (b/o)

Amgen beats by $0.17, reports revs in-line; raises low-end of FY17 EPS, revs guidance 

• Reports Q3 (Sep) earnings of $3.27 per share, excluding non-recurring items, $0.17 better than the Capital IQ Consensus of $3.10; revenues fell 0.7% year/year to $5.77 bln vs the $5.75 bln Capital IQ Consensus.
• Repatha (evolocumab) sales increased driven by higher unit demand. Quarter over quarter sales growth was tempered by changes in inventory and accounting adjustments that benefited the second quarter of 2017.
• Update on Puerto Rico Operations
  • In the five weeks since Hurricane Maria hit Puerto Rico, Amgen has been providing support to our staff members and the local community while implementing our robust business continuity plans and restoring manufacturing at our site in Juncos. Our drug substance manufacturing and packaging plants are fully operational and we expect to resume formulation/filling and small molecule commercial production by the end of October 2017. The Company continues to provide an uninterrupted supply of medicines for patients around the world.
  • The Company incurred $67 million of pre-tax expenses, or $0.07 EPS, in the third quarter related to Hurricane Maria. In the fourth quarter, the Company expects additional pre-tax expenses in the range of $75 million to $100 million, or $0.08 to $0.11EPS. The expenses related to Hurricane Maria are included in our GAAP and non-GAAP results. At this time, the Company does not expect a significant impact to full-year 2018 results. The above estimates do not include possible insurance recoveries.
• Co raises guidancefor FY17, sees EPS of $12.50-12.70 (Prior $12.15-12.65), excluding non-recurring items, vs. $12.56 Capital IQ Consensus Estimate; sees FY17 revs of $22.7-23 bln (Prior $22.5-23 bln) vs. $22.86 bln Capital IQ Consensus Estimate.

=CytomX Therapeutics (CTMX) and Amgen (AMGN) announce strategic collaboration in immuno-oncology

CytomX Therapeutics and Amgen (AMGN) announce strategic collaboration in immuno-oncology; Amgen to make upfront payment of $40 mln and purchase $20 mln of common stock 

The companies will co-develop a CytomX Probody T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells in tumor microenvironments. In preclinical studies, CytomX's Probody versions of EGFRxCD3 bispecific therapeutics induced tumor regressions and increased the therapeutic window for this high potential cancer target.

• Under the terms of the agreement, Amgen and CytomX will co-develop a Probody T-cell engaging bispecific against EGFRxCD3 with CytomX leading early development. Amgen will lead later development and commercialization with global late-stage development costs shared between the two companies. Amgen will make an upfront payment of $40 million and purchase $20 million of CytomX common stock. CytomX will be eligible to receive up to $455 million in development, regulatory and commercial milestones for the EGFR program. Amgen will lead global commercial activities with CytomX able to opt into a profit share in the U.S. and receive tiered, double-digit royalties on net product sales outside of the U.S.
• Amgen will also receive exclusive worldwide rights to develop and commercialize up to three additional, undisclosed targets. Should Amgen ultimately pursue all of these targets, CytomX will be eligible to receive up to $950 million in additional upfront and milestone payments and high single-digit to mid-double digit royalty payments on any resulting products. CytomX will also receive the rights from Amgen to an undisclosed preclinical T-cell engaging bispecific program; Amgen is eligible to receive milestones and royalty payments on any resulting products from this CytomX program.

Read more:http://hosting.briefing.com/cschwab/InDepth/InPlay.htm#ixzz4uXeCaRRl

=Amgen (AMGN): results from the Phase 3 ARCH study

Amgen announces results from the Phase 3 ARCH study

Amgen (AMGN) and UCB announced detailed results from the Phase 3 ARCH study showing that 12 months of EVENITY (romosozumab) followed by alendronate was superior in reducing new vertebral, clinical, non-vertebral and hip fracture risk in postmenopausal women with osteoporosis at high risk for fracture, compared to alendronate alone.

• Overall adverse events and serious adverse events were generally similar between the treatment groups with the exception of the previously reported imbalance in positively adjudicated cardiovascular serious adverse events.
• The results were simultaneously published in the New England Journal of Medicine (NEJM) and presented today as a late-breaking abstract at an oral scientific session at the Annual Meeting of the American Society for Bone Mineral Research (ASBMR) in Denver.
• At primary analysis, postmenopausal women in the EVENITY treatment group experienced a statistically significant 19.0 percent relative reduction in the risk of non-vertebral fractures.
• An imbalance in adjudicated cardiovascular serious adverse events was observed during the 12-month period in 50 patients treated with alendronate, with cardiac ischemic events and cerebrovascular events accounting for the imbalance.
• There were six patients with positively adjudicated events of atypical femoral fracture during the open-label alendronate period, two patients treated with EVENITY followed by alendronate and four treated with alendronate alone.
• "The ARCH study shows that romosozumab can provide superior fracture risk reduction over alendronate, a commonly used, first-line osteoporosis treatment."

=Amgen (AMGN) and Allergan (AGN) announced data from a Phase 3 study

Amgen and Allergan (AGN) present Phase 3 data between ABP 980 and Trastuzumab adds to the totality of evidence of biosimilarity 

• Amgen (AMGN) and Allergan plc (AGN) announced data from a Phase 3 study evaluating the efficacy and safety of ABP 980, a Herceptin (trastuzumab) biosimilar, compared with the originator product in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer.
• The co-primary endpoints of the study were risk difference and risk ratio of pathologic complete response in breast tissue and axillary lymph nodes, and the prespecified equivalence margins were +/-13% for RD and 0.759 to 1.318 for RR. According to local review, 48% and 40.5% of patients in the ABP 980 arm and trastuzumab arm, respectively, achieved pathologic complete response.
  • RD and RR of pathologic complete response were 7.3% (90% CI: 1.2, 13.4) and 1.19 (90% CI: 1.033, 1.366) respectively. Based on central independent review, which was conducted as part of a sensitivity analysis, 47.8% and 41.8% in the ABP 980 arm and trastuzumab arm, respectively, achieved pathologic complete response.
  • RD and RR of pathologic complete response respectively were 5.8% (90% CI: -0.5, 12.0) and 1.14 (90% CI: 0.993, 1.312).
• Frequency, type and severity of adverse events were similar between ABP 980 and trastuzumab. No new safety signals compared to the known safety profile of trastuzumab were detected

=Amgen (AMGN): FDA has accepted for review the BLA for Aimovig

Amgen announces that the FDA has accepted for review the BLA for Aimovig (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month :

The BLA for Aimovig includes data from pivotal studies of more than 2,600 patients experiencing four or more days of migraine per month.

• Phase 2 and Phase 3 clinical studies of Aimovig versus placebo have demonstrated a reduction in the number of migraine-affected days, disability and acute medication use for patients with episodic and chronic migraine.
• The safety profile of Aimovig was similar to placebo across all treatment arms in the Phase 2 and Phase 3 studies for up to six months.
• The most common adverse events across the studies were upper respiratory tract infection, injection site pain, nausea and nasopharyngitis.

The FDA has set a Prescription Drug User Fee Act (:PDUFA) target action date of May 17, 2018.

===Coherus (CHRS) : FDA rejects Coherus' biosimilar for Amgen's Neulasta

• FDA does not ask Coherus for additional trial 

June 12 (Reuters) - Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration (FDA) did not approve its biosimilar version of Amgen Inc's blockbuster treatment, Neulasta, which fights infections in cancer patients.

Shares of Coherus tumbled 34 percent to $13.70 in trading before the bell.

The FDA's response comes as Amgen expects biosimilar competition for Neulasta by the fourth quarter of 2017. The treatment generated about $4.6 billion, or a fifth of the U.S. biotech's total sales last year.

The agency did not ask Coherus to conduct another trial, but requested a re-analysis of some existing data and more manufacturing information, the company said on Monday, adding that it would work with the agency to address the requests.

The FDA last year declined to approve Novartis AG's biosimilar copy of Neulasta, while Mylan NV and Biocon Ltd are expecting a decision on their Neulasta biosimilar by October.

Biosimilars aim to copy biologic drugs, which are made inside living cells, but they can never be exact duplicates, so manufacturers of biosimilars need to conduct clinical trials to show their products work as intended.

Developing biosimilars requires considerable expertise and is relatively costly, but the field is attracting growing investment as many blockbuster biotech medicines start to go off patent.

Redwood City, California-based Coherus' Neulasta biosimilar, CHS-1701, is among its lead experimental drugs. The company is also developing biosimilars for AbbVie Inc's rheumatoid arthritis drugs, Enbrel and Humira.

==== Amgen (AMGN) cholesterol drug cuts heart attack, stroke, but not enough to quell value debate

• New cholesterol Repatha drug lowers heart attack risk, but costs $14,000 a year A long-acting cholesterol medicine cut the risk of having a heart attack or some other serious problems by 15 to 20 percent in a big study that's likely to spur fresh debate about what drugs should cost.
• Amgen's study, known as Fourier, found no difference between Repatha patients and those taking benign placebos in terms of cardiovascular death. Repatha, however, cut down on the risk of heart attack by 27%, stroke by 21% and coronary revascularization by 22%.
• The drug was launched in 2015 and is approved for patients deemed to be at a high risk of suffering a cardiovascular event because, for instance, they have previously had a stroke or heart attack.
• There are roughly 10m people in the US who still have dangerously high levels of cholesterol despite taking a statin, according to Amgen. 
• Price: $14,000 a year for the medicine, which is intended to be taken for life, against just a few cents a day for a generic statin. 
• Repatha works by blocking the interaction between the PCSK9 protein and the LDL receptor. Doing so cuts down on the "bad" LDL cholesterol in the blood. Praluent, from Regeneron (REGN) and Sanofi (SNY), has a similar mechanism.

Repatha cut the combined risk of heart attacks, strokes and heart-related death by 20 percent compared with a placebo in patients already on high doses of cholesterol-lowering statins, such at Lipitor. Most trial subjects had had a prior heart attack or stroke.

Separately, Repatha cut heart attacks by 27 percent and stroke by 21 percent. In the second year of the study, the results were more pronounced, with a 35 percent reduction in heart attack risk and a 24 percent decrease in stroke risk.

"Just like in statin trials the benefit appeared to grow over time," said Dr. Marc Sabatine, the study's lead researcher, who presented the data at the American College of Cardiology scientific meeting in Washington.

"As a clinician this is very big news. We have another tool to significantly reduce heart attacks and stokes. That's a big win," said Sabatine from Brigham and Women's Hospital in Boston.

There was no difference in cardiovascular death in the two groups, which may disappoint some investors. Researchers said that may be due in part to the study's length, with a median duration of 26 months.

Longer term, Sabatine said, there could be a reduction in deaths as well.

The trial's primary composite goal included need for artery clearing procedures and hospitalization due to chest pains from angina in addition to heart attack, stroke and death. On that measure, the overall risk reduction was 15 percent, primarily due to no difference from placebo in angina hospitalizations.

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Repatha and rival Praluent, from Regeneron Pharmaceuticals and Sanofi, work by blocking the PCSK9 protein that prevents LDL being removed from the blood.

Repatha costs just north of $14,000 per year. Regeneron and Sanofi's Praluent costs $500 more.

Due to the high rejection rate, sales have been anemic - just $58 million for Repatha and $41 million for Praluent in the fourth quarter.

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The results of Amgen's Fourier study could be telling for drugs from rival companies, and showed up in stock action Friday. Shares of rival The Medicines Company (MDCO) dove nearly 21% at one point but settled back for an 8% loss. Nearly half of analysts see Medicines Company's cholesterol drug, Inclisiran, as having a cardiovascular benefit.


Esperion (ESPR) stock tumbled more than 30% at one point, but recovered somewhat and closed down 20.2. Only 6% of analysts expect its cholesterol drug, bempedoic acid, to have a cardiovascular benefit, according to investment bank RBC.

New Drugs for 2015 From Novartis, Pfizer, Amgen, Regeneron, Vertex

(Barron's March 3, 2015)

• Here are the 5 biggest drug launches expected this year. Each of them could prove to be a blockbuster.

The drug industry has a tough act to follow. In 2014, the industry’s research and development pipeline had its most productive year in two decades, as the Food and Drug Administration gave the green light to 41 new drug compounds for a wide range of diseases, including viruses, cancer and skin infections. It was also the year of the most successful drug launch in history, with $10.3 billion in sales of Sovaldi, the new hepatitis C drug from Gilead Sciences (ticker: GILD ).

But the very success of last year may make life harder for the drug industry’s class of 2015, despite promising new treatments for high cholesterol, breast cancer, cystic fibrosis, and heart failure. It comes down to money: Sovaldi and other new hepatitis C drugs face scrutiny from insurance companies — and politicians — over their eye-popping price tags. Gilead, for example, charges $84,000 for a 12-week course of treatment with Sovaldi. Other new drugs could endure slow launches and dimmed — or in some cases demolished — revenue prospects as private insurers and government health plans struggle to control rising costs in a market where desperate patients demand innovation.

It is never easy to predict which drugs will not only win approval by the FDA, but also go on to beat expectations by enough to boost the stock price of the big drug makers. As we do each year, Barrons.com has picked five drugs due to launch in the U.S. that advance the treatment of serious illness, have a high probability of regulatory approval in 2015, and have the potential to deliver annual sales of more than $1 billion — in layman’s terms, to become blockbusters.

Five Drugs to Watch

Drug	Company (Ticker)	What It Treats	2020 Estimated Sales	Stock Performance
PCSK9 inhibitors	Amgen (AMGN) and Regeneron (REGN)	high cholesterol	$4.5 billion**	33% and 25%
LCZ696	Novartis (NVS)	heart failure	$4 billion	28%
palbociclib	Pfizer (PFE)	breast cancer	$4 billion	12%
Cosentyx	Novartis (NVS)	psoriasis	$1.3 billion	28%
Kalydeco and lumacaftor combination	Vertex (VRTX)	cystic fibrosis	$2.5 to $3 billion	43%
*Total returns for the trailing 12 months as of Feb. 26.
**Sales estimates are for the entire drug class, in which Amgen and Regeneron are the front runners.

Sources: Leerink Partners, Bernstein Research

In the best of times, the FDA is unpredictable. Even though — or perhaps because — more Americans are able to afford prescriptions under the Affordable Care Act, new medicines face a market that is more skeptical and cost conscious than ever before.

“We all have to face the reality that the system may not be able to bear all of these costs,” says Seamus Fernandez, a pharmaceutical industry analyst with Leerink Partners, a health-care investment bank. “Science is advancing fast and for managed care to put the kibosh on that would do a lot of damage.”

Here is our list of the five most-promising new drugs for 2015 and their sales potential.

PCSK9 Inhibitors

Whether Amgen ( AMGN ) or Regeneron Pharmaceuticals ( REGN ) and its partner Sanofi ( SNY ) are the first to hit the market this summer with this new class of cholesterol-lowering drug remain to be seen. But given an estimated annual cost of $7,000 to $12,000, and as many as 15 million potential patients, insurers have already begun complaining about the financial impact of this drug class.

Nevertheless, PCSK9 inhibitors, which block a protein that stops the liver from removing low-density lipoprotein (LDL), or so-called bad cholesterol, from the blood, could be a $10 billion drug class in 10 years, says Marshall Gordon, an analyst with ClearBridge Investments.

How? The drug targets patients who have failed to control their cholesterol with commonly used drugs known as statins. It’s a big potential market. Of the 50 million Americans eligible for statin therapy, 10% can’t tolerate the drugs and many others can’t reach their targets for various reasons, such as genetically high levels of bad cholesterol.

Studies released last year showed PCSK9 inhibitors reduced LDL levels by half to two-thirds across various patient subgroups. Whether the drugs also help reduce the occurrence of heart attacks and strokes will be determined in 2018, when results are expected from several large studies now underway. That could drastically expand the potential market.

Doctors and patients may be hesitant to use an injectable drug, making for a slow launch, says Bernstein Research analyst Geoffrey Porges. Still, he sees global sales of $4.5 billion by 2020.

LCZ696

This heart failure drug could be a new blockbuster for Novartis ( NVS ).

Heart failure is an increasing problem in developed countries, where the populations are aging and waistlines are expanding. In the U.S. alone, 5.1 million people suffer from the condition. Current treatments include diuretics and older drugs known as ACE inhibitors and ARBs. But study data showed a 20% lower risk of death caused by a “cardiac event” among patients using LCZ696, as well as fewer hospitalizations. That gives Novartis leverage with insurers and pharmacy benefit managers regarding reimbursement as well as priority placement on drug formularies, or the lists of prescription medicines that are covered.

Leerink’s Fernandez sees sales of $4 billion by 2020.

Palbociclib

This oral breast cancer drug from Pfizer ( PFE ), also known by the brand name Ibrance, received FDA approval in early February, more than two months earlier than expected.

Designed to block a pair of enzymes to prevent malignant cells from replicating, palbociclib treats a specific form of the disease where tumors feed on estrogen but do not contain the HER-2 protein. Studies showed that for patients whose tumors had spread to other parts of the body, those taking the drug lived more than 20 months without the disease worsening.

“It’s not curative, but it is a meaningful increase in survival over the standard therapy,” says ClearBridge’s Gordon.

Insurers could balk at the price tag, which runs $9,850 for a month’s supply, or roughly $118,000 annually before discounts. Nevertheless, palbocicib is being studied on earlier stage breast cancer patients. Sales could reach $4 billion by 2020, says Leerink’s Fernandez.

Cosentyx

There is no shortage of effective therapies for psoriasis. Still, in January, regulators approved this Novartis drug, which offers a new way to treat the itchy and sometime debilitating skin condition.

Called an interleukin-17A inhibitor, Cosentyx blocks a protein that plays a role in inflammation. In four clinical trials, more than 80% of patients taking the drug saw at least 75% of their symptoms disappear. The drug also prevailed in head-to-head studies with rival medications.

Researchers are studying the drug as a treatment for other autoimmune diseases as well. While doctors could be slow to give up more established therapies, Leerink’s Fernandez predicts sales will hit $1.3 billion by 2020.

Vertex’s combination pill for cystic fibrosis

In 2012, Vertex Pharmaceuticals ( VRTX ) became the first drug maker in more than a decade to launch a new treatment for cystic fibrosis when the drug Kalydeco won regulatory approval. But Kalydeco only works on a small fraction of patients; those who have a specific genetic mutation.

But when paired with the experimental drug VX-809, also called lumacaftor, this new combination medication can also be used on the most common form of the rare and fatal genetic disorder, a group with virtually no treatments.

The FDA is slated to render a decision by July, though doctors may be slow to adopt the new therapy. Eventually, sales could reach $2.5 billion to $3 billion, according to estimates by Bernstein’s Porges.

Full Disclosure

• Bernstein Research has a Market Perform rating on Amgen.

• Bernstein Research has a Market Perform rating on Vertex Pharmaceuticals.

• Bernstein Research has an Outperform rating on Regeneron Pharmaceuticals.

• Leerink Partners has an Outperform rating on Novartis.

• Leerink Partners has a Market Perform rating on Pfizer.

• ClearBridge Investments held 11,297,258 shares of Amgen as of Dec. 31, 2014, according to Bloomberg.

• ClearBridge Investments held 179,590 shares of Regeneron Pharmaceuticals as of Dec. 31, 2014, according to Bloomberg.

• ClearBridge Investments held 10,197,611 shares of Pfizer as of Dec. 31, 2014, according to Bloomberg.

Biotech takeover interest more fad than fashion?

(Reuters) - Investors betting on a wave of big biotechnology deals following Amgen Inc's $10 billion bid for Onyx Pharmaceuticals Inc may well be disappointed.

Shares of companies like BioMarin Pharmaceutical Inc , Seattle Genetics Inc, Ariad Pharmaceuticals Inc, Regeneron Pharmaceuticals Inc, Vertex Pharmaceuticals Inc and Clovis Oncology Inc have all rallied on news late last month that Onyx had spurned Amgen's offer.
Experts in the field agree that the bid, rejected as inadequate by Onyx, confirms a healthy interest in small to mid-cap biotechs, but said it does not raise the likelihood of more deals in the already hot sector.
A major reason is that valuations have gotten very rich, with the Nasdaq Biotech Index up more than 43 percent in the past 12 months. Some of the companies concerned also have existing drug development agreements with larger drugmakers, making takeovers more complicated and potentially more expensive.
"People are being more disciplined and saying, yes I wish I would have bought it for $2 billion a few years ago, but I'm not going to turn that regret into overpayment now," said an M&A lawyer familiar with the industry.
The sector-wide rally, while making it more difficult for larger companies to put together an economically feasible deal, has also eased the pressure on smaller companies who may not be interested in being acquired.
Amgen's takeover interest in Onyx was followed by news last week that Switzerland's Roche Holding AG sought financing to mount a bid for Alexion Pharmaceuticals Inc , sending the smaller company's shares up 10 percent. With Alexion now valued at nearly $22 billion, chances for a near-term deal have been further complicated.
"I don't think this will drive a biotech buying frenzy," said Morningstar analyst Karen Andersen. She noted that whoever ends up acquiring Onyx might also have been the logical buyer of a company like BioMarin, which develops high-priced drugs used to treat rare genetic diseases.
Amgen's move highlights the appeal of oncology companies like Onyx, which sells drugs for liver, kidney and colon cancer in partnership with Germany's Bayer AG. The company's crown jewel is considered to be Kyprolis, a blood cancer drug fully owned by Onyx which was approved by regulators last year.
Alexion sells just one drug, but it is a premium-priced treatment for a very rare disease that Deutsche Bank estimates will achieve peak annual sales of $4.6 billion by 2018.
"I don't necessarily believe this puts every company in play," said Clay Siegall, Chief Executive Officer at Seattle Genetics, which has seen its shares rise 20 percent since mid-June. "There will be more (deals) with time but I don't think it changes the environment."
He said the focus at Seattle Genetics remains expanding use of its lymphoma drug Adcetris. "Right now we are an emerging company ... we have a great trajectory in the future," Siegall said. "I believe that our big shareholders are supportive of that. I don't have any pressure on me to try to run out and do some deal."

FEW REAL BIDDERS
The last major biotech deal was in 2011 when French drugmaker Sanofi SA acquired Genzyme, another maker of medicines to treat very rare conditions, or "orphan" diseases, for $20 billion.
On June 30, Onyx rejected the unsolicited Amgen bid of $120 a share - a premium of about 38 percent to the company's share price. Onyx said it would consider other potential buyers and its shares have since soared nearly 47 percent. On Thursday, sources familiar with the matter said that Pfizer Inc had decided not to pursue a competing bid, leaving Amgen in the pole position for a takeover and shares of Onyx fell back to the $128 range.
The Onyx offer "says more about Amgen than it does about the deal environment," said Sanford Bernstein analyst Geoffrey Porges. "Onyx fits really well with what Amgen needs. Amgen has a scarcity of near term growth opportunities and a surplus of infrastructure."
Onyx is fairly unique in its status as a biotech company on the verge of becoming profitable. "The buyers recognize that and I think they are really going to step up," Porges said.
BioMarin is also close to becoming a profit-making company, but CEO Jean-Jacques Bienaime said earlier this year that he would not consider a buyout offer for even a 25-30 percent premium.
Shares of BioMarin, which topped Morningstar's 2013 list of biotech takeover candidates, have gained nearly 8 percent in the last month. Onyx was No. 4 on that list, which included companies like Seattle Genetics and Regeneron.
Price is a potential obstacle for buyouts of other perennial takeover targets. Andersen said an acquisition of Regeneron - up more than 11 percent in the last month - has become more problematic given the near doubling in its share price so far this year. Sanofi also holds a big stake in Regeneron.
"Most of these companies would be in the high single-digit or low double-digit billions, whereas with Regeneron you are talking a market cap closer to $22 or $23 billion," Andersen said. "Apply a premium to that ... you have a risky proposition."
Ariad, with shares up 11 percent since the Onyx news, has a commercial product, leukemia drug Iclusig, but its revenue potential is comparatively limited. It also has a pipeline of experimental drugs that will require investment.
Others are encumbered by existing development deals with larger companies. Medivation Inc - up 17 percent over the past week - has partnered its promising prostate cancer drug with Japan's Astellas Pharma Inc, while Pharmacyclics Inc - up 18 percent - is developing leukemia drug ibrutinib in partnership with Johnson & Johnson.
"Seattle Genetics is a very rational acquisition target," Porges said. "But the case of Seattle Genetics is nothing like the case of Onyx where Onyx has already got the cash coming in. Turn off the spending and it automatically becomes profitable."
Meanwhile, neither Roche or Alexion have commented on whether they are in discussions, but some analysts have questioned whether such a costly acquisition would make sense for Roche, which is best known for its innovative cancer medicines and diagnostics business.
"We haven't had a rally like this in more than 10 years - where all the stocks go up and the valuations go out the window," said Summer Street Research analyst Carol Werther. "Once this trend reverses it is going to be very, very ugly."

Amgen (AMGN) near $10.5B deal to buy Onyx (ONXX)

SAN FRANCISCO (MarketWatch) -- Amgen Inc. (AMGN) is reportedly near a deal to acquire Onyx Pharmaceuticals Inc. (ONXX) for $10.5 billion. The New York Times reported that sources close to the companies said the deal could be officially announced by Monday. By acquiring Onyx, Amgen would obtain the rights to Kyprolis, a drug used in treating multiple myeloma, as well as revenue from the liver and kidney cancer drug Nexavar. The deal would value Onyx at about $125 a share.

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Onyx (ONXX) Explores a Sale After Rebuffing a Bid by Amgen (AMGN)

Onyx Pharmaceuticals said on Sunday that it is weighing a sale of itself, after having rejected an unsolicited $8.7 billion takeover bid by Amgen last week as too low.

The company said in a statement that Amgen had proposed paying $120 a share in cash, a 38 percent premium to Onyx’s closing price on Friday. The biopharmaceutical drug maker said that it has hired the investment bank Centerview Partners to contact possible suitors.

Big drug manufacturers have shown an appetite for biopharmaceutical companies, hoping to use their specialized products to refill their product pipelines as older offerings face pressure from generic competitors.

Onyx sells or helps sell three cancer drugs, two of which won approval in 2012, broadening its portfolio and making it more attractive to potential acquirers.

Its oldest drug, which it sells with Bayer, is Nexavar, which is approved to treat liver and kidney cancers. Last year, Bayer won approval for Stivarga to treat colorectal cancer. Onyx helps sell that drug in the United States and gets a royalty on global sales.

Onyx also won approval last year for its first wholly owned drug, a treatment for multiple myeloma called Kyprolis.

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“Onyx has tremendous momentum and, with the expansion of our pipeline and two successful product launches, the company and our talented employees have created significant value for Onyx shareholders,” N. Anthony Coles, Onyx’s chairman and chief executive, said in a statement. “We are actively exploring the potential to combine Onyx with another company as an option to create additional value for Onyx shareholders.”

In 2012, Onyx had total revenue of $362.2 million and a net loss of $187.8 million using generally accepted accounting principles. Onyx’s share of the revenue from Nexavar was $288.4 million, about the same as the year before. Sales of Kyprolis, which was approved in July, were $64 million.

While Kyprolis is considered Onyx’s best growth prospect in the near term, a possible hidden gem for the company is that it is entitled to an 8 percent royalty on a drug now being developed by Pfizer that has shown extremely promising early results in treating breast cancer, though more study is needed.

Mark Schoenebaum, an analyst with ISI Group, said the Pfizer drug, palbociclib, could reach the market in 2015 to 2017 and reach global sales of over $2 billion, and perhaps much more.

For Amgen, buying Onyx would expand its reach into cancer drugs, a priority for the company. The world’s biggest biotechnology company by sales, Amgen already sells various drugs for use in treating cancer patients.

But many of them treat side effects of chemotherapy rather than directly attacking the tumor, as Onyx’s drugs do.

Amgen (AMGN) - news

• 12/13/13 : Amgen (AMGN) increases quarterly dividend ~30% to $0.61 from $0.47 per share  112.16 -0.41
• 6/13/13 3:12PM : Amgen confirms FDA approves its XGEVA (denosumab) for the treatment of giant cell tumor of bone (AMGN) 98.28 +1.91 : Co confirmed that the FDA has approved a new indication for XGEVA (denosumab) for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity. The approval of XGEVA is based on positive results from two open-label trials that enrolled patients with GCTB that was either recurrent, unresectable, or for which planned surgery was likely to result in severe morbidity. The overall objective response rate of the 187 patients evaluated was 25 percent. The estimated median time to response was three months. In the 47 patients with an objective response, 51 percent (24/47) had a duration of response lasting at least eight months. Three patients experienced disease progression following an objective response. The safety profile of XGEVA in patients with GCTB was similar to that reported in studies of patients with bone metastases, and also appeared to be similar in skeletally mature adolescents and adults.

US Biotechs to Benefit from Prices and Demand

(DOW JONES NEWSWIRES) The large biotech drug makers will begin reporting first-quarter results next week and should face easier year-over-year comparisons from last year's tough period. Demand is expected to be stronger, and many companies are expected to continue benefiting from price increases on
key products.

Aside from the numbers, a key area of discussion will be the effect of health-care legislation on the industry. The law is largely seen as helping companies by providing coverage to more patients and giving long exclusivity to lucrative biologic drugs.

Aside from the removal of that overhang, analysts warn that the dollar's strength may make overseas revenue growth lower than expected, something that could continue in subsequent quarters.

"We don't anticipate any major beats vs consensus, and on this basis we would not anticipate any of the companies making major revisions to their 2010 guidance this quarter," writes Sanford Bernstein analyst Geoffrey Porges.

COMPANIES TO WATCH:


Biogen Idec Inc. (BIIB) - reports April 20 (AM)

Wall Street Expectations: Analysts expect earnings of $1.13 a share on revenue of $1.12 billion, according to Thomson Reuters. A year ago, earnings were 84 cents a share, or $1.05 a share excluding items, on revenue of $1.04 billion.

Key Issues: Biogen recently cut a deal with activist shareholder Carl Icahn to give him more board representation, but the possibility of restructuring and other changes remains. Current Chief Executive Jim Mullen is retiring this summer, and the company is continues its replacement search. Aside from product sales, Wall Street will be looking at patient numbers for multiple sclerosis drug Tysabri, which Biogen sells with Elan Corp. (ELN) and is key to the growth of both companies. Any additional updates or related news on cases of a rare
brain infection, known as PML, among users of the drug will be notable.

Genzyme Corp. (GENZ) - reports April 21 (AM)
Wall Street Expectations: Analysts predict Genzyme will report earnings of 33 cents on revenue of $1.14 billion. A year ago, the company reported earnings of 70 cents a share, or $1.04 excluding items, on revenue of $1.15 billion.

Key Issues: Few people will focus on Genzyme's quarterly financial performance, as operational issues dominate investor concerns. Meanwhile, Icahn is trying to put himself and three others on the company's board. Genzyme has had manufacturing and regulatory problems stretching back to 2008 at its main production facility, the sole source of its two top-selling drugs. The company
expects a consent decree from the Food and Drug Administration, which probably will add years of third-party oversight to the Allston, Mass., facility. Lumizyme, a long-delayed version of Pompe disease treatment Myozyme produced at a larger scale, should get an FDA decision by June 17, and related comments also could be important.

Amgen Inc. (AMGN) - reports April 21 (PM)

Wall Street Expectations: Analysts predict earnings of $1.24 a share on revenue of $3.65 billion. A year ago, profit was 98 cents a share, or $1.08 excluding items, on revenue of $3.3 billion.

Key Issues: Investors will watch the sales strength of core products, anemia drugs Epogen and Aranesp and anti-inflammatory Enbrel. Amgen sells Enbrel with Pfizer Inc. (PFE) and has given it an increased sales push in recent months.
Investors will focus on the ongoing FDA review of experimental bone drug denosumab after its initial attempt was rejected in October. A decision on the resubmission is expected by July 25. The company plans to file for approval in a second use in cancer patients later this year.

Celgene Corp. (CELG) - reporting April 29 (AM)

Wall Street Expectations - Analysts are expecting earnings of 60 cents a share on revenue of $757 million. A year ago, Celgene reported earnings of 35 cents a share, or earnings of 44 cents a share excluding items, on revenue of $605.1 million.

Key Issues: Celgene's investors will watch for sales updates on flagship drug Revlimid, along with associated insights about market share and duration of usage among patients. Celgene recently held a pipeline review but may provide more insight into plans for expanding Revlimid's approval as an initial treatment and maintenance option for multiple myeloma patients.